Health and Care Bill

Committee (9th Day) (Continued)

20:15:00

Lord Ashton of Hyde (Con)
My Lords, I am a bit reluctant to get up again and say something, because when I did this yesterday, we sat until 3.25 am. The Opposition Chief Whip has asked me to point out that we still have 10 groups to go. Unfortunately, I am speaking mainly to the Front Benches, which have been very co-operative, but we still have 10 groups to go, and the usual channels have agreed between us that this Bill must complete this evening. So I implore noble Lords not only to be brief, as I have said many times before, but to limit their points to those that are relevant to the amendments before the Committee. I know the Front Benches will seek to do the same, so I hope all noble Lords will try to be very brief and to the point. Then we can get through this in a reasonable time.

Amendments 293 to 294 not moved.

Amendment 295

Moved by

295: After Clause 148, insert the following new Clause—
 “Ambulance response times: local reporting
 (1) The Secretary of State must, not later than 31 July 2022, make regulations which require ambulance trusts in England to publish the following information on the internet within two weeks of the end of each month—(a) category 1, 2, 3 and 4 ambulance response times for the trust area for the previous month broken down by—(i) integrated care system area, and(ii) postcode, and(b) for all incidents where the relevant response time was missed by a margin set out in the regulations, a detailed explanation of why that target was missed.(2) In this section—“ambulance trusts” means ambulance trusts whether they are NHS trusts or NHS foundation trusts;“category 1, 2, 3, and 4 ambulance response times” has the meaning given in the NHS England Ambulance Response Programme.(3) Regulations under this section may make such incidental or transitional provision as the Secretary of State considers appropriate.(4) Regulations under this section must be made by statutory instrument and are subject to annulment in pursuance of a resolution of either House of Parliament.”Member’s explanatory statement
 This amendment would require ambulance services to provide more accessible and localised reports of ambulance response times.

Baroness Walmsley (LD)
My Lords, I hope the Government Chief Whip will send the memo round.

Last Tuesday, my noble friend Lady Barker introduced a Question for Short Debate about ambulance response times. In introducing the debate, she looked behind the distressing headlines about people with life-threatening illnesses waiting too long, sometimes fatally, for an ambulance. She outlined the underlying factors important in identifying the problems and solutions for our ambulance services.

The NHS has set out national targets for a seven-minute average response time for life-threatening incidents. However, the average has been rising and was over nine minutes in December 2021. Targets for less serious incidents have also been rising. This amendment would put in place just one of the potential solutions to the ambulance crisis, which my noble friends Lady Barker, Lady Brinton and Lord Scriven referred to in that debate. It would set up a system for ambulance trusts to collect data about ambulance response times by integrated care system and by postcode. They would also have to publish information about where response targets were missed. In any situation that requires corrective action, it is vital that we know where we are starting from, and transparent and detailed data collection and publication does exactly that.

During the debate, my noble friend Lord Scriven suggested that in order to understand why ambulance services are so hard-pressed, we need to look up the line to primary care services. He was, of course, correct: many urgent cases occur because patients have been unable to get a GP appointment, despite the fact that GPs tell us they are now carrying out more consultations than ever through triage telephone consultations.

The problem is caused by the shortage of GPs, particularly in some areas. We have been promised 5,000 more GPs but that has not been achieved. My noble friend also mentioned the lack of community mental health services, and in some cases the almost complete absence of child and adolescent mental health services that often lead to a mental health crisis resulting in the patient calling an ambulance.

Another major issue is caused by problems downstream. Paramedics have to wait outside hospitals to hand over their patients to A&E staff, meaning that they cannot go out to another case. It is incredibly frustrating and demoralising for them. Sometimes paramedics have to leave a serious case in the hands of a family member in order to go to an even more serious case elsewhere. It is well known why ambulances are piling up outside A&E: there are no free beds because the patients already inside cannot be transferred to a bed in the main hospital or discharged. The main hospital cannot discharge patients because of the lack of social care elsewhere, and so it rolls on. These delayed transfers of care are the result of serial underfunding of social care and poor workforce planning. The problems are both upstream and downstream, but we cannot solve all those with one amendment. However, I hope the Minister will accept that collecting and publishing data on a very detailed basis will at least help.

The detail is important. During the debate my noble friends referred to the fact that there is enormous regional variation in ambulance response times. My honourable friend Helen Morgan, MP for Shropshire North, collected a worrying set of data in her very rural area, where four ambulance hubs have recently been closed. Her constituents are rightly horrified about this. Ambulance services in Cornwall have also recently shown unacceptably long waiting times, even for category 1 cases where lives are at stake.

Collecting the data referred to in this amendment would certainly help to identify the specific issues in areas such as these so that action can be taken. It may be harder to serve very rural areas, but residents in those areas deserve as good a service as anyone else. Better data plus better workforce planning, which we are dealing with under another amendment, would ensure that the resources available are adequate to take account of geography and other factors. I beg to move.

Baroness Merron (Lab)
My Lords, I thank the noble Baroness, Lady Walmsley, for presenting this amendment. I too take the view that ambulance services play a significant role in our National Health Service, particularly in the redesign of care pathways to reduce pressure on hospitals and provide better care to patients. If that can be at the right time, in the right place, that produces the greatest benefits.

The amendment in the name of the noble Baroness, Lady Walmsley, sets out the case for a more rigorous and accessible reporting system for ambulance services on response times. As your Lordships’ House debated just last week, and as the Minister acknowledged, at present performance is below what is acceptable. I am pleased that under the amendment, the method for introducing regulations would be subject to proper review by Parliament. On the specifics, it is welcome that there is a requirement of the use of data already captured by ambulance control and dispatch systems, specifically requiring analysis by integrated care system area and by postcode. This would provide a valuable source of further evidence about inequalities in care provisions which would mean that it was possible to identify and address them.

On the proposed requirement for the recording of explanations for all incidents where the relevant response time target was missed, it would of course be important to ensure that any extra recording of data in an emergency care environment did not add to existing pressures. I look forward to the Minister’s response.

Baroness Penn (Con)
I thank the noble Baroness, Lady Walmsley, for bringing this short but important debate before the Committee.

The Government fully recognise the importance of ambulance response times and of patients receiving the help they need when they need it. Like other emergency care services in the NHS during the pandemic, ambulance trusts have come under significant pressure, answering almost a million 999 calls in December alone —an increase of 22% on the year before. That is why we have put significant support in place to help ambulance trusts at this time. I will not go into the detail, which we covered in the debate last week. Instead, I will respond to the specifics of the amendment.

It is the Government’s view that it is right that reporting happens at the level of ambulance trust region. Trusts are commissioned to meet response time targets at a regional level, not at a more granular part of their operating area such as postcode or integrated care board area. It is inevitable that there will be variations in response times within regional footprints from month to month. However, the existing ambulance response time standards already include a mechanism to performance-manage significant variation or long waits for ambulances. All ambulance response time categories include a 90th centile response time standard to measure the “tail” of ambulance response times. This means that trusts are measured on the response to every call they receive and cannot favour some parts of their region over others to game response time targets. Reporting response times down to a postcode level would require a massive expansion to existing reporting that would not be reasonably deliverable.

I also reassure noble Lords that the service transparently provides clinical outcomes data. These indicators were introduced in 2011 and provide detailed information on clinical outcomes for cardiac arrest, heart attack, sepsis and stroke patients. While the Government acknowledge the challenges to ambulance response times and are working hard to address them, for the reasons I set out, I hope the noble Baroness feels able to withdraw her amendment.

Baroness Walmsley (LD)
I thank the noble Baroness, Lady Merron, and the Minister for their responses to this proposition. I still think that somewhat more granular collection of data would be really helpful, because a region is a very big area and there are all kinds of factors that affect how quickly ambulances get to people who need them. It is particularly important in the case of category 1 incidents, where life is at stake and interventions can have the most amazing results, if only they get to the patient within 40 minutes, say, in the case of stroke.

So, it is vital that we get that granular information. I accept what the Minister said about the additional money that has been provided, but as I and my noble friends have said, the problems are both sides of the ambulance: downstream and upstream. It is a systemic problem, and it needs to be looked at as a whole. Having said all that, I beg leave to withdraw the amendment.

Amendment 295 withdrawn.

Amendments 296 to 297E not moved.

The Principal Deputy Chairman of Committees (The Earl of Kinnoull) (CB)
My Lords, in the next group of amendments, the noble Baroness, Lady Brinton, will be participating remotely.

Amendment 297F

Moved by

297F: After Clause 148, insert the following new Clause—
 “References to women inpatients
 (1) An NHS Trust must not record or refer to women who—(a) have requested a sex-specific ward, or(b) have made a complaint to the relevant NHS Trust about being accommodated with inpatients who have undergone gender reassignment,in pejorative terms, including the term “transphobe”, on that ground alone. (2) An NHS Trust must not record women who have undertaken the action referred to in subsection (1)(a) or (1)(b) as having committed a non-crime hate incident on that ground alone.”

Baroness Nicholson of Winterbourne (Con)
My Lords, the noble Lord, Lord Blencathra, and I have grave concerns about the present single-sex ward provision which our two amendments seek to obviate. I have had the opportunity already to discuss this with the Minister himself—the noble Lord, Lord Kamall—and I am grateful for the opportunity he gave me also to meet with his officials. None the less, these two amendments address the very sensitive issue of hospital bed space allocation and hospital service provision for women.

Traditionally, female patients in the NHS and in private hospitals have been allocated beds in single-sex wards accommodating only women patients. Transgenderism —I speak as a woman—has undermined that provision, with the 2019 NHS guidance authorising self-selection of patient gender on arrival in hospitals, something neither enshrined in law nor backed by public demand, and overriding the exemption for hospital services in the Equality Act 2010. Yet Parliament and our Ministers have consistently declared that women both need and should have privacy, dignity and safety in their most vulnerable of situations, such as when sick or pregnant. As consistently, Ministers on all sides of both Houses have declared that this will be or already is the case.

20:30:00

In 1999, for example, when serving in the other place, the then Health Minister, the noble Lord, Lord Hutton of Furness, responded to powerfully expressed concerns from the Member for New Forest East about female privacy by guaranteeing single-sex wards and enshrining that promise in the Patient’s Charter. Later, when the NHS constitution replaced the Patient’s Charter, the same firm commitments were made. Today, nurses, whose code of practice ensures that all patients have their privacy respected and dignity and safety assured, should have a simpler task in ensuring that these truly fundamental responsibilities to all patients are fulfilled, since the old Nightingale wards, in which sex segregation was much needed, really do not exist in the present NHS hospitals, where there is a mixture of single rooms and four-to-six bed bays. It is therefore easier for ward sisters to keep the sexes apart, rather than having mixed-sex bays, which give rise to discomfort for female and male patients alike.

None the less, female patients consistently find that the reality of mixed-sex wards has won through against the Aesculapian tradition of prioritising patient care on medical grounds alone. We now find that the earlier guarantees of the safety, dignity and privacy of women are blown apart up and down the country by hospital trusts, which are mandated to follow annexe B of the NHS 2019 guidance on same-sex accommodation. I have found too many errors and wrong quotations of the Equality Act to feel comfortable with this guidance and its annexe B. While the guidance demands same-sex wards for 11 pages, saying that,

“Providers of NHS-funded care are expected to have a zero-tolerance approach to mixed-sex accommodation”,

it then contradicts itself on page 12, saying:

“Trans people should be accommodated according to their presentation: the way they dress, and the name and pronouns they currently use”.

These two requirements are not only incompatible; they are irreconcilable and do not follow the Equality Act.

A staff nurse told me that her NHS trust policy makes it impossible for her to do her job. She is obliged to advocate for the vulnerable, but trans rights supersede all other rights and concerns, and if she speaks out, she is challenged. A cervical smear test of a 14 year-old whose mother requested a female nurse could not be done. The child left because it was very clearly a natal male who came forward to offer the service.

Nurses tell me that they feel inhibited in doing their jobs and are afraid to speak out for fear of being called bigots or disciplined through loss of their job. I have met several nurses who have lost their jobs because of this. Surely, human rights are about the dignity of each person; they are not the privilege of the few to the detriment of the many. A doctor told me that he no longer feels able to make comments about sex and gender. He recently delivered a baby, said it was a girl, and was accused of transphobia. In fact, hospital services are excluded from the Act, and in any event, mixed-sex bathing and toileting facilities are precluded both by the nursing code and by the NHS constitution handbook, as are mixed-sex wards, except under exceptional medical need and at the patient’s request. However, that same premise is discarded if a male patient self-declares as a woman. He then has access to all the female toileting facilities, for example.

Turning to patient safety, recently, on a respiratory care ward, a male patient got into the bed of a female patient. The woman was so distressed that she refused to wear the necessary breathing apparatus in case it stopped her being able to escape a similar situation. On a mixed-sex ward, a male nurse, now serving a prison sentence for the offence, violently raped a female patient.

It is axiomatic that in any hospital setting, patients are at their most vulnerable and NHS medical professionals take great care to avoid any extraneous stress. It is therefore puzzling as to why the NHS has chosen to prioritise mixed-sex wards or bays, assigning beds in female spaces as a matter of right for patients who are in the gender-transition process, when the physical and the psychological diverge, or who may have completed transition but none the less can never recover their prepubertal undeveloped strengths. It is surely obvious that prostate cancer patients remain male and that loss of breasts in women cancer patients does not remove their womanhood.

Of course, there are voices which claim that sex is assigned at birth, when it is noted and recorded, and that sex can be changed through a mix of operations and continuous hormonal drugs. I do not hear the NHS making that claim, and since in our society we follow the science—here in our House the noble Lord, Lord Winston, has made that very clear—we must conclude that, so far, the NHS cannot change a patient’s sex. My argument rests on that assumption.

In common with traditional practices, which affect all faiths, ethnic backgrounds and historic behaviour patterns, our amendments request a restoration of earlier female patients’ safety, privacy and dignity, the core purpose of single-sex wards or bays. I conclude that the NHS has taken a wrong turning on this issue, since its own policy is to provide same sex accommodation, and since Parliament chose to make hospitals exempt from the service provisions of the Equality Act—a decision which has not, to the best of my understanding, been reversed in either House of Parliament. It is my contention that this policy profoundly disadvantages women in the entire NHS hospital setting.

Of course, the gender bias adopted by the NHS reflects mainly males in women’s settings, and recently the Equality and Human Rights Commission has announced that it will be publishing—very soon, I believe—a paper on this issue, and we wait for that. Its current guidance discusses service provision and reminds us that male transgender patients are not deprived of hospital service provision; it is simply that they should not be placed with women. They can easily also be placed away from male wards that may disturb them, perhaps in side rooms, so that all have equal access to services, and all will be treated with dignity, privacy and safety. Non-placement on women’s wards does not in any way undermine this. It also reiterates the balance of rights, and the need to ask patients their preferences. This does underline the need for a review, with women’s voices and a full equality assessment.

Of course, we must ensure that all voices are heard, and for that purpose I have set up a working group of trans persons to clarify what rights they see as missing or underfunded. I hope to present the results to the Minister to add to his department’s body of knowledge.

I end by saying that language is very important. A parent wrote to me today:

“It is only since becoming the mother of a disabled child that I realise quite how nefarious the ‘wrong body’ narrative is”—

that is another part of this argument.

“If someone can be born ‘wrong’, that implies there are inherently right and wrong types of people. History has surely taught us that this line of thinking never ends in a happy place. Like you, I believe that all children, whatever their circumstances, are born perfect and deserve to be treated with respect and love.”

At the core of human rights, which must be the foundation stone of her argument, is the concept of human dignity. Bodily integrity is closely related to dignity and autonomy, and has been described by Hale LJ—now the noble and learned Baroness, Lady Hale—in her judgment as

“the most important of civil rights”

and

“the first and most important of the interests protected by the law of tort.”

Bodily integrity is protected by Article 3, freedom from torture and inhuman or degrading treatment, and by Article 8, respect for private life, of the European Human Rights Convention. Other groups—women and persons with disability—enjoy special protection. Language matters: it leads to human action, and whether that be good or bad for us comes from the language in which our views are expressed. Humiliation, separation and degradation of others all stem from the language used to describe a group or an individual. “Cis woman” is as unacceptable as “wrong body”. Both degrade the individual.

The National Health Service is magnificent—I speak as its former global special envoy—but it cannot always be perfect. I urge the Minister to set up a review of language and actions used to sustain the safety, dignity and privacy of all patients—especially, in this context, women. I beg to move.

The Principal Deputy Chairman of Committees (The Earl of Kinnoull) (CB)
My Lords, the noble Baroness, Lady Brinton, is participating remotely, and I invite her to speak now.

Baroness Brinton (LD) [V]
My Lords, I will speak against Amendments 297F and 297G, spoken to just now by the noble Baroness, Lady Nicholson. One incident last week explains why they are dangerous and unnecessary. A woman, whom I will not name, was in hospital said the following on Twitter:

“This is incredibly hard to say, and I couldn’t feel more foolish, embarrassed, awkward and dumbfounded as I do now, but it’s been confirmed that the person I believed to be male on the hospital all female bay I was on, was … in fact, a female. This has been 100% verified … I have no words other than how on earth did I mistake a woman for a man? Delicately and with respect I say she was a very emasculated woman and I’m just totally stunned right now at the mistake, my mistake… and am … mortified that I took to Twitter utterly convinced that the woman who looked and sounded like a male, turns out to be quite genuinely a female. I apologise for causing a storm and will take some time off here while I let it sink in. I cannot understand how I got it so wrong … I feel a complete idiot.”
 

The problem is that these two amendments feed into the conspiracy movement against trans people and prey on vulnerable women such as this who believe that there is a problem. The fear inculcated by the gender-critical movement means that she felt entitled to aggressively call out a complete stranger minding her own business in her own hospital bed, in case she was a trans woman. Yet the reality is that there is absolutely no evidence whatever of trans people causing problems on single-sex wards. All the examples of assault given by the noble Baroness, Lady Nicholson, were by men, not trans women.

What is more, trans people, just like people who are not trans, have a right to privacy and dignity in hospital, just like everyone. Imagine if the patient who had been aggressively called out by this woman had been a trans woman. Is that sort of behaviour towards someone ill in hospital in any way appropriate? Of course not.

Amendment 297F, also in the name of the noble Lord, Lord Blencathra, sets out how to record instances where people complain about trans people simply on the basis that they are trans. Such behaviour may be part of a pattern of behaviour that may result in risks to any patient who is trans, visibly gender non-conforming or, as in this case, a woman. Not allowing the recording of such incidents may then place the NHS trust at risk of failure in its duty of care if something subsequently happens between the two parties.

The noble Baroness, Lady Nicholson, started to outline the definition of “harassment” under the Equality Act: “violating” a person’s “dignity” or

“creating an intimidating, hostile, degrading, humiliating or offensive environment”.

The amendment would only restrict recording of incidents involving trans people—not other gender non-conforming people. As such, it would be discrimination because trans people would be prevented from having discriminatory actions against them recorded, while everyone else would not be so prevented.

Amendment 297G flies in the face of current hospital practice. The NHS already has policies relating to where trans people should be housed, which reference the types of treatment required and the requirement for respecting the privacy and dignity of the trans person, alongside the privacy and dignity of all other patients too. This amendment would overrule those policies and therefore override the privacy and dignity of trans patients. It would clearly breach basic human rights legislation. And, by the way, trans people may require medical treatment for conditions relating to their lived-in sex: trans women may get breast cancer, for example. Requiring them to be housed in different accommodation could mean that the specialist nursing care required for their recovery may not be available.

But there might also be an unintended consequence of this amendment. If trans people know that they will be housed with people of their birth sex, rather than of their lived and legal sex, many will avoid going to hospital altogether, leading to many having increased and dangerous health complications. This could be potentially life-threatening, which is implicit discrimination under the Equality Act.

As the recent incident highlighted on Twitter shows, there actually is no real problem to be solved, and all that these amendments do is seek to demean and ostracise trans women in our society. I hope that the Minister will not support them.

20:45:00

Lord Sandhurst (Con)
My Lords, I speak in support of Amendment 297G. This will give much-needed statutory force to what has been long-stated NHS policy, but which has not always been properly implemented. This is why we will demonstrate why current guidance is equivocal upon it. I hasten to add that I am not a conspirator against trans people—I make that absolutely plain. I resent the suggestion that those speaking in support of this amendment might be thought to be.

The current NHS guidance, which goes a long way back historically, as we have heard, is in these terms:

“All providers of NHS-funded care are expected to prioritise the safety, privacy and dignity of all patients”—
 

we all agree with that. It continues:

“Adherence to this guidance is an essential part of this.”
 

It then goes on to talk about mixed accommodation:

“What is a mixed-sex accommodation breach? … Patients should not normally have to share sleeping accommodation with members of the opposite sex. Patients should not have to share toilet or bathroom facilities with members of the opposite sex. Patients should not have to walk through an area occupied by patients of the opposite sex to reach toilets or bathrooms; this excludes corridors.”
 

This is what hospitals should be doing. In particular, I ask your Lordships to note the terminology and the use of the terms “mixed-sex” and “opposite sex”. Sex, we all know, is physiological; it dates from conception and is not assigned at birth or at some later date. The definitions of man and woman in Sections 11 and 212 of the Equality Act refer to sex, not gender. Further, Part 7 of Schedule 3 of the Equality Act provides at paragraph 27:

“A person does not contravene section 29 … by providing a service only to persons of one sex if … the service is provided at a place which is, or is part of … a hospital, or … the circumstances are such that a person of one sex might reasonably object to the presence of a person of the opposite sex.”
 

Hospitals are free to do what they wish and to prioritise single-sex wards. However, in contradiction to the law, physiology and the primary guidance to which I have referred, annexe B of the guidance provides:

“Transgender … is a broad, inclusive term referring to anyone whose personal experience of gender extends beyond the typical experiences of their assigned sex at birth.”
 

We are moving from sex to gender, and it is premised on a scientific flaw. Building on that error, it continues:

“If patients are transferred to a ward, this should also be in accordance with their continuous gender presentation (unless the patient requests otherwise).”
 

The guidance is not saying that they should be put somewhere safe or separate but that they should go to the ward that they wish. If they say a women’s ward, they go to a women’s ward. That is not what Secretaries of State have said and not what has been policy for 20 years, and it departs from the primary guidance. I submit that it is wrong—and I am sure noble Lords will all agree. It discriminates against women who do not wish to be in the presence of someone who is an intact male, as some trans people will be.

Amendment 297G is perfectly reasonable and absolutely right, and I urge noble Lords to adopt it.

Lord Blencathra (Con)
My Lords, I support the amendments in the names of my noble friend Lady Nicholson of Winterbourne and myself. I pay tribute to her for raising this issue of vital importance to women, and for being their champion over many years in the face of some bitter attacks from a minority of trans zealots.

I must say to the noble Baroness, Lady Brinton, that I resent the implication that somehow we are attacking trans people in these amendments. There is no conspiracy against them; we want equal treatment for everyone in the NHS. If there is any conspiracy it seems to be to demean the status of women. I also say to her that, yes, if these amendments were accepted, NHS policy would have to change to comply with the law of the land—the Equality Act 2010—because it is in breach of the exemptions in that Act at the moment.

As we all know, there is no real privacy in hospitals, however hard they may try. If one ties that funny gown the wrong way, like a dressing gown, one’s front is exposed; if one ties it properly, the rear is exposed. Even when one is recovered and wearing pyjamas or female bed attire, it is impossible in a hospital to carry out the routine of getting into and out of bed, and using the washing and other facilities, without some part of one’s anatomy being exposed. Many patients neglect to close or lock washroom doors. Some with mental health problems may express sexual disinhibition. When doctors come round and pull the screens around the bed, of course, there is still the discussion of one’s condition and the medical profession’s obsession with bowel movements, as we all know about.

I am old enough and ugly enough not to care what parts of my body medical professionals see. They have all poked, prodded and cut out various bits of it over the years so I am reasonably immune to embarrassment with them. However, I would find it highly embarrassing if I found a woman, or a man declaring as a woman, in the next bed and encountered her in the ablutions. Of course, it is highly unlikely that I would meet a woman since an infinitesimally small number of women identify as men, but many more men identify as women.

All my life, there has been an NHS policy of single-sex wards and Governments of all colours have been slammed on those occasions when men and women were sharing hospital accommodation. The policy is that patients should not have to share sleeping accommodation, nor toilet or bathroom facilities, with members of the opposite sex. The operative word is “sex”—biological sex, not gender.

Since we are speaking about women, sex and hospitals, I will put some astonishing medical information on the public record which has resulted in some women being sacked or abused for saying it. I stand to be corrected by medical experts present. I believe that only women can give birth to children, since only women have wombs. No matter what one declares one’s gender to be, only men get prostate and testicular cancer. Only women can breastfeed their children and men who have chests cannot. The sex of babies is not assigned at birth. Babies are born as boys or girls, and that includes those born with those rare congenital disorders of sexual development. No one decides to assign male or female to a baby; they are born that way, so that is why the term “sex assigned at birth” is so offensive.

In the course of daily life, working in most jobs or going to the pub et cetera, sex and gender do not matter and one can call oneself what one likes. But when it comes to medical treatment, two vital factors can determine the diagnosis and that treatment. These factors are age and sex. Sex is the only thing which matters medically, not gender, and that was always the case until the mistaken guidance issued in September 2019. The NHS always recognised that single-sex accommodation was essential not only for a patient’s privacy and dignity but for their treatment and recovery. Doctors recognised that patients in distress for whatever reason cannot recover as easily as those who are comfortable in their surroundings, and who are not fearful of people of the opposite sex seeing their body at a time when they are at their most vulnerable. That is why the NHS guidance stated in absolutely unambiguous terms:

“There are no exemptions from the need to provide high standards of privacy and dignity at all times”.
 

As my noble friends have pointed out, it all went haywire in annexe B of the guidance, which failed to implement the Equality Act 2010 and said that trans people should be accommodated according to their self-identification, which the guidance says

“may not always accord with the physical sex appearance of the chest or genitalia”.

It goes on to say that

“pre-operative transgender people should not share open shower facilities.”

I am sure that Jewish or Muslim women find it immensely reassuring that they can be in a shower with a man, so long as he has had some operation on his genitalia.

This is the advice I received from a Jewish expert in medical ethics. The religious requirements of Orthodox Judaism mandate single-sex facilities for both men and women where people are likely to be in a state of even partial undress. This includes the requirement for single-sex hospital wards, bathrooms and changing rooms. The distress, both psychological and spiritual, that is likely to be caused to Orthodox Jews if they are forced to share facilities with members of the opposite sex is considerable, as is the impact on the patient’s family. Orthodox Jews are protected under the Equality Act on the basis of their religious belief. It would be wholly unacceptable if an Orthodox Jewish woman were to be counselled by NHS staff into accepting the presence in the bed next to hers of a male patient who identifies as transgender. That is the advice I have received on Orthodox Judaism. I do not know, but I assume that the requirements of Islam are similar.

The needs of these women should apply to all women, whether religious, atheist or pagan, and not just those with particular religious beliefs. What is wrong with NHS guidance Annex B is that the Equality Act 2010 specifically exempts hospitals and the provision of joint services where a joint service for persons of both sexes would be less effective and in circumstances where a person of one sex might reasonably object to a person of the opposite sex.

I say to the Minister that the law is clear: women have the right to be kept in hospital accommodation with only other women. One of course exempts intensive care units, where patients are unconscious or nearly unconscious; their medical treatment is best served by all being in the same specialist unit together. I call on my noble friend the Minister to withdraw this flawed guidance on transgender patients and instruct the NHS to comply with the law of the land.

I will say a brief word on Amendment 297F. I have read the reports that some NHS trusts have logged women as transphobic, when all they have done is request single-sex accommodation and not to be in a bed next to a man who identifies as a woman. There are a few reports of this. It is nothing to do with anyone on Twitter posting a rant about some hateful person next to them; it is ordinary women saying, “Please can I be in a room where I do not have a man next to me?” It is as simple as that. I am told they are recorded as being transphobic, merely for making that request.

I asked my noble friend, in a Written Question, what evidence he has of this. He said that unfortunately —or fortunately—the NHS does not collect this information centrally; it is left to the trusts. I accept that, but I would like my noble friend to issue an instruction to all NHS trusts that it is perfectly legal for a woman to make this simple request and that she must not be stigmatised as transphobic for asking. That is completely separate and quite different from anyone who makes racist, offensive, threatening or genuinely hateful transphobic remarks.

There must be no discrimination against trans people in hospital or discrimination against anybody. Our amendment makes it clear that trans people must receive equal medical treatment, but that does not mean that their gender identity wish must be accommodated over and above the wishes of people of the opposite sex. If there were a finely balanced conflict of rights here, I would take the view that those demanding it is their right that their gender identify should take precedence over women’s sex are wrong and the rights of women should prevail. But there is no fine balance here. In my opinion, the NHS is breaking the Equality Act 2010, and I request that it obeys it as soon as possible.

Lord Hunt of Kings Heath (Lab)
My Lords, I want to ask the Minister a brief question. The contention is that there is a tension between the NHS England guidance on single-sex wards, which is eminently sensible, and Annex B. I would be grateful if the Minister could respond on that specifically. In particular, he knows that under Schedule 3 to the Equality Act, on single-sex services, to which the noble Lord referred, it is permissible for the NHS to provide separate accommodation for women who are biological females. But my reading of Annex B is that it excludes that option. Again, I ask the Minister for the Government’s view on this.

My main reason for intervening is to say this. Surely there is a case now for a government review of the guidance. The Minister will know that the Equality and Human Rights Commission will shortly be updating its guidance on single-sex services. Clearly, it would be very sensible to review the NHS guidance in the light of that. An assurance that this will happen would be very appropriate.

21:00:00

Lord Clement-Jones (LD)
My Lords, I support the noble Lord, Lord Hunt, in his very reasonable request for the Minister to confirm that a review will take place.

I remember that some 20 years ago I was challenging the noble Lord, Lord Hunt, when he was Health Minister. The pledge for single-sex wards had been made by his predecessor, the noble Baroness, Lady Jay. It was a very slow road towards single-sex wards. Reading Annex B, it seems that, suddenly, we are in a completely different place—the goalposts have been moved. I do not quite understand who was consulted about Annex B and where we go from here, in the face of completely different wording in the main guidance from the annex itself. How can one reconcile the gender-friendly Annex B with a single-sex broad pledge in the main guidance? At the very least, there needs to be a review of what exactly the regime is that we want to support? I entirely agree with noble Lords who believe that anyone who raises this issue should not be labelled in one way or another.

I was particularly concerned to see that, effectively, if you classify yourself as non-binary you can choose to go into a ward of any sex. I do not know that I see that in any equalities legislation or human rights legislation. That seems to me to be the hardest point. I cannot understand quite why that has appeared.

No purpose is served by lurid examples of this, that and the other. As a lawyer, I know that hard cases make bad law but, at the very least, the conflict between the main guidance and Annex B must be resolved in one way or another, clearly, and probably with parliamentary approval. It must conform with equalities legislation, and I hope that the Minister pledges to take that forward.

Lord Berkeley of Knighton (CB)
My Lords, I always enjoy listening to the noble Lord, Lord Blencathra, because he has an absolutist way of delivering his ideas. But his ideas here have prompted other noble Lords to a very sensible suggestion that we need to look further at this.

We have to look at this question with great compassion —compassion for women who feel uncomfortable and compassion for women who are trans. We all know that, sometimes, people are born with mixed chromosomes. It is not black and white. It is a very complex issue. The suggestion of the noble Lord, Lord Hunt of Kings Heath—I see the noble Lord, Lord Blencathra, nodding —must be the right way forward. It needs to be looked at with great care and in great detail, by people who know what they are talking about.

Lord Lucas (Con)
My Lords, I very much agree with the noble Lord, Lord Hunt, and others. I was here for 20 years during the struggle for single-sex wards, and it was a notable achievement of the Benches opposite that they got there. I remember, in those long debates, getting a real understanding of the distress that women felt at being made to suffer in mixed-sex wards. I do not think it is right to destroy all that just in the cause of a small group of patients.

The rights of women need to be considered alongside those of trans people. Both matter, both are important, and we should not, as Stonewall has sought to do, bend the law to impossible interpretations and impose that covertly on the National Health Service. We should try openly to discuss this difficult issue and arrive at a compassionate solution that does our very best for all patients. I have faith that if the Minister promises that, we will get that.

Baroness Barker (LD)
My Lords, the noble Lord, Lord Hunt, used the important word “contention”—a contention that there is a tension between the rights of women and those of trans women. He and I disagree about that because I believe that they both deserve to be treated properly and respectfully. I believe that the Equality Act enables that to happen.

It is that Act which enables there to be single-sex provision. It is precisely because there are occasions and times when it is important for that to happen that we have to embody it in law, otherwise it could not exist. That is why under the Equality Act there is a specific statement that there should be safeguards in place, that there are special circumstances where treatment needs to be sex-specific, and that where it is assessed that a trans person should be put in an otherwise gendered ward, such departures are allowed but they need to be proportionate to achieving “a legitimate aim”. Like my noble friend Lady Brinton, I do not believe that making assumptions about a person because of the way they look is a legitimate aim.

I have listened carefully to all the speeches that have been made, and they have contained some very powerful contentions and assertions. What they have not contained is any evidence at all that this is a significant problem in the NHS. The amendments would cause a significant problem in the NHS—for all patients, not just trans patients, if one thinks through the implications of what has been written in them.

Day to day, NHS staff routinely have to deal with patients of all sorts, with all sorts of difficult problems, and as professionals they make judgments day in, day out about what is appropriate care. Unless and until there is significant evidence that backs up the assertions and contentions of the noble Baroness, Lady Nicholson, and the noble Lord, Lord Blencathra, I believe we should leave them with the guidance that has worked perfectly well up till now.

Baroness Jones of Whitchurch (Lab)
My Lords, I intend to be brief because we do not believe that these two amendments are either necessary or appropriate in the context of the Health and Care Bill. If the Equality and Human Rights Commission is conducting a wider review into single-sex services then we should consider those issues at that time, but not in the context of this Bill.

I agree with the noble Baroness, Lady Brinton, that the Equality Act 2010 and the 2019 NHS guidance Delivering Same-Sex Accommodation already provide an effective mechanism for inclusion in the context of single-sex wards. The two amendments seek to cut across long-standing provisions in both the Act and the guidance. There is no substantial evidence to suggest that the status quo is not working and that NHS professionals are unable to use the existing guidance, which clearly sets out the principles and practice to be followed.

We also consider that the amendments could do harm if implemented, because they would create a blanket rule requiring trans women to be treated on men’s wards and trans men to be treated on women’s wards. At best, that would create an environment contrary to the dignity and well-being of the patients. At worst, it would leave trans patients at the risk of harm and abuse by outing them in a public context at a time when they are particularly vulnerable.

Like other noble Lords, we have received a detailed briefing from Stonewall imploring us to oppose these amendments. Given that we do not consider that the Bill is the right place for the consideration of these issues, we will not be lending our support to the amendments.

Lord Kamall (Con)
My Lords, I am grateful to my noble friend Lord Blencathra for bringing this discussion before the Committee and to my noble friend Lady Nicholson for taking the time to meet to discuss this issue, on which she is a strong advocate.

It clearly arouses strong feelings, but it is really important that we remember two principles: dignity and respect. There are people who feel they were born in the wrong body, and we should respect their rights as trans men or trans women; at the same time, there will be some women in wards who, on seeing someone who, to them, seems like a man, may feel slightly vulnerable at a particularly vulnerable time—in hospital. It is right that we get the right balance.

I hope noble Lords will be aware that NHS England is currently reviewing the Delivering Same-Sex Accommodation guidance to ensure that it remains focused on privacy, safety and dignity for all patients. The NHS is committed to meeting its duties under the Equality Act and, as such, needs to give due regard to both those whose gender identity is the same as their biological sex at birth and those whose gender identity is not. This means that the rights and needs of women and trans women are equal in law.

Following the review, the new content of the guidance will be informed by engagement with a wide range of stakeholders and by the statutory duties of the NHS outlined in the Equality Act 2010, including the public sector equality duty. NHS England is currently under- taking this review and is fully aware of its importance. The guidance, which will be updated if appropriate, is due to be published later this year. I call on noble Lords not to pre-empt the outcome of the guidance review. Any guidance will—indeed, must—be compatible with the requirements and duties placed on NHS bodies by the Equality Act 2010.

I am aware that concerns have been raised about the safety of women in single-sex wards. We, as a Government, believe that violence of any kind has no place in NHS facilities. We expect that hospital staff will act in the best interests of all patients and can, if necessary, call on security staff and law enforcement to ensure that everyone is safe. I repeat my request to my noble friend Lady Nicholson for evidence of such cases, whether it be women who feel uncomfortable or patients or staff who have raised concerns and been accused of being transphobic. If that is the case, I ask her to bring these cases to my attention and we can look at them further.

However, given that NHS England is currently reviewing the guidance, I hope noble Lords can appreciate the need to allow it time to review it in full. I ask the noble Baroness to withdraw her amendment.

Baroness Nicholson of Winterbourne (Con)
I thank the Minister very much for his immensely helpful statement, while reminding him that the rights of another group do not supersede the rights of the group that is already there. In other words, it is not really worth listening to the simple comment, “Women and trans women are equal”. We are all equal under the law; we all have dignity and equal rights. My contention is that the dignity, privacy and safety of women patients, which have been fought over for several decades in both Houses, are now being diminished significantly and their health and recovery from illness significantly undermined by the imposition of new rights of others on top of women’s rights. It amuses me that no one is suggesting they should be on top of men’s rights.

This is, I am afraid, a matter of great concern to all women. I know that Members of other Benches have demanded evidence. I can guarantee that, within 24 hours, if you wish it, I can get 20,000 to 40,000 letters in front of the Minister claiming that women need privacy, safety and dignity, and that they are not receiving it with these new impositions. If noble Lords want evidence, feel free.

21:15:00

I deliberately did not raise the case the noble Baroness, Lady Brinton, has seen fit to raise, of the lady on Twitter. I know her, she has many problems. I know exactly who she is, her name and where she lives. She has invited me to visit her, and I probably will. I know that she has problems and therefore I have persuaded her to get off Twitter and not to cause herself any more distress. She is very poorly, and I do not think that was a fair person to bring up.

I thank the Minister immensely. I fully accept his offer that we will be having this review, but I ask that we are all involved in it. I know that women have not been involved in the earlier discussion that produced this extraordinary annexe B. I withdraw the amendment.

Amendment 297F withdrawn.

Amendments 297G to 297K not moved.

Amendment 297L

Moved by

297L: After Clause 148, insert the following new Clause—
 “Mandatory training on learning disability and autism
 (1) In regulation 18(2) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (S.I. 2014/ 2936), for sub-paragraph (a) substitute—“(a) receive—(i) such appropriate support, training, professional development, supervision and appraisal as is necessary to enable them to carry out the duties they are employed to perform, and(ii) in particular, specialist training in person on learning disability and autism, appropriate to their role, as set out in the code of practice issued by the Secretary of State under section (Mandatory training on learning disability and autism) of the Health and Care Act 2022.”(2) With regard to specialist training on learning disability and autism, the Secretary of State must prepare and publish a code of practice (“the code”) containing guidance addressing—(a) the content of mandatory training and its co-production,(b) the appropriate levels of training required across staff roles,(c) the co-delivery of training,(d) the accreditation of training,(e) the procurement of training,(f) the monitoring and evaluation of the impact of training, and(g) the implementation of mandating of training across regulated health and social care providers.(3) The code must incorporate—(a) the most recent Learning Disabilities Core Skills Education and Training Framework (or its successor framework, regardless of its name),(b) the most recent Core Capabilities Framework for Supporting Autistic People (or its successor framework, regardless of its name),(c) the autism strategy published under section 1 of the Autism Act 2009, and(d) recent guidance issued in accordance with section 2 of the Autism Act 2009.(4) The Secretary of State must seek the participation of and consult such persons and bodies as they consider appropriate—(a) in preparing the code,(b) in incorporating the relevant publications as set out in subsection (3), and(c) in revising it. (5) The Secretary of State may not issue the code or any revision unless a draft has been laid before and approved by a resolution of each House of Parliament.(6) The Secretary of State must review the code every three years and lay their findings before Parliament.(7) In this section—“appropriate to their role” has the meaning given by the code;“autism” means a spectrum of disorders which start in childhood, the clinical manifestations of which include atypical social communication and social interaction and restricted, repetitive patterns of behaviour;“in person” means training delivered by people in the personal presence of the trainee and not by electronic or digital communication;“learning disability” means a disability which includes a significantly reduced ability to understand new or complex information or to learn new skills, with a reduced ability to cope independently, which started before adulthood, with a lasting effect on development;“specialist training” means training co-produced and co-delivered in person by persons who themselves have a learning disability or autism, or are a family member of someone who has a learning disability or autism, and that is accredited, in conformity with the code.”

Baroness Hollins (CB)
My Lords, Amendment 297L seeks to introduce mandatory training in learning disability and autism for all health and care staff. My noble friend Lady Bull is unable to be in her place tonight but asked me to express her strong support for this amendment.

The amendment is important because of the sheer scale of health inequalities that people with a learning disability and autistic people face. According to NHS England, people with learning disabilities have a median life expectancy 20 to 30 years shorter than those without a learning disability. In 2014, the Confidential Inquiry into Premature Deaths of People with Learning Disabilities found that 37% of those deaths may have been avoidable with better-quality healthcare.

There are a number of obstacles to achieving better outcomes. These include the low confidence of health and care professionals in their ability to identify and treat serious illness in these groups. The amendment aims to increase their knowledge and skills so that they can provide equitable care for people with learning disabilities and autistic people.

For many years the Government’s view was that mandating standards for training was not needed and that awareness raising should be enough, but then 18 year-old Oliver McGowan died—another tragic and wholly avoidable death of an autistic man with a learning disability. I could name so many grieving families who hope for some justice for their sons and daughters—families who hope that no other family will have to go through what they did. Oliver’s mother, Paula McGowan, is one determined lady and she persuaded the honourable Caroline Dinenage, then Minister of Health, to commission, pilot and evaluate the Oliver McGowan mandatory training programme for all health and social care staff. I welcome the Government’s continuing commitment to introduce the training.

The evaluation of the three pilots is nearly ready. So, what will happen then and how soon will the promised training begin? Of course, there are practical issues in rolling out an effective training programme nationally. I can understand possible government concern about the potential cost of introducing this, but these concerns should not hold us back from putting on statute something that the Government have agreed to. Oliver’s name was not permitted on the amendment but naming the training after Oliver would not only pay tribute to him and his family who have campaigned so hard but would remind us, and those doing the training, that this is not some dry academic subject. It is about people like Oliver: people who can be put at serious risk if staff are inadequately trained.

One aspect of the amendment goes beyond the Government’s existing commitment. This is the proposal for a code of practice with guidance on how the training would be created and delivered. The code would ensure that the key asks of campaigners would be put on a statutory footing, particularly the co-production and co-delivery of training with those with lived experience. Without this, I fear that the training would not reflect the key issues which people with a learning disability and autistic people face on a regular basis in the NHS.

I recognise that training might vary in detail depending on whether or not staff have a patient-facing role, and that clinical staff need a higher level of skill. I designed and led the delivery of training for medical students and trainee psychiatrists at St George’s Hospital Medical School for around 30 years, directly involving experts by experience from the beginning. This included working with disabled arts groups. For 20 years, I employed people with learning disabilities on the teaching staff to co-deliver the teaching and to participate as standardised patients in final clinical examinations. This meant that students had a chance to practise the communication skills that are central to improving outcomes for their patients; online training does not work to the same extent.

Currently, this type of education is dependent on a champion such as me to sustain it and that is a key reason why it needs to be mandated. One challenge that I am expecting from the Government is that it would be difficult to recruit and train experts by experience. I challenge this, given that only 6% of people with learning disabilities and 18% of autistic people are in paid employment. There is a ready workforce if there are willing employers and there are a number of academic departments able to offer the very simple and straightforward training and support they would need.

It is also crucial for the training to reflect and link with existing pieces of legislation and regulations such as the Autism Act, the learning disabilities core skills education and training framework, and the core capabilities framework for supporting autistic people. The amendment would require the code of practice to incorporate these and to ensure that any revisions to these regulations and legislation would be reflected in the code of practice and the training delivered. Building on this theme of co-production is the amendment’s requirement for the Secretary of State to

“consult such persons and bodies as they consider appropriate”

in the development of the code.

I hope the Minister will welcome this amendment, given the cross-party support that the development of the Oliver McGowan mandatory training programme has received in the other place. I beg to move.

The Deputy Chairman of Committees (Baroness Fookes) (Con)
My Lords, the noble Baroness, Lady Brinton, is taking part remotely. I invite the noble Baroness to speak.

Baroness Brinton (LD) [V]
My Lords, I am delighted to support Amendment 297L from the noble Baroness, Lady Hollins, which proposes mandatory training on learning disability and autism and how to care for people in the health sector. The amendment is also signed by the noble Baronesses, Lady Bull and Lady Merron.

People with learning disabilities and autism need to be cared for by those who really understand their condition so that they can carry out their roles effectively. This amendment formalises that in terms of the plan, what needs to be covered and what the code itself needs to cover. Those of us who have family members with learning disabilities or who have worked closely with them know that this specialist understanding is vital, and for a broader range of people working with them than is usually understood.

The noble Baroness, Lady Hollins, highlighted the need to ensure good understanding of health issues and how they are managed. Oliver McGowan’s story is shocking and we need to ensure that it is not repeated at a strategic level. During the pandemic we heard of far too many “do not attempt resuscitation” orders for people with learning disabilities. Indeed, it took some considerable time to get access to Covid vaccines for people with Down’s syndrome and other learning disabilities, even though they were more susceptible. It took too long to get that changed. My Down’s nephew in Spain is still not entitled to a vaccine.

In an earlier amendment we discussed abuse in institutional settings. Last year, there were some appalling undercover videos of staff physically abusing autistic students at a residential school. One of the comments was that it was evident that some staff had not been trained to understand and manage autism. Training is not needed just to prevent bad behaviour; well-trained staff in health and education settings are a joy to watch when they are working with those they are supporting, and it can truly enrich their lives.

Lord Warner (CB)
My Lords, I rise briefly to speak in support of this amendment. I declare my interest as a vice-chairman of the All-Party Group on Autism and the grandfather of a child with very serious autism. In particular, I want to emphasise a point which I think I have made before in this Chamber about the problems of achieving a diagnosis. You achieve a diagnosis when people start to recognise the problems that a young person is suffering from. Carers do not get any kind of services until there is a recognition of the condition by people in the different agencies.

I thoroughly support this amendment, because it would put on a statutory basis the need to improve training for a range of people who are likely to come in contact with the family from time to time, so that they are on the lookout for this condition, which, I can tell the Committee, can be very disruptive to family life and very difficult to deal with. The people who are carers of young people with autism have a terribly difficult job and a tremendously difficult road to travel. So the more help we can give clinicians and professionals in recognising the condition and bringing help to these families, the better.

Baroness Watkins of Tavistock (CB)
My Lords, I too support this amendment, which is absolutely in tune with reducing health inequalities for a particular section of our population and should be warmly supported across the House.

Baroness Jones of Whitchurch (Lab)
My Lords, I thank the noble Baroness, Lady Hollins, for this amendment. Like others, I pay tribute to her tremendous work on behalf of people with learning difficulties and autism, which we all acknowledge and respect.

The amendment would reinforce and hasten the implementation of and the legislative basis for the Government’s commitment to developing a mandatory training and professional development system for health and social care staff. It would also establish a statutory code of practice, to be updated every three years, setting out guidance on the content, accreditation, delivery, monitoring and evaluation of the training.

The NHS England pilots for the modules to support the development of the training are currently under way, as the noble Baroness said. They involve key stakeholders, including Mencap and the National Autistic Society. It would be helpful if the Minister could provide the Committee with an update on the progress and timescale for completing and assessing the pilots and for moving forward and implementing the new training system.

The amendment is comprehensive in terms of both amending the 2014 regulations under the Health and Social Care Act 2008 and setting out issues that the code must address, including the relevant core education and training frameworks and strategies applying to learning disabilities and autistic people. It also contains the definitions of autism and learning disability on which the code should be based.

In this debate, we are all sadly reminded of the tragic death of Oliver McGowan, who died after those treating him medicated his autism incorrectly. His mother’s petition and determined campaign for mandatory training is thankfully coming to fruition, so that we can ensure that all staff receive proper training and can develop the skills and experience needed to provide the safest and most effective care and support for people with learning difficulties and autism. Including the mandatory training requirement on the face of the Bill would be a major step forward and I look forward to the Minister’s response.

Baroness Penn (Con)
My Lords, I too am grateful to the noble Baroness, Lady Hollins, for bringing the important matter of staff training on learning disability and autism for the health and social care workforce before the Committee today. Evidence tells us that there is a pressing need to improve understanding and awareness of learning disability and autism among health and social care staff and that the staff themselves want this training. Introducing mandatory training is an important way in which we can address persistent disparities in health and care outcomes for people with a learning ability and autistic people. As we set out in the Right to Be Heard publication of November 2019, the Government have committed to requiring all NHS and social care providers who carry out regulated activities to ensure that their staff have achieved the learning outcomes relevant to their role.

21:30:00

We are committed to doing this through training known as the Oliver McGowan mandatory training, which was developed and trialled in 2021 with more than 8,000 people. The training will help to reduce knowledge gaps, ensuring that health and social care staff have the necessary training to support and meet the specific needs of people with a learning disability and/or autistic people. I would like to thank Paula and Tom McGowan for their tireless campaigning and input to make this happen in memory of their son Oliver. We can all agree that introducing mandatory training in learning disability and autism is the right thing to do. Everyone deserves high-quality, person-centred care that delivers the best possible outcomes.

However, as the noble Baroness anticipated I might say, there are practical challenges with the proposed amendment. The Oliver McGowan mandatory training trial evaluations are still under way, and we expect the final report to be published in March 2022. The evaluation report is critical to inform the wider rollout. It will provide detailed information on costs and on the best way to achieve desired outcomes. It will also inform on how best to operationalise the training. Therefore, this amendment pre-empts key findings from the evaluation and would come into effect too soon. It is for this reason that I ask the noble Baroness to withdraw her amendment today. I propose instead that we make a commitment to review all options to introduce mandatory learning disability and autism training once the final evaluation report is published in March. This would include returning to the issue of how this could be included in the secondary legislation referred to in the amendment. I hope the noble Baroness feels sufficiently reassured by that commitment and will withdraw the amendment.

Baroness Hollins (CB)
My Lords, I thank noble Lords who have spoken in this short debate. I am disappointed that the Government do not feel that it is timely. March is just one month away—by the time the Bill becomes an Act and is implemented, it will be here. This amendment does not set in stone exactly how the training would be implemented. It talks about a code of practice which would, after consultation, develop the means and the method.

I know that questions were asked about whether the aim was to mandate a standardised and evaluated training and to define a set of standards in schools that have to be met, and that Paula and Tom McGowan favour a standardised training programme, the Oliver McGowan mandatory training programme. I want to end by again acknowledging and putting on record my appreciation of the hard work they have done. It will stand people with learning disabilities and autistic people well in the future. I look forward to further conversations with the Minister. There does need to be a link to health outcomes, whatever route is taken, through the national mortality review, and a willingness to review the adequacy of the programme on a regular basis, and I would be happier if it were in the Bill. I beg leave to withdraw the amendment.

Amendment 297L withdrawn.

Clause 95 agreed.

Amendment 308

Moved by

308: After Clause 95, insert the following new Clause—
 “Pre-appointment scrutiny of HSSIB chair and Chief Investigator
 Appointments to the posts of—(a) chair, and(b) Chief Investigatorof the HSSIB must be subject to pre-appointment scrutiny by the House of Commons Health and Social Care Select Committee.”Member’s explanatory statement
 This reflects a recommendation of the Joint Select Committee, to provide pre-appointment scrutiny to the appointment of the HSSIB Chair and Chief Investigator.

Lord Hunt of Kings Heath (Lab)
My Lords, I welcome the intention to make the Healthcare Safety Investigation Branch a statutory body. We know that healthcare is very complex and that adverse events unfortunately occur very regularly. Recognising that weak safety systems create the conditions for the inevitability of error is vital to achieving high levels of patient safety. The noble Lord, Lord Patel, and I chaired the National Patient Safety Agency at different times, and we saw there the problems of having an agency where there was no mechanism for turning its work into appreciable action in the health service. I have great hopes that the HSSIB may well have a major impact on how the NHS improves safety.

In 2019, we had a Bill that was interrupted by the general election, and we now have these clauses in this Bill. Prior to the Bill in 2019, there was pre-legislative scrutiny from a Joint Select Committee of both Houses. This Select Committee argued that the most critical priority is to ensure that the prohibited disclosure of safe space provisions is fully fit for purpose in protecting the identity and statements of individuals who participate in our national safety investigations. The whole concept of safe space is so important. Without people in the service having the confidence to be able to tell the branch what is happening and where things have gone wrong, I do not think the branch is going to be able to work effectively.

It is very significant that the Select Committee concluded that any concession to safe space proposals—to coroners, for example—might significantly harm the branch’s ability to conduct effective safety investigations and would undermine one of the core principles under which the branch is being established. The Government have never once given any explanation of why over 90 coroners should be allowed to override the safe space concept.

I am very disappointed to see that the senior coroners can, under paragraph 6 of Schedule 14,

“require the disclosure of protected material by the HSSIB”.

I am very supportive of the amendment of my noble friend to remove those coroners. In fact, I do not believe this is going to work unless we succeed in doing so. I look forward to some decent, substantive explanation—not just that the MoJ insisted on it, which we think is probably the real reason the Department of Health failed to stop this—as to why coroners should be allowed to impede the success of this endeavour.

The leadership of this organisation is clearly critical, and we have seen in recent weeks just how critical. The Joint Select Committee thought that, to emphasise the wider accountability of the HSSIB to Parliament, both the chair and the chief investigator should be subject to pre-appointment scrutiny by the Commons Health and Social Care Select Committee. The Government agreed at that time to have a look at it, and I would be grateful if the noble Baroness could tell me what the conclusions are. Again, I would say that, in the light of recent very unfortunate experience within the leadership of this organisation, parliamentary scrutiny is very much justified.

There is some debate about whether the Secretary of State should have the power in Clause 97 to direct the branch to carry out an investigation. I do not think that undermines the independence of the branch. I think it is perfectly proper for the Secretary of State to be able to order an intervention; after all, he or she is responsible for the NHS to Parliament. But it is sensible that that power should not be unlimited and that the branch should have sufficient resources to carry out such an investigation and not have all its work diverted because of a request or instruction by the Secretary of State—hence my Amendment 309.

It is also important that, where an investigation is carried out under such a direction, a copy of the final report should be laid before Parliament, setting out what action the Secretary of State proposes to take in response to the report. That is the subject of my Amendment 310.

In Clause 115, the oversight functions of the Secretary of State are laid out, including a power of direction in the event of HSSIB failure. That is quite normal. Such direction may not direct the outcome of a particular investigation. That seems sensible to me, but it should happen only in exceptional circumstances, and in the interest of transparency and accountability, the clause surely needs strengthening through my Amendments 312AA and 312AB.

I think the Government will find there is a great deal of support for the establishment of the branch as a statutory agency, but unless they can resolve the safe spaces concept and strengthen the governance, this branch may have some difficult challenges in the future. I beg to move.

The Deputy Chairman of Committees (Baroness Fookes) (Con)
My Lords, the noble Baroness, Lady Brinton, is taking part remotely. I now invite the noble Baroness to speak.

Baroness Brinton (LD) [V]
My Lords, I will speak to first three amendments in this group, but I support the others.

The office of the Health Services Safety Investigations Body is vital. It has the capacity to make the step change in patient safety that Parliament has been asking for on a regular basis, over many years. Amendment 308 makes it clear that it is vital that there needs to be scrutiny of the appointment of the chair and the chief investigator by Parliament. The history, outlined by the noble Lord, Lord Hunt, but also in the amendments your Lordships’ House has considered during the course of the Bill, arises very much out of the recent First Do No Harm report, which the noble Baroness, Lady Cumberlege, led. This was a recommendation, as the noble Lord, Lord Hunt, said, of the Joint Select Committee, pre 2019. It emphasises the public scrutiny of these appointments, the importance of the HSSIB and the fact that it must fulfil its duty to the best of its ability and be very much in the public eye.

Amendment 308A talks about financial stability over a period of years. It is all too easy for new bodies being set up by the Government to have a one-year budget. I am thinking, just as an example of the moment, about the position the public health budget has been in, where there is no stability at all. Quite often, in March, health bodies find out exactly what they will get to start the next financial year in April. Let us not do that with the HSSIB. Let us give it a three-year plan for financial stability.

Amendment 309 is vital if the HSSIB is going to succeed. It has to have adequate funds and resources to carry out one of its core roles—that of investigation.

I also echo the concerns of the noble Lord, Lord Hunt, about coroners, and support the amendments in the name of the noble Baroness, Lady Young.

Baroness Young of Old Scone (Lab)
My Lords, I will speak to our Amendments 310A, 311A, 312A and 319, and I thank the noble Lord, Lord Patel, and my noble friend Lord Hunt of Kings Heath for their support. I declare former interests as a chair of the Care Quality Commission and a recent chancellor of Cranfield University, which has a major teaching research role in air, rail and accident investigation in the UK and globally.

I share the view of my noble friend Lord Hunt that this is an important step forward for patient safety. The whole point of setting up the HSSIB is its independence and the concept of safe space and protected material. However, the Government, having made a good call in proposing that it be set up in these terms, have immediately screwed up—if noble Lords will pardon the technical term—by eroding its foundations from birth.

I know we are not supposed to rely on Explanatory Notes, but I will quote them, as they give some indication of the original and admirable intentions of Government:

“The Bill creates a ‘safe space’ within which participants can provide information to the HSSIB for the purposes of an investigation without fear that it will be disclosed to others.”
 

This good model can be compared with the air, rail and marine accident bodies. Safe space enables the improvement of safety by promoting learning and not attribution of blame. This is a founding principle behind establishing a safe space.

The importance of safe space is well documented in air accident investigation. The key point is that the evidence is collected on a not-for-blame basis and cannot be utilised in another, different sort of investigation. There are UK and international examples of the chilling effect of the impact of compromising the safe space principle. I can provide them for the Minister, if she would like them.

One of the most graphic examples I heard was a fatal air accident in New Zealand where police seized the cockpit voice recorders. The result was that pilots across New Zealand no longer trusted the CVR data to be protected as a matter of principle and withdrew their co-operation from the collection of cockpit voice recorder data. In fact, they routinely disabled the CVRs after the start of each flight and reported it as a fault. This withdrawal of co-operation continued until full protection of the CVR data was put in place in line with international standards. That is a sign of what can happen to a community of interest if they do not feel they can trust the rules.

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There is absolutely nothing stopping valid parallel investigations by, for example, the police, the coroner and the Civil Aviation Authority that attribute blame but collect their evidence separately and on different and distinctive terms. The crucial thing is that an individual coming forward with information understands what kind of process they are in and what the risk is that the information they provide for one use may be used by a different sort of process.

If HSSIB is really going to be about no-blame investigations, it must protect the safe space absolutely. Any sharing of protected material, even to another safe space, such as is proposed by the ombudsman, means a risk of data leaking. As the Bill stands, the safe space has several wide-open doors, with access for coroners, the Secretary of State and, if the amendment tabled by the noble Baroness, Lady Neuberger, is accepted, the ombudsman. I urge the Minister to think again and truly protect the safe space.

My Amendments 310A, 311A and 312A defend the principles of establishing that safe space. Amendment 310A would remove the ability of the Secretary of State to make regulations authorising disclosure of protected material beyond that provided for in the Bill. Amendment 310B, tabled by my noble friend Lord Hunt, does much the same job as my amendment; I guess that he did not quite like mine. Amendments 311A and 312A would remove the provision allowing coroners to require the disclosure of protected material; my noble friend spoke very eloquently of that. Despite searching widely, I cannot find anybody who supports this power for coroners other than the coroners themselves and the Ministry of Justice—even with its provision whereby a senior coroner has to apply to the High Court for an order if they want to disclose the protected material to anyone else.

I am against this proposal on coroners in the Bill for two reasons. First, any disclosure of protected material to another party represents a risk to the safe space. It would have a chilling effect, preventing people coming forward to HSSIB and therefore making it less able to improve patient safety, and undermining one of its very foundations, as my noble friend Lord Hunt said. Secondly, the dealings of coroners are adversarial: they are about blame. Their processes and their use of data are totally alien to HSSIB’s founding principle of no blame. The Government have clearly not thought through the risk of undermining HSSIB before it starts, so can the Minister tell us why he believes that opening the doors up to coroners is necessary and does not risk the whole foundation of the principle of HSSIB?

I would like to address, with some trepidation, Amendment 311, tabled by the noble Baroness, Lady Neuberger, in the same context of the need for primacy of the safe space. Opening up the right to disclosure further to the health service ombudsman would infringe that principle. I understand the international principle of unregulated access to all sources for the ombudsman, as outlined in the Venice Commission principles, but there must be a proper balance between that and the whole point of HSSIB, which is to secure improvements in patient safety by encouraging people to engage openly and with the confidence that the information they are providing will be in the safe space and be treated as protected materials.

I am very grateful to the ombudsman, who took the time last week to discuss this with me and to explore his concerns about any diminution in the ombudsman’s powers. I fully understand that the ombudsman would be able to use the protected materials publicly only if a High Court judge agreed, but in reality, any sharing of protected materials from the safe space, even if it is to somebody else’s safe space, represents a risk to the integrity of the confidentiality in which individuals gave that information. That is the principle on which HSSIB fundamentally relies, and it would be eroded by opening up to the ombudsman.

In reality, the ombudsman would be in no worse a place than he is in cases where HSSIB has not undertaken an investigation. He can still investigate ab initio and take into account HSSIB’s published summary report. In reality, the number of cases in which both HSSIB and the ombudsman are likely to be involved is very small. The ombudsman estimated that it could be as low as one case per year. So, we are talking about jeopardising the foundation of HSSIB for the sake of one case a year. While I understand the concern of the noble Baroness, Lady Neuberger, I do not believe her amendment justifies in seriousness or scale undermining the fundamental principle that HSSIB has been set up to deliver.

Finally, my Amendment 319 addresses the other founding principle of HSSIB: its independence. The Bill’s Explanatory Notes refer fulsomely to independence, but if the Secretary of State has the ability to direct HSSIB, that does not do much for its independence. In another place, the Minister said that the Secretary of State needs powers to direct HSSIB to carry out an investigation in order to smooth the transition from the current arrangements to the new body. If this temporary power is indeed needed, let us make it temporary. My Amendment 319 would introduce a sunset clause and limit the power of direction to an 18-month transitional period.

The concerns that I and other noble Lords are raising about the powers of the Secretary of State to direct investigations and the erosion of the safe space are not something we have just dreamt up. The Government have received representations from several groups of leading experts, the current HSIB advisory panel, HSIB executives and members of the Joint Committee that previously scrutinised the original draft Bill, as well as from harmed families. Can the Minister tell the House why such senior, extensive and unanimous advice on these issues seems to have been ignored?

Baroness Kramer (LD)
My Lords, this is my only intervention on this Bill, and I will limit myself at this hour to speaking to my own Amendment 309A, which deals with whistleblowers. I want to make a slight distinction from the safe space discussion, because for very many whistleblowers, if not the overwhelming majority, safe space becomes an irrelevance. They have raised their issues with their colleagues and with management. They have often raised the issues in very public settings and have been identified. Sometimes—often, in fact—the information they have is so particular that they can be identified easily by the organisation from the issues on which they are speaking out.

When I looked at this Bill, I was absolutely stunned to see that we were creating a Health Services Safety Investigations Body without any mention directly of whistleblowers and just some minor reference to disclosure. I am afraid that this tells us something about the attitude of those in charge of the health sector, and sometimes that of the Government and Ministers.

Whistleblowers have been absolutely key to exposing scandal after scandal but are treated quite disgracefully by the system. Typically, they are ignored or disbelieved, often for years—and that is when they go out beyond even a safe space, if that is available to them, and begin to talk to the media out of desperation to make action happen. Attempts are then made to silence them, typically by the offer of settlements that contain aggressive non-disclosure clauses, called confidentiality clauses here in the UK, which are both common and very aggressive within NHS settlement agreements. Many whistleblowers are subject to aggressive retaliation, requiring them to fight for as long as seven years through employment tribunal systems just to clear their names and sometimes be awarded some compensation for a career completely destroyed.

Yet without whistleblowers, failures in healthcare, whether from incompetence or abuse, would rarely be exposed and would remain hidden for much longer. Let me repeat what I have often said before: whistleblowers are the citizens’ army that provides crucial information to regulators and enforcement bodies. They are the canaries in the mine that the HSSIB will need. If it treats them with respect and—even more importantly—protects them, they will provide deterrence, which is always better than cure.

When I raised this with Ministers, the answer I was given is that whistleblowers are protected in the healthcare system by the National Guardian’s Office and some 800 “freedom to speak up” guardians put in place after the damning Francis report in 2015. Guardians are typically NHS trust employees, already busy but taking on additional duties. Ministers may say that over 20,000 cases were raised to such guardians last year, but the guardians, no matter how much they might have wished to do, in most cases have been able to do little more than provide advice and direct people to various channels of reporting. Unfortunately, the guardian system has no power to enforce action following a disclosure and no tools to protect a whistleblower from retaliation. “Guardian” is a misnomer.

There is no time today to go through the individual cases of whistleblowers as each is incredibly complex. I have in my pile of papers evidence from seven very different whistleblowers, which I will summate. Dr Kevin Beatt and Dr Raj Mattu are leading cardiologists. There is no way they could have reported their complaints in a safe-space system; they would immediately have been identified as those who are bringing forward the issues. Mr Peter Duffy is a urological surgeon, Mrs Sue Allison is a radiographer, Dr Chris Day is a junior doctor, Steve Turner is a nurse and lecturer and Dr Ed Jesudason is a paediatrician. Between them, they spoke up on issues including a cover-up of preventable children’s deaths, understaffing and overcrowding, unsafe surgery due to specialist staff shortages, lax attendance by senior doctors, bullying and blacklisting.

Every one of those seven suffered terrible retaliation. Some are still fighting, some have been vindicated after long, bruising struggles and one has even received an MBE, but they are the tip of the iceberg. From speaking to just one civil society group, WhistleblowersUK, I found that it was inundated by calls from whistleblowers last year, who had found no adequate response from the National Guardian’s Office or the Care Quality Commission.

My amendment gives the HSSIB responsibility for setting in place a secure process for whistleblowers to report safely and confidentially any concerns on patient safety. In a sense, you could look at it as a safe space arena. It also requires transparency, at least in aggregate, about how the HSSIB acts on that information. The amendment goes well beyond a safe space, which is a reflection of the current Public Interest Disclosure Act, by offering confidentiality to everyone, not just employees. It also requires the HSSIB to report any retaliation against whistleblowers to the Secretary of State.

I hope the many whistleblowers who are suffering acute detriment under the current system or are too afraid to speak out can read Hansard tomorrow and hear from the Minister some positive and powerful responses to this amendment.

Baroness Neuberger (CB)
My Lords, I am also rather nervous. I spoke at Second Reading about how worried I was by the exclusion of the ombudsman—the PHSO—from the provisions to create a safe space for investigations carried out by the HSSIB. The safe space is of enormous significance, although I agree with the noble Baroness, Lady Kramer, that there is an issue about where whistleblowers fit—that is right. We need the safe space but, as currently drafted, the Bill cuts across the unique and long-standing role of the Parliamentary and Health Service Ombudsman to investigate complaints about the NHS. Although I take the point of the noble Baroness, Lady Young of Old Scone, that the number of cases are very few, there is a constitutional principle here.

22:00:00

There could be serious consequences for members of the public who use the ombudsman service, for the health sector more broadly, particularly looking at system failure, and for the reputation of, and trust in, the ombudsman. It is, however, worse than that. Parliament gave the ombudsman extensive powers, equivalent to those of the High Court, both in 1967 and again in 1993, to access information from all areas of public administration, including the NHS. If this amendment is not accepted, the ombudsman will, in fact, be partially stripped of those powers, including the routine right to investigate fully a tranche of patient-safety cases without going to the High Court first. This is quite serious: it is a constitutional issue, and it violates the 2019 Venice principles—Principles on the Protection and Promotion of the Ombudsman Institution— and the 2020 UN General Assembly resolution, which was co-sponsored by the UK Government. It is a constitutional change by the back door.

If the ombudsman is unable to investigate robustly all aspects of complaints about the NHS, except with the permission of the High Court, patients may find it harder to get access to justice. The NHS may well become less accountable for its system failings, and the ombudsman will inevitably become judicialised, which we really do not want and was explicitly warned against by Court of Appeal judges, anxious to preserve non-legal approaches to dispute resolution.

The Bill at present has things completely the wrong way around. We all agree—it is enormously clear that agreement has broken out across the Committee—that coroners should not have access to the safe space. We all agree about that—what we do not agree on is the PHSO. In the Bill, the coroners have access and the PHSO does not. This does not make sense. If the coroners have access to the safe space and the PHSO does not, we have quite a serious situation. The noble Baroness, Lady Young of Old Scone, is completely right to say that coroners’ inquests are becoming increasingly adversarial; there is a real risk of individuals’ names being mentioned and fingers of blame being pointed during proceedings, as watching an inquest shows.

If I were a health professional, I would be nervous in these circumstances of giving information to the safe space. Allowing coroners access will discourage healthcare professionals from disclosing matters frankly to the safe space. The ombudsman, on the other hand, does not name names, but looks at institutional failures rather than individual ones, and points to system failures. Without the ombudsman’s work, and without its having access to the safe space once it exists, how would the ombudsman be able to do the sort of work that it has done on some of the most remarkable issues, such as issues to do with people with learning disabilities in the health service or issues to do with eating disorders. We could give other examples.

Baroness Young of Old Scone (Lab)
Will the noble Baroness admit that, in reality, the ombudsman has for many years undertaken that valuable work without having access to the safe space because the safe space did not exist? It can continue to do so by gathering evidence afresh in the way that it does in many other cases that are not going to be dealt with by HSSIB.

Baroness Neuberger (CB)
Of course I accept that, but I do not think it is right. Once the safe space exists and is part of the system, and the ombudsman has those rights—or traditionally has had those rights—we have to allow the ombudsman, who does not reveal the material and does not name names, access. We are obviously going to disagree on that.

I am no legal expect, and my noble and learned friend Lord Etherton will deal with the legal and constitutional principles. However, I ask the Minister to look again at this and to consider removing the coroners from the safe space, an approach that makes no sense at all, but allowing the ombudsman—the PHSO—to have access on condition that there is no disclosure to a third party, thus retaining the important role that the ombudsman holds in our constitutional arrangements.

Lord Etherton (CB)
My Lords, I have added my name to Amendment 311 in the name of the noble Baroness, Lady Neuberger. The heart of the complaint which has prompted the amendment is that the Bill fails to provide a proper balance between the role of the HSSIB and the role and standing of the PHSO, and it fails to recognise and provide for the PHSO to be treated as part of the HSSIB’s safe space under the Bill.

The Bill’s prohibition on disclosure by the HSSIB to the PHSO of material obtained by the HSSIB in connection with its investigation of incidents that may have implications for patient safety impedes the statutory functions of the PHSO, diminishes the standing of the PHSO, is contrary to the independent, non-judicial constitutional role of the PHSO, and is contrary to the UK’s obligations as a member of the Council of Europe and the United Nations regarding ombudsmen.

The PHSO in his role—and it is a “he” at the moment —as the Parliamentary Commissioner for Administration acts pursuant to the statutory framework in the Parliamentary Commissioner Act 1967; and, as the Health Service Ombudsman, he acts pursuant to the Health Service Commissioners Act 1993. Under those statutes, his role is to investigate complaints by members of the public who claim to have suffered maladministration or to have sustained injustice or hardship in the delivery of a health service.

The legislation which I have just mentioned effectively gives the PHSO unrestricted access to evidence and other information in order to carry out his investigations fully and effectively. As the noble Baroness, Lady Neuberger, has said and as is obvious, there will often be an overlap between the work of the PHSO and that of the HSSIB both in respect of particular incidents and in relation to general inadequacies in practice and procedure—reference has been made to eating disorders and learning disabilities. There are very limited exceptions under the Bill for disclosure by the HSSIB of protected material to third parties. These do not include routine disclosure of evidence and information which is relevant to investigations by the PHSO, who will be able to obtain such material only if he obtains an order from the High Court. This is so even if both the PHSO and HSSIB are investigating the same incident and even if the PHSO in his capacity as parliamentary commissioner is investigating a complaint by a person of maladministration on the part of the HSSIB itself. This simply does not make any sense.

Notwithstanding the observations made by the noble Baroness, Lady Young of Old Scone, it seems that the restriction on disclosure is based on a misunderstanding about the confidentiality of material held by the PHSO and about the safe space in which he currently operates. The legislation governing the PHSO provides that he must conduct his investigations “in private”. Subject to limited exceptions, the PHSO is not permitted to disclose to third parties information obtained in the course of an investigation. Disclosure cannot be made by the PHSO in any circumstances where that would be contrary to the public interest. Information obtained by the PHSO is also subject to absolute exemption from disclosure under the Freedom of Information Act 2000. No persons are identified in the PHSO’s reports, and names are anonymised. Mirroring the safe space provisions in the Bill for HSSIB investigations, reports of the PHSO do not apportion blame to individuals, and do not assess or determine civil or criminal liability or whether disciplinary action needs to be taken.

Furthermore and critically, the terms of the proposed amendment would impose a complete legal block, prohibiting the disclosure to a third party of any protected material disclosed to the PHSO by the HSSIB except by order of the High Court, and then only for certain very limited purposes. The effect of the existing statutory provisions and the conditions in the amendment prohibiting disclosure to third parties mean that the PHSO and the HSSIB fall legally and naturally within the same safe space.

As presently worded, this will be the first occasion on which the PHSO’s access to information will have been curtailed. At the same time, in extending the right of disclosure of the HSSIB’s protected material to coroners, the Bill discloses an incomprehensible inconsistency, since not only are inquests increasingly adversarial, as has been noted by a number of speakers, but such disclosure is not allowed by the PHSO under the PHSO’s governing legislation. As the noble Baroness, Lady Neuberger, has said, ombudsmen are internationally regarded as having a constitutional role in addressing the imbalance of power between the individual and the providers of public services, and in their autonomy and independence from the executive and judicial branches of government. That constitutional role is enshrined in the Venice principles adopted in 2019 by the Council of Europe and by the UN’s General Assembly in 2020. A written opinion of the Venice Commission, published in October 2021, concluded that the exclusion of the PHSO from the safe space created by the Bill, and denying the PHSO to full access to the HSSIB’s protected material, would be contrary to the Venice principles. It would therefore place the United Kingdom in breach of its international obligations. The amendment is, for all those reasons, both necessary and desirable.

Lord Patel (CB)
My Lords, I will try to be brief, and to cover the points about the exercise of a patient safety investigation and learning from it, which is the important part. My name is on amendments tabled by the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Young of Old Scone. I listened carefully to my noble friend Lady Neuberger and my noble and learned friend Lord Etherton. I could not argue with him on constitutional matters; I would not even try to. But I can say this: after nearly five years of experience as chairman of the National Patient Safety Agency, which carried out such investigations—it was an arm’s-length body rather than a statutory one—the purpose of the exercise is to use an index case, where an event may have led to harm to a patient, to learn if there was a systems failure. If an event happened in one hospital, the chances were that it was also happening in other hospitals. The aim was to do an in-depth, root-cause analysis to get the necessary evidence in detail, and to find out where the systems failure might be occurring. I can give you several examples of what happens and how it can be corrected.

I agree with the noble Baroness, Lady Young of Old Scone and the noble Lord, Lord Hunt of Kings Heath, and with my noble friends that the coroners should not be able to invade the safe space and access the protected material. If I was asked to choose between the coroner and the PHSO, I would choose the PHSO, because of the less adversarial way of dealing with matters.

There are two problems in the legislation. One is compulsion: as a doctor, I will be compelled to give the evidence and the information required by the HSSIB to investigate a case and to find out where the systems failure might be. That compulsion comes with a protection—that the information I give will be completely protected from being used by anybody else against me or in any other legal procedures that may arise. That will give the health professionals or anybody else the confidence required that there is openness, honesty and transparency, because the purpose is to have as much information as necessary to find the systems failure that may occur.

If you look at the list of the 22 investigations carried out by the HSIB so far, you will find that they tend to be generic. I could read out the list, but I will not. They are not about individual investigations. I take the point that the PHSO’s role is to protect against harm done to an individual but also to deal with the system failures that may occur—I get that. My plea would be that to make the HSSIB a success, the principle of protecting the information given in confidence is a key part of the whole process. If that confidence is destroyed in any way at all, the whole exercise will not work.

22:15:00

What we have to discuss is this: how can we make the HSSIB a success, which leads to identifying systems failures in our health service and improves patient care? Any threat to confidentiality will make the job of the HSSIB extremely difficult, if not impossible. If individuals thought that what they were saying was likely to be made available to anybody else, and could be used in some way, they would not be open and transparent. I make a plea that, while we are discussing who should have the right to invade the protected space, we bear that in mind and ask: will this affect the success of the HSSIB? If is likely to affect its success, we should not do it.

We have other means to get that information—the PHSO has other means. It is not left out in the cold; it does not even have to go to the High Court. By the way, in the five-year existence of the HSIB, the PHSO has never asked for information, as I understand it, from the HSIB hitherto. Obviously, it has not felt the need to ask for information or even to ask that it inspect the information collected by the HSIB. That is the crucial point.

One other point to make is that the power of the Secretary of State to ask the HSSIB to disclose the information to anybody else is not correct. I do not think the Secretary of State should have the power to instruct the HSSIB to disclose the information is has. It should be protected from the Secretary of State also.

In summary, my plea is that we think of how the HSSIB can be made a success, and what the threats to its success will be, by asking what it is we are trying to do. But I absolutely agree that, if I had to choose between the coroner and the PHSO, I would choose the PHSO.

Baroness Parminter (LD)
My Lords, I will be brief. I am not a medical expert, as many are in this Chamber, but I have seen at close hand the value of the PHSO, particularly in the report in 2017 into eating disorders. For the reasons that I saw in that report, I have added my name to the amendment from the noble Baroness, Lady Neuberger.

I appreciate the need for a safe space. However, there are two things that I would like to say. First, to follow on from what the noble and learned Lord, Lord Etherton, said, the PHSO does not apportion blame to individuals; it looks at systemic failures. It did this so well in its report on eating disorders, where it looked at failures across the system, rather than at individuals. Therefore, I think that medics, who are extremely intelligent people, will understand that it is not about apportioning blame and so they have nothing to fear—there will be no chilling effect on them as individuals, because it is about the systems.

Secondly, and again as the noble and learned Lord, Lord Etherton said, the way the amendment is structured includes the ombudsman within the safe space, because there are such strong protections; the information given to the ombudsman cannot be released unless you go to the High Court. That is a very strong, ironclad protection, and again, I think medics would understand that and see that it is not something that would diminish the value of the safe space.

The point that I particularly want to make, since others have made the point about the constitution far better than I could, is that if there is this information in the future that the HSSIB has but the ombudsman does not, that will fundamentally undermine public confidence in the ombudsman’s ability to do its job. Let us not forget that the ombudsman is the last resort for members of the public when they have been let down by the NHS. If it does not have information that other people can get, what does that mean for people having confidence in the transparency and value of that process?

That is something that has not been mentioned so far tonight: the confidence of the public in the ombudsman to carry out its constitutional role to protect people and their families when there have been appalling failures, to give them some sense that someone may not have to go through this in the future because the ombudsman has set in train a process that will make the system better.

As I say, I do not know enough about autism—the noble Baroness, Lady Hollins, is not in her place to do it but there are other people who can talk about the role of the ombudsman and the importance of the report that it did on autism—but I know from my involvement with eating disorders that the work of the PHSO in its 2017 report was seismic in working alongside those of us who campaign desperately for changes in the treatment of eating disorders. It has done so much to give some sense of security to individuals and their families who have been let down that things might change. If we do not accept this PHSO amendment, public confidence in anything in the future will be fatally undermined.

Lord Kakkar (CB)
My Lords, I support the intervention by my noble friend Lord Patel. In so doing, I declare my own interest as a registered medical practitioner. The issue is a complicated one. There is no doubt that the work of the HSIB is critical to ensuring that we can continue to drive patient safety at the heart of clinical practice.

The safe space is essential for a number of reasons that have been clearly recognised and, indeed, described in this debate. One of the most important features attending the safe space is a recognition of the fact that modern clinical practice is very complicated. It is a question not only of medical practitioners but of a broader team of healthcare practitioners who come together to deliver care, all of them recognising the opportunity for them to contribute to ensuring that lessons are learned where intervention, clinical practice and, indeed, broader health service intervention have failed individual patients in the system.

It is also complicated because there are other bodies that play an important role, such as the ombudsman and coroners, but I believe an infringement of that safe space has the potential to truly undermine the capacity for all involved in the delivery of healthcare to learn from individual experiences, and from system failures more broadly, to ensure that mistakes and inadequacies in the delivery of clinical care and practice are not repeated and that we can continue to improve and deliver higher-quality and safer care for all patients.

The question is how these tensions and inconsistencies are addressed in the Bill. It is important for Her Majesty’s Government to be able to reassure people that the safe space is not undermined; that all healthcare professionals are able to contribute in an open, transparent and confident way to investigations that are established; and that in so doing they can feel confident not only with regard to their own position—of course, their first duty must be to those who for whom they have the privilege to care—but that they can ensure that all others, as part of the team delivering services, are able to come together to contribute to those investigations.

Certainly, it would be wrong to undermine the position of the ombudsman—that would be detrimental. A loss of confidence in the ombudsman service would be a detrimental consequence of this particular Bill. But we have also heard that the coroners’ process is increasingly adversarial, and that undermines confidence. It would undermine confidence in the work of the investigative body if that anomaly were to continue as part of the passage of the Bill.

Ultimately, the focus must be on the interests of patients, and, as currently drafted, the Bill fails to achieve that critical interest. I hope that Her Majesty’s Government will consider amendments in this group and determine how these tensions and inconsistencies can be resolved, ultimately for a purpose that I think all Members of your Lordships’ House agree on: namely, ensuring that we can continue to improve the delivery of our services and health system to ensure not only the highest quality but the greatest safety for all patients attending our healthcare institutions.

Baroness Walmsley (LD)
My Lords, from these Benches we welcome the fact that the HSSIB is to be put on a mandatory footing. The intention of the legislation is to create a safe space in which to shine a light on systemic failures in the NHS, and to learn lessons rather than apportioning blame.

The key to the success of this work is the independence of the body and the confidence of both patients and the workforce, so that those providing evidence can give a full and candid account of what happened. Whistleblowers in particular must be protected because there is substantial evidence that, in the past, they have been penalised for being public spirited—that must not continue. My noble friend Lady Kramer’s Amendment 309A would address that situation, and I support her.

However, there are some concerns. We support Amendment 308 because pre-appointment scrutiny is an element of the most significant public appointments. The chair and chief investigator of the HSSIB are posts that protect and safeguard the public’s rights and are vital for the reputation and credibility of the organisation. So I hope that the Minister will accept the amendment.

We support Amendment 308A because there is widespread recognition that the ability to do financial planning over a long funding cycle is valuable for all organisations. The Institute for Government has confirmed that multiyear allocations provide certainty and stability, which is what we want for the HSSIB. Sufficient resources are essential for it to carry out its job; however, if the Secretary of State were to direct the organisation to carry out an additional investigation, it would be only right that appropriate resources were allocated.

Amendment 319, in the name of the noble Baroness, Lady Young of Old Scone, would limit the Secretary of State’s power to direct the organisation to carry out a specified inquiry and report by a particular date. I agree that this could compromise the independence of the organisation, so I look forward to hearing from the Minister why the Government feel that this power is justified.

Amendment 310A, in the name of the noble Baroness, Lady Young, and several other amendments in this group would restrict the powers of the Secretary of State to allow information to be disclosed and would restrict other people, such as coroners, in obtaining information given in confidence. We support these amendments: coroners should not expect the HSSIB to do their work at the expense of risking its own work.

A case has been made by the Parliamentary and Health Service Ombudsman for it to be allowed to have information. As my noble friend Lady Parminter has pointed out, the PHSO does not apportion blame; instead, it identifies systemic failures. It is concerned with systems, not individuals. Amendment 311 from the noble Baroness, Lady Neuberger, would provide a complete iron curtain on the disclosure by PHSO of any information originating from HSSIB, unless there is a High Court ruling. The PHSO has a constitutional duty to achieve justice for patients failed by the NHS.

22:30:00

The PHSO and the HSSIB have somewhat different roles but are complementary to each other, and I look forward to the Minister telling the House how the functions of the two organisations will be reconciled without compromising the constitutional role of the ombudsman. It must also be remembered that the HSSIB, as well as having no role in apportioning blame, has no role in regulatory action. Other organisations that can do this will continue to operate after the HSSIB is set up in law. They will continue to have their own powers to obtain information and take appropriate regulatory action. However, as most noble Lords have said, it is vital that the powers to compel people to give evidence are balanced by the ability of witnesses to give their evidence in confidence and in safety. As we have heard from the noble Lords, Lord Patel and Lord Kakkar, any access to evidence given in the so-called safe space must be minimal and highly protected, otherwise the objective of learning and safety improvement will be compromised.

The amendments in this group have been laid not to damage the objective of the HSSIB but to enable and protect it. I hope the Minister will be able to accept that and give us some reassurance in his response.

Baroness Merron (Lab)
My Lords, this has been a very detailed debate and has explored what is at the heart of the subject before us. It has focused very much on what it is to have a safe space—something to which I will return briefly. I want to thank my noble friend Lord Hunt for leading this group of amendments and I will not repeat the points he made so ably in setting them out. As the noble Baroness, Lady Walmsley, said, I hope the Minister will take these amendments in the spirit they are intended. Clearly, they have been very carefully crafted and debated in order to improve this section of the Bill, and I believe that they are very worthy of merit.

We on these Benches also support the development of a culture where staff feel able to speak up about mistakes without a presumption of blame. Since its creation, the work of the HSIB has placed an important focus on learning and improvement when things have gone wrong. However, there must be a balance with the need for appropriate accountability and redress, for the public to be protected from unsafe practices and practitioners, and for public confidence in the system to be maintained.

This debate has been rightly supportive of the HSSIB, its mission and the concept of safe spaces—on that I think there is agreement. There is also agreement that it must be independent to be effective and trusted. However, following this debate, it seems that there is much work to be done by the Government on reviewing where, and to whom, disclosure of information can be made. Although the debate has expressed agreement that it is not appropriate for coroners, with their adversarial role, to have such access—and I share this view—there is a finely balanced debate about the issue of the ombudsman. As the noble Lord, Lord Kakkar, said, this is complex—which I think is something of an understatement. The debate reflects the reality of the world in which the HSSIB seeks to improve the delivery of service.

The noble Baroness, Lady Neuberger, and the noble and learned Lord, Lord Etherton, have put forward their view that the ombudsman needs to be able to investigate robustly. I am sure there is agreement on that. I am sure the difficulty that the Minister will want to unpick as she takes away the views of your Lordships’ Committee today is how it will be possible to allow the ombudsman to do its job and yet retain safe spaces. As the noble Lord, Lord Patel, said, it is so important to give confidence to professionals that they can contribute to the investigations into systems failure.

I say to the Minister that I hope there will be a close examination of all the points put forward in today’s debate. I feel that by further investigation into and thought about the points that noble Lords have made, this part of the Bill can certainly be strengthened.

Baroness Penn (Con)
My Lords, I thank all noble Lords for this debate and reassure them not only that I have listened carefully to it but that the Government will of course again look carefully at the arguments made. As the Committee has heard, HSSIB is no ordinary investigatory body. It will look at systemic risks and focus on learning lessons. It is not about blame; it is about improving patient safety incidents across the system and making a real difference to patient safety.

The Government agree that the integrity of the safe space is paramount. Safe space conditions will encourage patients, families, NHS staff and other investigation participants to speak freely and candidly. Without guarantees that this information will not be shared, except in very limited circumstances, we risk eroding the confidence of all those participating in an investigation, potentially leading to information being withheld and reducing the effectiveness of the investigation.

I turn to Amendments 311, 311A and 312A. We have sought to strike a fine balance between protecting safe space and acknowledging the need for very limited exceptions. We have allowed senior coroners to have access to information from the HSSIB, but only when it is appropriate and necessary for them to fulfil their judicial functions, and not to disclose onwards without further protections in place. Where the HSSIB has information about a death which the coroner is investigating, we need to ensure that the coroner’s judicial role is not undermined and that they have accurate and clear information. It does not mean that the coroner will have complete access to safe space information—far from it—nor that they will be able to automatically share this information. We have drafted provisions so that this does not happen. It is an intentionally limited and contained exemption.

Regarding Amendment 311, the Bill’s provisions are likely to have a very limited impact on the Parliamentary and Health Service Ombudsman’s ability to fulfil its important independent role of investigating complaints, given that it will still be able to use its existing powers to obtain material directly from the same primary sources. It will often not be investigating the same incidents as the HSSIB, as we have heard in Committee. If the PHSO felt it needed to access protected material held by the HSSIB, it could apply to the High Court. We do not envisage this being a common occurrence, as the HSSIB’s purpose will be very different from that of the PHSO. However, it means that the PHSO does have a way to gain access to protected information in certain circumstances.

We are committed to monitoring the impact that the safe space provisions may have on the PHSO’s ability to carry out its functions. We shall report to the House of Commons Public Administration and Constitutional Affairs Committee on this issue within 12 months of the HSSIB being fully operational, which we expect to be 12 months after the Bill gains Royal Assent.

A number of amendments relate to the role of the Secretary of State in relation to the HSSIB. We believe it is appropriate that the Secretary of State can direct the HSSIB to investigate particular qualifying incidents. This is an important tool available to the Secretary of State, which enables him and the HSSIB to respond to emerging or ongoing patient safety issues, which may arise at any time. It would therefore not be appropriate or prudent to limit the Secretary of State’s ability to direct the HSSIB to the first 18 months of its operation.

More importantly, the Secretary of State would not be able to direct the HSSIB on how to conduct a particular investigation. Clause 115 rightly allows the Secretary of State to intervene if

“the HSSIB is failing or has failed to exercise any of its functions, and … the failure is significant.”

The Secretary of State is accountable to Parliament for the HSSIB’s performance, and it is in the public’s best interests that the HSSIB functions effectively.

I turn to Amendments 310A and 310B. Given the broad scope of the HSSIB’s investigation function, some flexibility is needed so that the Secretary of State can set out additional circumstances when the prohibition on disclosure—safe space—does not apply. It is vital that the HSSIB can adapt as clinical and record-keeping practices change on the front line and practice evolves. This power is about future-proofing and continuous improvement, not eroding safe space.

On Amendments 308A and 309, I understand the importance of the HSSIB having predictable budgets for planning, but requiring a three-year budget would cut across the established processes of spending reviews and put it out of step with the confirmation and allocation of budgets across government and other arm’s- length bodies.

Turning to Amendment 310, I reassure noble Lords that the HSSIB’s reports will be published. Organisations will generally be required to respond to the HSSIB’s recommendations and it may publish these responses. In some cases—for example, an investigation into a private provider—it would not be appropriate for the Secretary of State to publish an additional report.

I turn to Amendment 308. In line with the Cabinet Office’s Governance Code on Public Appointments, the chair of the HSSIB will undergo pre-appointment scrutiny by the Health and Social Care Committee. However, the appointment of the chief investigator, which is not a public appointment, will be undertaken directly by the non-executive members of the HSSIB, including the chair, with the consent of the Secretary of State. We believe that this strikes the right balance between scrutiny, accountability and operational independence, without compromising the effectiveness of the board.

Finally, I turn to Amendment 309A. Whistleblowing is a distinct legal concept, with an existing legislative framework to ensure that whistleblowers are protected. The purpose of the HSSIB’s investigations is to identify risks to the safety of patients and address them by facilitating the improvement of systems and practices in the provision of healthcare services in England. A disclosure to the HSSIB concerning patient safety is complementary to but distinct from whistleblowing, so it is right that it should sit outside that legal framework.

However, I reassure the noble Baroness, Lady Kramer, that information shared with the HSSIB to alert it to a patient safety issue will be protected by the safe space provisions if it fulfils the definition of protected material. If, as mentioned in the amendment, a concern is raised that conduct is illegal, we would expect it to be raised with an appropriate person. Similarly, concerns relating to unethical conduct would not be best dealt with solely by the HSSIB. This amendment would risk blurring the lines with other organisations which may be better placed to deal with such matters.

I suspect that I have not given noble Lords as much reassurance as they would like in order not to return to this issue, but I hope I have given them enough that they feel able withdraw or not move their amendments at this time.

Lord Hunt of Kings Heath (Lab)
My Lords, I am very grateful to the Minister—she was succinct but we certainly got the drift of the Government’s arguments. We have had just over an hour’s debate. Ideally, we would have taken this as a separate Bill, as we did in 2019, because these are clearly very complex issues. The heart of it is the tension between the purity of the safe space concept and the statutory duties of a number of officeholders, including senior coroners and the ombudsman. We will not resolve that tonight. The pity of it is that we will move to Report and probably vote on this; I cannot help thinking that there is a need for a proper round-table discussion before that to see whether we can collectively tease out a way forward. Having said that, it has been an excellent debate and I beg leave to withdraw my amendment.

Amendment 308 withdrawn.

Schedule 13: The Health Services Safety Investigations Body

Amendment 308A not moved.

Schedule 13 agreed.

Clause 96 agreed.

Clause 97: Deciding which incidents to investigate

Amendment 309 not moved.

Clause 97 agreed.

Clause 98 agreed.

Amendment 309A not moved.

Clause 99: Final reports

Amendment 310 not moved.

Clause 99 agreed.

Clauses 100 to 108 agreed.

22:45:00

Clause 109: Exceptions to prohibition on disclosure

Amendments 310A and 310B not moved.

Clause 109 agreed.

Schedule 14: Prohibition on disclosure of HSSIB material: exceptions

Amendments 311 and 311A not moved.

Schedule 14 agreed.

Clause 110 agreed.

Clause 111: Restriction of statutory powers requiring disclosure

Amendment 312

Moved by

312: Clause 111, page 98, line 19, leave out from “provision” to the end of line 23 and insert “—
 (i) would be within the legislative competence of the Northern Ireland Assembly if contained in an Act of that Assembly, and(ii) would not, if contained in a Bill for an Act of the Northern Ireland Assembly, result in the Bill requiring the consent of the Secretary of State under section 8 of the Northern Ireland Act 1998.”Member’s explanatory statement
 This amendment makes a drafting change to reflect the fact that consent of the Secretary of State under section 8 of the Northern Ireland Act 1998 is given in relation to an Assembly Bill rather than an Assembly Act.

Amendment 312 agreed.

Amendment 312A not moved.

Clause 111, as amended, agreed.

Clauses 112 to 114 agreed.

Clause 115: Failure to exercise functions

Amendments 312AA and 312AB not moved.

Clause 115 agreed.

Clauses 116 to 120 agreed.

Schedule 15 agreed.

Clause 121 agreed.

Amendments 312B to 312D

Moved by

312B: Before Clause 81, insert the following new Clause—
 “Information about payments etc to persons in the health care sector
 (1) The Secretary of State may by regulations require manufacturers or commercial suppliers of health care products, or connected persons, to—(a) publish information about payments or other benefits provided by them to relevant persons, or(b) provide such information to the Secretary of State.(2) The regulations may make further provision about when and how the information is to be published or provided.(3) The information may, in particular, include information about—(a) a payment or other benefit,(b) the person who provided it, or(c) the person who received it.(4) The regulations may make provision permitting or requiring the further sharing, publication or use of the information.(5) The regulations may impose requirements on manufacturers or commercial suppliers of health care products, or connected persons, about the retention of information relating to payments or other benefits provided by them to relevant persons.(6) The regulations may—(a) authorise the Secretary of State to designate as a “relevant scheme” any scheme under which information about payments or other benefits to relevant persons is collected or published by a person other than the Secretary of State, if the Secretary of State considers that the provision of information under the scheme would render compliance with some or all of the requirements imposed by the regulations unnecessary;(b) create exceptions from requirements to publish or provide information imposed by virtue of subsection (1) where information is provided under a relevant scheme;(c) if such exceptions are created—(i) require a person who holds information mentioned in subsection (1) in connection with the operation of a relevant scheme to provide the information to the Secretary of State;(ii) permit or require the Secretary of State to publish the information.(7) The regulations may impose requirements on a person mentioned in subsection (6)(c)(i) about the retention of information mentioned there.(8) The provision for exceptions that may be made by the regulations includes provision authorising the Secretary of State to grant an exception from a requirement imposed by the regulations in a particular case, on grounds specified in the regulations. (9) The regulations may provide that the disclosure of information under the regulations does not breach—(a) an obligation of confidence owed by the person making the disclosure, or(b) any other restriction on the disclosure of the information (however imposed), other than a restriction imposed by the data protection legislation.(10) Provision made by the regulations may, in particular, be framed by reference to manufacturers or commercial suppliers with a specified connection to the United Kingdom or a part of it.(11) In this section—(a) “connected person”, in relation to a manufacturer or commercial supplier, means a person who has a connection, of a description specified in regulations made by the Secretary of State, with the manufacturer or commercial supplier;(b) “relevant person” means—(i) a person who provides health care in the United Kingdom or a part of it, whether or not under arrangements made by another person, or(ii) another person who carries on activities connected with health care provided in the United Kingdom or a part of it and is of a description specified in regulations made by the Secretary of State.(12) In this section—“commercial supplier”, in relation to a health care product, means a person who supplies the product otherwise than in the course of providing health care;“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018;“health care” means all forms of health care provided for individuals, whether relating to physical or mental health;“health care product” means a medicine, medical device or other product which is supplied or prescribed in the course of the provision of health care;“manufacturer”, in relation to a health care product, means a person who manufactures or assembles the product;“payments or other benefits” includes any payment or other benefit—(a) wherever it is provided,(b) whether or not it is of a financial nature,(c) whether it is provided under a contract or otherwise, and(d) whether it is provided directly or through a third party.”Member’s explanatory statement
 This New Clause would enable regulations to require the reporting and publication of information about payments and other benefits provided to persons in the health care sector by manufacturers and suppliers of health care products.

312C: Before Clause 81, insert the following new Clause—
 “Regulations under section (Information about payments etc to persons in the health care sector): enforcement
 (1) Regulations under section (Information about payments etc to persons in the health care sector) (1) may make provision for the enforcement of requirements imposed by the regulations, including provision conferring on the Secretary of State the power to impose a financial penalty on a person who, without reasonable excuse—(a) fails to comply with such a requirement, or(b) provides information in response to such a requirement that is false or misleading to a material extent.(2) The amount of the financial penalty is to be specified in, or determined in accordance with, the regulations. (3) Regulations by virtue of subsection (1) must include provision—(a) requiring the Secretary of State, before imposing a financial penalty on a person, to give the person written notice (a “notice of intent”) of the proposed financial penalty;(b) ensuring that the person is given an opportunity to make representations about the proposed financial penalty;(c) requiring the Secretary of State, after the period for making representations, to decide whether to impose the financial penalty;(d) requiring the Secretary of State, if the Secretary of State decides to impose the financial penalty, to give the person notice in writing (a “final notice”) imposing the penalty;(e) enabling a person on whom a financial penalty is imposed to appeal to a court or tribunal in accordance with the regulations;(f) as to the powers of the court or tribunal on such an appeal.(4) The provision that may be made by the regulations by virtue of subsection (1) includes provision—(a) enabling a notice of intent or final notice to be withdrawn or amended;(b) requiring the Secretary of State to withdraw a final notice in circumstances specified in the regulations;(c) for a financial penalty to be increased by an amount specified in or determined in accordance with the regulations in the event of late payment;(d) as to how financial penalties are recoverable.”Member’s explanatory statement
 This New Clause would enable provision to be made for the enforcement of requirements relating to information about payments etc to persons in the health care sector, including through the imposition of civil penalties.

312D: Before Clause 81, insert the following new Clause—
 “Regulations under section (Information about payments etc to persons in the health care sector): consent
 “(1) Before making regulations under section (Information about payments etc to persons in the health care sector), the Secretary of State must—(a) obtain the consent of the Scottish Ministers in relation to any provision which—(i) would be within the legislative competence of the Scottish Parliament, if contained in an Act of that Parliament, and(ii) is not merely incidental to, or consequential on, provision which would be outside that legislative competence;(b) obtain the consent of the Welsh Ministers in relation to any provision which—(i) would be within the legislative competence of Senedd Cymru, if contained in an Act of the Senedd, and(ii) is not merely incidental to, or consequential on, provision which would be outside that legislative competence;(c) obtain the consent of the Department of Health in Northern Ireland in relation to any provision which—(i) would be within the legislative competence of the Northern Ireland Assembly, if contained in an Act of that Assembly, and(ii) is not merely incidental to, or consequential on, provision which would be outside that legislative competence.(2) Consent is not required under subsection (1)(c) in relation to any provision if— (a) a Bill for an Act of the Northern Ireland Assembly containing the provision would require the consent of the Secretary of State under section 8 of the Northern Ireland Act 1998, and(b) the provision does not affect, other than incidentally, a transferred matter (within the meaning of that Act).”Member’s explanatory statement
 This New Clause requires the Secretary of State to obtain consent of the Scottish Ministers, the Welsh Ministers or the Department of Health in Northern Ireland (as appropriate) before making provision within devolved legislative competence in regulations relating to information about payments etc to persons in the health care sector.

Amendments 312B to 312D agreed.

The Principal Deputy Chairman of Committees (The Earl of Kinnoull) (CB)
My Lords, in this next group, the noble Baroness, Lady Brinton, is participating remotely.

Clause 81: Information standards

Amendment 298

Moved by

298: Clause 81, page 71, leave out lines 34 to 37
 Member’s explanatory statement
 The intention of the amendment is to retain the existing obligations on NHS England to have regard to standards published under this section. Clause 81 (d)(6B) appears to remove the explicit obligation that previously existed under Section 250(6)(b) of Health and Social Care Act 2012 that NHS England (“the Board”) “must have regard to an information standard published under this section” and replaces it with a power for such obligations to be waived by Regulations.

Lord Hunt of Kings Heath (Lab)
My Lords, we come to a debate on confidentiality of patient data. We debated some of this last week in considering my Amendment 145, on the power to disclose information relating to patients. I think there was general agreement then that public confidence in the handling of patient data by the NHS depends on the safeguards that are put in place. Without that public confidence, the huge potential we can see in the digital transformation of healthcare will not be realised, and that is behind the concerns I have raised in this series of amendments. They are linked together and are designed to probe just how secure patient data is.

Amendment 298 relates to information standards as set out in Clause 81, page 71, line 34, and would leave out proposed new section (6B). I am hoping the Minister will briefly set out the reasons for this proposed new section, how the power is intended to be used and what guarantees are in place in relation to patient confidentiality.

Amendment 299 concerns the importance of maintaining an accredited data access environment. I propose restricting

“existing dissemination of information via access in an accredited data access environment”.

The Bill is drafted on the basis of a departmental

“commitment that GP data will be used exclusively in a Trusted Research Environment”.

I do not think that is sufficient. It is important that the

“new clause amends the dissemination powers of NHS Digital to reflect stated policy and the promises made both to patients and the profession”.

The term “accredited data access environment” is used in my amendment, rather than “Trusted Research Environment” because while research information must be protected, so should information used for planning and managerial purposes.

Amendment 300 relates to shared care records and is aimed at probing

“what progress has been made in relation to the introduction of shared care records”,

the process by which patients can opt out of the record, and the rigour of that process. The potential of shared care records is, of course, a key part of the digital revolution. They allow staff involved in a patient’s care to access health and care records and to provide better joined-up care across different parts of the health and social care system. The problem is that consent for shared care records is basically a postcode lottery. In some places, the patient has not been told what has been created for them and if they do happen to find out, the way they can opt out varies. Some places have interpreted NHSX’s vague information governance guidance to mean a one-stop shop for opting out, whereas other places require patients to go to each different care provider, which is a very difficult and challenging thing to do.

Most people have no idea that the shared care records programme is happening. The application of the national data opt-out, introduced in 2018, is inconsistent in practice and does not prevent many other uses of patients’ data, in respect of which patients already have legal rights to consent. The debacle, twice now, of the Care.data saga shows the importance of getting this right, and of informing the public.

Amendment 304 concerns the soon-to-be-abolished duties of the Health and Social Care Information Centre, to be taken on by NHS England. The clause in question relates to data and the general duties of the information centre. My amendment would

“require NHS England to balance out the needs of research and planning with patient”

opt-out from data use “for purposes beyond direct care”.

My final amendment, 305, is in many ways the most important in this group. Very simply, I believe that patients should be able to see how the NHS uses data about them. My amendment aims to

“allow any patient with a verified NHS login to see a personalised data usage report containing detail of every use of data about them for purposes beyond direct care, and showing how the duties”

of the information centre have been implemented. The only way forward for wider use of NHS patients’ data involves the NHS providing more factual information to patients about those uses. I do not believe that the NHS understands this yet, but I am convinced that we need to make some move down this route if we are really to command the confidence we need to see in the future.

My other amendments, Amendments 302 and 303, really should have been grouped under the Healthwatch debate we had what seems like a very long time ago. The noble Lord, Lord Patel, and I are concerned to see that Healthwatch gets access to all relevant data in order to carry its responsibilities effectively. I hope the Minister will be able to agree to this. I beg to move.

Lord Davies of Brixton (Lab)
My Lords—

Lord Clement-Jones (LD)
Sorry, my Lords—I assumed that my noble friend Lady Brinton was going to speak next.

The Principal Deputy Chairman of Committees (The Earl of Kinnoull) (CB)
Thank you very much for reminding me. I am frightfully sorry. I invite the noble Baroness to make a speech now.

Baroness Brinton (LD) [V]
My Lords, I am grateful to the noble Lord, Lord Hunt, for outlining the amendments in this group, and look forward to my noble friend Lord Clement-Jones’s contribution shortly.

I want to speak particularly to Amendments 298, 299 and 300. Before I do that, I want to support my noble friend Lady Tyler of Enfield and her Amendment 307. I thank the Minister for the meeting last week on children’s issues, and just want to say that my noble friend’s proposal is a neat way of resolving what has been, up until now, a nightmare, through which children at risk of abuse or with other care needs have been missed by officers in different departments using different identifying numbers. A unique identifying number can close that lacuna.

The national plan for open government published a “reset” on health data, and it is worth repeating here its commitment 4, objective 1. Objective 1 is “accountability and transparency”:

“Improving communication and engagement with the public about the access and transparency of health data, and decision-making relating to public health.”
 

It then asks:

“What is the problem that the commitment will address?
 

Civil society groups have raised concerns that health data collected and used by government is not clear, transparent or accountable enough. It leads to a failure of trust between citizens and government.”
 

How right that is. I pick up the points made by the noble Lord, Lord Hunt, on shared care records. There is a definite need for a solution to the problem that he outlined. Opting out is patchy, complex and—worse—inconsistent.

Last year, on part 2 of care.data, the Government decided to change the way they held and used confidential patient data, and thought it appropriate, in the 21st century, just to announce the changes on the web. There was no direct contact with patients about the changes and, unlike the debacle the time before, there was not even a leaflet going to every household. There certainly was not a wider discussion with civil society. Worst of all, there was not even a discussion with GPs. Unsurprisingly, GPs and patients were horrified and the idea was ditched last summer. However, there is one serious long-lasting result. There is now real concern that this Government are trying to be cavalier with patient data, and the NHS does not understand the problems that it is has.

Data collection and sharing are important and have been instrumental in advancing medical capabilities and improving population health. Equally, individuals have the right to understand how and why their health data is being used, and to give permission on any confidential data. Frankly, the wealth of data held by the NHS should be used only for the benefit of the health service and for research; it should not be shared for marketing or insurance purposes, or as a benefit for a provider to make use of outside the original contract, as happened with the big data firm Palantir at the beginning of the pandemic. In February 2021, the tech justice firm Foxglove issued a law suit on behalf of openDemocracy over the NHS contract with Palantir, because of a failure to consider the impact of the deal on patients and the public without an impact assessment or consultation.

If the Government are to live up to their commitment, they need to set up a clear framework on health data with the public that sets out the fundamental principles and responsibilities for assessing whether a data-sharing partnership is in their interests and those of the NHS, while protecting privacy. That is why we need Amendment 298, because new subsection (6B) in Clause 81 appears to remove the explicit obligation that was in Section 250(6)(b) of the Health and Social Care Act 2012 that NHS England

“must have regard to an information standard published under this section”

and replaces it with a power for such obligations to be waived by regulations. That completely contradicts objective 1, “accountability and transparency”, as set out in the national plan, as I outlined at the start.

I will leave my noble friend Lord Clement-Jones to explain how the data can be protected in a much more effective way. Access to health data must be for public and patient benefit. These amendments set out to protect that patient data and put a responsibility on the Government to live up to what they claim they want to do in their national plan.

23:00:00

Lord Clement-Jones (LD)
My Lords—

Lord Davies of Brixton (Lab)
My Lords, I want to speak to this group of amendments—

Baroness Penn (Con)
My Lords, it might be appropriate for the mover of one of the amendments in the group to speak.

Lord Clement-Jones (LD)
I was not being discourteous, but I thank the Minister. We just go along the line of amendments.

It is a pleasure to follow the noble Lord, Lord Hunt, and my noble friend Lady Brinton. Of course, we all recognise the benefits of using health data which arises in the course of treating patients in the NHS for research that will lead to new and improved treatments for disease and for the purposes of public health and health service planning. It has been a great benefit in helping to improve the treatment of Covid during the pandemic.

However, the track record of the department and the NHS in protecting patient data has not been a glorious one. We have heard a few examples. Let us go back to December 2019 and the discovery by Privacy International that the Department of Health and Social Care had agreed to give free access to NHS England health data to Amazon, allowing it to develop advertising and sell new products, applications, cloud-based services and/or distributed software.

My noble friend Lady Brinton talked about the successful case brought by openDemocracy and Foxglove against the department over a Covid-19 datastore deal with big data firm Palantir Technologies for failing to consider the impact of the deal on patients and the public by a consultation and performing a fresh data protection impact assessment on a new deal.

Then, of course, we had the situation last year, mentioned by the noble Lord, Lord Hunt, which has been described as

“the biggest data grab in the history of the health service”

of GP patient data. I pay tribute to the campaigners, including a group of Tower Hamlets GPs who refused to hand over patient data. Ministers first announced that implementation would be delayed until 1 September, and then in a letter to GPs in July last year put the whole scheme on hold, including data collection.

After this bungled approach—the noble Lord, Lord Hunt, used the word “debacle”, which is perhaps more apposite—more than 1 million people have now opted out of NHS data sharing. There is a deep worry here that the Government have learned nothing from the fate of the care.data project. The Government have now had to revise their approach, devise a simpler opt-out system and commit to the publication of a data impact assessment before data collection starts again. They have had to commit that access to GP data will be only via a trusted research environment and to a properly thought-through engagement and communications strategy.

Wade-Gery does acknowledge some of these concerns but if we are going to retain and build trust in the use of health data, we really need a clear governance framework. The Government must gain public trust through honesty, transparency and rigorous safeguards, and the individual must have the right to choose whether or not to share their data and understand how it will be used. I hope that NHSE—and, indeed, NHSD—will take on board the ICO’s recommendations in its audit report of NHS Test and Trace regarding governance and accountability and processor and third-party supplier relationship management, which looks at the policies and procedures that were introduced to keep data secure. There are some valuable lessons to be learned there.

As the noble Lord, Lord Hunt, has described, all health data must be held anonymously and accessed through an accredited data-access environment, designed to cover not only the promised trusted research environment but where data is used for planning purposes.

As to the detail of the amendments in this group, the noble Lord, Lord Hunt, has described them and the patient-centred intent behind them admirably. I will simply lay out the rationale for Amendment 305, tabled by me and supported, I am glad to say, by the noble Lord, Lord Hunt.

The data held by the NHS must be considered as a unique source of value held for national benefit. My noble friend Lady Brinton reinforced that. As it is, NHSE has refused to publish the list of projects and organisations to which it releases data. Retaining control over our publicly generated data, particularly health data, for planning, research and innovation is vital if the UK is to maintain its position as a leading life science economy and innovator.

Having read speeches by Ministers trumpeting the UK’s

“new, bold approach to international data transfers”,

debated the UK approach to data sharing, particularly in the context of the passage of the Medicines and Medical Devices Bill and the Trade Bill, and seen the wording of new international trade agreements, such as that with Japan, I am not at all confident about the Government’s approach to this. Emphasis in coverage of the UK-Japan agreement was placed upon championing

“the free flow of data”.

Health data in particular amounts to a significant national asset or resource with the potential to function as a dynamo in relation to research, innovation and the continued growth of the life sciences, health and care sectors.

It seems that the Government recognise this, but by the same token, we need a guarantee that our health data will be used in an ethical manner, assigned its true value and used for the benefit of UK healthcare. Any proceeds from data collaborations that the Government agree to, integral to any “replacement” or “new” trade deals, should be ring-fenced for investment in the health and care system with a sovereign health fund. It should have governance mechanisms, such as those set out by the Ada Lovelace Institute in Exploring Legal Mechanisms for Data Stewardship last year. Those are the right foundations for health data governance and that is why I have tabled Amendment 305A.

I am not greatly reassured by the recent announcement by the DCMS of the creation of the International Data Transfer Expert Council; it looks rather as though data protection will be low on its list of priorities.

Baroness Tyler of Enfield (LD)
My Lords, I rise to speak to Amendment 307 in my name. I am very grateful to the noble Baroness, Lady Finlay, and the noble Lord, Lord Warner, for adding their names to it. I am also grateful for the support already received from my noble friend Lady Brinton.

As I have argued in earlier debates on this Bill, it is a real problem that measures under Part 2 that aim to improve the sharing of information and data apply only to adults. This is despite the clear need to improve how children’s data is shared between health and social care and also between other agencies, including education and wider local services. The current absence of a single unique identifier makes identification of children who are in touch with multiple services very difficult and is a real barrier to joined-up support. My amendment seeks to address this glaring gap by requiring the Secretary of State to publish plans to use the NHS number as a single unique identifier for children.

Everyone in England and Wales is assigned a unique NHS number at birth or after the first time they interact with NHS services and that number is valid for life. Currently, the NHS number is used to store information on patients within healthcare records. However, we know that children and young people are frequently in contact with other agencies and services which are, more often than not, all using different identifiers. It is no wonder that too many children, including the most vulnerable, fall through the cracks, leading to the tragic and absolutely horrendous examples of extreme child cruelty and death that we have heard about recently.

The 2021 annual report on local children’s safeguarding practice reviews, previously known as serious case reviews, states:

“Much has been written about the continuing barriers to sharing information between safeguarding partners and we found that those issues remain and were highlighted in almost half of all reviews”—
 

I repeat: some 50% of the reviews.

Using the NHS number as a unique identifier would have the following benefits. It would reduce the risk of incorrect identification, improve multiagency working and improve care pathways. It would certainly ease the transition into adulthood, because the NHS number is for life. That NHS number stays with patients wherever they move within the country or between England and Wales. These are really important points.

A key finding of the House of Lords Public Services Committee report on child vulnerability was that

“in most local areas, services working with children are unable to match unique pupil identifiers on the national pupil database with children’s NHS numbers. This limits the ability of early intervention services to reach the most vulnerable children”.

Simon Kenny, the NHS England national clinical director for children and young people, added to these calls, stating that we “definitely” need a unique identifier, and that there needs to be

“a legal framework to enable it.”

This Bill provides just that opportunity.

Both the Children’s Commissioners—Anne Longfield, the previous Children’s Commissioner, and Dame Rachel de Souza—have supported the call for a single unique identifier number for children. I spoke with Anne Longfield about this only yesterday, and she described this approach as a force for good.

I finish by referring to a briefing from the Royal College of Paediatrics and Child Health, for which I am very grateful. It strongly supports a single unique identifier for children using the NHS number and says that it would be utterly transformative in how services address the needs of children and young people, particularly the most vulnerable.

Lord Warner (CB)
My Lords, I have added my name to Amendment 307, introduced so ably by the noble Baroness, Lady Tyler. I have raised this issue from time to time over the past decade or so, including in a spirited correspondence with the noble Earl, Lord Howe, when he was a Health Minister—which shows how long this issue has been kicked around Whitehall. The one number every child has is the NHS number, as the noble Baroness, Lady Tyler, mentioned, but to adopt it means education, social services and possibly police would have to accept it, and—terribly, of course—they would have to modify their IT systems. In short, what we have here is a good, old-fashioned, Whitehall bureaucratic struggle.

However, now the Children’s Commissioner Rachel de Souza has joined in rather powerfully because of all the children missing from schools, many more than before the pandemic. There has been a problem with children missing from schools from well before the pandemic—some going to illegal schools, others being home-schooled, often without much evidence of being taught curriculum subjects. There is now to be a home-schooling register. The Children’s Commissioner has made it crystal clear that she wants all children to have a unique identifying number across the NHS, school and social services. That is the only way these kinds of changes can be made to work. What we have is a situation now where children at risk are put at unnecessary risk because there is no unique identifier across the different services.

Personally, I would not bet on the Children’s Commissioner getting her well-deserved wish. Last week, the Department for Education trotted out its traditional line—that it will introduce the home-schooling register at the “earliest possible legislative opportunity.” But the department was totally silent on the unique identifier issue, which was so important to making this work.

We have had this issue sculling around Whitehall for many, many years. There is now a chance for a decisive Minister, like the noble Lord, Lord Kamall, to do something about it, bang a few bureaucratic heads together and put the NHS number to work protecting children at risk across a range of services. At the very least, it would be helpful if he could consider protecting children through the Government having a pilot scheme to take this idea forward.

Lord Davies of Brixton (Lab)
My Lords, I apologise to the House and the noble Lord, Lord Clement-Jones, in particular; but having sat through nine days of this Committee, I was keen to get stuck in. I wanted to speak on group 10, particularly in support of the amendments of my noble friend Lord Hunt of Kings Heath.

The issue of data is clearly crucial. It is a shame, as was said on the previous group, that there is not a Bill on it in itself; it is worthy of that level of discussion. It is such a shame that we are discussing it now late at night under pressure of time.

23:15:00

I have three concerns about the use of data available from our NHS. I hope the Minister will take on board the concerns that have been widely expressed and indicate a desire to see what can be done to address them. Data is the lifeblood of research, which is important for planning our health service. We know it is essential, but it needs to be handled with the utmost care.

First, it has to be recognised that it is always relatively easy to identify people from even anonymised health records. A war is going on between people who have developed smart programmes which can identify people from minimal information. That very much needs to be kept in mind. The Catch-22 is that we need the information for it to be useful. At the same time, useful information becomes readily identified. It is not just a matter of removing names; it is the way in which different databases are put together. Mobile phone records are clearly a big key here.

Secondly, a single, centralised database cannot be adequately secured against serious attack or accidental breach. It will always be there and always be challenged. The more monolithic it is, the more readily it will be available to be hacked. There are other less risky ways of achieving the data.

Thirdly and most crucially, we need more clarity about what exactly is to be shared. Is it the data or access to the data? If the data is retained by those who acquire it in the first place, it will be much harder for it to get into the hands of a third party. If only the ability to query data is available, it will be much harder to lose control.

These issues are hard and I am sure we will discuss them again. Will the Minister acknowledge the problems and the need for them to be addressed?

Lord Scriven (LD)
My Lords, I would also like to speak quickly on these amendments. The last suite of amendments was about professionals having confidence in the health service. Patient data is the bedrock of individuals and citizens having confidence in their health service and how their data is used. I used the phrase “living in a parallel universe” in Committee a few days ago. Today, the Government published Joining up Care for People, Places and Populations, their proposals for health and social care integration. On reading chapter 4 on digital and data, it would appear that we are living in a parallel universe, because there are clear issues about what the Government say this integration will be. The document states:

“This will ensure each ICS has a functional and single health care and adult social care record for each citizen by 2024”.
 

There is nothing about opt-out. This is a very clear view about what will happen. I will explain why it is a fantasy world in a minute.

I come back to Amendment 300 in the name of the noble Lord, Lord Hunt. There is a really important thing about the standard process for opt-out. In the area where I live, there is a DGH, a teaching hospital, a community care trust, a mental health trust, a maternity unit, a social care provider—it could be the council or from the voluntary and third sector—and my GP. If there is no standardised approach to opt-out, it will be needed in nine or 10 organisations. That is why we need a standard opt-out approach. It is absolutely wrong for the citizen to trail through nine different organisations, probably with nine different processes, if they wish to opt out, because not every citizen may wish to be part of a single health and adult social care record by 2024. I hope that most will, because they are important, but there is the issue of opt-out.

The document goes on to state how data will be used; it goes way beyond individual healthcare. It talks about population health platforms, and how data will be used and can be directed with a single standard from the centre. On information governance, paragraph 4.15 says that

“This will make sure that when it is accessed or provided (for whatever purpose), it is in a standard form, both readable by and consistently meaningful to the user or recipient”.
 

It is good to have it in a standard form but “for whatever purpose” leads to a wider definition. The document also says that the standard will be laid out in the Bill but, as the noble Lord, Lord Hunt, said, that is at the direction of the Secretary of State through regulation, which is worrying.

I ask the Minister, clearly, how this new document fits with the Bill we are discussing. Why, yet again, is a White Paper ahead of the legislation we are talking about today? There are things we could amend that would stop some of the things in this White Paper.

Baroness Jones of Whitchurch (Lab)
My Lords, I will respond to the debate, but my comments apply equally to the next group, so I hope that the noble Baroness, Lady McIntosh, will forgive me if I do not respond to that group separately. We have heard some very thoughtful and persuasive contributions to the debate on these amendments this evening, and once again my noble friend Lord Hunt and the noble Lord, Lord Clement-Jones, have very eloquently led the charge. I congratulate them on their contributions and the constructive detail of their proposals. Issues such as this require some specific proposals to have any meaning and their amendments very much do that: they spell out some solutions to the challenges we face. I also welcome the specific proposal from the noble Baroness, Lady Tyler, who made the case well for a single identifier for children.

The underlying issues around the use of information collected by the NHS are not new. As we know and have heard, the NHS is almost unique in being a single player in this field, at least for some purposes. It can and often does lead the world in its ability to collect and aggregate patient data to drive improvement and for other non-profit-making purposes.

Since the organisational changes of the 1990s, data collection and use have been well developed, and information and analysis—for example, from the Secondary Uses Service and some GP sources—have been extensively used by academics and researchers, as well as operational managers, to huge public benefit. But we have struggled, as we have heard. Despite hugely expensive meanders into, for example, the National Programme for IT, we are far from the goal of integrated data sharing, even in a single hospital, let alone all hospitals, let alone for all care. Clearly, technical, legal and cultural barriers need to be overcome before we can maximise the use of all the data collected.

As noble Lords have pointed out, the groundswell of opposition to data collection and the related concerns about who gets to use it and for what purposes runs along these barriers. We know that the NHS often has dismal communications—for example, around CareCo and the recent changes to the use of GP data, which we have heard about this evening.

Although we do not own our data, there is a very powerful set of legal protections over what data can be collected and stored about us and what it can be used for. If the public had absolute confidence in the systems and usage rules, there would be far fewer objections to their information being used to drive improved healthcare, innovative drugs research or better preventive or public health information programmes. But the reality is that concerns are widespread—about data breaches, about NHS data reaching people who do not need to see it and, more recently, as we have heard, about data being used by a number of unethical organisations and private companies to drive profitability rather than for the improvement of public health.

Many patients would wish to be able to refuse to allow data collected about them to be used simply to drive a better marketing campaign for slimming or cosmetic aids but would allow their data to be aggregated so that better drugs could be developed and treatments improved to save lives; that would be an altogether different matter. Amendment 305A, in the name of my noble friend Lord Hunt, on establishing a sovereign health fund to invest in data-driven healthcare assets to generate long-term income for health and care makes that point, and I am sure it would have public support.

The key principle should be that all data collected for the purposes of care should be held and controlled by the public sector and its use protected. It should be subject to ethical guidelines and independently verified by an expert oversight group. These amendments would strengthen these rights in those regards.

Anyone who visited a hospital 20 years ago and walked around would probably have come across a trolley stacked with files that could easily have been removed or read. However, IT and the ability to aggregate vast amounts of data, allowing serious data breaches, is a modern and valid concern. My noble friend Lord Davies illustrated this with specific concerns about smart programmes which can identify individual people from a very small amount of data about their lives.

So we do feel that these amendments would be a very helpful way to address the underlying and fundamental problems of the lack of patient and public confidence in how their data is going to be used and shared. I hope the Minister, the noble Baroness—no, it is the noble Lord—agrees that these proposals offer a helpful way forward in addressing these concerns. While we will not press the amendments to a vote this evening, I hope he is able to offer some reassurance that some of these practical proposals will be taken forward by the Government.

Lord Kamall (Con)
Let me assure the noble Baroness that I was not trying to opt out of my duty to respond.

I thank all noble Lords for their contributions to this important debate. I reassure many noble Lords across the House that when I first became a Minister, I had many of these questions myself—and I continue to have them, if I am perfectly honest.

I will turn first to the amendments before deciding how to go forward, as it were. In response to Amendment 298, Clause 81 explicitly mentions NHS England as a body to which mandatory information standards can be applied. As set out in this clause, the exact procedure for publishing information standards, as well as any procedure for granting waivers in respect of compliance with these standards, will be set out in regulations subject to parliamentary scrutiny under the affirmative procedure. The regulations may set out limits on the circumstances in which a waiver may be granted. For example, a temporary waiver might be considered where an organisation does not have funding in place to implement the required changes.

The noble Lord, Lord Hunt, also referred to accredited data access environments and rightly acknowledges that their function is not just to support research but for analysis to support service planning, as well as other essential activity. I believe that we are fulfilling our promises to the profession and the public at the moment, but clearly more could be done. We have made clear that data collection for General Practice Data for Planning and Research will now begin only when: first, we have in place the ability to delete data if patients choose to opt out of sharing their GP data with NHS Digital; secondly, a trusted research environment is available, where approved researchers can work securely on deidentified patient data; and, lastly, a campaign of engagement and communication has increased public awareness, explaining how data is used and patient choices.

In addition, the Government have committed to developing, this year, rules for such data environments in the NHS, including technical specifications and a framework for accreditation. However, while we expect secure data environments to be appropriate for the vast majority of uses, there are likely to be exceptions. For example, where patient consent has been given for data to be made available to an external researcher or organisation, or where there is a court order requiring data, it may have to leave the secure data environment. I assure the noble Lord that we will continue to examine how secure data environments operate and are governed, to make sure that they are fit for the future.

23:30:00

Regarding Amendment 300, we remain committed to ensuring that data is used transparently, proportionately and safely. There are strict legal, privacy and security controls on when organisations can share data and for what purposes. Many noble Lords have rightly spoken about concerns in the past. Having the right information at the right time in the hands of health and care professionals, as noble Lords acknowledged, saves lives. We hope that the shared care records will allow those involved in providing care to access health and care records safely, so that they can provide care in a better, joined-up way as people move between different parts of the health and social care system. Allowing people to opt out of shared care records would have serious negative impacts on the effective delivery of care, but, clearly, we must get the balance absolutely right with those who wish to opt out and what that would mean for their standard of care.

Amendment 302 requires providers and commissioners of publicly funded health and care services to collect data relevant to Healthwatch’s functions. This goes beyond the intention of Clause 82. It would create an additional burden on different organisations in the sector, as it would impose further data requirements on multiple organisations. In relation to Amendment 303, it is already the case that any relevant local Healthwatch, or Healthwatch England, can require anonymous information under the proposed powers in Clause 82 as public bodies exercising functions in connection with the provision of health services or of adult social care in England.

Quickly turning to Amendment 304, while I agree with the noble Lord on the importance of NHS Digital having regard to research and planning and individual choice, these amendments are not necessary to achieve this. Clause 83 amends the list of matters that NHS Digital must have regard to when exercising its functions. It adds that NHS Digital must have regard to the need to promote the effective and efficient planning, development, and provision of health services and of adult social care in England. Planning is already included in this, and research is also covered by that wording, as it is intrinsic to those activities. Similarly, NHS Digital’s current requirement to have regard to the need to respect and promote the privacy of recipients of health services and adult social care implicitly includes the individual’s choice to opt out.

On Amendment 305, it is important that people have a choice about how their healthcare data is used and that they can trust that their data and their choices will be treated with respect. The final version of our health and social care data strategy will build people’s trust and confidence in how their data and information are used to improve health and care. The strategy will commit to co-designing, with patient groups and stakeholders, a transparency statement setting out how health and care data has been used across the sector.

On Amendment 305A, to bring investment in data-driven healthcare and bring value back to the NHS from its data, these aims are underscored by key commitments in the Government’s Life Sciences Vision and the draft Data Saves Lives strategy for health and social care. These commitments will better enable data- driven innovation, generating long-term benefits for the NHS, patients and the public. The value return from data partnerships goes beyond direct financial return or income, and includes access to technology that improves patient care, reduces pressure on the NHS workforce, and supports UK companies and taxpayers. Once again, it is important to recognise the patient’s right to opt out and their right to know how their data is being used. Our guidance, Creating the Right Framework to Realise the Benefits for Patients and the NHS Where Data Underpins Innovation, sets out the need for NHS organisations to ensure fair terms for not just their organisation but the NHS as a whole.

I turn to Amendment 307. I am very grateful to the noble Baroness, Lady Tyler, and other noble Lords who attended the meeting last week to discuss this. We recognise that there is a great deal of support for adopting a consistent child identifier; it is seen as key to supporting effective information sharing, but also to making sure that children do not fall between the gaps. The Department of Health and Social Care, the Department for Education and the Home Office are working together to develop cross-government, multi-agency proposals for improving the sharing of information for safeguarding purposes. Clearly, in the context of this debate, many noble Lords would prefer that it was the NHS number: if this were an education debate, the request might well be that it was the education number, and similarly if it were a Home Office debate. We want to get this absolutely right, and the Department for Education will be leading a multidisciplinary deep dive looking at the feasibility of a common child identifier, and we will consider other ways to facilitate the sharing of data through the existing child protection information sharing system.

I have to say, as a bit of a geek and having done databases in the past, that effectively the NHS number is a primary key.

Lord Warner (CB)
I am sorry to interrupt the Minister at this time of night, but I think he has no idea how many Ministers have stood in this place over the last 10 to 15 years making very similar speeches to this. We now have “deep dives”, but the idea of Whitehall co-operating on this issue is always dead in the water after these deep dives, if I may mix my metaphors. What we really need is at least an assurance that some kind of pilot scheme will actually emerge from this deep diving and be put in place so that something actually happens, with all the agencies co-operating.

Lord Kamall (Con)
I thank the noble Lord, first for his earlier confidence in my abilities and now for questioning my abilities, as it were, and rightly so. I am very interested in this, and noble Lords will remember that, in the meeting, I discussed what I saw as technical solutions to this. If there are different primary keys, it does not take a complicated bit of code to give equivalence or, in fact, restricted views, as it were, as appropriate. However, once again, those views would have to be agreed across government: while it might seem appropriate for the Department of Health number or the NHS number to be used, that could give access that is not considered appropriate, and we have to get the right balance. I ask the noble Lord, Lord Warner, to revert back to his earlier confidence in my abilities to do something —assuming I am here for some time.

In the coming months, the Department for Education will be providing an update to the existing information-sharing guidance. We believe that provides a real opportunity. One thing I have been quite clear about—for example, in the life sciences vision—is that I want to work with my counterparts and have been working with my counterparts in other departments; in BEIS, in DIT but also with the adviser in No. 10. I fully recognise the Committee’s interest in promoting data protection, ensuring that patients’ data is used appropriately. We have all been on a learning curve over the years as people share their data on such things as Facebook and now realise what happens to that data, how it is used and sold. I alhso refer to the ownership of data: at the end of the day, the data has to be the patient’s data. They have to be quite clear about that ownership and what happens to it.

All processing and sharing of information under Clauses 81 to 87 will meet the requirements of data protection law, including the UK GDPR. An individual’s personal information will be shared only in specific circumstances: where the individual consents to the use of the data, where there is a legal requirement to share or where sharing such data is necessary. I recognise as well that noble Lords, if we get through this, will be having a meeting tomorrow on confidential data and I hope that we can have some more, deeper conversations, not only tomorrow but in future. I have committed previously to meetings: there is a particular issue with one of the meetings and I will explain that to the noble Lords I spoke to previously about it, but I hope that for now, noble Lords will have some reassurance, although perhaps not complete reassurance, and will feel able to withdraw their amendments at this stage.

Lord Hunt of Kings Heath (Lab)
My Lords, I am very grateful to the Minister. I am conscious of what my noble friend Lord Davies said about the time we have to debate these complex and important matters. Clearly, we would like to reflect on the Minister’s reply, which was constructive and helpful, although I cannot help recalling meetings that I held as a DoH Minister with the Department for Education Ministers in about 2002, where we were discussing this very issue. My noble friend Lady Hughes—Beverley Hughes—was the Education Minister and, alas, nearly 20 years later, here we are still talking about these issues, which is why we are a little pessimistic about the dive that the noble Lord is about to make.

In the end, this is all about public confidence and the balance between the needs of our health and care system and the benefit that accrues from the exchange of, and access to, information. I am alarmed by the figure for opt-outs—a million—and it puts at risk the integrity of having the shared information system. That is a reflection of the challenge that the NHS in particular faces and I still doubt whether it really recognises just what it needs to do. Making opt-out easier is one way in which we build confidence in the system, and it might mean that fewer people opt out in the future. The current system of making it as hard as possible for people to opt out is not the way to grow confidence. That is probably the most important point that I want to make.

Having said that, I thank the Minister for his constructive response, and we look forward to these further meetings. I beg leave to withdraw the amendment.

Amendment 298 withdrawn.

Amendment 299 not moved.

Clause 81 agreed.

Amendments 300 and 301 not moved.

Clause 82: Sharing anonymous health and social care information

Amendments 302 and 303 not moved.

Clause 82 agreed.

Clause 83: General duties of the Health and Social Care Information Centre etc

Amendments 304 to 305A not moved.

Clause 83 agreed.

Clause 84 agreed.

Clause 85: Collection of information about adult social care

Amendment 306 not moved.

Clause 85 agreed.

Clause 86 agreed.

Clause 87: Medicine information systems

Amendment 306A

Moved by

306A: Clause 87, page 80, line 19, at end insert—
 “(e) requiring the Secretary of State to facilitate sharing of information for research purposes.”Member’s explanatory statement
 This amendment would require the linking of information systems to ensure engagement with equivalent international bodies and enable better sharing of data for post-market surveillance.

Baroness McIntosh of Pickering (Con)
My Lords, I support and welcome Clause 87 on medicine information systems. My amendments would simply add to the regulations on information systems. I want to explain why I want to do so and set out how.

Amendments 306A to 306C would require the linking of information systems to ensure engagement with equivalent international bodies and enable better sharing of data for post-market surveillance, and Amendment 306D would require the linking of information systems relating to medical devices to ensure engagement with equivalent international bodies and enable better sharing of data for post-market surveillance of devices. They are intended primarily as probing amendments to enable me to thank and congratulate my honourable friend Anne Marie Morris in the other place, who brought forward these amendments, and to explain why they are needed.



Registries for both medicines and devices are a critical tool in effective commissioning of medicines and in post-market surveillance, which the report by my noble friend Lady Cumberlege rightly noted is essential for patient safety. Although clinical trials can provide some evidence, this needs to be continually updated to ensure that the knowledge is current and that any adverse reactions can be monitored.

23:45:00

This measure would work like a more proactive version of the MHRA yellow card system and would allow us to identify issues with a medicine or device as quickly as possible and to locate all patients who are using it. If a fault develops in a washing machine, for example, we can notify all customers promptly—surely we must be able to do so in the same way if a product that has been installed in our own bodies is identified as faulty.

A devices registry has been hypothetically established in the Medicines and Medical Devices Act, and the Health and Care Bill establishes provision for a similar registry for medicines. Both need to be as inclusive as they can be. Can my noble friend the Minister confirm that, as yet, no devices registry has been established, although I understand that a statutory instrument needs to be laid as soon as possible to deliver one to ensure that patient safety is indeed a priority? Equally, a medicines directory should be created and implemented as soon as possible, and the architecture of both directories needs to enable links to be established with patient data within the NHS to enable health outcomes from individual medicines and devices to be monitored and assessed. An architecture sympathetic to international standards would achieve more than the international reach of these medicines and devices.

Together with the MHRA, the NHS should be obliged to undertake an annual review of any new medicine or device approved by a UK regulator within the preceding 24 months for evidence of abnormal outcomes. In dealing with the reactive discovery of an adverse event, the NHS must put in place protocols and procedures to examine the relevant registries forthwith to determine what action to take; this may be a call for further evidence gathering or recall.

NHS patient data is currently collected and stored in siloes within primary care, secondary care and other systems. The Bill is designed to enable standardised data collection and sharing across the NHS. This must include the NHS and healthcare systems in their broader sense and include public health and social care. The data collected by the NHS, in primary and secondary care, regarding patient experience of these medicines and devices needs to be linked to these directories so that any medicine or device can be monitored and anything adverse identified early. Patient safety has to be paramount. The ease of use by healthcare professionals is crucial if adoption is to be achieved.

Digitisation across all healthcare systems will be necessary, not just nice to have. We need to create a system to ensure patient safety for the long term and to ensure that data-management architecture is put in place to join together the data-gathering processes, registry format and storage protocols, as well as to enable inquiries of it, both to support research and, again, to ensure patient safety, using robust data-mining techniques. The critical path must focus on the outcomes to be achieved rather than simply on collating information that is already being gathered.

Finally, on medical research, the Bill currently has provision for better data sharing between primary and secondary care. However, health data is the building block for medical research, and, without it, new medicines simply will not happen. Medicine development requires access to real-world data, alongside data from clinical trials—which we discussed earlier. Therefore, the data collected by the NHS needs be securely anonymised so that it can be used for research without fear of compromising patient confidentiality. To achieve this, NHS England must develop a new system to securely anonymise data and to establish access to ensure that that data can be accessed for research purposes. I understand that the department is already undertaking work to anonymise this data and, therefore, my request is that we put in place a system which maximises the data which can become available for research, rather than adopt a minimalistic approach focused merely on today’s research priorities.

These four modest amendments before us this evening are intended simply to plug a gap and loophole in the current Clause 87. I beg to move.

Lord Clement-Jones (LD)
My Lords, I rise very briefly to speak to this amendment. I have considerable doubts about it. In relation to patient data, it looks like a possible thin end of a wedge—in fact, it might even be the thick end of a wedge.

I take this opportunity to come back to the Minister to add a query about the data governance regime which he has described this evening and into which we dipped our toe with the last group of amendments. My noble friend anticipated me in discussing the White Paper, which, in turn, follows from the Data Saves Lives draft strategy. I hope we will have the opportunity to meet the Minister to discuss this further because it is a very complex area.

I want to add to that conversation the fact that we variously have IGARD, CAG and the National Data Guardian for Health and Care—as well as NHS Digital, which we hope will remain separate, but we will come to that shortly. We have all these different bodies, but we need a simple regime which helps us understand, for instance, whether the Minister will say, “Yes, it’s already happening”, to the noble Baroness, Lady McIntosh, or, “No, it’s not going to happen.” I could not tell you the answer to that question in my current state of knowledge about the ability to transfer information across the health service and internationally.

There is a balance to be struck between the established protections and new provisions which might expedite the development of access to new and improved treatments and technologies—but it must be done in a safe way. I hope that, between Committee and Report, the Minister will take the opportunity to ensure that we have all the information we need on plans to perform a so-called reset of or new direction for—or however he might like to describe it—the NHS’s use of our health data.

Lord Kamall (Con)
I am grateful to the noble Baroness, Lady McIntosh, for bringing this discussion before the Committee. I also thank the noble Lord, Lord Clement-Jones, for his contribution. The information collected by the future medicine information systems has the potential to be used appropriately to support relevant research and improve the way in which we monitor medicines across the UK. However, once again, referring to the previous debate, we must be quite clear about whose data that is and the right to opt out.

Exchanging information with both national and international institutions is already integral to the MHRA’s post-market surveillance activities. Appropriate sharing of data from medicine information systems and medicine registries could also help support wider research to directly inform regulatory decision-making and to further support patient safety. Once again, we must respect patients’ concerns and their right to opt out.

The clause already provides the necessary power, by inserting new subsection (7A)(2)(c), enabling regulations to be made about the use and disclosure of information held within medicine information systems.

In regard to the noble Baroness’s admirable desire to ensure international co-operation with other bodies for post-market surveillance, medicines information systems will be established to support the MHRA developing medicine registries. As the regulatory authority, it is the MHRA’s international collaboration, rather than the information centres’, that will be key to supporting post-market surveillance. To ensure that this can continue, there are already specific powers in the Medicines and Medical Devices Act which enable the Secretary of State, and by extension the MHRA, to appropriately share information with international partners. Once again, going back to a previous debate, it is about what is an appropriate sharing of data.

As with medicines information systems, we already have sufficient legal powers to appropriately share. On the second element of this amendment, the existing provisions in Section 19, specifically Section 19(2)(c), enable regulations to address the use and disclosure of information held within medical devices information systems, providing an ability to appropriately share information within a future system. There will need to be careful consideration and consultation on the sharing and use of information, as we have previously said. However, there is a beneficial impact that the system could have in research and post-market surveillance.

In response to the specific question, I recognise the desire to see a system set up under the regulation-making powers in place, but given the importance of this matter, it is crucial—I hope that the noble Baroness reflects on the previous debate—that we take the time to get this right. Any regulations made under Section 19 and the wider system will need to be informed by extensive engagement and consultation, working closely with our partners in the devolved Administrations, so that they can deliver their full potential for patients and clinicians across the UK, taking account of the very real concerns raised about patient data. Once again, we are trying to get that balance right: better healthcare and better research feeding into health, but at the same time patients having the right to opt out.

NHS Digital is well placed to deliver and operate the medical devices information system. Alongside key partners, such as the devolved Administrations, we will consider how we can establish this system in a controlled, staged manner that builds on the confidence and momentum behind this issue.

Finally, I will be moving Amendment 306AA in my name. The amendment is supported by the Scottish Government; it is simply a clarification in wording. It makes clear that any powers or duties conferred on Scottish Ministers in relation to their role in collecting information for medicines information systems can be treated in the same way as other NHS powers or duties in Scotland and be delegated to health boards in Scotland. It is my sincere intent not only to respect the devolved settlement but to create the best possible system, one that will work UK-wide. This amendment supports that aim. It is for that reason that I ask noble Lords to support this amendment and invite my noble friend to withdraw hers.

Baroness McIntosh of Pickering (Con)
My Lords, I am grateful to my noble friend the Minister and the noble Lord, Lord Clement-Jones, for their contributions. I quite understand that my noble friend feels that there has to be a proper consultation, mindful of the sensitivity of patient data. I remember that being discussed during the passage of the Medicines and Medical Devices Bill in this place. It would be helpful to have an idea of what the timetable is for the consultation period and the introduction of the regulations. I do not know if my noble friend is able to put a timetable on that. Perhaps he could do that when we meet at the round table; it would be extremely helpful.

I am grateful for the reassurance he has given and for the opportunity to have aired the issues this evening. At this stage, I beg leave to withdraw the amendment.

Amendment 306A withdrawn.

Amendment 306AA

Moved by

306AA: Clause 87, page 80, line 40, at end insert—
 “(b) provide for powers or duties conferred on the Scottish Ministers to be treated for the purposes of section 2 of the National Health Service (Scotland) Act 1978 as functions relating to the health service (within the meaning of that Act).”Member’s explanatory statement
 This amendment enables the Scottish Ministers to delegate functions conferred on them under medicine information systems regulations to certain health bodies in Scotland.

Amendment 306AA agreed.

Amendments 306B to 306D not moved.

Clause 87 agreed.

Amendment 307 not moved.

00:00:00

Clause 88: Relevant bodies

Amendment 227

Moved by

227: Clause 88, page 83, line 6, leave out paragraph (b)
 Member’s explanatory statement
 The Government has announced that it will be using the powers in this Clause to merge NHS Digital and NHSX to form part of the new Transformation Directorate within NHSE. The Health and Social Care Information Centre is an executive non-departmental public body created by statute, also known as NHS Digital. This amendment which would prevent this happening to the Health and Social Care Information Centre, is designed to probe what safeguards are being built in to protect patient data.

Lord Clement-Jones (LD)
My Lords, it is regrettable that we are dealing with the very important Clauses 88 and 89 at this time of night—and obviously it is regrettable that the House has to have me as a poor substitute for the noble Lord, Lord Hunt.

These amendments relate to the abolition of the Health and Social Care Information Centre and the implications for the integrity of patient data. Clauses 88 and 89 give the Secretary of State powers through regulations to transfer a function from one relevant body to another, and the relevant bodies are defined as Health Education England, the Health and Social Care Information Centre, the Health Research Authority, the Human Fertilisation and Embryology Authority, the Human Tissue Authority and NHS England. Other than NHS England, each of those bodies can be abolished under the clause as the result of a transfer of functions.

Amendment 227 to Clause 88 refers to the abolition of the Health and Social Care Information Centre. The Government have announced that they will be using the powers in that clause to merge NHS Digital to form part of the new transformation directorate within NHSE, and of course we have seen that NHSX has now been abolished and the relevant personnel have moved into the transformation directorate. The Health and Social Care Information Centre is an executive non-departmental public body created by statute, usually known by the term “NHS Digital”. This amendment, which would prevent that from happening to the HSCIC, is designed to ensure that NHS Digital continues as an entity to safeguard patient data. The merger of NHS Digital with NHSE risks losing the skills and experience that currently sit within NHS Digital. I have mentioned that NHSX has ceased to exist.

There are two risks for patients. One is that important knowledge and skills will be lost as talented people leave the organisation and time is devoted to the nuts and bolts of making the organisation function rather than on achieving its aims. The other is that the new merged organisation will just be too big and unwieldy to respond in an agile way to major challenges such as workforce planning and digital innovation. If NHSE leaders understand how important these challenges are then they will be able to prioritise them and make them part of the organisation’s core function.

I turn to the functions of the statutory safe havens in relation to Clause 89. Part 9 in Chapter 2 of the Health and Social Care Act 2012 lays out the functions and obligations of what is described as the statutory safe haven for patient data from across the health and social care system required for the production of national statistics and for commissioning, regulatory and research purposes, in addition to supporting patient care. Amendment 228 seeks to keep these statutory protections in place and ensure that NHS England does not take on that responsibility, because of a potential conflict of interest in its role.

The bottom line is that we need to retain NHS Digital’s statutory safe haven functions separate from NHS England. As the BMA has said, it is of the utmost importance to retain a quasi-autonomous body for the purposes of collecting, storing and distributing sensitive patient data—something that would be lost under a merger of NHSD and NHSE.

There is one other major advantage of keeping NHS Digital as the digital safe haven. The statutory safe haven’s legal name is the Health and Social Care Information Centre, so there is some obligation to social care. NHSD has always given some thought to integration, even when there was very little on the social care side to integrate with, and little interest from NHSE in doing that work itself. If it all gets merged into NHSE then how will the obligation to collect social care data continue to exist, since NHSE’s responsibility is to the NHS? If this transfer of functions takes place, who will be responsible for the national collection of social care data? Each bit of the social care world will see NHSE as a different entity from NHS Digital. What are the Government’s joining-up plans in respect of the future governance of this kind of data? I beg to move.

Lord Patel (CB)
My Lords, I shall speak to my Amendments 229 and 230. I thank the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Walmsley, for adding their names to them. The House of Lords Constitution Committee report on the Bill raises serious concerns about the range of Secretary of State powers in the Bill and concludes that these new powers, coupled with new powers for the Secretary of State of oversight, delegation and transfer of function,

“could alter the balance between the Government’s constitutional responsibility for the provision of health care and providers’ ability to function in a manner that can respond effectively to local needs. It also risks undermining accountability by making it more difficult to understand which body is responsible for a particular function of the NHS.”

That is a claim that we must take seriously.

All the amendments in the group are important but, as has already been said, the hour is late and we need to rush so we cannot discuss them fully.

As the Bill is drafted, the Secretary of State would have the power to confer, abolish or change the function of a list of bodies that includes NHS England, Health Education England and the Human Fertilisation and Embryology Authority, to name but a few. One safeguard included in the Bill in relation to NHS England is that the Secretary of State would stop short of changes that would make NHS England redundant—but “redundant” is not defined. However, nothing on the face of the Bill sets out how high or low that bar would be set.

I recognise the logic of the Secretary of State having powers to confer responsibilities on arm’s-length bodies via secondary legislation. However, these new powers are far more extensive than that, and there is a real danger that their application could threaten the operational independence of key parts of the NHS. The Secretary of State should not have the power to abolish a body such as the Human Fertilisation and Embryology Authority, or to transfer the majority of its powers. Health Education England and the Health Research Authority were established through the Care Act 2014. If the Secretary of State believes that any of these bodies should be abolished or have functions removed, Parliament should have the opportunity to debate and understand why he desires to take that action, hence my amendment to reduce the scope of these powers and remove the Secretary of State’s powers.

Lord Warner (CB)
My Lords, after consultation with the clerks and for the convenience of the Committee, I have moved my Amendment 318 into this group. Before I speak to it, I say that, as a person who has culled a few quangos in his time, I think that the amendments in the names of the noble Lords, Lord Hunt, Lord Clement-Jones and Lord Patel, are important. Even I never had the nerve to actually abolish bodies set up by Parliament just because I thought that it would be a good idea. That seems to be the approach taken in some parts of this legislation. It is worth bearing in mind a point made already: that attracting skilled professional staff to many of these bodies would be much more difficult if they were in an omnibus body such as NHS England. Many high-quality professionals would not want to work in that environment.

The purpose of Amendment 318 is simple: to delay implementation of Parts 1 and 3 of the Bill until the Government have reduced substantially the huge backlog of patients awaiting NHS diagnosis and treatment. The amendment is based on the proposition that, however meritorious the NHS reorganisation that the Government propose is, implementing it when they have told the NHS that their top priority is reducing the backlog seems a considerable risk. As a former Health Minister, I regard this as highly ill-advised and not in the best interests of patients. Let me briefly set out the arguments.

In its report of 1 December, the NAO made clear the unprecedented scale of the backlog that the Government have finally faced up to. It has taken over two months for the Government to come to Parliament, which they did yesterday, to acknowledge the true scale of the backlog. Some 6 million patients are now known to be on the NHS waiting list; 300,000 of those have waited for over a year, and 18,000 for over two years. But the NHS data tells only part of the backlog story, as the NAO pointed out over two months ago. We know that 10 million patients have not come forward during the pandemic. The Health Secretary has acknowledged that it is unclear

“whether it will be 30% or 80%”

of this 10 million who come forward. We do not know how many of these people will request treatment. The Health Secretary said:

“Even if half of these people come forward, this is going to place huge demand on the NHS”.— [Official Report, 8/2/22; col. 805.]
 

The Institute for Fiscal Studies forecast

“a likely peak of between 8 and 11 million”

people on NHS waiting lists.

What will the new NHS plan do to deal with this? It says that the waiting lists should start to fall “around March 2024”. But that assurance is without knowing the true size of the waiting list, as the Secretary of State acknowledges. The Treasury—the good guys in all of this—wanted more ambitious NHS targets. Instead, the NHS has been allowed to retain a March 2025 deadline for dealing with the 300,000 patients waiting more than a year for treatment. This is the situation in which the Government are trying to introduce a major reorganisation of the NHS, and that is why I have put forward this amendment, which would defer implementation of Parts 1 to 3 of the Bill.

The Government, approved by Parliament, will be asking NHS staff to be pre-occupied with implementing the changes made in this Bill, while often changing jobs as new integrated care bodies and partnerships are established and made to work. The Government are asking them to do this at the same time as they are working to reduce this huge, unprecedented backlog of patients needing diagnosis and treatment.

When he took office, the current Health Secretary’s instinct was to scrap the Bill, and when it began its passage through Parliament the actual scale of the backlog was not known. The Health Secretary needs to return to his initial instinct, which was very sound, and postpone its passage. If he does not, he will be putting many NHS patients at unnecessary risk. I suspect the Minister will tell us that in many areas the boards and partnerships are ready to go. If he does, I would be interested to have a list of those areas, to save a parliamentary Question. If that is the Government’s position, I would be interested to know why the NHS has been allowed to do this before the Bill has been approved by Parliament and the expenditure authorised. Despite the dubious legality of implementing before Royal Assent the changes made in this Bill, Amendment 318 avoids unscrambling what I might call illicit reorganisations.

It is the job of this House to get the Commons to think again. That is what this amendment does. It does not wreck the Bill; it simply defers implementation until the NHS has the huge backlog of treatment under better control. I beg to move.

00:15:00

Baroness Walmsley (LD)
My Lords, I added my name to Amendments 229 and 230 from the noble Lord, Lord Patel, to limit the Secretary of State’s powers in Part 3 of the Bill to transfer or delegate functions. Part 3 as it stands would give the Secretary of State a wide range of powers to abolish or modify the functions of a body without primary legislation. That goes to the heart of the matter. I share the concerns of the Constitution Committee. In the absence of proper parliamentary scrutiny, it is necessary to narrow the scope of these powers. To this end, the two amendments would remove from scope the power to abolish a function of the body, the power to change the purpose or objective of a body and the power to change the conditions under which the body works.

The amendments go to the heart of what the Government are trying to do in Part 3. We will come to the wholesale removal of Part 3 in the next group but, for now, will the Minister explain why these powers are needed, why they need to be so broad in scope and why the Government are so frightened of Parliament that they do not want to give Peers and MPs an opportunity to make a judgment on their justification? It would be helpful if the Minister could say how it is anticipated these powers will be used. Give us some examples, please.

I also support Amendment 318 in the name of the noble Lord, Lord Warner. The Minister may recall that at Second Reading and at the beginning of Committee stage, five exhausting weeks ago, I expressed similar concerns about the ability of the NHS to cope with this wholesale reorganisation at this time. The NHS has been in crisis for the last two years and the noble Lord, Lord Warner, has laid out clearly the extent of the backlog—as far as any of us know about it. There is a big difference between 30% and 80%. The Secretary of State himself makes it clear that he knows that the backlog will go up before it comes down again. We have what we call “the dark backlog”; we do not know how many people are going to come forward.

There is also the issue of the pre-emption of Parliament, as the noble Lord, Lord Warner, suggested. A lot of these bodies have been set up and we do not know whether Treasury rules have been broken by the expenditure of money in their setting up. Perhaps questions will be asked about that. I hope that the Minister will bear in mind what the noble Lord, Lord Warner, said in conclusion. The amendment is not intended to destroy the Bill, but to delay it to a point when the NHS can cope with it, without damage to patients.

Baroness Merron (Lab)
My Lords, this is a mixed group of amendments and it has been extremely helpful to hear from noble Lords about the various aspects. I thank the noble Lord, Lord Clement-Jones, for introducing the group.

Amendment 227 is about the powers to merge NHS Digital and NHSX into the new transformation directorate of NHS England. It would also allow the health and social care information centre to be swept up in the changes. This amounts to the abolition of the health and social care information centre and I look forward to hearing from the Minister about the implications for the integrity of patient data and what safeguards might be applied.

I draw the Minister’s attention to the article in the Health Service Journal on 8 February entitled “Revealed: How NHSE’s New Transformation Directorate Will Operate”. It sets out how this new transformation directorate will function and how all the appointments have already been made despite Parliament having not yet completed its deliberations. It would be helpful to hear from the Minister on this point.

Amendment 228 modifies the power to transfer functions. It has already been argued that this power function should not be given so lightly. The amendment emphasises that point.

In the previous debate, we heard some excellent contributions about patient data and the need for safeguards but also about the need for public confidence in the systems, process and governance. It is far from clear that the changes to allow the Secretary of State to take powers in this complex and contested territory are at all wise.

I thank the noble Lord, Lord Patel, for Amendments 229 and 230, which seek to limit the scope of the powers of the Secretary of State. Since we continue to oppose these additional powers of the Secretary of State altogether, we certainly acknowledge the need to limit that scope, as defined within the amendments.

Amendment 318 is in the name of the noble Lord, Lord Warner, who has set out the scale and the reality of the challenge of waiting lists and how that affects the wisdom or otherwise of the Bill and its timing. I emphasise that we are now talking about reducing numbers on a waiting list to below 1 million, but that is not only due to Covid. The NHS went into the pandemic crisis of waiting lists with a pre-existing crisis of its own. It is important that the Minister addresses the fact that this has been going on for some time. Just how long it will really take for the recent recovery plan to reduce the length of the waiting lists for hospital treatment below 1 million is far from clear. As we have heard, this amendment rightly highlights the points about the pre-emption of Parliament and the fact, which we have raised on several occasions, in the Chamber and in meetings, that appointments have already been made ahead of Parliament coming to a conclusion. That remains a matter of concern, as the Minister is well aware.

The remaining amendments in this miscellaneous group are those from the Government, which are consequential on obligations and relations with the devolved Administrations. We were advised by the Minister that these would be forthcoming, somewhat late on in consideration of the Bill. We thank the Minister for advising us, but we cannot support these amendments as our position relates to the original clauses to which they relate, as they are not ones with which we find favour. I hope that the Minister will reflect and respond on the points raised in this debate.

Lord Kamall (Con)
My Lords, as many other noble Lords have said, this group contains a range of amendments in relation to the power to transfer the functions of the arm’s-length bodies. Because some of the bodies within the scope of this power perform functions in areas of devolved competence, Clauses 88 to 94 engage the legislative consent process. To ensure that we can proceed on a UK-wide basis, the Government have agreed to make a number of amendments, while recognising the comments of the noble Baroness about support for those amendments. Following the recent conclusion of our negotiations with the devolved Governments, I am pleased that they have now recommended to their respective legislatures that legislative consent Motions be granted provided that these amendments are accepted.

Amendments 231A and 231B will remove devolved Ministers, the Northern Ireland Department of Health and Welsh NHS trusts from the list of appropriate persons to whom property rights and liabilities can be transferred through a transfer scheme, following a transfer of functions. Following a request by the devolved Governments, we determined that it would not be necessary for such a transfer to those entities to occur.

Proposed Amendment 231C creates a requirement for the Government to obtain the consent of the devolved Governments for any transfer of functions that are within the competence of their legislatures or that modify functions exercised by Welsh Ministers, Scottish Ministers or a Northern Ireland department. While the majority of the functions within the scope of the power relate to reserved matters or apply in England only, certain bodies have functions that meet the criteria laid out above. This requirement to obtain the consent of devolved Ministers replaces the requirement to consult them. The Secretary of State will still be required to consult any body to which the regulations relate and can consult such other bodies as the Secretary of State deems appropriate. A memorandum of understanding is currently being finalised that sets out how the devolved Governments will be engaged from an early stage of policy formulation.

Amendments 231D to 231G are consequential on the changes to Clause 94 made by Amendment 231C. We have also agreed with the Welsh Government to make Amendment 227A, which clarifies that the powers in Part 3 of the Bill apply only in relation to England-only and cross-border special health Authorities and not Wales-only special health authorities. It has never been the Government’s intention for references in Part 3 of the Bill to special health authorities to include Wales-only ones. This amendment simply makes that explicitly clear.

I would also like to provide some reassurance to the devolved Governments about Clause 91(6), which sets out that the consequential provision that may be made when making regulations to transfer functions includes consequential changes to devolved legislation. The reason this is necessary is that there are references to the relevant arm’s-length bodies in devolved legislation that may need to be amended to reflect a transfer of functions or the renaming of a body. Amendments to devolved legislation under this power may be made only if they genuinely flow from a transfer of functions. This is not a broad power to make sweeping substantive changes to devolved legislation.

In a similar vein, we want to provide assurance to the devolved Governments about Clause 149, which is a wider power to enable the UK Government to make consequential amendments that may be necessary following the passage of the Bill. This type of power is quite common in a Bill as large as the Health and Care Bill and there are many examples of similar powers in legislation already on the statute book. Amendments, including amendments to devolved legislation, under this power may be made only if they are genuinely consequential upon provisions within the Bill. Like Clause 91(6), this is not a broad power to make sweeping substantive changes to devolved legislation.

I now turn to Amendments 229 and 230 relating to Clause 91 that have been spoken to by the noble Lord, Lord Patel. Clause 91 does not create powers in and of itself. Rather, it sets out certain types of provision that may be made when the Secretary of State uses the power to make consequential provision where making regulations under the Bill—Clause 150—alongside the power to make regulations under Clauses 89 or 90 transferring or delegating functions. Anything done under the powers to which this clause relates, therefore, would need to be genuinely consequential, supplementary or incidental to a transfer or delegation of functions.

It is impossible to predict every consequential provision that may arise from a transfer of powers and functions. Therefore, it is appropriate that the list in Clause 91(1) should be non-exhaustive, and include provision for abolishing and changing functions, as well as conferring them. Any changes would be made under the affirmative procedure, allowing Parliament to scrutinise them, and I hope the noble Lord will feel that he does not need to press his amendments.

I turn now to Amendment 227 and 228, tabled by the noble Lord, Lord Hunt, and spoken to by the noble Lord, Lord Clement-Jones. The merger of NHS Digital and NHS England was a recommendation of the Wade-Gery review. The aim is to give NHS England overall accountability for leading the transformation of digital services in the NHS, which includes how we use data effectively and securely.

Years ago, when I did my master’s in information systems management, one of the things we found out about companies or push-back companies was that digital and technology should not be separate or a bolt-on. They should be an integral part of the strategy and NHS Transformation tells me how integral technology is to transformation. If you consider it a bolt-on, it will not be integral to the overall strategy. To quote from Putting Data, Digital and Tech at the Heart of Transforming the NHS:

“data and analytics must become a core capability for NHSEI and the wider healthcare system going forward … Currently, this capability is split across NHSEI, NHSX and NHSD and, as a result, is being underutilised with duplicated activities, investments and capabilities.”

The report makes clear the benefits of these proposed changes.

There is also no question of diluting the current patient data protections. The planned merger will largely be achieved through a transfer of functions, staff, services and platforms from NHS Digital to NHS England. The Government will continue to hold NHS England to account for delivery of these functions, just as it currently holds NHS Digital to account. None of the changes we are making will remove the protections in respect of patient data.

I thank the noble Lord, Lord Warner, and the noble Baroness, Lady Walmsley, for for moving their amendment into this group. Placing these kinds of constraints on the Government’s power to commence legislation would be both unusual and counterproductive; we believe that our elective recovery delivery plan, which was announced yesterday, is better suited to solving the issues in this debate. We have committed an additional £2 billion this year, plus a further £8 billion, and laid out how we expect to tackle the backlog. As the noble Baroness, Lady Merron, rightly said, there was a backlog before, and we would have been tackling it earlier had it not been for Covid. We intend to deliver on our proposals, and those in the 2019 NHS Long Term Plan.

00:30:00

Joint working arrangements have been in place, though not on a statutory basis, for some time—one of the reasons this Bill was called for was for them to be on a statutory basis. Delaying the implementation of these reforms would undermine the ability of local health systems to tackle the challenges of recovery, including bringing down waiting times.

This Bill is evolutionary, not revolutionary; it builds on many changes, and we believe that blocking the implementation of its key elements could do more harm—completely the opposite effect, I am sure, to those intended by noble Lords in this amendment. For these reasons, I ask the noble Lord to withdraw his amendment and other noble Lords not to press theirs on all these issues, but if further discussion is needed, I am happy to come back.

Lord Clement-Jones (LD)
My Lords, the Minister will probably get the “Just a Minute” prize for the evening. I will not try to reply to all the amendments, purely those tabled by the noble Lord, Lord Hunt, to which I have spoken. However, if ever I saw candidates for return on Report, they are those in this part of the Bill, in all respects that have been spoken to this evening. This is an extremely unsatisfactory part of the Bill, which gives far too much power to the Secretary of State.

However, I thank the Minister for his response. He looked rather baffled when I spoke to Amendments 227 and 228—perhaps because Dr Wade-Gery, who is its chair, unaccountably suggested that she did not really understand the dual function of NHS Digital. It is rather extraordinary. It is a dual function; neither I nor the noble Lord, Lord Hunt, have any quarrel with the transfer of digital capabilities to NHS England—it is the safe haven aspects, a really important second function of NHS Digital, that we object to. In moving all the data across to NHS England, it will no longer have the independence and objectivity of NHS Digital. It is a really backwards step in data governance.

We can have the digital transformation and data-analytical capabilities within NHS England, but I fear we will not have the same safeguarding of the actual data that we have at the moment. Even that is not satisfactory, as the Minister has heard this evening. That said, we will no doubt return to that in conversation and I beg leave to withdraw Amendment 227.

Amendment 227 withdrawn.

Amendment 227A

Moved by

227A: Clause 88, page 83, line 10, at end insert—
 “Special Health Authority” means a Special Health Authority established under section 28 of the National Health Service Act 2006.”Member’s explanatory statement
 This amendment makes it clearer that the powers in Part 3 of the Bill apply only in relation to England-only and cross-border Special Health Authorities (and not Wales-only Special Health Authorities).

Amendment 227A agreed.

Debate on whether Clause 88, as amended, should stand part of the Bill.

Member’s explanatory statement

This is part of a group that would remove part 3 from the Bill. It would prevent the following bodies being abolished: Health Education England, Health and Social Care Information Centre, Health Research Authority, Human Fertilisation and Embryology Authority, Human Tissue Authority.

Baroness Merron (Lab)
My Lords, Part 3 of the Bill has seven clauses: Clauses 88 to 94. This group of amendments seeks to oppose each of them and has been tabled in the name of my noble friend Lady Thornton. The title of Part 3 is:

“Secretary of State’s Powers to Transfer or Delegate Functions”.
 

It puts into legislation what is proposed in the Integration and Innovation White Paper, which was justified by reference to the need to be able to respond rapidly and —once again, we see this word—flexibly.

It is a fair observation that the existence of multiple arm’s-length bodies is a side-effect of the more modern NHS, as we see more distancing from government. Some of them have worked better than others and, of course, some are listed specifically in the Bill. So the question for the Minister is: why does the Secretary of State need the broad powers outlined in the Bill to intervene in the running of these arm’s-length bodies, and why now? In the White Paper, in Committee in the other place and since, nothing has come forward to explain why giving even more powers in this way can be justified, so it would be most helpful if the Minister could illustrate what would happen were these powers not granted to the Secretary of State.

Of course, there is a danger here. If the arm’s-length bodies know that they are subject to these powers, they will inevitably become a lot less arm’s-length and less able to fulfil the functions for which they have been established. I venture to suggest that this is about consolidation of power at the top while pushing accountability down or further away, and I would welcome the Minister’s observations on this.

Throughout the deliberations of this Committee and the Committee in the other place, numerous concerns have been expressed about giving greater powers to the Secretary of State. Unless a compelling case is made and appropriate safeguards built in, I believe it is right that we oppose these clauses standing part of the Bill. I beg to move.

Baroness Walmsley (LD)
My Lords, the 2012 Act removed certain powers from the Secretary of State, and Jeremy Hunt, the former and longest-serving Secretary of State, says that he never felt the lack of them. He had all the levers he needed to carry out his role of ensuring that the mandate and the five-year forward view were carried out and responsible to Parliament. However, Part 3 of the Bill puts a whole lot back—and more. These powers appear all over the Bill but particularly in Part 3, and we have spent the last five weeks pushing back against most of them.

There is a real danger that, if the Secretary of State were to use these powers, it could threaten the stability, proper management and operational independence of key parts of the NHS. The Constitution Committee raised serious concerns about the range of Secretary of State powers and concluded that the new powers

“could alter the balance between the Government’s constitutional responsibility for the provision of health care and providers’ ability to … respond effectively to local needs.”

I make no apology for the fact that I have quoted this section of the committee’s report before. It applies to so much of the “We know best” power grab that it bears repeating.

If the Minister wishes to abolish, change or transfer functions between arm’s-length bodies to this extent, it should be scrutinised by Parliament. Should it be necessary and appropriate in the future to make these changes, the Secretary of State should find another piece of primary legislation in which to do it. But to take these overreaching powers with no indication of how they will be used—or why—is going too far.

Lord Kamall (Con)
I thank both noble Baronesses for bringing this debate before the Committee. The proposal is to remove Part 3 of the Bill entirely. I understand that the noble Baronesses are principally concerned to prevent Health Education England, NHS Digital, the Health Research Authority and the Human Fertilisation and Embryology Authority from being abolished as a consequence of this power.

I clearly understand the concerns in this debate, but I stress that this is not a power to take away services currently being performed by arm’s-length bodies. The power is to enable the transfer of functions between arm’s-length bodies, and the delegation of the Secretary of State’s functions to arm’s-length bodies, to improve consistency and coherence in the arm’s-length body landscape. There is no free-standing power simply to abolish an arm’s-length body contained in this clause, and it is not the Government’s primary intention to use this power to abolish bodies. The only circumstances where a body may be abolished under this power is where it is, as the result of transfers of its functions to other bodies, effectively rendered redundant. To not have the power to abolish such bodies in these circumstances would effectively leave shell arm’s-length bodies with no significant functions, which would weaken the efficiencies we are seeking to create.

I reassure the noble Baronesses that all proposals will be considered through a full and extensive engagement and consultation process. Regulations providing for transfers under this power will be subject to the affirmative procedure. This ensures that Parliament can scrutinise the use of this power, including any necessary amendments made to primary legislation. This would follow on from a consultation with the relevant parties.

The Secretary of State must, at a minimum, consult the arm’s-length bodies and devolved Governments to which the transfer relates. Additional stakeholders whom it may be appropriate to consult will vary depending on the nature of the transfer of functions contemplated. The Bill therefore provides that such other persons as the Secretary of State considers appropriate should also be consulted, which is in line with the department’s and the Government’s commitment to engaging with stakeholders.

We have set out the principles of engagement and consultation with the devolved Governments through a memorandum of understanding, which has been negotiated and is close to agreement. This will sit along- side the legislation and provide the opportunity for the devolved Governments to be involved at a formative stage of policy development. In addition, the principle of Amendment 231C, which we have just discussed, is a requirement for the relevant devolved Governments’ consent to be given to transfer any functions that are within their legislative competence or that modify functions exercised by the devolved Government.

Although the majority of the arm’s-length bodies and functions within the scope of the power relate to reserved matters or apply in England only, certain bodies have functions that meet the criteria laid out above. We all know that the arm’s-length body landscape is complex, and this power will ensure that there is a transparent process throughout, including formal consultation, so that any relevant arm’s-length bodies and devolved Governments, and Parliament, will have the opportunity to scrutinise any plans for its use. I hope that that has given some assurance, and for these reasons I ask the noble Baroness to withdraw her opposition to the clause standing part.

Baroness Merron (Lab)
I thank the Minister for his reply and the reference to parliamentary scrutiny. He will know that, in discussions in this Committee, the call for transparency and scrutiny has often been repeated. I am interested in the reassurances that the Minister has given and will consider his points further. I am sure that he understands that there is a feeling that these powers are still not necessary—not now—but I will certainly consider his points. With that, I beg leave to withdraw my opposition to Clause 88 standing part.

Clause 88, as amended, agreed.

Clause 89: Power to transfer functions between bodies

Amendment 228 not moved.

Clause 89 agreed.

Clause 90 agreed.

Clause 91: Scope of powers

Amendments 229 and 230 not moved.

Amendment 231 had been withdrawn from the Marshalled List.

Clause 91 agreed.

Clause 92: Transfer schemes in connection with regulations

Amendments 231A and 231B

Moved by

231A: Clause 92, page 87, line 4, leave out paragraphs (c) to (e)
 Member’s explanatory statement
 This amendment removes the Scottish Ministers, a Northern Ireland department and the Welsh Ministers from the list of persons to whom property etc can be transferred under Clause 92.

231B: Clause 92, page 87, line 9, at end insert “established under section 25 of the National Health Service Act 2006”
 Member’s explanatory statement
 This amendment removes Welsh NHS trusts from the list of persons to whom property etc can be transferred under Clause 92.

Amendments 231A and 231B agreed.

Clause 92, as amended, agreed.

Clause 93 agreed.

Clause 94: Consultation on draft regulations

Amendments 231C to 231G

Moved by

231C: Clause 94, page 88, line 2, leave out subsection (1) and insert—
 “(1) Before making regulations under section 89 or 90, the Secretary of State must—(a) obtain the consent of the Scottish Ministers in relation to any provision—(i) which would be within the legislative competence of the Scottish Parliament, if contained in an Act of that Parliament, and is not merely incidental to, or consequential on, provision which would be outside that legislative competence, or(ii) which modifies the functions of the Scottish Ministers;(b) obtain the consent of the Welsh Ministers in relation to any provision—(i) which would be within the legislative competence of Senedd Cymru, if contained in an Act of the Senedd, and is not merely incidental to, or consequential on, provision which would be outside that legislative competence, or(ii) which modifies the functions of the Welsh Ministers;(c) obtain the consent of a Northern Ireland department in relation to any provision—(i) which would be within the legislative competence of the Northern Ireland Assembly, if contained in an Act of that Assembly, and is not merely incidental to, or consequential on, provision which would be outside that legislative competence, or(ii) which modifies the functions of a Northern Ireland department.”Member’s explanatory statement
 This amendment requires the Secretary of State to obtain consent of, rather than consulting with, the Scottish Ministers, the Welsh Ministers or a Northern Ireland department (as appropriate) before making provision within devolved legislative or executive competence in regulations under Clause 89 or 90.

231D: Clause 94, page 88, line 26, leave out “Consultation is not required under subsection (1)(d)(i)” and insert “Consent is not required under subsection (1)(c)(i)”
 Member’s explanatory statement
  This amendment is consequential on the replacement of consultation obligations in Northern Ireland with consent obligations in relation to Northern Ireland.

231E: Clause 94, page 88, line 32, at end insert—
 “(2A) Before making regulations under section 89 or 90, the Secretary of State must consult the following about a draft of the regulations—(a) any body to which the regulations relate, and(b) such other persons as the Secretary of State considers appropriate.”Member’s explanatory statement
 This amendment is consequential on the amendment inserting consent requirements into Clause 94. It moves to a different place the duty on the Secretary of State to consult bodies that are not subject to the consent requirements.

231F: Clause 94, page 88, line 33, leave out “subsection (1)” and insert “this section”
 Member’s explanatory statement
 This amendment is consequential on the other amendments which re-structure the consultation obligations in Clause 94.

231G: Clause 94, page 88, line 37, after “whether” insert “consent is obtained or”
 Member’s explanatory statement
 This amendment provides for consent (under the new requirements being inserted into Clause 94) to be capable of being provided before commencement of the Clause.

Amendments 231C to 231G agreed.

Clause 94, as amended, agreed.

Clauses 122 to 133 agreed.

00:45:00

Amendment 231H

Moved by

231H: After Clause 133, insert the following new Clause—
 “CHAPTER 2HYMENOPLASTY OFFENCESHymenoplasty offences: England and WalesOffence of carrying out hymenoplasty: England and Wales
 (1) It is an offence under the law of England and Wales for a person to carry out hymenoplasty.(2) “Hymenoplasty” means the reconstruction of the hymen (with or without consent).(3) An offence is committed under subsection (1) only if the person—(a) is in England and Wales, or(b) is outside the United Kingdom, and is a United Kingdom national or habitually resident in England and Wales.(4) “United Kingdom national” means an individual who is—(a) a British citizen, a British overseas territories citizen, a British National (Overseas) or a British Overseas citizen,(b) a person who under the British Nationality Act 1981 is a British subject, or(c) a British protected person within the meaning of that Act.”Member’s explanatory statement
 This new Clause creates an offence under the law of England and Wales of carrying out hymenoplasty.

Baroness Penn
My Lords, it is a pleasure to hopefully conclude this Committee stage of the Bill with some government amendments, which I hope will receive a welcome from the Committee. When we announced our intention to become one of the first countries in the world to fully ban virginity testing, in the Tackling Violence Against Women and Girls strategy, we also stated that we would establish an independent expert panel to review the ethical, legal and clinical aspects of hymenoplasty, a cosmetic procedure to reconstruct a hymen. This announcement followed concerns, highlighted in an internal review into virginity testing and hymenoplasty, that demand for hymenoplasty is driven by a repressive approach to female sexuality and is closely linked to virginity testing—an abhorrent practice that the Government brought forward an amendment to ban in the House of Commons.

However, as hymenoplasty is a cosmetic procedure, we recognised that a ban on it would mark a step change that could be counter to existing regulation on cosmetic procedures. Further concerns were raised that a ban would take away a woman’s right to choose what happens to her body. The panel’s task was to carefully consider these incredibly difficult and competing issues at length. The panel has now delivered its final report to the Government, which includes a robust set of recommendations. I take this opportunity to thank the co-chairs and all the panel members for the time and commitment they have dedicated, on a voluntary basis, to this incredibly important issue.

As we announced in Our Vision for the Women’s Health Strategy for England, the Government agree with the panel’s core recommendation that hymenoplasty should be banned. It is inextricably linked to virginity testing, and failure to prohibit hymenoplasty would not only undermine the Government’s commitment to address the violence against women and girls by criminalising virginity testing but also leave women and girls at risk of further harm and continue to perpetrate the harmful myths and attitudes towards virginity.

The package of amendments brought before the House today delivers on this promise. It would create three offences: carrying out hymenoplasty, offering hymenoplasty, and aiding or abetting another person to carry out hymenoplasty in the UK or on UK nationals overseas. Each of these offences carries a maximum penalty of five years’ imprisonment and/or an unlimited fine. This sentencing reflects the long-term physical and psychological damage that this repressive practice can cause. These offences, alongside the proposed virginity testing offences, begin to tackle the harmful misconceptions that surround a woman’s sexuality.

In response to concerns that vulnerable women and girls will be taken abroad and subjected to hymenoplasty once the offence is banned in the UK, these offences also carry extraterritorial jurisdiction. These proposals have been discussed by Health Ministers across the UK, and my noble friend is working with them to ensure the whole of the UK, together, tackles this harmful practice.

These amendments are an important milestone in this Government’s ongoing mission to safeguard women and girls but our work will not stop here. The Government recognise that banning virginity testing and hymenoplasty alone will not tackle the harmful misconceptions and misbeliefs surrounding virginity. That is why we will also put in place a programme of education in community, education and clinical settings.

Finally, I give thanks to my noble friend Lady Sugg for bringing the practice of hymenoplasty to the attention of this House, and for the wider work she is doing on this issue to improve the lives of women and girls. I hope the House will pass the Government’s amendments today and allow our important work on safeguarding and improving the lives of women and girls across the UK to continue. I beg to move.

The Principal Deputy Chairman of Committees (The Earl of Kinnoull) (CB)
My Lords, the noble Baroness, Lady Brinton, is participating remotely and I call her to speak.

Baroness Brinton (LD) [V]
My Lords, I want to speak very briefly to thank the Ministers for listening to the noble Baroness, Lady Sugg, and the noble Lord, Lord Patel, and others who have been working with the RCOG and others to ensure that both virginity testing and hymenoplasty procedures are banned. As the noble Baroness, Lady Penn, said, to ban one without the other would have been unhelpful, because they are inextricably linked. It is particularly good to see that extraterritorial jurisdiction is included too.

I am also delighted to hear about the creation of resources for education and training, which is vital for working with young people and their communities to ensure that they are kept safe from virginity testing and hymenoplasty. Will there be special funding for this? Without funding and resources, it will be difficult to make sure that this work is carried out throughout the at-risk communities.

Baroness Sugg (Con)
My Lords, I originally had an amendment down to criminalise hymenoplasty in this Bill, but I have been pleased to withdraw that and put my name to the government amendment instead.

I asked a question on banning hymenoplasty of my noble friend Lord Kamall back in October. He gave me his word that he would push this as much as possible to make sure that we ban both virginity testing and hymenoplasty. He has kept to his word, and I am very grateful to him.

It is late in the evening—well, early in the morning—but I want very briefly to give your Lordships a first-hand account of why this is such an important amendment. Hafsah—which is not her real name—was raped as a child. Afterwards, her parents became obsessed with the idea of presenting her as “pure” on her wedding night, and her father told her that surgery would “fix her shame”. This surgery is widely available on Harley Street and in private clinics at a cost of around £2,000. In support of this amendment, Hafsah said:

“If hymenoplasty had been illegal when I was a teenager, it would have saved me a lot of emotional abuse. I’m sure it will be a great comfort to vulnerable girls in a similar position to know that the law is on their side. It should give them the strength to stand up for themselves.”
 

This ban on both virginity testing and hymenoplasty will be a substantial step forward in tackling the damaging myths and stigmas about virginity. Neither procedure has any medical benefit. Both are harmful practices that create and exacerbate social, cultural and political beliefs that attach a false value to women and girls in relation to whether they have a sexual history.

I am grateful to my noble friend the Minister for explaining the work that the Government will do on education in community and clinical settings. I hope that they will also ensure that they implement the other recommendations of the expert panel on hymenoplasty and sustainably fund the specialist organisations that support women and girls at risk of honour-based abuse.

Finally, there have been many campaigners involved over a number of years to bring about this change in the law: IKWRO, Karma Nirvana, MEWSo, Nimco Ali, the Royal College of Obstetricians and Gynaecologists, the Royal College of Midwives, Garden Court Chambers, Richard Holden MP, all those on the expert panel, and many others. I pay tribute to their hard work, tenacity, perseverance and patience. It has been my privilege to speak on their behalf in this place. This amendment will make a difference to the lives of many women and girls, and it has my full support.

Lord Patel (CB)
My Lords, I rise very briefly to thank in particular the noble Baroness, Lady Sugg, for so tenaciously making sure that this important amendment is passed. In my view, this is some of the most important legislation in the Bill. As the noble Baroness said, it will save a lot of young girls and women from a lot of pain and hardship. I was pleased to add my name to the amendment.

Baroness Barker (LD)
My Lords, very briefly in view of the early hour, I wish to join others in welcoming this amendment and thanking the Minister for taking notice of what the noble Baroness, Lady Sugg, chair of All-Party Parliamentary Group on Population, Development and Reproductive Health, has done with other actors.

I want to make two points. First, the people who have brought the work to this point recognise that this practice, although rare, happens disproportionately within particular cultural and religious groups. I therefore ask the Minister whether the religious element of this will feature in the materials that are to be prepared.

Secondly, will FCDO staff learn lessons from the forced marriage legislation on how we spot young girls who are particularly vulnerable to this and particularly at risk of being taken abroad? Can I make the assumption that, were any medical practitioner registered in the United Kingdom to be found performing these operations abroad, they would still be dealt with by the medical authorities in this country when that came to light?

Baroness Merron (Lab)
My Lords, I am very glad that the Government have heeded the calls of victims and experts alike to make hymenoplasty a criminal offence, along with virginity testing. As we have heard repeatedly both this evening and in the course of campaigning for this, the two practices are inextricably linked. It is right that those who carry out or facilitate these practices should face justice and that no woman or girl should have to suffer these abusive, intrusive and medically unsound practices. This legislation will send the strongest of messages and I am very glad that education will underpin it.

Of course, the fight to end violence against women and girls is not over, but it has taken a step forward in this measure. I add my thanks to all those who have campaigned tirelessly on this, as outlined by the noble Baroness, Lady Sugg. I thank the noble Baroness, the noble Lord, Lord Patel, and others for all they have done in your Lordships’ House to bring this forward. This is a positive point on which to bring our deliberations in Committee to a close. I very much welcome this move.

Baroness Penn (Con)
My Lords, I thank noble Lords for the short but constructive debate on these amendments. I add my thanks to the noble Lord, Lord Patel, for his support on this issue.

My noble friend Lady Sugg asked about the other recommendations in the panel’s report. Of course, the amendments brought forward today satisfy many of the recommendations made in the final report, including: prohibiting the advertising of hymenoplasty; the inclusion of extraterritorial jurisdiction; ensuring that women will not be criminalised for undergoing hymenoplasty; and that there should be no defence or exemption for a healthcare professional or anyone to carry out hymenoplasty. The Government are carefully considering the panel’s remaining recommendations and will provide an update on this in due course.

There were also a number of questions about implementation. Guidance will be produced alongside these offences coming into force. It will make clear that hymenoplasty is a form of violence against women and girls and lay the framework for how it can be prevented and, when it has taken place, reported. While the details of the guidance are being carefully considered, I can say that it will focus on how the Government, local authorities, social services, the police, education providers and third-sector organisations and community groups can work together to effectively safeguard women and girls.

A number of other specific points were raised, such as whether the FCDO can learn from legislation relating to forced marriage and measures to spot girls who are at risk, the religious element which may feature within this, and UK-registered practitioners conducting these practices abroad. I suggest I write to noble Lords with further detail in response to those questions.

Amendment 231H agreed.

Amendments 231J to 231U

Moved by

231J: After Clause 133, insert the following new Clause—
 “Offence of offering to carry out hymenoplasty: England and Wales
 (1) It is an offence under the law of England and Wales—(a) for a person in England and Wales to offer to carry out hymenoplasty in the United Kingdom or hymenoplasty that has a sufficient jurisdictional connection, or(b) for a person anywhere to offer to carry out hymenoplasty if the person is a United Kingdom national or habitually resident in England and Wales. (2) Hymenoplasty has a sufficient jurisdictional connection for the purposes of subsection (1)(a) if it is carried out in relation to a person who is—(a) a United Kingdom national, or(b) habitually resident in the United Kingdom.(3) In this section—“United Kingdom national” has the meaning given by section (Offence of carrying out hymenoplasty: England and Wales)(4);“hymenoplasty” has the meaning given by section (Offence of carrying out hymenoplasty: England and Wales)(2).”Member’s explanatory statement
 This new Clause creates an offence under the law of England and Wales of offering to carry out hymenoplasty.

231K: After Clause 133, insert the following new Clause—
 “Offence of aiding or abetting etc a person to carry out hymenoplasty: England and Wales
 (1) It is an offence under the law of England and Wales for a person who is in England and Wales, or for a person who is outside England and Wales but who is a United Kingdom national or habitually resident in England and Wales, to aid, abet, counsel or procure the carrying out of hymenoplasty that has a sufficient jurisdictional connection.(2) Hymenoplasty has a sufficient jurisdictional connection for the purposes of subsection (1) if it is carried out in relation to a person who is—(a) in the United Kingdom,(b) a United Kingdom national, or(c) habitually resident in the United Kingdom.(3) This section does not affect the application to an offence under section (Offence of carrying out hymenoplasty: England and Wales) of any rule of law relating to aiding, abetting, counselling or procuring.(4) In this section—“United Kingdom national” has the meaning given by section (Offence of carrying out hymenoplasty: England and Wales)(4);“hymenoplasty” has the meaning given by section (Offence of carrying out hymenoplasty: England and Wales)(2).”Member’s explanatory statement
 This new Clause creates an offence of aiding, abetting, counselling or procuring a person to carry out hymenoplasty in circumstances where the hymenoplasty itself might not be an offence under the law of England and Wales (depending on the location or status of the person carrying out the hymenoplasty).

231L: After Clause 133, insert the following new Clause—
 “Hymenoplasty offences in England and Wales: penalties
 (1) A person who commits an offence under section (Offence of carrying out hymenoplasty: England and Wales), (Offence of offering to carry out hymenoplasty: England and Wales) or (Offence of aiding or abetting etc a person to carry out hymenoplasty: England and Wales), is liable—(a) on summary conviction, to imprisonment for a term not exceeding the maximum summary term for either-way offences or a fine (or both);(b) on conviction on indictment, to imprisonment for a term not exceeding 5 years or a fine (or both).(2) In subsection (1)(a) “the maximum summary term for either-way offences” means—(a) in relation to an offence committed before the time when paragraph 24(2) of Schedule 22 to the Sentencing Act 2020 comes into force, 6 months; (b) in relation to an offence committed after that time, 12 months.”Member’s explanatory statement
 This new Clause sets out the penalties for the new offences under the law of England and Wales relating to hymenoplasty.

231M: After Clause 133, insert the following new Clause—
 “Hymenoplasty offences: ScotlandOffence of carrying out hymenoplasty: Scotland
 (1) It is an offence under the law of Scotland for a person to carry out hymenoplasty.(2) “Hymenoplasty” means the reconstruction of the hymen (with or without consent).(3) An offence is committed under subsection (1) only if the person—(a) is in Scotland, or(b) is outside the United Kingdom, and is a United Kingdom national or habitually resident in Scotland.(4) “United Kingdom national” means an individual who is—(a) a British citizen, a British overseas territories citizen, a British National (Overseas) or a British Overseas citizen,(b) a person who under the British Nationality Act 1981 is a British subject, or(c) a British protected person within the meaning of that Act.”Member’s explanatory statement
 This new Clause creates an offence under the law of Scotland of carrying out hymenoplasty.

231N: After Clause 133, insert the following new Clause—
 “Offence of offering to carry out hymenoplasty: Scotland
 (1) It is an offence under the law of Scotland—(a) for a person in Scotland to offer to carry out hymenoplasty in the United Kingdom or hymenoplasty that has a sufficient jurisdictional connection, or(b) for a person anywhere to offer to carry out hymenoplasty if the person is a United Kingdom national or habitually resident in Scotland.(2) Hymenoplasty has a sufficient jurisdictional connection for the purposes of subsection (1)(a) if it is carried out in relation to a person who is—(a) a United Kingdom national, or(b) habitually resident in the United Kingdom.(3) In this section—“United Kingdom national” has the meaning given by section (Offence of carrying out hymenoplasty: Scotland)(4);“hymenoplasty” has the meaning given by section (Offence of carrying out hymenoplasty: Scotland)(2).”Member’s explanatory statement
 This new Clause creates an offence under the law of Scotland of offering to carry out hymenoplasty.

231P: After Clause 133, insert the following new Clause—
 “Offence of aiding or abetting etc a person to carry out hymenoplasty: Scotland
 (1) It is an offence under the law of Scotland for a person who is in Scotland, or for a person who is outside Scotland but who is a United Kingdom national or habitually resident in Scotland, to aid, abet, counsel, procure or incite the carrying out of hymenoplasty that has a sufficient jurisdictional connection.(2) Hymenoplasty has a sufficient jurisdictional connection for the purposes of subsection (1) if it is carried out in relation to a person who is—(a) in the United Kingdom, (b) a United Kingdom national, or(c) habitually resident in the United Kingdom.(3) This section does not affect the application to an offence under section (Offence of carrying out hymenoplasty: Scotland) of any rule of law relating to aiding, abetting, counselling, procuring or inciting.(4) In this section—“United Kingdom national” has the meaning given by section (Offence of carrying out hymenoplasty: Scotland)(4);“hymenoplasty” has the meaning given by section (Offence of carrying out hymenoplasty: Scotland)(2).”Member’s explanatory statement
 This new Clause creates an offence of aiding, abetting, counselling, procuring or inciting a person to carry out hymenoplasty in circumstances where the hymenoplasty itself might not be an offence under the law of Scotland (depending on the location or status of the person carrying out the hymenoplasty).

231Q: After Clause 133, insert the following new Clause—
 “Hymenoplasty offences in Scotland: penalties and supplementary
 (1) A person who commits an offence under section (Offence of carrying out hymenoplasty: Scotland), (Offence of offering to carry out hymenoplasty: Scotland) or (Offence of aiding or abetting etc a person to carry out hymenoplasty: Scotland), is liable—(a) on summary conviction, to imprisonment for a term not exceeding 12 months or a fine not exceeding the statutory maximum (or both);(b) on conviction on indictment, to imprisonment for a term not exceeding 5 years or a fine (or both).(2) Where a person outside Scotland commits an offence under section (Offence of carrying out hymenoplasty: Scotland), (Offence of offering to carry out hymenoplasty: Scotland) or (Offence of aiding or abetting etc a person to carry out hymenoplasty: Scotland) the person may be prosecuted, tried and punished for the offence—(a) in a sheriff court district in which the person is apprehended or in custody, or(b) in a sheriff court district determined by the Lord Advocate,as if the offence had been committed in that district.(3) Where subsection (2) applies, the offence is, for all purposes incidental to or consequential on the trial and punishment, deemed to have been committed in that district.(4) In this section “sheriff court district” is to be construed in accordance with section 307(1) of the Criminal Procedure (Scotland) Act 1995 (interpretation).”Member’s explanatory statement
 This new Clause sets out the penalties for the new offences under the law of Scotland relating to hymenoplasty.

231R: After Clause 133, insert the following new Clause—
 Hymenoplasty offences: Northern IrelandOffence of carrying out hymenoplasty: Northern Ireland
 (1) It is an offence under the law of Northern Ireland for a person to carry out hymenoplasty.(2) “Hymenoplasty” means the reconstruction of the hymen (with or without consent).(3) An offence is committed under subsection (1) only if the person—(a) is in Northern Ireland, or(b) is outside the United Kingdom, and is a United Kingdom national or habitually resident in Northern Ireland.(4) “United Kingdom national” means an individual who is— (a) a British citizen, a British overseas territories citizen, a British National (Overseas) or a British Overseas citizen,(b) a person who under the British Nationality Act 1981 is a British subject, or(c) a British protected person within the meaning of that Act.”Member’s explanatory statement
 This new Clause creates an offence under the law of Northern Ireland of carrying out hymenoplasty.

231S: After Clause 133, insert the following new Clause—
 “Offence of offering to carry out hymenoplasty: Northern Ireland
 (1) It is an offence under the law of Northern Ireland—(a) for a person in Northern Ireland to offer to carry out hymenoplasty in the United Kingdom or hymenoplasty that has a sufficient jurisdictional connection, or(b) for a person anywhere to offer to carry out hymenoplasty if the person is a United Kingdom national or habitually resident in Northern Ireland.(2) Hymenoplasty has a sufficient jurisdictional connection for the purposes of subsection (1)(a) if it is carried out in relation to a person who is—(a) a United Kingdom national, or(b) habitually resident in the United Kingdom.(3) In this section—“United Kingdom national” has the meaning given by section (Offence of carrying out hymenoplasty: Northern Ireland)(4);“hymenoplasty” has the meaning given by section (Offence of carrying out hymenoplasty: Northern Ireland)(2).”Member’s explanatory statement
 This new Clause creates an offence under the law of Northern Ireland of offering to carry out hymenoplasty.

231T: After Clause 133, insert the following new Clause—
 “Offence of aiding or abetting etc a person to carry out hymenoplasty: Northern Ireland
 (1) It is an offence under the law of Northern Ireland for a person who is in Northern Ireland, or for a person who is outside Northern Ireland but who is a United Kingdom national or habitually resident in Northern Ireland, to aid, abet, counsel or procure the carrying out of hymenoplasty that has a sufficient jurisdictional connection.(2) Hymenoplasty has a sufficient jurisdictional connection for the purposes of subsection (1) if it is carried out in relation to a person who is—(a) in the United Kingdom,(b) a United Kingdom national, or(c) habitually resident in the United Kingdom.(3) This section does not affect the application to an offence under section (Offence of carrying out hymenoplasty: Northern Ireland) of any rule of law relating to aiding, abetting, counselling or procuring.(4) In this section—“United Kingdom national” has the meaning given by section (Offence of carrying out hymenoplasty: Northern Ireland)(4);“hymenoplasty” has the meaning given by section (Offence of carrying out hymenoplasty: Northern Ireland)(2).”Member’s explanatory statement
 This new Clause creates an offence of aiding, abetting, counselling or procuring a person to carry out hymenoplasty in circumstances where the hymenoplasty itself might not be an offence under the law of Northern Ireland (depending on the location or status of the person carrying out the hymenoplasty).

231U: After Clause 133, insert the following new Clause—
 “Hymenoplasty offences in Northern Ireland: penalties
 A person who commits an offence under section (Offence of carrying out hymenoplasty: Northern Ireland), (Offence of offering to carry out hymenoplasty: Northern Ireland) or (Offence of aiding or abetting etc a person to carry out hymenoplasty: Northern Ireland), is liable—
 (a) on summary conviction, to imprisonment for a term not exceeding 6 months or a fine not exceeding the statutory maximum (or both);(b) on conviction on indictment, to imprisonment for a term not exceeding 5 years or a fine (or both).”Member’s explanatory statement
 This new Clause sets out the penalties for the new offences under the law of Northern Ireland relating to hymenoplasty.

Amendments 231J to 231U agreed.

Amendment 313 had been withdrawn from the Marshalled List.

Clause 134 agreed.

Schedule 16: Virginity testing: consequential amendments

Amendments 313ZA to 313ZM

Moved by

313ZA: Schedule 16, page 233, line 2, leave out “(123 or 124” and insert “123, 124, (Offence of carrying out hymenoplasty: England and Wales), (Offence of offering to carry out hymenoplasty: England and Wales) or (Offence of aiding or abetting etc a person to carry out hymenoplasty: England and Wales)”
 Member’s explanatory statement
 This amendment adds the new England and Wales offences relating to hymenoplasty to section 65A of the Police and Criminal Evidence Act 1984 (qualifying offences for the purposes of Part 5 of that Act).

313ZB: Schedule 16, page 233, line 3, after “virginity testing” insert “and hymenoplasty”
 Member’s explanatory statement
 This amendment is consequential on the other amendment to paragraph 1 of Schedule 16 that appears in the Minister’s name.

313ZC: Schedule 16, page 233, line 11, leave out “or 132” and insert “, 132, (Offence of carrying out hymenoplasty: Northern Ireland), (Offence of offering to carry out hymenoplasty: Northern Ireland) or (Offence of aiding or abetting etc a person to carry out hymenoplasty: Northern Ireland)”
 Member’s explanatory statement
 This amendment adds the new Northern Ireland offences relating to hymenoplasty to Article 53A of the Police and Criminal Evidence (Northern Ireland) Order 1989 (qualifying offences for the purposes of Part 6 of that Order).

313ZD: Schedule 16, page 233, line 13, after “virginity testing” insert “and hymenoplasty”
 Member’s explanatory statement
 This amendment is consequential on the other amendment to paragraph 2 of Schedule 16 that appears in the Minister’s name.

313ZE: Schedule 16, page 233, line 23, at end insert—
 “(d) section (Offence of carrying out hymenoplasty: England and Wales) (carrying out hymenoplasty);(e) section (Offence of offering to carry out hymenoplasty: England and Wales) (offering to carry out hymenoplasty); (f) section (Offence of aiding or abetting etc a person to carry out hymenoplasty: England and Wales) (aiding or abetting etc a person to carry out hymenoplasty).”Member’s explanatory statement
 This amendment adds the new England and Wales offences relating to hymenoplasty to Schedule 7A to the Criminal Justice and Public Order Act 1994 (offences for which cross-border powers of arrest available).

313ZF: Schedule 16, page 233, line 30, at end insert—
 “(d) section (Offence of carrying out hymenoplasty: Scotland) (carrying out hymenoplasty);(e) section (Offence of offering to carry out hymenoplasty: Scotland) (offering to carry out hymenoplasty);(f) section (Offence of aiding or abetting etc a person to carry out hymenoplasty: Scotland) (aiding or abetting etc a person to carry out hymenoplasty).”Member’s explanatory statement
 This amendment adds the new Scottish offences relating to hymenoplasty to Schedule 7A to the Criminal Justice and Public Order Act 1994 (offences for which cross-border powers of arrest available).

313ZG: Schedule 16, page 233, line 37, at end insert—
 “(d) section (Offence of carrying out hymenoplasty: Northern Ireland) (carrying out hymenoplasty);(e) section (Offence of offering to carry out hymenoplasty: Northern Ireland) (offering to carry out hymenoplasty);(f) section (Offence of aiding or abetting etc a person to carry out hymenoplasty: Northern Ireland) (aiding or abetting etc a person to carry out hymenoplasty).”Member’s explanatory statement
 This amendment adds the new Northern Ireland offences relating to hymenoplasty to Schedule 7A to the Criminal Justice and Public Order Act 1994 (offences for which cross- border powers of arrest available).

313ZH: Schedule 16, page 233, line 37, at end insert—
 “Criminal Procedure (Scotland) Act 1995
 3A_ The Criminal Procedure (Scotland) Act 1995 is amended as follows.3B_ In section 19A (samples etc. from persons convicted of sexual or violent offences), in the definition of “relevant violent offence” in subsection (6), in paragraph (h), after sub-paragraph (v) insert—“(vi) section 126, 127, 128, (Offence of carrying out hymenoplasty: Scotland), (Offence of offering to carry out hymenoplasty: Scotland) or (Offence of aiding or abetting etc a person to carry out hymenoplasty: Scotland) of the Health and Care Act 2022 (offences relating to virginity testing and hymenoplasty).”3C_ In section 271BZA (child witnesses in certain solemn cases: special measures), in subsection (2), after paragraph (f) insert—“(fa) an offence under section 126, 127, 128, (Offence of carrying out hymenoplasty: Scotland), (Offence of offering to carry out hymenoplasty: Scotland) or (Offence of aiding or abetting etc a person to carry out hymenoplasty: Scotland) of the Health and Care Act 2022 (offences relating to virginity testing and hymenoplasty);”.”Member’s explanatory statement
 This amendment adds the new Scottish offences relating to virginity testing and hymenoplasty to certain provisions of the Criminal Procedure (Scotland) Act 1995.

313ZJ: Schedule 16, page 233, line 42, leave out “or 124” and insert “, 124, (Offence of carrying out hymenoplasty: England and Wales), (Offence of offering to carry out hymenoplasty: England and Wales) or (Offence of aiding or abetting etc a person to carry out hymenoplasty: England and Wales)”
  Member’s explanatory statement
 This amendment adds the new England and Wales offences relating to hymenoplasty to section 51C of the Crime and Disorder Act 1998 (notices in certain cases involving children).

313ZK: Schedule 16, page 233, line 43, after “virginity testing” insert “and hymenoplasty”
 Member’s explanatory statement
 This amendment is consequential on the other amendment to paragraph 4 of Schedule 16 that appears in the Minister’s name.

313ZL: Schedule 16, page 234, line 2, at end insert—
 “Protection of Vulnerable Groups (Scotland) Act 2007 (asp 2007)
 4A_ Pending the commencement of its repeal by section 81(2)(d) of the Disclosure (Scotland) Act 2020, paragraph 2 of Schedule 1 to the Protection of Vulnerable Groups (Scotland) Act 2007 (relevant offences) has effect as if it included a reference to an individual who commits an offence under section 126, 127, 128, (Offence of carrying out hymenoplasty: Scotland), (Offence of offering to carry out hymenoplasty: Scotland) or (Offence of aiding or abetting etc a person to carry out hymenoplasty: Scotland) of this Act (offences relating to virginity testing and hymenoplasty).”Member’s explanatory statement
 This amendment means that the new Scottish offences relating to virginity testing and hymenoplasty will be treated as relevant offences within paragraph 2 of Schedule 1 to the Protection of Vulnerable Groups (Scotland) Act 2007 pending the commencement of the repeal of that Schedule.

313ZM: Schedule 16, page 234, line 12, at end insert—
 “(d) section (Offence of carrying out hymenoplasty: England and Wales) (carrying out hymenoplasty);(e) section (Offence of offering to carry out hymenoplasty: England and Wales) (offering to carry out hymenoplasty);(f) section (Offence of aiding or abetting etc a person to carry out hymenoplasty: England and Wales) (aiding or abetting etc a person to carry out hymenoplasty).”Member’s explanatory statement
 This amendment adds the new England and Wales offences relating to hymenoplasty to Schedule 4 to the Modern Slavery Act 2015 (offences to which defence in section 45 does not apply).

Amendments 313ZA to 313ZM agreed.

Schedule 16, as amended, agreed.

Amendment 313A

Moved by

313A: After Schedule 16, insert the following new Schedule—
 “STORAGE OF GAMETES AND EMBRYOSPART 1AMENDMENTS TO HUMAN FERTILISATION AND EMBRYOLOGY ACT 1990Introductory
 1_ The Human Fertilisation and Embryology Act 1990 is amended as follows.Maximum storage periods
 2_(1) Section 14 (conditions of storage licences) is amended as follows.(2) In subsection (1), for paragraph (c) substitute—“(c) that the requirements of subsection (3) (maximum storage periods) are met,”.(3) For subsections (3) to (5) substitute— “(3) The requirements referred to in subsection (1)(c) are as follows—(a) gametes must not be kept in storage for longer than such period not exceeding 55 years beginning with the day on which they are first placed in storage as the licence may specify;(b) an embryo must not be kept in storage for treatment purposes for longer than such period not exceeding 55 years beginning with the day on which it is first so kept as the licence may specify;(c) an embryo that is kept in storage for the research or training purpose but not for treatment purposes must not be so kept for longer than such period not exceeding 10 years beginning with the day on which consent was given under Schedule 3 to the storage of the embryo for that purpose as the licence may specify;(d) a human admixed embryo must not be kept in storage for longer than such period not exceeding 10 years beginning with the day on which it is first placed in storage as the licence may specify.(4) Where under Schedule 3 consent is given to the storage of an embryo for the training or research purpose by different persons on different days, the reference in subsection (3)(c) to the day on which consent was given is to be taken as a reference to the last of those days.(5) For the purposes of this section—(a) “treatment purposes” are purposes referred to in paragraph 2(1)(a) or (b) of Schedule 3;(b) the “training purpose” is the purpose referred to in paragraph 2(1)(ba) of that Schedule;(c) the “research purpose” is the purpose referred to in paragraph 2(1)(c) of that Schedule.”3_ In section 47 (index), omit the entry for the “Statutory storage period”.4_ In Schedule 3 (consents), in paragraph 2(2)(a), for “statutory storage period” substitute “period for which, by virtue of section 14(3), the gametes, embryo or human admixed embryo may be stored under the licence”.Disposal of material
 5_ In section 14 (conditions of storage licences), in subsection (1), after paragraph (c) insert—“(ca) that any gametes, embryos or human admixed embryos that have been kept in storage pursuant to the licence must, once they may no longer lawfully be so kept, be removed from storage and disposed of, and”.6_ In section 17 (the person responsible), in subsection (1)(c), for “allowed to perish” substitute “removed from storage”.Consent to storage
 7_(1) Schedule 3 (consents) is amended as follows.(2) In paragraph 1—(a) in sub-paragraph (1), before the first “and” insert “any renewal of consent,”;(b) in sub-paragraph (2), before the first “and” insert “any renewal of consent by a person unable to sign,”;(c) in sub-paragraph (3)—(i) the words from ““effective consent” to the end become paragraph (a);(ii) after that paragraph insert—“(b) references to renewal of consent are to renewal of consent to the storage of any gametes or embryo under paragraph 11A or 11C.”(3) In paragraph 3, in sub-paragraph (1), after “gives” insert “or renews”. (4) After paragraph 11 insert—“Renewal of consent to storage of gametes11A_(1) This paragraph applies where—(a) the gametes of a person (“P”) are in storage,(b) P’s consent to the storage of the gametes is required under paragraph 8(1),(c) there is effective consent from P to the storage of the gametes, and(d) the gametes are being kept for use for the purposes of providing treatment services to—(i) P, or(ii) P and another person together.(2) The person keeping the gametes in storage (“K”) must, in each consent period, request P to renew consent to storage of the gametes within the renewal period.For the meaning of “consent period” and “renewal period”, see paragraph 11B.(3) A request under sub-paragraph (2) must be given in writing before the start of the renewal period.(4) The duty in sub-paragraph (2) ceases to apply if K is notified that P has died.(5) The duty in sub-paragraph (2) does not apply in relation to any consent period if—(a) K has at any time been informed in writing that P has been certified as lacking capacity to renew consent to storage of the gametes, and(b) K has not subsequently been informed in writing, before the start of the renewal period which relates to that consent period, that P has been certified as having capacity to renew consent to storage of the gametes.(6) P renews consent by informing K in writing that P consents to the storage of the gametes.(7) If P’s consent is not renewed under sub-paragraph (6) before the end of the consent period, K must, as soon as possible after the end of that period, give a notice to P stating that if P does not renew consent before the end of the renewal period, the gametes will be removed from storage and disposed of.(8) P’s consent to the storage of the gametes is to be taken as having been withdrawn at the end of a renewal period that relates to a consent period if—(a) K has complied with the requirements of sub-paragraphs (2) and (7) in relation to that consent period, and(b) P’s consent is not renewed under sub-paragraph (6) before the end of the renewal period.But this is subject to sub-paragraphs (9) and (10).(9) If, in a case referred to in sub-paragraph (8)(a) and (b), P dies before the end of the renewal period—(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but(b) if at the end of the period of 10 years beginning with the day on which P died there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time.(10) If, in a case referred to in sub-paragraph (8)(a) and (b), before the end of the renewal period P is certified as lacking capacity to renew consent—(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but(b) if at the end of the period of 10 years beginning with the day on which P was so certified there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time. (11) But P’s consent is not to be taken as withdrawn under sub-paragraph (10)(b) if, before the time it would be taken to be withdrawn under that sub-paragraph—(a) P is certified as having capacity to renew consent to storage of the gametes, and(b) P renews consent to storage of the gametes by informing K in writing that P consents to their storage.(12) In a case where P renews consent under sub-paragraph (11)(b), this paragraph applies subsequently as if references to a consent period were to—(a) the period of 10 years beginning with the day on which P so renewed consent, and(b) each successive period of 10 years.11B_(1) For the purposes of paragraph 11A, each of the following is a “consent period”—(a) the period of 10 years beginning with the relevant day, and(b) each successive period of 10 years.(2) In sub-paragraph (1)(a) “relevant day” means—(a) the day on which the gametes are first placed in storage, or(b) in a case where sub-paragraph (3) or (5) applies, the day on which P gives consent to the storage of the gametes.(3) This sub-paragraph applies where the gametes are taken from or provided by P before P attains the age of 18 years and, at the time the gametes are first stored—(a) P has not attained the age of 16 years and is not competent to deal with the issue of consent to storage of the gametes, or(b) P has attained that age but, although not lacking capacity to consent to the storage of the gametes, is not competent to deal with the issue of consent to their storage.(4) In relation to Scotland, sub-paragraph (3) is to be read as if, for paragraphs (a) and (b), there were substituted “P does not have capacity (within the meaning of section 2(4) of the Age of Legal Capacity (Scotland) Act 1991) to consent to storage of the gametes”.(5) This sub-paragraph applies where the gametes are taken from or provided by P after P attains the age of 16 years and, at the time the gametes are first stored, P lacks capacity to consent to their storage.(6) In paragraph 11A “the renewal period”, in relation to a consent period, means the period which—(a) begins 12 months before the end of the consent period, and(b) ends 6 months after the end of the consent period.(7) In paragraph 11A “certified” means certified in writing by a registered medical practitioner.(8) In paragraph 11A and this paragraph, in relation to Scotland, references to a person lacking or having capacity to consent or renew consent are to be read as references to the person being or not being incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of consenting or renewing consent.Renewal of consent to storage of embryos11C_(1) This paragraph applies where—(a) an embryo, the creation of which was brought about in vitro, is in storage,(b) the embryo is being kept for use for the purposes of providing treatment services to— (i) a person (“P”) whose gametes or human cells were used to bring about the creation of the embryo, or(ii) P and another person together,(c) P’s consent to the storage of the embryo is required under paragraph 8(2), and(d) there is effective consent from P to the storage of the embryo.(2) The person keeping the embryo in storage (“K”) must, in each consent period, request P to renew consent to storage of the embryo within the renewal period.For the meaning of “consent period” and “renewal period”, see paragraph 11D.(3) A request under sub-paragraph (2) must be given in writing before the start of the renewal period.(4) The duty in sub-paragraph (2) ceases to apply if—(a) K is notified that P has died, or(b) K is notified under paragraph 4A(1)(c) of the withdrawal of a person’s consent to storage of the embryo.(5) The duty in sub-paragraph (2) does not apply in relation to any consent period if—(a) K has at any time been informed in writing that P has been certified as lacking capacity to renew consent to storage of the embryo, and(b) K has not subsequently been informed in writing, before the start of the renewal period which relates to that consent period, that P has been certified as having capacity to renew consent to storage of the embryo.(6) P renews consent by informing K in writing that P consents to the storage of the embryo.(7) If P’s consent is not renewed under sub-paragraph (6) before the end of the consent period, K must, as soon as possible after the end of that period, give a notice to P stating that if P does not renew consent before the end of the renewal period, the embryo will be removed from storage and disposed of.(8) P’s consent to the storage of the embryo is to be taken as having been withdrawn at the end of a renewal period that relates to a consent period if—(a) K has complied with the requirements of sub-paragraphs (2) and (7) in relation to that consent period, and(b) P’s consent is not renewed under sub-paragraph (6) before the end of the renewal period.But this is subject to sub-paragraphs (9) and (10).(9) If, in a case referred to in sub-paragraph (8)(a) and (b), P dies before the end of the renewal period—(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but(b) if at the end of the period of 10 years beginning with the day on which P died there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time.(10) If, in a case referred to in sub-paragraph (8)(a) and (b), before the end of the renewal period P is certified as lacking capacity to renew consent—(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but(b) if at the end of the period of 10 years beginning with the day on which P was so certified there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time.(11) But P’s consent is not to be taken as withdrawn under sub-paragraph (10)(b) if, before the time it would be taken to be withdrawn under that sub-paragraph— (a) P is certified as having capacity to renew consent to storage of the embryo, and(b) P renews consent to storage of the embryo by informing K in writing that P consents to its storage.(12) In a case where P has renewed consent under sub-paragraph (11)(b), this paragraph applies subsequently as if references to the consent period were to—(a) the period of 10 years beginning with the day on which P so renewed consent, and(b) each successive period of 10 years.(13) Where P’s consent is taken as withdrawn under this paragraph, K must, as soon as possible, take all reasonable steps to give notice of the withdrawal to each person whose gametes or human cells were used to bring about its creation.(14) Storage of the embryo remains lawful until—(a) the end of the period of 6 months beginning with the day on which P’s consent is taken as withdrawn under this paragraph, or(b) if, before the end of that period, K receives a notice from each person notified under sub-paragraph (13) stating that the person consents to the disposal of the embryo, the time at which the last of those notices was received.11D_(1) For the purposes of paragraph 11C , each of the following is a “consent period”—(a) the period of 10 years beginning with the day on which the embryo is first placed in storage, and(b) each successive period of 10 years.(2) In paragraph 11C “the renewal period”, in relation to a consent period, means the period which—(a) begins 12 months before the end of the consent period, and(b) ends 6 months after the end of the consent period.(3) In paragraph 11C “certified” means certified in writing by a registered medical practitioner.(4) In paragraph 11C , in relation to Scotland, references to a person lacking or having capacity to renew consent are to be read as references to the person being or not being incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of renewing consent.”PART 2TRANSITIONAL PROVISIONInterpretation
 8_(1) In this Part of this Schedule—“the commencement day” means 1 July 2022;“the transitional period” means the period beginning with the commencement day and ending with 30 June 2024.(2) In this Part of this Schedule—“the 1990 Act” means the Human Fertilisation and Embryology Act 1990;“the 2009 Regulations” means the Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) Regulations 2009 (S.I. 2009/1582);“the 2020 Regulations” means the Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) (Coronavirus) Regulations 2020 (S.I. 2020/566).(3) In this Part of this Schedule—“gamete storage licence” means a licence under Schedule 2 to the 1990 Act that authorises the storage of gametes; “embryo storage licence” means a licence under Schedule 2 to the 1990 Act that authorises the storage of embryos;“storage licence” means a licence under Schedule 2 to the 1990 Act that authorises the storage of gametes, embryos or human admixed embryos;“pre-commencement”, in relation to a storage licence, or a storage licence of any description, means granted before the commencement day and “post-commencement” means granted on or after that day.(4) In this Part of this Schedule—“statutory storage period” has the same meaning as in the 1990 Act immediately before the commencement day;references to gametes, embryos and human admixed embryos have the same meaning as in that Act;“the training purpose”, “the research purpose” and “treatment purposes” have the same meanings as in section 14(3)(c) of that Act.Application of Part 1 to material already in storage
 9_(1) The amendments in paragraphs 2 to 6 of this Schedule have effect in relation to pre-commencement storage licences under which gametes, embryos or human admixed embryos are kept in storage on or after the commencement day (as well as having effect in relation to post-commencement storage licences).This is subject to sub-paragraphs (2) and (3).(2) In the case of a pre-commencement embryo storage licence, the condition imposed by section 14(3)(c) of the 1990 Act (as substituted by paragraph 2 of this Schedule) does not apply in relation to an embryo which, on the commencement day, is kept in storage for the training or research purpose but not for treatment purposes.(3) In the case of any pre-commencement storage licence, the condition imposed by section 14(1)(ca) of the 1990 Act (as substituted by paragraph 5 of this Schedule) applies only in relation to times on or after the commencement day.10_ The amendments made by paragraph 7 of this Schedule have effect in relation to the storage of gametes and embryos under a pre-commencement gamete or embryo storage licence, where the gametes or embryos are kept in storage on or after the commencement day (as well as having effect in relation to the storage of gametes and embryos under a post-commencement gamete or embryo storage licence).Date of first storage
 11_(1) This paragraph applies if the person storing gametes or an embyro under a pre-commencement gamete or embryo storage licence—(a) has, before the end of the transitional period, taken all reasonable steps to establish the date on which the gametes were or embryo was first placed in storage, but(b) is unable to establish that date.(2) The person may give a notice to each person whose consent to the storage is required under Schedule 3 to the 1990 Act specifying a date on which the gametes are or embryo is to be regarded as having been first placed in storage.(3) Where notice is given under sub-paragraph (2), the gametes are or embryo is to be regarded, for all purposes of the 1990 Act and this Part of this Schedule, as having been first placed in storage on the date specified in the notice.Storage periods specified in pre-commencement storage licences
 12_(1) For the purposes of section 14(3)(a) of the 1990 Act (as substituted by paragraph 2 of this Schedule), a pre-commencement gamete storage licence under which, on and after the commencement day, gametes are kept in storage is to be regarded as specifying the period of 55 years beginning with the day on which the gametes were first placed in storage.(2) For the purposes of section 14(3)(b) of the 1990 Act (as substituted by paragraph 2 of this Schedule), a pre- commencement embryo storage licence under which, on and after the commencement day, an embryo is kept in storage for treatment purposes is to be regarded as specifying for those purposes the period of 55 years beginning with the day on which the embryo was first so kept.Storage after expiry of pre-commencement consent
 13_(1) If a pre-commencement consent to the storage of gametes or an embryo expires at any time in the transitional period, the storage of the gametes or embryo for the remainder of that period is not unlawful merely because of that fact.(2) In sub-paragraph (1)—(a) “pre-commencement consent” means consent given under Schedule 3 to the 1990 Act before the commencement day;(b) the reference to expiry of consent does not include withdrawal.Storage with no effective consent prior to commencement
 14_(1) This paragraph applies in relation to the storage of gametes or an embryo under a pre-commencement gamete or embryo storage licence where, immediately before the commencement day, there is no effective consent to the storage by a relevant person.(2) The person keeping the gametes or embryo in storage must request the relevant person to give consent to the storage under Schedule 3 to the 1990 Act.(3) A request under sub-paragraph (2) must be given before 1 July 2023 in writing.(4) The storage of the gametes or embryo at any time before the end of the transitional period is not unlawful merely because there is no effective consent to the storage by the relevant person.(5) In this paragraph—“effective consent” means consent under Schedule 3 to the 1990 Act which has not been withdrawn;“relevant person” means a person whose consent is required under Schedule 3 to the 1990 Act to storage of the gametes or embryo.Time for first renewal of consent
 15_(1) This paragraph applies in relation to the storage of gametes under a pre- commencement gamete storage licence where the statutory storage period applicable immediately before the commencement day was provided for by—(a) regulation 4, 4A, 7 or 8 of the 2009 Regulations, or(b) regulation 4 of the 2020 Regulations.(2) For the purposes of paragraph 11A of Schedule 3 to the 1990 Act (as inserted by paragraph 7 of this Schedule), paragraph 11B(1)(a) of that Schedule has effect as if the reference to the period of 10 years beginning with the relevant day were a reference to the period which—(a) begins with the relevant day, and(b) ends at the end of the statutory storage period referred to in sub-paragraph (1).16_(1) This paragraph applies in relation to the storage of an embryo under a pre-commencement embryo storage licence where the statutory storage period applicable immediately before the commencement day was provided for by—(a) regulation 3, 3A, 5 or 6 of the 2009 Regulations, or(b) regulation 3 of the 2020 Regulations.(2) For the purposes of paragraph 11C of Schedule 3 to the 1990 Act (as inserted by paragraph 7 of this Schedule), paragraph 11D(1)(a) of that Schedule has effect as if the reference to the period of 10 years beginning with the day on which the embryo was first placed in storage were a reference to the period which—(a) begins with the day on which the embryo was first so placed, and(b) ends at the end of the statutory storage period referred to in sub-paragraph (1).Renewals falling due in the transitional period
 17_(1) This paragraph applies in relation to the storage of gametes under a pre-commencement gamete storage licence in a case where—(a) paragraph 11A of Schedule 3 to the 1990 Act applies in relation to the storage, and(b) for the purposes of that paragraph, the first consent period (see paragraph 11B(1)(a) of that Schedule) ends in the transitional period.(2) Where this paragraph applies, paragraph 11A of Schedule 3 to the 1990 Act has effect in relation to that first consent period as if—(a) for sub-paragraphs (2) and (3) there were substituted—“(2) The person keeping the gametes in storage (“K”) must request P to renew consent to storage of the gametes before 1 July 2024.(3) A request under sub-paragraph (2) must—(a) be given in writing before 1 July 2023;(b) state that if P does not renew consent before 1 July 2024, the gametes will be removed from storage and disposed of.”;(b) in sub-paragraph (5)(b), for “the start of the renewal period which relates to that consent period” there were substituted “1 July 2023”;(c) sub-paragraph (7) were omitted;(d) for sub-paragraph (8) there were substituted—“(8) P’s consent to the storage of the gametes is to be taken as having been withdrawn at the beginning of 1 July 2024 if—(a) K has complied with sub-paragraph (2), and(b) P’s consent is not renewed under sub-paragraph (6) before 1 July 2024.But this is subject to sub-paragraphs (9) and (10).”;(e) in sub-paragraphs (9) and (10), references to the end of the renewal period were to 1 July 2024.18_(1) This paragraph applies in relation to the storage of an embryo under a pre-commencement embryo storage licence in a case where—(a) paragraph 11C of Schedule 3 to the 1990 Act applies in relation to the storage, and(b) for the purposes of that paragraph, the first consent period (see paragraph 11D(1)(a) of that Schedule) ends in the transitional period.(2) Where this paragraph applies, paragraph 11C of Schedule 3 to the 1990 Act has effect in relation to that first consent period as if—(a) for sub-paragraphs (2) and (3) there were substituted—“(2) The person keeping the embryo in storage (“K”) must request P to renew consent to storage of the embryo before 1 July 2024.(3) A request under sub-paragraph (2) must—(a) be given in writing before 1 July 2023;(b) state that if P does not renew consent before 1 July 2024, the embryo will be removed from storage and disposed of.”;(b) in sub-paragraph (5)(b), for “the start of the renewal period which relates to that consent period” there were substituted “1 July 2023”; (c) sub-paragraph (7) were omitted;(d) for sub-paragraph (8) there were substituted—“(8) P’s consent to the storage of the embryo is to be taken as having been withdrawn at the beginning of 1 July 2024 if—(a) K has complied with sub-paragraph (2), and(b) P’s consent is not renewed under sub-paragraph (6) before 1 July 2024.But this is subject to sub-paragraphs (9) and (10).”;(e) in sub-paragraphs (9) and (10), references to the end of the renewal period were to 1 July 2024.”Member’s explanatory statement
 Part 1 of this new Schedule makes provision for the maximum period for which gametes and embryos may be stored, for what happens at the end of that period, and for a requirement that consents to storage be renewed periodically. Part 2 contains transitional provision.

Amendment 313A agreed.

Clause 149 agreed.

Clause 150: Regulations

Amendments 313B and 313C

Moved by

313B: Clause 150, page 128, line 13, at end insert—
 “(1A) A power to make regulations under section (Information about payments etc to persons in the health care sector), 89 or 90 includes power to make different provision for England, Wales, Scotland or Northern Ireland.”Member’s explanatory statement
 This amendment provides for regulations under Part 3 of the Bill, and regulations relating to the reporting and publication of information about payments and other benefits provided to persons in the health care sector, to be able to make different provision for different parts of the UK.

313C: Clause 150, page 128, line 18, at end insert—
 “(aa) regulations under section (Information about payments etc to persons in the health care sector);”Member’s explanatory statement
 This amendment provides for regulations relating to the reporting and publication of information about payments and other benefits provided to persons in the health care sector to be subject to affirmative procedure.

Amendments 313B and 313C agreed.

Amendment 314 had been withdrawn from the Marshalled List.

Clause 150, as amended, agreed.

Amendment 314ZA not moved.

Clause 151 agreed.

Clause 152: Extent

Amendments 314ZB to 314B

Moved by

314ZB: Clause 152, page 128, line 37, at end insert—
 “(aa) in Part 2, sections (Information about payments etc to persons in the health care sector), (Regulations under section (Information about payments etc to persons in the health care sector): enforcement) and (Regulations under section (Information about payments etc to persons in the health care sector): consent) (information about payments etc to persons in the health care sector);”Member’s explanatory statement
 This amendment provides for the powers relating to the reporting and publication of information about payments and other benefits provided to persons in the health care sector to extend to the whole of the United Kingdom.

314A: Clause 152, page 128, line 40, at end insert—
 “(ca) in Part 5, section (Storage of gametes and embryos) and Part 2 of Schedule (Storage of gametes and embryos) (storage of gametes and embryos);”Member’s explanatory statement
 This amendment makes provision for the extent of the new Clause relating to the storage of gametes and embryos and Part 2 of the new Schedule. The extent of Part 1 of the new Schedule is dealt with under Clause 152(5).

314B: Clause 152, page 129, line 1, leave out subsections (3) and (4) and insert—
 “(3) The following extend to Scotland only—(a) sections 126 to 129 (offences relating to virginity testing);(b) sections (Offence of carrying out hymenoplasty: Scotland), (Offence of offering to carry out hymenoplasty: Scotland), (Offence of aiding or abetting etc a person to carry out hymenoplasty: Scotland) and (Hymenoplasty offences in Scotland: penalties) (offences relating to hymenoplasty).(4) The following extend to Northern Ireland only—(a) sections 130 to 133 (offences relating to virginity testing);(b) sections (Offence of carrying out hymenoplasty: Northern Ireland), (Offence of offering to carry out hymenoplasty: Northern Ireland), (Offence of aiding or abetting etc a person to carry out hymenoplasty: Northern Ireland) and (Hymenoplasty offences in Northern Ireland: penalties) (offences relating to hymenoplasty).”Member’s explanatory statement
 This amendment amends the extent clause in consequence of the new Clauses relating to hymenoplasty.

Amendments 314ZB to 314B agreed.

Clause 152, as amended, agreed.

Clause 153: Commencement

Amendment 315 not moved.

Amendments 315A and 316

Moved by

315A: Clause 153, page 129, line 8, at end insert—
 “(2A) Section (Storage of gametes and embryos) and Schedule (Storage of gametes and embryos) (storage of gametes and embryos) come into force on 1 July 2022.”Member’s explanatory statement
 This amendment provides for the new Clause and Schedule relating to the storage of gametes and embryos to come into force on 1 July 2022.

316: Clause 153, page 129, line 10, leave out “on 1 January 2023” and insert “at the end of the period of two months beginning with the day on which this Act is passed”
 Member’s explanatory statement
 This amendment provides for the provisions relating to advertising to come into force two months after Royal Assent, instead of on 1 January 2023. The prohibitions contained in them will not apply until 1 January 2023 as a result of other amendments but this amendment enables regulations etc to be in place beforehand.

Amendments 315A and 316 agreed.

Amendments 317 to 319 not moved.

Clause 153, as amended, agreed.

Clause 154 agreed.

House resumed.

Bill reported with amendments.

Lord Ashton of Hyde (Con)
My Lords, just before we finish, I say on behalf of us all a big thank you to the clerks, the doorkeepers, the Bill team and all the officials who have worked so late.

House adjourned at 1.04 am.