A brighter Brexit? The biopharmaceutical world more optimistic than last year

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The biopharmaceutical industry is growing optimistic about the effect of Brexit on research and manufacturing in the UK, according to a survey by GlobalData, while the enactment of the trade and cooperation agreement between the UK UK and EU May Day brings mixed prospects for the country.

The GlobalData survey “Brexit and the Healthcare Industry – 2021 Edition” (GDHCHT265, April 2021) reveals the expectations of 150 global healthcare industry professionals surveyed from February 8 to March 3, 2021.

Respondents from the US and UK were, on the whole, positive that the UK remains an attractive destination for healthcare research and manufacturing post-Brexit. While Brexit has caused significant uncertainty for the UK healthcare sector, UK government initiatives, such as the Medicines and Medical Devices Act 2021, provide much-needed opportunities to shape the healthcare environment. innovative post-Brexit healthcare. The law, which came into force on February 11, aims to boost the UK healthcare industry by supporting access to medicines, regulation of new therapies, clinical trials and innovation in the field of health, such as artificial intelligence (AI). The greatest skepticism was seen among European respondents, with only 24% seeing the UK as an attractive destination for healthcare research and manufacturing after Brexit.

The percentage of respondents who think the UK will continue to be an attractive destination has increased by more than 10% this year in the UK and US compared to previous years. The pharmaceutical industry is well known for its risk aversion. With uncertainty surrounding the new relationship between the UK and the EU, the majority of respondents in 2018 and 2019 were unconvinced that the UK would remain an attractive destination for healthcare after Brexit .

This latest change may have been influenced by the finalization of the UK-EU Trade and Cooperation Agreement (TCA), as well as the intentions of the Medicines and Healthcare Products Regulatory Agency (MHRA) to join the U.S. Food and Drug Administration (FDA) Orbis project. , a global program aimed at accelerating patient access to innovative cancer treatments.

Even though the vast majority of European respondents remained negative, their positivity has increased by 10% since 2019, suggesting that the UK-EU TCA has given some confidence in the UK healthcare sector post-Brexit. Among the reasons for pessimism, respondents cited regulatory complexities and “brain drain” due to restrictions on free movement.

UK-EU trade and cooperation agreement

The UK-EU TEA has been provisionally in force since January 1 and was officially ratified on May 1. While removing the prospect of a “no deal” Brexit, it introduced changes ranging from border controls to additional regulations for businesses based in the EU and UK.

The agreement allows free trade in pharmaceutical products for sale on the domestic market, but not for redistribution to a third country. Companies will need to be more careful about their supply chains to determine if their products can benefit from trade without tariffs or quotas. “Companies whose products come from a third country will probably want to avoid transporting these products between the EU and the UK, except for the purpose of sale in the second state, to avoid customs duties being incurred. pay a second time,” notes Alison Dennis, a partner at the law firm Taylor Wessing, on the company’s website.

The UK and EU will mutually recognize each other’s Good Manufacturing Practice (GMP) inspections and documentation, but the EU will not recognize UK batch testing and drug release certification. The UK will continue to accept the release of QPs in the European Economic Area (EEA) until 1 January 2023. (For more, see “New EMA Headquarters Announced; Brexit Drug Manufacturing Guidance Released” , B/POR, December 2017.)

While all existing EU marketing authorizations granted by the European Commission (EC) have been automatically converted to UK marketing authorizations, since January 1 companies have to follow different routes. in order to obtain marketing authorizations if they want to sell their products in both the EU and UK.

The ATT secures UK access to the EU’s €95.5 billion ($114.4 billion) research and innovation program, Horizon Europe (the successor to Horizon 2020). The UK will, however, be excluded from the European Innovation Council’s new accelerator fund, which aims to provide equity investment to start-ups, university spin-offs and small and medium-sized enterprises (SMEs).

Updated EU clinical trial regulations, due to come into force next year, may not become part of UK law, according to current MHRA guidance. For clinical trials conducted in the EEA, the sponsor or legal representative must be based in the EEA and the trial must be registered in the EU Clinical Trials Register.

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