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London-based European Medicines Agency (EMA), and Maybe Industry, Threatened by Brexit

July 1, 2016

By Mendy Hecht, Hamaspik Gazette

Headlines all over the world were screaming on June 23 with the news that Great Britain had voted to leave the European Union (EU)—one of the biggest stories in decades.

Stories described at length how the planned secession would affect Britain, the EU and the world in any number of areas.

How “Brexit,” or the British EU exit, would affect public health and policy in Great Britain and beyond is thus a subject in its own right. 

In the meantime, though, Brexit looms large for the European Medicines Agency (EMA), the EU’s pharma regulator, whose headquarters is in London.  According to at least one report, the EMA may have to leave London as a direct result of the Brexit vote. 

The same report also suggested that U.K. pharmaceutical business leaders were largely opposed to Brexit.

However, a market analyst mentioned in the same report also said that most major drugmakers, which would include the Britain-based pharma giant GlaxoSmithKline, earn less than three percent of total revenue from U.K. sales.

The director general of the British Generic Manufacturers Association and the British Biosimilars Association, Warwick Smith, raised the possibility that Britain would continue to work with the EMA, with a single European marketing authority beneficial, in his opinion, for both his industry and the country’s National Health System.

According to Mr. Smith, the EMA helps reduce complexity and cost for drugmakers. “The UK generic and biosimilar medicines industry,” he said in a statement, “urges the government to do everything possible to maintain this European marketing authorization system in the forthcoming negotiations with the European Union.”

Other concerns raised by industry experts include whether British health and pharma companies will have to add British patents and trademarks to their existing EU patents and trademarks—or even whether such companies may lose their patent and trademark protections before they can obtain British patent and trademark protections.

But whatever ultimately changes, there is time to prepare: By official rules, once the U.K. officially notifies the European Council of its intention to leave, it has two years before the Brexit would actually go into effect.

As for the EMA, which moved into its London building just two years ago, officials in Italy, Sweden and Denmark have all already expressed interest in taking over as host country.