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.
Chair of the Committee, Dr Sarah Wollaston MP, says:
"In order to minimise harm to their citizens, both the UK and the EU-27 should look to secure the closest possible regulatory alignment in the next round of the Brexit negotiations. Failure to do so would signal a triumph of ideology over the best interests of patients."
The Committee welcomes 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, will be adversely affected by regulatory divergence and seriously so in the event of a 'no deal' Brexit
However, the European Council has 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 are dependent on similar agreements across the whole of the negotiations. We believe it is not just prudent, but essential, that scrutiny is 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 is vital that the UK life sciences sector is able to continue to participate in Europe-wide clinical trials. If the UK does not adopt the new clinical trials regulations and is 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.
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 is 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
We support 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.