Brexit spells upheaval for EU and UK drug regulation

* European Medicines Agency may have to move from London

* Duplicate regulatory system could cause confusion

* Currency moves to influence company earnings

By Ben Hirschler

LONDON, June 24 (Reuters) - Britain's vote to leave theEuropean Union spells regulatory uncertainty for drug companies,with the London-based European Medicines Agency (EMA), whichapproves treatments for all EU countries, expected to have torelocate.

The association of Germany's pharmaceuticals industry saidon Friday that Europe's equivalent of the U.S. Food and DrugAdministration would need to move to a city within the EU,bringing administrative headaches for companies.

Britain's biggest drugmaker, GlaxoSmithKline, saidthe exit vote "creates uncertainty and potentially complexityfor us in the future", though the impact on its global businesswould be small, while the UK pharma trade association warned ofchallenges to future investment, research and jobs.

Industry executives fear upheaval at the EMA could snarl theEU's drug approval process and Britain may have to develop itsown domestic regulatory system, leading to further confusion.

Although Britain could continue to take part in the EMAsystem if it remains in the European Economic Area, like Norway,many of those supporting its exit from the EU oppose thatoption.

As a result, British patients could move to the back of thequeue for new medicines as companies prioritise the larger EUmarket, and some medicines could be left in regulatory limbo.

The EMA, with a full-time staff of more than 600, is thelargest EU body in Britain and has overseen pan-European drugapprovals since 1995 from its headquarters tucked away amongglobal banks in London's Canary Wharf.

An EMA spokeswoman said it was premature to comment on itsfuture. "It is too early to foresee the implications of thisdecision and at this stage we are waiting for further guidancefrom the European Commission," she said.

Drug companies and healthcare officials in Sweden, Denmark,Italy and Germany have all expressed interest in hosting the EMAinstead of London, since firms in these countries are keen to belocated close to the region's key regulator.

CURRENCY IMPACT

The impact on profits of Britain's EU exit will be limitedfor many global drug manufacturers as the United States is byfar the largest market for prescription medicines and Asia isalso of growing importance.

GSK said it did not anticipate a material hit to itsbusiness -- and in the short term analysts expect it to enjoy anearnings boost from a weaker pound as overseas revenues aretranslated into sterling.

AstraZeneca, which reports in dollars, and Swissrival Roche won't enjoy such a currency lift but bothsaid it was vital that Britain continued to support the lifesciences industry in the wake of the referendum.

The pharmaceuticals industry employs more than 70,000 peoplein the UK and accounts for 25 percent of all business researchand development spending in the country.

Many scientists are concerned that funding for academicresearch, which has been well supported by the EU in recentdecades, will now be jeopardised, along with importantUK-European research collaborations.

"Now that the direction has been set to leave the EU, it iscrucial that the government develops clear plans to safeguardthe future of science and research in the UK," said RobertLechler, president of the Academy of Medical Sciences. (Additional reporting by Ludwig Burger in Frankfurt; Editing byKeith Weir)