Pharma groups have warned chief Brexit negotiators Michel Barnier and David Davies that an unorderly withdrawal of the UK from the EU could wreak havoc with the supply of medicines.
Eight associations from the UK and Europe have written an open letter to the negotiators to plead for an early partnership agreement on medicines, saying that drugs could be “held either at border checks, in warehouses or manufacturing and/or subject to extensive retesting requirements”.
Getting an early deal on medicines regulation “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”, say the industry bodies.
The letter was signed by the heads of the European Federation of Pharmaceutical Industries and Associations (EFPIA), EuropaBio, the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) along with groups representing generic and over-the-counter drugs.
The UK and EU have already agreed a phased approach to the mammoth task of negotiation Brexit, and the pharma industry is pushing for the legal and regulatory aspects of the medicines trade to be included in the first wave to “avoid any adverse impact on public health and patient safety in both the EU-27 and UK after the UK leaves the EU”.
Last week, UK health secretary Jeremy Hunt and business secretary Greg Clark said in a letter to the Financial Times that the UK “would like to find a way to continue to collaborate with the EU” on the regulation of medicines after 30 March 2019 – the date when the UK officially leaves the EU under the two-year Article 50 process.
The industry associations’ letter welcomes that move and says “we would like to explore this possibility to maintain close regulatory ties between the EU and the UK and to begin these discussions immediately”.
The letter emphasises that it’s very much a two-way problem. Aside from the large number of medicines produced in the UK and destined for EU-wide distribution, the UK Medicines and Healthcare products Regulatory Agency (MHRA) makes a significant contribution to the current operations of the European Medicines Agency (EMA) – soon to move from its London base to an EU-27 home – and its withdrawal could hit capacity at the EU regulator.
“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,” says the letter.
“This will allow companies time to make the necessary arrangements to avoid any unintended consequences on the availability of medicines.”