5 years ago

BREXIT: What lies ahead for the UK Life Sciences sector?

DWL has received several questions about Brexit recently from translators but there is currently little hard information we can give them. What we do know from the government is that Brexit means Brexit…but Brexit means what for the UK’s life sciences sector? This was one of the topics covered in a 2-day meeting of the Clinical & Contract Research Association (CCRA) held at the Royal Society of Medicine in London on 24 and 25 January 2017 and attended by the CEO of DWL, Samuel J. Wirth, and the Medical Director, Dr Iain Matheson.


Day 1 (entitled UK Clinical Research: A Professional Awareness Update) began with a talk by Matthew Speers, CEO of the Life Sciences Organisation, part of the Department for International Trade. He pointed out that the life sciences sector in the UK is very vibrant, with 220,000 employees, more than 5600 companies and a turnover of £61 billion and emphasised the need to promote the UK and to drive inward investment. Many overseas companies (especially in the US) see the UK as the natural stepping stone into Europe but this advantage has now been lost with Brexit, possibly to the benefit of Ireland or Germany. The role of the Medicines and Health Products Regulatory Agency (MHRA) will need to evolve – will it develop closer relationships with the US Food and Drug Administration (FDA) or relationships outside the EU (e.g. with Australia and New Zealand)? Questions for which there are not yet any answers… There is also uncertainty over what the US approach will be, now that Donald Trump is in the White House. Matthew Speers pointed out that the National Health Service (NHS) should be viewed as an asset, but that there might not be the necessary skills available due to the immigration policy post-Brexit. Over the two days, many speakers and delegates referred to the NHS as a “unique selling point” for the UK life sciences sector because of the availability of a huge amount of data in a single organisation.


Dr Martin O’Kane, Head of the Clinical Trials Unit at the MHRA, provided an update on the progress of the new EU Clinical Trials Regulation on Day 1. The need for a regulation has arisen from the failings of the Clinical Trials Directive, which has in some ways hampered research. The regulation will not become effective until the EU portal for processing clinical trial applications and the database have been audited and found to be suitable. User testing on the portal is currently taking place and will continue in 2017. The audit is scheduled for autumn this year. If the audit outcome is favourable, the EU Clinical Trials Regulation will come into effect by October 2018. It is unclear how Brexit will affect implementation in the UK. It is possible that the regulation will roll-over after any repeal act especially as the regulation contains many proposals favoured by the UK. As with all things Brexit, only time will tell…


A show of hands at the start of Day 2 entitled UK Clinical Research: The Landscape for CROs Post-Brexit indicated that most attendees thought that the UK would weather the Brexit storm and that it was not all doom and gloom. Professor Richard Barker, OBE, Director of the Centre for the Advancement and Sustainability of Medical Innovation, pointed out that the UK has some of the world’s top clinicians, that with the fall in the pound’s value the UK has become a cheaper market and that being a relatively small market the UK needs to be distinctive. The attractiveness of the UK as a place for life sciences organisations to do business needs to be promoted.


Professor Angus Dalgleish, Professor of Oncology at St George’s Hospital, London, and an unsuccessful parliamentary candidate for UKIP in the 2015 General Election, offered a different view. He felt Brexit had led to a lot of hysteria and that it offered tremendous opportunities for the life sciences sector in the UK. He pointed out that the training of doctors had suffered because of the European Working Time Directive as it deprived them of valuable clinical experience and that the EU Clinical Trials Directive had been detrimental to clinical research in the UK, especially as it was interpreted very rigorously here and had meant some research had had to be abandoned. He reminded us that long before the Maastricht and Lisbon treaties there had been a lot of cooperation at European level, such as the European Space Agency, the European Molecular Biology Laboratory, the European Organization for Nuclear Research (CERN) and, of course, Concorde and Airbus.


Stephen Dorrell, Chair of the NHS Confederation and a former Secretary of State for Health in John Major’s government in the 1990s, rounded off the Brexit debate. He believed that a quick, innovative and flexible approach to clinical trials was needed so that patients can benefit internationally. A nationalistic regulatory view is therefore contrary to his belief that innovations in healthcare should be implemented as widely as possible. As he sees it, an international research environment functions best and this of course requires the availability of a skilled workforce, something that is likely to be a stumbling block if a more rigorous immigration policy is enforced post-Brexit. He tempered the enthusiasm of some of the delegates about the NHS. Although it is a key national idea, in Dorrell’s view, the NHS should be viewed not as a single organisation but as many smaller organisations.


We hope to be able to give an update on the implications of Brexit later in the year.


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