LONDON, June 27 (APM) - Regulatory challenges pose the most immediate concern for the UK's pharma industry following the result of the referendum, according to a report.
The white paper published on Friday by research firm GlobalData described several challenges now faced by the UK life sciences industry - which accounts for over 180,000 jobs and revenue of over $80 billion - after the UK public voted to leave the European Union (EU).
The most immediate impact will be felt in the area of drug and medical device regulation, where the UK currently follows and contributes to decisions made by the European Medicines Agency (EMA).
The paper said that the two-year period of negotiations that are expected to take place before the UK fully exits the EU may be a "very short" period of time to work out an effective replacement system, and the increased uncertainty may affect investment in the industry.
Elsewhere in the report, GlobalData said there are uncertainties over whether the UK will take up the new EU Clinical Trials Directive, which is due to take effect in October 2018, claiming that if the country does not take up the legislation "the number of multi-centre clinical trials in both the UK and EU is likely to be reduced".
This is because it will be very difficult and costly to integrate national trial authorisation procedures with the new EU centralised trial authorisations.
Other challenges highlighted by GlobalData include the UK being denied access to the Horizon 2020 fund, which is the core of the EU research budget.
According to the report, the UK receives around 15% of the fund, which provides $1.9 billion for healthcare research, with exiting the EU likely to cause significant disruption to projects under way. This means the UK government will need to underwrite their completion or projects will be closed.
In an interview with APM on Friday, Mike Thomson, chief executive of trade body the Association of the British Pharmaceutical Industry (ABPI), had said investment in life sciences is now more likely to go to continental Europe than it is to come into the UK (APMMA 48456).
Although the report is mainly concerned with the challenges the UK life sciences industry is likely to face, it also points out that it is possible to have a successful pharma industry outside the EU, mentioning Switzerland, Canada and Israel as examples of countries with a thriving life sciences industry.
Potential areas for the UK to explore in this area include maintaining access to the single EU market via the European Economic Area agreement, as used by Switzerland, or the Deep and Comprehensive Free Trade Area (DFTA) agreement, which was established with Georgia, Ukraine and Moldova.
GlobalData said it is likely that a solution will be found in any case, commenting: "Given the mutual requirement for citizens to be able continue to access effective medicines and medical devices, there would be considerable good will on both sides to meet a resolution."
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