UK and EU pharmaceutical industry jointly urges protection of medicines before Brexit transition period ends
As the deadline for Brexit negotiations approaches, the UK and EU pharmaceutical industry trade bodies, the Association of the British Pharmaceutical Industry (ABPI) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), have asked for medicines to be prioritised in continuing trade talks between the UK Government and the European Commission.
The ABPI and EFPIA are requesting for urgency between the regions to reach an agreement on:
- Mutual Recognition Agreement (MRA) for medicines manufacturing
- a one-year ‘phase in’ of the Northern Ireland Protocol with respect to medicines.
Over 80 million packs of medicines are transported between the UK and EU every month. These medicines need to conform to quality and safety standards acceptable by both regions. To this end, there is optimism, as “MRAs are often signed outside of trade agreements. Doing so means that, should a comprehensive trade deal not be reached, negotiators will still have a clear way forward to remove significant risk to medicines supply in January.”
Failure to reach an agreement could delay crucial medicines for up to six weeks and “will only benefit other regions with competing life science industries as both the UK and EU become less competitive globally.”
The UK Government has recently published a list of approved countries to “enable UK importers and wholesalers to continue to recognise batch testing, QP certification and regulatory standards for active substance manufacture performed in certain countries in the same way as before 1 January 2021.”
It is hoped that this guidance will provide a basis to aid the two regions to reach an MRA.
Meanwhile in Northern Ireland, “the industry is requesting a one-year phase-in process – starting from the point when the UK and EU reach agreement on its interpretation”, as well as further clarification on the interpretation and implementation of the Northern Ireland Protocol for medicines.
The full joint statement can be read here.