Following the announcement by UK and European Union (EU) authorities of the progress made in Phase One of the negotiations between the UK and EU over the UK’s withdrawal from the EU (i.e., Brexit), the European Union and UK pharmaceutical industry are calling for priorities relating to the supply of medicines in the next round of talks.

UK Prime Minister Theresa May and European Commission President Jean-Claude Juncker announced on December 8, 2017 that they had reached an agreement in principle across the following three areas in the first phase of negotiations: protecting the rights of EU citizens in the UK and UK citizens in the EU; the framework for addressing the unique circumstances in Northern Ireland; and a financial settlement. The parties issued a joint report on December 8, 2017 to detail the progress made thus far on these and other issues. A summit of EU leaders will meet on December 14-15 at which time they are expected to adopt the draft guidelines to enable Phase Two of the negotiations, which will decide the future relationship between the UK and the EU, including a possible trade treaty. The UK is scheduled to leave the EU on March 29, 2019, but the terms of its withdrawal and the nature of its future relationship with the EU are yet to be decided.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents European innovator, research-based companies and national pharmaceutical associations, released a statement on December 7, 2017 to outline its priorities that it says will “determine the risk in Brexit’s impact on patients and public health across Europe.”

These priorities include: (1) bringing close cooperation between the EU and UK on the regulation of medicines and medical technologies to ensure that UK and EU patients will continue to have access to life-saving medicines and medical technologies; (2) establishing a common framework for collaboration in research and information sharing between the EU 27 (i.e., the 27 members states of the EU not including the UK) and the UK; (3) ensuring that there are continued reciprocal healthcare arrangements between the EU and UK; (4) developing strong coordination between the EU and UK on public health, including in pandemic preparation and disease-prevention programs; and (5) ensuring EU and UK health professionals continue to benefit from mutually beneficial training and education opportunities, including automatic recognition of qualifications.

The British pharmaceutical industry also weighed in on the implications of Brexit on the UK pharmaceutical industry, in particular on drug-safety monitoring. To coincide with a December 12, 2017 hearing, “Brexit: The Regulation of Medicines, Medical Devices and Substances of Human Origin” in the Health Select Committee of the UK Parliament’s House of Commons, the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) have published new research on the public health implications of Brexit. ABPI represents pharmaceutical manufacturers in the UK, and the BIA represents biotechnology companies in the UK.

The report assesses the various potential public health and economic impacts according to different possible combinations of trade and regulatory agreements between the UK and EU. The report says that the public health implications of Brexit will become more severe as public health cooperation and trade relationships lessen between the EU and the UK. Also, the report says the public health impacts may not only occur in the UK, but many may also be significant in the remaining counties of the EU and the European Economic Area.

The UK pharmaceutical industry is urging prioritizing issues relating to the supply of medicines in the next round of Brexit talks. “While a breakthrough on ‘sufficient progress’ is a significant step forwards this momentum must now be carried forward to prioritizing the issues that matter the most to people in the EU and the UK in the next round of talks,” said ABPI CEO Mike Thompson, in an agency statement.

Steve Bates, chief executive officer of the BIA, says he plans to use the research to urge the governments of the EU and the UK to “safeguard public health in the UK and Europe by making the regulation and supply of medicines the first priority in Phase two of Brexit talks.”

In the event of Europe and the UK are no longer cooperating as they do currently on medicines and public health, the report highlights several potential problems: (1) the sharing of important drug safety information or information relating to adverse medical events could face a five-month delay; (2) Europe’s management of large-scale emerging public health concerns or crises, such as the Zika virus, could be at risk; and (3) a potential for increased frequency of medicines shortages due to administrative burden, customs delays and tariff measures.

The research assesses the consequences arising from legal and regulatory changes associated with Brexit based on four scenarios– from full EU/UK cooperation on public health and trade to no cooperation. In Brexit scenarios where the UK fails to negotiate continued participation in public health activities or a free-trade agreement, medicines safety, incident and crisis response to public health threats and the medicines supply chain are all found to be detrimentally affected in Europe and the UK.

The report finds that the UK has detected the greatest number of signals, meaning information relating to a possible causal relationship between an adverse event and a drug, of all EU27/European Economic Area (EEA) countries since 2012. However, in Brexit scenarios 2, 3, and 4, the UK’s expertise will no longer be directly and immediately available to the EU27/EEA, nor the EU’s to the UK.

The analysis concludes that in a Brexit scenario where the UK and the EU fail to reach a trade agreement on pharmaceuticals, medicines will be subject to tariff and non-tariff measures that could increase administrative burden, cause customs delays, and increase costs.

Source: Association of the British Pharmaceutical Industry (ABPI) , BioIndustry Association, and European Federation of Pharmaceutical Industries and Associations