Friday January 31 2020 was officially dubbed “Brexit Day” as the UK finally left the EU, following British Prime Minister Boris Johnson’s sweeping election victory on a promise to “Get Brexit Done”.
The UK now enters an 11-month transition period to disentangle political and economic ties from a single market that allows people, goods, services, and money to move freely across member countries’ borders. While conditions continue on the same footing until 31 December 2020, companies will need to prepare for new trading arrangements (still to be negotiated) as of 2021.
Brexit’s uncertainty poses a big threat to the British pharmaceutical industry in particular, as the former relies heavily on the political and regulatory conditions of its country.
For many years, the UK has been at the forefront of pharmaceutical and biotechnology development. Britain’s life sciences industry supported almost 500,000 jobs in 2015, contributing more than GBP 30bn to the UK’s GDP that same year, according to a PwC-commissioned review.
Nonetheless, of the 12,300 medicines used in the UK, around 7,000 come from or via the EU. Securing co-operation between both parties is critical to ensure EU and UK patients continue to have access indispensable medicines post-Brexit. The EU has proposed a voluntary framework “in areas of mutual interest” such as “public health and consumer protection”.
The run-up to Brexit has resulted in the sharpest increase in pharmaceutical stockpiles in decades, as well as “[the planning of] alternative supply routes where possible,” according to Dr Richard Torbett, executive director of commercial policy at the Association of the British Pharmaceutical Industry (ABPI).
Brexit’s biggest tangible toll on the British pharmaceutical industry so far is perhaps the relocation of the European Medicines Agency (EMA) – responsible for providing the scientific, regulatory and trade infrastructure in Europe – from London to Amsterdam. The Agency is still in the process of rebuilding its workforce as 900 jobs were lost upon its relocation.
Moving forward, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) wants “to retain a close working partnership with the EU to ensure patients continue to have timely access to safe medicines and medical devices.” As it happens, the EU is prepared to give the UK access to its market as long as the UK’s regulatory standards remain in alignment [source].
Meanwhile, the EMA has made assurances that “Marketing authorisation holders / applicants can still be established in the UK and Qualified Persons for Pharmacovigilance (QPPVs) and pharmacovigilance system master files (PSMFs), as well as quality control testing sites, can still be based in the UK until the end of 2020” [source].
Another big Brexit-related worry for industry executives in the UK will be their future ability to attract highly skilled talent. With the UK’s exit from the EU potentially changing the rights of UK citizens to live and work anywhere in Europe (and vice versa), the UK government recently announced a fast track visa scheme, Global Talent, for leading scientists, as well as future reforms to the immigration policy post-Brexit.
Talks are not scheduled to start until March, giving the UK and EU only a few months to strike an agreement. While Johnson believes they “have ample time to get on and build a new free trade partnership”, the last 3.5 years of unsuccessful negotiations would suggest otherwise. The possibility of leaving the EU without a trade deal threatens patient safety and the continued uncertainty undermines the attractiveness of the country.
Brexit-related guidance for the life-sciences sector is due in the coming weeks.