The Secretary of State for Health and Social Care (Matt Hancock)

- Hansard -

Copy Link

- - Excerpts

I beg to move, That the Bill be now read a Second time.

While the world grapples with the challenge of coronavirus, it is vital that we do not lose sight of the important long-term reforms that we must make. Medicines and medical devices are evolving faster than ever. Not long ago, we could only record an ECG with hospital-grade equipment; now we can do it at home with a cheap device linked to our phone. Already, artificial intelligence is being used to discover new drug compounds. Now that we have left the European Union, we need a regulatory system that is nimble enough to keep up with those developments while maintaining and enhancing patient safety. That is what this Bill will achieve.

The aims of the Bill are fourfold. First, it gives us the means to depart from EU rules and regulations in future, moving at a faster pace, if that is what we choose to do as an independent, self-governing nation. Secondly, it ensures that we can easily amend regulation through secondary legislation without having to bring a new Bill before the House every time we need to revise the rules. That means our system of regulation will be flexible and responsive, quick to adapt to innovation and quick to respond when a safety issue emerges. Thirdly, the Bill will strengthen patient safety by strengthening the Medicines and Healthcare Products Regulatory Agency, our world-class medicines and medical devices regulator. That includes giving it powers that were not available under the EU, including over registration of devices and disclosure. Fourthly, the Bill will ensure that we strike the right balance between capturing the benefits of innovation without compromising patient safety.

Matt Hancock

- Hansard -

Copy Link

- - Excerpts

We do not have a figure for medicines and medical devices specifically. As a nation, we have a goal that we should reach 2.4% of GDP spent on research. We are increasing the medical research budget; for instance, we are doubling the budget for research into dementia. As my right hon. Friend rightly points out, the public budget for research is only one part of it. There is huge private sector and charitable sector investment —for instance, from the Wellcome Trust. The Bill will allow research money—whether it comes from the public sector, private sector or third sector—to go further and get medicines and medical devices to NHS patients faster, as well as supporting our life sciences sector.

Matt Hancock

- Hansard -

Copy Link

- - Excerpts

It is almost as though the hon. Gentleman has read my speech. That is the broad intent of that part of the Bill. I will come to it in more detail in a moment, and I am glad about the constructive tone that has been adopted across the House when discussing the Bill.

As I said, the fourth purpose of the Bill is to get innovation while not compromising patient safety—indeed, I would argue that we will enhance patient safety by being able to use modern techniques. It will do that by requiring the Secretary of State to have regard to the safety of medicines and medical devices; to the availability of medicines and devices, because sometimes getting availability as fast as possible is crucial for both innovation and patient safety; and to the attractiveness of the UK as a place to conduct clinical trials and bring medicines and medical devices to market. I will come on to clinical trials in more detail.

Let me turn to the main parts of the Bill. The first part, covering clauses 1 to 7, gives us the ability to update the law relating to human medicines—for example, to reflect changes in manufacturing methods or new types of product. We need that ability because coming down the track are cutting-edge personalised medicines that a hospital might literally have to assemble at the patient’s bedside. Those include gene therapies, medical gases and 3D-printed tablets—bespoke treatments so tailored to the individual that they will only be produced once, with a shelf life that might be measured in minutes. It is just not appropriate to regulate those kinds of treatment in the same way as a mass-produced factory drug, with mandatory batch numbers and packaging information. The Bill gives us the flexibility to respond to those developments. It also allows us to make changes to the regulation of clinical trials, ensuring that we are a globally attractive market to test new drugs and treatments.

But the Bill is not just about the latest science and innovation. It also means that we can update the rules on things such as labelling requirements—for instance, whether the leaflet in a pill packet should have a digital equivalent; rules on how online pharmacies ensure that medicines reach their intended customer; and rules on how the medicine brokerage market works.

We have said that we want to do more to boost the role of our brilliant community pharmacists, and the Bill helps us to do exactly that. It will allow us to remove the barriers to hub-and-spoke dispensing once EU rules no longer apply. Large companies such as Boots already do that, but the law as it stands prevents small, independent pharmacies from joining this kind of arrangement if the hub is not part of the same retail business as the spokes. That is an unnecessary barrier for smaller businesses in the pharmacy sector, and the Bill means that we can remove those barriers.

It also allows us to continue to add to the range of healthcare professionals who can prescribe medicines, which will relieve pressure on the frontline NHS, and it gives us the ability to make rapid changes to regulations to ensure the availability of and access to medicines in an emergency; I am sure we can all understand right now why that is important. Nothing in the Bill changes all the regulations immediately. Instead, it is about getting ahead of the game and giving us the power to make these changes as and when we need to, suitably scrutinised by Parliament.

The next part of the Bill concerns veterinary medicines. It broadly replicates the first part, giving us the ability to amend or supplement the Veterinary Medicines Regulations 2013. Changes could include, for instance, how veterinary medicines are supplied and the information that must be supplied with them. It sets out that, in making new regulations, we have an obligation to consider the safety of the medicines in relation to animals, humans and the environment. These are important matters, not least for me as the Newmarket MP. The Bill will ensure that we have a veterinary medicine system that is fit for purpose.

The third part of the Bill deals with the medical devices regulatory framework, covering everything from MRI scanners to embolisation coils and pacemakers to prophylactics. Like the first part, it allows us to fast-track a new diagnostic test in response to an emerging disease.

Matt Hancock

- Hansard -

Copy Link

- - Excerpts

Yes, that is right. This Bill empowers us to be able to move faster. Essentially, it empowers the UK to build a life sciences regulatory framework that is the best in the world—of course, working with EU partners, but also with partners from right around the world—and all with the intention of getting the most innovative products, as quickly as possible and as cost-effectively as possible, into the NHS. That is the goal of the entire Bill. It is a benefit of Brexit, but it is also worth doing in its own right.

The measures to strengthen innovation with respect to diagnostic tests again strengthen patient safety, because they strengthen the role of the Medicines and Healthcare Products Regulatory Agency. This includes, for instance, allowing us to legislate to create a comprehensive statutory register of medical devices in the UK. Such a register could be held by the MHRA, and we would make it compulsory to register a device along with information such as who manufactures and supplies it. This would mean that the MHRA could conduct post-market surveillance of devices in the UK, making it easier to trigger device recalls where a safety concern arises.

Indeed, we will enhance patient safety by giving the MHRA a new power to disclose to members of the public any safety concerns about a device. This was not possible while we were part of the EU. Previously, if an NHS trust raised a concern about a device and asked if similar reports had been received elsewhere, too often the MHRA was restricted in sharing that information; nor could it always routinely share information with the Care Quality Commission or other NHS national bodies. This Bill gives us the ability to share vital information about reporting patterns with the NHS family, and where necessary with the public, with enforcement powers that will be proportionate, transparent and suitably safeguarded.

Matt Hancock

- Hansard -

Copy Link

- - Excerpts

In some cases it was possible to share that information but not in all cases, and it will be possible now. I have no doubt that the hon. Member, like others on the frontline, will have received some information, but the MHRA is currently limited in the information that it can share with other NHS bodies. We are removing the limits on that information sharing, which of course needs to be done appropriately, but should not be set in primary legislation.

Our goal is this: we want the UK to be the best place in the world to design and trial the latest medical innovations. This Bill gives us the powers we need to make that happen. It will mean that the NHS has access to the most cutting-edge medicines and medical devices, with enhanced patient safety; it will help our life sciences seize the enormous opportunities of the 2020s, supported by a world-leading regulator; and it will help us pave our way as a self-governing independent nation. I commend the Bill to the House.

Matt Hancock

- Hansard -

Copy Link

- - Excerpts

I am sure that this debate will continue in Committee, but for clarity, those delegated powers existed under the European Communities Act 1972. The Bill proposes to replace existing delegated powers from the 1972 Act with new powers to make such regulations under the new Act. This is not a new set of delegated powers; it replaces one set with another—indeed, the Bill replaces those powers with clearer safeguards on those matters to which the Secretary of State must have regard.

The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)

- Hansard -

Copy Link

- - Excerpts

First, let me thank all hon. Members for their support in discussing this enabling legislation. It is a pleasure to close this debate on the Medicines and Medical Devices Bill. The Bill is both a piece of legislation to future-proof our regulatory regime going forward and an opportunity to clarify and improve the one that we have now.

I am gratified that hon. Members have approached this debate with thoughtful consideration. Obviously, there is a lot more to discuss in Committee, because several themes came up during the course of this afternoon’s debate on which I can only touch now. I will take up the request of my hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson) and write to her. I have not had the chance thus far to have a specific briefing with the hon. Member for Central Ayrshire (Dr Whitford), so perhaps we could do so to enable us all to understand our direction of travel.

Patient safety is not a partisan issue; it is paramount. It is what drives us to do what we do. It does not matter which side of the House we sit on, the patient is at the centre of our concern. We hope that, in going forward, we can enhance and strengthen that view and show ourselves as an exemplar to the world in the way that we conduct trials and in the way that the life science and pharmaceutical industries work. We hope to assist the whole industry in making sure that we never compromise on patient safety.

This will be the first opportunity in 40 years for the UK to make choices regarding how we regulate medicines, veterinary medicines and medical devices in the best interests of the UK now that we have left the EU. This is all part of our making sure that we transition smoothly on 1 January next year. Members from all parts of the House feel passionately about the outcome of negotiations on the future relationship. I would like to assure hon. Members that the Bill allows us, in the future, to set rules that are best for the UK, whatever the outcome of those negotiations. The Bill is important, as it makes clear the Government’s commitment to the life science sector, which is worth over £75 billion to our economy and which contributes almost 250,000 jobs to the UK. We are rightly proud of that sector, but innovations and advancement must be matched by rigorous standards to protect patients. I very much take on board the comments of the hon. Member for Twickenham (Munira Wilson), which were particularly pertinent to the experience that she brings to this House. I hope to enjoy more of that debate when we are in Committee.

The Bill sets out clear principles: ensuring patient safety; ensuring their continued access to medicines and devices; and maintaining the attractiveness of the UK as a market and a place for clinical trials. There is a delicate balance there that we must continue to strike, and the debate today demonstrates the paramount importance of all those principles. On that point, I will move on to the comments of hon. Members.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

As the right hon. Gentleman knows, I am always happy to have a discussion to see whether any accommodation can be made. As far as veterinary medicines go, I should say that, unlike with human medicines, we pay attention to the environmental impact as they go through.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

I am happy to give my hon. Friend the assurance that there will be that continuity. That is precisely the aim of the Bill.

The shadow Secretary of State asked me to comment on reports that he had read in the papers today about health security. The UK is open to exploring co-operation between the EU and other specific narrowly defined areas when it is in the interests of both sides—and on matters of health security, it would be foolish not to.

Several Members discussed clinical trials, with a particular eye to the rare diseases cohort, which is obviously, by its nature, small. It is only sensible to ensure that we have the ability to collaborate across Europe to determine that we have the best environment for the development of drugs. I would caution people to breathe before we go forward. We are committed to ensuring that we remain the best place for those on rare disease trials.

The Medicines and Healthcare Products Regulatory Agency has taken steps to ensure that there is absolutely no disruption to clinical trials and that they can continue seamlessly. It is important that we are tempered in tone to ensure that people’s clinical trials carry on. We want a world-leading regulatory system for clinical trials that allows us to collaborate effectively—not only across Europe, but globally. We have one of the best life sciences industries in the world, for which effective collaboration is important.

Now that we have left the European Union, it is important to make it clear that UK sponsors will still be able to run multi-state trials across the world. We want a regulatory system that maintains and enhances the attractiveness of the UK as a site for global co-operation in research.

I move on. We will extend prescribing rights to physician associates through other means. We are discussing the extension of physician associates’ rights for prescribing in the context of the increase in clinical professionals who will be working in the health service. The broader ability of the Bill to ensure prescribing rights will be carried through only in collaboration with the appropriate regulatory oversight, whether from the General Medical Council or the Health & Care Professions Council, depending on whether allied health professionals or physician associates are involved.

The hon. Member for St Helens South and Whiston (Ms Rimmer) asked whether clinical trials data would include those forced to participate. I assure her that clinical data used to support regulatory activity in the UK needs to comply with international good clinical practice standards, including ethical considerations such as the critical principle of informed consent. That means that the appalling cases to which she alluded could not be involved in clinical trials.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

I thank the hon. Member for that intervention.

Let me point out to the shadow Secretary of State that it is possible that the use of artificial intelligence—to determine what treatment to give a patient, for example—would fall within the scope of the regulation-making powers in the future. It is right that we have the tools to respond to this kind of technology in the years ahead. I was most interested by the comments of my hon. Friend the Member for Bolton West (Chris Green) about better patient outcomes. I could not agree with him more about the importance of the life sciences sector, and about using data to inform as we go forward. The MHRA will be able to conduct inspections for manufacturing, distributions, clinical trials, laboratories and pharmacovigilance, and it is important that that continues to ensure that we uphold standards.

There were numerous other comments, particularly about the medicines and medical devices lists and register. I look forward to ensuring that we have a robust debate in Committee about what is best for the patient and the clinician. My hon. Friend the Member for Bosworth (Dr Evans) made an important point about clinicians perhaps annotating patients’ notes with information about why they used a particular medicine or device.

We have spoken about medical devices perhaps being manufactured at a patient’s bedside. The shadow Minister mentioned having a barcode on each device. It would be quite hard to barcode a device when it was manufactured in order to put it on to a register. I hope that having this discussion in later stages will inform us all how best to do this.

I hope that the spirit of this debate—one in which we are all in support of a common purpose—carries through to the examination of the Bill. This legislation offers an opportunity for the UK to protect patients, support the development of an exciting and important sector, and do what is best in the UK for the UK’s interests. I commend this Bill to the House.

Question put and agreed to.

Bill accordingly read a Second time.

Medicines and Medical Devices Bill (Programme)

Motion made, and Question put forthwith (Standing Order No. 83A(7)),

That the following provisions shall apply to the Medicines and Medical Devices Bill:

Committal

(1) The Bill shall be committed to a Public Bill Committee.

Proceedings in Public Bill Committee

(2) Proceedings in the Public Bill Committee shall (so far as not previously concluded) be brought to a conclusion on Thursday 23 April 2020.

(3) The Public Bill Committee shall have leave to sit twice on the first day on which it meets.

Proceedings on Consideration and up to and including Third Reading

(4) Proceedings on Consideration and any proceedings in legislative grand committee shall (so far as not previously concluded) be brought to a conclusion one hour before the moment of interruption on the day on which proceedings on Consideration are commenced.

(5) Proceedings on Third Reading shall (so far as not previously concluded) be brought to a conclusion at the moment of interruption on that day.

(6) Standing Order No. 83B (Programming committees) shall not apply to proceedings on Consideration and up to and including Third Reading.

Other proceedings

(7) Any other proceedings on the Bill may be programmed.—(James Morris.)

Question agreed to.

Medicines and Medical Devices Bill (Money)

Queen’s recommendation signified.

Motion made, and Question put forthwith (Standing Order No. 52(1)(a)),

That, for the purposes of any Act resulting from the Medicines and Medical Devices Bill, it is expedient to authorise the payment out of money provided by Parliament of:

(1) any expenditure incurred by a Minister of the Crown, a government department, a person holding office under Her Majesty or any other public authority by virtue of the Act; and

(2) any increase attributable to the Act in the sums payable by virtue of any other Act out of money so provided.—(James Morris.)

Question agreed to.

Medicines and Medical Devices Bill (Ways and Means)

Motion made, and Question put forthwith (Standing Order No. 52(1)(a)),

That, for the purposes of any Act resulting from the Medicines and Medical Devices Bill, it is expedient to authorise the charging of fees, or other charges, arising by virtue of the Act.—(James Morris.)

The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)

- Hansard -

Copy Link

- - Excerpts

It is a pleasure to serve under you, Mr Davies. I agree with the hon. Member for Nottingham North that we have worked on the Bill in a spirit of co-operation, and I would very much like that to continue, because sitting at its heart is the patient, and patient safety is what we are after here. I will come on to the two specific points, but I shall address now the sunset element and why, in our opinion, that is not the way to proceed, because of its time-limited nature.

As the hon. Gentleman said, the Bill is necessary because at the end of the transition period, we will lose the ability to update. I am grateful for his words saying that both he and the shadow Secretary of State for Health and Social Care understand what we are trying to do. We need to be able to amend the legislation that governs human medicines and medical devices and veterinary meds. This measure will enable us to update the regulations in the light of patient needs and in the light of changes and innovation. I am sure that the hon. Member for Nottingham North would agree that one challenge is the dynamic nature of how medical devices in particular, but also medicines, are changing—at the bedside, but also right across healthcare. Patients and their best interests are at the heart of the Bill, and that is where I want to start.

On amendment 9, what the hon. Gentleman says is important, but the explanatory statement, while giving clarity, still leaves us with the challenge of an overarching sunset clause for the Bill, such that two years after Royal Assent, the primary legislative framework would fall away and Parliament would have to re-legislate for the provisions in the Bill once again. I understand that the hon. Gentleman’s intention is to ensure that Parliament reconsiders, and those checks and balances are important —it is important that we think about the legislation that we are passing. One would hope that at that time, Parliament will be sitting under normal circumstances, but, to be frank, we are not sure. That said, I would like to set out specifically why this proposal would be unhelpful and cause a potential risk to patient safety.

The Bill, in the main, does not deliver any immediate change to the regulation of medicines and medical devices. It provides a framework of powers to ensure that regulatory change can be made as and when necessary. It does, as I hope all hon. Members will recognise when we reach the relevant clauses, increase the level of parliamentary scrutiny, and it is that that enables us to look before something goes forward. There is going to be more scrutiny, under the affirmative procedure, for us to look and understand what it is we are legislating for than we have had thus far. Use of the affirmative resolution is made near universal, other than in the event of an emergency and for very minor changes.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

This will be done in consultation with pharmacists, in a discursive way. As the hon. Gentleman has articulated, we have found ourselves in unusual times. Ensuring that we seize the advantage, in a way that is clear, transparent and consultative, is the aim of what we are trying to set out.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

First, patient safety is paramount. That is where I began my journey into Parliament. In my case, it was access to cancer drugs—something close to my heart. With regard to Orkambi, I understand and share the frustration felt by everyone. My heart goes out to those affected, who are very often parents. The cystic fibrosis campaign has, I think, a 98% sign up of all parents who have had children with cystic fibrosis. On their fight for Orkambi, I am sure everybody feels sympathy for them, because it took so long to provide access.

Drug companies have a responsibility here. This refers slightly to the comments the hon. Member for Nottingham North made about life science sectors or pharmaceutical companies all being large. The drug companies have a responsibility to price their drugs responsibly in a way that reflects the benefits that they bring to patients. I feel that the arrangements that we have in place in the National Institute for Health and Care Excellence and the cancer drugs fund have helped people to get access to medicines rapidly. There is still work to do, but they need to be marketised at a fair price. We made a commitment in our manifesto to establish an innovative medicines fund to address slightly some of the points that he made.

Amendments 22 to 27 relate to the three considerations the appropriate authority must have regard to when making regulations in relation to medicines for human and veterinary use and medical devices. The effect of the amendment would be to remove the requirement to have due regard to the attractiveness of the UK as a place to market and develop these products, and to assert the primacy of patient safety above all other considerations.

The safety of patients and the environment, people and animals—when moving into the area of veterinary medicine—absolutely underpins the regulatory decisions that are made. It is absolutely the case that we would never seek to make a regulatory change that puts somebody’s health at risk; that would be counter-intuitive. However, I do not think that patient safety or safety in general is in conflict with the other considerations that these amendments are intended to affect.

The purpose of the regulation is to ensure that we do what is in the best interests of UK patients, or the veterinary sector when it comes to animals, so that they receive the best possible treatment without undue impact on the environment. It is likely that having a dynamic and innovative market, where treatments or technologies are developed in the UK, contributes to the overall benefit of the patient, as those treatments will become available to them. These are not binary principles where regulation works only in the interests of one or the other.

The hon. Member for Nottingham North mentioned Nottingham—I also shout out to Cambridge, which is just down the road, and London, which the hon. Member for Bethnal Green and Bow mentioned. This country’s life sciences sector is envied. The Government have committed to supporting it through the life science industrial strategy, in which we have sought to address the challenges faced by the industry and provide an environment that encourages companies to start and grow. All large companies start somewhere, and the hon. Member for Nottingham North knows that in the incubators around Nottingham, Cambridge and even my constituency of Bury St Edmunds, lots of small firms are working on the most incredible things to help patients.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

I thank the hon. Lady for her intervention. The reason why the safety of human medicines is listed first is because safety is the paramount objective in everything.

In the life sciences industrial strategy, we have sought to address the challenges faced by the industry, provide an environment that helps companies to grow, and support collaboration between the NHS and industry better to adopt innovative treatments and technologies. Life science is one of the most productive and strategically important parts of the UK economy—it is worth more than £74 billion per annum—and we wish to cement our position as a world leader in that field to allow patients to benefit from cutting-edge treatments as soon as possible. The Bill is a key part of that, and it also keeps safety right at the top of the agenda. It is therefore right that, when we make regulations, the appropriate authority considers their impact and looks at whether they would constrain companies from seeking to bring new and innovative medicines or medical devices to market.

The concern of the hon. Member for Nottingham North is that the consideration of the UK’s attractiveness, if applied, would mean a reduction in regulation on the sector, such that safety concerns would arise. That is simply not the case. I appreciate that he would like clarity on how the attractiveness consideration would work in practice, and the hon. Member for Central Ayrshire quizzed me about that too. The consideration would not mean reduced regulatory barriers to manufacturing, for example, as that would be to the detriment of patient safety. No! We have not sought to define attractiveness in the Bill, because the definition is as it is in ordinary language. There is no hidden or nefarious intent here. We want the UK to remain at the cutting edge of medical advancement, and that is done by recognising that the pharmaceutical industry benefits patients by making innovative therapies available through clinical trials and bringing them to market, or, indeed, collaborating in the event that expedited access to treatments is necessary.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

I thank the hon. Member for St Helens South and Whiston for raising this issue and the pack that she so diligently sent to us all over the weekend, which I read with great interest. I know she holds this issue dear to her heart and she is passionate about it. I fully understand the intention behind the amendment. It is absolutely right that medicines that enter the UK supply must not have been manufactured or developed to using organs or human tissues that do not come from authorised sources.

I can assure the hon. Lady that safeguards are in place to provide surety on these issues. The requirements around the donation, procurement, testing, processing, storage and distribution of organs, tissues and cells intended for human application are set out in the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Human Tissue Act 2004, which are separate from measures on medicines manufacture.

Medicines legislation already ensures that human tissues and cells used in the manufacture of medicinal products must meet those requirements. Safeguards are in place in those Acts to ensure that the appropriate quality, safety and origin of human tissue is known—for example, consent and traceability requirements apply to any human tissue or cell component imported into the United Kingdom and used as a material in the manufacture of a medicinal product. Importantly, a researcher is not able to conduct research on human tissue in the UK if they cannot provide evidence that it has been obtained ethically and in accordance with legal requirements. The Government will ensure that, under the new deemed consent arrangements for organ donations, donations of cells for advanced therapy and medicinal products cannot happen without expressed consent.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

I understand the hon. Member’s passion for this area. As she said, she has tried to find every nook and cranny. I gently repeat that the Bill is not the right place for amendment 1, but I commit to writing to my Foreign and Commonwealth Office counterpart on this point and to exploring it further, if that would be of assistance to her. However, I say again that the Bill is not the vehicle for the amendment and I ask her to withdraw it.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

As I said, I am willing to write to the Minister for Asia and the Pacific to explore this matter further, but I am afraid at this point that is all I can commit to.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

Yes, of course, I will be happy to inform the Committee when I write to the Minister for Asia and the Pacific, if hon. Members would find that helpful. We heard from the hon. Member for St Helens South and Whiston, and I am sure we all read the pack she sent at the weekend about the trade in human organs, which is truly heinous.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

The clause allows for changes to be made to the law relating to the manufacturing, marketing and supply of human medicines. It provides an exhaustive list of matters on which amendments can be made by regulation, giving clarity and limits on what may be done by secondary legislation. I will take each subsection in turn as these are important areas for the Committee’s consideration.

Subsection (1)(a) provides that changes may be made to update regulations in relation to manufacturing to reflect advances and innovation in the way in which medicines are prepared. That will enable us to take a revised approach to regulation, ensuring that regulations do not become barriers to patient access and to medicines manufactured in new ways while maintaining high regulatory standards to protect patient safety.

Subsection (1)(b) allows for changes to be made to the law governing the import of human medicines. It will support the continued ability to ensure that imported medicines are safe. We also want to be able to ensure that no unnecessary additional burden is placed on companies so that the UK remains an attractive place to supply medicines while protecting patients.

Subsection (1)(c) allows for changes to be made to the law governing the distribution of medicinal products by way of wholesale dealing. A wholesale dealing authorisation is required to supply or sell human medicines to anyone other than the patient using the medicine. In the light of any emerging safety concerns or innovative new techniques or technologies, changes may be required to maintain the quality of, and ensure proper distribution of, medicinal products. That could include such matters as providing and maintaining staff, premises equipment and facilities for the handling, storage and distribution of medicinal products under a wholesale dealer’s licence as are necessary.

Subsection (1)(d) provides that changes may be made to the law relating to marketing authorisations for human medicines. We want to ensure that UK patients have access to high-quality medicines and new treatments, so we need a regulatory system that maintains and enhances the UK’s attractiveness as a place to market novel and generic medicines while ensuring that medicines are safe and efficacious. We could, for example, amend the current regulations to offer additional statutory rewards or incentives for a certain type of application for a marketing authorisation, which would encourage new medicines to continue to come to the UK in a timely fashion.

Subsection (1)(e) allows for changes to be made to the law governing the manufacture, import or distribution of active substances. An active substance is an ingredient used to make a finished medicinal product and gives medicine its therapeutic effect. The ability to amend and update regulations in relation to active substances is necessary to protect public health, because if there is not adequate control of an active substance, contamination can carry over to the finished medicinal product. The ability to change the rules governing active substances means that we can update the UK regulations to react in response to emerging public health risks resulting from issues relating to active substances and ensure continued supply.

Subsection 1(f) allows for changes to be made to the law governing the brokering of human medicines. The brokering of medicinal products consists of negotiating independently and on behalf of another person in relation to the sale or purchase of medicinal products. We need to be able to amend the rules governing brokering in response to any new industry practices that arise and risk infiltration of the supply chain with falsified medicines. We could use this provision to restrict such activities, thereby securing the medicine supply chain and reducing the risk to patient safety.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

I am grateful to the hon. Gentleman for raising the development of new medicines in new clause 2, which are important in new clause 3 as well. Antimicrobial resistance, as he has mentioned, is an absolutely critical issue of today. I will first set out what we are doing in that area. The development of medicines is an integral part of the UK life sciences sector, and we are committed to making sure that we can develop such medicines. The Bill gives us powers to maintain an effective system for regulating, including with respect to clinical trials. New clause 4 allows us to adapt the regulatory framework around them in a way that best suits the industry. The development of medicines is the role of the pharmaceutical industries and researchers, and we want to support them fully. The Government are committed to supporting a thriving sector, investing more than £1 billion a year in health research through the National Institute for Health Research, which is committed to openness and transparency about where the funds go. It ensures that all trials publicly register before any patient intervention, and key trial outcomes are made publicly available. However, the arrangements for Government support and funding through trials is not within the Bill.

I will address some of the work that the hon. Member for Nottingham North alluded to at Public Health England’s Porton Down campus, sometimes referred to in the context of medicine developments. The current PHE facilities at Porton Down do not develop medicines for Government, but engage in a range of scientific work for commercial and public sector customers. This includes the safety and efficacy of testing vaccines and therapeutics, and discovery work relating to novel and dangerous pathogens. Porton Down is also the site for work by Porton Biopharma Ltd, which is a public non-financial corporation and is outside central Government. Although PBL develops and manufactures biopharma products, this falls outside the Government and we are therefore not in a position to publish reports on the development of its work.

The hon. Gentleman also raised the important issue of AMR in new clause 4. I want to reassure the Committee that tackling AMR is a high priority for the Government and that its impact remains on the national risk register. The UK continues to lead the way on global action to tackle AMR, working alongside international partners, the most famous of whom is probably the most recent chief medical officer before Professor Sir Chris Whitty, Professor Dame Sally Davies, who has taken up her position as the special envoy for AMR. Her role will continue to underline the UK’s position as a world leader in developing and delivering international action in that space.

In January 2019, the UK Government published their vision to contain and control AMR by 2040. Achieving that is supported by the delivery of a five-year national action plan from 2019 to 2024. The delivery of the cross-Government commitments in the action plan is being overseen by a joint DHSC and Department for Environment, Food and Rural Affairs-chaired programme board, established in October 2019. The commitments in the national action plan cover all sectors, including human health, animal health, food and the environment.

The UK has already made good progress in reducing its use of antibiotics in humans and animals, and we now have the fifth-lowest level of antibiotic consumption in food-producing animals out of 31 European countries. We have also seen unprecedented levels of investment in collaboration in research on AMR nationally and globally. The UK invests significantly in AMR through the Fleming Fund and the global AMR innovation fund.

The hon. Member for Nottingham North is correct that the Government should prioritise the development of new medicines to address antimicrobial resistance, including antibiotics. Indeed, we already do. Having a pipeline full of antimicrobial drugs is critical to our efforts to contain, control and mitigate AMR, as outlined in the strategy towards 2040.

In July 2019, the UK formally launched a project for developing and testing the world’s first subscription-style payment model for antibiotics. If successful, it would mean that pharmaceutical companies received payment up front for access to their antibiotic products, based on the products’ value to the NHS, as opposed to the volume used. We are the first country in the world to test such a model and more information will be published on it in due course.

Although we know how important new medicines are in tackling antimicrobial resistance, a strengthened focus on prevention and the control of infection will help to contain the emergence and spread of resistance to antibiotics. By limiting and reducing the need to use antibiotics in the first place, we are taking a zero-tolerance approach to avoiding infection in human healthcare settings, as set out in the action plan. Our plan will result in at least 15,000 fewer UK patients being affected by infections each year by 2024, and 5,000 fewer drug-resistant infections.

In parallel, we are focusing on reducing animal exposures and susceptibility to pathogens that could result in the need for treatment with antimicrobials. By working closely with the veterinary profession to implement those preventive measures, we will reduce the need for new antimicrobial medicines as we reduce them in the food chain.

I hope that hon. Members will agree that the UK Government are working hard to ensure that AMR is controlled and contained through the vision for 2040 and the five-year action plan. New clause 4 is not necessary for the Bill. If the hon. Member for Nottingham North has further specific questions in relation to either medicines by the Government or AMR, I would be happy for him to write to me and I will endeavour to answer those points in a closed format. On that basis, I ask him to withdraw the new clause.

The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)

- Hansard -

Copy Link

- - Excerpts

It is a pleasure to be back this afternoon. I am grateful to the hon. Member for raising the important issue of fees in his amendment, and I recognise the intent of that probe. I am sure we agree that it is important that all new fees for human medicines are set in an open, fair and transparent way. I want to reassure him that what the amendment seeks to achieve is already standard practice and is happening. I will rapidly set out the steps already in place to ensure the fairness, openness and transparency that underpin the fees regime for human medicines.

The current fees have been subject to consultation and are provided for in legislation. They are published online and publicly available at gov.uk. All of that is supported by a formal and standardised process for reviewing existing fees and for the introduction of new fees for human medicines. The standard approach for setting statutory fees is full cost recovery, as the hon. Member alluded to, which means that fees must be set at a cost that reflects the activity involved in carrying out such a specific regulatory function.

The full cost recovery approach is set out by Her Majesty’s Treasury in its “Managing public money” guidance, which ensures that the Government neither profit at the expense of consumers nor make a loss for taxpayers to subsidise. Therefore, fees cannot be set arbitrarily, and the fee must reflect the cost of the regulatory work carried out. I think that goes some way to addressing the hon. Member’s probe on size.

Existing fees for human medicines are kept under active review by the Medicines and Healthcare Products Regulatory Agency. The amendment is specifically concerned with new fees that might be introduced under the powers in the Bill. It is already a requirement that new fee proposals are subject to consultation, and that duty continues for fee proposals under the Bill. We will publish impact assessments with the new proposals, which will set out the effects of any changes to fees in the UK on Government, industry or the general public. Her Majesty’s Treasury will be engaged throughout the fee proposal process, and any proposals for new fees will be subject to approval from HMT. It is also standard practice for the MHRA to engage with industry and trade bodies through regular meetings to discuss any new fee proposals that might be coming up.

I trust my explanation has reassured the hon. Member for Nottingham North that the requirements are and will continue to be in place so that fees for human medicines are fair, open and transparent. I therefore ask him to withdraw his amendment.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

Clause 5 provides that changes can be made to the law relating to human medicines with respect to fees, criminal offences and the powers of inspectors. Regulations made under clause 1(1) allow us to change the UK’s regulatory framework for human medicines as science, technology and clinical needs evolve. When the regulatory regime is updated, it is important that the regulator—in this case, the MHRA—can continue to regulate effectively and maintain compliance with all elements of the regime. To ensure this, it may be necessary to make provision about charging fees, creating criminal offences, and updating inspectors’ powers when making changes to the regulatory regime. Regulations made under clause 1 and relying on clause 5 will enable us to do this. We will consult before making any of those changes.

Clause 5(1)(a) allows us to make provision about the charging of fees. The regulator is self-funding for the purposes of medicines regulation. This work includes assessment for marketing authorisations and clinical trials of human medicines and inspections. It is funded by fees payable by the pharmaceutical industry in relation to the services and regulatory work provided. The current fees are set out in the Medicines (Products for Human Use) (Fees) Regulations 2016 and vary according to the specific areas of work.

It is important that existing fees can be amended, or fees can be introduced in connection with the MHRA exercising functions conferred by human medicines provisions as they evolve. Any proposal to introduce new fees is subject to consultation. The impacts on industry, Government and the general public would be evaluated through the usual process of an impact assessment. As part of its regulation of human medicines, the MHRA is able to impose criminal sanctions for certain regulatory breaches. As the regulatory regime is updated in future, it is important that we have the ability to also update the corresponding list of offences against which the MHRA can take action.

Clause 5(1)(b) allows us to create criminal offences with a maximum of two years’ imprisonment to cover updated requirements to supplement the evolution of the regulatory regime. MHRA inspectors play a critical role in ensuring compliance so that medicines are safe and effective for patients, and so that manufacture, research and surveillance processes are carried out to recognised standards. Inspectors already have all the powers to enter premises at any reasonable time to determine whether there has been a contravention of medicines regulations. For example, they may take samples or copies of documents if it is suspected that an offence has been committed. We have published two illustrative statutory instruments to demonstrate how provision can be made in regulations, relying on clause 5(1)(b) in combination with subsections of clause 2, to create a criminal offence for failing to comply with the new requirement set out in the regulations.

Clause 5(1)(c) allows us to update the relevant powers of entry and other powers of inspectors to align with new elements of the regulatory regime as it evolves. I commend the clause to the Committee.

Question put and agreed to.

Clause 5 accordingly ordered to stand part of the Bill.

Clauses 6 and 7 ordered to stand part of the Bill.

Clause 8

Power to make regulations about veterinary medicines

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

I am grateful to the hon. Gentleman for raising the important issue of the availability of veterinary medicines. The intention is clear: to ensure continued access to veterinary medicine equitably for all the nations’ animals.

The Bill provides the power to amend or supplement the Veterinary Medicines Regulations 2013, which cover the full supply chain of veterinary medicines from development to supply. The requirement for the appropriate authority to have regard to the availability of veterinary medicines, as set out in clause 8, therefore ensures that when making regulations under the clause, the availability of veterinary medicines throughout the supply chain is considered.

Although the intended effect of amendment 12 is to expand on those factors, the actual effect would be to inadvertently narrow their scope to focus only on the availability of veterinary medicines services, such as the dispensing of veterinary medicines, rather than the availability of veterinary medicines more widely and more equitably. Veterinary medicines services alone are not the determining factor in the availability of veterinary medicines.

Clause 8, as drafted, ensures that the appropriate authority must have regard to the availability of veterinary medicines throughout the supply chain, so that the rural versus urban comparison the hon. Gentleman used would not be a comparator and medicines would be equally available. I therefore ask him to withdraw the amendment.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

Clause 8 provides the power to amend or supplement the Veterinary Medicines Regulations 2013. Subsection (1) gives the appropriate authority a power, by regulation, to make amending or supplementing provision within the scope of the matters set out in clauses 9 and 10. The appropriate authority may use this power only to build on—in other words, amend and supplement —the current regulatory framework for veterinary medicines. Clauses 9 and 10 set out an exhaustive list of matters about which regulations could be made on veterinary medicines. An in-depth explanation of those clauses will be shared with the Committee throughout the course of these sittings.

Subsection (2) sets out three matters to which the appropriate authority must have regard when making regulations under clause 8: the safety of veterinary medicines in relation to animals, humans—including consumers of produce from treated animals—and the environment; the availability of veterinary medicines; and the attractiveness of the relevant part of the UK to industry for developing or supplying veterinary medicines. Subsection (3) explains that

“the relevant part of the UK”

depends on where the UK regulations will apply. The environmental safety aspects could include considering the potential impact of veterinary medicines on terrestrial and aquatic eco-systems and their flora and fauna—for example, the environment can also be affected by slurry application and excretion by grazing animals.

Subsection (4) sets out the appropriate authority for the purposes of regulations made under clause 8(1). The appropriate authority able to exercise this delegated power for England, Scotland and Wales is the Secretary of State. For Northern Ireland, the appropriate authority is either the Department of Agriculture, Environment and Rural Affairs in Northern Ireland acting alone, or the Secretary of State and the Northern Ireland Office acting jointly. This means that the powers can be exercised on their own, as well as jointly on a UK-wide basis.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

I am grateful to the hon. Member for raising the matter of capacity within the veterinary industry as it stands, in order to provide equity throughout. I recognise that he has given us examples of north-south disparities and so on, and I recognise the good intentions behind the new clause and his desire to ensure that the veterinary industry is working to full capacity and in unanimity across the piece. We agree that vets are an essential part of our animals’ lives and a key component of the UK system of protecting food safety, providing international assurance and upholding standards in welfare.

The Government are already working with various veterinary sector stakeholders, including the Royal College of Veterinary Surgeons and the British Veterinary Association, to understand the UK’s veterinary resourcing needs and ensure that there are adequate numbers of vets in the short and long term. We are working with a variety of initiatives to build a sustainable, diverse and modernised UK veterinary infrastructure to ensure that we maintain access to the right people, with the right skills and knowledge, supporting food safety and animal health and welfare, as well as trade. DEFRA has successfully secured a place for the veterinary profession on the Home Office shortage occupation list, and we are grateful to the Royal College of Veterinary Surgeons and British Veterinary Association for their work on the issue. It makes it easier for veterinary employers to gain visas.

To turn to specifics, as Members will know, the Bill introduces a statutory duty to consult before making changes to the Veterinary Medicines Regulations 2013. That consultation duty, in clause 40, requires that the appropriate authority must, before making regulations, consult those it considers appropriate. That is the most suitable route for ensuring that all those in the veterinary industry who need to be consulted are included. We are working across Government and with the veterinary profession to help to develop a flexible, skilled workforce that meets UK needs and irons out disparity of service. I want to assure the hon. Member for Nottingham North that it is a key priority to enable an innovative, productive and competitive veterinary medicine sector that invests in its people and skills. To help to achieve that, we shall ensure that there is access to sufficient appropriately skilled labour to drive continued industry growth and productivity, while ensuring that the environment for humans and animals is safe.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

A clause or so back, the hon. Gentleman gave us a snapshot of what a cascade is, and I do not think I could put it better. My notes say that veterinary surgeons can prescribe gabapentin, a human medicine, to treat chronic pain in animals, particularly if it is of a neuropathic origin, as there is no equivalent in veterinary medicine. As the hon. Gentleman said, the cascade is about making sure that there is something in the veterinarian’s bag to enable appropriate care to be given to animals.

I am grateful to the hon. Member for Nottingham North and to the hon. Member for Central Ayrshire, who I think also signed the amendment, for raising the important issue of the prescribing cascade. However, not only is the amendment not necessary, but I argue that it could be unhelpful in certain instances. I recognise the desire to ensure that the use of prescribing cascades is regulated. The cascade enables veterinary surgeons to have access to a wider range of medicines to treat animals under their care and, in particular, to prevent the unacceptable suffering that might occur if they could not prescribe those alternatives.

The provisions with regard to the cascade are set out in schedule 4 to the Veterinary Medicines Regulations 2013 and the Bill already confers discretionary powers that would allow the appropriate authority to decide, following consultation, whether and how cascade requirements in the existing regulations might be amended in the future. That is provided for in clause 9(1), for the professionals to decide, arguably.

The amendment as drafted would appear to obligate the Secretary of State to update the regulations with regard to the cascade, as opposed to making those changes when it is appropriate to do so, and evaluate the cascade above other important aspects of the veterinary medicines regulatory framework. Although the cascade is important, it is our position that the regulations should be updated when it is clear and necessary to do so, rather than operating under a compulsion to do so for any one element, as putting it in the Bill might lead to. In that light, I ask the hon. Gentleman to withdraw it.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

On amendment 13, I will write to DEFRA to seek clarification for the hon. Gentleman if that would be helpful. As we move through the Bill in the spirit of co-operation, I am more than happy to continue the conversation.

Clause 9(1) provides that amendments may be made to the Veterinary Medicines Regulations 2013 about the manufacture, marketing, supply and field trials of veterinary medicines. The Committee will note that in large part, clause 9(1) makes very similar provision to clause 2(1). I will take each subsection of clause 9(1) in turn.

Subsection (1)(a) sets out that the regulations made under the power in clause 8(1) may make provision about authorisations to manufacture veterinary medicines. The subsection means that it will be possible to update the rules around manufacturing authorisations—for example, to reflect the latest scientific advances in manufacturing and to address the manufacture of novel and innovative veterinary medicines. The subsection is therefore needed to future-proof the regulatory regime.

Subsection (1)(b) allows provision to be made about authorisations to import veterinary medicines, which is needed to continue to secure supply chains for those medicines entering the UK. By updating our existing regulatory framework, we can maximise the availability of veterinary medicines, while taking care that our approach does not place an additional burden on those who import medicines. Such a change can benefit animal owners, as it can lead to quicker access to veterinary medicines, a point that my hon. Friend the Member for Penrith and The Border brought up on Second Reading. We could use the subsection to allow additional professions, for example veterinary nurses, to import certain types of veterinary medicines with appropriate controls.

Subsection (1)(c) allows for provision to be made about authorisations to distribute veterinary medicines by way of wholesale dealing, which would ensure that we can provide further assurance on the quality and security of the full distribution chain for veterinary medicines. We could, for example, amend the application process for a wholesale dealer’s authorisation, supplement the requirements that must be met by the holder of such an authorisation, or amend the exceptions to the requirements for an authorisation.

The subsection could also be used to change the requirements for a wholesale dealer’s authorisation to cover new and novel products that may have new or additional storage and distribution requirements. That would maintain the quality and security of the distribution chain for such veterinary medicines and ensure that they are stored appropriately and safely throughout.

Subsection (1)(d) allows for provision to be made about marketing authorisations for veterinary medicines. This would help to ensure that the UK remains an attractive place for the pharmaceutical industry to bring to market both new and established medicines, and that UK animal owners do not have to wait for new, innovative or generic veterinary medicines. As an example, regulations could offer statutory rewards or incentives for certain types of applications for marketing authorisation.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

The short answer is probably yes, but I will just give the hon. Gentleman half a page of explanation.

I recognise that, as before with amendment 10, amendment 11 would ensure transparency, in essence, on fees that stakeholders may have to pay with regard to veterinary medicines, such as fees for marketing, manufacturing and distribution. The fees relating to veterinary medicines are set out in schedule 7 to the Veterinary Medicines Regulations 2013, and the power in the Bill is to amend the fees where necessary, rather than to create anything new. Indeed, it is unlikely that any new or amended fees would be introduced within three months following Royal Assent. The fees are already published online and are publicly available on the gov.uk website, as I mentioned earlier.

Therefore, the amendment would create an obligation for the Secretary of State simply to republish the existing fee regime, which is already publicly available; hence the continuity element. Any proposal to amend fees or to introduce new fees would be subject to consultation. In addition, potential impacts on businesses or organisations based in the UK would be evaluated through an impact assessment, which would also be made publicly available during the consultation process.

In light of that explanation, I cordially ask the hon. Gentleman to withdraw his amendment.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

Clause 10 provides that regulations made under clause 8(1) may make provision about charging fees, criminal offences and powers of inspectors. It enables the recovery of costs incurred in the administration of improvement or seizure notices under the Veterinary Medicines Regulations 2013.

We need to ensure that the regulator—the Veterinary Medicines Directorate, which I will now call VMD for ease—can continue to effectively regulate and confirm compliance with new or updated elements of the 2013 regulations. Therefore, it may be necessary to make appropriate changes to fees, offences and inspectors’ powers before making any such change; as I have constantly said, consultation will take place if that is the case.

The VMD is required to recover the costs of the regulatory services that it provides from fees and charges. It is important that existing fees can be amended or that fees can be introduced to meet the cost of functions exercised by the VMD. An essential part of protecting animal, human and environmental safety is ensuring compliance with the Veterinary Medicines Regulations 2013. The existing regime imposes criminal sanctions for breaches of the regulatory framework. This clause would allow for making the breach of requirements or prohibitions introduced under clause 8(1) a criminal offence, punishable by imprisonment of up to two years.

VMD inspectors play a critical role in ensuring compliance with the 2013 regulations, helping to ensure that medicines are safe and effective for animals by monitoring their manufacture and supply. Inspectors already have powers to enter premises at a reasonable time to ensure compliance with the 2013 regulations. Clause 10 would allow for the extension of existing powers of entry and inspection to new prohibitions and requirements introduced by regulations made under the Bill.

Subsection (2) provides that regulations made under clause 8(1) may not confer a power of entry to premises used wholly or mainly as a private dwelling, unless those premises or any part of them are approved, registered or authorised for the sale of veterinary medicines under the 2013 regulations.

I commend clause 10 to the Committee.

Question put and agreed to.

Clause 10 accordingly ordered to stand part of the Bill.

Clause 11 ordered to stand part of the Bill.

Clause 12

Power to make regulations about medical devices

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

I do not think anybody in the room is unmindful of the issues of environmental impact and durability, but the hon. Gentleman’s point is well made. He alluded to Baroness Cumberlege’s report, which will be out on 8 July. One of the challenges is that when something is implanted in the body, it is often there for a long period of time, and we would not want it to not be durable. That is always a consideration because, for example, we would not want something biodegradable sitting in a moist, wet environment—that product is not going to be doing its job in the long term.

I will address amendment 15, which relates to the requirement on the Secretary of State to have regard to certain factors when making regulations for medical devices. Clause 12(2) sets out those factors as

“(a) the safety of medical devices;

(b) the availability of medical devices;

(c) the attractiveness of the United Kingdom as a place in which to develop or supply medical devices.”

As I understand it, amendment 15 would oblige the Secretary of State to have regard to

“the environmental sustainability of medical devices”

as part of the assurances contained in clause 12(2).

I assure all hon. Members that the Government are fully cognisant of the need to ensure the ongoing sustainability of the environment, and have made major commitments not only on the broader issue of climate change, but to make sure that we are mindful of the reusability or sustainability of the things we use. All of this has to bring us back to the points that were made this morning about the need to be mindful of patient safety and so on. My understanding is that the intent of the amendment relates to the safe and environmentally friendly production of devices, which could include the transportation and sale of those devices, their import, and—where achievable—the reuse of devices after reprocessing. The hon. Member for Nottingham North has mentioned people getting in contact with him to say, “You’re not having my hip after I’ve used it,” but there are cases in which reuse would be appropriate, and we should be mindful of those.

The Bill is designed to support the safety of patients by maintaining a robust framework for the regulation of medicines and medical devices. The medical device regulations that clause 12 seeks to enable focus principally on the standards of pre-market and post-market assessment, as well as the vigilance required when placing devices on the UK market, so that UK patients feel safe about the products they can access. Amendment 15 would require consideration of facts beyond the regulator’s purview and introduce an added burden on the development of regulations, particularly when changes might be needed expediently to address issues of patient safety.

I totally understand the hon. Gentleman’s intention to put these issues at the forefront of our minds. However, I say gently that legislation to protect the environment, such as the Environmental Permitting (England and Wales) Regulations 2016, already exists and runs throughout the statute book, so checks and balances are in place. It is appropriate that manufacturers, suppliers and users of medical devices continue to have regard to the legislation specific to their circumstances, including the appropriate existing regulations that achieve the hon. Gentleman’s aim. I therefore ask him to withdraw the amendment. If the Opposition have points to press—with specific items, for example—they should write to me directly.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

Clause 12 provides the power to make changes to the Medical Device Regulations 2002, which regulate medical devices in the UK. Those regulations provide for the assessment of requirements and standards that must be met to place medical devices on the UK market, including in relation to packaging, labelling and user instructions, and for the requirements on manufacturers to conduct post-market surveillance of devices.

The first subsection of the clause is a delegated power allowing the Secretary of State to make amending or supplementing provisions to the Medical Devices Regulations. The exercise of that power is limited to making provisions about matters specified in clauses 13 to 15. Those clauses provide an explicit and exhaustive list of topics and give more detail on how the regulation-making power may be exercised. The Committee will, I am sure, hear in-depth explanations of those clauses during our consideration of them.

Subsection (2) explains that the Secretary of State must have regard to three factors when making provisions under subsection (1): the safety of medical devices; the availability of medical devices; and the attractiveness of the UK as a place in which to develop or supply medical devices. Those three factors must be taken into account, and they have been included to provide reassurance that future provisions are made with the best intentions for the safety of people and patients in the UK, as well as the continued development of our life sciences sector.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

I will not bluff but, off the top of my head, I think that the MHRA would look at medical devices, as it does medicines—I was looking to where my box of officials would normally be. I am fairly sure that the MHRA pays regard to devices, as with the centre at Watford to which the hon. Gentleman alluded. That centre used to do its practices at the Cardington air hangars many years ago, I think, on fire in buildings, for example. Yes, I believe that there is sufficient regulatory oversight to ensure the safety of medical devices.

Medical devices are a reserved matter in relation to Wales, Scotland and Northern Ireland. As a result, unlike the enabling powers at clauses 1(1) and 8(1), regulations made under clause 12(1) can only be made by the Secretary of State.

Question put and agreed to.

Clause 12 accordingly ordered to stand part of the Bill.

Clause 13

Manufacture, marketing and supply

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

Once again, I understand fully the intention of the amendment: to tease out the fact that small, incremental changes might lead to a divergence further down the line. However, I gently say that the purpose is to enable, so that, come January, we are in exactly the same place.

I will also say that innovation is a two-way street.An example is our ability to publish online to help people who might find it difficult to read the small print on paper in a packet of medicines, or who might be better able to understand from pictures how a device can be enabled or can help them. There is the chance, once we are in January 2021, to make those positive movements. That may lead to the Europeans looking and thinking, “Actually that would be useful.” There is no unique place for the good idea—I think that that is what I am gently trying to say. There is no place for a particular divergence, and we would not want there to be. As I said, there is consultation with stakeholders and the industry to be done on the exact points that have been alluded to.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

I am grateful to the hon. Member for mentioning the importance of establishing a UK device register that records UK representatives for non-UK manufacturers. We have actually spoken more broadly, but we both appreciate—as does the hon. Member for Central Ayrshire—that it is something on which we will probably need to have broader discussions in order to go forward.

First, I will look at the spirit of the amendment. I recognise that there is a desire to strengthen the Secretary of State’s ability to conduct market surveillance by including in the Bill a power to compile a register of representatives for non-UK manufacturers. I wish to reassure hon. Members that the regulation-making powers in the Bill are sufficiently robust to enable the Secretary of State to conduct effective market surveillance. In particular, clause 13(1)(h) empowers the Secretary of State to make provision for the creation of a device register. Discussing how that is to be done is the next step. As hon. Members can see, the intention is already laid out.

The register would hold information about the medical devices that become available for sale on the UK market. That could include information on non-UK manufacturers, if they have devices that are sold within the UK on the UK market. Government policy is to record the responsible person for all devices available on the UK market after the transition period. Furthermore, current registration requirements allow the Secretary of State to record manufacturer information for the lowest-risk devices, custom-made devices and all in vitro diagnostic devices in the UK. Mandatory registration with the MHRA provides a level of additional scrutiny on such products that would otherwise be absent.

The Bill provides a power to expand current registration requirements to deliver a more comprehensive record of information about a wider range of medical devices entering the UK market, in order to support the role of the MHRA and its post-market vigilance activity. The will is there but, as the hon. Member for Nottingham North knows, I am very keen that we get such a register, registry or data collection, over which there is already quite a lot of confusion out there. We need to work hard with clinicians and others to ensure we get this right. On that basis, I ask the hon. Member for Nottingham North to withdraw the amendment.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

Clause 13(1), which is similar to clause 2(1) on human medicines, provides for amending supplementary provisions to be made to the medical devices regulatory framework. Clause 13 lists the matters relating to the manufacture, marketing and supply of medical devices that may be under clause 12(1). The list is exhaustive in order to provide clarity.

Paragraphs (a) to (d) of subsection (1) provide the changes that can be made to regulatory requirements, which must be met before a product can be placed on the UK market, and outlines who can make such an assessment. The provision includes requirements about the characteristics of devices, such as design, manufacture and packaging, and the requirements placed on people involved in the marketing and supply of devices. Those paragraphs also allow for changes to be made to the rules governing the appointment of a specified person or persons, UK-based or not, to assess and certify that medical devices meet all relevant requirements. Changes may be made to conformity assessments, which are assessments of whether requirements, which could include conforming to agreed standards, have all been met. Under subsection (1)(e) and (f) provision could be made about the information to be provided to demonstrate that a device has met regulatory requirements. That could include specifying declarations that manufacturers must make, or certificates that must be provided, to show that a device has been through the appropriate kind of conformity assessment.

Clause 13(1)(g) enables provision to be about labelling, packaging, and information requirements for devices. That might, for example, include specifying warnings or expiry dates that must be included on the label or packaging for a device, and what information to include in the instructions for the use of the device.

We have considered additional ways in which we can improve our regulatory system to improve patient safety and aid market surveillance activities undertaken by the Medicines and Healthcare Products Regulatory Agency. One is the provision made in clause 13(1)(h), which would empower the Secretary of State to make registration requirements for devices marketed in the UK about the registration of devices and their manufacturers and suppliers, including information—this is probably our starting point—to be entered in a register. That is where I do not want the landscape to get confused. It is important that the register sits as that important piece.

Regulations made under clause 12(1) and relying on clause 13(1)(h) will enable the MHRA to create a register of medical devices available on the UK market. That could be requirements to increase the scope of current registration rules. Currently the lowest risk class of device—where they have been self-assessed by the manufacturer rather than assessed by a notified body—is required to be registered with the MHRA. Specified information in such a register, which would not include commercially sensitive information or personal data, could be made publicly available under clause 13(1)(h)(iii), allowing clinicians and patients access to information on the device that they intend to use. Again, there would be transparency.

Under clause 13(1)(i) and (j) changes could be made to the rule around investigations and evaluations for safety, performance and clinical effectiveness, and monitoring of performance through market surveillance. Having the ability to update the rules is essential to maintaining patient safety standards.

The UK does not operate in isolation to the rest of the world, and we have provided at subsection (2) that, where regulations are made relating to matters in clause 13(1)(a)—requirements that must be met in relation to medical devices—those requirements can refer to international agreements or standards for marketing or supplying medical devices.

Question put and agreed to.

Clause 13 accordingly ordered to stand part of the Bill.

Clauses 14 to 16 ordered to stand part of the Bill.

Ordered, That further consideration be now adjourned.–(Maggie Throup.)

The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)

- Hansard -

Copy Link

- - Excerpts

I would also like to say what a pleasure it is to resume under your chairmanship, Mr Davies.

Amendment 29 seeks to amend clause 17 with regard to the suspension notices. I understand totally why hon. Members are looking to double-check where we are. The clause provides an enforcement authority with the power to serve a suspension notice on a person, where doing so is considered necessary to restrict the availability of a medical device in order to protect health and safety. It lists a number of prohibitions that may be imposed, and seeks to add a specific prohibition on advertising a medical device.

The Government recognise that the intention behind the amendment is to equip the enforcement agency with the ability to prohibit a recipient of a suspension notice from advertising a medical device where there is a need to protect health and safety. I assure hon. Members that the enforcement authority has the ability to do what the hon. Member for Nottingham North is asking and prohibit the advertising of a product already catered for in the clause. That is already in the Bill as it is currently drafted.

Hon. Members will note that prohibitions that may be impose include, in clause 17(2)(b), “offering to supply”, which encompasses advertising or an advertisement. Although I am grateful for the probe, I respectfully ask the hon. Gentleman to withdraw the amendment.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

My explanation covered both points. Clause 18 provides an enforcement authority with the power to serve a safety notice on a person where doing so is considered necessary to restrict the availability of a medical device in order to protect health and safety. It provides the enforcement authority with discretion about the prohibitions that may be imposed. The amendment seeks to add a specific prohibition on advertising a medical device. We recognise that the purpose behind it is to equip the enforcement agency. I would like to reassure hon. Members that that sits in the Bill. On that basis, I commend the clause to the Committee.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

I beg to move amendment 2, in clause 24, page 13, line 26, leave out ‘case’ and insert

‘proceedings for such an offence’.

This amendment, and amendments 3, 4, 5, 6 and 7, amend certain provisions to ensure they operate effectively in relation to Scotland.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

Amendments 2 to 7 relate to the clauses about defences available for offences under clause 23 and regulation 60A to be inserted into the Medical Devices Regulations 2002 by schedule 2.

Clause 23 will provide that it is an offence to fail to comply with a compliance, suspension, safety or information notice. Schedule 2 makes it an offence to fail to comply with certain provisions of the Medical Devices Regulations 2002. Further, the Bill provides that a defence of due diligence will be available with respect to each of those offences. That means that a person charged with an offence under either clause 23 or regulation 60A will be able to argue that they have not committed an offence because they took reasonable steps to avoid doing so.

The provisions that make those defences available are in clause 24 and schedule 2. It is those provisions that we seek to amend. Amendments 2 to 4 are to clause 24 and amendments 5 to 7 are to schedule 2.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

On that basis I commend the amendment to the Committee.

Amendment 2 agreed to.

Amendments made: 3, in clause 24, page 13, line 32, after ‘hearing’ insert ‘of the proceedings’.

See the explanatory statement for Amendment 2.

Amendment 4, in clause 24, page 14, line 2, at the end insert ‘, and

(b) the reference in subsection (3) to “the hearing of the proceedings” is to be read as a reference to “the trial diet”.’—(Jo Churchill.)

See the explanatory statement for Amendment 2.

Clause 24 , as amended, ordered to stand part of the Bill.

Clauses 25 and 26 ordered to stand part of the Bill.

Schedule 1

Medical devices: civil sanctions

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

I would like first to address the intention behind the amendment. I recognise that it is driven by the desire to ensure that the Government issue guidance on the new civil sanctions regime within three months of the Bill gaining Royal Assent. The new civil sanctions regime will complement the consolidation of the current enforcement regime, enabling the Medicines and Healthcare products Regulatory Agency to impose a monetary penalty, an enforcement cost and a recovery notice, or to accept an enforcement undertaking as an alternative to criminal prosecutions. That will enhance the MHRA’s ability to incentivise compliance with the Medical Devices Regulations 2002.

Under paragraph 13 of schedule 1, the Secretary of State has to publish guidance on the new civil sanctions regime. However, the timeframe for doing so is not specified on the face of the Bill. Before it is fully operational, the new civil sanctions regime provided for by the Bill will require further provision, to be set out in supplementary regulations made under paragraph 9 of schedule 1. The regulations will cover matters such as enforcement and monitoring of compliance with enforcement undertakings and appeals.

Clause 40 provides that any regulations made under paragraph 9 of schedule 1 must be consulted on. There needs to be enough time to do that, which is why a three-month period is perhaps too truncated. The Government wish to allow sufficient time for such a consultation on these matters before we make the regulations, in order to ensure that they best fit the situation that we are trying to enforce. As I have explained, the civil sanctions regime will not be fully effective before the regulations are made. Under paragraph 13 of schedule 1, the Secretary of State must also consult before issuing guidance on the new regime.

It is right that we consider the views of stakeholders. As we discussed at length on Monday, this is about getting it right for patients and all stakeholders before we bring the regulations into force. It is important that we allow sufficient time to engage effectively and to ensure that we act in the best interests of both patients and the healthcare sector. The effect of the amendment would be that the Government are required to consult on, and publish guidance on, the civil sanctions within a tight three-month period before the regulations have been made, and at a point when the consultation might still be ongoing, so that we arrive at the best place.

Paragraph 13 of schedule 1 already places a duty on the Secretary of State to publish the guidance in order to be transparent, and the new civil sanctions regime will require consultation and secondary legislation. It is therefore impractical to specify on the face of the Bill that we would have a timeframe for doing so. On that basis, I hope that the hon. Member understands that we wish to get this right, and that he will withdraw the amendment.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

Once again, I recognise that the hon. Gentleman is probing, to ensure we make good legislation. For that, I am extremely grateful.

The Government have every intention of providing greater transparency about the safety and effectiveness of medical devices on the UK market, including on how our use of civil sanctions will achieve that aim. On that basis, I confirm that the Cumberlege report will definitely be with us on 8 July, which I do not think I stated during proceedings on Monday. I take on board the hon. Gentleman’s point that we may well be looking at things in the round.

Civil sanctions will provide an alternative to criminal prosecution where the latter is not suitable. If, for example, a breach is judged to have had the potential to cause harm but it does not, the civil sanction is a second tool in the toolbox. As the hon. Gentleman said, there have been very few prosecutions in the last decade. Criminal prosecutions can be used where the breach of regulations leads to a serious incident or death, or where a manufacturer has directly contravened the conditions set out in a safety or suspension notice. As I am sure he will agree, other incidents very often need a flag raising, and that is the point of bringing civil sanctions into the legislation.

Currently, as the hon. Gentleman said, the Secretary of State is committed, under paragraph 15 of schedule 1, to publishing reports on the use of civil sanctions from time to time. The requirement to publish reports on the use of civil sanctions is in line with existing obligations on other Government agencies that already operate a civil sanctions regime for their sector. The Environment Agency is one—in respect of environmental civil sanctions—while the Secretary of State for Business, Energy and Industrial Strategy, who is responsible for enforcing the Ecodesign for Energy-Related Products Regulations 2010, is another. Those regulations explicitly state that reports on the use of civil sanctions will be published “from time to time”.

The new civil sanction regime would require supplementary legislation, as per paragraph 9 of schedule 1. A consultation on the supplementary legislation would be necessary to ensure that the new regime is operational. I assure Members that the Government intend to publish reports on their use of those measures at regular and appropriate intervals, and the hon. Gentleman will bring me up on that. The Government may indeed decide that reporting annually is appropriate. However, as the new regime will require secondary legislation, which must be consulted on before it comes into force, it is not practical to specify at this point the frequency of Government reports on the use of civil sanctions.

On the hon. Gentleman’s specific point about burden of proof and how we arrived at that, I will write to him. On that basis, I invite him to withdraw the amendment.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

The Government consider the new recall power to be crucial to ensuring that unsafe devices are removed from the market. It is important to note, however, that subsection (3) requires that the power is used only as a last resort.

The Bill introduces this statutory power for the MHRA, on behalf of the Secretary of State, to conduct recalls on the rare occasions when a manufacturer is either unwilling to carry out a recall imposed under clause 18 or is unable to do so because the manufacturer no longer exists as an entity. I am sure Members will agree with this power, as it is intended to ensure the safety of devices for patients and, without it, there would be a gap. In the case of companies unwilling to take action, devices that are not recalled might well present risks to patients. It is right that the regulator can take action if and when companies fail to recall devices.

The statutory power also addresses an anomaly in the existing enforcement regime, whereby the MHRA has the statutory power to conduct a recall under the General Product Safety Regulations 2005 where the medical device in question meets the definition of a consumer good—typically, a low-risk medical device—but the MHRA does not currently have the commensurate statutory power to conduct recalls for higher-risk medical devices that are not also consumer goods under the GPSR. That would appear to be an inconsistency that does not align with risk to patients. I am sure all hon. Members would agree that, where possible, that is what good legislation should do, and the Bill seeks to correct that anomaly.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

The MHRA has a specific compliance department. It works on a case-by-case basis, and it would issue a notice—see clause 18—and it would move forward on that basis with an individual recall against a company. I hope that clarifies the situation.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

I am grateful to the hon. Gentleman for raising, through amendment 19, the issue of the commencement of chapters 2 and 3 of part 3 of the Bill, which is concerned with medical devices. Chapter 2 introduces a new enforcement regime that includes the civil sanctions set out in schedule 1, which we discussed. Chapter 3 concerns data and disclosure provisions, and contains a number of consequential amendments, which facilitate the introduction of the new enforcement regime in chapter 2.

On chapter 2, as I have said, a key element of the new enforcement regime is the addition of civil sanctions, which will act as a flexible, proportionate enforcement mechanism to enhance the MHRA’s ability to incentivise compliance. Supplementary regulations must be made under paragraph 9 of schedule 1 before the new civil sanctions can be fully operational. Those regulations, which could relate to matters such as the enforcement of a monetary penalty regime, monitoring compliance with an enforcement undertaking, and the provision of appeals, are subject to a consultation requirement, as set out in clause 40. It is right that we consider the views of stakeholders before bringing the regulations into force, and it is important to allow for time to engage effectively, so that we can ensure that we act in the best interests of patients, and thereby in the best interests of the healthcare sector that serves them.

The data and disclosure provisions in chapter 3 will provide greater transparency about the safety and effectiveness of medical devices on the UK market. I am sure we all agree that that is what we are after: knowing what is going where and helping whom, and, if there is an issue, being able to isolate and highlight it, and then provide a remedy. The Government are exploring how we can ensure that the new powers are as effective as possible and secure the needs of the healthcare community, patients and the wider public. It is therefore appropriate that due consideration be given to how the powers can most effectively be used before they are commenced. An amendment putting in place a deadline by which the powers must come into force could limit the MHRA’s ability to find the most effective route, and it could limit the time that MHRA has before commencement for the important process of engaging with stakeholders on the powers.

Finally, the consequential provisions in clause 36 are linked to the disapplication of the previous enforcement regime in part 2 of the Consumer Protection Act 1987. They too must be commenceable by regulations, so that they come into force at the same time as the new enforcement regime.

I reassure hon. Members that the Government are committed to bringing the enforcement, data and disclosure chapters of the Bill into force as soon as is appropriate, in order to enhance the safety of the medical devices regime, which I think we all see as important. I therefore ask the hon. Member for Nottingham North to withdraw the amendment.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

As the hon. Gentleman knows, I am also enthused and excited about the register, because it offers us a space to do something good. I am very grateful to him and the hon. Member for Central Ayrshire, to whom I spoke at the weekend, as I said on Monday, and I noted that she would not be with us for Committee proceedings.

A registry of long-term implantable medical devices as suggested in new clause 6 is of significant interest to many Members. On Second Reading, many Members put forward good ideas on how we could make a register work for the benefit of patients. We should consider this in the context of the forthcoming report from the independent medicines and medical devices safety review and the matters it looked into, particularly the use of pelvic mesh, and how we oversee medical devices, including post-market surveillance. It is not only the point when the device is implanted that is vital, but also the potential impacts some years later. I know we all recognise the critical importance of ensuring that patients are heard and that concerns about medical devices are identified and dealt with quickly and effectively. That must be at the forefront of our minds. As the hon. Gentleman said, the impact on an individual’s life can be significant.

New clause 6 is similar to new clause 1, which was tabled in the name of my hon. Friend the Member for Newton Abbot (Anne Marie Morris). I know that she and many other Members in the House and the other place are interested in what more we could do to improve the tracking of implantable medical devices. The issue has also been a subject of interest to the Health Quality Improvement Partnership and the Royal College of Surgeons. It is very topical.

Clause 13(1)(h) provides for the creation of a register of medical devices to capture which devices are available on the UK market and to ensure that the MHRA can identify which device has been produced by which manufacturer. There has been some confusion in some of the written evidence as to whether that is intended to constitute a registry. A registry as in new clause 6 suggests bringing together patient and clinical information with device information. We have device registries, such as the national joint registry in the UK, which is seen as a global exemplar, so it is important to make sure that we do what we need to in order to enhance what is already in the system.

I understand the intent behind the new clause and, as ever, I am keen to understand what more we can do to protect patients in a fast-moving and constantly innovating environment, but I am not sure that new clause 6 is practical. The hon. Member for Central Ayrshire and I discussed the fact that it was heading in the right direction, but we need to work on it.

Patient safety absolutely underpins everything in our approach to regulation of medical devices in the Bill. It is the key consideration for all of us, as set out in clause 12(2)—the Government have put it there as the key priority. That is why we have introduced the ability for the Secretary of State to disclose information in the event of a safety concern, as we discussed.

I am not sure that the new clause achieves what the hon. Members for Central Ayrshire and for Nottingham North want it to. The intent is to establish a UK registry linking together all existing device registries, so that duplication of the entry of information is reduced, and to require the information entered to include the specifics of a device, such as the clinician who implanted it—information that, in the event of something going wrong, would give a clear picture of what happened. Although that is a commendable aim, the existing registries have been established over time and have expanded into different regions, evolving as they go. We have not had conversations on linkages to the registers in various parts of the country and in devolved Administrations. It is right and proper that we pull back and ensure that we have taken in the views of all stakeholders, and done the proper engagement to ensure that we collect the information from registers appropriately. That needs some work, partly due to the differing operating approaches in each registry. I gently suggest that the proposal in subsection (6) that all implanted devices without a specialist registry be logged on a national registry is a little broad at this stage. We perhaps need to talk about that with stakeholders and others.

The new clause also seeks to establish a governance structure, after consultation with a range of stakeholders, on the management of and access to the proposed registry. I suggest that the consultation requirement is out of step with the consultation duty in clause 40, which provides that consultation with those considered appropriate must take place before we make the regulations. It is a little cart before the horse but, that notwithstanding, this is very much the direction of travel. I remain of the view—no doubt we will come to this point—that we must ensure that we do not inadvertently rule out consulting those who ought to be consulted.

The hon. Member for Nottingham North and I have had discussions in this space, and we are united in wanting this idea to get to the right place. I appreciate the careful consideration that was given to the new clause, and I am grateful for it. I would welcome further discussions in the near future.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

I thank the hon. Member for his intervention. We are not talking about cosmetic devices here, but I very much take his point. If it involves implantation, it is worth talking about, in the round, during consultation; however, many of the cosmetic issues he refers to may be temporary—if, for example, a device is inserted and then taken away. The legislation is about implanted devices. Again, it is something that we would talk about and ensure that we had consulted on, but for the purposes of the Bill, we are specifically looking at medical devices, and the definition of them.

As I said, I welcome discussion with those interested in these matters, particularly as we look forward to Baroness Cumberlege’s review, which is coming very shortly. On that basis, I ask the hon. Members for Central Ayrshire and for Nottingham North to withdraw the motion, but I will commit to following up with arrangements to have those discussions in a timely fashion.

The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)

- Hansard -

Copy Link

- - Excerpts

I beg to move, That the clause be read a Second time.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

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 where 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 from 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.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

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.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

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 to 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 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) alluded to, 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 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 oral questions this morning, I can say that I know we both share that commitment to drive patient access to radiotherapy and treatments together. Many hon. Members know that that is dear to my heart, having 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 place.

Jo Churchill

- Hansard -

Copy Link

- - Excerpts

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.