Brexit and EU regulatory procedures

‘Brexit could delay introduction of new cancer drugs by up to two years, experts warn’ says an article published in The Pharmaceutical Journal on 14 Feb 2017.

Following UK Secretary of State for Health, Jeremy Hunt indicating that he did not expect that the UK would remain a part of the (currently) London-based European Medicines Agency (EMA) post-Brexit, drug regulation experts have issued warnings of potential repercussions for patients in the UK; including the possibility that the approval of important new drugs could be delayed in the UK for up to two years as a direct result of leaving the EMA. They warn that drug companies will prioritise winning approval for access to the larger European market and therefore when the UK leaves the EU, UK patients may have to wait up to two years longer to gain access to new medicines including cancer drugs.

Sir Alasdair Breckenridge, former chair of the UK Medicines and Healthcare Regulatory products Agency (MHRA), speaking on BBC Radio on 10 February 2017, warned that drug companies will prioritise application to the EMA over the UK regulator, as the UK market is much smaller that the EU market. Furthermore, as an additional drug application will definitely attract a further cost for a drug company, there will be a delay in getting important new drugs –anti-cancer drugs, anti-infective drugs – to patients in the UK.

Also speaking on the same radio programme was David Jeffreys, Vice President of Japanese drug company Eisai. He also estimated that UK patients could face a delay of up to two years in accessing new drugs.
Virginia Acha, Executive Director for Research and Medicine at the APBI commented “The proper functioning of medicines regulation, clinical development and monitoring of public health across Europe has been built upon effective integration and alignment, with the UK playing a valued role. “If we don’t find a way to continue to align the UK regulatory system with the EU through cooperation, patients in the UK and in Europe both face the real risk of disruption and delay,” she added. “Securing cooperation between the UK’s medicines agency and the EMA is a sensible solution and we will continue to make the case for an agreement to be reached.”

Sir Kent Woods, former Chief Executive of the MHRA, was positive in his assertion that he believes that an agreement could be made between the EU and the UK on co-operation over drug regulation in the future, but he expressed concern that the issue could become absorbed into wider negotiations over trade terms between the UK and EU. “If this gets subsumed into potentially a more confrontational issue about trade then we may well lose sight of that public health dimension and that would be my concern,” he added.

There is much to gained by keeping the UK and MHRA part of European medicines procedures and systems and with some big hitters making a strong case for this hopefully an agreement that benefits both UK and EU patients will be reached.