Medicines Regulation

Steve Brine Excerpts

Tuesday 21st November 2017 Westminster Hall

[John Woodcock (Barrow and Furness) (Lab/Co-op)]

It is a pleasure to serve under your chairmanship, Mr Davies. It is unfortunate that I am following two superb contributions. I congratulate my hon. Friend the Member for Bishop Auckland (Helen Goodman) on securing this important and timely debate. She and my hon. Friend the Member for Lewisham East (Heidi Alexander) spoke powerfully and persuasively about the risks that the UK pharmaceutical industry in its entirety faces. I am not going to attempt to add to what they said and the questions they asked. Rather, I am going to focus on the cephalosporins business, which is carried out on three sites, two of which are in the UK—in the constituency of my hon. Friend the Member for Bishop Auckland and in Ulverston in my constituency, where there is a genuinely world-class sterile facility where the drugs are created. They are then placed in a powder form in Barnard Castle and in vials in Verona.

As the Minister is surely aware, there was great celebration in Ulverston, and it was heralded by the then Prime Minister and Chancellor, David Cameron and George Osborne, when David Cameron visited the day after the 2012 Budget and made a Budget roll-out announcement that GSK was going to be investing at least £350 million in a new biopharm pharmaceutical facility, largely as a result of the patent-box tax legislation, which the Conservative Government continued from Labour’s innovative tax policy, introduced by Prime Minister Gordon Brown. In July, GSK announced—out of the blue, for all intents and purposes—that it is going to pull that investment and scrap the entire project, leaving our community devastated. Not only that, but it is launching a strategic review of the existing cephalosporins business, which has been running for decades across both sites and is growing in profitability and potential.

Although cephalosporins are not a new product, they are well established. British manufacturing of such products in Ulverston and Barnard Castle, and across into the EU in Verona, has enabled them to penetrate new markets and benefit many more critically ill patients in hospitals. They are the very strongest antibiotics, and are typically used in hospitals for people with very serious vulnerabilities and infections. That business had and has a great future, but GSK has clearly signalled at a corporate level that it wishes to divest. Officially, that is a review of the business, but the company at the highest level is clear that it wants to find a new buyer.

When the company dropped its bombshell in July, it was clear and categoric that the decision was not as a result of Brexit. The company took care to say that, and we have to take it at its word. We can detect the thinking of the new chief executive officer, Emma Walmsley—a Barrovian, by the way, which has made the decision all the more stinging—that GSK wants to focus on fewer products, completely cutting some and potentially divesting itself of others. Although Brexit may not have triggered that deeply worrying blow to pharmaceutical manufacturing in the north of England, however, it is certainly a significant factor in whether we will be successful in finding a new buyer for the plant who is prepared to invest and to take the business to new heights, sustaining the employment of people in my constituency and in Barnard Castle, as well as creating more jobs in the decades ahead.

Every business, in no matter what sector, operates on the basis of wanting certainty and stability and of not liking uncertainty or the potential risk in what is at the moment the complete lack of clarity that the Government can give on the future of the regulatory environment for medicines in this country. I therefore really hope that the Minister is listening to what we are saying.

In another sector that is enormously important to our regional economy, civil nuclear, we do get a sense that, at the ministerial level at least, the Government are working hard to overcome this—I absolutely agree with my hon. Friends—absolutely nonsensical decision to rule out anything based on ECJ jurisdiction, thereby creating all the problems. We need to hear from the Minister that he is prepared to do whatever it takes to ensure that the transition is seamless. He should not only produce something a year down the line but give a level of certainty now, ready for GSK in Ulverston to attract new buyers to the site.

The Minister might be aware that I have formed the GSK Ulverston taskforce—which brings together community stakeholders and the site directors, with input from the Department for Business, Energy and Industrial Strategy and the local authorities—to ensure that we all maximise the chances of attracting a new investor. The decision will principally be a commercial decision, of course, but the Government can help in many ways. I would say that they have a duty and a responsibility to help, given the level to which they heralded the new jobs that have now been cancelled.

Other important areas include infrastructure, but I do not expect the Minister to go into those today. He can, however, acknowledge the difficulty that uncertainty causes to attracting new investors. I hope he will give more certainty today, and he should certainly undertake to go away and come back in short order to inform Parliament of what the relationship will be, so that the Government and we as a taskforce can better communicate that to the stakeholders.

My final request is that the Minister or his counterpart in the other place, Lord Howe—

[The Parliamentary Under-Secretary of State for Health (Steve Brine)]

Lord O’Shaughnessy.

[John Woodcock]

Lord O’Shaughnessy—apologies, the previous Minister in the Lords has moved on. I thank the Minister here for the correction. I hope that he or Lord O’Shaughnessy will meet with me, my hon. Friend the Member for Bishop Auckland and other members of the taskforce. Lord Prior was really helpful when he spoke to me on the day of the announcement but there has been significant progress since then and many more challenges need to be met. If the Minister undertakes to make that happen, it will be very helpful.

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[The Parliamentary Under-Secretary of State for Health (Steve Brine)]

I will do my best, Mr Davies.

I congratulate the hon. Member for Bishop Auckland (Helen Goodman) on securing this debate. Medicine regulation is a critical issue that I know she has raised many times in the House. This is probably the quietest Westminster Hall debate that I have responded to, but that does not mean that it is not one of the most important—there are competing issues in the main Chamber today. The fun that we are missing!

Modern medicine is transforming. We are moving from an era in which drugs and devices were mass produced and marketed to millions of patients globally, to one in which new medicines and therapies will increasingly be designed and personalised for individual patients. The chief medical officer’s annual report earlier this year on genomics was a landmark piece of work, and it set out how that will revolutionise our ability to diagnose and treat illness in the future. It is within that context that we discuss medicines regulation. Put simply, if the future regulation of medicines does not keep up with the pace of development for those medicines, patients in the UK, and internationally, will not have access as quickly as they should to transformational new treatments. That would be a bad thing.

While answering as many questions as I can, let me outline the world-leading work of our domestic medicines regulation, the Medicines and Healthcare Products Regulatory Agency, as well as our plans for the future in the context of Brexit. The MHRA has been our national regulator for more than 30 years, and it has acted as the lead regulator for more than 3,500 medicines now on the EU market. It is recognised globally as an authority in licensing, inspections and batch release and through its pharmacovigilance—a great word—and medical devices regimes. It plays a leading role in protecting and improving public health through the regulation of medicines, medical devices and blood components for transfusion services. In addition, the agency hosts two organisations that, although little known, play an important role in supporting the development and use of medicines. The agency’s clinical practice research datalink uses anonymised NHS clinical data to keep patients safe and aid the development of new drugs, and the National Institute for Biological Standards and Controls develops global standards for the use and control of more than 90% of biological medicines used globally.

[Helen Goodman]

When preparing for this debate, it occurred to me that some of these issues apply also to animal health. Is there any responsibility for animal health in these institutions, or do we need to ask DEFRA Ministers about that separately, on another occasion?

[Steve Brine]

I think it is the latter, but I will check and come back to the hon. Lady on that point.

[Dr Whitford]

The veterinary medicines division is part of the EMA, so it comes under that—I am not sure whether that is what the hon. Member for Bishop Auckland (Helen Goodman) was asking.

[Steve Brine]

I thank the hon. Lady; she is always there when we need her.

As I was saying, those skills and expertise have allowed the MHRA heavily to influence global practice and regulations, which is why I say it is a world leader. A majority of medicines available in the UK—around 90%—already receive a national UK licence issued directly by the MHRA. It also leads the assessment of more than 20% of new medicines licensed by the EMA, with particular expertise and specialism in more complex new drugs that come to market. Similarly, on medical devices, five of the EU’s 55 notified bodies are in the UK, and they undertake a disproportionate amount of work. We estimate that they assess between 50% and 60% of the highest-risk devices on the EU market—a big player.

The strengths of our world-leading regulator are similarly reflected in the UK’s life sciences sector. The UK has one of the strongest and most productive life sciences industries in the world, with more than 5,000 companies, more than 233,000 employees, and an eye-watering turnover of more than £63.5 billion each year. It also provides products that the NHS and patients rely on every day—I know that the constituency of the hon. Member for Bishop Auckland has seen the benefits of that productive industry.

GlaxoSmithKline announced this year an investment at its Barnard Castle facility in Teesdale, as part of a wider £140 million investment in the expansion of manufacturing HIV and respiratory medicines. However, we cannot be, and are not, complacent, and we must continue to work hard to support the industry, and we have done just that. The industrial strategy Green Paper was launched in January this year, and it set an “open door” challenge to industry to come up with proposals to transform their sectors through various sector deals.

[Heidi Alexander]

I am grateful to the Minister for his exposition of the current state of life sciences in the UK, all of which we could probably find out if we typed a few words into Google. May I bring him to one of the first questions, which is of pressing importance? What will the regulatory environment be for pharmaceutical companies that wish to get a pan-European licence in April 2019, during the so-called transition period envisaged by the Prime Minister, following the conclusion of negotiations on article 50?

[Steve Brine]

I will come to that.

[Heidi Alexander]

Please, come on. Just get straight to it.

[Steve Brine]

We should always try to be courteous to one another in this House, if we can manage that. To refer to the previous point, DEFRA is responsible for animal medicines policy; EMA covers both human and animal medicines. The Department of Health and DEFRA work incredibly closely together; therefore, DEFRA Ministers answer on applications for animals. I can assist with that at any time.

We are working with Sir John Bell and others in the life sciences sector to consider the industrial strategy in more detail, and specifically what action can be taken by Government and industry in partnership through an ambitious sector deal. At the launch of “Life Sciences: Industrial Strategy”, the Secretary of State for Business, Energy and Industrial Strategy, who has been much spoken of already in this debate, reiterated the Government’s commitment to the sector by announcing the first phase of their investment—£146 million for leading-edge healthcare, which is expected to leverage more than £250 million of private funding from the industry.

Leaving the EU, with all its challenges, allows us to make fresh choices about how we shape our economy and presents an opportunity to deliver a bold industrial strategy that prepares us for the years ahead. Our approach to the EU exit negotiations for medicines regulation is focused on building on the strengths of the MHRA and the UK life sciences sector that I have just set out. As the UK leaves the EU, both parties will have the shared aim to protect the health of patients across Europe and to ensure the safe and timely access to medicines and medical devices that I know concerns hon. Members as it concerns me. It is in the interests of patients and the life sciences industry for us to find a way to continue UK-EU co-operation and to ensure continued sharing of data, even if our precise relationship with the EU will, by necessity, change.

Earlier this year, the Secretary of State for Health and the Secretary of State for Business, Energy and Industrial Strategy published an open letter in the Financial Times setting out Government’s aim to retain a close working partnership in respect of medicines regulation after the UK leaves the EU. Our approach is underpinned by three key principles, which are worth stating. First, patients should not be disadvantaged; secondly, innovators should be able to get their products into the UK market as quickly and simply as possible; and thirdly, the UK should continue to play a leading role in promoting public health.

Yesterday, obviously, the new location of the EMA was announced; in 2019 it will move to Amsterdam. Both the UK and the EU have a collective responsibility to make sure that the process is as seamless as possible, in order to minimise disruption to existing regulatory procedures and public health protection. There are no benefits to UK or EU patients in tearing up the sort of close working relationships that get crucial drugs on the market as fast as possible, share early alerts about problems with medicines or allow patients to benefit from new scientific discoveries earlier. As the Prime Minister has said, there is also no need to impose tariffs where we have none now, which is the case for medicines and medical technologies.

Continued collaboration is in the interests of public health and safety across the continent of Europe, and in the UK for our constituents, because we all know that health is different. Medicines and med tech are different from other consumer products. Patients who need an innovative treatment cannot simply pay more or consume less but otherwise carry on as they were, marginally worse off. We recognise that it could be the difference, as has been said, between life and death. We look forward to discussing these issues as early as possible with our EU counterparts as part of the negotiations.

[John Woodcock]

Presumably the Minister recognises the need for cross-border manufacture with European nations to remain absolutely seamless. The issue of cephalosporins in GSK affects not only in Barnard Castle and Ulverston but Verona, which obviously is in Italy.

[Steve Brine]

Yes, of course. I want to come on to the many different questions asked. The hon. Member for Central Ayrshire (Dr Whitford) said that Scotland would have bid for the EMA if it had voted yes a couple of years ago. I do not think that it would have done, because it would not have been a European Union member state.

[Heidi Alexander]

I am grateful to the Minister for giving way. Mr Davies, I hope that it is not out of order to say that the Minister does not quite seem himself. If he is poorly, and my earlier remarks were somewhat curt, I apologise for them.

It would help everyone here to understand the Government’s overriding objective for medicines regulations in a post-Brexit environment. Do we intend to automatically follow EU authorisations in future, or does the Minister foresee divergence from EU regulations?

[Steve Brine]

rose—

[John Woodcock]

On a point of order, Mr Davies. If the Minister is struggling and feeling unwell, is there a way in which we could bring the debate to an earlier close and he could write to us in response to our questions? I am concerned by how he seems.

[Geraint Davies (in the Chair)]

The Minister is the last speaker. He can stop the debate at any time, at which point I will ask Helen Goodman to make her closing remarks for two minutes. Feel free to end whenever you feel is appropriate, Minister.

[Steve Brine]

Thank you; I am not feeling unwell at all.

In the event that it is not possible to reach a deal that secures ongoing, close collaboration between the UK and Europe, we will set up a regulatory system in the UK that protects the best interests of patients and supports industries so that they can grow and flourish, as set out in the letter in the Financial Times. We will ensure that our system is robust and does not impose any additional bureaucratic burdens. Our successful past should give us confidence in achieving a prosperous future, whatever form that takes. I want to be clear that that is not a threat to the EU27. I must be honest and transparent in saying that if it is not possible to secure close collaboration, we will of course look to put in place an effective system and work with international partners in a way that best protects patients and supports industry and innovation.

I will attempt to answer some of the many questions that the hon. Member for Bishop Auckland put to me. I can rule out a free-standing structure incorporated into the FDA. She asked how much the EU expects us to pay towards the cost of relocating the EMA. The arrangements for withdrawing from the EU, including any financial settlement, is a matter for the withdrawal agreement, as she knows, as part of the ongoing article 50 process. The Government are absolutely committed to working with the EU to determine a fair settlement for Britain’s exit and the best deal for UK taxpayers. As part of the exit negotiations, the Government will discuss with the EU and other member states how best to continue co-operation in the field of medicines regulation, in the best interests of business, citizens and patients in the UK and the EU. I do not think that it would be appropriate, nor is it possible, for me to prejudge the outcome of those negotiations. There are many who would love that crystal ball, but I do not have it.

[Helen Goodman]

One can envisage a situation in which medicines are assessed in the European Union and in the UK and there is an agreement for mutual recognition between those institutions. That, one can picture. But what I cannot understand, if we are not all in one system, is how—down the track when medicines are used—if something goes wrong, the Europeans can have a claim on us or we could have a claim on them if we do not share the ECJ institutional machinery.

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[Steve Brine]

I share the hon. Lady’s concern. As I said, so much about this is still subject to negotiation. I cannot give her the exact assurance that she wants at this time.

The hon. Lady also asked about the EU exit transition. The Government are clear that we want to continue collaborating with the EU in the interest of protecting patient safety. The detail of any future relationship is, of course, subject to that negotiation. That is nothing new. We recognise completely that new arrangements can take time to implement, and we will work closely with the industry and key health system partners to ensure smooth implementation. The European Union (Withdrawal) Bill, which is going through the House at the moment, will ensure that a known legal framework is in place immediately after we leave the EU.

The hon. Lady talked about the Secretary of State “flirting” with leaving the EMA for the FDA. Earlier this year, the Secretaries of State for Health and for BEIS published a letter in the Financial Times setting out our aim to retain a close relationship in respect of medicines regulation. The FDA has been clear that it would not let another country “join” FDA processes even if we wanted to, but if we are outside EU processes, we will certainly look at how we can co-operate more closely with other global regulators.

The hon. Member for Lewisham East (Heidi Alexander) asked whether we had had contact with Australia and New Zealand. The chief executive of the MHRA chairs the International Coalition of Medicines Regulatory Authorities, and we of course have had discussions through that group on a contingency basis with Canada, Australia and others about the potential for greater collaboration once we have left the EU.

The hon. Lady asked whether I can guarantee that the adverse effects of drugs will be detected quickly. She also asked about orphan drugs and clinical trials. Increasingly, information about the adverse effects of drugs is shared at a global level. The EMA collaborates with many third countries. There is no need for a broad deal to agree to share safety information. We want to continue collaboration with the EU on orphan drugs for rare diseases, which she rightly pointed out are a subset of the wider issue. If we are outside EU processes, we will need to consider incentives for orphan drug development, and we are doing that. Clinical trials all receive national approval today, and they will receive approval under the EU clinical trials regulation, which is due to come into force in late 2019. The UK will remain a leading centre for clinical trials. There is no reason why multi-country trials cannot include the UK after Brexit.

Several Members, including the shadow Minister, the hon. Member for Ellesmere Port and Neston (Justin Madders), asked about MHRA resources. Some 90% of medicines on the UK market already have a national licence from the MHRA; fewer than 10% come via work that we do for the EMA. We have world-renowned scientific assessors at the MHRA. Some work and workloads may change post-Brexit, but I do not think that claims of fundamental change are correct. MHRA has full contingency planning in place.

[Justin Madders]

On that point, can the Minister confirm that Department of Health budgets will not be used to fund any additional MHRA costs?

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[Steve Brine]

I know that the hon. Gentleman asked that question. I cannot confirm that today—I am sorry—but when I can, I will.

A couple of Members, including the hon. Member for Central Ayrshire, talked about the absence of impact assessments of the health implications of leaving the EU. I fully concur with Members’ concern that complex discussions about the future of medicines regulation were not at the forefront of the referendum campaign. That is obvious. That is the problem with referendum campaigns. That is about as far as a diplomatic Minister can go. Sadly, the subject did not feature on the side of any buses. However, as part of our work on preparing to make a success of our departure from the EU, we are carrying out a full suite of economic analyses, as any Government would be expected to do. That means looking at 58 sectors, including life sciences, and at cross-cutting regulatory, economic and social issues. It will of course take time to collate that information and ensure that it is informative and accessible. We will provide it to Parliament as soon as possible.

[Dr Whitford]

Is the Minister aware of whether an impact assessment is being done with regard to health, not as part of the economy but as a benefit to people in the UK?

[Steve Brine]

There is a huge body of work going on in the Department about the impact of Brexit on every single area of every single Minister’s responsibility.

[Heidi Alexander]

What assessment has the Minister made of how staying in the European economic area might impact medicines regulation, were we to go down that route instead of the one the Government are currently pursuing?

[Steve Brine]

The hon. Lady asks me to visualise all the different scenarios for the current negotiations. We have been clear that we want a comprehensive deal. A number of Members mentioned that no deal is some sort of ideological obsession for some Government Members. That may be true, but they do not speak for Government policy. We are not looking for no deal; we are looking for a comprehensive deal.

The hon. Member for Barrow and Furness (John Woodcock) asked about meeting my colleague Lord O’Shaughnessy. I cannot speak for my colleague’s diary, but I will speak to him. If he cannot meet the hon. Gentleman and his taskforce, I will. The hon. Gentleman always speaks passionately for his constituency, and I am more than happy to try to sort that out for him.

The hon. Member for Central Ayrshire raised a concern about safety data. That absolutely should always be shared at a global level. The MHRA leads about a third of the EU’s pharmacovigilance work. The EMA already shares data with third countries. It is in all our interests for that to continue. If we are outside EU regulatory procedures, we will ensure that the UK remains an attractive market and that regulation does not delay patient access. A number of Members expressed concern about that, and it is a concern of mine, which is why it is a priority for us.

[Dr Whitford]

Does the Minister recognise the data protection issue? Some people have suggested that the UK will be in a position to follow its own line on utilising data. Ending up on the outside as an untrusted country—or as an untrusted set of countries within the UK—would obviously kill our ability to take part in clinical trials and research.

[Steve Brine]

It would. That is why, as the hon. Lady knows, we are working extremely hard not to be in that position. As ever, she makes her point well.

Whatever our future relationship with the European Union on the regulation of new drugs, the MHRA, our world-leading regulator—I have mentioned some of the reasons why it is world leading—will be empowered to protect patient safety both in the UK and internationally. We will also ensure, as everyone said, that patients are at the forefront of our thinking and do not get new drugs any slower than they do now.