Medicines Regulation

Philippa Whitford Excerpts

Tuesday 21st November 2017 Westminster Hall

[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.

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

I too congratulate the hon. Member for Bishop Auckland (Helen Goodman) on securing such an important debate. Unfortunately, it is competing with the main arena, so this Chamber is not full.

I do not think that people yet recognise what the impact of Brexit on medicines regulation will be. The EMA represents all the countries within the European economic area, their drug-licensing bodies having come together in 1995, and it has been based here in London. That has been of huge benefit to London, not only as a result of the 900 jobs mentioned but as a result of world pharmaceutical industries—especially Japanese and other Asian ones—basing their European hubs here.

There is no question that the biggest challenge will be the impact on patients. The EMA assesses and licenses new drugs, and safety-monitors all drugs. It provides the service of pharmacovigilance. Recently we have had debates on the Primodos and valproate syndrome situations, where things have not been spotted early enough. For us to end up outside the European pharmacovigilance system will be a real danger.

The hon. Member for Lewisham East (Heidi Alexander) alluded to the possible delay. As I raised in Prime Minister’s questions way back in January, countries such as Canada and Australia get access to new drugs approximately six months to a year after the UK. The reason why we get early access is that we are part of a market of 500 million, on a similar scale to America. Without that, we slide way down the pecking order.

I am hearing from pharmaceutical firms that it is not just the size of the UK population but the fact that accessing the NHS in the UK takes several years. Given the budget impact assessment that has been added for new and expensive drugs, some firms are beginning to say, “Well, it won’t just be six months to a year; it might be several years, because what’s the point of paying to go through the process early but getting knocked back?” We might have to wait until our price has dropped, in which case Canada, Australia, Japan and so on will all be ahead of us.

Patients get access to new drugs that are expensive through the cancer drugs fund or the New Medicines Fund for rare diseases in Scotland. They also have opportunities through individual patient treatment requests. If the drug is simply not licensed in the UK, however, accessing it would be really problematic.

The EMA has obviously been a driver and organiser of research. As was also mentioned by the hon. Member for Lewisham East, in particular with rare diseases, we would be trying to recruit for research from a population of 50 million instead of 500 million—there is no comparison from the point of view of getting answers. Purely because of such research, breakthrough drugs for rare diseases, in particular children’s congenital and rare diseases, have come on stream over the past 10 years.

The EU is the biggest research network in the world because of Horizon 2020 and all its forerunners. Until last year, the UK was its biggest beneficiary, but we have already slipped down the pecking order to behind Germany. People who lead international research teams are already being asked to step aside; they may take part and co-operate, but they may no longer be the principal investigator. The whole drive of academic, medical and clinical research in the United Kingdom is sliding down. The impact of that is significant.

There are a whole lot of different reasons. We have been talking about certainty, but universities and EU nationals need certainty. We have seen disruption to the EMA, which estimates it will lose 20% of its staff. Many have already left because they have been in limbo, like my husband, a German GP, for the past 16 months. They have therefore jumped before they might be pushed. Others might not choose to move to Amsterdam, even though it is quite an attractive place. As a member of the Scottish National party, I wish the people of Scotland had voted yes in 2014, because Edinburgh and Dundee would certainly be bidding to be a site for the new EMA, as we are also major pharmaceutical researchers.

The loss of the EMA from a business point of view is significant, but the main thing is the impact on patients and people. We will become a third country, and the idea that we can somehow leave the EU and yet keep all the bonuses that we have had is frankly naive. In my constituency I have Merck, a pharmaceutical company that develops drugs, although its main role is providing materials to other pharmaceutical industries—cell growth medium. It is therefore involved in all sorts of complex supply chains. This is just like aerospace. Components and ingredients move backwards and forwards as the drugs are constructed.

The other parts of Merck’s business are quality control and lot release. When drugs arrive in huge quantities they have to go through strict quality control testing, again under the EMA. Up until now such work has been carried out only inside the EU. Merck has three big BioReliance centres in Scotland, which carry out work for other firms. Other firms in my constituency such as GSK—again, I have a big plant—do that in-house. If they have to start moving some of that work to Europe—many pharmaceutical industries are already looking at having bases in Europe for their lot release work—other jobs tend to trickle after them, because gradually the refrain becomes, “We would do better to put everything in one place.”

I am sorry for the hon. Member for Barrow and Furness (John Woodcock), who is losing such a great production centre in his constituency. I wish him well in finding a solution, but in the current uncertainty it is really hard to see what kind of pharmaceutical business will open a new plant in this country. For the big global multinationals weighing up where to put future centres, they might put a small centre in the UK, but sadly they are likely to put their main centres on mainland Europe. We need to deal with these things going forward.

The issue of quality control means we could have drug shortages as well as job losses. Anyone on medication—I put my hand up; I am on multiple medication—will often be handed something in the pharmacy that could be in any one of the EU languages with a little sticker in English on the top. That is because drugs move around all the time. The most important thing is to ensure that we do not get into a no-deal Brexit. Ultra-Brexiteers keep standing up and saying that World Trade Organisation rules are not so bad and would be quite good and advantageous—but that is not the case from the point of view of drugs supply.

The 0% tariff drug list has not been updated since 2010, so on any new drugs developed in the past seven years there would be automatic tariffs. The potential of trying to hang on to things such as BioReliance jobs would simply be impossible because there would be no chance of negotiating mutual recognition agreements or parallel agreements. Going forward we need an assessment of the impact of Brexit on health: everything from EU nationals, the potential threats to health, reciprocity, right through to research networks and how we get our drugs.

What will the MHRA do? It provides about 25% of the assessments for the EMA and it therefore has expertise, but it would need funding if it was to replace the EMA for drugs within the UK. How would we attract big global firms to go through the process when they might not sell any real quantity to the NHS for several years? Would it be suggested that we simply would not charge them? If that were the case, how would we fund it? I assume that in the position of getting a sensible deal around Brexit, the MHRA would try to mirror everything from the EMA, but that simply would not solve all the problems.

We are still in a separate situation. The strength has been in co-operation. There was no discussion before the referendum and no recognition of the benefits we have had from the EU in the past 40 years. Those were never discussed and are being thrown away. The EMA did not increase bureaucracy, but decreased it. Imagine a small firm trying to go through 27 regulatory agencies in multiple languages. That will not happen. The EMA created one thing. The trials regulation system, due in the next year or so, does exactly the same for research: one trials portal.

We also have to tackle the issue of data protection and data sharing. If the UK sees Brexit as the potential to go off the reservation and cuts standards or is sloppy around data and sells the data or does not protect it, we will become a pariah, which will not do our patients any good. The issue is ideologically driven. Nobody with any sense of what brings the biggest benefit for patients within the United Kingdom would think of leaving the EMA. It is driven, as was said in the Health Committee in January, by the need to leave the European Court of Justice, the decision to leave the single market and the decision to leave the customs union. I have a simple plea: why don’t we just not do that? Why not just stay in the single market and accept that we need an arbiter, and that the ECJ is as good an arbiter as any other? We should hang on to the fantastic benefits that we have had from Europe for 40 years.

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[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.

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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.

[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.