Bad Brexit Risks Lives

Eight trade associations representing the European and British pharmaceutical industries have written to Brexit negotiators, Michel Barnier and David Davis, to underline the importance of close cooperation between the EU and the UK on medicines (1).

The letter warned against an “unorderly withdrawal” that would risk medicines being held up at EU/UK borders during customs checks or in warehouses as a result of new extensive retesting requirements. “This would lead to a severe disruption of most companies’ supply chains, which would lead to potential supply disruptions of life-saving medicines,” said the authors.

The Association of the British Pharmaceutical Industry (ABPI), one of the signatories, has described the letter as an “unprecedented step”. The seven other signatories spanned the EU/UK pharmaceutical sector: the Association of the European Self-Medication Industry (AESGP), the European Federation of Pharmaceutical Industries and Associations (EFPIA), EuropaBio, Medicines for Europe, British Generic Manufacturers Association (BGMA), BioIndustry Association (BIA), and the Proprietary Association of Great Britain (PAGB).

The authors also called for an “implementation period” after the UK leaves the EU on March 30, 2019, so that pharma and biotech companies can transition to a new framework. The authors said, “This will allow companies time to make the necessary arrangements to avoid any unintended consequences on the availability of the medicines.”

The MHRA’s contribution to the work of the EMA was also highlighted, along with the potential for a loss of capacity and expertise within the EMA – both for the review of medicines and pharmacovigilance – should the UK withdraw from the European regulatory network. “A capacity building exercise would be needed, leading to duplication of assessment work at EU and national level,” states the letter, which also notes that Qualified Persons Responsible for Pharmacovigilance (QPPVs) would need to be relocated or replaced – a consequence of the UK leaving the European Economic Area (as John Barber argued in last month’s issue of The Medicine Maker) (2). “This would have an overall impact on the running of the systems that ensure the safety and efficacy of medicines treating EU patients,” said the authors.

In January this year, UK health secretary Jeremy Hunt said that leaving the EU meant there would be “separate regulatory arrangements” and that he did not expect the UK to be a part of the EMA because it would entail being “subject to the European Court of Justice.” He did not, however, rule out the possibility of a mutual recognition agreement between the EMA and the MHRA (3).

Hunt reiterated the government’s desire to “work closely” with the EMA after Brexit in a letter to the Financial Times earlier in July (4). But the letter also went on to state that if the UK government does not achieve its “desired relationship” with the EU, it would set up a regulatory system that “protects the best interests of patients and supports the UK life science industry to go from strength to strength.”