Pharmaceutical industry leaders are calling for an orderly implementation relating to the regulation, manufacture, and supply of medicines post Brexit. So what are their chief concerns?

The chief executives from eight UK and European pharmaceutical and life-sciences associations are urging the UK and European Union (EU) negotiation teams to consider the implications of a Brexit implementation on medicines in Europe. DCAT Value Chain Insights examines the major concerns voiced by the industry.

The pharmaceutical industry and Brexit
The chief executive of The Association of the British Pharmaceutical Industry (ABPI), which represents innovator and research-based pharmaceutical companies in the UK, and leaders from seven other UK and European pharmaceutical and life-science industry bodies, have written a joint letter to the UK and European Union (EU) Brexit negotiation teams to underscore the importance of securing ongoing cooperation between the UK and EU on medicines in the wake of the UK’s pending exit from the EU (i.e., Brexit).

The letter, dated July 13, 2017, was sent to Michel Barnier, the chief negotiator to the European Commission, and David Davis, Secretary of State for Exiting the European Union. In addition to the ABPI, the letter was signed by the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents European pharmaceutical companies and national pharmaceutical industry associations in Europe; EuropaBio, which represents the biotechnology industry in Europe; the BioIndustry Association (BIA), which represents the UK biotechnology industry; Medicines for Europe, which represents the generic-drug industry in Europe; the British Generic Manufacturers Association (BGMA), which represents the generic-drug industry in the UK; the Association of the European Self-Medication Industry (AESGP), which represents companies providing non-prescription or over-the-counter (OTC) medicines; and The Proprietary Association of Great Britain (PAGB), which represents the OTC industry in the UK.

The letter follows a letter published in the Financial Times earlier this month in July 2017 by Jeremy Hunt, UK Secretary of State for Health, and Greg Clark, UK Secretary of State for Business, which outlined the UK government’s plans for the regulation of medicines post-Brexit. That letter, say the UK and European pharmaceutical industry, signaled an opportunity to secure cooperation on the regulation of medicines as part of the Brexit negotiations. “We would like to explore this possibility to maintain close regulatory ties between the EU and the UK and to begin these discussions immediately,” said the leaders from the UK and European pharmaceutical and life-sciences associations.

The letter from ABPI, AESGP, EFPIA, BGMA, BIA, PAGB and EuropaBio and Medicines for Europe addressed the need for an orderly Brexit transition to ensure the supply of medicines in the UK and EU. “… 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,” said the letter. “In fact, this would lead to a severe disruption of most companies’ supply chains, which would lead to potential supply disruptions of life-saving medicines.”

The EU and UK associations also are calling for a timely plan for dealing with medicine supply and regulation post Brexit. “It is important that there is as much certainty as possible, as early as possible, to enable the pharmaceutical and life-science industry to transition smoothly into the new framework, ensuring there is no disruption to patient access to medicines.”

The letter further stated: “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,” said the letter. “This will allow companies time to make the necessary arrangements to avoid any unintended consequences on the availability of the medicines.”

The leaders from the UK and European pharmaceutical and life-sciences bodies point to several key issues important in achieving an orderly transition post Brexit. They point to the need to maintain previously granted European marketing authorizations both in the UK and the EU and the need for continued cooperation between national competent authorities as facilitated by the European Medicines Agency and European Commission.

The UK and European associations further underscore that any changes to the EU-UK trading relationship should not adversely affect the research, development, manufacture, and supply of medicines across Europe, including for clinical trials. They point to the loss in capacity and expertise of the UK’s regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), for the surveillance and safety supervision of products in the EU in a post-Brexit environment and the need for a capacity-building exercise for assessment work at the EU and national levels and the need to have UK-based Qualified Persons Responsible for Pharmacovigilance (QPPV)  relocated, trained, or replaced to fill this void.

The leaders from the UK and EU further stress the need to have an implementation period that adequately reflects the time needed by pharmaceutical and biotech companies to transition to a new framework agreed on by negotiators. They say that an implementation period will allow companies time to make the necessary arrangements to avoid any unintended consequences on the availability of the medicines that patients rely on, both in the UK and the 27 member states of the EU. For example, pharmaceutical and biotech companies may need to submit applications for the transfer of marketing authorization for specific products, move batch release for products, or move personnel into the EU-27 from the UK, all of which would take a significant amount of time.

The associations say that an implementation period will also be necessary for national competent authorities who need to ensure they are adequately resourced to deliver the procedures and maintenance activities associated with the new regulatory framework.