After the Brexit win last week the London-based European Medicines Agency (EMA), which approves medicines for all EU countries, may have to be moved to another country. There is alsi concern that the life science division of Europe’s new Unified Patent Court might have to be moved from London. This is just two of the countless concerns that affect the pharma industry with Britain’s historic vote to give up on European unity.
Over the warnings of business leaders in pharma and all other industries, U.K. voters by a 52% to 48% margin opted to quit the EU. Many industry officials believe the EMA, as an EU agency governed by EU legislation, will have to relocate from London to a remaining member state.
With a full-time staff of more than 600, the EMA is the largest EU body in Britain and has overseen pan-European drug approvals since 1995 from its headquarters. Now, after the Brexit election, Europe’s equivalent of the U.S. Food and Drug Administration may have to find a new home, in a jolt to the current drug approval system, reports Reuters.
Reuters also reports that this could slow the approvals of medicines across Europe during this transition process, including in Britain if it has to re-engineer its system. The loss of British expertise would also be a major blow to the agency; in 2014, the latest year for which figures are available, British experts were leaders or co-leaders in examining 27 new drug applications submitted to the EMA, according to the agency’s annual report, reports Reuters. That compares with 15 for Germany, 14 each for Spain and the Netherlands, and 13 for Sweden, the next most active countries.
It is possible Britain could continue to participate in the EMA system as a non-EU member, as happens with Norway, Iceland and Liechtenstein, but this would be subject to negotiation.
According to FiercePharma, Warwick Smith, director general of the British Generic Manufacturers Association and the British Biosimilars Association, in a statement pointed to the benefits that a single European marketing authorization has had for drugmakers and Britain’s National Health System by reducing complexity and cost for drugmakers. He raised the possibility that the U.K. would continue to work through the EMA.
“The UK generic and biosimilar medicines industry therefore urges the government to do everything possible to maintain this European marketing authorisation system in the forthcoming negotiations with the European Union,” Smith said.
Already, officials in Italy, Sweden and Denmark have all expressed interest in taking over as host country, FiercePharma reports.
“For Sweden it is important that we act quickly and start analyzing the situation and nurish our relations with the UK. But also observe how the European cooperation within life science is affected by this election. Most likely EMA needs to leave London and Sweden should look through the possibilities and act for the new headquarter to be located in Sweden. But regardless where the headquarter will be located it is important for life sciences in Sweden and in Europe that the movement is as smooth as possible and that we do not loose speed in terms of development of regulations,” commented Ingrid Heath at SwedenBIO to Life Science Sweden.
There is also concern that the life sciences division of Europe’s new Unified Patent Court might have to move from London before it even opens, reports Reuters. The court is designed to simplify patent litigation by limiting disputes to a single forum and a lease for the London branch was signed in August, ahead of a potential 2016 opening.
Industry bodies representing British-based pharmaceutical and biotechnology companies have expressed concern about the Brexit threat in submissions to an ongoing House of Lords inquiry.
“The UK is a very logical and attractive headquarters location for life sciences companies entering Europe and I would hate to see that imperilled,” said Richard Barker, founding director of the Centre for the Advancement of Sustainable Medical Innovation, a partnership between Oxford University and University College London.