Industry demands ‘closest possible relationship’ between UK and EU

The request was made as part of a joint statement​ issued by the European Federation of Pharmaceutical Industries and Associations (EFPIA), Medicines for Europe and the Association of the European Self-Medication Industry (AESGP) calling for disruption to medicine supply to be minimized.

The statement notes that “the EU and UK should have the closest possible relationship for pharmaceuticals, prioritizing the health of citizens and the uninterrupted supply of medicines.”​

A key step in ensuring this is through the rapid establishment of a mutual recognition agreement (MRA) on good manufacturing practices (GMP) between the two parties.

The benefits of establishing this early into trade negotiations would be the money saved on duplicated testing, as well as ensuring ‘timely access’ to medicines and the continuity of supply, the associations stated.

Further than this, the statement suggests that continued work between regulators of the two regions would allow for a continued focus on the inspection of third countries – those outside of the European Union (EU).

The focus on agreeing an MRA early into negotiations is part of concerted effort by industry to align regulatory requirements on manufacturing, whilst also minimizing the need for various regulatory agencies to reinspect facilities.

This has seen the EU and Japan extend their MRA​ on active pharmaceutical ingredients (APIs) and biologics, and the EU and the US complete their MRA​, in recent years.

The statement echoed the need for greater global harmonization: “Global alignment is central to allowing the global supply chain to function, and this is why notification of regulatory revisions is regularly included in MRAs.”​

Beyond this, the organizations also call for sharing of data, the protection of intellectual property (IP), custom facilitation, and rules of origin. It is also suggested that a working group on pharmaceuticals and medical devices should be set up, similar to an existing agreement between the EU and South Korea.