Brexit: medicines, medical devices and substances of human origin Contents

2Protecting and enhancing the UK’s position in Europe and globally

Global life science industry

28.The life science industry is increasingly global. Within the EU, the UK benefits from being part of one of the three major global markets. They are the US, EU and Japan.32 Steve Bates, Chief Executive of the BioIndustry Association, described how developments in other countries, such as China and Brazil, mean the UK would be prudent to adopt a global mindset while seeking to maintain a close relationship with the EU.33

29.To exemplify this, he explained how the Chinese government has prioritised its country’s regulation of medicines and medical products, to kick-start their life science industry, saying:

They have essentially retooled their regulatory route with support from the Gates Foundation in the US, and they have very rapidly adopted some of the best practice around breakthrough designation and other things in an endeavour to kick-start their industry … I think this is turning the heads of global companies and we should be conscious of it. If you have a very fast new regulator offering fantastic service, with a fantastically large market, at a time when we are removing ourselves from a significant global market, we just need to be on our mettle to make sure that we are making the most of the NHS assets, the NHS data, the genomics stuff, which we have, and be speedy.34

30.We want the UK to remain an attractive place for global life science companies to research, develop, manufacture and launch new medicines, devices and other medical products. A resounding message from the written and oral evidence we received is that continued alignment with the EU and the EMA is by far the best option to achieve that. It is widely accepted that the UK’s share of the global life science industry, approximately 3%, means that as a country we are too small to ‘go it alone’, by creating a standalone regulatory system. Roche, a large pharmaceutical company, told us that the bottom line is that the UK must align with a larger market.35 This assumption is endorsed by the UK Life Science Industrial Strategy, which says:

Relatively speaking, the UK market is too small even with the fastest and most innovative regulatory system in the world to stand alone from a larger decision-making bloc.36

International Council on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH)

31.The global nature of the life science industry is exemplified by the International Council on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). The ICH is a global regulatory body which aims to harmonise the development and registration of pharmaceuticals across the world.37 For example, the ICH’s good clinical practice sets standards for the quality of pharmaceuticals globally. These standards are usually adopted into law. The inclusion of ICH standards into the laws of participating members influences the regulatory landscape of countries seeking to export products to these countries. WTO rules covering the resolution of trade disputes refer to the ICH guidelines, thereby giving them further weight internationally. Continued compliance with the ICH is therefore critical for the UK.

32.The EU, as one of the founding members, has significant influence on the ICH’s standards. The MHRA, as the UK’s representative, currently participates in the ICH as part of the EU’s delegation, and sits on many of the ICH’s expert working groups, allowing it to influence international standards. Professor Boyd from the Academy of Medical Royal Colleges told us:

It will be very important, once we are outside that, that the UK gets a seat at that table because that is what controls medicines regulation on a global basis. Again, it is something that has not been talked of very much, but it is a very important group and is an example of our international influence.38

33.Dr Beth Thompson from the Wellcome Trust echoed this point, describing the interplay between ICH, EU and domestic legislation, saying:

There is a very interesting interplay between voluntary standards, which may be global and are there to shape the way people trade and to make trade easier, and legislation, both at the UK and EU level. Our regulators in the UK have to keep playing a crucial role across that spectrum of activities. Clearly, direct influence on EU legislation will be harder, and we see that EU legislation is often a gold standard or tends to shape wider international norms for regulation. However, we must make sure that our regulators are well enough resourced so that they can continue to play in that space and be influential. When working on things like the International Council for Harmonisation of clinical trial guidelines, we have to make sure that the MHRA has a key place at that table and can continue its involvement in discussions, because the UK has a very pragmatic, proportionate approach to regulation, and patients everywhere, not just in the UK, would suffer if they lose that important role.39

34.The UK, after Brexit, can apply for Observer status at the ICH and then for full membership, as a Regulatory Member, after two years.40 However, once a member, the UK could be its own independent voice at the ICH, as opposed to a member of the EU’s delegation. While this brings opportunities for the UK, we heard that we must act now, at the start of a transition period - the earliest we can legally act - if we are to limit the time before full regulatory membership is afforded to us and these opportunities can be sought.

35.The UK should aim to have a seat at the International Council on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) in its own right. We call on the Government to confirm that it will apply for full membership of the ICH at the earliest possible opportunity and to set out its timeline for doing so.

UK’s position and influence in Europe

36.The development, manufacture and supply of medicines, medical devices and other medical products is highly integrated across Europe.41 UK-based researchers, companies and patients participate in, and benefit from, European research collaborations and networks, pan-European clinical trials and pharmacovigilance systems and supply chains in which raw materials and finished products touch several jurisdictions before they are released onto the market.42 We support the Government’s intention to negotiate the same, or a new, close relationship with the EU and the EMA. We believe this is clearly in the interests of patients, citizens and governments in both the UK and the EU. As Phil Thomson of GSK, one of the UK’s leading global pharmaceutical companies told us:

Maybe win-win is the wrong way to describe it because it is just fundamentally important for both sides to get this right. I think you are absolutely right to be thinking about how Europe sees this and the loss of the UK, whether it is pharmacovigilance or that the UK gives more approvals for post-approval studies than any other European country. We have enormous excellence and capacity here in the UK. The UK contributes disproportionately in many regards to what Europe does around health. Therefore, it is in both our interests to prioritise health and the impact particularly on patients in this next round, and what happens with the future arrangement.43

Medicines and Healthcare products Regulatory Agency

37.The UK’s expertise and reputation, including that of the MHRA, has enabled the UK to be a maker and a shaper of EU regulations in the life science sector. For example, Dr Beth Thompson from the Wellcome Trust praised the MHRA, saying:

Our very strong regulators—the Medicines and Healthcare products Regulatory Agency—are world leading, and that helps to bring that credibility, for example, in the clinical trials space and in the licensing space. It cannot be underestimated.44

38.The loss of the MHRA from Europe was emphasised by Dr Spink from the Genetic Alliance:

… the MHRA’s lead on between 20% and 35% of the EMA’s licensing and vigilance work—which is higher in the case of advanced therapies—if we have a gap there in that provision of expertise, you could expect to see a knock-on effect for patients across Europe and also in standards and safety monitoring, and the impact that that might have on exports and imports of innovative products, many of which are manufactured here in the UK.45

Influence of the UK Government, national bodies and institutions in European regulations

39.We heard several examples of how the UK has played a prominent role in shaping current and forthcoming EU regulations on medical devices and in-vitro diagnostics, clinical trials, data protection, but also innovative, and often controversial, medical advances. For example, Dr Jane Spink from the Genetic Alliance told us that “The UK has historically provided a lot of influence and thought leadership, particularly with innovative medicines and innovative approaches such as gene therapy, research using human embryos and advanced therapies.”46

40.The UK government, national bodies and institutions have been advocates and champions of innovation, whereas some other EU Members States have adopted a more precautionary stance.47 Dr Beth Thompson from the Wellcome Trust told us that:

… almost every important piece of legislation that you look at across our sector you see the work of the UK. That is a combination of the UK Government, who do really well at the moment in terms of influencing legislation within Brussels, but also organisations such as the charities—Wellcome, Cancer Research UK and many others—who play a key civil society role in influencing that legislation and bringing often a non-industry or patient voice into those discussions.48

41.The UK’s absence from European decision-making could shift the regulatory environment in Europe towards a more precautionary environment.49 Such a move could create both opportunities and risks for the UK. However, the worst outcome would be for the UK to become an isolated rule-taker in a more precautionary environment which is less supportive of innovation. We heard worrying signs that the UK’s influence within the EU is beginning to dwindle. Suzanne Halliday, from the British Standards Institution, told us, she had seen:

… the UK already start to lose influence in the European Union… Nothing has changed so far, and in Europe it is already, “You are from the UK. You are leaving. Why would we care what you think?” That is my actual experience now.50

42.Echoing this, Hugo Fry from Sanofi, told us:

There are signs that the UK influence, even on sentiment, is waning, so it would be great to have some attention and some political pressure on that to keep it going because we do believe it is important. That is what I would call the “R” bit—the research bit.51

43.Steve Bates, from the BioIndustry Association, offered a more optimistic observation, saying:

I do not get that sense in my meetings. I get the sense that there is an understanding of the validity of having a science-based, sensible voice with capacity among those people who are on the team or around the table with experts from the UK, and there is a desire to see whether there is the possibility to put something together. They are not quite sure what or how, but I think that there is a pragmatic desire, certainly among some colleagues in the EU 27, and that is because the challenges that we are still going to face—the challenges of new forms of disease and of pharmacovigilance—are going to remain. In a sense, that is why Europe came together in this area, to battle the challenges discovered through the thalidomide scandal and the information flows of that being delayed, which caused problems continuing for a period of time that otherwise need not have. Some people have longer memories, understand the basis for this and have a desire to see that continue. We also have a number of things that work through the Council of Europe and other formats. There are a number of layers of this that you can look at. We have grown together over a generation, over a lifetime, and I do not think everybody is of the view that it is, “Shut the door on your way out.”52

44.We are proud that the UK Government, national bodies and institutions have been champions of innovation inside the European Union, using their expertise and reputation to influence EU decision-making in a way which is innovation-friendly. If a close relationship with the EU and the EMA is not achieved, our view is that the worst position for the UK is that it becomes isolated from, but dependent on, a European Union which, adopts a more precautionary attitude to regulation of the life science industry.

45.We support the Government’s intention to negotiate a close relationship with the European Union, including associate membership of the EMA. The UK, with the expertise and capacity of the MHRA, has a great deal to offer its European partners. We believe this is in the interests of citizens and governments on both sides of the negotiations and should be prioritised in the next phase. Failure to achieve an ongoing collaboration would signal the triumph of political ideology over patient care. In the context of continued collaboration with the EMA and maintaining regulatory alignment, it will be in the interests of both sides for the EMA to benefit from the expertise of the MHRA and to continue to allow participation of UK representatives in decision making.

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35 Roche (BRX0030) para 2.1

37 ICH Official web site: ICH, Mission, accessed 12 March 2018

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40 Members & Observers: ICH, accessed 4 March 2018

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44 Q143 [Dr Thompson]

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Published: 21 March 2018