Out-Law / Your Daily Need-To-Know

UK drugs companies face disadvantage due to EMA Brexit approach

02 Jul 2018, 4:11 pm

The European Medicines Agency's (EMA's) assumption that the UK will be a ‘third country’ after its withdrawal from the EU, and no longer part of the Europe-wide drugs safety monitoring system, would put UK-based drug companies at a disadvantage, a life sciences expert has said.

Charlotte Weekes of Pinsent Masons, the law firm behind Out-Law.com, was commenting after the EMA's latest operational plan (22 page / 471KB PDF) for EudraVigilance, the drug safety monitoring system, said it and the European Commission were working on the assumption that the UK would be a third country as of 30 March 2019, when it leaves the EU.

“This means that access to a number of systems and applications supporting the approval and safety monitoring of medicines across the EU would have to be closed to the UK as of that date,” the EMA said.

Weekes said: “Companies with operations in Europe and the UK have already started suggesting that they will focus first on what they need to do to bring drugs to market in Europe due to the larger population before directing their attentions to putting products on the market in the UK. The risk is that patients in the UK will get slower access to new and improved medicines.”

"If the UK was treated as a third country after Brexit and excluded from EudraVigilance, UK operating companies would have to get marketing approval from the Medicines and Healthcare products Regulatory Agency (MHRA), and then do a separate application to European countries in order to get authorisation to market the same product in European countries," she said.

“The UK clearly wants to cooperate closely with Europe and the EMA on medicines regulation, recognising the complications that not doing so will bring," Weekes said. "The UK wants to seek the closest possible regulatory alignment with the EU, particularly during the transitional period, to minimise the risks to all stages of the development and timely supply of medicines and devices. However, it seems that this ideal is not within its hands."

In May a House of Commons committee warned that the cost of new drugs could increase in the UK if the UK's regulatory framework diverged from the EU's post-Brexit. MPs called on the government to maintain cooperation with the EMA to avoid replication of drug manufacturing sites or testing.