The United Kingdom’s withdrawal from the European Union (EU)—“Brexit”—will affect many aspects of the provision of health, social care and the wider life sciences sector, both in the UK and the EU. In order to minimise harm to their citizens both sides should look to secure the closest possible regulatory alignment as a priority in the next round of negotiations.
We welcome the Government’s stated intention to maintain regulatory alignment with the European Medicines Agency (EMA). The UK, with the expertise and capacity of the Medicines and Healthcare products Regulatory Agency (MHRA), has a great deal to offer its European partners. We believe this is in the interests of patients, citizens and governments on both sides of the negotiations. The entire supply chain of pharmaceuticals, from research and development, timely licensing, production, quality control, through to the product being launched and available on a pharmacy shelf, will be adversely affected by regulatory divergence and seriously so in the event of a ‘no deal’ Brexit.
However, while the European Council has reiterated its wish to have the UK as a close partner in the future, it has also set out that preserving the integrity of the Single Market excludes participation based on a sector-by-sector approach. As negotiations under Article 50 will be conducted as a single package, any provisions which are put in place for continued co-operation between the EU and the UK in the life sciences are dependent on similar agreements being made across the whole of the negotiations. We heard evidence from witnesses that their preferred option was Britain’s continued membership of the Single Market and Customs Union or retaining a Norway type EFTA/EEA relationship. We note that the Government has ruled those options out. In the absence of a change in the Government’s approach, we believe it is not just prudent, but essential, that scrutiny is undertaken of the Department of Health and Social Care’s (DHSC) contingency planning for a ‘no deal’ situation.
For the benefit of patients, particularly those living 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 infrastructure that has been developed within the EU to underpin them, a variety of difficulties for patients and the life science industry could emerge both in the short and medium to long term.
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. This should include ensuring that all UK pharmacovigilance organisations continue to be members of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), 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.
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 in the event of failure to achieve free and frictionless trade in pharmaceutical products.
We heard a consistent and repeated message during our inquiry that to minimise the risks to all stages of the development and timely supply of medicines and devices, the Government should seek the closest possible regulatory alignment with the EU.
Published: 21 March 2018