Medicines Regulation

Helen Goodman Excerpts

Tuesday 21st November 2017 Westminster Hall

[Helen Goodman (Bishop Auckland) (Lab)]

I beg to move,

That this House has considered the future of medicines regulation.

What a pleasure it is to see you in the Chair, Mr Davies. I am very pleased that you have been elevated to the Panel of Chairs. Yesterday, the European Parliament agreed to move the European Medicines Agency from London to Amsterdam. Today, we are asking the Minister to tell the British Parliament what will happen to medicines regulation in this country after we have left the European Union. My concern arises from the fact that I have a GlaxoSmithKline plant in Barnard Castle in my constituency that employs 1,200 people. Winston Churchill decided that production should take place in the middle of the Durham countryside, so it would not be hit by Hitler’s bombs; I certainly hope that it will also survive the Government’s Brexit.

[Nick Thomas-Symonds (Torfaen) (Lab)]

I congratulate my hon. Friend on securing this timely and important debate, and declare an interest as the chair of the all-party parliamentary group on off-patent drugs. Does she agree that, irrespective of what happens with the Brexit negotiations, the Government should guarantee that any patient who needs access to drugs will not wait any longer as a result of Brexit?

[Helen Goodman]

In one sentence, my hon. Friend gets to the nub of the issue; I will probably take 20 minutes to reach it. He is absolutely right. The problem is that the Government did not make a plan, and as yet have not resolved how they will regulate medicines from 1 April 2019. I have been asking about that for a year. We have had no clear explanation, no policy statement, and no impact assessment. The Government refused to debate the matter in the course of the legislation for triggering article 50. We have not been able to debate it properly as part of the scrutiny of the European Union (Withdrawal) Bill, which is in Committee today, in parallel with our debate.

We are therefore extremely interested to hear what the Minister will say, especially as two months ago there were leaks from the Department of Health that the Secretary of State was flirting with the idea that we should leave the EMA and join the American Food and Drug Administration. I was particularly surprised that that was being floated, because the Association of the British Pharmaceutical Industry has said consistently that it thinks that we should be aligned with EMA standards. Alignment with Europe on regulation of medicine does not simply mean having the same rules on exit day; it means having a mutual recognition agreement with the EMA, and continued alignment of future regulations as they change, which they inevitably will.

[Jim Shannon (Strangford) (DUP)]

I congratulate the hon. Lady on what she is saying. Obviously, as a Brexiteer, I probably have a very different opinion about what will happen on 31 March, but that is by the bye. Does she agree that it is imperative that the phenomenal work done by the Medicines and Healthcare Products Regulatory Agency and the EMA, which she referred to, can continue? Ensuring that we are able to supply safe and effective medication not simply to the UK but to all nations worldwide must be high on the priority list of the Brexit team. That is something that she and I very much agree on.

[Helen Goodman]

The hon. Gentleman truly is a gentleman, and I agree with him entirely. We want to see continued UK participation in EU regulatory and medicine safety processes as well. The ABPI has also said, reasonably enough, that it wants to maintain trading terms equivalent to being a full member of the customs union, and to have a common system for VAT.

In May, the EMA and the European Commission issued a statement saying that if the United Kingdom does not stay in the single market, stick with the EMA, or join the EEA—the European economic area—but goes for a clean break, drugs made in the United Kingdom will no longer be authorised for use in the European Union, and drugs made in the European Union will no longer be authorised for use in the UK. Tackling that would involve costly and time-consuming checks. It could even mean that the availability of drugs would diminish dramatically.

What response have the Government made to that statement? What practical steps have Ministers taken? All we have seen is a letter from the Secretary of State for Health and the Secretary of State for Business, Energy and Industrial Strategy to a newspaper, which said that they want a “close working relationship” with the EU, and that patient safety matters, as does certainty, long-term stability, and innovation. The letter said that Ministers will set up a regulatory system with competitive fee pricing. This afternoon, we would like the Minister to explain that.

Currently, the UK Medicines and Healthcare Products Regulatory Agency—MHRA—contributes to the EMA’s work, and the UK pays approximately a fifth of the overall costs. It is universally acknowledged that the MHRA could not take on the task of licensing all drugs without astronomical costs for the industry and the taxpayer.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Is part of the problem not that there appears not to have been a specific assessment of all the health-related impacts of leaving the EU?

[Helen Goodman]

I agree entirely. We tabled amendments when the article 50 legislation went through requesting impact assessments on many things, including the effect of possibly leaving the EMA, and we have not heard about them. That is extremely alarming, because it gives the impression that Ministers are basing decisions not on fact and analysis, but on prejudice and assertion—not a very good basis when it comes to health or economics.

This issue matters because life sciences and pharmaceuticals is one of the UK’s most successful industries. The combination of first-class scientific research in our universities and high-quality manufacturing means that we have been exceptionally successful. The life sciences employ 220,000 people—of which pharmaceuticals accounts for 90,000—in good quality, well-paying jobs. They are careers, not gigs. The industry is innovative and internationally competitive. In fact, it has the highest manufacturing gross value added, which means that every employee contributes £330,000 to the British economy every year. The value of our exports is £30 billion. Obviously, the industry wants to continue in those collaborations and develop new medicines.

One of the major costs in pharmaceuticals is research and development; another is complying with regulations. Inspections take several days, and internationally there are two dominant regulators: the EMA, which looks at about a quarter of all drugs globally, and the American FDA, which looks at about a third. Clearly, we do not want regulatory complexity, because that would simply add to costs. As Andrew Witty, the former head of Glaxo said, when the regulatory systems of 27 European countries were unified into one, that was a big deal.

Ministers need to keep in mind that the pharmaceutical industry is international and highly mobile. There is world-class production in France, Switzerland and America, and generics are made across the globe, in China and India. Senior executives answer to their shareholders; if it is cheaper to move, they will, so we need to do everything we can to keep costs down in this country. Quite honestly, I cannot understand why Ministers do not just commit to staying in the EMA—it is so obviously the cheapest and simplest solution—but their crazy ideological obsession with escaping the European Court of Justice means, to quote the Secretary of State for Brexit, “putting politics above prosperity”.

What is even worse is that Ministers are cutting across their own stated principles and are creating a highly uncertain environment. Business needs certainty to invest. For example, in my constituency, a new production facility was started a year ago. It will cost £120 million and will take four years to come into production. We are now only 16 months away from 1 April 2019, but yesterday, AstraZeneca wrote to Members of Parliament to say that it needs a transition period of two to three years.

The Prime Minister made things worse—I do not think she intended to, but she undoubtedly did—when, in her Florence speech, she said there would be a transition period. Everybody imagined that there would be time to look at what the post-Brexit regime would be, to have clear negotiations and to make a plan—to go through everything in a systematic way. Her insistence on putting the March date into legislation shrank that time overnight, from 40 months to 16 months.

Industry is taking decisions now. One plant has already closed in Southampton. GSK is implementing its contingency plans nationally, which include relocating some members of staff to other European Union countries. In Barnard Castle and Ulverston, it is reviewing the production of cephalosporins, which my hon. Friend the Member for Barrow and Furness (John Woodcock) will talk more about later in the debate.

But this is not just about jobs; it is also about health. Every month, the United Kingdom sends 45 million medicine packets to Europe and we receive 37 million medicine packets from Europe. Some 80 million people need those medicines. Border delays in the medical supply chain will affect not just the final product but intermediate production, especially where we are talking about time and temperature-sensitive drugs, such as for cell and gene therapy. More than 2,600 final products have some stage of manufacture in the UK. Delays as they cross the border during production could mean the loss of lives. That is why the Association of the British Pharmaceutical Industry and its European counterparts wrote a joint letter to Monsieur Barnier, the European negotiator, and the Brexit Secretary of State, to sort this out promptly. Ministers should put patients and public health first, and should start co-operating with the European Union on solving this problem. Given the long lead times, they need to speed up the work and sort out the transition phase.

I have seven questions for the Minister. Will he rule out introducing a freestanding, new, regulatory structure? Will he rule out incorporating the MHRA into the American FDA? Will he confirm the Government’s stated aim of keeping British regulation aligned with the EMA’s European regulation? Will he tell us what moving the EMA and setting up a new regime will cost? Will he set out the legal basis for our continued co-operation and participation in the EMA system from 1 April 2019? Will he say how he intends to legislate? And will he commit to more than another 90-minute debate on an affirmative statutory instrument? If he cannot even do that, half of the debating time that Parliament will have on this important subject will be this afternoon.

--- Later in debate ---

[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.

--- Later in debate ---

[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.

--- Later in debate ---

[Helen Goodman]

I am grateful to all hon. Members who took part in the debate. The Minister clearly understands why medicines regulation matters and shares our interest in making it work, but I and other hon. Members asked many questions and, to be honest, the only conclusive answer that he gave was that we will not join the American FDA. I would therefore be grateful if officials provided us with written responses to those questions. I know that the Minister does not deal with this area on a day-to-day basis, but I am concerned that the Department seems to have made little progress since 4 July, which was four months ago. That will not do. Hon. Members present would like a private meeting with Lord O’Shaughnessy, the Minister’s colleague in the Lords with day-to-day responsibility for this area, who obviously was not able to participate in this debate, so that we can press him on some of the details.

Question put and agreed to.

Resolved,

That this House has considered the future of medicines regulation.