Brexit: What will it mean for the regulation of medicines?

Mark Quick, executive vice president of corporate development at Recipharm, comments on the current situation and the potential implications of the UK exiting the European Union (EU).

Brexit is a topic that is dominating the news agenda, yet many in the pharmaceutical industry are still unclear on the implications for the movement of medicines from and into the UK.

On the 17th July 2018, MPs in the House of Commons backed an amendment to the government’s suggested Trade Bill on the regulation of medicines after Brexit. MPs voted for the UK to take ‘all necessary steps’ to participate in the regulatory network operated by the European Medicines Agency (EMA) after it leaves the EU, which is certainly a positive move in favour of ensuring the smooth flow of medicines to British patients.

EMA: ‘Step up’

The best outcome is that a mutual recognition agreement is maintained between the EU and UK, meaning there will be limited to no immediate regulatory changes. The worst-case scenario, where no agreement is reached, may result in medicine shortages with patients suffering the consequences.

The current state of play is concerning. A recent EMA survey of pharmaceutical manufacturers identified gaps in industry preparedness for Brexit. It led the agency to call for some companies to ‘step up efforts to ensure medicine supply in the EU’. It revealed that marketing authorisation holders (MAHs) for more than half (58%) of the 694 centrally authorised products (CAP) with an important step in their regulatory processes in the UK are on track with their regulatory planning to ensure that their marketing authorisation remains valid once the UK leaves the EU.

Both regulatory authorities and MAHs play an important role in preparing for the consequences of Brexit and safeguarding the continuous supply of medicines, however contract manufacturers must also support these efforts.

Supply of vital medicines

As a CDMO with a presence in both the UK and mainland Europe, Recipharm has a taskforce dedicated to meeting the Brexit challenge head-on. As such, we expect to see a greater demand for outsourced manufacturing services from UK MAHs wishing to supply to Europe.

Of course, ensuring the reliable supply of medicines post-Brexit is paramount and should be one of the main focuses of the industry over the coming months. We would like to see more action and guidance from the EMA to help pharmaceutical manufacturers navigate the changing landscape and make the required preparations. The initiatives shown by the UK government regarding a pragmatic approach to Brexit have not received any pragmatic response from the EMA which remains firm in its hard-Brexit approach.

Those manufacturers who are already adept at third-party importation practices may be best placed to deal with the challenges if the UK becomes a ‘third country’ post-Brexit. The additional layers of complexity could delay the supply of vital medicines and add greater regulatory and resource burden to MAHs and their contract manufacturers.

It is Recipharm’s view that the Brexit challenge needs to be faced in a pragmatic way and details need to be confirmed and communicated as a matter of priority or, as the EMA survey has found, patients across the UK and EU could suffer.