Medicines and Medical Devices Bill

Lord Bethell Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

Moved by

[Lord Bethell]

Relevant documents: 19th Report from the Delegated Powers Committee. 10th Report from the Constitution Committee.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, the Medicines and Medical Devices Bill is crucial to the development of a modern, safe, medical regulation regime. Its focus is the development of important innovations that will improve and save lives for the next generation, and the protection of patients in an area which has, historically, been slow to move and which, in a few months, passes from European to domestic legal oversight. When we look at our plans for the health of the nation, having the agility to revise our key regulatory regimes is not a “nice to have”; it is absolutely essential to protect the lives of patients and empower the innovations that will extend their length and quality.

I begin with safety. The first and most critical consideration of any Bill on medicines and medical devices must be the safety of patients. We also consider the safety of providers, the environment and, in Part 2 of the Bill, animals, but the safety of patients is paramount. We have all reflected on the detailed and thorough report of my noble friend Lady Cumberlege. I have listened to the testimony of some of the patients and families who have campaigned on patient safety, and shared, in a small way, their pain and suffering. They brought to life how critical this Bill is. We owe them a huge debt of thanks, as we would not be here today without their determination.

There is no disagreement among us on the importance of the safety of patients. The Bill puts safety at the heart of regulatory decision-making, facilitating the sharing of information to support public health concerns and creating mechanisms to track the use of medical devices or medicines against a patient record. The thoughtful, thorough, modern use of data is how we know that something is going wrong and how to put it right. That is the view of the Government, which my noble friend Lady Cumberlege and her team brought vividly to life in the Bill’s passage in another place. That is why I am delighted with Clause 16, introduced as an amendment, which ensures that data provisions in the Bill are central to its effectiveness. By introducing a medical devices information system—or database—we have radically improved that effectiveness.

We once faced a situation where patients could not be traced, and a conversation could not be had between a patient and their clinician because we did not know which specific device had been implanted into a person or by whom. When I found this out, I was dumbstruck. This must not happen in the future. The Bill will support the tracking and tracing of medical devices and will enable a future system of clinical registries, such as the National Joint Registry, to ensure that UK patients are better supported.

When there is a problem, it is important not only that we know that something has happened, but that we take forceful action. Part 3 of the Bill therefore sets out a consolidated suite of powers available to the regulator, including the ability to step in and recall a device if the manufacturer fails to do so where necessary. Chapter 4 of Part 3 of the Bill clarifies the powers of disclosure around devices, allowing the Secretary of State to warn members of the public about safety concerns. We must ensure that avoidable harm is avoided by acting expeditiously to protect patients. Let me be clear: the regulator can and does work in close partnership with industry to deliver on behalf of patients, but it has, and will continue to have, teeth when industry fails to protect patients.

We live in a world where big data, artificial intelligence and genetics have become enormously powerful engines of innovation, and where engineering and computer science have combined with medicine to create an unexpected synthesis. These drivers of development are generating exciting new medical innovations that are aiding patients who were previously beyond help, bringing down the costs of treatment and driving growth in Britain’s thriving life sciences industry. I have seen the power of innovation at first hand in the last few months, during the Covid-19 crisis. Our National Health Service is the first around the world to have determined the importance of an effective therapeutic drug, dexamethasone, through the recovery clinical trials programme. Our medical manufacturing industry worked closely with the regulator to move swiftly and safely and put 14,000 ventilators into the health system. In the area of diagnostics—my specialist subject—innovation is driving the accuracy, cost, speed and scale of devices beyond our initial hopes.

We need this pace of innovation in day-to-day, back-to-business delivery too. That is why we are investing in the partnership between the NHS, with its unique pool of patients, and the life sciences sector, which can make treatments happen. I pay tribute to the noble Lord, Lord Darzi, who is chair of the excellent Accelerated Access Collaborative, which gets the best new treatments and technologies into the hands of patients and clinicians faster than ever before. We face a new horizon of tailored treatments and diagnostics that we never could have envisaged five or even three years ago: biotechnology, artificial intelligence, robotics. We are at an inflection point where innovation can make a huge difference. I am pleased and proud to be a Minister championing the role of innovation in the healthcare system at this incredible time. Supporting innovation through this Bill ensures that UK patients benefit from the thriving life sciences sector by bringing investment, jobs and prioritisation to Britain’s medical needs, balanced by the need to manage risk.

Availability and attractiveness are the twin pillars of the Government’s strategy on medicines and medical devices, and the key themes of this Bill. Availability means the reliability of medicines and medical devices and their availability to UK patients. Attractiveness means doing everything reasonable to be the first place where new treatments are rolled out and adopted, where investment in life science takes place and where the enrolment of patients in clinical trials is supported.

Recent months have proved how the availability of medicine relies on fast, accurate, responsive regulation. It is the work of the regulator, hand in hand with the industry, that has ensured that therapeutics, including those used in intensive care, have been in safe supply and that devices, including the important vaccines, get into the right hands to bring this crisis to an end. Clauses 2, 6, 8, 12 and 15 all deal with how we ensure the essential and safe flow of medicines and medical devices. Clauses 2, 8 and 12 allow for regulations to be made that could, for example, affect how medicines or devices are distributed. Clauses 6 and 15 allow us to make pre-emptive regulations to reflect the realities of an emergency, such as a pandemic, and to prepare early.

It is right that we do more to get regulated medicines into patients’ hands and do not keep people waiting long for innovative treatments. I pay tribute to a number of noble Lords who I know tirelessly make the case for certain therapeutics or treatments to be accelerated through the health system. The attractiveness of the UK is fundamental to getting new breakthroughs to patients here quickly.

Let me say a word about regulating for the future, and the work of the Delegated Powers and Regulatory Reform Committee and the Constitution Committee. I pay tribute to learned colleagues on these committees: I know they approach their work diligently and seriously, with significant legal expertise, and I anticipate discussion of their conclusions. I know a number of noble and noble and learned Lords will wish to speak to those reports today, and I will pay serious attention to the points raised.

This is, as it must be, a framework Bill. I recognise that concerns have been expressed about the breadth of the powers and a number of suggestions have been made as to how the Bill might be improved. I am listening, but it is important to note the challenges of taking a different approach to that outlined here.

These delegated powers are necessarily broad, given the hundreds of pages of the Human Medicines Regulations alone. These regulations can span many different matters and it is vital that the ability to make a change for the benefit of patients, where even a really minor point can be important, is not lost. We live in a world where it was only 12 years ago that the iPhone was released, yet today we are trying to figure out how to regulate an AI-supported cancer-screening gadget from KardiaMobile that plugs in to your smartphone and delivers a medical-quality ECG in about 30 seconds. We live in a world where 3D bionic arms, such as the Hero Arm from Open Bionics, have multigrip functionality, and where the national lung matrix trial at the University of Birmingham is exploring how patients with non-small cell cancers respond to tailored treatments.

Primary legislation cannot be relied on to be passed quickly when there are matters of concern for the safety of medicines and medical devices. For example, when concerns were raised across the EU about the scrutiny of notified bodies, and safety concerns arose from certain implants, it took years to update legislation. My noble friend Lady Cumberlege has made clear what happens when change is slow: it has an impact on patients. I know this from another area and I will give an example. When the Communications Act 2003 was passed, the internet was hardly mentioned. Some will say we could not have predicted the immense role that video sharing and social media platforms would now play in our lives, but I remember at the time that legislators were urged to take internet innovations seriously and put in place frameworks to anticipate technical change. Now we have widespread fake news, cyberbullying, the intimidation of public figures and a pornography boom, but without the legislative powers that perhaps we would like to stop or regulate them, because there was no framework to make new regulations to cover these innovations. I am here to listen, so I would like to listen to the advice of the Chamber on how to handle this complex challenge.

In conclusion, I remind noble Lords that because of its importance for patients, we need to get the Bill done and to secure the ability to protect patients quickly if the need arises. We need powers to deliver and to trace and track medical devices as soon as possible. I know it is important that we discuss these issues properly, but the Bill is not just exciting, ambitious and direction-setting; it is essential that it makes it to the statute book by the end of the year. I look forward to listening to the contributions ahead; we are receptive to how we might make the Bill better, as we did in the other place. My door is open, and in that spirit of co-operation and consensus building, I beg to move.

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, what a debate. This is without doubt the House of Lords at its best, with thoughtful and powerful points covering medical regulation, legal propriety, patient safety, the European transition, animal welfare, foreign relations and much more. We have listened to powerful points made by 50 speakers. There was a great deal to take in. Our time together in Committee and on Report promises to be rich with important material. I fear I will therefore be unable to address every single point from every noble Lord who has spoken today, but I will give it my best shot.

Noble Lords addressed five broad themes in their contributions: my noble friend Lady Cumberlege’s review, improving regulation for medicines and medical devices, the Delegated Powers and Regulatory Reform Committee report, organs and tissues, and the UK’s future relations with the EU. I will take them in turn.

I am exceptionally grateful to my noble friend Lady Cumberlege for her report and her contribution today. Noble Lords have sent a clear message to the Government and the public that patient safety must be paramount in how we regulate medicines and medical devices. My noble friend is right that patients should be believed. She is also right that it is counterproductive to create an environment in which health professionals clam up or go into hiding. I note her intention to table an amendment on a patient safety commissioner and the large number of noble Lords who expressed their support.

The noble Lord, Lord Alton, gave poignant testimony from his own long-standing campaign on these important causes, including on Primodos. The noble Baroness, Lady Hollins, spoke of the epistemic injustices towards the disfranchised, and the noble Baroness, Lady Burt, spoke movingly about mesh, giving testimony of what she called “medical misogyny” that was hugely uncomfortable. There is a limit to how much I, as a man, can really understand all these cases, but as a husband and a father of two daughters I understand the claim that our healthcare system has not treated women fairly. This Government and this Minister are committed to doing what we can to address this.

I have heard the clear commitment from many Peers, including the noble Lords, Lord Brooke and Lord Patel, the noble Baronesses, Lady Ritchie, Lady Uddin and Lady Watkins, and my noble friend Lord Sheikh to see the report of my noble friend Lady Cumberlege implemented. I said that I would listen, and I have heard very clearly the support for a patient safety commissioner. The nine strategic recommendations in the review need to be considered carefully and we will respond in due course.

I reassure the noble Baroness, Lady Barker, who asked that registries of devices as well as databases should be our expressed direction of travel: we have set this out in the government guidance published alongside the amendment. I would be happy to write to set this out clearly. Many have spoken of the importance of Clause 16 and the underpinning of data. I assure Members that we are able to capture all devices where it is considered necessary to track their use. My noble friend Lord Mancroft is quite right that it is unacceptable in the 21st century, and makes no sense, that our National Health Service cannot keep track of who puts what in whom, and we are determined to change that.

The noble Baronesses, Lady Barker, Lady Walmsley and Lady Andrews, and the noble Lords, Lord Patel and Lord Brennan, raised patient safety. That must be a first consideration. I concur completely with the Minister in the other place that patient safety is paramount—under no circumstances will we seek to make changes that increase risk to patients in the UK. It is absolutely right that we ensure the delicate balance between supporting innovation and maintaining the UK’s position as an attractive place to develop new medicines and devices, but patient safety remains paramount. Innovation and patient safety are not mutually exclusive, and we want to continue to ensure that our regulatory framework facilitates the furtherance of both.

Several noble Lords mentioned the importance of consultation with patient safety groups on regulation that directly affects patients. I reassure all noble Lords that the consultation clause is worded such that where matters affect a particular group or groups, it will be entirely appropriate for them to be consulted.

I turn to the improved regulation of medicines and medical devices. The noble Lord, Lord Patel, expertly described the need to ensure the safety of medical devices. This is something I have indicated that we are wholeheartedly committed to, as indicated by the inclusion of Clause 16. The Government are determined to deliver regulatory change to the current UK system for medical devices to increase patient safety and drive pre-market scrutiny, and we will continue to assess opportunities to improve the wider regulatory system at the end of the transition period. The Bill is vital as it provides the necessary powers that will allow us to make regulatory changes in the interests of patient safety and confidence. The Government are committed to ensuring that patients continue to have rapid access to new medicines, and we have increased access through the early access to medicines scheme. We recognise the importance of innovation and clinical trials for patients and are absolutely committed to building on the UK as a centre of excellence for trials after the end of the transition period. We will ensure that no patients are disadvantaged.

I reassure my noble friend Lord Balfe that the UK already has substantial capacity and expertise to regulate and evaluate the safety of our medicines and medical devices. The Bill ensures that the legal frameworks around medical devices, human medicines, veterinary medicines and clinical trials can be updated to protect patient safety and reflect innovative practices. This is vital as negotiations on the UK’s future global relations continue, as several noble Lords alluded to.

I agree with the noble Baronesses, Lady Redfern and Lady Whitaker, and the noble Lords, Lord Ramsbotham, Lord Bhatia, Lord Willis and Lord Bradley, that it is right that patients are treated by the healthcare professional best qualified to care for them, including prescribing for them where that is safe and appropriate. However, putting individual professions on the face of primary legislation is not the right platform for any potential amendments to medicine supply or prescribing responsibilities. Over time the roles of staff within the health service will evolve and, using this proposed power, professional groups can be given new or additional powers to supply or prescribe medicine, subject to consultation, by amending human medicines regulations. NHS England and NHS Improvement are considering across all non-medical groups, influenced by learning from the Covid-19 pandemic, where there is a need to consider undertaking formal consultation on potential amendments to prescribing responsibilities for several professional groups.

The noble Lord, Lord Hunt, spoke of his frustration that the NHS is slow to adopt new technologies. He is right. Uptake of new medicines is still too slow, and we are working to address that. We recognise the importance of aligning regulatory and health technology assessment processes to ensure timely access to effective medicines.

My noble friend Lord Lansley is right that 10% of global medical innovations in the UK is good—but it is not good enough. I welcome his persuasive points on a new innovation fund and confirm that the Government have made a commitment to support innovative medicines by extending the successful Cancer Drugs Fund into an innovative medicines fund. The Cancer Drugs Fund shows the impact that this approach can have for patients, with 81 drugs treating 167 cancer indications funded by the CDF since July 2016.

I reassure the noble Baroness, Lady Bennett, that there is no contradiction between an intention to change very little in the immediate future and a commitment to evolving our domestic regime to protect patients, to meet the opportunities of technical revolution and to make Britain a destination for life sciences investment, clinical trials and better health services for patients.

My noble friend Lord O’Shaughnessy spoke wisely about the regulatory arms race, the impact of the FDA’s competitiveness and the opportunity of leaving the EMA. I welcome my noble friend Lady Blackwood’s point about the fact that the Bill is incredibly timely, irrespective of EU exit. I am proud of the energy and flexibility that the MHRA has shown during the response to Covid. I agree wholeheartedly with my noble friend Lord O’Shaughnessy that this is an opportunity that must be taken.

The noble Lord, Lord Clement-Jones, speaks knowledgeably about falsified medicines and the importance of commercial data. I reassure him that our objective is to fully consult with industry, patient groups, pharmacists and all interested parties on any regulatory changes before they are implemented.

To the noble Baroness, Lady Sheehan, I say respectfully that I reject the idea that we need to move away from the intellectual property rights regime that has provided incentives to create new inventions and accelerate the development of health technologies, such as Covid vaccines, over more than a generation.

By way of conclusion of this point, I echo my noble friend Lady Blackwood, who set out the opportunity well: there are key areas of regulation where we must choose to develop new regulatory regimes, including gene therapies, genetics, AI and big data. The Bill will help us to produce future-proof, proportionate regulations and standards in full consultation and largely with affirmative regulations that will have full parliamentary scrutiny.

On the question of parliamentary scrutiny, I turn to the DPRRC report. I reassure noble Lords that the majority of the delegated powers in the Bill are not new. They are absolutely necessary if we are to have the appropriate powers to make changes to the critical regulatory frameworks after the end of the transition period. We can currently make changes to those frameworks under Section 2(2) of the European Communities Act 1972, but that power will not be available once we have left the EU and we cannot allow those regulations to stagnate. While oversight of the delegated powers in the Bill will be different from that which currently occurs, we have taken deliberate steps to ensure that the oversight will involve greater parliamentary scrutiny and secure greater involvement by patients, industry and other experts. We will carefully consider the specific and detailed recommendations of the DPRRC as to how we might go further.

As reiterated by my noble friend Lady Blackwood, the majority of regulations are subject to the draft affirmative procedure—a high level of scrutiny that has usually been applied when we have used Section 2(2) of the European Communities Act 1972. As noble Lords know, by its nature this procedure requires parliamentary approval before those regulations may be made and come into force.

I am grateful to my noble friend Lord Blencathra for early sight of his speech, which was a model of courtesy and delicacy. I have heard his message loud and clear. I would welcome his counsel on the central challenge of how to legislate for a fast-moving industry in which there is so much opportunity and so much danger, but also so much uncertainty.

The noble Lord, Lord Hunt, and the noble and learned Lord, Lord Woolf, called for sunset clauses. Here I must express some scepticism. Sunset clauses would emasculate a Bill that is meant to give regulators the powers to be effective and to future-proof medical regulations in a fast-changing industry for many years to come. We must understand the impact on an industry that needs regulatory certainty or else, as many noble Lords have noted, will move elsewhere.

I firmly agree with my noble friend Lord O’Shaughnessy that the Bill gives us the ability to respond flexibly in future to regulate, for example to support the transformation of community pharmacy, to respond to innovations in the market and to improve standards of scrutiny of medical devices. Without the powers in the Bill to update the existing comprehensive regimes, we will be in danger of having static rules that could jeopardise patient safety. We must not allow ourselves to end up in this position.

The noble Baroness, Lady Barker, suggested that there is no scrutiny of the regulations generated under this Bill, but in fact the regulations come back to Parliament and cannot be enacted without scrutiny. I assure the noble Baronesses, Lady Andrews and Lady Walmsley, that we are certainly listening carefully. We are open to ideas for improving the Bill.

I welcome the constructive remarks by my noble friend Lord Lansley, my noble and learned friend Lord Mackay and the noble and learned Lord, Lord Woolf, on the building of a clear framework for the Bill. I have sought to outline such a framework in my remarks on patient safety, availability and attractiveness. I anticipate that these thoughts will be developed ahead of Committee and I look forward to further discussions on these points.

On China and organs, I have heard clearly the points of the noble Lords, Lord Hunt, Lord Collins, Lord Sheikh and Lord Alton, the noble and learned Baroness, Lady Butler-Sloss, the noble Baronesses, Lady O’Loan and Lady Northover, and my noble friends Lord McColl and Lord Ribeiro on imported human tissue, the suggested role of British firms in enabling this trade, the plight of the Falun Gong and the Uighurs, and potential forced organ donors. As the noble Lord, Lord Alton, put very clearly, the idea that British companies are profiting from these trades is abhorrent.

The noble Lord, Lord Collins, is right that we have one of the most ethical regimes for human tissue use in the world, and I share his concerns that we should in no way enable a horrible trade. I recognise that noble Lords are concerned about reliance on overseas reassurances, as outlined in the Human Tissue Act, and I hear these arguments clearly. I note that the noble Lord, Lord Alton, and the noble Baroness, Lady Finlay, will bring an amendment with the support of other noble Lords, including the noble Lord, Lord Balfe, and my noble friend Lord McColl. I reiterate my offer to the noble Lords, Lord Alton and Lord Hunt, and the noble Baroness, Lady Finlay: I would be happy to meet them to discuss this in further detail and will take this up with my noble friend Lord Ahmad, Minister for South Asia and the Commonwealth.

On EU exit, I am committed to ensuring that the UK has one of the best regulatory regimes that ensures patient safety and that patients benefit from innovative products. My noble friend Lord Lansley and the noble Lords, Lord Turnberg, Lord Kakkar and Lord Sharkey, raised the EU clinical trial regulations, which are currently expected to take effect during 2022. I am committed to ensuring that the UK’s regulatory framework for clinical trials is geared towards providing the best possible environment that takes into account the needs of patients, industry, non-commercial researchers and hospitals. That is why this Bill is so critical. The powers will ensure that we have the flexibility to adapt our regulatory framework and that the UK retains a thriving clinical trials environment, so that those engaged in clinical trials can continue to develop innovative and cost-effective treatments that both benefit patients and boost growth.

To the noble Baroness, Lady Morgan, I say that I am totally committed to improving the clinical trials regime. I assure the noble Baroness, Lady Masham, who touched us all with her account of the life-saving efficacy of modern medicines, that we are looking to give the MHRA the resources it needs to provide the best regulations and to give horizon-scanning intelligence and industry insight to help innovation.

The noble Lords, Lord Clement-Jones and Lord Freyberg, highlighted the importance of data. We are considering how to improve the regulation of software-driven devices, including AI and algorithms, and will consult on this. The Bill provides a power to make regulations about the use of data collected for the purpose of preventing the supply of falsified medicines.

Currently, the EU scheme information held on the system can also be used for the purpose of reimbursement, pharmacovigilance and pharmacoepidemiology. Determining the best model for the UK will be subject to consultation and parliamentary scrutiny of the proposed regulations. I will be happy to follow up with further detail in writing.

To my noble friend Lord Balfe, whose knowledge of European democratic structures is extensive, I say that we should embrace the opportunity we have now to discuss our own future and regulatory system here in this place. However, we should continue to work with our international partners.

A number of noble Lords referred to the importance of co-operation with the EU and EMA. As outlined in our approach to negotiations with the EU, we want to agree with the EU an annexe on medicinal products to facilitate trade and support high levels of patient safety.

The noble Lords, Lord Hunt and Lord Rennard, referred to the guidance published yesterday on standstill arrangements. We recognise the importance of continued access to medicine and medical devices. Therefore, to ensure continuity of supply of medicines and medical devices from 1 January 2021, the UK will unilaterally recognise certain EU regulatory processes for a time-limited period. By communicating this well in advance of the end of the transition period, we are providing industry with clarity on the preparations that need to be taken for the 1 January and beyond to ensure the supply of vital goods to UK patients. I would be happy to meet the noble Earl, Lord Devon, to discuss his concerns.

The noble Baroness, Lady Ritchie, referred to arrangements in Northern Ireland and I want to underscore that the implementation of the Northern Ireland Protocol is a top priority for the Government.

There is much more that could be said about the debate tonight. It is a testament to the interest in these issues and the importance of getting this right. I welcome the scrutiny of noble Lords in seeking to make the Bill better, as we so diligently try to do when it reaches us.

Bill read a second time and committed to a Grand Committee.