Medicines Regulation

Heidi Alexander Excerpts

Tuesday 21st November 2017 Westminster Hall

[Heidi Alexander (Lewisham East) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Davies. I congratulate my hon. Friend the Member for Bishop Auckland (Helen Goodman) on securing the debate and on introducing the topic in such a comprehensive manner.

This debate is both timely and hugely important. It is timely due to the announcement yesterday that Amsterdam is to become the new home of the European Medicines Agency when it leaves London—a relocation that is necessitated by our departure from the EU, and which also symbolises the changing regulatory environment—and it is hugely important because, although the word “medicine” conjures up images of bottles of cough medicine being bought over the counter, it encompasses the whole range of drugs and pharmaceutical products used to treat the many different illnesses, diseases and chronic conditions that could affect each and every one of us over our life course.

If we think the EMA leaving London is bad, the potential implications of the UK leaving the EMA are far worse, and we should be clear—leaving the EMA is precisely what the Government envisage happening. As the Health Secretary said when he appeared before the Select Committee on Health in January this year, he does not expect us to stay in it. The Prime Minister’s ideological red line on European Court of Justice jurisdiction makes it impossible. The loss of 900 jobs and all the associated economic activity brought to our country as a result of the EMA being headquartered in London pales into insignificance when we contemplate the possible consequences of withdrawing ourselves from the EMA’s pan-European drug-licensing processes and its supervisory and compliance mechanisms, which have a key role in ensuring that medicines on the market here are safe and effective.

The Government have given little information about how their desired future close co-operation with the EU might work on medicines regulation. Indeed, as recently as July, the chief executive of the Medicines and Healthcare Products Regulatory Agency, the national regulatory body that works alongside the EMA in the UK, suggested that two options were being considered by the Government. One is a partnership approach, where presumably the UK would seek to mirror future EU authorisations in order to maintain regulatory equivalence going forward; the second is a stand-alone system, whereby the UK could diverge from EU regulations, perhaps aligning itself more closely with American, Australian or Canadian systems.

[Mr Gregory Campbell (East Londonderry) (DUP)]

Would the hon. Lady agree that, whatever route the Government decide to take, one of the things that we must protect—this was alluded to earlier in the debate—is the excellence of the research and development facilities that we have across the United Kingdom? That must be paramount in the considerations by the Government, as we go beyond March 2019.

[Heidi Alexander]

I agree with the hon. Gentleman, but when I speak to scientists at institutions across the UK, they are already seeing the effect of last year’s referendum result in terms of EU-wide partnerships being withdrawn and being harder to secure.

It would be helpful if the Minister could update us on which of the two approaches the chief executive of the MHRA talked about in July the Government now favour. It would also be helpful if he could tell us what discussions he has had with Ministers in the Department for Exiting the European Union or with the EU negotiating team about future co-operation on medicines regulation. Has the Minister or anyone from the Department of Health had contact with Australia and New Zealand about potential alignment with their regulatory systems?

I have a lot of questions for the Minister today. Can he be clear about the Government’s plans for the so-called transition period that the Prime Minister thinks will follow the conclusion of the article 50 negotiations? After all, it is a mere 16 months away. If pharmaceutical businesses will have to deal with only one set of changes, as the Prime Minister promised, presumably the licensing arrangements for new drugs will stay the same for that period.

I see two main problems in setting up some sort of stand-alone replica system to fill the gap vacated by the EMA if we leave the EU. First, will UK patients get the same quick access to new innovative drugs that come on to the market? Secondly, will UK patients benefit from the same high levels of safety and compliance checks that the EMA currently performs for already-authorised medicines in its role in enforcing standards in the pharmaceutical manufacturing process and at clinical trial sites?

I fear that we could see delays in new drugs being launched in the UK. If a small pharmaceutical company has to choose between paying to get a licence in the EU, which accounts for 25% of the global pharmaceutical market, and paying for one in the UK, which accounts for 3% of the global market, which will it choose? The UK is currently a priority location for launching new innovative treatments, but how long before we become a second-tier country?

What guarantees can the Minister give about the next phase of immunotherapies, which are three to four years away from coming to market? They are potentially twice as effective as current immunotherapies and could give cancer sufferers an extra three to four years of life. Will UK patients in a post-Brexit regulatory environment get them as quickly as they would if we were still part of the EMA? Can the Minister guarantee that adverse effects among uncommonly used drugs will be picked up as quickly if the expanded patient pool that would be available for checks across the EU is limited to the UK? Will the UK still have access as quickly to orphan drugs to treat the rarest of diseases, for which pharmaceutical companies have less of an incentive to develop products? What about the participation of UK patients in pan-European clinical trials, which are critically important, full stop, but all the more so for rare diseases and illnesses in children, for which the patient pool is smaller? At the moment, a quarter of cancer research clinical trials involve one or several European countries. Will we comply in the future with the new EU clinical trials regulations, which have been postponed and may not be implemented until March 2019?

The Minister needs to answer many questions if the Government intend to diverge from European processes, but there will be basic problems no matter what new system is put in place. How much will all of this work to reinvent the wheel and beef up our regulatory bodies cost? Will we have to ask UK taxpayers to pay a greater amount for this process, given that we currently share the cost with 27 other member states? What preparatory work has the MHRA done to ascertain what the impact of leaving the EMA will be on both its income and its future staffing requirements? What training of staff will need to be done so they can take on responsibility for tasks they have not previously performed? What impact will the relocation of the EMA have on medicines regulation across the whole of Europe?

I read the EMA’s Brexit preparedness business continuity plan yesterday, and I admit to having a feeling of utter shame about the disruption that our decision to leave the EU has forced on that agency. The huge upheaval will undoubtedly have an impact not just on this country but on others, too. As anyone who has ever moved office knows, projects get put on hold and the basics become harder to deliver.

There are so many questions to ask, and I am sure I have not touched on even half of them. I would like to finish with some more general observations. In 10 years’ time, when we have delayed access to new cancer treatments, compared with, say, France or Germany, will the fact that we have blue passports make up for it? Children with rare diseases will not be able to get new drugs as quickly or easily as they can now, but is that a price worth paying for coming out of the jurisdiction of the ECJ? This is all utter madness. Ministers can bang on about creativity in the negotiations all they like, but we need certainty and clarity. Pharmaceutical companies and patients need certainty and clarity, and the mums and dads of seriously ill children need that, too.

--- Later in debate ---

[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.

[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—

--- Later in debate ---

[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.