Parliamentary Committees and Public Enquiries
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Contingency plans needed to protect UK science

EU life sciences regulation – medicines and therapies, and biotechnologies – fosters cross-border research collaboration and allows UK science access to the EU market, the Science and Technology Committee has said in its report. The Government should be putting in place a contingency plan to protect our science sector in the event of a leave vote.

Chair's comment

Nicola Blackwood MP, Chair of the Committee, said:

"While there is no question the EU needs to improve its approach to evidence based policy and the responsiveness of its regulation, it is clear that there are benefits of being in the EU for UK life sciences and research bodies in terms of collaboration and access to an EU market many times bigger than the UK market alone. If we left, our life sciences sector would still have to follow EU regulations to sell in the single market. But Britain wouldn't get a say in setting those rules putting us at a competitive disadvantage.

"The Swiss experience in particular should be a cautionary tale. When the Swiss voted to curtail free movement of people, the EU revoked access science funding and collaboration, undermining the country's science sector. Following lengthy negotiations Switzerland was permitted re-entry to Horizon 2020 but on much more restrictive terms. Furthermore, non-Member States do not own the IP of any research they do conduct in collaboration with the EU so in the event of Brexit the value of any EU based research for exploitation may be limited."

"In light of this, the Government must conduct a risk analysis of the impact that a vote to leave would have on science funding and international collaboration. Ministers must put in place contingency plans to protect us from any adverse consequences for our science and innovation sector as well as consolidating any benefits."

Report findings

By harmonising the way research is conducted and intellectual property protected, EU regulation helps to foster EU-wide collaborations. Once medicines and implants and other technologies are approved under the EU system they can be sold across the EU.

While the cost of EU regulation can be more than a national equivalent system, the process opens up access to the wider EU market—the UK represents 3% of the global market for pharmaceuticals, the EU market 27%. Over half of the UK’s £21bn of pharmaceuticals exports go to the EU.

The UK is a net receiver of EU research funding. The UK has secured 15.4% of the EU’s Horizon 2020 funding to date. A further €1.6bn of the EU Structural and Investment Funds is to be allocated to the UK for 2014-2020 to be spent on research and innovation projects.

More than 50 biotech and pharmaceuticals chief executives recently stated in an open letter that 'leaving the EU would leave a significant research funding gap.'

The inquiry found that the UK's regulator—the Medicines and Healthcare products Regulatory Agency (MHRA)—has been able to positively influence the EU medicines regulatory regime. However, there are areas where the EU regulatory system still needs improvement.

Its costs and complexity need to be addressed as part of the EU’s commitment to "regulatory simplification and burden sharing". The EU system for life sciences can result in protracted regulatory timescales, including when correcting previous bad regulation.

The Clinical Trials Directive has been inflexible and inconsistently applied, and it has taken almost two decades for a replacement to be introduced. The 'precautionary principle' has also been misused, most notably on GM. The Committee urges the Government to renew its efforts to promote a more robust scientific application of the principle.

Chair Nicola Blackwood MP concluded:

"The EU system for regulating the life sciences is not perfect. Improvements need to be made to reduce its complexity, speed it up and make it more evidence-based on emotive issues like GM. Nevertheless, UK life sciences benefit significantly from EU funding and scientific collaboration across member states, Brexit would put this at risk."

EU Referendum

The Committee does not seek to prejudge the outcome of the forthcoming Referendum on the UK's membership of the European Union, and its report does not express a view about which outcome would be best for the UK life sciences or for the UK more generally. Whatever the result, however, there will need to be action to address the concerns about the way the life sciences are regulated.

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