Brexit. One word which can divide a room quicker than asking if pineapple has any right to be considered a pizza topping. Whilst much media coverage has been dedicated to issues such as the customs union, free movement and the (in)famous Irish backstop, much less time has been dedicated to the potential impact on the pharmaceutical and medical industries. However, as the 29th of March quickly approaches, there are a number of serious considerations for both individuals and companies who work in or rely on this sector.
Regardless of whether Britain leaves the European Union (EU) with or without a deal at the end of March, the relocation of the European Medicines Agency (EMA) to Amsterdam, and the current plan – involving the listing of Britain as a Third country (a country outside of the EU or European Economic Area (EEA)) – will have significant consequences for the licensing and approval processes for new therapeutics. EU law states that – amongst many other stipulations – marketing authorisation holders, marketing authorisation applicants, qualified persons for pharmacovigilance and pharmacovigilance master files must reside with the EU or EEA; companies looking to obtain initial or continued EMA approval for their therapeutics must therefore plan accordingly to ensure that they can meet the terms imposed by the EMA .
1-Whilst Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) will take over the approval process for companies looking to license their medicinal products within Britain, and has already put into place a number of contingencies – such as the conversion of Centrally Authorised Products (CAPs) into UK Marketing Authorisations (MAs)  – there are still a number of hurdles relating to MHRA-EMA relations and the transfer of medicines across the EU-Britain border. For example, if Britain is listed as a Third country, then any medication exported to Europe which has been manufactured in the United Kingdom (UK) will be considered as an imported active substance, therefore requiring certification that the manufacturing processes meet the standards demanded by the EMA’s Good Manufacturing Practice (GMP) guidelines . There are other practical considerations surrounding these issues, for example if the marketing authorisation holder changes as a result of the Third country designation, or the batch release site for their product changes, then the therapeutic compound will need to be completely repackaged moving forwards – including the manufacture of EU and UK specific packaging with the inclusion of the respective new marketing authorisation numbers . Although many pharmaceutical companies are quite rightly concerned with the impact of Brexit on the approval status of their existing and new therapeutic portfolios, many may overlook the practical considerations of updating packaging which could find them liable for serious costs if not planned for efficiently.
2-Another potentially serious consequence of both medicine-specific and wider customs issues following Brexit is the possibility of a shortage of medications; if a shortage does occur, it may have significant negative consequences for many patients within the UK. As issues such as the acceptability to the MHRA of EU-based therapeutic batch testing [1,3], alongside the probable disruption caused by the adoption of new border and customs protocols and procedures, are likely to affect the importation of medicinal products, the British government have put into place a contingency plan which includes the stockpiling of essential medications. Whilst the government previously requested pharmaceutical companies stockpile at least six weeks’ worth of medicinal products on top of their usual buffer, some companies – such as Sanofi – have stated that they will have stockpiled enough medication to ensure a fourteen-week supply. Whilst statements such as these are reassuring, the fact remains that increasing their stockpiles is a large-scale operation for many pharmaceutical companies, and it remains to be seen whether these contingency plans will be sufficient, or if they will even be needed at all.
3-Whilst there are several negative consequences, not just for the UK pharmaceutical and medical industries but also for patients, as no member state has left the EU or EEA before there are no precedents which could be used to determine which scenario is most likely to unfold following the 29th of March 2019. Therefore, careful planning and consistent monitoring of the unfolding situation is required to safeguard not just their profit margins and intellectual property, but also the patients whose lives are improved by the availability of their medicinal products.
For more information, including the potential effects of Brexit on issues such as clinical trials, biosimilars, generic medications and blood products – amongst other considerations – please refer to the published advice available from the EMA, gov.uk and MHRA, alongside information provided by industry-specific groups such as the UK Bioindustry Association (BIA) and The Association of the British Pharmaceutical Industry (ABPI).
European Medicines Agency. Questions and Answers related to the United Kingdom’s withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure. 2019.
Medicines & Healthcare products Regulatory Agency (MHRA). Preparations in the event of a No-Deal Brexit: Conversion of Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs). 2018.
Department of Health & Social Care. Batch testing medicines if there’s no Brexit deal. GOVUK 2018. https://www.gov.uk/government/publications/batch-testing-medicines-if-theres-no-brexit-deal/batch-testing-medicines-if-theres-no-brexit-deal (accessed February 18, 2019)