Brexit – medicines, medical devices and substances of human origin

The United Kingdom: House of Commons: Health and Social Care Committee published a report Brexit – medicines, medical devices and substances of human origin on the 21 March 2018. The Committee urged UK and EU negotiators to prioritise patient safety in next round of Brexit negotiations.

Negotiators on both sides must heed the call of industry and patient groups in securing the closest possible regulatory alignment in the next round of Brexit talks.

Further information

+ Regulatory alignment

The Committee welcomed the Government’s stated intention to maintain regulatory alignment with the European Medicines Agency (EMA). The entire supply chain of pharmaceuticals, from research and development through to the product being available on a pharmacy shelf, would be adversely affected by regulatory divergence and seriously so in the event of a 'no deal' Brexit.

However, the European Council had stated that preserving the integrity of the Single Market excludes participation based on a sector-by-sector approach. Any provisions for continued co-operation between the EU and the UK in the life sciences were dependent on similar agreements across the whole of the negotiations. The Committee believed it was not just prudent, but essential, that scrutiny was undertaken of the Department of Health and Social Care’s contingency planning for a ‘no deal’ situation.

+ Clinical Trials and Research and Development

For the benefit of patients, particularly with rare conditions, on both sides of the Channel, it was vital that the UK life sciences sector was able to continue to participate in Europe-wide clinical trials. If the UK did not adopt the new clinical trials regulations and was unable to access the EU infrastructure developed within the EU to underpin them, difficulties for patients and the life science industry could emerge.

The UK should seek to continue to be a member of EU Research and Development (R&D) funding and research mechanisms such as Horizon 2020 after leaving the EU, if possible on the same terms as it currently enjoys.

+ Patient safety

The UK should also seek mutual recognition of pharmacovigilance mechanisms by the MHRA and the EMA as a priority in the next round of negotiations, as the failure to do so could affect patient safety both in the UK and the EU. It was also in the best interests of patients for the UK to continue membership of all of the major EU pharmacovigilance systems and databases, including the European Database on Medical Devices (EUDAMED) and Eudravigilance.

+ Trade, customs and supply chains

The Committee supported the case for free and frictionless trade with the EU. The Government should assess the impact of the loss of parallel imports. We also recommend that the Government undertake further contingency planning on the impact on the supply chain of a failure to achieve free and frictionless trade in pharmaceutical products.

UK: Parliament: House of Commons: Committees: News, 21.03.18: Brexit negotiators urged to prioritise patient safety http://www.parliament.uk/business/committees/committees-a-z/commons-select/health-and-social-care-committee/news/brexit-medicines-substances-report-published-17-19/

United Kingdom, Scotland: Scottish Parliament: SPICe Briefing, No.18/07 (30.01.18): Leaving the EU - Implications for Health and Social Care in Scotland http://www.europeansources.info/record/leaving-the-eu-implications-for-health-and-social-care-in-scotland/

ESO: Find further information in ESO on Brexit and healthcare http://www.europeansources.info/advSearchLink?keyword=brexit%20healthcare%20&searchOption=all

ESO: In Focus: Brexit - The United Kingdom and the European Union http://www.europeansources.info/record/brexit-the-united-kingdom-and-the-european-union/

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