Report stage, 3rd reading in the Commons
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The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)Conservative- Quote
- I beg to move, That the clause be read a Second time.
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- 15:41
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Mr Deputy Speaker (Mr Nigel Evans)Conservative- Quote
- 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.
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- Jo ChurchillConservative
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- 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.
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Alex Norris (Nottingham North) (Lab/Co-op)Labour- Quote
- 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.
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- Jo ChurchillConservative
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- 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.
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- Alex NorrisLabour
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- 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.
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Ms Marie Rimmer (St Helens South and Whiston) (Lab)Labour- Quote
- 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.
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Jim Shannon (Strangford) (DUP)Democratic Unionist Party- Quote
- 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.
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Madam Deputy Speaker (Dame Rosie Winterton)Labour- Quote
- I call Tim Farron. [Interruption.]
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Tim Farron (Westmorland and Lonsdale) (LD)Liberal Democrat- Quote
- 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.
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- Jim ShannonDemocratic Unionist Party
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- 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?
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- Tim FarronLiberal Democrat
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- 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.
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- Jo ChurchillConservative
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- 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.
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Patrick Grady (Glasgow North) (SNP)Scottish National Party- Quote
- 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.
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- Jo ChurchillConservative
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- 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. Clause 14 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). Clause 35 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. Clause 38 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. Clause 40 Consultation Amendments made: 5, page 22, line 11, leave out “sections 1(1), 8(1) or 12(1), or paragraph 9 of Schedule 1” and insert “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. Clause 41 Procedure Amendments made: 7, page 22, line 32, leave out “section 1(1), 8(1) or 12(1), or paragraph 9 of Schedule 1,” and insert “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)” and insert “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 “— (a) ”. See the explanatory statement for Amendment 8. Amendment 16, page 23, line 36, at end insert “, and (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. Clause 43 Commencement Amendment made: 18, page 24, line 15, at end insert “, and (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.
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- Madam Deputy Speaker (Dame Rosie Winterton)Labour
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- I will now suspend the House for three minutes.
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