Committee (5th Day)
Relevant documents: 19th Report from the Delegated Powers Committee, and 10th Report from the Constitution Committee
A participants’ list for today’s proceedings has been published by the Government Whips’ Office, as have lists of Members who have put their names to the amendments or expressed an interest in speaking on each group. I will call Members to speak in the order that they are listed. Members are not permitted to intervene spontaneously; the Chair calls each speaker. Interventions during speeches or “before the noble Lord sits down” are not permitted.
During the debate on each group I will invite Members, including Members in the Grand Committee Room, to email the clerk if they wish to speak after the Minister, using the Grand Committee address. I will call Members to speak in order of request and will invite the Minister to respond each time. The groupings are binding and it will not be possible to degroup an amendment for separate debate. A Member intending to move formally an amendment already debated should have given notice in the debate. Leave should be given to withdraw amendments.
When putting the Question, I will collect voices in the Grand Committee Room only. I remind Members that Divisions cannot take place in Grand Committee. It takes unanimity to amend the Bill, so if a single voice says “Not content”, an amendment is negatived and if a single voice says “Content”, a clause stands part. If a Member taking part remotely intends to oppose an amendment expected to be agreed to, they should make this clear when speaking on the group.
49: After Clause 6, insert the following new Clause—
“Extending prescribing rights
The Secretary of State must, within three months of this Act being passed, lay before each House of Parliament proposals and a timetable for extending prescribing rights to additional healthcare professionals under section 2(1)(n).”Member’s explanatory statement
This new Clause requires the Secretary of State to publish proposals and a timetable for additional healthcare professionals to be given appropriately restricted prescribing rights.
My Lords, I said at Second Reading that we on these Benches are supportive of the extension of prescribing rights to additional health- care professionals, including radiographers, dietitians, orthoptists and speech and language therapists. It is time that this issue was resolved and that is our intention in tabling this amendment. The new clause would require the Secretary of State to publish proposals and a timetable for additional healthcare professionals to be given appropriately restricted prescribing rights. I thank my noble friends Lord Bradley and Lord Hunt, and the noble Lord, Lord Ramsbotham, for their support and I look forward to hearing their remarks.
The background to this issue is that, in February 2020, in response to a Parliamentary Question tabled by my honourable friend Geraint Davies MP, the Government said:
“Subject to Parliamentary approval, the Medicines and Medical Devices Bill currently before Parliament will give the Government powers to extend prescribing responsibilities to new professional groups where it is safe and appropriate to do so.”
We support that extension and our proposed amendment to the Bill will expedite that, resulting in better outcomes for patients and the system as we face a surge in demand on health services both now and in the future due to the Covid-19 pandemic.
The extension will build on the groundwork already undertaken by the NHS England scoping exercise over the past few years on extending prescribing rights to members and professionals. Extending prescribing rights would help to deliver better support and more timely care for patients. It would improve patient safety, as allied health professionals with appropriate expertise would be able to make decisions rather than relying on junior clinicians signing off clinical management plans. It would decrease the number of patient group directions needed, thus reducing the time spent on development, use and training, and it would bring prescribing expertise closer to the patient. It would reduce the pressure on other stretched professionals, including GPs, and it would improve system efficiency by reducing the duplication of work among health professionals, with a potential result of significant time and resource savings. The extension of prescribing rights to these professionals and others would make a significant and positive difference to those professionals and to the ability of the wider health system to respond as swiftly and efficiently as possible to the post-Covid-19 surge in demand on health services, including the rehabilitation and recovery of post-Covid-19 patients.
It is important to recognise the impact of Covid-19 and how it has emphasised the urgency of taking action. When we discussed these issues before the Bill came before the House, representatives expressed their frustration at how long it seemed to be taking to get approvals to work their way through the system. Given that we have managed to shortcut various systems because it has been necessary to do so with Covid-19, it seems that this is one that presents itself and needs a positive response. It will benefit the NHS, patients and expert health groups. I beg to move.
My Lords, I support my noble friend’s amendment and the potential for increasing prescribing responsibilities. The noble Baroness, Lady Cumberlege, was a huge champion of prescribing rights for nurses. I was able to extend that to community pharmacists and I want to see us now build on that by extending it to other professions in healthcare. Dietitians, occupational health therapists, orthoptists, radiographers and speech and language therapists all have a hugely important role to play and giving them prescribing responsibilities would help to deliver safer, better and timelier patient care.
We have seen already how dietitians have hugely expanded their role in the treatment of diabetes, gastroenterology, bariatrics, metabolic conditions and oncology. Orthoptics has seen its roles expand in stroke management and neuro-rehabilitation and neuro-ophthalmology, in particular among children with SEN and for paediatric ophthalmology. Diagnostic radiographers are increasingly performing routine interventional procedures under imaging control, while speech and language therapist roles have developed in respiratory care, ear, nose and throat services, critical care and end-of-life care. Occupational therapists have increased their advanced practitioner roles and are demonstrating a hugely beneficial impact across all areas of the NHS.
There is a problem. It has been reported that the current ability of these professions to administer medicines to support patients through patient group directions and/or patient-specific directions is apparently becoming increasingly difficult. They are either taking longer to secure or they are being more restrictive, to the detriment of patient care and safety. I ask the Minister why this is. I refer to his interesting comment on Second Reading, when he said:
“NHS England and NHS Improvement are considering across all non-medical groups, influenced by learning from the Covid-19 pandemic, where there is a need to consider undertaking formal consultation on potential amendments to prescribing responsibilities for several professional groups.”—[Official Report, 2/9/20; col. 432.]
This is very welcome—and, of course, implied in that statement is a recognition that during the past six months we have had to rely on professional and other staff adding to their responsibilities and going beyond the extra mile. By extending prescribing rights, we would be recognising that fact and recognising that many of our professionals can do more, if they are given the ability to do it.
Provided that this happens within safe bounds—and so far, prescribing for non-medics seems to have worked very successfully—we have a total win-win situation, in which patients will benefit and the professional development and satisfaction of many of our staff groups will increase. I believe that my noble friend’s intention is to give the Minister all support for charging on with the extension of prescribing rights, and I hope that she will embrace that support and get a move on.
My Lords, I must declare two interests in explaining why I have put my name to the amendment—first, as co-chair of the All-Party Parliamentary Group on Speech and Language Difficulties, and secondly, as an honorary fellow of the Royal College of Speech and Language Therapists. As always, it is a great pleasure to follow the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt, both of whom know a great deal more about this subject than I do.
As I reported on Second Reading, on 12 August the Minister in the other place wrote that the Bill would allow the Government to update those professional organisations that can prescribe medicines when it was safe and appropriate to do so. This is in line with what the Minister said on Second Reading, which was quoted by the noble Lord, Lord Hunt. If the experience of dieticians, orthoptists, diagnostic radiographers and speech and language therapists is anything to go by, the role of such people has expanded considerably during the pandemic, during which there has been ever-increasing pressure on health professionals.
Prescribing responsibilities would enable allied professions to share the burden with their NHS colleagues and avoid unnecessary delay and duplication for patients. Their call for increased prescribing responsibilities is backed up by hard-pressed NHS trusts, which have identified a means of increasing their capacity. Therefore I hope that, on the basis of experience during the pandemic, the Minister will be able to announce proposals and a timetable for extending prescribing rights for certain carefully chosen health professional organisations within three months of the Bill being passed, as part of the NHS long-term improvement plan.
My Lords, I am pleased to support this timely amendment, which, as we have heard, would introduce a new clause to the Bill to extend prescribing rights to additional healthcare professionals. It is a consequence of the debate on Second Reading, which clearly laid out the benefits of extending prescribing rights to such allied health professionals as dieticians, orthoptists, diagnostic radiographers and speech and language therapists. I will not repeat all the advantages this would bring, because that argument has already been well made, both on Second Reading and in the speeches we have already heard this afternoon. In summary, I believe that it would help to deliver better support and more timely care for patients, reduce pressure on other health professionals, increase system efficiency and maximise the ability to respond to the Covid-19 pandemic, both now and in the predicted post-pandemic surge in the pressure on services.
As we have heard, it was welcome when, in responding to the Second Reading debate, the Minister said:
“NHS England and NHS Improvement are considering across all non-medical groups, influenced by learning from the Covid-19 pandemic, where there is a need to consider undertaking formal consultation on potential amendments to prescribing responsibilities for several professional groups.”.—[Official Report, 2/9/20; col. 432.]
This will build on the groundwork already undertaken by NHS England’s scoping exercise over the last few years, particularly since 2016.
So let us be clear: the case for extending prescribing responsibilities, where it is safe and appropriate to do so, has strengthened since 2016, because, first, the roles of allied health professionals have developed. For example, speech and language therapists’ roles have developed into respiratory care, into ear, nose and throat services, into critical care and into end-of-life care. As we heard from the noble Lord, Lord Hunt, diagnostic radiographers are increasingly performing routine interventional procedures under imaging control —for example, joint injections and biopsies.
Secondly, the volume of patients has increased considerably since 2016. For example, growing numbers of patients with type 2 diabetes, irritable bowel syndrome and severe obesity require the support of dieticians. And again, speech and language therapists have seen an increase in patients with head and neck cancer, including HPV.
Thirdly, as we are all well aware, there is increasing pressure on all health professionals, particularly as a result of the pandemic. The amendment would facilitate the delivery of a one-stop approach, reducing the need for multiple appointments with different healthcare professionals.
Finally, since 2016, there has been a growth in allied healthcare professionals operating advanced levels of practice. Prescribing responsibilities would help widen the scope of their practice and would support the workforce transformation laid out in the NHS Long Term Plan and the NHS People Plan. As we have already heard from the noble Baroness, Lady Thornton, and the noble Lords, Lord Hunt and Lord Ramsbotham, all these benefits have been reinforced by the impact of Covid-19. Allied health professionals have learnt to work in new ways to support not only Covid cases but non-Covid patients—for example, those with cancer.
Further extending prescribing responsibilities could help those people better to support vulnerable groups of patients who need to minimise contact with healthcare professionals, I believe that the arguments for the new clause are overwhelming. Much of the work to achieve its aim has already been undertaken, so there should be no delay. A commitment to bring back a proposal and a timetable for implementation is completely reasonable, so I hope that the Minister will respond favourably to the amendment, which proposes to insert a new clause in the Bill.
It is a great pleasure to follow the four noble Lords who tabled this amendment, all of whom are working from exactly the same brief as I am—I can tell that from the quotes. First, I should declare an interest: I have not been present in Committee before, but am here as a former president of the British Dietetic Association, a TUC-affiliated union. The Bill was published during the dying days of my presidency and I undertook to speak in support of the proposed new clause.
I have nothing substantial to add to what has been already been so ably said by colleagues. I will just point out that dieticians are one of the groups seeking to extend this, and people often misunderstand what dieticians are for. The number of times I have been asked whether I am associated with Weight Watchers has rather driven me insane, but dieticians are actually more involved with undernutrition than overnutrition. Although people think of obesity and what are now the more popular things, the biggest challenge facing the average dietician is a person probably over 80 years old, almost certainly living alone and generally not caring for themselves. So the role of a dietician is often to get people to eat a balanced diet. They work in hospitals and in the community, and with other health professionals, particularly in developing clinical management plans. That effort would be reduced if this proposed clause were accepted.
Points about dieticians and others have been extensively made. I understand that
“within three months of this Act being passed”
is a big ask, but also that, unless we ask for something, we will probably not get anything at all. The noble Lord, Lord Bradley, has already quoted the Minister at Second Reading saying that they were
“considering across all non-medical groups … where there is a need to consider undertaking formal consultation on potential amendments to prescribing responsibilities”.—[Official Report, 2/9/20; col. 432.]
I realise that, at the time of Covid, there is a huge number of demands on the Minister’s department and the staff therein but, overall, if this can be made to work, it will benefit and increase the productivity of health professionals. So, in associating myself with the previous speeches, I also encourage the Minister to give as positive a response as he is able to. I am sure that, if we extend prescribing rights, we will be benefiting many patients and the medical profession. We will also be enabling many health workers to play a more effective role in the care of their patients.
My Lords, I support Amendment 49 in the names of the noble Baroness, Lady Thornton, and the noble Lords, Lord Hunt of Kings Heath, Lord Ramsbotham and Lord Bradley. It mandates the Secretary of State to publish proposals and a timetable for additional healthcare professionals to be given appropriately restricted prescribing rights. As other noble Lords have said, for well over 20 years, some appropriately trained nurses have been prescribing from a restricted list. I see no reason why, as the noble Baroness, Lady Thornton, described, appropriately trained allied health professionals and others, working from a list of approved medicines commensurate with their profession, should not do the same.
This is entirely appropriate at the moment, when it is not always easy to access a GP. We have seen how successful giving prescribing rights to both community and practice nurses has proven to be. Patients are becoming more willing to have appointments with AHPs and nurses, rather than GPs, which frees doctors to concentrate on patients requiring more experience, such as those with unusual or complex conditions. This is a win-win amendment and I heartily commend it.
My Lords, I recognise that there is keen interest in how we may use powers in Clause 2(1)(n) of the Bill, relying on Clause 1(1), to continue to update the prescribing and supply responsibilities of healthcare professionals. However, I hope to persuade noble Lords that Amendment 49, in the name of the noble Baroness, Lady Thornton, is unnecessary.
I am very pleased to say to noble Lords that NHS England and NHS Improvement are already leading work to scope the current and potential future use of medicines supply, administration and prescribing mechanisms by a range of non-medical healthcare professionals. On 15 October, they started consulting on a range of proposals to extend medicines administration and supply responsibilities, and to update the medicines that some existing independent prescribers may prescribe.
The consultations cover the use of patient group directions by biomedical and clinical scientists and operating department practitioners, exemptions enabling dental therapists and hygienists to supply some medicines, and changes to the controlled drugs that can be prescribed by physiotherapists, podiatrists and paramedic independent prescribers. If progressed, these proposals would allow patients to get timely and safe access to medicines from the most appropriate healthcare professionals, without the need for extra appointments from other prescribers, such as a GP. The current consultation will run until 10 December and is of course a public consultation. It will be informed by the views of key patient and professional groups, with engagement starting shortly through a series of online events.
I reassure noble Lords that we are committed to updating the prescribing and supply responsibilities of professional groups, where it is safe and appropriate to do so. In keeping with the rest of the Bill, any such changes will be made in a way that serves the best interests of patients. The powers allow us to ensure that professional responsibilities can be updated to reflect developments in professional practice, new approaches to care, changing scientific understanding and growing technical abilities. This ensures that we can continue to make full use of the skills available to us among NHS professionals, and support patients to receive the best possible care and support from NHS staff.
I know that a number of NHS professional groups are keen to see their members taking on responsibility for supplying or prescribing medicines. We have recently seen papers put forward by the British Dietetic Association, the Royal College of Occupational Therapists, the British and Irish Orthoptic Society, the Society of Radiographers and the Royal College of Speech and Language Therapists. I am very grateful to the professional groups for the careful consideration that they have given to these issues.
I reassure noble Lords that NHSE/I already has extensive joint working and engagement under way with these and other professional groups to consider whether any other changes would help keep patients safe and well. This will build on the historic work with various professional bodies and the devolved Administrations, over the last few years, which resulted in a number of changes, including allowing paramedics and therapeutic radiographers to be independent prescribers. As well as this, a wider scoping project is being led by NHS England and NHS Improvement, with the devolved Administrations and professional bodies, on the current and potential future use of medicines supply, administration and prescribing mechanisms by a range of non-medical healthcare professionals.
I also reassure the noble Baroness, Lady Thornton, the noble Lord, Lord Hunt, and other noble Lords who raised this that NHS England and NHS Improvement’s work on prescribing and supply will of course account for lessons learned from the Covid-19 response. For instance, NHSE/I wishes to learn from professional bodies and, in its scoping work, is asking them how the use of medicines mechanisms contributed and how they can play a role in increasing capacity to respond to future challenges. On that basis, I hope that the noble Baroness, Lady Thornton, feels able to withdraw her amendment.
I have received no requests to speak after—
I actually just sent in my name.
Oh, right. I have received one request to speak after the Minister. I call the noble Baroness, Lady Thornton.
I am sorry; it was possibly delayed. It was really just to ask the noble Baroness: when is the earliest she thinks there will be change? Are we looking at three months, six months or a year?
I might need to pick this up with the noble Baroness in writing afterwards. The consultation will close in December and, obviously, work has to be done after that—but it is probably safest to write, if that is okay.
If these were normal times, I would have just popped up and asked that question.
I thank my colleagues—my noble friends Lord Hunt and Lord Bradley. My noble friend Lord Bradley is one of my roommates here. I have not seen him since March and I am missing him very much. So it is very nice to see him, even on the screen, and he made a very powerful case. I also thank the noble Lord, Lord Ramsbotham, who has enormous expertise in the very important areas of speech and language therapies. I also thank the noble Lord, Lord Balfe, and the noble Baroness, Lady Jolly.
Given the promise that we might actually, at some point, have a date, I beg leave to withdraw the amendment.
Amendment 49 withdrawn.
Amendment 50 not moved.
Clause 7 agreed.
Clause 8: Power to make regulations about veterinary medicines
51: Clause 8, page 5, line 12, at end insert—
“(1A) The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote one or more of the following—(a) the health and welfare of animals;(b) the health and safety of the public;(c) the protection of the environment.”Member’s explanatory statement
This amendment provides that the appropriate authority may only make regulations under subsection (1) of Clause 8 if satisfied that they would promote the health or welfare of animals, the health and safety of the public or the protection of the environment.
Amendment 51 agreed.
Amendments 52 and 53 not moved.
54: Clause 8, page 5, line 13, leave out “making regulations under subsection (1)” and insert “considering whether they would”
Member’s explanatory statement
This amendment requires the appropriate authority to have regard to the factors mentioned in subsection (2)(a), (b) and (c) of Clause 8 in considering whether regulations under subsection (1) would promote the health or welfare of animals, the health and safety of the public or the protection of the environment.
Amendment 54 agreed.
Amendment 55 not moved.
Amendments 56 and 57
56: Clause 8, page 5, line 15, leave out “in relation to animals, humans and the environment”
Member’s explanatory statement
This amendment is consequential on the amendment in the Minister’s name inserting a new subsection after subsection (1) of Clause 8.
57: Clause 8, page 5, line 18, leave out paragraph (c) and insert—
“(c) the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to develop or supply veterinary medicines.”Member’s explanatory statement
This amendment clarifies what was meant by the version of Clause 8(2)(c) in the Bill as brought from the House of Commons.
Amendments 56 and 57 agreed.
Amendments 58 to 61 not moved.
Clause 8, as amended, agreed.
We now come to the group consisting of Amendment 62. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Clause 9: Manufacture, marketing, supply and field trials
62: Clause 9, page 6, line 11, at end insert—
“(1A) The Secretary of State must by regulations make provision about the use of the Cascade.”Member’s explanatory statement
This amendment gives the Secretary of State the responsibility to make provisions regarding the Cascade, a risk-based decision process where veterinarians can dispense different medicines to animals beyond the terms of authorisation.
My Lords, I am pleased to move Amendment 62 in the name of my noble friend Lady Thornton. It amends Clause 9 of the Bill dealing with manufacture, marketing, supply and field trials. This is a probing amendment. It would give the Secretary of State the responsibility to make provisions, in respect of the cascade, risk-based decision-making process, allowing vets to prescribe unauthorised medicines when they are unable to get hold of suitable authorised medicines.
The cascade provision for the medical treatment of animals will be vitally important if there are problems with the supply of veterinary medicines in the event of no deal. The British Veterinary Association has underlined the importance of maintaining the cascade, and of the Veterinary Medicines Directorate reviewing the cascade to consider whether it would be possible to allow greater flexibility on the use of medicinal products licensed elsewhere in the EU and those of other partners within the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicine Products, known as VICH.
I am always struck by how much one learns during the course of working on legislation in the House of Lords, and how much is new that one was previously unaware of but should have been. The cascade system for prescribing unauthorised medicines is a good example for me. It is a vitally important procedure, underpinned by 2019 guidance from the Veterinary Medicines Directorate, whereby vets are permitted to use their clinical judgment where there is no suitable veterinary medicine authorised in the UK for the specific condition in the animal being treated. Cascade gives vets access to a wider range of medicines to treat animals within their care and to prevent unavoidable suffering that could happen were a vet unable to prescribe a suitable alternative.
The cascade goes through the various stages of decision-making in the treatment of animals in descending order of suitability, commencing with the desired outcome of using an available authorised UK veterinary medicine and going through other stages, including the use of clinically suitable alternatives of, for example, human medicines authorised in the UK or in another member state for use in animals. The final provision is for the use of a medicine prescribed by the vet responsible for treating the animal and prepared specially on the occasion of the treatment being required—known as “extemporaneous preparation”. This has to be prepared by a vet or a pharmacist or a person holding an appropriate manufacturer’s authorisation.
In exceptional circumstances, where no suitable veterinary medicine is available either as an authorised product or under the cascade, a vet may treat an animal with a medicine authorised in a country outside the EU via the Special Imports Scheme. Clearly, the guidelines and appropriate primary legislation will need to be amended in the light of our forthcoming exit from the EU—or if there is no deal. So can the Minister tell the Committee what preparations are being made in respect of this very important matter?
Prescribing decisions under the cascade are made on a case-by-case basis. The prescribing vet is personally responsible for the choice of product, is subject to the Royal College of Veterinary Surgeons’ code of professional conduct and must always obtain the owner’s consent for their animal to be treated under the cascade. Accurate record keeping is also required under the guidelines. Supplies of products used under the cascade and associated records can be examined during inspections of vets’ premises by the VMD and the RCVS. Under the last tier of the cascade, extemporaneous preparations —also known as veterinary specials—can legally be prescribed, supplied and used, recognising that they carry a higher risk than authorised medicines.
So this is an important scheme and the maintenance of the veterinary medicines cascade is a vital issue in the medical treatment of animals post Brexit, particularly in the event of no deal, as I said. I look forward to the Minister’s explanation of the action being taken to ensure that the cascade is maintained, continued and, if possible, simplified in line with the BVA’s recommendations. We need assurance that the Government will not use the powers in this Bill to diverge from the cascade after it is passed.
Finally, the BVA has underlined that, if it is to remain as one of the leading agencies in Europe and beyond, the Bill must be used to establish a national authorisation procedure for veterinary medicines, on the same scientific and evidence-based technical requirements as adopted by the EU, firmly rooted in the established standards set for quality, safety and effectiveness. The association has emphasised that, to have an influential voice in global veterinary regulatory affairs, it is vitally important for the UK to seek full membership of the international technical requirements registration body, the VICH, to which I referred earlier. I look forward to the Minister’s response on this vital issue.
The noble Baroness, Lady Wheeler, has given a really good description of the cascade and the way in which it works. It is a risk- based decision process whereby vets can dispense different medicines to animals beyond the term of authorisation. The BVA supports maintaining the cascade. Can the Minister confirm the arrangements if no suitable UK drugs are available? Can she also confirm that veterinary drugs will be part of trade deals with both the EU and the US?
My Lords, I am grateful to the noble Baroness, Lady Wheeler, for raising the important issue of the prescribing cascade, as put forward in Amendment 62. I recognise the desire to ensure that the use of the cascade continues to be regulated. It is an important tool for veterinary surgeons, as they can access a wider range of medicines to treat animals under their care and avoid unacceptable suffering. However, I reassure the noble Baroness that this amendment is not necessary. The Bill already confers discretionary powers that will allow the appropriate authority to decide, following public consultation, if and how the existing cascade provisions in the Veterinary Medicines Regulations 2013 should be amended.
The existing provisions for the prescribing cascade are well used and well understood by veterinary surgeons who are responsible for their prescribing decisions. The provisions were so well described by the noble Baroness that I shall not repeat them here.
The noble Baroness, Lady Wheeler, is right that the second option under the cascade is the use of human medicine authorisation in the UK or a veterinary medicine authorised in an EU member state. She and the noble Baroness, Lady Jolly, asked what will happen after the end of the transition period. On 1 January, the second option will be extended to encompass the importing of veterinary medicines from any other country, rather than only EU member states. This is being provided for through secondary legislation taken through last year, I believe.
The Veterinary Medicines Regulations 2013 also set out additional conditions that need to be met when a product is prescribed under the cascade for use in food-producing species. These conditions help protect the safety of consumers of produce from treated animals. The conditions state that the pharmacologically active substances contained in the medicines must have a maximum residue limit, an appropriate withdrawal period must be specified, and specified records must be kept. These conditions help protect the safety of consumers of produce from treated animals. We do not plan to significantly diverge from the current prescribing cascade for veterinary medicines.
The new EU regulation 2019/6 on veterinary medicinal products will apply in the EU from January 2022. This regulation introduces changes to the cascade, such as separate cascade structures for food producing and non-food producing animals. It includes provisions on the use of antimicrobial medicines under the cascade. For example, the European Commission may, by means of implementing Acts yet to be adopted by the EU, establish a list of antimicrobials which shall not be used under the cascade and a list of antimicrobials which shall be used, subject to certain conditions for cascade use. If it is in the best interests of the UK, we can make provision corresponding or similar to those in EU regulation under the powers in the Bill.
The UK Government and animal sectors have already shown their commitment to tackling antimicrobial resistance and the sectors have substantially reduced their use of antimicrobials in food-producing species—a 53% reduction in sales between 2014 and 2018. The Government will consult on proposed changes to the VMR, including changes implementing our priorities on antimicrobial resistance.
The amendment that the noble Baroness has proposed would obligate the Secretary of State to make changes to the regulations on the use of the cascade. I hope I have reassured her that the cascade remains of vital importance, and it is right that we have the option to amend the regulations when it is appropriate and necessary, subject to consultation, rather than being obliged to do so.
I will write to the noble Baroness, Lady Jolly, on her question about trade deals.
In the light of that response, I ask the noble Baroness, Lady Wheeler, to withdraw her amendment.
I thank the noble Baroness, Lady Jolly, for her support and the Minister for her response. As I said, I have learned a great deal about this valuable procedure. I am grateful for the Minister’s reassurance on the Government’s continued support for and commitment to the cascade. I will certainly read her comments carefully. I did not hear any reference to the VICH, but if she would write to me on that that would be very helpful. With that, I withdraw the amendment.
Amendment 62 withdrawn.
Clause 9 agreed.
Clause 10: Fees, offences, powers of inspectors, costs
Amendment 63 not moved.
Amendments 64 and 65
64: Clause 10, page 6, line 27, leave out from “regulations,” to end of line 28
Member’s explanatory statement
See the explanatory statement for the amendment in the Minister’s name inserting new subsection (1A) into Clause 10.
65: Clause 10, page 6, line 35, at end insert—
“(1A) Regulations under section 8(1) may not provide for an offence to be punishable with a sentence of imprisonment of more than two years.”Member’s explanatory statement
This amendment, and the other amendment to clause 10 in the Minister’s name, ensures that regulations under Clause 8(1) may not provide for any offence to be punishable with a sentence of imprisonment of more than two years.
Amendments 64 and 65 agreed.
Clause 10, as amended, agreed.
66: After Clause 10, insert the following new Clause—
“Disclosure of information in accordance with international agreements
(1) This section applies to information which a relevant authority holds in connection with veterinary medicines.(2) The relevant authority may disclose information to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of veterinary medicines.(3) The relevant authority may not disclose commercially sensitive information in reliance on subsection (2) unless the relevant authority— (a) considers that it is necessary to do so for the purpose mentioned in that subsection, and(b) is satisfied that the making of the disclosure is proportionate to what is sought to be achieved by it.(4) Except as provided by subsection (5), the disclosure of information in accordance with this section 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).(5) Nothing in this section authorises a disclosure of information which—(a) contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section), or(b) is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016.(6) In this section—“commercially sensitive information” means commercial information whose disclosure the relevant authority thinks might significantly harm the legitimate business interests of the undertaking to which it relates;“relevant authority” means—(a) the Secretary of State, or(b) the Department of Agriculture, Environment and Rural Affairs in Northern Ireland;“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018.”Member’s explanatory statement
This new Clause makes clear that information held by the Secretary of State or the Department of Agriculture, Environment and Rural Affairs in Northern Ireland in connection with veterinary medicines can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.
Amendment 66 agreed.
Amendment 67 not moved.
Clause 11 agreed.
We now come to the group beginning with Amendment 67A. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the course of the debate.
67A: After Clause 11, insert the following new Clause—
(1) Within six months of the day on which this Act is passed the Secretary of State must set up a working group to conduct a review of the regulation of veterinary devices.(2) The review under subjection (1) must make reference to the impact of the current system of regulation on—(a) animal welfare;(b) human safety; and(c) the environment.(3) The working group must consult bodies or individuals who are subject to regulation concerning veterinary devices during the course of the review. (4) The review under subsection (1) must make a recommendation as to whether further regulation should be introduced in light of its findings.(5) The Secretary of State must lay a copy of the review before both Houses of Parliament.”
My Lords, this Bill is about medicines and medical devices, and also includes veterinary medicines, which I understand the profession welcomes. I support government Amendment 131.
I confess, I wondered whether the veterinary part of the Bill was a bit of an afterthought, as although veterinary medicines are covered, I was somewhat bemused that there was no mention of veterinary devices. Modern vets make much use of veterinary and medical devices. Many pet owners expect their pets to be treated as well as they are by the NHS, and they are ready to pay. Many large animals, particularly stud animals, are of considerable value to their owners, who also expect modern treatment.
With a growing market for veterinary devices there are areas in which the absence of these devices often involves medical devices, but the profession anticipates that the veterinary device market will only increase and specialise. The Committee will appreciate that size is an issue. At present, many vets manage by using human medical devices, but I am sure the Committee will understand that vets treat animals of all sizes, from a hamster to a chihuahua, to a prize bull. I tabled these amendments in anticipation of a vibrant veterinary device market. To use devices designed for a human body weight is not always appropriate.
My amendment calls for the Secretary of State to set up a working group to conduct a review into the regulation of veterinary devices, referencing animal welfare, human safety and the environment, and make appropriate consultations before laying a copy of the review before both Houses. Amendment 67B is also in my name and calls for a review of the impact of the Bill on veterinary medicines.
We are in a transition, and by the end of 2021 or thereabouts there will be a clearer picture about veterinary medicines, a year after leaving the EU. The Secretary of State should consult relevant bodies, such as the BVA, the NFU and animal welfare groups such as the PDSA and the RSPCA, but I think noble Lords should agree that there is a case for veterinary devices in the Bill.
My Lords, I am pleased to speak to government Amendment 131, merely to ask a question. The amendment will require reporting, which is positive and is to be welcomed. However, it leaves the matter of who is to be consulted to the discretion of the Secretary of State, because proposed new subsection (2) refers to
“such persons as the Secretary of State considers appropriate”,
while proposed new subsection (3)(a) requires the Secretary of State to take account of
“concerns raised, or proposals for change”,
but only those made by a person in accordance with subsection (2). Those persons are left to the discretion of the Secretary of State. It is not only the people who are consulted who are chosen; the list is produced by the Secretary of State.
To have any substance to it, the proposed new clause ought not to leave it to the whims of the individual Secretary of State to decide who ought to be consulted. There should be some minimal statutory list, or principles that can guide a list in practice, to give transparency and confidence. My question is quite simple: is it likely that the Government will produce a list of who they will consult?
My Lords, I put my name down to speak on this group primarily to speak to Amendment 106 in the name of the noble Baroness, Lady Thornton, but I will comment briefly on the excellent Amendment 67A from the noble Baroness, Lady Jolly. It seems to address an obvious lacuna in the Bill and I hope that the addition of veterinary devices would be a really simple procedure that the Government could take on board. I also commend Amendment 67B in the name of the noble Baroness, Lady Jolly, and associate myself with the remarks from the noble Lord, Lord Patel, on the concerns about the apparent weakness of government Amendment 131.
I wanted to speak to Amendment 106 because many of us who have been in different roles in politics over many years are used to receiving cries for help from people who feel as if medical systems have made them more ill, treated them badly and failed to live up to the oath of “first do no harm”. It is very hard for a person in your Lordships’ House or in politics to make a judgment call on what can be done and how people can be helped—on how systematic the issue really is and where this should be going. What we really need is a place where records are kept overall; it does not feel as if that is happening at the moment. The amendment lays down a way to address that. Of course, we have not heard yet from the noble Baroness, Lady Thornton, so I am interpreting what her amendment says.
There is also a broader point here, which we need to address throughout the Bill, and which I have been thinking about in the context of Covid-19. We really have a huge problem of trust, given the concern among significant parts of the public about how systems are working and whether decisions are being made in the right interests. One thing we need to do is to make sure that the whole system is transparent and open, and that records are there and accessible. We know of so many cases—the noble Baroness, Lady Cumberlege, set out some—where there tends to be a particular issue with the way that medicine has treated women.
There is also an issue in that the people who come to us and are able to make a fuss are often those who, in one way or another, have some form of social capital in their education, knowledge and ability to reach out and seek help. If we do not have regular systems of keeping records to see problems arising, it may be the most vulnerable who suffer without really knowing how to speak out and initiate action. I commend Amendment 106 to the Committee and look forward to hearing further discussion on it.
My Lords, our Amendment 106, which I am speaking to on behalf of my noble friend Lady Thornton, is in this group on reporting requirements under the Bill. Specifically, it would add a new clause providing for an annual report to Parliament on medical devices information systems established by NHS Digital under the powers conferred by Clause 16. I am grateful to the noble Baroness, Lady Bennett, for her support for this amendment.
Clause 16(1) gives the Secretary of State the power by regulations to make provision for NHS Digital to establish and operate
“one or more information systems”
for medical devices. Under the Bill, these relate to the safety, performance and
“clinical effectiveness, of medical devices … placed on the market; … the safety of individuals who receive or are treated with a medical device”,
or who have one implanted in them, and
“the improvement of medical device safety and performance through advances in technology”.
The annual report proposed in our amendment would provide for the operation of these information systems to include information on the overall data in relation to
“the number of patients who receive or are treated with a medical device, or into whom a medical device is implanted; … any safety concerns received; and … any regulatory action taken.”
Finally, the amendment would ensure that the Secretary of State provided a copy of the report from the information centre on these related areas to the devolved Administrations in Scotland, Wales and Northern Ireland.
The Government’s own Amendment 131, providing a new clause after Clause 41 on consultation provisions and requirements, limits itself to the provision of a biennial report to Parliament starting:
“As soon as reasonably practicable after”
the Bill has passed on the operation of regulations laid on human medicines, veterinary devices and medical devices. The amendment is part of the Government’s response to the Delegated Powers and Regulatory Reform Committee. It also provides for regulations to be subject to public consultation before they can be made and requires the Secretary of State to include in the biennial report, as part of a consultation process, a summary of the concerns expressed or proposals put forward and, in consulting, to set out how the key issues of safety, availability and attractiveness have been taken into account.
The Minister’s letter to Peers of 13 October, which, as my noble friend Lady Thornton has already pointed out, we did not receive until after the amendments had been laid, underlines the importance of the Government’s amendments in providing a reporting obligation on the Secretary of State which
“will inform Parliament of the outcome of consultations on regulation made under Clauses 1, 8 and 12 during the two-year period under consideration, and provide a look ahead to expected regulatory change in the future”.
While consultation before the preparation of the report and information on the consultation, concerns and proposals are welcome, we do not accept that Amendment 131 fully meets the concerns of the DPRRC. We consider that an annual report to Parliament is essential, given the vital importance of the scrutiny and accountability that Parliament must be able to exercise.
We also consider that the government amendment should make a specific commitment to consultation with the devolved Administrations in Scotland, Wales and Northern Ireland, and not just to the Secretary of State consulting such persons as he/she considers appropriate. We will take up the key issue of consultation with the devolved Administrations in our later amendment and I look forward to the Minister’s response to the question of the noble Lord, Lord Patel, on these areas.
Finally, I strongly support Amendments 67A and 67B from the noble Baroness, Lady Jolly, which call for reviews to be laid before Parliament of the regulation of veterinary devices and the Bill’s impact on veterinary medicines after the Act is passed. The noble Baroness made a pretty convincing case for these amendments. The delegated powers in Part 2 of the Bill to amend the Veterinary Medicines Regulations 2013 are wide-ranging. Close scrutiny of the impact on animal welfare, human safety and the environment, together with full consultation with key stakeholders and recommendations on the need for further regulation, will be crucial. Similarly, the review of the Act’s impact on veterinary medicines, to be published one year after it is passed; on safety in relation to animals, humans and the environment; on availability in the UK; and on the UK’s participation in the development and supply of veterinary medicines would ensure full scrutiny of how the provisions in Clauses 9 and 10 were working in respect of these key issues.
I have two further points. During the Commons Committee on the Bill, we raised the importance of the availability of veterinary medicine services, as well as medicines across the country, and of ensuring that they are available in rural and urban settings. This would ensure that we do not have a two-tier system whereby there is better access to veterinary medicines and services in certain communities. We also called for a full assessment of the capacity of the veterinary industry to meet the regulatory and other requirements set out in the Bill. These are key issues which the review process set out in the amendments of the noble Baroness, Lady Jolly, would address. Can the Minister tell the Committee what work is being undertaken with veterinary sector stake- holders, including the British Veterinary Association and the Royal College of Veterinary Surgeons, on these issues —particularly to ensure that, post Brexit, we have the sustainable, diverse and modernised UK veterinary infrastructure and skilled workforce that we need to ensure a safe environment for humans and animals?
My Lords, Amendment 67A, put forward by the noble Baroness, Lady Jolly, relates to veterinary devices. This is a proposed new clause seeking to ensure that the Secretary of State sets up a working group to review the regulation of veterinary devices within six months of this Act passing.
There is currently no specific legislation for veterinary medical devices. The market is small and manufacturers may choose to market their products for dual use—for humans and animals. The medical devices regulations are intended only for human devices. However, we consider that the regulatory framework is also suitable for ensuring the quality and safety of equipment for veterinary use. The Bill allows us only to amend or supplement the existing veterinary regulations in the manner described in Clauses 9 and 10. Those clauses do not provide authority for regulations to introduce substantial new standalone requirements for veterinary medical devices. If a medical device is packaged with a veterinary medicine, the marketing authorisation application would need to set out relevant information on that device. The device would therefore be assessed together with the veterinary medicine before a marketing authorisation is granted. Therefore, this type of medical device falls under the regulation of veterinary medicines.
The Royal College of Veterinary Surgeons’ code of professional conduct states that vets must provide care that is appropriate and adequate. If the actions of a vet, by using a device, do not meet these standards, the RCVS could take action to protect animal health and welfare, including removing the veterinary surgeon from the register. I hope that this reassures the noble Baroness that her amendment is unnecessary; after all, the Bill is not aimed at regulating veterinary medical devices, and the RCVS’s professional supervision of vets provides reassurance that vets will provide appropriate care when using devices.
In Amendment 67B, the noble Baroness, Lady Jolly, raises the important point about considering the impact of the Bill on veterinary medicines. I recognise the desire to make sure that any regulations we make under the Bill have a positive impact on veterinary medicines, and in particular on safety, availability and their development and supply in the UK. On the noble Baroness’s good point about the different sizes of human and animal devices, I would be glad to commit to writing a clarification. I can assure her that her amendment is not necessary, as we have already included all these considerations explicitly on the face of the Bill in Clause 8(2).
I would like to speak to Amendment 131, tabled in my name, which inserts a new clause after Clause 41. The new clause obliges the Secretary of State to report to Parliament on the operation of any regulations made under Part 2 of the Bill that were in force during the two-year reporting period. I say to the noble Lord, Lord Patel, that this rolling process of two-yearly reports on regulations is quite different from the initial round of consultations, which will abide by the usual Cabinet Office rules and values applying to consultations. These very important obligations, our commitment to public consultation and, indeed, parliamentary scrutiny of the regulations, when they are made, will provide ample and regular opportunity for reviewing the impact of our regulations on veterinary medicines and others besides.
Amendment 106, in the name of the noble Baroness, Lady Thornton, would require the provision of an annual report to Parliament and the devolved Administrations on the operation of any information system established under Clause 16. I completely understand that her intent is to keep Parliament and the devolved Administrations informed about the information system. It is unlikely that that system will have been established and fully operational long enough to provide an annual report within 12 months of the Bill being granted Royal Assent. Regulations will be made to establish an information system under the powers in Clause 16(1), but this will not happen immediately.
Comprehensive engagement with all stakeholders, as well as public consultation, is required to develop the information system and establish the content of the regulations. That would include details of what information will be collected. It would be premature to specify in the Bill, by virtue of a reporting requirement, what data the information system must collect in advance of the required consultation. Discussions have already begun at official level on how to develop the information system so that it works well for all partners. The government amendment to Clause 41 that I have proposed requires consultation with the devolved Administrations in the development of the regulations. This will give a specific footing to support the existing working arrangements.
I have heard the calls for greater visibility of the Government’s plans for regulatory change, beyond even a debate on an affirmative statutory instrument, such that Parliament is given greater opportunity to reflect and be satisfied that we have taken the right steps to support UK patients. Amendment 131, in my name, seeks to achieve a number of important outcomes in support of the effective and appropriate use of key delegated powers in the Bill. It provides an answer to that concern.
We discussed earlier in Committee the amendments tabled by the noble Lord, Lord Patel, and the noble Baroness, Lady Thornton, to seek draft consolidated legislation within a set period. Amendment 131 places an obligation on the Secretary of State to report on the operation of any regulations made under Clauses 1(1), 8(1) and 12(1) every two years. This reporting obligation is both forward-looking and backward-looking. That is because the report must include a summary of any concerns raised or proposals for change made regarding the operation of the regulations during consultation, and the Secretary of State’s response, including any plans for further regulation. The report must be laid before Parliament.
This will have two significant effects. First, it offers an opportunity to inform Parliament on how the regulations are operating, with reference to concerns and proposals made by consultees. Secondly, Parliament will have early indication of possible plans for further regulatory changes under Clauses 1, 8 and 12. It would be an indication of the Government’s intended direction of travel and, naturally, I do not doubt Parliament’s capacity to offer views on that direction of travel.
Amendment 131 works alongside the other amendments in my name, changing the consultation obligation and providing clarity on how the considerations have been given regard to so far in developing the consultation proposals for regulatory change. In combination, these amendments will ensure significantly greater transparency and opportunity for oversight and scrutiny throughout the policy development and, later on, the operation of the regulations made under the powers we are seeking.
The noble Lord, Lord Patel, made points on consultation. Although we are not tabling a specific list of consultees, we are guided by the very clear and demanding government guidelines on this.
I hope that the noble Baroness, Lady Jolly, will feel able to withdraw her amendment, and that others will not feel compelled to move theirs.
I have received one request to speak after the Minister. I call the noble Lord, Lord Patel.
I merely wish to ask the Minister about the consolidation legislation, to which he referred. Am I to understand that the Minister is saying that the Secretary of State will respond to Parliament, and that the matter will be available for debate?
I will get to back to the noble Lord with the specific answer to that question, if I may.
My Lords, I shall not detain the Committee for very long. I thank the Minister for his comments. I feel inclined at the moment not to withdraw my amendment, but I would like to read Hansard, consult and decide whether to return with these amendments, or something like them, on Report. I beg leave to withdraw the amendment.
Amendment 67A withdrawn.
Amendment 67B not moved.
Clause 12: Power to make regulations about medical devices
68: Clause 12, page 7, line 22, at end insert—
“(1A) The Secretary of State may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.” Member’s explanatory statement
This amendment provides that the Secretary of State may only make regulations under subsection (1) of Clause 12 if satisfied that they would promote the health and safety of the public.
Amendment 68 agreed.
Amendments 69 to 71 not moved.
72: Clause 12, page 7, line 23, leave out “making regulations under subsection (1)” and insert “considering whether they would”
Member’s explanatory statement
This amendment requires the Secretary of State to have regard to the factors mentioned in subsection (2)(a), (b) and (c) of Clause 12 in considering whether regulations under subsection (1) would promote the health and safety of the public.
Amendment 72 agreed.
Amendments 73 to 76 not moved.
77: Clause 12, page 7, line 27, leave out paragraph (c) and insert—
“(c) the likelihood of the United Kingdom being seen as an attractive or favourable place in which to develop or supply medical devices.”Member’s explanatory statement
This amendment clarifies what was meant by the version of Clause 12(2)(c) in the Bill as brought from the House of Commons.
Amendment 77 agreed.
Amendments 78 to 82 not moved.
83: Clause 12, page 7, line 28, at end insert—
“(3) Within 12 months of this section coming into force, the Secretary of State must initiate a comprehensive technical review of the definition of “medical device” under the Medical Devices Regulations 2002 with a view to addressing the inclusion of artificial intelligence software and algorithms including methodologies for the interpretation of data and associated technical architecture in medical devices.”Member’s explanatory statement
This amendment seeks to improve how the Bill addresses new technologies which have significant potential for harm, aligning with and improving on the EU and US equivalents.
My Lords, I thank the Minister for the opportunity to speak today about medical devices that make use of data-processing methodologies, algorithms, artificial intelligence and other technical architecture. In moving Amendment 83, I shall speak also to Amendments 112 and 113.
I am a long-standing advocate of the use of patient data to provide better healthcare. Noble Lords can therefore rest assured that I by no means seek to introduce obstacles to the vital research and innovation that I know the Government wish to encourage and facilitate to improve the nation’s health. However, I seek to guarantee patient safety in our increasingly data-driven health service and to ensure that the UK is well placed to become a rule-maker and world leader post Brexit.
Others in this place have spoken eloquently about the need to prioritise consideration of patient safety in the Bill. In particular, I was moved by the expert and passionate speech made by the noble Baroness, Lady Cumberlege, at Second Reading. I hope and anticipate that the noble Baroness, Lady Bennett of Manor Castle, will remind us of the social and environmental consequences we should pay heed to in encouraging innovation in medicines and medical device development, which, I believe, should result in closer consideration of the implications of the growth in digital healthcare for the climate as the Government prepare to host COP 26. However, it was the noble Lord, Lord Patel, who helpfully reminded us of the importance of precision in the definitions and wording we agree in this place, and it is my intention here to do the same.
In speaking to Amendments 112 and 113, I am recommending specific protections in the form of an up-to-date definition of a medical device, because the Bill currently relies on a definition from the Medical Devices Regulations 2002, which were updated to include the term “software” in 2007 and therefore do not safeguard individuals from the potentially harmful effects of the full range of contemporary medical devices. The effect of my amendment would be to update the definition of a “medical device” and bring it in line with regulatory provisions in the EU and the US. The use of technology has advanced significantly since 2007 and I can see no good reason why the UK should be a laggard at this time.
In moving Amendment 83, I recognise that we are always, in some senses, on the cusp of new developments or breakthroughs in science and technology that have the potential to transform healthcare services as well as outcomes for individuals. I can therefore understand the Government’s desire for flexibility in presenting this Bill as they have done. However, I am certain that the Minister will agree that we find ourselves on the cusp where growth in the use of artificial intelligence in healthcare is concerned, not least because the Department of Health and Social Care has invested more than £250 million in establishing an AI lab this year and is preparing to publish the first national health and care data strategy this autumn, which is expected to state that the Government will prioritise the
“safe, effective and ethical use of data-driven technologies, such as artificial intelligence, to deliver fairer health outcomes”.
As such, I very much hope that the Government will, at the very least, support Amendment 83, the effect of which would be to require the Secretary of State to initiate a comprehensive technical review of the definition of a “medical device” under the Medical Devices Regulations 2002 within 12 months of this Bill coming into force, with a view to addressing the inclusion of artificial intelligence, software and algorithms, including methodologies for the interpretation of data and associated technical architecture, in the legal definition of a “medical device”.
I thank the Minister, the noble Lord, Lord Bethell, for his detailed correspondence with me since the Bill’s Second Reading. I will rehearse some of the questions and answers we explored for the benefit of other noble Lords. They are, admittedly, broad-ranging and of a technical nature, so I apologise in advance for the detail of what comes next, but I hope they will explain what is at stake.
In his letter of 4 November to me, the Minister appeared to confirm that algorithms are already covered by the term “software”, which would negate the need for my Amendments 112 and 113, but only in so far as algorithms underpinning medical devices amount to what might be termed “static” instructions, as distinct from the dynamic algorithms with which I am particularly concerned. My understanding is that, in addition to software involving static algorithms, modern healthcare is also making growing use of dynamic algorithms. These result in exceedingly complex data-processing functions which are arduous to audit or control adequately from the perspective of versioning.
For example, deep neural network—DNN—algorithms, which since 2016 have facilitated the exponential growth of the artificial intelligence market, are what is termed “black box” approaches where there is no way to work backwards from the outcome to determine the calculation or processing steps that arrived at the decision or recommendation. At present, it is also my understanding that they cannot be scrutinised for approval by a human being in the same way that static algorithms, such as QRISK2, or other traditional clinical calculators, can be. Therefore, will the Minister say whether and how they are currently being regulated in practice, since he appears to take the view that the Bill’s provisions suffice as they stand?
Of course, the data that a deep neural network approach relies on is as crucial as the algorithm or model used in any software, and updating a training dataset can significantly alter the function of an AI model through changing the weighting of components in an algorithm. In this instance, the algorithm is unchanged, but the weighting of different parts thereof does change. Would such an algorithm be deemed a new medical device in the eyes of the regulatory framework that the Government propose to introduce? It could, after all, result in a change with the potential to cause harm, such that it could be said to pose a risk to patient safety if left unchecked.
Beyond this, there are leading-edge approaches, such as reinforcement learning, where over time and through iterative processing an algorithm self-alters as the outcomes of different clinical decisions become apparent. These techniques are such that software per se is constantly changing and, as each case is resolved in a clinical setting, the ongoing function of the algorithm is altered. In practice, this means that on any given run of the software underpinning devices in relation to healthcare, the output could be different. Here, there are services, tools and devices available in different markets which use this technology in healthcare that would not be classed as a medical device as the Bill stands.
A specific example is GOQii, which is an app that tracks lifestyle conditions including, for example, diabetes and hypertension:
“Its ecosystem of wearables can currently track blood pressure and heart rate. The app mines this data and uses AI to make predictions about a possible fatal health situation that should serve as a warning for people.”
GOQii does not currently appear in the MHRA’s register of medical devices, and the developer’s website states that the platform does not amount to a medical device—but it would constitute a medical device that would be difficult to audit due to the lack of versioning control were all algorithms covered by the term “software” in the Bill, as the Minister appears to be suggesting is the case.
Moreover, reinforced learning has been applied in experiments that date back to 2017 and were designed to optimise antiretroviral therapy in HIV, tailor anti-epilepsy drugs for seizure control and determine the optimum approach to managing sepsis. Is it really in the interests of patient safety not to take further safeguarding action at this time? Without a formal commitment to update the definition of a medical device as I have proposed, I have to say that I remain concerned about the nexus of issues that Amendments 112 and 113 seek to address.
In writing to me, the Minister also helpfully sought to address the relative merits of including reference to the term “artificial intelligence” in the Bill, which is relevant to the review that Amendment 83 would require to take place within 12 months of the clause coming into force. Here, however, I must be candid and say that I am less persuaded still of the stance that the Minister appears to have taken, because he himself acknowledges that Her Majesty’s Government intend to
“examine the options to strengthen the regulations for software and AI”,
echoing his commitment in response to my contribution at Second Reading.
Does this stated intention to examine the options perhaps reflect the fact that the pertinent MHRA guidance is non-statutory and currently “under review”, with further non-statutory guidance anticipated by the end of the year? Or is it perhaps the case that the Minister is concerned about how decisions regarding “edge cases” are taken or monitored in practice in the absence of formal “accountability and regulatory measures”—a situation that is potentially exacerbated by the lack of a clear definition of “medical purpose” in the Bill? Certainly, these are all issues with which I am concerned.
Finally, why would the FDA and pertinent bodies in the EU be looking at how to treat artificial intelligence in relation to innovation in medical device development were it the case that AI was already adequately defined? I wonder: might the Minister have in mind an alternative form of words to Amendment 83, calling for a review over the course of the coming year, that would provide me with the comfort that I seek if I am not to reserve the right to revisit my amendments on Report?
I know that the Minister is absolutely committed to patient safety as well as to facilitating innovation in the development of medicines and medical devices, as was made plain only recently when NHSX launched its digital technology assessment criteria for health and social care in beta. However, there has perhaps never been a more thoroughgoing appreciation of the inextricable link between health and wealth than is the case at present, during the ongoing public health emergency. Algorithms that impact the exam results that people receive impact their life chances. We must ensure that algorithms with the potential to impact people’s health, and which could even represent a threat to life, are appropriately regulated. As such, I hope that the Government will make good the Minister’s commitment to champion patient safety, in parallel with taking steps to ensure that the UK is among the best places in the world to develop, test and deploy an array of next-generation medical devices. I thank noble Lords for their patience in listening to this long speech and I beg to move.
My Lords, I want to strongly support the amendments in the name of the noble Lord, Lord Freyberg, and myself, and to commend him on an extraordinarily well-informed speech in support of them. I absolutely support the amendments, in particular Amendment 83, which calls for the comprehensive technical review.
The noble Lord made all the points about dynamic algorithms, deep neural networks, the whole question of self-alteration by algorithm and the absolute need to avoid black-box AI, which chime strongly with everything that I know about artificial intelligence. I welcome, right at the beginning, the Minister’s agreement to meet the noble Lord, Lord Freyberg, and me to discuss these issues further. So I am taking this debate not as the end of the road but as the beginning of a dialogue on these issues.
The big question is: does the Minister really believe that we should be reviewing the definition of “medical device”? Does he believe that it is out of date but is simply reluctant to enshrine it in legislation? All Ministers hate their legislation being tampered with, but I am afraid that I am quite sure that this Bill will suffer some treatment on Report.
Even more important than the definitions is the question of how regulation takes effect on these medical devices, in particular on the new medical devices that incorporate algorithms in this way, and whether the regulation is fit for purpose. Without going into the paper at too great a length, I commend to the Minister the discussion paper from the US Food and Drug Administration, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device. I have searched but I could not find that the MHRA had done anything of an equivalent quality. I will take a few quotes from the document that illustrate that this is exactly the kind of work that our own regulator needs to do.
The document states:
“Artificial intelligence- and machine-learning-based technologies have the potential to transform healthcare by deriving new and important insights from the vast amount of data generated during the delivery of healthcare every day … The traditional paradigm of medical device regulation was not designed for adaptive AI/ML technologies, which have the potential to adapt and optimize device performance in real-time to continuously improve healthcare for patients.”
That is positive, but it also puts on regulators a particular duty to continuously assess and monitor, as the nature of the medical device and the algorithm within it changes.
The paper sensibly goes on to suggest a completely different way of regulating this kind of dynamic algorithm and type of artificial intelligence incorporated in medical devices. It distinguishes between locked—static—algorithms and dynamic algorithms and states:
“In contrast to a locked algorithm, an adaptive algorithm (e.g., a continuous learning algorithm) changes its behavior using a defined learning process. The algorithm adaptation or changes are implemented such that for a given set of inputs, the output may be different before and after the changes are implemented.”
Those are exactly the points that the noble Lord, Lord Freyberg, made.
The FDA, of course, is one of the great regulators globally. In a sense, it carries on regardless of whatever Administration are in place. So it has a very high reputation. I hope that we are heeding the wise words of the FDA and I very much hope that we are taking on board all the suggestions that the FDA has made for better regulation of algorithms. They are different. I hope that the Minister is not being Canute-like in holding back the thought that new technologies need new treatments in regulatory terms and I am looking forward to what he has to say.
My Lords, it is a great pleasure to follow two such wonderfully informed and informative speeches and I thank the noble Lords for tabling this amendment. So that the Committee can understand my position in this, I will say that I wrote part of a master’s thesis 20 years ago on artificial intelligence. That of course is an age in terms of these things, but I had cause to engage with the issues of medicine and artificial intelligence just last year when I was asked to take part in a debate on the subject. One of the things that I found was that a lot of the language has not changed. Twenty years ago, AI was almost there and now, while we have a great deal of big data, how much closer we are to actual artificial intelligence is another question. The noble Lord, Lord Clement-Jones, referred to what happened this year with the exam results fiasco, which was very much a cautionary tale about the use of this.
I would position myself as a cautious sceptic of AI in general. The noble Lord, Lord Freyberg, was absolutely right in deducing that the reason I put my name down to speak on this amendment was that I am particularly concerned about the social issues associated with such systems. We have seen, in the last couple of years, a great deal of rising awareness of the ways in which they can discriminate against certain populations that are already discriminated against—be that according to gender or socioeconomic status, or people from BAME and other backgrounds.
I want to draw noble Lords’ attention to an excellent article in the Journal of Information Policy from 2018, which I think was one of the early articles on this issue, entitled, “How Algorithms Discriminate Based on Data They Lack: Challenges, Solutions and Policy Implications”. It talks about software and systems engineers, scholars, researchers and people making decisions for business, education, social services and other enterprises having to ask themselves lots of questions. I would, of course, add into that list regulators. When is it appropriate to collect and use sensitive information? When does it cause harm and when does it prevent harm? My personal addition to this list is: when are you not collecting information that you need? The article states:
“Answering these questions requires understanding the practical and moral sides of a process involving people, data, and computation conceived as a sociotechnical system.”
What we are looking at here is growing complexity. As the noble Lord, Lord Clement-Jones, said, the risk of a black box AI system is that some very bad things can happen inside that black box. Furthermore, I come back to the points I made in the earlier group of amendments: we have a real issue of confidence in medicine and in the systems, and a need for transparency and for independent oversight. Simply relying on what are often for-profit companies making decisions and reassuring us that things are going to be fine has not worked out well in the past. As we enter this age of increasing complexity, it is crucial that we do not operate on that basis in the future.
I commend the noble Lords for tabling Amendment 83 and the consequent amendments. I look forward to the Minister’s response to my comments and theirs. In particular, I ask the Minister: if regulation of this crucial area of medicine is not going to appear in the Bill—if this amendment or something like it is not going to be adopted—how will the Government ensure oversight?
My Lords, the amendments in this group relate to technologies. Amendment 83, from the noble Lord, Lord Freyberg, to which I have added my name, seeks to improve how the Bill addresses new technologies which have significant potential for harm, and it aligns with and improves on the EU and US equivalents. The critical issue is: what is a medical device? Amendment 113, also from the noble Lord, Lord Freyberg, and my noble friend Lord Clement-Jones, updates the definition of a medical device to bring it in line with the EU and US regulation, acknowledging the progress of technology beyond the Medical Devices Regulations 2002, which, in the world of programming, is very nearly the dark ages. I wonder if noble Lords remember ALGOL, FORTRAN and BASIC.
I support Amendment 83, to which I have added my name, and received a very helpful letter about Amendments 112 and 113 from the noble Lord, Lord Freyberg. I listened very carefully to both him and, of course, my noble friend. I am happy to support their arguments and their amendments.
My Lords, the noble Lords, Lord Freyberg and Lord Clement-Jones, have done the Committee a great service today. I was fascinated by the speech from the noble Lord, Lord Freyberg, which set the tone for this discussion. I welcome his main points and his knowledge. He knows that I am a supporter of his work in this area, particularly on the protection of patient data.
It is a constant source of concern that either through carelessness, lack of expertise, unscrupulousness or policy fragmentation, our NHS will not benefit from AI and the use of patient data. I see this amendment as part of that discussion and that effort to decide what happens. The noble Lord, Lord Freyberg, has asked some very pertinent questions about algorithms, how they change and how they develop. Our job, surely, during the course of this Bill, is to find legislation that is ahead of the technology for once, not behind it. I was particularly struck by what the noble Lord, Lord Freyberg, has to say about GOQii and the MHRA, and the definition for medical devices and algorithms. The use of AI and algorithms is not impartial. We know that, particularly given our recent experience with A-levels, which was mentioned by the noble Lord, Lord Clement-Jones.
The Minister has to find a way of ensuring that this Bill reflects the modern situation and does not stop innovation. I really hope that she is not going to say that those of us who are asking these questions are opposed to innovation, because that is absolutely not the case. These are very important questions indeed for the future, as we find ourselves between the FDA and the European Union, and we make our way in this particular world.
My Lords, all the amendments in this group deal with the important matter of forward-thinking regulation—regulation that evolves as technology evolves. I say to the noble Baroness, Lady Thornton, that all the questions raised in this debate are very pertinent and are pro-innovation, not anti-innovation questions, concerned with ensuring that we can regulate this area properly.
As my noble friend the Minister said in previous communication to the noble Lord, Lord Freyberg, artificial intelligence is already in use in medical device technology and is already regulated—for example, Babylon’s mobile application Healthcheck is software that provides a general health assessment to users. That application is registered as class 1 medical device by the MHRA. We are also working on equipping our regulator for these products. The MHRA secured £740,000 from the Regulators’ Pioneer Fund to work with NHS Digital on developing a pilot in order to test and validate algorithms and other AI used in medical devices. There are other works in train to get the benefit of artificial intelligence in the health service. The Artificial Intelligence Award is run by the Accelerated Access Collaborative in partnership with NHSX and the National Institute for Health Research. It is making £140 million available to accelerate the testing and evaluation of the most promising AI technologies that meet the strategic aims set out in the NHS Long Term Plan.
I recognise that the intention of Amendments 83, 112 and 113 is to address the potential to cause harm to patients without appropriate regulation of these technologies. I can reassure noble Lords that software used for the application of medical devices falls within the definition of a medical device under the EU medical device directive, transposed into UK law through the Medical Devices Regulations 2002. Artificial intelligence and algorithms are encompassed within the term “software” where they have a medical purpose, and I can reassure the noble Lord, Lord Freyberg, that this covers static and dynamic algorithms.
In addition, within 12 months of this Bill gaining Royal Assent, we will start to develop new medical device regulations. The development of these regulations will include a full consultation on any changes proposed. I can commit here that the consultation will conclude within 12 months and will include the definition of a medical device, with particular reference to algorithms and methodologies used for the interpretation of data and associated technical architecture used within medical devices. This process will allow members of the public, patients and industry bodies—as well as perhaps noble Lords in this Committee—to help shape the future of regulation in the UK and the terminology that we use to describe what is captured by those regulations.
The amendments are accordingly unnecessary, as the outcome sought will be achieved under the umbrella of the wider-scale review of medical devices regulation in the UK, which will take place during a similar window as that sought by the amendment and will address the specific questions that it raises. So I hope that I have reassured the noble Lord, Lord Freyberg, that the existing definition covering both dynamic and static algorithms is sufficient and, if I have not, that he will take satisfaction from the Government’s commitment that, within 12 months, we will have concluded a consultation—to which I hope the noble Lord will contribute—that will include the definition of a medical device and specific reference to algorithms and methodologies used for interpretation of data.
This is an incredibly important debate. This is an emerging area of technology and, while we are reassured that the current regulations capture what they need to, we also need to look to the future, which is what the consultation can do. I hope that the noble Lord will feel able to withdraw his amendment.
I have received a request to speak after the Minister from the noble Baroness, Lady Thornton. I now call the noble Baroness.
I thank the noble Baroness the Minister. This is such an important issue, with the potential for huge benefits and huge harms. I regard it slightly like the sort of issues we dealt with in relation to the Human Fertilisation and Embryology Authority and the Human Tissue Authority—this is very important and runs very deep into our humanity. So the question I need to ask the Minister is: when the consultation is over, will we be looking at primary legislation, because I am not sure that regulation will quite do?
My Lords, the consultation will look at the specific issue of medical device regulation that takes place through secondary legislation. However, the noble Baroness is right in that this is not the only aspect of this issue that we are looking at and working on. There is work across government on a number of areas where this technology comes up, and we have established a number of bodies to help us in our work, such as the Centre for Data Ethics and Innovation. So, although the specific issue about the definition of a medical device and medical device regulations will take place under this Bill—subject to public consultation —there is a broader landscape that we will also address across the board and across government.
My Lords, I first thank the Minister for her attentiveness during my very long and quite tortuous speech, and for the very detailed responses I have had, back and forth, from the Minister’s officials, which have been exceptionally helpful. They have been doing that over many days and many weeks. I also thank the other noble Lords who supported my amendment: the noble Baronesses, Lady Jolly and Lady Bennett, and the noble Lord, Lord Clement-Jones. It was hugely welcome and I thank them for the contributions that they made.
I was fascinated by the fact that the Minister thought that it was both dynamic and static. That is not what I had understood from the letters, but I would like to look at that again. I will obviously follow her remarks in Hansard quite closely. Perhaps I could have further dialogue with her or the noble Lord, Lord Bethell, about that, because I am not entirely sure that that is how I have interpreted it—so I would like to come back on that, if I may.
Like the noble Baroness, Lady Thornton, I recall what the noble Baroness, Lady Cumberlege, said about the ongoing situation that faces those affected by sodium valproate and mesh. We do not want to be in a situation in years to come of not having something that adequately protects the public, and I worry that we are not getting to the root of this. So, while I am happy that the Minister has offered this review in 12 months’ time, I would like more information about that. In the meantime, I beg leave to withdraw my amendment.
Amendment 83 withdrawn.
Clause 12, as amended, agreed.
Clause 13: Manufacture, marketing and supply
Amendments 84 and 85 not moved.
We come now to the group beginning with Amendment 86. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
86: Clause 13, page 8, line 11, after “and” insert “unique device identification,”
Member’s explanatory statement
This amendment seeks to raise the issue of tracking of medical devices. Coupled with amendments by Baroness Finlay to page 8, line 17 and page 10, line 20, it would allow regulations to provide for the tracking of all devices via a Unique Device Identifier, as they are used, with the information recorded either in registries or through hospital episode statistics data.
My Lords, I will speak to Amendments 86, 88 and 102, standing in my name, and in support of Amendment 103 in the name of the noble Baroness, Lady Cumberlege.
My purpose in this group is to underscore the critical importance of unique device identifiers in maintaining patient safety. Fundamentally, I ask your Lordships to reflect on the systems we have in this country more broadly, say in retail, for product recall where a safety issue arises. Let us say that a tumble dryer is found to be a fire risk, or a washing machine is liable to flood people’s homes: it is dealt with by a media campaign urging people who have the product, with the relevant model number and bought at the relevant time, to contact their retailer and the manufacturer directly. We may examine, as the Fire Safety Bill presently before the House illustrates, whether this system is adequate for domestic electrical products, but that is for another day.
This afternoon, I hope that we can agree that devices left inside human beings and used in their medical treatment should be subject to a more rigorous and effective product recall system than tumble dryers. Tracking is absolutely essential in order to ensure that, if a product is discovered to be faulty or to have adverse effects of some kind, others who have had that device used in their treatment can be contacted and, if necessary, examined.
What is more, we already have the technology in place to make this a reality. In July this year, Scan4Safety published an evaluation of six pilot sites where a system of scanning and tracking was used. At these Scan4Safety sites, all patients have a unique GS1 barcode on their wristband, which is scanned before a procedure. The system also involves scanning all equipment used for the procedure, including implantable medical devices, and the location in which the procedure takes place. At some trusts, staff have barcodes on their badges that they can scan prior to a procedure. The result is full visibility of what has been done to which patient, when and where. To quote the noble Lord, Lord Prior, who as chair of NHS England wrote a foreword to the report, this system means:
“The time taken to recall products falls to hours from days or weeks, clinical time is freed up—significant as the NHS continues to face workforce challenges—and effective stock management becomes straightforward.”
The system is good both for patient safety—providing complete traceability, speed and accurate recall, alongside reductions in drug errors and those terrible “never events”—and for cost and efficacy. It leads to cost-effective product ordering, more efficient staff with better staff well-being, the creation of accurate patient-level costings, and reductions in unwarranted variation. Across the six trusts, the pilot produced £5 million in recurrent savings and £9 million in non-recurrent ones. Perhaps more importantly, the system is said to have released 140,000 hours of clinical time back to patient care.
The purpose of my amendments is to adduce from the Minister—who I hope will be willing to help—an absolute commitment that the Government see rolling out Scan4Safety as the future of medical device use in this country, and that we will not have devices put inside people without a clear record, including of which surgeon put in the device, when, where and so on. We will come back in the group starting with Amendment 87 and Amendment 95 to talk about registries that track outcomes. They are an absolutely essential part of this picture. However, the bare minimum for registries to function is to have a full and accurate database of what devices have been used in procedures, and on which patients.
Amendment 86 addresses this issue directly by stipulating that the provision about unique device identifiers—barcodes—must be included in regulations on medical devices made under Clause 12 of the Bill and should be part of the thinking when it comes to packaging and labelling. Amendment 102 seeks to strengthen the later Clause 16 by making the regulations about unique device identifiers mandatory.
I will briefly address Amendment 103 on patient consent. The noble Baroness, Lady Cumberlege, and I are broadly aligned on this. Her report recognises the GDPR issues around recording data on patients and storing it in a database. She distinguishes between database, the subject of this group, and the registry, which is more complex and useful, and which we will discuss in a later group. There is an issue as to whether the database we are discussing here is subject to the same level of patient consent as a registry. In a registry, patient outcome data will be recorded, in addition to the simple fact of a device having been used. I will be interested to hear the Minister’s position on that, and I strongly support the idea in Amendment 103 that any distinction should be set out clearly in the regulations under this Bill.
For my own part, I would hope that the consent process and shared decision-making that are used between surgeons, radiologists and so on and their patients in deciding to go ahead with a procedure, could be used both to set out a routine action to make an entry in a database and to participate in more complex registries. We will examine the purpose of registries more thoroughly in subsequent groups. For this group, I hope that the Minister will respond by confirming a shared belief in Scan4Safety and set out a timetable for an equivalent scheme to be rolled out across the NHS. It is an approach which has the strong support of the Royal College of Surgeons and whose broad use around the country is long overdue.
I hope that the Minister will also ensure full consultation with the devolved Administrations to ensure that a system of coding is compatible with all systems across the UK. I beg to move.
My Lords, it is a pleasure to follow the noble Baroness, Lady Finlay, who made a powerful case for knowing what happens to medical devices once they have been inserted. This was at the very centre of the Cumberlege review and to which I am sure my noble friend will draw our attention again, as well as to the key findings in this respect. Amendment 86 draws attention to the need for unique device identification information to be added to all packaging of medical devices, while Amendment 88 deals with the tracking of devices once inserted, as Clause 13(1)(h)(ii) requires information relating to the use of medical devices in individual procedures to be tracked and entered in a register or within hospital episode statistics data.
In my speech at Second Reading, I referred to Scan4Safety, which the noble Baroness, Lady Finlay, has just noted. In 2016, the Department for Health and Social Care awarded a total of £12 million to six hospital trusts in England for Scan4Safety demonstrator sites to investigate how the consistent use of point-of-care barcode scanning might improve efficiency and safety within the NHS. The noble Baroness also outlined the benefits of the GS1 barcodes. The result of the GS1 is a comprehensive, real-time view of stock, including that which is about to expire, as well as a complete audit trail. An audit trail is key to identifying problems with devices when they occur and to keep track of them in the future, as it may be many years before complications occur. Total hip replacements are one example. I have two of them, so I have a vested interest in knowing about the long-term future of those prostheses.
In June 2020, Scan4Safety published a report entitled A Scan of the Benefits. It gave two examples that are worthy of note and of repeating. In the North Tees and Hartlepool NHS Foundation Trust hospital orthopaedic department, barcodes helped to ensure that the correct patient is listed for the correct operation on the correct side. All items and implants are scanned before use. If the incorrect prosthesis is selected, for example a right knee implant for a patient who is supposed to be having an operation on the left knee, the barcode scanner buzzes and flashes, immediately notifying the potential error. At Leeds Teaching Hospitals NHS Trust, following the introduction of Scan4Safety, the average time taken to recall a product has fallen from 8.33 days to less than 35 minutes. The organisation reported £84,411-worth of staff efficiency savings on recall between January 2016 to December 2017 alone.
In Clause 16 on information systems, while I welcome the provisions, surely they are worthy of being strengthened by not using “may” so often. We need to move away from “may”, and its implied “perhaps”, to “must” and the implication that it will actually happen.
I shall end by restating my comments at Second Reading. The Government must undertake to mandate the tracking of all medical devices that are used in the UK, rather than a select few. I hope that these amendments will provide a means to do so. The Cumberlege review rightly recommended that a central patient identifiable database should be created, collecting key details of the implantation of all devices at the time of the operation. In the light of this, we strongly urge the Government to apply the powers provided for in Clause 16 as well and as widely as possible.
To give assurances in the context of this amendment, the Royal College of Surgeons believes that the Government should publish their intended regulations under Clause 16 in draft before Report, as they have for the various regulations on medicines. Early sight of the regulations would establish whether the Government intend to apply the powers covered by Clause 16 widely enough to satisfy the recommendations of the Royal College of Surgeons and those of the Cumberlege review.
In closing, perhaps the Minister would update us on the future of the medical devices information system and its application to the private sector.
My Lords, I very much appreciate the support that I have already received today from the noble Baroness, Lady Finlay, and my noble friend Lord Ribeiro. I am going to go into a bit of detail on what we found during the review, but I want to say to both noble Lords that I strongly support their views on Scan4Safety. Indeed, I spent a day in Derby going through the whole process with the clinicians, support staff and policymakers, and it was very impressive.
The noble Baroness, Lady Finlay, is absolutely right to say that we should look at more than just one example. Her research, which she has told us all about today, took on the six different areas, which is excellent. However, I agree with her that we should think seriously about introducing this system across the country.
During our review, we uncovered systemic failings at the healthcare system’s very core: lack of data and information. We discovered, to our astonishment, that no one in the healthcare system could tell us exactly how many women had received pelvic mesh implants and what had happened to those women. There is not a complete record of how many have suffered terrible, life-changing complications and the damage we heard so much about from so many women.
No one could tell us how many women taking sodium valproate to control their epilepsy had given birth while on the medication. As I know I have mentioned to your Lordships previously in Committee, there is a one in two risk of a baby being damaged by sodium valproate. This means that the system could not tell us how many babies have been born with physical and cognitive problems as a result of it. No one in the healthcare system knows how many women who took the hormone pregnancy test Primodos all those years ago went on to give birth to a damaged baby, or had a miscarriage and lost their baby for ever.
We were shocked by this, and concluded in our report that the system is flying blind. If the numbers of people affected by these medical interventions are not known, we do not know their health outcomes, what kind of help and support they need, and, crucially, whether a medicine or a medical device is safe, so we cannot act to prevent harm and, above all, learn from our mistakes. So collecting data, as noble Lords have already said, is vital. It is what enables us to provide the right care and support to those who need it. It informs our understanding of whether treatments are safe and it determines our actions.
In the review’s report, First Do No Harm, we set out how we could see this working. Take mesh implants as an example. If a woman were to choose to have a pelvic mesh implant, we said that the basic information about her and the procedure itself must be entered on a national database, as the noble Baroness, Lady Finlay, also referred to. We suggested it should contain the woman’s name or NHS number, her date of birth, the name of the hospital, the date of the procedure, the name of the implanting surgeon and the unique identifier of the device used. We felt that this basic information is so essential in being able to identify and trace safety concerns that it should be mandatory. In other words, we suggested that we really should have the patient’s consent, but not for the first mandatory identifying and trace database, because we felt we should collect that information without requiring the patient’s consent.
We met the Secretary of State last year and explained what we wanted and why we wanted it. He agreed with us. We also said that, in addition to this database or core data, it was important to collect further information about the short-term and long-term outcomes of the procedure, including patient-reported outcomes and experiences, and the patient’s wider medical record—what the information centre in the Bill refers to as the clinical data module. As the noble Baroness, Lady Finlay, said, we will discuss that later when we talk about registries.
We said that the registry would analyse all the data to identify patterns that give rise to safety concerns. As the noble Baroness said, this is more detail. Personal data should, in my view and that of my team, be subject to the patient’s consent, unlike the database. Patients should have the right to refuse or to give consent to their most intimate personal information being assessed by NHS Digital or the Health and Social Care Information Centre, as it is called in Clause 16. These consultations with hospital doctors and GPs are very personal stuff. It is important that if it is to be shared with others, consent should be given.
I am worried about how our recommendation is being interpreted by the Department of Health and Social Care. We argued for mandation to ensure 100% compliance with creating a database of all operations. However, to study outcomes and learn how to improve care, we need much more information about each patient treated, including personal medical information, the patient’s experience and functional outcomes. We believe that such registries, linked to the database, should be subject to patient consent. So, there is a difference between the two: we do not need consent for the first, but we do for the second.
Of course, this is not a new idea; it is simply a matter of human rights, as in the European convention and rooted in our common law. Our deep concern is that, as things stand, it appears that the Department of Health and Social Care and NHS Digital believe they have the right to access and cull patients’ hospital and GP records—to extend that database, as we defined it, into a register. That would then be without the patient’s consent or, indeed, their knowledge.
This might be legal under the GDPR and the 2012 health Act, but the fear is that this will lead to another care.data. We have been there before and seen the disaster that can be caused. It really did damage trust and ended in tremendous controversy. It is also not necessary as we will have the mandated database and the MHRA register of devices. Experience shows that most—indeed, nearly all—patients want to co-operate with the pelvic floor and other registers because it is very much in their interest to do so. They do so now with the joint and bone register, which has been very well used and put together, and is very much valued by clinicians and patients.
I am sure we all agree on the vital importance of collecting data and using it to improve safety and outcomes. I think we also agree that patients have rights, not least the right to know where, when and how their most personal medical information is being used and by whom, and the right to give or withhold their consent for such use.
The key issue, as I see it, is that Clause 16 is silent on the issue of which data should require the patient’s consent. My amendment would require that the types of data subject to consent should be clear when set out in regulations. I hope the Minister will agree that clarity for all concerned, not least for patients themselves, is essential. I look forward to his reply, as I have already given notice of my concerns and what I intended to say today.
My Lords, I add my voice to those of the noble Baroness, Lady Finlay, and the noble Lord, Lord Ribeiro, on their Amendments 86, 88 and 102, about having unique identifiers for medical devices. In these days of barcodes, this should not be too difficult nor add much, if any, cost for the manufacturers. Indeed, it has been proved to work with medical devices, as the noble Baroness explained.
It is important that products found to be faulty are speedily traced. If my digital radio can be recalled speedily because it might burst into flames, surely a medical device implanted in someone’s body must also be able to be recalled speedily. Recall could also be useful when something better comes along; it could be vital for the future treatment of the patient.
There are occasions when an individual product develops a fault, although the majority of products of that model are perfectly okay. If we are to learn lessons and improve products, as the noble Baroness, Lady Cumberlege, has just pointed out, it would be essential to know where they are and how the receiving patient has reacted to them. A unique identifier could facilitate that, and also provide some protection for the patient concerned, especially in the case of a recall.
I look forward to the Minister’s answers to the questions that the noble Baroness, Lady Cumberlege, asked about patient consent. It is vital that patients have confidence in the system. Confidence in their own privacy is part of that, and patients can have that confidence only if they know what is being shared, and by whom.
My Lords, I am pleased to speak to this group of amendments, and to thank the noble Baroness, Lady Cumberlege, who has been so diligent in her review in proposing such needed changes, and making good for the recipient and building user confidence in the devices offered. It is a pleasure to follow the noble Baronesses, Lady Finlay and Lady Walmsley, and the noble Lord, Lord Ribeiro—as well, of course, as the noble Baroness, Lady Cumberlege.
I spoke on Second Reading in support of an extensive programme for medical devices, to provide for high standards of safety and to share vital information, with data central to effectiveness. The noble Baroness, Lady Cumberlege, in her review, regarded being able to track which treatments and implants people have had as being of particular importance. A barcoded wristband, with equipment used in treatment, including implantable medical devices, being scanned and tracked to a patient’s record, would save much precious time for product recalls, and reduce drug errors.
This means knowing who has had a device used in their treatment, so that they can be swiftly notified if there is a problem. Having unique device identification is therefore very important. The noble Lord, Lord Ribeiro, said—and I agree—that we must consider tracking all medical devices used in the UK, rather than a select few.
My Lords, we support the amendments in the names of the noble Baroness, Lady Finlay of Llandaff, and the noble Lord, Lord Ribeiro, and Amendment 103 in the name of the noble Baroness, Lady Cumberlege. Registers are a tool that helps clinicians to track devices and those who have the devices fitted or implanted, and to use the data for research and to aid patients to seek redress.
The noble Baroness, Lady Finlay, explained clearly how the amendment would work to help to change a medical device that no longer functions. By citing the recall mechanism for a faulty domestic product, she illustrated what is required of a device register.
The amendments in this group relate to the tracking of medical devices, and the information stored. Amendments 86, 88 and 102 would allow regulations to provide for the tracking of all devices, as they are used, via a unique device identifier, with the information recorded either in registries or through hospital episode statistics data.
Amendment 103 is an important amendment, tabled by the noble Baroness, Lady Cumberlege, that seeks to clarify which information held by the healthcare system requires the consent of the relevant patient. Data is powerful, and should be kept appropriately. The governance of data has been a key issue in the NHS for more than 20 years.
Today in Committee we have heard the noble Baroness spell out what happened to those who had vaginal mesh implants that were not recorded in any sort of register or database that could readily be accessed. Consequently, they spent many years in extreme discomfort at best, and at worst, in agony.
If information is readily identifiable as belonging to an individual, it should be stored in the appropriate national register, patients should consent to those who wish to keep their data for their own use, and types of data should be clearly defined in regulation. I welcome the SI for which the noble Baroness, Lady Cumberlege, called, although at the moment I sometimes think that we have rather more SIs than we need—or perhaps they are not more than we need, but they certainly seem to be coming along thick and fast.
We welcome the amendments. In his closing remarks, would the Minister confirm that registers would be accessible to the private sector as well as to the NHS?
My Lords, I have greatly appreciated this debate, the expertise, and the explanations we have been given as to why the amendments are important. I particularly enjoyed the remarks by the noble Lord, Lord Ribeiro, about his hips: very important they are indeed.
Perhaps we should remind ourselves that Clause 16 was inserted in the Bill during the Commons stages after a cross-party effort involving the Labour Front Bench working with the Government. It provides for a data system to be set up by regulations to assist in tracking devices once they are implanted, so that safety performance and clinical effectiveness can be better monitored. The intention is that in the long term, that would support future device registries, allowing problems to be spotted earlier and patient harm to be prevented.
The amendments would tighten up that clause. The amendments tabled by the noble Baroness, Lady Finlay, are concerned with the operation of the tracker, using the devices’ unique identification. Currently, Clause 16 provides that unique device identifiers “may” be recorded as part of the data system. Quite rightly, the amendment would change that “may” to a “must”. So much of our work revolves around changing “may” to “must”.
Amendments 86 and 88 would amend Clause 13. Amendment 86 would require that UDIs should be considered as part of the packaging information on medical devices, and Amendment 88 would require that tracking devices used in individual procedures should be part of the Government’s consideration when regulating device registries. These amendments raise questions about the detail of device tracking. How will the unique identifiers be recorded and used? Those questions were raised by both the noble Baronesses, Lady Finlay and Lady Cumberlege. Will it be mandatory to record the unique device identifier in every procedure, and feed that into the data system? How can we ensure that that data is secure, and that it is recorded in the appropriate place? The Minister has those questions to answer at the end of the debate.
The noble Baroness, Lady Cumberlege, rightly addressed the issue of patient consent. She also underlined the fact that there is an opportunity in the Bill to get the law and the framework right. Amendment 103 would add to Clause 16 a requirement that the regulations must specify what information held by a data system is subject to a patient’s consent. The intention is that data held under the system should be used and shared to identify trends and trigger regulatory and clinical action where it is needed.
In her report, the noble Baroness cites the difference between a database and a registry. She is right to do so. The amendments explore the importance of the registry and the database, and the importance of patient consent —and whether we return to the subject at a later stage will depend on what the Minister now has to say.
My Lords, I am enormously grateful for that really important discussion of these critical amendments and provisions. I will take a moment to run through them in some detail. Device safety is absolutely critical to patient safety, and that is why the Government amended the Bill to include Clause 16. I pay tribute to my noble friend Lady Cumberlege, whose team helped inspire that amendment, and to the noble Baroness, Lady Finlay, who has participated in discussions on this clause. We have the benefit of her insight now.
Amendment 86 in the name of the noble Baroness, Lady Finlay, would add the unique device identifier number to the provisions in Clause 13(1)(g). These provisions currently allow the Secretary of State to make regulations about package labelling, provision of information and instructions for medical devices. UDIs would be one of the matters included within regulations made in reliance on Clause 13(1)(g), as drafted. It is therefore our belief that the amendment is not necessary.
The noble Baroness, Lady Finlay, and my noble friend Lord Ribeiro made important and fascinating remarks on Scan4Safety. I will limit my comments, which could be extensive, to the importance and value of that scheme. We are extremely supportive of the principle of fast and accurate traceability. Scan4Safety is not the only scheme of its kind, but it is a particularly good one. It is the hope that any UDI created by these regulations will empower these valuable services. We have a session on medical device information systems coming up in the diary, when I hope very much that we can discuss how that might work. If the concern of the noble Baroness is whether we intend to make provision to require manufacturers to provide a UDI, I reassure her that that would be a condition for being placed in the UK market.
Amendment 88 to Clause 13, as the noble Baroness, Lady Finlay, has indicated, is intended to support the tracking of devices used in medical procedures by recording the UDI in a register provided for in Clause 13 or within hospital episode statistics. I completely acknowledge the noble Baroness’s intent, but there is a difference between a register at Clause 13 and a database at Clause 16, or a registry. Clause 13 provides for a register or a number of registers. The register or registers we intend to create under Clause 13 will be a list of medical devices for sale on the UK market, held by the MHRA. It will not include the individual product identifier part of the UDIs and it will not contain data or monitoring information related to individual devices. The register forms part of wider market surveillance and vigilance activity. Regulations will be able to make provision requiring information to be entered into a register, such as the unique device identifier, which all manufacturers will be required to put on their devices. Amendment 88 is therefore unnecessary.
While the registers will enable some device identification to track individual devices, it is the information system, created under regulations made under Clause 16, which will ensure that devices and procedures are tracked in the event of a concern being identified, through which patients can be contacted and appropriate action taken in each case. The use of MDIS, which I will come on to, could prompt the MHRA to use the information in the register established under Clause 13 to identify the manufacturer and take action.
Amendment 102 would add information to be recorded in any information systems established under Clause 16. All the information set out in Amendment 102 can already be required under regulations made under Clause 16, but the regulations do not have to set out all those matters and can set out other descriptions of information.
A UDI may not always be available, such as for a custom-made device, so it may not always be possible for the providers to capture this. Amendment 102 would also require the recording of every procedure that related to a medical device. I have spoken before about the number of different medical devices on the market and that they vary greatly in risk profile. It would not be necessary or cost-effective to record every procedure related to a medical device, but they could be recorded in one of the registers provided for by regulations under Clause 12, as being on the UK market.
Amendment 103 in the name of my noble friend Lady Cumberlege deals with the important issue of patient consent. It would introduce an obligation that regulations made under Clause 16 would require the Secretary of State to set out the categories or types of information that are subject to patient consent that are held by the Health and Social Care Information Centre, otherwise known as NHS Digital, or by other persons.
My noble friend has raised this with me and with officials, and she is a tireless champion of patients. I am moved and affected by the accounts she has heard. As the testimony in her review shows, the absence of data in the healthcare system is absolutely medieval, and it is exactly the purpose of the Bill to fix that. Before any data can be collected relying on the provisions at Clause 16, regulations must be made. Those regulations are subject to consultation, as at Clause 41. It is absolutely right that the system is informed by patient views, and that the process is one where it is easy to engage, to understand what we want to do and to build consensus that it is the right thing.
My noble friend Lady Cumberlege has views on what data should be subject to opt-out versus opt-in. Privacy is a higher-order value that we should protect. The question of patient consent is really important. The noble Baroness, Lady Finlay, campaigned on the importance of opt-out organ donation and I congratulate her on her contribution to the recent change to organ donation privacy protocols, which are widely supported by the public and will save thousands of lives. She knows as well as I do that choosing to opt into measures is not as comprehensive as choosing to opt out. It is important to have enough data to draw conclusions.
Consent will not be required to input information about the surgical procedure and the UDI of the implanted device, linked to the patient, into the information system. The medical device information system is about protecting all patients who have had similar procedures, not just a particular patient. The detail of the specific device inserted, the procedure information and, if necessary, the effect that device has caused is what will be necessary for the information system to work. If there is no adverse report made by the clinician on behalf of that patient, that data acts as a control sample. It allows for other patients’ reports, where there have also been adverse reactions, to be understood as part of a wider data picture.
In her report, my noble friend raised the recommendation that detailed data should require consent in order that the data collected is necessary and proportionate. I reassure her that all data collected for the system will be necessary and proportionate. Data held by clinicians should be shared only under those circumstances, and data shared by the information system with, for example, a clinical registry for clinical assessment of whether there is an issue, should be only that which is necessary.
The intention is, that in the event there is a reported adverse reaction with a device, the medical device information system would send a report to a clinical registry. That report, suitably anonymised and stripped of patient-identifiable information but including the device UDI, would have the detail of all procedures, not just those involving adverse reactions, to further anonymise the incident. A clinical assessment would be conducted and, if it is concluded that the device is the issue, only relevant and necessary information would be sent to the MHRA to conduct its own tests.
This is a very important paragraph and one that I will emphasise. We do not need patient-identifiable information to determine whether compliance or enforcement action needs to be taken, but device information. There are routes to identifying that there are issues with adverse reactions when a clinical registry is not present, such as manufacturers’ reports or Yellow Card reports.
It is important to be clear that the medical devices information system will collect and hold only whatever information is necessary for it to deliver its function. I understand that patients often have a confidential, private relationship with their GP or physician. It is right that this information and these conversations are private. It is important too that information necessary to protect patients is collected. However, I do not think it helpful now to set out in the Bill which information is subject to explicit consent under Clause 16. It is right that, through consultation, we identify what data is necessary to capture in order to deliver the improvement to patient safety that patients want. We are speaking to the devolved Administrations and will speak to patients, registries and clinicians.
I can assure my noble friend with absolute clarity that the GDPR stands as a requirement. Her amendment also refers more broadly to information held by NHS Digital and other persons. It goes beyond the intent of Clause 16 and into the wider work of NHS Digital under the Health and Social Care Act 2012. This Bill solely enables the establishment and operation of the medical devices information system by NHS Digital, and does not deal with information held under other powers. I hope my noble friend would agree that these matters are not materially in scope.
I can confirm to the noble Baroness, Lady Jolly, that these data will not be accessible to the private sector, although they will need to share some of their data with the registries in accordance with the regulations. I hope that the noble Baroness, Lady Finlay, and my noble friend Lord Ribeiro are content with my explanation, and that my noble friend feels able not to move her amendment.
I have received a request to speak after the Minister from the noble Baroness, Lady Thornton, on whom I now call.
Can the Minister run it by me again how this will protect patients? I heard a lot being said about physicians and their reporting. I am not sure that I understand how this will avoid the problems with valproate and all the other situations with mesh unless “must” is used rather than “may”.
I can give a couple of illustrative examples if that would be helpful, but to run through the whole philosophy and system is probably beyond my ability or the time afforded by this Committee. In essence, the challenge identified by my noble friend Lady Cumberlege is that individual reports of adverse signals are not easily connected, unless those reports are somehow sent to a central registry and analysed by the kinds of experts who can spot mistakes and the connections made between those signals. This is how any problem identification system works. To do that process, you do not have to share personal details. You do not need the telephone numbers or personal identities of those concerned, but you need the clinical details and the full context in which signals have occurred. This pattern identification is often missing in the instances on which my noble friend reported. Having this information system, and analysis connected to it, will enable us to spot problems at a much earlier stage. Necessary interventions based on analysis and understanding will be much prompter and the connections made much more emphatic.
I am incredibly grateful to all noble Lords who have spoken in this debate. It has been very important and illuminating. We will all need to read the Minister’s words with care because there was an awful lot in them. I am most grateful to the noble Lord, Lord Ribeiro, for asking about the private sector, because if procedures are done in the private sector for patients who pay for themselves and those procedures are outsourced more and more, it will be important to make sure that this safety data is collected.
I am surprised that the word “must” is not being picked up. A supermarket will know how many tubs of mayonnaise it has ordered and which factory they came from. If there is glass in jam, a supermarket can track it back to the factory where the glass was. If we do not have complete data collection systems, we will find that all the places that are functioning above average will do really well. They will collect the data properly, and so on. But 50% of places are below the average line—that is the nature of an average. All patients need to be protected and standards need to be driven up. I was grateful to the noble Baronesses, Lady Walmsley, Lady Redfern and Lady Jolly, for elaborating on aspects of points that I have made, and particularly grateful to the noble Baroness, Lady Thornton, for giving us the history of the amendment and asking again how this would work in practice.
Consent is critical. Patients going into a hospital expect all the equipment to be safe and to be known about. They expect the fire alarms to work and that the oxygen pipes to anaesthetic machines are correctly positioned and known about, and that full servicing data is available. It is important. Here I should declare that I was a very junior doctor in a hospital, but on the periphery, when an anaesthetic accident happened many years ago. It was critical that things could be traced back urgently. Unfortunately, there are tragedies, even when it is possible to do that.
We need to be able to look right across the whole system. There is the safety aspect—the tracking and quality control—that goes along with all the routine procedures. If something faulty is used in 15 hospitals around the country, that needs to be known rapidly and safely. I, too, worry about relying on clinicians to report if there is a problem, and I rather felt that the Minister’s answer underlined the call for a distinct commissioner for safety. The noble Baroness, Lady Cumberlege, has been calling for that because we need somebody who can interrogate and analyse the data, and look at it carefully. She explained consent for patient details extremely well. The Montgomery test of consent is that you should be given the information that other reasonable people would expect. It is almost the Clapham omnibus test of what patients should be told.
This is not about what the clinicians want or do not want to tell patients. They might feel it unnecessary to tell them something, but most patients would want to know about it and therefore it should be disclosed to patients. A doctor might say, “This can happen, but it has never happened to me”, but they still have a duty to disclose. Linked to that consent, I would like us to have routine processes in clinical practice for consent data to be entered into a registry. Patients could opt out and say that they did not want it to be entered, so that box would not be ticked; their scanned-in data would then not be sent on with the additional information.
This debate has been incredibly important. It gets right to the nub of patient safety. I hope that the Minister will meet me and the noble Baroness, Lady Cumberlege. I have to say to the Committee that I am pretty convinced that we will return to this on Report because there is a lot more to do. However, we have another group of amendments to move on to, and that debate will be interesting and informative, so I beg leave to withdraw the amendment.
Amendment 86 withdrawn.
Amendment 87 had been withdrawn from the Marshalled List.
Amendments 88 to 91 not moved.
Clause 13 agreed.
We now come to Amendment 91A. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate. I call the noble Baroness, Lady Finlay of Llandaff.
My Lords, I beg the indulgence of the Committee for just a moment because I have a horrible feeling that I have lost my place. I had thought that we were moving to Amendment 95. Perhaps the chair would be kind enough to set me right on that.
I propose that we adjourn for five minutes.
My Lords, the Committee will now resume and I call again on the noble Baroness, Lady Finlay, to move her Amendment 91A.
91A: After Clause 13, insert the following new Clause—
“Innovative Medical Devices Fund
In section 261 of the National Health Service Act 2006, after subsection (9) insert—“(9A) The Secretary of State must make a scheme to promote the availability of innovative medical devices for human use within the National Health Service and must provide monies paid to the Secretary of State under subsection (9) for the benefit of that scheme to be known as the “Innovative Medical Devices Fund”.”
My Lords, I am most grateful for the kindness of all your Lordships. Lacking having all those wonderful papers in front of me really showed. It is the first time that I have missed walking into the Chamber with a large stack of papers.
Amendment 91A builds on the concept that we had in the previous debates of an innovative medicines fund, which had been carefully thought through, including how it was to be financed. It struck me then that we have fantastic potential in medical engineering in this country to develop new and innovative medical devices. I should declare an interest because my son is involved in developing devices for use in cardiology, for oblation procedures and so on.
The real issue, as the Minister pointed out in the previous debate, is about developing a piece of equipment which is a custom-made device, for one reason or another. When that happens it can turn out to be, serendipitously, something that solves a problem for clinicians in undertaking a procedure of some sort. However, when that happens, if it is a small clinical team in a district general hospital, it will not be linked into a commercial enterprise and funding its ongoing development is extremely difficult.
In previous debates, I referred to the investment that went on in Ireland—in Galway—to create an innovation hub and ensure that there is investment in innovation. This amendment would allow the Government to explore having a medical devices fund similar to an innovative medicines fund, and would allow that fund to be used to develop a device and test and trial it within the NHS, with it being available to NHS patients and clinicians much more rapidly than the current procedures require. It does not in any way suggest that the usual ethical approval processes and all the checks that go with it should be curtailed; it would simply be a way of making sure that, where a custom-made device that solves a major problem could be rolled out widely, it can be used for the benefit of UK plc, if you like to call it that. It would make sure that we have that investment, and that the clinicians do not have to give it away for the whole thing to be developed commercially elsewhere and then sold back to the NHS at huge cost. I again express my gratitude to the Committee and I beg to move.
My Lords, I am grateful to the noble Baroness, Lady Finlay of Llandaff, for tabling and moving this amendment for a number of reasons, the first of which is that it allows me to express my appreciation to the noble Lord, Lord Patel, for moving Amendment 28, in his name and mine, last week on the innovative medicines fund and to say how much I welcomed the debate on it, which I have read, and the Minister’s response.
I am also grateful to my noble friend the Minister for his subsequent letter about the innovative medicines fund. There is of course a direct parallel in that Amendment 91A would look for the innovative medical devices fund to be funded in a similar way. I just gently dispute one proposition with my noble friend: he said that the use of the rebate on the voluntary pharmaceuticals access scheme would not be appropriate for the innovative medicines fund because the amounts could vary sharply from one year to the next. This would be a problem only if there were a direct hypothecation for the amount, and that is not necessarily implied. The amount of the innovative medicines fund could be established as a fixed amount that would then be funded by the rebate or, in the absence of a rebate, by the Exchequer or though NHS England’s total budget. It would not necessarily rise or fall with the rebate. The same would of course be true for the innovative medical devices fund.
There is a central proposition that supports both an innovative medicines fund and a medical devices fund; it is not that we in the United Kingdom lack innovation, it is that we lack the adoption of innovation in the National Health Service. That was the starting point for the Cancer Drugs Fund, on which this proposition is based. The Cancer Drugs Fund arose, in policy terms, from an analysis by Professor Mike Richards, who was then the cancer tsar under the last Labour Government, that there was a significant lack of availability of the latest cancer medicines for cancer patients, compared with other, principally European, countries. At the time that was not true for some other disease groups and medicine available for other diseases. It was a problem particular to cancer.
Why does this happen? It is not simply about funding; there is a systematic issue here, separate from the amount of resource, which is that the United Kingdom has a single-payer system. A single-payer system necessarily makes decisions about the availability of medicines on the basis of the whole system moving together. I suspect the same is true for devices. Pretty much all of the other European systems are not single-payer systems, but insurance-based systems, where, essentially, clinicians advise, patients choose and insurers pay. That brings innovations into use much more rapidly. There is potentially a problem with the diffusion of innovation in the NHS, which we have seen before and we have to continually guard against.
I put this question to the Minister for when he responds to this debate: are patients in the NHS getting access to new, effective medical devices as quickly as patients in other countries? I do not know the answer to that. I am absolutely clear that there was a good case for the Cancer Drugs Fund. I am clear that there is a continuing need for the innovative medicines fund, because there is sometimes a continuing gap between the availability of the most effective new medicines here and in other countries. I do not know about devices.
To this extent I offer an apology to the noble Baroness, Lady Finlay of Llandaff, because a medical devices fund might be premature, in the sense that we do not know to what extent there is a gap in the adoption or diffusion of innovation where medical devices are concerned. We identified real potential in the previous debate on Amendment 85 about the funding mandate for medical devices. If that is rolled out, as I think is the intention, and extended to a faster and larger pipeline of medical devices going through the NICE evaluation process, then we may find there is not too much of a problem. There may well be a case for understanding to what extent medical devices are being adopted by the NHS, relative to other health economies. I hope the Minister will agree that is worth looking at.
My Lords, it is a great pleasure to speak to the amendment tabled by the noble Baroness, Lady Finlay, and to follow the noble Lord, Lord Lansley. Because this is about devices, I should remind the Committee that I am president of GS1 UK, the barcoding association, and chair of the advisory board of TenX Health.
I thought the noble Lord, Lord Lansley, posed a very interesting question about whether NHS patients have less access to innovative new medical devices than those in other European countries. My gut feeling is that they do, but I agree that the more information we can obtain the better so that we can debate whether the fund that the noble Baroness, Lady Finlay, proposed is a good way forward. On the face of it, I think it is. We have a situation in this country that is rather the case for medicines, where we have a very important health technology and medical devices sector. The ABHI informed me recently that the health technology industry employs over 127,000 people, generating a turnover of £24 billion. That is very substantial.
We also know from another briefing from the former chief executive of the BHTA, Ray Hodgkinson, that many companies in the devices sector, alongside the technology companies, have found the NHS very frustrating to deal with. There have been a number of initiatives in the past. One of the most recent is the HealthTech Connect portal, but my understanding is that very few companies indeed have got through that portal. The fact is that companies find the UK to have a very bureaucratic approach to deciding whether it will invest in innovative new devices. Other countries are more attractive and less bureaucratic.
I think the noble Lord, Lord Lansley, put his finger on it: there is a difference in the sense that the NHS is funded almost entirely out of funds voted by Parliament. Inevitably, money is constrained in a way that it does not seem to be in insurance and social insurance systems. In our highly centralised system, it seems the rewards are for those NHS bodies that constrain expenditure. One can see why, but the problem is that, as in medicines, it leads to a philosophy that sees new innovation as expensive and to be avoided almost at all costs. We end up with a very difficult situation where we have fantastic innovation in technology and devices, just as we do in medicines, but the NHS is very poor at taking advantage of those new developments and inventions.
In a letter the Minister sent out yesterday, which commented on our previous debate, which the noble Lord, Lord Lansley, and the noble Baroness, Lady Finlay, referred to when we talked about funds for new medicines, he talked about the effort the Government are making to increase procurement of medical devices that have received positive assessment from NICE. He then referred to the medtech funding mandate, due to be launched in April 2021, which will ensure that specified NICE-approved, cost-saving, innovative devices are funded locally. That is very welcome indeed, but I have to say that one’s whole experience of this is that it is likely to be a very bureaucratic process. Companies will have to go through endless stages and many will lose heart. This is a major problem and why the fund proposed by noble Baroness, Lady Finlay, may well be a different, faster approach. One thing is for sure: in the global world in which we operate, the UK has a fantastic health technology and medical devices sector, but we really do need to ensure that the NHS does its best to support it and that NHS patients get the benefit of what it is achieving.
My Lords, the amendment from the noble Baroness, Lady Finlay of Llandaff, would require the Secretary of State to introduce a scheme to promote the availability of innovative medical devices for human use within the NHS. The scheme would be known as the NHS innovative medical devices fund.
The Secretary of State is charged with providing the funding and I welcome that approach. She has explained that custom-made devices are both difficult and expensive to fund, especially for the subsequent development of innovative devices with repeated trials. It can also be frustrating. A medical devices fund could take an innovation from concept through its development to production and then be rolled out widely, with any gains being returned to the fund or to the NHS organisation hosting the work. Clearly, flesh needs to be put on to those bones, but as I explained in an earlier Committee session, there is a fund that is particular to orthopaedics which is managed by a charity. In effect, every year it calls for bids, often from start-ups. It supports a certain number of the bids and any profits come back to the charity, which can also choose to be a partner in the venture. Some of the bids come from academia and others from within the NHS, but it works.
This amendment is interesting and certainly worthy of consideration. The innovative medical devices fund would insert a new subsection into the National Health Service Act 2006. Section 261 provides powers for the Secretary of State in relation to voluntary schemes to control the cost of medicines. The section describes these as schemes that are joined voluntarily and limit the price that may be charged on the profits that may accrue from the manufacture and supply of health service medicines. The scheme also provides for manufacturers and suppliers to pay the Secretary of State an amount of money if the agreed limits are breached. Amendment 91A would create a voluntary scheme under Section 261 which would be specifically for medical devices to give them equal treatment as innovative medicines. The Minister will have to explain why that would not be a good idea.
In her speech at Second Reading, the noble Baroness, Lady Finlay, talked about making the UK a medical devices development and production hub. Too often the UK effort has been bought out by overseas manufacturers who then market the devices back to the NHS at great profit.
My Lords, Amendment 91A seeks to replicate the innovative medicines fund with a comparable fund for medical devices called the innovative medical devices fund. We have had a terrific debate on this. The ideas and insights shared by noble Lords have been extremely powerful, but perhaps I may address the points in turn.
The goal that is shared wholeheartedly by the Government is that we recognise the huge benefits that medical devices can deliver. My noble friend Lord Lansley and the noble Lord, Lord Hunt, put that particularly well. We recognise the astonishing pace of innovation and development that is creating new healthcare options for patients across the UK. In fact, that is one of the reasons we are considering this Bill. We are extremely ambitious and are determined to capitalise on the opportunities presented by new medical technologies to ensure that the best innovations are adopted and spread across the NHS.
Devices, like medicines, are key to ensuring patient health, but they are different and it is not necessarily helpful to use a system that was developed for medicines to be used for devices. For example, the primary purpose of the innovative medicines fund is to cover the cost of managed access agreements where NICE feels that there is insufficient evidence to give a positive opinion and asks for further evidence to be collected before the product is re-evaluated.
Devices are not assessed by NICE in the same way and we do not consider that mirroring the provisions for medicines would necessarily be beneficial. In particular, unlike medicines where, once licensed, they do not change, medical devices are constantly evolving. New iterations of medical devices are developed quickly, their impact on patients changes, often rendering earlier iterations completely obsolete within relatively short periods of time. That gives rise to the potential for funding mandates to be in place for devices that are no longer the best or most cost-effective in their category. Requiring the mandatory purchase of all but the most innovative devices by commissioners would not be a sensible use of NHS funds. We therefore need to find different systems of process to ensure that innovative and effective devices, along with other medical technologies such as digital, find their way to the NHS and to patients.
That is why we have boosted the remit of the Accelerated Access Collaborative. It will bring together leaders from across Government, the NHS, regulators and industry to address the underlying challenges that delay patient access and uptake.
As chairman of the AAC, the noble Lord, Lord Darzi, has been able to bring his world-leading expertise to bear to deliver a host of successes in recent years. Indeed, almost 750,000 patients have benefited from access to AAC-supported innovations in recent years, including more than 315,000 patients who have accessed new technologies supported through the innovative technology payment programme. The AAC is going further to deliver the commitment in the NHS Long Term Plan to accelerate the uptake of proven, affordable innovations with the introduction of a new medtech funding mandate. The mandate will ensure that all patients have faster access to selected cost-saving devices, diagnostics and digital products approved by NICE, via medical technologies guidance and, when available, NICE diagnostic guidance for innovations.
The final criteria to be used in the mandate will be announced in the consultation response to be published in December this year, and the mandate will take effect from April 2021. Additional steps are being taken to ensure that the mandate translates to front-line improvements in patient access. The NHS standard contract has already been updated to state that the relevant parties must comply with their obligations under the mandate guidance, and technologies receiving the mandate will benefit from dedicated support via the regional academic health sciences network to help drive local adoption and spread.
NICE also recognises the need to ensure its methods for assessing innovative medical technologies continue to support our ambition for the NHS to provide world-leading care that delivers value to patients and the NHS. The NICE methods review is therefore under way, with extensive input from industry and patient representative groups. The consultation on the case for change to existing NICE methodology is open until 18 December, and I encourage all those interested to submit their views.
Finally, it is also important to note that in her amendment the noble Baroness, Lady Finlay, stated that moneys should be paid to the Secretary of State under Section 261(9) of the National Health Service Act 2006 in order to support an innovative medical devices fund scheme. However, Section 261 of the National Health Service Act relates only to voluntary schemes agreed with pharmaceutical manufacturers which control the prices charged, or profits accrued, by manufacturers and suppliers of health service medicines. The vast majority of medical devices would not therefore be within the scope of such a scheme.
I trust that I have been able to reassure the noble Baroness that the funding of medical device technology in the NHS in England is of great importance to the Government and that we are actively putting in place mechanisms to support it. On this basis, I hope very much that the noble Baroness, Lady Finlay, will feel able to withdraw her amendment.
My Lords, I thank noble Lords for contributing to this debate. There were a couple of comments that I would like to come back on.
The noble Lord, Lord Lansley, asked whether there was evidence of the slow adoption of innovation. I have a series of different case studies that I will happily share with him. I shall highlight one. Cytosponge had a 19-year journey from when it was thought of to when it was adopted. It is estimated that it saves 7,190 QALYs having now gone through NICE. Companies do not feel incentivised to develop low-cost devices in this country.
Another example is the CoMICs study on conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery, which compared two types of bypass machines. The difficulties there resulted in most of the study going abroad and being conducted elsewhere. Our development of robotics has been impressive, but we have huge competition from the US market, in particular in device development.
So I suggest that we need to look at a way of making sure that we can develop devices. I accept that this amendment as worded may not be right for this Bill at this time, but I hope that we will not lose sight of the need to innovate. I would like to come back on Report to the concept of provisional licensing as a way of getting new and innovative devices through the system rapidly, possibly without burdening the NHS with the financial bureaucracy that this amendment might cause. I beg leave to withdraw the amendment.
Amendment 91A withdrawn.
Clause 14: Fees, information, offences
Amendment 92 not moved.
Clause 14 agreed.
Clause 15: Emergencies
Amendments 93 and 94 not moved.
Clause 15 agreed.
We now come to the group consisting of Amendment 94A. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
94A: After Clause 15, insert the following new Clause—
“Requirement to make regulations concerning medicinal cannabis and associated devices
(1) The appropriate authority must by regulations amend the law relating to medicinal cannabis and devices used to administer medicinal cannabis.(2) Regulations under subsection (1) must establish criteria for the licensing of cannabis medicines and medical devices.(3) In making regulations under subsection (1), the appropriate authority must have regard to—(a) the safety of medicinal cannabis;(b) the availability of medicinal cannabis;(c) international evidence of the efficacy of cannabis medicines.”
My Lords, I wish, with a straight bat, to move this amendment standing in my name and in the names of my noble friends. Looking at the names of those who will be contributing to this debate, I willingly admit that I probably know least about this subject—although, in declaring an interest, I probably bring a knowledge which most of your Lordships do not have. I use cannabis. My spine is breaking up. I have tried all the traditional painkillers, but they were worse than what they were actually trying to deal with. So I am not somebody who embraced cannabis as a first option; I was driven to it because no other traditional painkillers helped.
It is important to say what I am not asking for. I am not asking for a free-for-all for people who wish to use cannabis for recreational purposes. I understand their case, although I do not share it. Others may wish to use other opportunities to move that interest. I do not. Nor am I—or the other noble Lords who have signed this amendment—asking for a random control trial. We are asking for something much subtler. This medicine helps people and relieves pain, and it is the relief of pain that I wish this debate to concentrate on.
I am no snake oil salesman. I am not here to claim—on behalf of my fellow citizens who suffer, for example, from Parkinson’s or cancer—that this is a miracle cure. I am not arguing that. I know a number of people with Parkinson’s or cancer who have been helped by this, and their lives possibly extended. But in this amendment I am concentrating merely on how to relieve pain. In proposing the new clause, I am really making a plea to the Government to renew past conversations about how we might equalise access to cannabis in this country where people are totally concerned with controlling pain. Clearly—and rather appropriately, given the previous set of amendments—the new clause concerns itself with the devices by which cannabis can be delivered to a patient. Above all, it is a plea to change the schedule within which the drug sits, so that—if they so wish—GPs can prescribe this painkilling drug.
I do not know how many times others have been able to speak in a cannabis debate with your Lordships knowing that the person speaking is actually using that drug. My plea is, very simply, that there are pains that traditional painkillers cannot reach and there is considerable evidence that in those circumstances, when all the traditional painkillers have been tried, cannabis can sometimes work.
What is so unfair is that under the present arrangements, I can pay for my cannabis. There are huge numbers of other people, probably in greater pain than I, who cannot buy cannabis, as I do, within the law as a painkiller. I am therefore moving the amendment with its proposed new clause as a plea to the Government, on behalf of all of us who suffer pain in varying degrees and have tried the traditional methods of pain relief. Where that has failed—it often makes one even more ill than when one started to take those painkillers— we have found some redress in cannabis.
As a user and beneficiary, I hope that I therefore speak on behalf of many of my fellow citizens who get relief for their pain from cannabis. I wish to equalise access to cannabis in the way that I have benefited, so that others might too. I beg to move.
My Lords, it is a great pleasure to follow the noble Lord, Lord Field, who has knowledge that I do not have. I have never used cannabis, but he has made a powerful statement as a user.
The regulations affecting the production of prescription and medical cannabis are incredibly unhelpful. They result in about 1 million people—very sick, disabled people—accessing medical cannabis illegally, usually from the criminal market, although some go to Europe to access medicine for either themselves or their children. Although cannabis medicines have been legalised, most such people simply cannot get access to them. It just is not there for them at all.
Under the regulations in place at present, cannabis medicines are unlicensed—they are known as specials. This means that only consultants can prescribe them, on the basis that if there is a problem—it is extremely unlikely that there would be any problem with medical cannabis—the consultant has to take personal responsibility for having prescribed that medicine. The trouble is that doctors have not been trained in this complex group of medicines. The cannabis plant contains about 540 phytochemicals: 144 known as cannabinoids, 200 terpenes and 20 flavonoids have been identified so far. Maybe there will be more; I do not know.
Different mixes of these phytochemicals alleviate the symptoms for patients with a wide range of conditions. The noble Lord, Lord Field, concentrated on pain, and fibromyalgia is a particular type of pain, which apparently responds well to this. But there is also Crohn’s disease, treatment-resistant epilepsies, PTSD, Parkinson’s and an incredible number of others. I think that Germany approves medical cannabis for something like 40 conditions, which is extraordinary.
Not surprisingly, consultants have been very reluctant to prescribe medical cannabis. Only 204 prescriptions have been written in the two years since medical cannabis has been legalised, and only 10 within the NHS. It is pretty disastrous in terms of the regulations and it is essential that a way is found to license high-quality medical cannabis for the alleviation of symptoms for a specified list of conditions.
The Medicines and Healthcare products Regulatory Agency generally insists on random controlled double-blind trials, and I very much support that gold standard for the great majority of medicines. However, medical cannabis medicines are different from almost anything else I can think of, in part because in general—certainly until now—they claim only to alleviate symptoms. At this point they do not claim to be a cure, although there is some interesting current research on the curative potential of cannabis. But we will not talk about that now. Also, cannabis has been used as a medicine for thousands of years; I do not think there is any other medicine quite like it. A million patients use it today, and can provide evidence of its efficacy, minimal side effects and safety. Many patients have used it over many years, so I argue strongly that cannabis medicines are in a really different position from other medicines.
There are a considerable number of studies across the world that clearly show the efficacy and safety of medical cannabis. In 2017 the National Academies of Sciences, Engineering, and Medicine published a great volume called The Health Effects of Cannabis and Cannabinoids, a review of global research into the efficacy of cannabis medicines. It concluded:
“There is substantial evidence that cannabis is an effective treatment for chronic pain in adults.”
Why is this not taken seriously?
Until now the MHRA has been unwilling to consider that and much more international research. Bedrocan products have been widely used in Europe for more than 20 years, greatly benefiting patients. If the Government did nothing else but allow Bedrocan products to be approved in this country, that would be of enormous benefit to a huge number of patients. High-quality products are now available in the US, Latin America, Canada and many other countries across the world. Outcome data is available from Columbia Care, for example, but also from many other organisations, universities and so on.
Not only do the regulations place medical cannabis in the “specials” category, they also complicate the import and production processes, adding considerable costs to the medicines. The situation cannot, in my view, be justified. It creates criminals out of completely law-abiding incredibly sick and disabled people. It wastes police, court and prison time, and considerable sums of taxpayers’ money—and, indeed, NHS resources. Most important of all, it is ruining the lives of many of our most vulnerable citizens.
I am in touch with GW, the pharmaceutical company that has produced the only cannabis medicines licensed in this country. I hope to work with GW, and I have a meeting with its representatives—next week, I think. They understand the problem. Epidyolex, trialled by GW, is a single cannabinoid medicine. GW spent many years and hundreds of millions of pounds undertaking the double-blind trials of Epidyolex and, understandably, wants a return on its investment. I have huge sympathy with it.
Since that work started, research in other countries has shown that a single cannabinoid medicine is suboptimal for many treatment-resistant epileptic children. The evidence tells us that it helps 43% of children with two particular variants of epilepsy, and the reduction in symptoms is only 50%. I sincerely want Epidyolex to succeed. It may be the right drug for some children. However, more recent research internationally has shown that some children given whole plant products can achieve up to 100% improvement, with minimal side-effects .The evidence available justifies regulation changes to enable very sick patients to benefit from cannabis medicines, which patients say alleviate their symptoms more effectively and with substantially fewer side-effects, than prescribed medications, as the noble Lord, Lord Field, has told us from personal experience.
We genuinely wish GW well, and we are privileged to be in discussions with it to try to find a way forward that will benefit patients and work for pharmaceutical companies, while upholding the high standards of safety and efficacy for which this country is renowned. At a recent virtual meeting with our highly valued Minister and the CEO of the MHRA, I was encouraged to see that the CEO also recognised the need to discuss a possible way to increase access to cannabis medicines for patients who benefit significantly from them.
The aim of the amendment is to initiate a discussion with Ministers, alongside discussions with officials and experts, about how to remove the umpteen hurdles within the regulations which prevent patient access to cannabis medicines. We hope through these discussions to find a way forward, and I look forward to the Minister’s response.
My Lords, I heartily support the noble Lord, Lord Field, and the noble Baroness, Lady Meacher. I thank the noble Lord for his important evidence, and congratulate the noble Baroness on her many years of energetic campaigning on this matter. Noble Lords may know that I too have campaigned long and hard for medicinal cannabis projects, that have been proved to be safe and effective, to be prescribed on the NHS for UK patients. When the Home Office changed the status of medicinal cannabis two years ago, many of us thought that, given the mass of evidence that there are many such safe and effective products in widespread use abroad, such medicines would become available free to UK patients. That has turned out not to be so. Although some expert clinicians are prescribing them for appropriate patients—including the noble Lord, Lord Field—in a private capacity at high cost, very few patients have received their medicine free on the NHS. Why is this? It seems that it is because NICE has not approved them because there have not been any random controlled double-blind trials. Therefore, several health trusts are forbidding consultants who want to prescribe these medicines to do so, on pain of losing their jobs.
There are children with intractable epilepsy in this country whose lives have been saved by the medicines, for which their parents have had to fundraise. The lives of some of those children have been put at risk because the coronavirus has prevented that fundraising, and they suffered serious preventable fits. Many of these children have been treated with approved pharmaceutical medicines that have never been approved for use with children and have serious side effects. That is why we need a proper regulatory framework based on the full cadre of available evidence, which this amendment proposes. It will not be difficult to establish the safety of these medicines, as required by subsection 3(a). If those making the regulations are allowed to take into account the health records of people who have already been taking these medicines, and also the vast amount of evidence from other developed countries which the noble Baroness, Lady Meacher, has listed, that will subsection 3(c). Subsection 3(b) requires that availability be considered when making the regulations. These medicines are readily available. Indeed, a lot of them are being made in this country and exported because they cannot be sold here. How mad is that? Nor are they expensive as medicines go, and the NHS can bulk buy at a discount anyway.
In order to satisfy those who do not trust evidence from other countries—although why is beyond me—we also need to collect data from UK patients who are managing to get cannabis medicines in order to provide the information required by NICE, but there is no system in place to do that. Will the Minister say why the NHS Commissioning through Evaluation system is not being used? It is a well-established and approved system that collects patient data and clinician observation on the use of novel medicines and treatments. It strikes me that, given that cannabis medicine’s illegal status made it impossible to collect much UK data before 2018, it would be an ideal candidate for this trusted method of evaluation. Finally, I would welcome the Minister’s response to this suggestion.
I call the noble Lord, Lord Norton of Louth. Lord Norton? We will move to call the noble Lord, Lord Patel, and come back to the noble Lord, Lord Norton if we have time. I call the noble Lord, Lord Patel.
My Lords, I will need to speak only very briefly because the noble Lord, Lord Field of Birkenhead, and the noble Baronesses, Lady Meacher and Lady Walmsley, have covered the ground extensively, fully and informatively. It is a privilege to be involved in an amendment moved by my noble friend Lord Field of Birkenhead. We have been friends, discussing such issues for very many years, although he was in a different House, so it is a pleasure to see him and support his amendment.
My noble friend Lord Field spoke from personal experience, and my noble friend Lady Meacher spoke extensively about the information available. In 1998, the Science and Technology Committee of the House of Lords recommended that there should be a programme to assess the medicinal use of cannabis and that ways should be found to use it. NICE has recommended one or two areas where it can be used, as has already been said. Very few NHS prescriptions have been given out, but more than 1 million people use cannabis preparations bought privately at huge cost. They use them because they find benefit from them. The report suggests that the people who benefit from it mostly suffer from chronic pain. Despite that, reports have been published where people with Alzheimer’s, cancer, chronic pain, Crohn’s disease and multiple sclerosis, to name but a few, found benefits from it. More than 20,000 publications on PubMed, not of clinical trials, but of people’s experience and data collected from patients, show that they have found it to be beneficial.
When recommending and assessing medicinal products using cannabis, NICE suggested that research should be carried out in six or seven areas. I do not know what research has been carried out. The problem with such a recommendation is that it does not recommend who should do the research. So I ask the question: who should be doing this research to explore the benefits that patients find in medicinal cannabis?
Private clinics prescribe more and more cannabis on a daily basis, and more and more clinics are opening in cities in England where cannabis is available. My noble friend Lady Meacher and the noble Baroness, Lady Walmsley, alluded to two important issues. One is that a way needs to be found to collect information on patients’ experiences and data to show why so many patients go to private clinics to get cannabis products and what benefits they derive from them.
I look forward to the Minister’s response, but I hope she may agree, as it would not require legislation or an amendment to the Bill, that the NIHR or the Department of Health and Social Care through the NIHR should establish a forum of specialists, including patients, to find a way forward to collect information on a more formal basis. I hope the Minister will respond positively to that. It has been a pleasure to take part in this debate.
My Lords, the amendment signed by my noble friend Lady Walmsley and others would require the Secretary of State to make regulations concerning medicinal cannabis and associated devices. The noble Lord, Lord Field of Birkenhead, made his case clearly and strongly. I have a family member who used cannabis as a painkiller towards the end of their life when pharmaceuticals failed. Given the huge relief it can bring to patients with conditions such as epilepsy, it is vital that barriers to access are removed. We have heard that since the law was changed in November 2018, only a very small number of prescriptions have been written for medical cannabis.
The noble Baroness, Lady Meacher, my noble friend Lady Walmsley and the noble Lord, Lord Patel, have for many years supported the use of medical cannabis for a small number of conditions. Very few patients have received their medicine on the NHS because NICE has yet to approve the use of cannabis in any context. Evidence is available, so why are the Government fighting shy of using cannabis or its derivatives, thus forcing individuals to become criminals by having to go abroad to countries where cannabis is legally available, but at a huge cost, and then smuggle it home? It does not make sense. We support the amendment.
We do not seem to be able to contact the noble Lord, Lord Norton of Louth, so I call the noble Baroness, Lady Thornton.
I thank my noble friend Lord Field—he may not technically be my noble friend, but he is really—for bringing this issue to the Committee at this stage. He probably knows that he is not the only parliamentarian who has been driven to cannabis products for similar reasons, but my lips are sealed about who the others might be.
The noble Baroness, Lady Meacher, is absolutely correct. She and I have form. I have been supporting her from the Front Bench on this issue for quite a long time. While the debate was going on, I looked to see what Hansard had to say about this. The last time, I think, that we discussed this was in March 2019. At that time, the framework and law had been changed the previous November, so that is two years ago. At that point four people had managed to get cannabis products prescribed. When the noble Baroness put the question to the House, it was answered by the Minister’s predecessor. Will the Minister say how many more people there are now? I think it is probably not that many more, and I see this amendment as a scream of frustration about this issue. There is justifiable frustration that we have not managed to regulate this product in a way that makes it accessible to people who need it most. It also exacerbates the inequalities in our health system because, as the noble Lord, Lord Field, said, he can afford to buy it, but there are thousands of people who need it and cannot afford to buy it. I support this amendment, but I am really much more interested to see what on earth the Government are going to do to make progress with this.
I am now able to call the noble Lord, Lord Norton of Louth.
My Lords, I am delighted to have the opportunity to contribute to the debate and I apologise for not being able to contribute in my allocated slot.
I was very keen to add my name to the amendment to support the noble Lord, Lord Field of Birkenhead. I do not want to repeat the points that have already been made, but I draw attention to the fact that a few years ago I initiated a debate in the House on drugs policy. My point was to argue the case not for a change in policy but that policy must be—or should be—evidence-based. At the time, the Minister who replied said that opinion on this is divided. Someone afterwards pointed out that only the Minister disagreed with me because everyone else who spoke in the debate supported the case I was making that the Government were resisting going on the basis of evidence. For whatever reason, they were sticking their heels in.
As we have heard, the evidence really supports the case for change. The APPG for Drug Policy Reform showed the case and that there is evidence for the value of medicinal cannabis in relieving pain. There is a very strong argument on the basis of evidence and a moral case as well, given the sheer number of people who are forced, at great expense and possibly some danger, to find alternative ways of getting hold of cannabis for medicinal purposes, so I very much support what has been said by preceding speakers, including the noble Lord, Lord Field. I think the amendment is a step in the right direction in what it seeks to achieve. It is targeted and proportionate. It is designed to help to expand access to safe and regulated medicinal cannabis products in the United Kingdom. There were other points I was going to make in support, but I do not want to repeat points that we have already heard. I just wanted my name to be on the record as supporting the very powerful cases that have been made for the amendment.
My Lords, Amendment 94A in the name of the noble Lord, Lord Field of Birkenhead, deals with a topic of great difficulty. As the noble Lord has personally testified, patients and families deal courageously with challenging conditions, and I know that the issue of medicinal cannabis is one that has had much debate.
As other noble Lords have pointed out, it is almost two years to the day that the Government changed the law to allow the supply of medicinal cannabis under misuse of drugs legislation. These regulations provide that medicinal products containing cannabis can be prescribed or supplied when certain conditions are met. These conditions are that the relevant cannabis product is a special medicinal product, an investigational medicinal product for use in a clinical trial or a medicinal product with a marketing authorisation.
I do not have specific figures for the noble Baroness, Lady Thornton, on the number of people who may have accessed cannabis drugs since then. I understand that the collection of data on certain private prescriptions was suspended because of Covid-19, but we can go away and look for the latest data and, when it becomes available, update the House. I believe I heard the noble Lord, Lord Field, say that there may have been 204 prescriptions. While I cannot endorse that figure, and noble Lords may feel it is low, it is considerably higher than the figure that the noble Baroness quoted for one year after the approval of medicinal cannabis. Therefore, if it is correct, progress is being made in the right direction.
Noble Lords are right that cannabis remains a controlled drug. I appreciate that the noble Baroness, Lady Meacher, already expressed views on this in our discussions with the MHRA on whether it ought to be a controlled drug at all. The noble Lord, Lord Field, also made that point. However, the changes to its restrictions are set out in the Misuse of Drugs Act 1971, the Misuse of Drugs Regulations 2001, for England, Scotland and Wales, and the Misuse of Drugs Regulations (Northern Ireland) 2002. Those regulations are not within the scope of the Bill.
What is within scope is when those medicinal products are regulated as a human medicine. The noble Lord is asking for regulations to provide for a specific licensing regime for medicinal cannabis. However, I stress that medicinal cannabis products already have a route to market. They fall within the scope of the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004. It is entirely appropriate that they are subject to the same standards and requirements of evidence as any other medicine. The MHRA’s licensing process takes into account evidence of clinical efficacy. This includes consideration of all evidence supplied by the manufacturer. The regulators also inspect the factory where the medicine is to be made to make sure that supplies will be of a uniformly and consistently high standard. Companies can and do submit evidence of use from other countries, so there is no need to set an explicit requirement to consider efficacy internationally. If a company wishes to make a product available, it can within this regime.
Medicinal devices that administer medicinal products, including medicinal products containing cannabis, would also need to comply with the relevant provisions of the Medical Devices Regulations 2002. But a medicinal product in the UK must be safe. We have talked throughout the Committee about the critical importance of safety and the need to uphold standards. There is a paucity of evidence to support the quality, safety and efficacy of these products, meaning that very few hold marketing authorisations. To address this, the industry needs to further the evidence base and support the use of their products. Government is supporting this with a programme of two randomised control trials commissioned by the National Institute for Health Research. I hope that reassures the noble Lord, Lord Patel, as the National Institute for Health Research is engaged in assessing the evidence in this matter. These trials will be critical in ensuring that evidence for cannabis-based medicinal products can be developed to plan future NHS commissioning decisions for the many patients who may benefit from these innovative medicines.
Just to pick up on the question of how many drugs may already hold licensing, I can say that there are three such licensed products, including Sativex for MS and Epidyolex for rare epilepsies. These drugs are proof that cannabis-based products can meet the high standards of quality, safety and efficacy that we rightly expect in the UK. I say to the noble Baroness, Lady Jolly, that the drugs that have been licensed by the MHRA also have NICE approval for use in the NHS in certain appropriate conditions. As we heard in our meeting with the MHRA on Monday, it is able and willing to provide advice to researchers and companies that wish to conduct clinical trials and go through the licensing process for their products.
Cannabis-based products for medicinal use can also be supplied as unlicensed “special” medicines, as noble Lords have noted. A special medicinal product is a product that is manufactured or assembled according to the specifications of a specialist medical practitioner to meet the needs of a specific patient, in accordance with the stringent “specials” regime provided for in the Human Medicines Regulations 2012. Those unlicensed products have not been assessed by the National Institute for Health and Care Excellence for clinical or cost effectiveness. These are the foundations of NHS decisions about routine funding for medicines.
I appreciate that families with ill children, or patients themselves, would dearly love to have greater products available to them for more purposes, but this is not about creating new licensing routes. It is about companies coming forward and undertaking clinical trials and tests and it is about having the appropriate level of assessment and understanding of the impact. We are taking steps to improve the body of evidence available. When marketing authorisations are sought, they will be dealt with by the regulator, as they would for any other medicine. That may not be as quickly as some would like, but it is necessary to protect patients. On that basis, I hope that the noble Lord, Lord Field, is content to withdraw his amendment.
I have received requests from three noble Lords to speak: the noble Baronesses, Lady Finlay, Lady Walmsley and Lady Thornton. I call the noble Baroness, Lady Finlay.
My Lords, I am most grateful to be able to come in at the end of this important short debate. I particularly commend the noble Lord, Lord Field of Birkenhead, for his outstanding and long history as a parliamentarian and, yet again, for his clarity and ethical approach to every subject that he addresses.
I am glad that the Minister has referred to the two studies from the NIHR and simply support the idea that we need to wait for those, although I draw attention to the fact that, in 2018, there was a Cochrane database review, which looked at the 16 double-blind randomised control trials that it could find. It found some support, but it was not terribly strong. One of the difficulties here is that pain is a symptom that occurs in an enormous range of disorders, but the fundamental cause of the pain will be very different in different people. To get a matched population where you can compare one with another is extremely difficult. I hope that the change that NICE is looking to in the evidence that it seeks, where it will also look at evidence in practice, will support the evidence coming through from large patient cohorts who can then be put into broader groups.
The other point about pain is that, as people get multiple pathologies, they often take several other medications as well, which can interfere with the ability to assess them. They are also often elderly. The evidence certainly needs to be accrued. I would say as a clinician that one worry was always whether there would be a leak of cannabis on to the streets. However, in practice, I think that the leakage has gone other way so that it comes from the streets into people’s homes. Clinicians have had to look at this with Nelson’s eye because they do not want to support clinical activity. In a study that I did, while we did not ask patients to tell us specifically where they were getting some things from, when we put together all the different types of alternative therapies being used by a group of people who were cancer patients, the numbers were huge. This supports many of the comments that have already been made. I am glad that the Government are looking at it and I expect that it will not be too long before we find that the ability to get the medication that is needed is made easier. I worry that it may be too late for some patients, but we are getting there.
I thank the noble Baroness for her comments about the importance of evidence. The Government and the MHRA recognise some of the difficulties around these trials. That is part of the reason that NIHR is supporting two trials and is asking people to come forward. The MHRA has also indicated that it is willing to work with those who have these products in order to support them in the process for licensing.
That has reminded me of one other point. The noble Baroness, Lady Walmsley, asked me about the NHS commissioning through evaluation programme. I undertake to write to her with a response, perhaps when I update the noble Baroness, Lady Thornton, on prescription numbers.
My Lords, I thank the Minister for that. With regard to her earlier response, if it were as easy as that, there would have been tens of thousands of NHS prescriptions in the past two years, but clearly that has not been the case. The noble Baronesses, Lady Finlay and Lady Meacher, have both made it clear why it is very difficult to conduct randomised double-blind clinical trials for these products. That is why I have suggested that, while we wait for many more than two trials, the commissioning through evaluation system could be used. I am grateful to the Minister for promising to write to me about that.
I thank the noble Baroness for her comments. I emphasise that there has been a great deal of discussion in the debate about the use of evidence. That is what will guide the Government and the MHRA in this, and that is why we are supportive of these RCTs taking place.
I have two brief questions. I agree with the noble Baroness, Lady Walmsley, in what she said about 200 being two a week. That is really pathetic in terms of what the need is likely to be. I wondered if the problem was because early on, there was a certain nervousness among GPs and clinicians in terms of the legal issues as regards prescribing cannabis products. Is that still an issue? The other thing I want to ask the Minister about is whether the MHRA is drawing on international experience because some countries are much further ahead on these issues than we are.
The MHRA is very clear about its desire to be an international regulator and engage with other regulators across the world on all issues regarding the regulation of medicines and medical devices, so I am sure that it is working in this area. On the point the noble Baroness has made about the nervousness of clinicians on the legal status, this is not something that I am aware is still an issue, but I am happy to take the point away and look at it again.
My Lords, I wish to concur with some of the points made; I do not speak against anything said by the noble Baroness, Lady Finlay. We are in complete agreement and I do not counteract anything that she says anyway. Having said that, most people look at medicines as things that cure disease. Most medicines do not cure disease. Symptoms are what patients experience, and we have to treat those symptoms. As an obstetrician, I have spent most of my life treating the symptoms of pain, prescribing morphine and heroin as painkillers to mothers who are suffering from labour pains. I could not measure their pain in any way except by what they told me about it.
The problem with database evaluation is that it looks for the size of the randomised trials. I suggest that observational studies that look at the experience of patients are a good enough database to evaluate whether the substance used is effective in alleviating their suffering. That is the sort of evidence that I hope NIHR will seek to establish a proper database. I am pleased to hear the Minister say that NIHR is looking at ways of dealing with this.
My Lords, the only thing that I will add is that the noble Lord, Lord Field of Birkenhead, said that this was about equality. My point is that MHRA’s approach to medicinal cannabis is the approach it takes to licensing all other medicines. So whatever approach we take to evidence, or how we look at the appropriate gathering of that evidence, will be based on the approach we take to all medicines. The way in which cannabis is treated is not as a different or exceptional case, and we will want to ensure that that is the case going forwards.
My Lords, it may be because I am a new Member that I do not quite understand the nuances of language in the House of Lords. I thank most sincerely my fellow Peers who have participated in the debate, and I agree with the Minister’s wish that at this stage I should withdraw the amendment, but in doing so, I would like to say that we will return to this issue. I would particularly like to return to the issue that my noble friend Lady Thornton raised, about equal access.
Only 10 NHS prescriptions have been offered under the new provisions that Parliament made. When I got what had to be a private prescription and took it to Boots, the pharmacist came back with it as though I had left some terrible mess, dropped the prescription back on the counter and said, “We do not dispense that drug.” So all the talk that somehow, if only we could get a prescription, we would get a supply, is also a myth.
I am disappointed with the Minister’s reply. I thought it was pretty thin gruel to offer us. Although I beg leave to withdraw the amendment, I hope that those of us who are interested in this topic will return to it at the most suitable date.
Amendment 94A withdrawn.
Committee adjourned at 6.35 pm.