Why the BIA Says No to a Brexit

On June the 23rd, 2016, Britain will decide whether or not it wants remain a member of the European Union. A number of pharmaceutical executives have been vocal in their support of continued EU membership (1) – as has The European Federation of Pharmaceutical Industries and Associations (EFPIA [2]). Steve Bates, CEO of the UK BioIndustry Association – a trade association for enterprises involved in UK bioscience – also argues that a vote to leave would be damaging for the biopharma industry.

How important is UK influence on EU regulatory policy to the biopharma industry? The Medicines and Healthcare products Regulatory Agency (MHRA) has been particularly influential and proactive in discussions on accelerated access, contributing effectively to discussions on adaptive pathways and PRIority Medicines (PRIME) and linking these discussions back to UK specific initiatives such as the Early Access to Medicines Scheme (EAMS) and the Accelerated Access review (AAR). UK influence has also been at the heart of the development of EU regulations such as Advanced Therapy Medicinal Products (ATMP) regulation, the Orphan Medicines Regulation and the Clinical Trials Regulation. A key reason for the UK to remain in the EU is that it has a strong voice to influence EU regulation that impacts on the UK. If we were to leave we would lose this voice and still be in a position where we would likely mirror regulation that we had no influence over. How would the biopharma industry be affected by a Brexit? The BIA believes that the UK is the most attractive destination in Europe for life science companies. For example, we are the headquarters of choice for many US companies looking to enter the European market. If we left, the UK could remain strong, but would lack the catalyst provided by the EU. In the event of a “Brexit”, it is our view that the UK would either have to accept European legislation that it cannot influence (which is the model available under membership of the European Economic Area) or develop new UK-specific rules, at cost. Even if the latter option were pursued, in order for the UK to remain an attractive place to do business in for global companies, similar (if not identical) regulatory systems would need to be established. Beyond the impact on core regulatory matters, a “Brexit” could also pose significant risks to the UK’s attractiveness for inward investment and as a location for the world-leading talent the life sciences sector depends upon. All of this would have negative consequences for the UK and its economy. The UK accounts for under 3 per cent of the whole global market and we need to be realistic in thinking whether this will make the country an attractive destination for companies looking to headquarter their business in Europe or deciding on a first market to launch their drugs. What changes or reform would you like to see within EU regulations that you think will benefit science? One area where there is scope for improvement is where the precautionary principle has been misused. The precautionary principle has its roots in environmental law and has been defined as ‘when human activities may lead to morally unacceptable harm that is scientifically plausible but uncertain, actions shall be taken to avoid or diminish harm.’ An example of where the principle has been misused and led to EU policy making not being rooted in scientific evidence is Genetically Modified Organisms (both GM crops and GM insects).  EuropaBio, the European trade association for bio-industries, of which the BIA is a member, notes that the current legislation on GMO cultivation, under which member states are allowed to ban safe, EU approved GM crops on non-scientific grounds, illustrates how the misuse of the precautionary principle restricts access to innovation. By being part of the EU, the UK has the opportunity to demonstrate the benefits of its progressive science based approach to the wider EU members and has a strong and powerful voice to influence change in the European market.

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