Brexit: could European Medicines Agency stay in London?
As the UK, Europe and the rest of the world digest the implications of Britain’s decision to leave the European Union, the pharma industry is considering the potential impact on drug regulation in Europe.
The European Medicines Agency (EMA) is based in London, and with more than 600 staff, it is the largest EU organisation based in Britain. It has been based in the UK capital since it first began operations in 1995.
Responsible for approving the vast majority of new medicines across Europe, the EMA gives approval for drugs to be marketed across the European Union’s 28 member states, but its approvals are also recognised by European Economic Area (EEA) members Iceland, Liechtenstein and Norway.
The EMA relies heavily on the expertise of national regulators to review new drug filings on its behalf – as ‘rapporteur’ or ‘co-rapporteur’ and the UK’s MHRA is one of the leaders in Europe in this role.
Although Germany’s pharma trade body has already called for the EMA to be relocated to a large European city, industry leaders have called for the regulatory system to be preserved if possible.
The EMA will continue with its business as usual in the short term, and has said it is waiting for instructions from the European Commission.
Richard Bergstrom, director general at the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing European pharma, has said that the UK could remain within the EU system, via means such as EEA membership.
It may take as long as two years before any changes to the EU regulatory system are agreed, a period of uncertainty which will be damaging for the UK and Europe as a whole.
“The EMA situation is disruptive but is doable,” said Bergstrom in an interview with pharmaphorum.
Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry (ABPI), agreed: “In Europe they have huge respect for the talented group of people working at the MHRA. It is clearly not in anybody’s interests to have two regulatory processes.
“We have to be creative and do what is right for British patients and not follow some logic of separation that makes no sense.”
Sarah Rickwood, vice president of thought leadership for Europe at IMS Health says there are a number of potential post-Brexit scenarios for European drug regulation.
She says the question about the EMA and its location immediately comes into play.
One of these is “no change”, where the UK adheres to all EMA regulation, although this could require the UK to sign up to the terms of the EEA in a Norway-style arrangement.
One stumbling block to this could be the issue of migration, which was a leading reason for many voters to back the ‘Leave’ campaign.
Becoming an EEA member would mean the UK would also have to maintain a commitment to free movement of labour agreement with Europe – but this would pose problems given that many people voted to leave because of concerns about border control.
Other options include a new relationship negotiated between the UK and Europe more akin to that between the EU and Switzerland, which has bilateral trade agreements with Europe, but also has caps on migration.
The latter option would be possible if the UK ends up with looser ties to Europe through the European Free Trade Association, World Trade Organisation rules, or an entirely independent relationship.
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