The highly regulated industry fears disruption as the EMA relocates from London to Amsterdam, creating uncertainty about drug approvals after 2019. The EMA is already reallocating regulatory work done by experts in Britain to other countries.
Maintaining timely approvals for new products is crucial both for getting new medicines to patients and ensuring financial returns to drug companies, which work in decade-long product development cycles.
The British government has said it wants to see continued cooperation with Europe on medicines after Britain leaves the European Union, but there has so far been no agreement.
“It is now time for the government to end the uncertainty and translate words into actions. Some form of membership of the EMA is vital to the continued success of the pharma industry and to the welfare of British patients,” Rachel Reeves MP, chair of the Business, Energy and Industrial Strategy Committee, said.
This should include finding a way to keep some of the EMA’s jobs and facilities in Britain, she added on Thursday.
A report by her committee concluded that leaving the EU without an agreement for the pharmaceutical industry would diminish access to markets, including 11.9 billion pounds of exports.
Access to medicines would also be at risk, since nearly three-quarters of UK pharmaceutical imports are from the EU.
In the absence of a deal, drugmakers will have to duplicate regulatory activities across the UK and EU, pushing up costs. The committee report said a separate regime could impose extra costs of 45,000 pounds for each new drug, making Britain an unattractive market for innovative medicines.
Global drugmakers, including UK-based GlaxoSmithKline (GSK.L) and AstraZeneca (AZN.L), have called for continued co-operation after Brexit between the EMA and Britain’s Medicines and Healthcare products Regulatory Agency.
The issue is also a major concern for many Japanese drug companies that have made Britain their European base.
But it will be up to EU governments to decide whether to offer some kind of mutual recognition system to Britain once the country is outside the EU and no longer under the remit of the European Court of Justice, which oversees the EMA.
Reporting by Ben Hirschler; Editing by Alexander Smith