Post-Brexit access to the Single Market for medical devices and medicines
by Dr Nabil Asaad

With less than a year to go until the UK leaves the European Union, there is still a lack of clarity as to whether the mutual recognition of medical devices and medicines will continue after the UK’s planned exit date of 29 March 2019 and the end of any transitional arrangements which may extend the UK’s access to the Single Market until 31 December 2020. The position regarding any transitional deal is still very uncertain. If such a deal were agreed we would expect the current position to be preserved until the end of 2020 but it is difficult to make meaningful predictions until we have more clarity regarding any transitional arrangements.

Unless and until agreement is reached to the contrary, when the UK leaves the European Union:

• any certifications granted by UK-established Notified Bodies will cease to have the same validity as certifications issued in a Member State;
• where regulations require an economic operator (such as the holder of a Marketing Authorisation) to be established with the EEA, then establishment in the UK will not be sufficient; and
• the UK’s membership of pan-European organisations such as the European Medicines Agency will cease.

 
As was made clear in the European Commission’s “Notice to Stakeholders” on 22 Jan 2018, the UK will become a ‘third country’ upon Brexit. Despite the alignment between the regulatory environment and applicable safety standards in the UK and the remainder of the EEA, the UK’s departure from the European Union could leave manufacturers and rights holders needing to duplicate certifications and approvals in order to continue to market their medical devices and medicines in both the UK and the remainder of the Single Market.

A medical device manufacturer established in the UK could potentially continue to place their medical device on the Single Market after Brexit, provided that their representative (or third party marketing the medical device) was established in a Member State and registered with the Competent Authority in that Member State. Any certification issued by a UK-established Notified Body would need to be transferred to a Notified Body established in a Member State. Some UK-established Notified Bodies are seeking recognition in other Member States, which may assist with that process.

The position is more complicated for medicines, where regulations require that the Marketing Authorisation Holder/Applicant and the Qualified Person for Pharmacovigilance are established within the EEA and that the Pharmacovigilance Master File is held within the EEA. Furthermore, following Brexit, any active substances and finished products manufactured in the UK would be regarded as being imported into the Single Market from a third country rather than produced within the Single Market. Whilst the Marketing Authorisation itself may be transferred to an entity established within the Union, this alone may not be sufficient to ensure that a medicine that is currently manufactured and licensed in the UK will continue to be marketable within the EEA post-Brexit.

Given that the EU regulatory regime will continue to apply across the Single Market after the UK leaves, manufacturers and rights holders may seek to de-risk Brexit and ensure continued access to the Single Market by routing applications and certifications through entities established within the Union. The uncertainty around Brexit would then become a question of whether or not the UK would continue to recognise medical devices and medicines approved within the Single Market.

It would in any event be unfortunate if the UK’s departure from the European Union caused medical devices or medicines to be withdrawn from the UK or Single Market for want of the terms for continuing mutual recognition having been agreed.