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Brexit: what future for EMA and Big Pharma UK?

(Reuters Health) - The outcome of the referendum to leave the European Union outlines a rather complicated scenario, starting with the future awaiting the London-based European Medicines Agency (EMA), which approves medicines for all EU countries. It will most likely be transferred.

The association of German pharmaceutical companies has taken a clear position, declaring that moving the EMA to another city in the countries of the European Union will in any case cause administrative problems for companies.

Britain's largest pharmaceutical company, GlaxoSmithKline, said the vote to leave "creates uncertainty and potential complexity for the future", although it estimates the impact on its global business as low. The association of British pharmaceutical companies has a different opinion, which foresees problems for investments, research and work.

What repercussions on the regulatory process?
Industry executives fear that uncertainties over the fate of the EMA could clog the EU's drug approval process and that Britain may have to develop its own internal regulatory system, leading to further confusion.

As a result, UK patients could become the last in line on the introduction of new medicines as companies prioritize the wider EU market. Furthermore, some medicines could end up in regulatory limbo.

EMA, with a full-time staff of 600, is the largest European Union body in the UK and has overseen pan-European drug approvals since 1995.

An EMA spokeswoman said it was too early to comment on the future of the regulatory agency. "We cannot predict the consequences of this decision and we expect further guidance from the European Commission at this stage."

Conversely, pharmaceutical companies and health officials in Sweden, Denmark, Italy and Germany have expressed interest in hosting the EMA headquarters instead of London.

The impact of Brexit on profits
The impact Brexit will have on the profits of many global pharmaceutical companies is likely to be limited, as the US is currently the largest market for prescription medicines and Asia is also becoming increasingly important.

On the currency side, companies like dollar-based AstraZeneca and Swiss rival Roche won't benefit from a weaker pound, but both have said it will be crucial for Britain to continue to support the life sciences.

The pharmaceutical sector employs more than 70,000 people in the UK and accounts for 25% of all corporate R&D spending in the country.

Many scientists fear that funding for academic research, well supported by the EU in recent decades, could be jeopardized, along with important UK-European research collaborations.

"Now that it has decided to leave the EU, it is vital that the government comes up with clear plans to safeguard the future of science and research in the UK," said Robert Lechler, president of the Academy of Medical Sciences.

Source: Reuters Health News

(Italian version for Daily Health News)

June 24, 2016 - Daily Health News

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