Medicines Regulation

Debate between Heidi Alexander and Gregory Campbell

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.