Pharma Chiefs Write on Brexit Threat

24.07.2017 -

Industry leaders from European and UK pharmaceutical and life science associations have written a joint letter to the chief Brexit negotiators Michel Barnier (EU) and David Davis (UK) urging ongoing cooperation on medicines.

The letter dated Jul. 13 follows one published in the British newspaper Financial Times by UK health secretary Jeremy Hunt and business secretary Greg Clark, calling for continued cooperation with the European Medicines Agency (EMA) after the UK leaves the EU.

Securing an agreement, the signatories said, “is the best way of ensuring that patients across Europe and the UK are able to continue to access safe and effective medicines and to ensure that there is no adverse impact on public health.”

In the case of an unorderly withdrawal, there is a risk that all goods due to be moved between the UK and EU could be held either at border checks, in warehouses or manufacturing and/or subject to extensive retesting requirements, the pharma companies believe, and this could potentially lead to disruptions in the supply of life-saving medicines.

“An implementation period that adequately reflects the time needed by pharmaceutical and biotech companies to transition to a new framework should be agreed on by negotiators. This will allow companies time to make the necessary arrangements to avoid any unintended consequences on the availability of medicines,” the associations wrote. Market authorizations previously granted by the EU while the UK was a member should be maintained post-Brexit, they said.

Those signing the letter included the heads of the Association of the British Pharmaceutical Industry (ABPI), the Association of the European Self-Medication Industry (AESGP), the European Federation of Pharmaceutical Industries and Associations (EFPIA), EuropaBio, Medicines for Europe, British General Manufacturers Association (BGMA), BioIndustry Association (BIA), and the Proprietary Association of Great Britain (PAGB).

In an interview with FT, Mike Thompson, CEO of the ABPI, said that while many medicines first marketed in 2010 or earlier would be covered by a reciprocal agreement with the World Trade Organization (WTO), the rules do not apply to drugs produced after that date. In addition, medical ingredients or components such as placebos that are needed for research and development are also not necessarily covered by WTO rules.

Thompson told the newspaper it is “really critical” that the EU respond to the position laid out by Hunt and Clark no later than this autumn.