Brexit – a never-ending story?

There have been many twists and turns regarding Brexit, and just before this article was written, it was decided that the UK will go to the polls on 12 December after MPs backed Boris Johnson’s call for an election following months of Brexit deadlock. Now, Brexit will depend on the outcome of the election. The EU has agreed to the UK’s extension request, so Brexit could take place based on the existing deal on 31 January 2020. The deal could also be renegotiated, or there could be a referendum or a decision to cancel Brexit.

In the meantime, it is up to the international companies operating in the EU and UK to ensure they are prepared for whichever solution politicians decide upon. The European Commission has recently presented a general checklist for companies. Read more here.

As many regulations for the pharmaceutical and medical devices field are derived from EU legislation, Brexit, especially without a deal, would have major implications for this industry. Pharmaceutical and medical device companies may be affected in a broad range of areas, from product development and market approval to the shipping and distribution of medicines and medical devices.

In the event of a no-deal Brexit, mutual recognition of regulatory regimes will cease, and the UK could become a “third country” in relation to the EU by the withdrawal date. The following sets out some of the implications that should be considered in relation to companies in this industry in the event of no-deal.

Pharmaceutical companies:
• EU law provides for the transmission of personal data across EU Member States without additional requirements. As regards for example clinical trials, the transmission of personal data post-Brexit from the EU to the UK is subject to the rules for data transfers to third countries.
• Marketing authorisations granted by UK bodies will not be valid in EU Member States. A company that relies on UK authorisations must transfer them to EU Member States prior to Brexit to be able to supply to EU Member States.
• Companies that market products in both the UK and the rest of the EU will need a qualified person responsible for pharmacovigilance both in the EU and in the UK.
• When the UK leaves the EU, the Reference Member State for mutual recognition procedure (MRP)/decentralised procedure (DCP) approved products with the UK as Reference Member State (RMS) must be changed. The Swedish Medical Prod-ucts Agency has communicated that they welcome requests for Sweden to act as RMS for medicines authorised in MRP/DCP that currently have the UK as their RMS.

Medtech companies:
• UK notified bodies will no longer be considered EU notified bodies.
• Companies that rely on a UK notified body for certification must either transfer existing CE certification to an EU-27 notified body or consider obtaining new certification from such a body.
• Manufacturers of medical devices that have an authorised representative in the UK must switch to an authorised representative within the EU, an EEA country or a third country with which the EU has signed an agreement to offer the products on the internal market. The same goes for manufacturers in the UK that must obtain such an authorised representative.
• It is wise to identify elements in your own supply chain affected by Brexit. For example what products, materials, resources, etc. originate in the UK? What options are available?

We will be following discussions and developments closely!