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Brain drain: The experts the UK may lose due to Brexit

Published on 15/05/17 at 10:36am

The regulatory and drug approval process is destined to change once the UK leaves the EU. The problem is, nobody is quite sure how things will change and how they should react in turn.

There is no question that we live in a world that feels increasingly unpredictable. Who would have confidently predicted Trump’s run from outsider to presidency? How many people expected the Scottish referendum to run so close and for the SNP to then sweep to victory across a majority of Scottish seats? In a more recent example, after stressing for months that there was no intention to call a general election, there were few who were expecting Theresa May to call a snap UK general election in April.

Behind the last fact is the spectre of Brexit, as May reasoned that the general election was needed to secure a mandate. The triggering of Article 50 at the end of March has only added to the degree of uncertainty for people to adjust to. However, there are many whose jobs it will be to work within a vast network of interconnected EU-wide regulation that will shift irrevocably post-Brexit.

For all the discussions of a hard versus soft exit from the union, it is still unclear how the UK will determine its drug approval and regulatory process once it has left the EU. Will it continue to follow EMA guidance as an independent country, similar to Switzerland, or will it rely on the MHRA to expand its current role to fulfil the role vacated by the EMA?

If the latter, untangling these connections will take years and, even then, there will be some benefits that UK wants to keep and that the EU will not, in all likelihood, allow – the most obvious and pressing example is the EMA headquarters.

EMA headquarters – will it stay or will it go?

There have recently been rumours circulating that the UK will fight to keep hold of both the EMA headquarters and the European Banking Authority, the two illustrious EU hubs currently based in London. David Davis, Brexit secretary, is opposed to allowing the agencies to leave London without a fight and is keen to use them as bargaining chips in negotiations. A spokesperson from the UK Brexit department comments suggest that it is not certain that they will leave the UK: “No decisions have been taken about the location of the European Banking Authority or the European Medicines Agency — these will be subject to the exit negotiations.”

This stance has previously been contradicted by Secretary of State for Health, Jeremy Hunt, who conceded in January that: “The EMA is an EU institution. I think it's likely EU countries will want to move its headquarters outside the UK”. This back and forth within the same government is again only adding to the aura of doubt as we enter unprecedented territory.

Rationally, it seems highly unlikely that the EU will want to set a precedent whereby countries leaving the union could be allowed to retain member perks, after having very publicly rejected the union. Noises emerging from officials have previously stated that the move of headquarters will be a decision made by the European commission and will happen as quickly as possible.

The Agency is the jewel in the crown of the European drug approval and evaluation process – it receives an annual budget of €322 million, employs close to 900 highly skills workers and attracts around 36,000 experts to convene at its meeting every year. It is an attractive prize and certainly not short of suitors.

Power of the people

The long list of countries vying to become the new home of the headquarters is a long one, with as many as 21 different countries, and growing, having thrown their hat into the ring, with each professing their own unique selling point. As one headline cannily put it, ‘Brexit to stage left’ is possible – with Ireland keen to host the Agency, it can offer the perk of allowing employees to either commute to work or the benefit of not necessarily needing to move very far.

This particular point is of real interest to the people behind the Agency; there are people who have worked at the EMA headquarters since its inception two decades ago and have put down roots in the country that now look like they may be torn away. A real danger for the UK is the loss of such expertise – some of the leading figures in drug evaluation and in regulation will move on, leaving a gap in knowledge that will not be easily filled. There is also the bonus of having those individuals concentrated in London, placing the UK at the physical centre of the decision making process.

Speaking to Robert Clay, President of The Organisation for Professionals in Regulatory Affairs (TOPRA) he stressed that a major impact of the future of the EMA headquarters will be on those that work directly with the organisation. He said, “The EMA moving, perhaps, at some point, in the next few years to a new location is a major concern – both for colleagues at the EMA but also for people that work with the EMA. One of the things that the EMA has resulted in, since it located to London twenty years ago, is a concentration for regulatory professionals in London and in the UK.

“There are some jobs, for example, in pharmacovigilance, that are required to be in the European Union. I think the uncertainty creates a situation where people who are working at the EMA, those working in collaboration with EMA or those who are required to work in the EU are going to have a personal uncertainty – they don’t have any resolution to that but it will be of immediate concern.”

Broader than the expertise that is drawn towards the EMA headquarters, there are other benefits that are drawn towards the hub. The Netherlands is one country that is looking to host the headquarters and signalled the attraction there is in becoming the new host of the EMA hub in a statement: “A large number of pharmaceutical organisations are currently located in London, many of whom work intensively with EMA. It is likely that at least some of these organisations would want to relocate to the same place as EMA. This could strengthen the Dutch position in European pharmaceutical policy and would boost the Netherlands’ appeal for companies and institutions in the top sectors of life sciences and health, and agri-food.”

Bad for business?

This is perhaps a point that does not get raised often in the defence of the EMA; though it is part of a cross-EU collaborative function, it draws businesses and organisations to the UK. It makes the country that hosts the headquarters a default hub for life sciences.

Clay acknowledged that he had heard people express concern about what Brexit might mean for their business: “I would say that if you were bringing a small company to Europe, or starting a company in Europe, you would, perhaps, have second-thoughts about whether the UK was the best place to do that. I have heard people speculating on where they might want to do trials and where they might want to get advice from, to make sure it’s still relevant moving into the future. I personally don’t think that there’s a major concern about this but I have certainly heard people express concerns about where they would want to do their research and where they want to be based.”

Speaking to Pharmafocus, Sally Shorthose, of the international law firm, Bird & Bird, stressed that businesses disliked the insecurity regarding changes to regulation in the UK. She mentioned how her recommendation had changed from advising companies to wait out Brexit negotiations, until noises coming from negotiations make the outcomes more evident, to more often suggesting business consider options outside of the UK.

Regulatory limbo

As well as the interests of business looking to work within the UK, also comes the nitty-gritty issue of getting patients access to medicine. Shorthose wrote a paper entitled, Brexit: Life Sciences that looked to examine the implications of Brexit from a variety of angles. In the paper, she wrote on the potential changes to drug regulation that: “The life sciences sector is one of the most highly regulated and globally harmonised industry sectors, especially in terms of the development of pharmaceutical products. A large amount of the regulation originates from membership of the EU in the form of Directives or Regulations. In the case of Directives (e.g. Directive 2001/83/EC governing medicinal products) these have been implemented into national law and will therefore remain in place (subject to amendment). Regulations, in contrast, are directly applicable in the UK without the need for national implementation and therefore, in theory, when the UK leaves the EU regulations will no longer continue to apply. The Great Repeal Bill should go some way in buffering the effect of a lapse in applicability of regulations; if the bill serves as a way of incorporating existing regulations (subject to amendments) into UK law then the effect should be to fill the vacuum left if a regulation were to just cease to apply.”

The vacuum that could be left is a serious cause of worry, particularly if there is not a strong plan moving forward. The mixed messages from the government about the EMA headquarters does not bode well that there is a viable place in place. Without a solid strategy, there has been plenty of space given to discussing the potential negatives.

Before the referendum decision to leave the EU, the ABPI came out with strong reservations about the prospect of leaving and its potential impact on the pharmaceutical industry. Mike Thomson, CEO of ABPI, particularly outlined how leaving the EMA could create a regulatory nightmare, slowing treatments to patients: “We believe that staying in the EU will mean that patients in the UK will be more likely to get faster access to new medicines than if we left. With the European Medicines Agency, pharmaceutical companies have a one-stop shop for centralised licencing of new medicines and treatments across Europe. If we left the EU, this would mean that the licensing of new medicines would have to be handled by a UK agency as well as a European agency. Our members have confirmed that the applications for UK license would come after the European license due to the smaller patient population in the UK.”

Discussing the unfavourable possibilities, however, no longer holds as much stock as prior to the referendum. The mood across the industry has now shifted to pragmatism and discussions now look forward as to how the UK could react in light of the change.

Clay speculated on the prospects for change post-Brexit: “The national regulatory body will have to work out, and this is assuming the entirely independent scenario, how it’s going to manage taking over the EMA’s role and we, as regulatory professionals, will have to work out how to do that as well. If they duplicate the licenses of existing drugs, we will then have to send additional forms directly to the MHRA, which we already do electronically. At the other end of the spectrum, there’s another scenario where the UK agrees to continue to participate in the EU system, in the way that Norway and Iceland do. In which case, the transition will be simpler and smoother.

“We have a number of models already in Europe. We have the Swiss model, which is entirely independent but they use common guidelines, referring to CHMP guidances and ICH guidances to make an independent decision. Norway collaborates as part of the CHMP and the European system. Frankly, until we decide which option we’re faced with, there’s a limit to the amount of preparation we can do.”

The only certainty beyond inevitable change of some kind to the regulatory system is the increased role that the MHRA will have to play in the post-Brexit system. MHRA already assesses 20-30% of all drugs going through the EMA but would have to increase in size to cope with a full withdrawal from the EMA. The recruitment alone would put pressure on a system that would also have to deal with the burden of adjusting and coordinating the UK’s new place within the drug approval and regulation landscape.

There is, however, positivity regarding some aspects of the UK and, more narrowly, London’s position when it comes to negotiating a space for itself after Brexit. It is the home of a wealth of expertise, it will always hold a draw as English-language leaping point for the rest of Europe and its life sciences framework is well-established.

Let it be

Perhaps this confidence is the reason that discussing the issue of Brexit raises concerns but not outright negativity – or, possibly, it is a symptom of the stiff upper lip in the face of a challenge. Speaking to Clay, he drives home the fact that for most involved in the industry, there are still plenty of challenges in the short-term without worrying about what may come of Brexit. He said, “From my point of view, most of colleagues are in the ‘carry-on mode’ because nothing has changed. We know it’s going to change but nothing has changed right now. So, if you’re working in drug development and regulatory affairs today, you’re probably more concerned with the new clinical trial regulation or the new devices regulatory arrangement because these are real and happening now. Whereas, something we think is going to happen, in some fashion, in a few years, is hard to spend a lot of time on. I think most people are busier in the here and now.”

For all the uncertainty that Brexit is brewing, this seems like the most logical step. As has cropped up regularly, without any foresight about the future of the EMA headquarters, with nobody any the wiser as to which regulatory route the UK will follow after Brexit and a government that is keeping its cards close to its chest, in many ways it makes sense to carry on as if it is business as usual.

Clay did, however, mention the best way he felt he could prepare members of TOPRA for this uncertain future: “We’re holding a regulatory summit in July, of which the topic is global regulatory harmonisation and we have our annual symposium in early October, held in London. As a professional organisation, we want to bring people together to debate these things. We may not know a great deal more by then but I’m sure it will provide people an opportunity to discuss and develop ideas.”

Keeping communication open and transparent is crucial during this period of uncertainty. Discussing possible solutions to potential problems before the time when they are needed means that those involved in decision making, later down the line, will be mentally prepared to face those challenges.

Ben Hargreaves

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