Consideration of Bill, as amended in the Public Bill Committee
New Clause 1
‘(1) The Secretary of State may by regulations make provision about the establishment and operation by the Health and Social Care Information Centre (“the Information Centre”) of one or more information systems for purposes relating to—
(a) the safety and performance, including the clinical effectiveness, of medical devices that are placed on the market;
(b) the safety of individuals who receive or are treated with a medical device, or into whom a medical device is implanted;
(c) the improvement of medical device safety and performance through advances in technology.
(2) The regulations may (among other things) make provision—
(a) specifying descriptions of information in relation to medical devices which may or must be entered or retained in an information system established under subsection (1);
(b) requiring information to be provided to the Information Centre for the purposes of its functions under the regulations;
(c) about the use or disclosure of information contained in an information system established under subsection (1);
(d) requiring the Information Centre to have regard to specified matters in exercising its functions under the regulations.
(3) The provision mentioned in subsection (2)(b) may include provision—
(a) requiring specified persons or descriptions of persons to whom subsection (4) applies to provide information of a specified description to the Information Centre;
(b) about the manner in which, and the time at which, those persons must provide that information;
(c) enabling the Information Centre to require specified persons or descriptions of persons to whom subsection (4) applies to provide to it in a manner, and at a time, determined by the Information Centre—
(i) information of a specified description;
(ii) information for specified purposes;
(iii) any other information that the Information Centre considers it necessary or expedient to have for the purposes of its functions under the regulations;
(d) about any procedural steps the Information Centre must follow in requiring a person to provide information to it;
(e) requiring specified persons or descriptions of persons to whom subsection (4) applies to record or retain information which they are, or may be, required to provide to the Information Centre under the regulations;
(f) in relation to the enforcement of any requirement imposed by or under the regulations.
(4) This subsection applies to any person who provides services, or exercises any powers or duties, relating to medical devices.
(5) The descriptions of information specified in the provision mentioned in subsections (2)(a), (3)(a) and (3)(c)(i) may include—
(a) unique identifiers associated with medical devices;
(b) information in relation to individuals mentioned in subsection (1)(b);
(c) information about any procedure carried out in relation to a medical device (including information about any person involved in carrying out the procedure).
(6) The provision mentioned in subsection (2)(c) may include provision about—
(a) the analysis by the Information Centre of information contained in an information system (whether alone or in combination with other information) for the purposes mentioned in subsection (1) or for other purposes;
(b) the publication by the Information Centre of information contained in an information system;
(c) the disclosure (other than by way of publication) of information contained in an information system to specified persons or descriptions of persons, or for specified purposes;
(d) the use or further disclosure by any person of information disclosed to them under the regulations.
(7) The provision mentioned in subsection (3)(f) may include provision applying any provision of Chapter 2 of this Part (enforcement), with or without modifications, in relation to a requirement imposed by or under the regulations.
(8) In this section, “specified” means specified in regulations under subsection (1).’”—(Jo Churchill.)
This new clause would give the Secretary of State power to make regulations providing for a database of information in relation to medical devices to be established and managed by the Health and Social Care Information Centre. The clause would be inserted after Clause 15.
Brought up, and read the First time.
I beg to move, That the clause be read a Second time.
With this it will be convenient to discuss the following:
Amendment 21, in clause 1, page 2, line 6, at end insert—
“(5) In making regulations under subsection (1), the appropriate authority must give primary regard to the safety of human medicines.”
This amendment requires the appropriate authority to consider patient safety first when making regulations under subsection (1).
Amendment 20, page 1, line 5, at end insert
“for a period of three years following the day on which this Act is passed.”
This amendment provides a sunset provision for the Bill requiring the Government to return with primary legislation.
Amendment 19, in clause 2, page 2, line 26, at end, insert—
“(o) the origin and treatment of human organs used in the process of developing or manufacturing medicines”.
This amendment empowers the appropriate authority to make provisions on the process of developing or manufacturing medicines in relation to the origin and treatment of human organs.
Amendment 22, in clause 8, page 5, line 34, at end insert—
“(5) In making regulations under subsection (1), the appropriate authority must give primary regard to the safety of veterinary medicines in relation to animals, humans and the environment.”
This amendment requires the appropriate authority to consider animal, human and environmental safety first when making regulations under subsection (1).
Amendment 23, in clause 12, page 7, line 27, at end insert—
“(3) In making regulations under subsection (1), the appropriate authority must give primary regard to the safety of medical devices.”
This amendment requires the appropriate authority to consider safety first when making regulations under subsection (1).
Government amendments 1 to 18.
This Bill is an opportunity. It is necessary to ensure that we have the ability to continue to update our regulatory frameworks after the end of the transition period. We must ensure that we continue to be able to respond swiftly to pressing need. This is not a standstill Bill, however. It is designed to underpin the way in which the UK approaches the life sciences sector and innovation in health from 2020 onwards—an approach whereby we promote, to the best of our ability, patients’ access to cutting-edge treatments and encourage the cultivation of new, safe and patient-focused technology, balanced with the need to take swift and effective regulatory and system action, to ensure that patients do not experience adverse outcomes.
I put on record my gratitude to Members in all parts of the House. On Second Reading and in Committee, they have approached the Bill with a consensus that I hope will continue in the other place. We have all understood the principles behind the Bill, and any differences of opinion and scrutiny have been firmly in the best interests of patients and in the interest of ensuring that the Bill goes to the other place in good shape.
Our experience of the health system is a personal one. We have relationships with our GPs and clinicians, and some of us have long-term health conditions or short-term immediate needs that require surgical intervention. We all want to know that the health system is taking all possible steps to prevent harm to patients and that the regulator and the health system work in partnership to identify when something is going wrong and to take swift corrective action. We would hope that in the event that we experienced an adverse outcome or reported concerns to our doctor, GP or surgeon when something was not working properly, the patient, system and statistical significance of that outcome would be understood and properly addressed; and the clinician, the system and the regulator would engage with the patient on required action.
We also want to ensure that, where required, the regulator will continue proactively to engage with the manufacturer of a medical device and ensure that information is supplied alongside that device or improvements are made so that we learn from the patient experience. Finally, we want to ensure that data is available to drive regulatory or system action, to limit the use of that device or remove it from the system so that our experience as patients results in changes to prevent future harm and suffering, even if that risk cannot be removed completely.
I will first speak to the amendments tabled in the name of the Secretary of State for Health and Social Care, before I move on to those tabled by hon Members present. I thank all those who have shown an interest in this area, particularly my hon. Friend the Member for Newton Abbot (Anne Marie Morris) and the hon. Member for Central Ayrshire (Dr Whitford), who put forward their own amendments. Both were extremely well intended and thoughtfully drafted and there have been further thoughtful contributions from all parties and both Houses in thinking about what an amendment to that effect might need to deliver.
We all recognise that medical devices are not subject to the same comprehensive regulatory system of pre-market assessment that medicines are. The Government also recognise that the system could be made stronger in respect of how devices are purchased, used and reviewed. The issue is incredibly important. Like me, Members across both Houses are anticipating the forthcoming report from the independent medicines and medical devices review, which looked into significant matters, with an expectation that it might make recommendations in this area. I put on the record that I am deeply sympathetic to patients and families affected by the issues covered in the review. That is why I am keen to take action now, when we know that there are gaps that we might close in the regulations made under the powers in this Bill, rather than wait.
New clause 1 introduces a power for the Secretary of State to create a medical device information system through regulations for the purposes of the safety and performance, including the clinical effectiveness, of devices; the safety of individuals who receive or are treated with a medical device; and the improvement of medical devices’ safety and performance through advances in technology.
The new clause has a number of detailed subsections because there are a number of considerations that Members will wish to know are being taken into account in the light of the productive discussions that have been had in this place and elsewhere about the important question of patient safety and the system’s capacity to protect us all.
Some of the matters covered by the clause can be dealt with already, under the Health and Social Care Act 2012. That Act established the Health and Social Care Information Centre, otherwise known as NHS Digital, and allows for the Secretary of State to issue a direction, asking NHS Digital to collect data in respect of the NHS in England. It is under that Act that the Secretary of State sought to act late last year, by issuing a direction to NHS Digital to begin to collect data with regard to implanted devices in England so that we could begin to build a picture.
However, this issue affects the whole UK and patients in all four nations. Devices are also implanted in private institutions by providers who are under no obligation to provide data to a central system if they are not working under contract to the national health service.
In their amendments in Committee, Members referred to device registries. We have a number of existing device registries in this country and a global exemplar in the National Joint Registry, which describes its own mission as
“Working for patients, driving forward quality”.
It collects information on operations to monitor the performance of certain implants and the effectiveness of different types of surgeries, improving clinical effectiveness and benefiting patients, clinicians and the sector as a whole. That works for patients, at a local level, who receive devices under the aegis of a registry. But not all higher-risk devices have a registry, and some registries will generate insights or patterns that are of use to other types of implants or devices—or, indeed, to improving regulation and the safety of devices as well as our system responses.
Data is fundamentally a driver of change. It is how we identify trends and draw links between individual issues to find patterns. It is by bringing data together that we see a bigger picture that can drive our response. The new clause seeks to create the legal backbone for future data collection and construct an information system to support existing and new registries in the future.
Members will be concerned about how data is safeguarded, how it might be used and by whom, and I will come to that shortly. But it is worth reflecting and understanding that the benefits of this system will be broad. Such a system would monitor the performance of devices and ensure that patient outcomes can be tracked. The longer-term aim is to intervene earlier, through clinical analysis of the data in the information system, to prevent patient harm before it happens by enabling the healthcare system to flag concerns, drive clinical system and regulatory action where appropriate, and use alternative and better devices and procedures to mitigate risk to UK patients. It would support the registries, both present and future, to take action underpinned by the national data from all four corners of the United Kingdom.
Such a system, subject to safeguards, could allow for the sharing of certain types of information with clinicians, the regulators, the NHS and other healthcare partners in the longer term. That would improve the data available on medical devices, as part of post-market surveillance. As a result, the UK’s regulator, the Medicines and Healthcare products Regulatory Agency, will be better able to take action early and more effectively as part of its regulation of devices on the UK market.
New clause 1(2) sets out some of the matters that regulations that establish this system might make provision for. It enables provision to be made so that the information is provided to NHS Digital in order that it can carry out its functions under the regulations. It enables provision to be made about using or disclosing the information, and for NHS Digital to have regard to certain matters, such as the need to reduce burdens on healthcare institutions when exercising its functions.
Subsection (3) clarifies subsection (2) by asking a private provider of, for example, breast implants to supply data to the information centre and to do so in a manner and in such a time that is provided for in the regulations. Along with the UK-wide nature of the power, it would ensure that we have a national picture that would support the aim we are all here to drive forward.
Subsection (4) makes it clear that anyone whose services, powers or duties relate to medical devices can be specified in the regulations and thus required to provide that information to NHS Digital for the purposes of the information system. That is important, as we would not wish to inadvertently have a gap as technology and procedures move on.
Subsection (5) sets out that the kind of information we might expect to require is retained and entered in the information system. The first and most immediate use of the information system must be to ensure that if there is an issue with a device it is possible to find and then notify a patient. To support that, the unique device identifier must be retained, along with the details of the patient in whom the device has been implanted, through, for example, their patient record, and the information about any procedure that has taken place, including the name of the clinician who has implanted it. This was raised in discussions and the provision is, if you like, an indication at the outset of what we would expect to capture, but subsection (5) does not limit us to that if consultation takes us further.
Subsection (6) deals with the disclosure and analysis of information. There was considerable discussion on Second Reading, led by the hon. Member for Twickenham (Munira Wilson), of the need to trust how data is used and analysed in order for such a system to be supported by patients. Subsection (6) is therefore critically important in being transparent at the outset that it would be necessary not only to capture the information, but to ensure that it can be used to identify patterns or trends to determine whether a patient’s experience of a device is personal and highly specific to their particular circumstances, or whether there is something clinicians or regulators need to do to improve the way in which that device can be used.
Patients are absolutely critical. They want to know that their data is protected, and subject to data protection legislation and other safeguards. They wish to know that they can be traced in the event of a problem with a device, and that the healthcare system professionals they interact with may know their surgical history as part of any future or ongoing procedures. They also wish to know that system change will be informed by their experiences—that their voices will be heard and change will occur as a result.
I recognise there is a lot of concern in this place and in the other place about how we ensure sensitive information is kept securely and processed for legitimate reasons only, and that there are strict safeguards on who has access to it. I wish to assure Members now that this legislation is here to provide the backbone for future regulation. The benefit of secondary legislation is that we do not have to have all the elements in place immediately, but we can put building blocks of data together to access it slowly over time, with the proper process of consultation with patients, clinicians and devolved Administrations and consensus behind the most appropriate course of action to build the longer-term vision that I have set out. We have specified the kind of things the regulation under this amendment might enable us to do, but we will need to return to Parliament with the detail. I can commit myself now to our intention that the consultation on regulations will indeed have considering voices of patients at its heart.
Enabling provision to be made in secondary legislation means that any information system can be updated to reflect collaboration with existing and future clinical registries, so that the processes for data collection remain streamlined, avoid duplication and reduce the burden on organisations providing the data. Future amendments to the secondary legislation governing the operation of any information system will ensure that the system remains as effective as possible in monitoring the safety of medical devices, but while that is the future, we do intend to ensure through regulations that, in the short term, data are subject to appropriate safeguards such as anonymisation by NHS Digital, and able to be shared within the NHS system and with the regulator so that patients get the benefit immediately of improved product safety and the comfort of knowing they can be traced if there is information that they need about their specific advice. That can and should be in place before we are in a position to put in place the vision of a system of clinical registries.
We have spoken to Ministers from the devolved Administrations, and there is broad agreement about the need for improved tracking of medical devices. The benefits for product and patient safety that an information system could bring are beyond party politics. It is the right thing to do for patients. IT projects are notoriously difficult and I think it would be difficult, if not impossible, to put one in legislation in detail. We have sought to strike the right balance between detail on what might be in the regulations in the interests of transparency, and enough flexibility to respond properly to the consultation on what the future should look like with those most affected by this. It is absolutely critical that this works, not least for clinicians who will need to record the information. We have published a detailed document setting out the long-term aspiration and some of how we would like to get there to accompany the amendments and to support Members’ scrutiny. I hope the amendment has support in all parts of the House.
Let me turn to the minor and technical amendments in the name of the Secretary of State. These are very small matters. Amendments 2, 3, 4, 5, 6 and 7 and 18 all make minor changes in order to enable new clause 1. Amendments 8 to 17 make minor and consequential amendments to enable regulations made under the powers in the Bill subject to the negative procedure to be combined in a single statutory instrument with regulations under powers which are subject to the affirmative procedure, or with regulations under powers in other legislation which are subject to the negative procedure. Allowing for different provisions to be combined in a single statutory instrument makes for greater efficiency within the parliamentary timetable.
I move now to amendments tabled by the hon. Members for Nottingham North (Alex Norris) and for St Helens South and Whiston (Ms Rimmer). I thank them for tabling them and hope that I can engage as much as possible with the points raised. Amendments 21, 22 and 23 are similar to those put down—
It is a thrill for a Government Minister to move my amendments, although that might be giving me false hope. But I just wanted to put on record for colleagues that the purpose of amendment 21 is to make patient safety the uppermost priority.
I thank the hon. Gentleman for his intervention. We are in completely unusual times: I get to respond to his amendments before he has actually spoken to them himself, but we will crack on.
I recognise that the hon. Gentleman said at the time that he wished to return to these issues during the proceedings and I was expecting him to do so. We agree that patient outcomes and patient safety are matters that we would expect the House to consider very seriously.
Amendments 21, 22 and 23 all seek to establish a hierarchy of considerations applied by the Secretary of State or the appropriate authority when making regulations under the Bill, making safety the primary consideration. It is important to say at the outset that there is a consensus on both sides of the House on patient safety. It matters to us as individuals and as MPs representing our constituents, who rightly wish to know that their safety and their animals’ safety is of uppermost importance when we look to make regulatory change.
Patient safety is critical, and through the Bill we are trying to do what is important for patients. The Bill includes changes such as adding prescribing professions for veterinary medicines, reflecting the desire to make medicines as accessible as possible while not compromising animal safety or the safety of the person administering the medicine. This could mean allowing a physician to prescribe a medication outside its licensed purpose, because it will give a better clinical outcome for that patient in those circumstances than no drug at all or a drug that will be harmful alongside another medicine that they are already taking. The Bill is about patient safety, but it is also about a combination of factors that deliver on behalf of patients.
Not all regulatory changes are made with the intention of changing the way in which a device or medicine makes its way to the patient, or are about whether the substance or device is safe to a patient. In 2013, changes were made to the Human Medicines Regulations 2012 so that brokers, importers, manufacturers and distributors of active substances could apply to make oral representations to the Medicines and Healthcare products Regulatory Agency to have certain decisions, such as a decision to vary or suspend their registration, reviewed. That made no palpable difference to the safety of patients, but it did make a regulatory change that could be said to respond to the attractiveness consideration. Regulations are not the only route to protect patients. In addition, the MHRA, the NHS and the Department of Health and Social Care have multiple points at which the safety of medicines and patient safety are addressed and considered.
The NHS also has ways to interact with the regulator, such as the yellow card scheme, to raise patient safety concerns that can result in suspension of the use of medicines and devices. That is an example of our regulatory regimes in action, fulfilling the primary purpose they were created for: protecting patient safety. In addition, NHS Improvement established a patient safety strategy in July 2019, which it will continue to develop in consultation with clinicians and patients. There are also patient safety managers in hospital trusts, as well as leadership within DHSC responsible for ensuring patient safety. Those examples, in addition to the consultation required under the Bill, will feed into the decisions that are made when making regulations under the Bill, ensuring that consideration of any impact on the safety of medicines and medical devices is always well informed.
When it comes to the considerations set out in the Bill to be taken into account before making regulations, it is our view that there need be no hierarchy, because the combination of all three considerations provides the best outcomes for patient safety—the safety of the medicines and devices themselves, the availability of those medicines and devices, and a UK market that will encourage the continual development of innovative, more effective and, importantly, safe medicines and devices. It is not a choice between having safe medicines and having a strong and secure supply chain, nor is it a choice between having safe medicines and being an attractive place for the development of new medicines. Those considerations go hand and hand and must continue to do so, so that our regulations continue to ensure that safe and effective medicines reach UK patients and that our vibrant life sciences sector is supported.
I was grateful to the hon. Member for Nottingham North for the points he made in Committee. We agree on the need to send a clear message about the importance of patients. We also agree that patients—be they human or animal—should and must come first in our consideration of regulatory changes that affect them, and that that consideration must include the safety of medicines and devices, alongside availability and attractiveness of the UK market, to ensure the best outcomes for patients, which is what we are both working for.
The sunset provision in amendment 20, is intended to limit the operation of the Bill to a three-year period after Royal Assent. The amendment is similar to the one tabled in Committee. The practical consequence of a sunset provision is that, at its end, the Government would be compelled to return to Parliament with new legislation. There has been much consideration in this House and elsewhere of the extent of these powers in legislation, particularly legislation designed to ease our way out of the transition period and into the UK’s regulatory autonomy. The hon. Gentleman himself has said that the arrangements in the Bill could be said to reflect current arrangements, and I would argue that the arrangements in the Bill—there must be consultation before regulations may be made and they must be laid in draft before the House and subject to the affirmative procedure—provide for a significant increase in parliamentary scrutiny of any changes to the current framework.
The hon. Gentleman said in Committee that he wished to see proper consultation across the sector in order to set up a world-class, safe and effective regulatory regime. I would say that that is precisely what we wish to achieve through the Bill as it is drafted. Proper consultation does not mean simply the act of providing evidence to Parliament; rather, it is the ongoing consideration of changes to regulations that affect the sector. That is precisely what clause 40 is intended to produce.
The hon. Gentleman concluded in Committee by making two points, and I hope that I can address them both here. First, he asked whether this provision—the ability to make regulatory change via secondary legislation —would mean a diminution in protection. I would say absolutely not. This is not about reducing UK standards; it is about ensuring we can modify and adapt our regulatory regime so that we can take account of new technologies and ensure effective regulation that keeps pace with innovation. We have approached the drafting of the Bill with the intent of creating legislation that will stand for some time, and that is why we have focused on which regulations may be made to amend or supplement existing legislation. It is also why we have sought to consolidate the enforcement regime so that it is transparent and clear to companies and the MHRA how we ensure operation within the law.
The hon. Gentleman also asked whether the Government could accept that the liberty to make bold changes by using the delegated powers in the Bill should not give the Government the chance to make any changes they wanted. It is right that we take a sensible and proportionate approach to regulatory change. Small changes, such as adding Braille to packaging, are common sense, but I agree that changes such as how we approach community pharmacy and novel technologies are something else. I can assure him that we have no intention of making bold changes to regulations without full consultation and bringing the issue back to the House with the assumption that we will be expected to justify those changes.
The amendment would mean returning to primary legislation within three years. In practical terms, that would be likely to mean within two years, given the need to have sufficient parliamentary time for the passage of the Bill. There are two months after Royal Assent before we can make the regulations, other than in emergencies, and those regulations are subject to a statutory consultation and then the affirmative procedure, all of which takes time. This would mean that we would have 18 months, at most, of practical operation of the legislation before we had to go back to its principles. We would not know, for example, whether the civil sanctions regime had had the desired material effect, as it would simply not have had enough time to run. We would cease being able to disclose pertinent safety information from the MHRA to the NHS, and it would be unclear whether the registers facilitated by clause 13—or, indeed, the medical device information system introduced by the new clause—would be able to continue to operate, or whether we were starting from scratch. Some regulatory changes take years to put into effect. Manufacturers, companies, hospitals and so on must expend financially on preparing for them, putting them into effect and sustaining them. We would like, as much as possible, to be certain that any regulatory change we have introduced in the UK is sustainable and ongoing. It is key that we get this right.
The Bill’s drafting, and our approach to making transparent the kinds of changes one might expect from the delegated powers, have been carefully thought out. Our approach has been consistent with the recommendations of the Delegated Powers and Regulatory Reform Committee in relation to the Fisheries Bill in the last parliamentary Session, 2017 to 2019. We have, in fact, gone beyond the work of that Bill and produced six illustrative draft statutory instruments. We have recognised the need for Parliament to have a greater role and, other than in specific circumstances, the affirmative procedure applies and is supported by a mandatory obligation to consult.
This is not a stopgap Bill to get us through the transition period. It is a proportionate approach to regulating an industry that moves quickly, with regulators who wish to take effective action and who are renowned for working with the industry in the best interests of patients, such as during covid. We can get this right now, and not suggest to industry, the regulators or patients that this is not the right answer for the future of regulation such that Parliament would need to revisit it swiftly by applying a sunset clause.
I turn to amendment 19, which was tabled by the hon. Member for St Helens South and Whiston. I recognise the great passion with which she spoke about this amendment in Committee. In particular, she raised the issue of human organs used in the development of medicines and medical devices when consent has not been obtained, and the matter was raised specifically in relation to China. I thank her for the additional context that she has shared on the amendment both in Committee and through subsequent correspondence. However, these issues are not best addressed through primary legislation dealing with the regulatory framework for human medicines in the UK. I have written to the Minister for Asia regarding the issue and asked him to hold a meeting to discuss the matter further, and I believe that the relevant offices are in communication.
Comprehensive legislation that governs human organs and tissues for transplantation or the manufacture of medicinal products currently exists in the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Human Tissue Act 2004. The safeguards provided by this legislation ensure the appropriate quality, safety and origin of human tissues by setting out requirements around the donation, procurement, testing, processing, storage and distribution of organs, tissues and cells intended for human application. The requirements apply to any products that are administered to humans and, crucially, include requirements around consent and the traceability of human tissues and organs. Amendment 19 would not provide for future amendments to be made to the legislation governing human tissues.
Although I am entirely sympathetic to the concerns of the hon. Member for St Helens South and Whiston, I reassure Members that the current legislation provides extensive safeguards to ensure the ethical and appropriate use of human tissues in medicines and medicinal products. Equally, although I am sympathetic to the hon. Member’s intentions, I do not believe that the amendment would have the intended effect. I look forward to hearing further contributions from hon. Members.
It is a pleasure to resume proceedings on the Bill. The exchanges in Committee were of a high quality in both content and tone, and I look forward to more of the same this afternoon. I was proud to take the lead for the Opposition in Committee, as I am during the remaining stages of the Bill, and I thank my predecessor in the early rounds, my hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson).
Let me turn to new clause 1. I am so pleased to see the Government introduce what we spoke of in Committee as a device registry, which is now called the information centre. Bad medicines and devices cause exceptional harm. The noble Baroness Cumberlege is looking at the impact of three of these: Primados, sodium valproate and surgical mesh. I pay tribute to the campaigners and their allies in this place for all their work to ensure that those who are suffering, or who have suffered, are not forgotten. Clearly there have been devices that, knowing what we know now, we would not have used. There is a risk of similar things happening in the future, and it is a risk that we cannot fully mitigate, so an information centre will at least put us in the strongest possible position to react quickly and clearly.
I am personally grateful to the Minister for the level of engagement from her and the Government in general. I and my colleagues in the other place are committed to continuing to develop the idea. I know that the hon. Member for Central Ayrshire (Dr Whitford)—who will be watching proceedings, and whose expertise and creativity are missed—is ready to do the same. I can tell from my inbox that there is considerable interest in the sector in making this work, and I hope the Minister will commit to full consultation with it.
I want to take this opportunity to talk about the Cumberlege review. I had rather hoped that the remaining stages of the Bill might fall after the review reports on 8 July. That is important, because the report could have a profound impact on how we view the Medicines and Healthcare products Regulatory Agency and on how we view the past and what we need to do in the future. Presumably, proceedings in the other place will fall after that date, so I hope the Minister will at least be able to commit not only that the Government will engage seriously with that review—I am sure they will—but that, crucially, they will be willing to make amendments to this Bill or changes more generally to the MHRA through other legislation, regulations or other ways to ensure that it is fit for the future and addresses the challenges that come up in that review.
This is a simple Bill and the sunset clause that my amendment 20 would introduce reflects that. The Bill takes our current arrangements as governed by our previous membership of the European Union and transplants them into UK law—so far, so simple. It then hands Secretaries of State the power to amend those arrangements as they wish via secondary legislation. The Minister and I agree on a great deal of things—probably the vast majority of things—but our views diverge on whether that power is a downgrade from where we are. While I accept that the democratic deficit in the European Union is the face that launched a thousand undergraduate essay ships, there are nevertheless multiple independent stages across the Commission, the Parliament and the Council. Whether or not that is a good process is for the birds for us now, but if nothing else, there are lots of eyeballs to pick up mistakes.
Under the Bill, we will have a Secretary of State governing high-risk medicines and medical devices, with decisions essentially ratified by a Committee or occasionally, perhaps, on the Floor of the House, where the Secretary of State will have a majority come what may. I think that in any terms that is a diminution, and the Government will need to be mindful of that.
All amendment 20 asks is that the Secretary of State returns to Parliament after having had the powers for three years and resets the arrangements, creating an holistic new status quo, as we are doing now. That is not to say that the status quo would then be locked in for ever—it would have to be a moving picture—but it would just give us an understanding in the round of all regulations and allow Parliament to have a full consideration, rather than doing it bit by bit. Given how much scrutiny will be coming out of the process, the measure is not onerous. Nevertheless, I accept that a sunset clause is an inelegant solution so I do not intend to press the amendment to a vote. It is the best we have as an Opposition, and I hope that the Government will bear it in mind in the other place.
Page 4 of the Government’s impact assessment says that before a medical device enters the UK market, the domestic notified body—for us, that is the MHRA—must sign it off and say it is safe. It must then be signed off by two other notified bodies from other member states. That is a triple lock. Under the Bill, it will be just the MHRA and the Minister. That is a high wire, and it leaves the potential for a lot of harm.
A sunset clause—I would probably rather characterise it as a reset clause—would allow us to consider or evaluate one particularly critical by-product of the Bill that I can guarantee every Member will hear about from their constituents, if they have not done so already. If colleagues comb the Bill or do a ctrl+f search looking for the words “hub and spoke”, they will not find them. They can be found only on page 10 of the Government’s impact assessment at paragraph 42. Buried deep in there is the idea that the Government may—or do—plan to change the age-old principle that the pharmacy that dispenses is the pharmacy that distributes, either at the counter or via home delivery.
Paragraph 42 raises the idea that instead, mobile deliverers will be able to partner with dispensing pharmacies to deliver their prescriptions for them or, more likely, be able to dispense and deliver on their behalf, leaving pharmacists to pick up new clinical responsibilities. There are very strong valid arguments on both sides of the issue. I cannot tell the House with certainty how I would vote if asked to pick a side at this very moment. Some say that the measure will destroy community pharmacy and others say that it will unleash community pharmacy into the brave new world.
I can tell the House this: it is the most profound reform to community pharmacy in our lifetimes. It is delicate and it is important. Our constituents care about it, as do our local businesses. The Bill opens it up. I would even say that the impact assessment prejudges the matter, and it is not even on the face of the Bill. That is why the Bill needs a sunset clause. We know we have to support the Bill’s Third Reading, or we will not have a regulatory regime for medicines and medical devices, but how on earth did we get to the point where we are practically committing ourselves to an entire new model for pharmacy along the way? I cannot understand that, and I hope the Minister will respond in summing up and make a strong commitment to the broadest possible consultation on the matter, because we will have to tread very lightly indeed.
As for amendments 21, 22, and 23, when Paul wrote to the Corinthians, 13:13, he spoke of three things you discover as you grow up. We are entering the wedding season now—happily we are allowed to do that again—so Members will recognise this message:
“And now these three remain: faith, hope, and love; but the greatest of these is love.”
Similarly, on clause 1(2) of the Bill, there are three things when it comes to human medicines—or, in the case of my other amendments, veterinary medicines or medical devices: safety, availability, and attractiveness of the UK market. Surely, the greatest of these is safety.
I know the Minister has a strong personal commitment to patient safety, so I still cannot quite understand why in the Bill it is seen as equal to the attractiveness of the UK as a driving force of the Secretary of State’s decision making. I reckon we could stand in the Members’ Lobby all day without finding an hon. Member who would make attractiveness a coequal priority with patient safety. I am keen to hear what legal advice she has had on this point. Are we certain that there is not a vulnerability facing a future Secretary of State who is said to have prioritised patient safety over the attractiveness of the UK market to litigious and exceptionally powerful pharmaceutical companies? I do not intend to push this to a Division, but I would be keen to hear the Minister’s reflections on this point and ask that it be considered in the other place.
Amendment 19, which stands in the name of my hon. Friend the Member for St Helens South and Whiston (Ms Rimmer), deals with an exceptionally important issue. Again, there would be complete unanimity that human tissue harvested without consent is repulsive and that we in this country would want nothing to do with it—I have no doubt of that at all—but we also know that globally it is happening, and so it is incumbent on us all to make sure we are certain that such tissue does not enter the UK for the purposes we are discussing today. I listened carefully to what the Minister said in Committee. She provided a good deal of reassurance—and she has provided further reassurance this afternoon—but it is clear from correspondence from campaigners since that there might yet be gaps in the current arrangements and that we must act either today or in the other place.
Finally, I turn to the remaining Government amendments. As I said in Committee, I find it reassuring when there are Government amendments, because it means they are still reading their own Bill, which is a very good thing—I see it as a point of strength. I do not have any quarrel with these remaining amendments, but I want to make a final point about the use of secondary legislation powers, which the entire Bill is built on. This point is made clear on page 10 of the delegated powers memorandum. Not only is the Secretary of State reserving for himself significant powers via secondary legislation, but many are via the negative procedure. Examples include labelling, prohibiting, advertising, and the fees regime governing human medicine—an awful lot of very important things, and all at the stroke of a pen before Parliament has even said a word about it. I cannot help wondering whether the Government should be careful what they wish for. This is a high wire they have stepped out on to.
That summarises the Opposition’s views on the amendments. They are good amendments, both the Government and the Back-Bench ones, and I hope the Government will give the Opposition amendments strong consideration either today or at a later stage.
I thank the Minister for providing us with sight of her letter to the Minister for Asia. As she committed herself to doing in Committee, she communicated it to all Committee members. I sincerely thank her for that.
Amendment 19 would empower the appropriate authority to make provisions for the process of developing or manufacturing medicines in relation to the origin and treatment of human organs. This is necessary because of the actions by the Chinese Government in Beijing. The China tribunal, headed up by Sir Geoffrey Nice QC, launched the first independent legal analysis of all evidence relating to organ harvesting in China and found beyond reasonable doubt that forcible organ harvesting was taking place. China was invited to provide evidence to this tribunal but failed to do so.
Further, a study by the medical journal BMJ Open has raised ethical issues on over 400 Chinese medical studies, and there is clear evidence that China is abusing the human rights, including the right to life, of Uyghurs, practitioners of Falun Gong, conscientious objectors and political prisoners. There is no reason to believe that China is not also experimenting on such prisoners without consent and then harvesting organs to examine the results of such experiments, and we must protect the UK health system from being morally compromised by this.
The Minister stated in Committee that my amendment was not required as regulations are already in place under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Human Tissue Act 2004. There are codes of practice in respect of the 2007 regulations, but section 1(4) of the 2004 Act explains that subsection (1) does not apply for a body to which subsections (5) or (6) apply:
“Subsections (1) to (3) do not apply to an activity of a kind mentioned there if it is done in relation to…a body to which subsection (5) applies”—
which includes a human body that has been imported—
“or…relevant material to which subsection (6) applies”,
and that applies to “relevant material” if it has been imported. “Relevant material” means material consisting of human cells, so imported human tissue does not require appropriate consent.
The importing of human body tissue for medical research does not require any consent or traceability—it is only advised, not required—meaning that human tissue from countries like China can legally be imported to the UK for the purpose of medical research without traceability, documentation or consent. Imported human body tissue for use in medicines requires traceability from donor to recipient. Although technically consent documentation does not legally require consent, in reality it would be difficult to demonstrate donor selection requirements without it.
Without my amendment, we have no assurance that harvested organs cannot find their way into our national health service. Although the legislation and regulations provide guidance, it is just that: guidance. Why should we not want to make it clear that harvested organs will not find their way into this country? International checks on the system are failing, with the World Health Organisation’s assessment of the Chinese organ transplant system actually being one of self-assessment, as stated by the WHO to the Foreign and Commonwealth Office. Thus, the regime breaking the ethical standards is also assessing whether it meets them.
The British Medical Association has called on the Government
“to reconsider its position on this issue in light of the findings of the Tribunal”.
My amendment would empower the Government to do just that, and to close the hole in the existing legislation. It aims not to shut down the trade in medicines between the United Kingdom and China, but to ensure that it is ethical. It would not force the Government to implement the regulations now; it would merely empower them and the relevant authorities to take the steps necessary to regulate on this issue, when and if they are prepared to do so.
I do not intend to push my amendment to a Division today, although frankly, I should not have to: the moral and practical case is as clear as day, and the Government should accept it. It seems that they will not do so at this stage, but they should when the Bill is debated in the other place. I want to make it abundantly clear that I will not let this matter lie. A growing group of cross-party parliamentarians, both here and in the other place, are determined to stop this from happening. We now need the Government to do their bit. I will leave it there.
It is a pleasure to be able to speak on this issue. The Minister knows how pleased I am to see her in her position. I have always followed her progress, and she has done very well. I am pleased to note how capably she responds to the issues that are raised in the debate. What a pleasure it is, too, to see the shadow Minister, the hon. Member for Nottingham North (Alex Norris), in his place.
I am pleased to follow the hon. Member for St Helens South and Whiston (Ms Rimmer). We are good friends and have a similar staunch interest in the issue of organ harvesting, which she addressed in her speech. I am greatly concerned about the fact that China seems to undertake almost commercial organ harvesting, including those of Falun Gong, those of people of Christian belief and those of Uyghur Muslims and many others. I very much want to see all the protections that the hon. Lady has asked for, and I look forward to the Minister’s response.
Back before the 2017 election, I had occasion to be in hospital for three operations. If for nothing else but that one thing, I realised not only how good the NHS is and how well its people work, but also how unfashionable those surgical gowns are. It really scares me to think about it, never mind anything else, but that is the nature of life.
We are all aware that the Bill is an important piece of legislation. It is part of the drive to achieve the ambition to maintain the UK’s position as a world leader in science and research beyond the Brexit transition period. That is also referred to in the background notes. The Queen’s University research facility is world-class and is part of the team who are driving the search for a covid-19 vaccine, backed by the £20 million Government grant to find a vaccine and understand the virus. Sometimes it is not said, but it should be said and I say it now, that the Government have done some great work. It is in the nature of life that we sometimes say what has not been done, but let us give credit for what has been done; it has been really good stuff.
The Patrick G. Johnston Centre for Cancer Research and the Wellcome-Wolfson Institute for Experimental Medicine are both internationally recognised and acclaimed for the work that has been done there. Having been there many times in person, I cannot but be impressed by the leading world-class facility at Queen’s University in Belfast. There is more that can be achieved, and I hope the Bill will free up the Queen’s researchers to reach their potential. Perhaps the Minister would confirm that that would be the case. Queen’s University leads the field.
It is important that we do not just maintain current standards. I believe that the Bill will enable us to raise standards above and beyond—retain what we have and, hopefully, do better. I am so proud of what we have achieved in this country and confident that we can go further in the future. The Bill is therefore essential. However, future regulations enabled by the Bill must also ensure that patients are not disadvantaged and that the UK remains an attractive market for the international industry. I want to ensure that that is the case and I am sure it will be, but as the Minister will confirm, there is a fine balance to be achieved between regaining our sovereignty, which is of the utmost importance—and which I support totally—and ensuring that we are still competitive and able to work closely with the global market. I believe that we can achieve that, just as, last week, I spoke on the importance of assuring the future of the aerospace industry by means of regulations that enable continued easy access to the EU but also give the best protection for our own industry.
One of the questions that came up in my discussions was mentioned by the Minister. For years I have had a particular interest in rare diseases. I want to confirm that those with rare diseases will still have access to the specific clinical trials relating to their diseases. The Minister says, rightly, that the legislation will affect all of the United Kingdom of Great Britain and Northern Ireland, and that all four regions will be part of that. I have had some correspondence from the British Heart Foundation—an organisation which I highly respect, and which is highly respected by all of us in the House. We appreciate the level of work that it undertakes to benefit people throughout the whole of the United Kingdom of Great Britain and Northern Ireland.
The BHF communicated with us about the Bill and I ask its questions, which are as follows. Close UK-EU collaboration is protected through full alignment with the EU clinical trials regulation, allowing patients access to vital pan-EU clinical trials regulation and encouraging industry to continue to invest in UK science and research. Will that continue? Patients currently have quick supplies of crucial medicines through close participation in the European Medicines Agency licensing process; will that continue? From 2004 to 2016, the UK collaborated with other EU countries in 5,000 clinical trials—the third highest number of joint clinical trials with EU countries—and we were playing our part, as we often do, above and beyond. The outcome of the trials has been impressive, and we must ensure that co-operation without capitulation is the key. The UK ranks in the top four EU countries for cardiovascular disease clinical trials, according to the 2017 analysis, with 586 CVD trials registered in the European clinical trials database. In 2016-17, the BHF spent 24% of its research income on clinical research, 31% of this on clinical trials and the rest on epidemiology, genetic studies and so on. The UK supplies 45 million packs of drugs to Europe every month and 37 million packs of drugs come the other way. We need to ensure that this can continue.
Despite its having a number of bilateral trade agreements with the EU, it is estimated that Switzerland gains access to new medicines, on average, 157 days later than the EU27. In Australia and Canada, new medicines come to market, on average, six to 12 months later than in the EU or the USA. This is a very great concern of the BHF that I understand. However, it must also be remembered that as we are at the cutting edge of many of these technological and medicinal advances, we will not necessarily be delayed in our procurement of medicines that could not happen at all without our involvement. We need to ensure that we keep pressing on with our research and sharing information and communication on mutually beneficial projects.
I welcome the Minister’s commitment in her opening speech with regard to data protection for patients—that is sensible and helpful. That was another of our concerns, but she has already answered it, so I thank her. I am absolutely in agreement with the stated aims of the Bill: making it simpler for NHS hospitals to manufacture and trial the most innovative new, personalised and short-life medicines as their usage increases and they are taken up in local clinics and theatre; increasing the range of professions able to prescribe and supply certain medicines, making the most effective use of the NHS workforce where recommended by experts; and developing more innovative ways of dispensing medicines in local pharmacies.
May I ask the Minister a very specific question that I, some of my colleagues and others in Northern Ireland are wondering about? In relation to the protections provided through this Bill, can she advise on what impact the Northern Ireland protocol will have on the medicines being transferred between mainland UK and Northern Ireland? We want to ensure a seamless, transparent, easy system, and it will be important that this is the case. [Interruption.] I am almost at the end, Madam Deputy Speaker—I give you my word that I will keep within the time limit.
It is also essential that we remove unnecessary bureaucracy for the lowest-risk clinical trials to encourage rapid introduction of new medicines while still maintaining safety. That is crucial for the wellbeing of our patients in all of the United Kingdom of Great Britain and Northern Ireland. This is a marvellous opportunity. Our research and development needs to keep us as world-leading innovators, and yet the foundation of all of this must be the safety of the patient—that is paramount. I know that that is the Minister’s intention, and it would certainly be mine. It is my belief that we can achieve this and still share communication and projects with EU countries. I am supportive of this Bill—I want the Minister to know that—and hopeful for our future in this field. We can have safety, security and co-operation without mindless red tape, and I hope that that is exactly what this Bill will do. I welcome it as the Minister prepares to reply.
Jim, you could have carried on a bit longer, couldn’t you? It is an honour to follow the hon. Member for Strangford (Jim Shannon).
When it comes to the regulation of the introduction of new, innovative medicines, treatments and technologies, I am bound to say that cancer will be at the forefront of many of our minds. It is an area that deeply concerns every single one of us, and it could be severely impacted if we do not get the negotiations right. The NHS long-term plan, which is full of very good and wise things, recognised the significant problem that we have in the United Kingdom with our cancer survival rates. Our survival rates, and it has been the case under many Governments of different colours, are among the worst in Europe. We have the second lowest survival rate for lung cancers and below average survival rates for nine of the 10 major cancers. The terrifying statistic for us personally is that one in every two of us is likely to get cancer at some point in our lives. That means we will, all of us, almost certainly be touched by cancer in some way in our families at some point during our lives, if we have not been already.
The need to step up our efforts to fight this horrific disease is amplified by the current context. We have seen a 60% drop in cancer referrals and a 20% fall in the numbers of those starting treatment during the covid crisis—for obvious reasons, and some of them justifiable reasons. Clearly, there are people who are at risk of their immunity being suppressed during the virus or who could gain the infection via surgery during the pandemic, so we understand why clinicians make such decisions.
The week past was Men’s Health Week, and I know the hon. Gentleman is of the same opinion as me about the importance of highlighting prostate cancer. Bowel cancer is another example. Those are two of the cancers that take people out of this world very quickly. I know the Minister will respond very positively, but is it the hon. Gentleman’s understanding that those are two of the cancers that, critically, we need to address early on?
The hon. Gentleman makes a very good point. The two statistics I rattled out—and not for the first time, even today—are the 60% drop in referrals and 20% drop in treatments beginning. The referrals one is broadly down to people not coming forward because they do not want to trouble the NHS. It is massively important to amplify what I know Ministers and clinicians are saying around the country, which is that if people are even the remotest bit concerned, they must come forward and seek advice, because the NHS undoubtedly is open. Some of the cancellations of treatment have been for other reasons, such as not having had full access to kit and, in the early days, NICE advising against it taking place when perhaps it could have done. However, I am pleased that the Government have managed to make significant progress in recent weeks.
The statistics on the reduction in people coming forward for treatment and for referral, and on the reduction in treatments beginning, are, of course, all true, yet the number of people with cancer at this point is the same as it would be in any other year, give or take. That tells us that we are in danger of seeing a serious peak in late diagnoses, and, therefore, sadly, in people tragically not living as long as they would have done otherwise.
In the context of the Bill, removal from the European Medicines Agency would do our people harm. Choosing to go from being part of an organisation that represents 25% of medicine sales on the planet to one making up only 3% will inevitably see us fall down the list of those applying for new drugs and treatments. In that case, the wisest course of action would be to negotiate associate membership of the European Medicines Agency. We must be at the cutting edge of cancer treatment, yet we will hobble ourselves if we reduce access to new treatments and scale back research and development.
Of course, Britain’s membership of the EMA is no guarantee of progress. I am thinking particularly of radiotherapy technology. NHS England has just agreed to roll out the commissioning of stereotactic ablative radiotherapy—SABR technology—and to bring it forward by a year. This comes after an arduous 10-year battle for this precise and powerful treatment to be rolled out to every cancer centre in the country. Although, 100% of radiotherapy centres are equipped to give this treatment, only half of them are currently commissioned to do so. I am very grateful to Ministers and in particular to the one in her place, who intervened to ensure that all centres will now be commissioned. We are very grateful.
The reason given time and again by NHS England for wasting this resource was that it did not have enough data. This is relevant, because this was a treatment being used effectively across Europe with significantly improved outcomes. If this is the case when the data is there, I dread to think what the impact will be of having reduced access to data on medicines and medical devices when we are outside the EMA.
If effective and co-ordinated implementation does not follow regulation, regulation becomes utterly meaningless. Many colleagues have rightly raised concerns about maintaining access to the best possible treatment for those in the UK, but we also need to recognise that countless people are not able to access the treatment that they need and that has been approved even now. The idea that this could be further curtailed and cost further lives is deeply troubling. Indeed, it would be an outrageous injustice. The process between the approval of a medicine or medical device and its use to treat illness and save lives is hugely important, as the experience of the development of radiotherapy in this country proves.
A lack of co-ordination, damaging bureaucracy and the absence of consistent investment have left us lagging behind Europe in a treatment for which, ironically, we lead the field in innovation. Our machines should be replaced every 10 years, but a survey undertaken by Action Radiotherapy revealed that there are machines up to 17 years old. Replacing them would work out at about £400 per patient—the same as a single night’s stay in hospital. This is a highly curative cancer treatment, so I call for swift action to ensure that we stop lagging behind. A ring-fenced central funding pot to replace machines more than 10 years old would secure fast and uninterrupted patient treatment, solve the £140 million backlog in machine replacement costs, and secure the treatment’s future.
Recognising the gap between approval and access also means recognising that access to treatment can mean physical access. People in Westmorland face a three-hour round trip for radiotherapy, and many of the elderly and extremely ill choose not to make the trip at all—they choose shorter lives because they cannot face the longer journeys. It is essential that we invest the £250 million for new network treatment delivery centres to bring treatment closer to home and avoid long travel for the 3.5 million people who live farther away than the recommended 45-minute maximum travel time. For us, that would mean a long-overdue radiotherapy centre at Westmorland General Hospital in Kendal.
Access to innovative treatment is essential, and it must be in no way be diminished at the end of the transition period. However, that is only half the picture: access and approval must be followed by a co-ordinated and effective roll-out to patients. We cannot tolerate red tape leading to life-saving innovation being left unused in hospitals, just as we cannot risk having reduced access to those innovations in the first place.
If we claim to value the lives of the British public, we owe it to them to get this right and ensure they have easy access to the best and most effective treatment. That means ensuring a close deal with our neighbours and tackling our home-grown bureaucracy, which is more than capable of stifling innovation and costing lives.
I am most grateful to hon. Friends and hon. Members for their contributions. This is not a stop-gap Bill to get us through the transition; it is a proportionate approach to regulating an industry that moves quickly, with regulators that want to take effective action but are renowned for working with the industry in the best interests of patients. It is about setting a new direction and making clear what the UK wants after the end of the transition period.
Let me turn to the points that hon. Members made. I reiterate to the hon. Member for Nottingham North the commitment to consult when the Cumberlege report is published. We are keen to take account of its recommendations and ensure we are taking the necessary steps to protect patients, as patient safety is paramount in the future of medicines and medical devices regulation. We have of course had routine engagement with the review team, as would be expected, to ensure it is adequately supported and resourced to conduct its review.
I believe that the situation for pharmacies is quite the contrary to what the shadow Minister outlined. For hub-and-spoke dispensing, we intend to give smaller community pharmacies the same opportunity that large pharmacy businesses already enjoy. We will support them, and remove the legal barrier that allows such an arrangement only when the spoke pharmacy and the central dispensing hub are part of the same retail pharmacy business. That would level the playing field for smaller community pharmacies, rather than put them under threat. As I outlined in Committee, particularly during covid, all 11,600 of our community pharmacies have gone above and beyond. They have kept their doors open and have been there every single day for our constituents. I thank them once again. We have committed ourselves to consulting before making regulations, and that applies to any changes to rules on pharmacy registration. It means that no changes can be made without first undertaking proper consultation.
I understand the passion of the hon. Member for St Helens South and Whiston (Ms Rimmer) on the subject she raised. As the hon. Member for Strangford (Jim Shannon) observed, we are talking about a thoroughly abhorrent process. As I indicated, the Foreign and Commonwealth Office regularly raises concerns with China, including on the extensive use of the death penalty, and on the treatment of religious and ethnic minorities, which sit at the heart of this. I look forward to having a conversation with her after she has had that meeting, in order to understand what was discussed and to continue the conversation further.
I thank the hon. Member for Strangford for his kind words and for highlighting the fact that we have a unique ecosystem here; we have brilliant academics, such as those he mentioned from Queen’s and others from right across the UK. We have a world-leading life science industry, employing some 240,000 people, and they are working to bring the best products to patients. We want to ensure that in and around clinical trials we have a regulatory system that maintains and enhances the UK as a site for global co-operation in research and allows us flexibility to achieve what is best for patients.
On clinical trials, the Government value the strong, collaborative partnerships we have across Europe in the areas of science, research and innovation, and we want to continue to support those opportunities. We are committed to ensuring that the UK maintains its position as a global science superpower and continues to collaborate with Europe on scientific research. The Prime Minister has made it clear that the UK sits ready to consider a relationship in line with non-EU member states’ participation in Horizon Europe, provided that that represents value for money and is in the UK’s interest.
The Bill, as drafted, does not breach the Northern Ireland protocol and the powers in the Bill are capable of being exercised compatibly with the protocol. We will ensure that that is the case. We are clear that the protocol provides that where a GB authority currently approves goods for sale, it will continue to be able to do so, in order to have that free-flowing movement.
To the hon. Member for Westmorland and Lonsdale (Tim Farron), who never misses an opportunity to remind me that he would like more services close to his constituents, I say: I hear you, again. Following health questions this morning, I can say that I know we share that commitment to drive patient access to radiotherapy and treatments together. Many hon. Members know that that is dear to my heart, as I have had cancer on more than one occasion. I came here to try to get more cancer nurse specialists and to make sure that on their journey those who have metastatic cancer, which is rarely spoken about in this place, are treated as people who still have full lives to live. Living with and beyond cancer is something we should embrace. The next round of negotiations with the EU will start shortly and we will continue to explore with the EU what future relationship arrangements can look like.
In conclusion, I would like to thank everyone for their efforts in getting us to this point.
I was not in the Chamber earlier, but just before the Minister comes to a conclusion, I wish to thank her for her comments about the engagement she has had with my hon. Friend the Member for Central Ayrshire (Dr Whitford), who has not been able to participate in person in the process of this Bill. I know, however, that my hon. Friend has been grateful for the engagement on a cross-party basis, for the comments the Minister made about the amendments tabled by the Scottish National party in Committee, for the commitments the Government made in response to them, and for their engagement with the Scottish Government. I just want to place on the record our thanks for all that, and my sympathy with the amendment tabled by the hon. Member for St Helens South and Whiston (Ms Rimmer). A number of my constituents, like those of several other Members, have raised concerns about these issues of forced organ harvesting, and I hope some of that can be considered as well.
I thank the hon. Gentleman for his contribution. These are unusual times, so it was my pleasure to work with the hon. Member for Central Ayrshire (Dr Whitford) to do what we could to ensure that the Bill proceeded with a degree of consensus, as it was to work with her on access to off-licence drugs some years ago.
Our consideration of the Bill has been led by good sense and common ground, and by general understanding and consensus about its purpose. I am grateful to everyone who contributed along the way. I think the themes we heard today and in Committee—the paramount importance of patients; the need to ensure that we carefully consider and scrutinise legislation and that it is made after consultation; and the use of data to underpin better regulation and improve safety—were the right ones for us to consider. Although it is not necessarily part of regulatory scrutiny, I am grateful to the hon. Member for St Helens South and Whiston for raising the important issue of the UK’s continued promotion of human rights and ethics.
I am grateful to the Clerks for their help; these are unusual circumstances, but I have felt no less supported, and, working towards ensuring that we can make progress in the other place, we will continue to use imagination. The Bill is a framework for where we want to go. It will allow us to ensure that the regulation that governs critical areas that matter for us all and are likely to affect us all indirectly is up to date and supports the thriving life sciences sector and patients. To that end, I commend the Bill to the House.
Question put and agreed to.
New clause 1 accordingly read a Second time, and added to the Bill.
Fees, information, offences
Amendment made: 1, page 8, line 35, leave out “efficacy” and insert
“performance, including the clinical effectiveness,”.—(Jo Churchill.)
This amendment clarifies the matters relating to medical devices the recording of information about which may be the subject of provision in regulations under Clause 12(1).
Offence relating to information
Amendments made: 2, page 18, line 36, at end insert—
“(2) A person to whom information is disclosed under regulations under section (Information systems) commits an offence if the person uses or discloses that information in contravention of those regulations.”
This amendment and Amendment 3 provide that a person who discloses information in breach of regulations made under the new clause inserted by NC1 commits a criminal offence.
Amendment 3, page 18, line 37, after “subsection (1)” insert “or (2)”.—(Jo Churchill.)
See the explanatory statement for Amendment 2.
Power to make consequential etc provision
Amendment made: 4, page 21, line 41, leave out “and 12(1)” and insert
“, 12(1) and (Information systems)(1)”.—(Jo Churchill.)
This amendment enables regulations made under the new clause inserted by NC1 to make consequential and other provision.
Amendments made: 5, page 22, line 11, leave out
“sections 1(1), 8(1) or 12(1), or paragraph 9 of Schedule 1”
“a provision of Part 1, 2 or 3”.
This amendment and Amendment 6 have the effect that the Secretary of State is required to consult before making regulations under the new clause inserted by NC1.
Amendment 6, page 22, line 29, after “section 12(1)” insert
“or (Information systems)(1),”.—(Jo Churchill.)
See the explanatory statement for Amendment 5.
Amendments made: 7, page 22, line 32, leave out
“section 1(1), 8(1) or 12(1), or paragraph 9 of Schedule 1,”
“a provision of Part 1, 2 or 3”.
This amendment has the effect that regulations made under the new clause inserted by NC1 are to be made by statutory instrument.
Amendment 8, page 22, line 42, leave out
“section 1(1), 8(1) or 12(1)”
“a provision of Part 1, 2 or 3”.
This amendment and Amendments 9 to 17 enable regulations under powers in the Bill which are subject to negative procedure to be combined in a single statutory instrument with regulations under powers which are subject to affirmative procedure, or with regulations under powers in other legislation which are subject to negative procedure.
Amendment 9, page 23, line 12, leave out
“to which subsection (9) applies”.
See the explanatory statement for Amendment 8.
Amendment 10, page 23, line 13, at end insert
“if the only regulations under a provision of Part 1, 2 or 3 that it contains are regulations to which subsection (9) applies”.
See the explanatory statement for Amendment 8.
Amendment 11, page 23, line 14, leave out
“to which subsection (9) applies”.
See the explanatory statement for Amendment 8.
Amendment 12, page 23, line 16, at end insert
“if the only regulations under section 1(1) or 8(1) that they contain are regulations to which subsection (9) applies”.
See the explanatory statement for Amendment 8.
Amendment 13, page 23, line 18, leave out
“to which subsection (9) applies”.
See the explanatory statement for Amendment 8.
Amendment 14, page 23, line 23, at end insert—
“, if the only regulations under a provision of Part 1, 2 or 3 that it contains are regulations to which subsection (9) applies”.
See the explanatory statement for Amendment 8.
Amendment 15, page 23, line 24, after “to” insert
See the explanatory statement for Amendment 8.
Amendment 16, page 23, line 36, at end insert
(b) regulations under paragraph 9 of Schedule 1”.
See the explanatory statement for Amendment 8.
Amendment 17, page 23, line 37, leave out subsection (10).—(Jo Churchill.)
See the explanatory statement for Amendment 8.
Amendment made: 18, page 24, line 15, at end insert
(d) section (Information systems)”.—(Jo Churchill.)
This amendment provides for the new clause inserted by NC1 to come into force two months after the Bill is passed.
Bill read the Third time and passed.