- As the clock ticks down to the U.K.'s exit from the European Union, known better as Brexit, the European Medicines Agency has moved into the third phase of its business continuity plan.
- To safeguard its core activities, the EMA is temporarily scaling back guideline development and revision from Nov. 1 on, and putting non-product working parties on hold. Exceptions will be made for product-related working parties, and for a number of urgent guidelines.
- Phase 4 of the plan, along with additional temporary suspensions and reductions, will begin on Jan. 1 and include moving the EMA's headquarters from London to Amsterdam. The agency expects that activities should be back to normal by June 30, 2019, about three months after Brexit's scheduled date of March 29.
One of the concerns following the U.K.'s 2016 vote to leave the EU has been the potential impact on clinical trials carried out in the U.K.
A report from Reuters, based on Fitch data, suggested that early signs of a clinical trial downturn began last year. Just 597 trials were initiated in the U.K. in 2017, compared with an annual average of 816 between 2009 and 2016 — a fall of 25%.
As uncertainty continues, a specific example of this has emerged. Earlier this month, the BBC reported that Ricardio, a San Francisco-based company focused on regenerative therapies for cardiovascular diseases, had pulled dutogliptin trials planned for U.K. sites in Clydebank, Leeds and Exeter. The company reportedly suspended all U.K. activities because of uncertainties about post-Brexit drug approvals, and the acceptability of U.K. data to the EMA after the country exits the EU.
In guidance updated on Sept. 14, the U.K.'s Department of Health and Social Care said that, in the case of no deal, the country would no longer participate in the European regulatory network and would have the Medicines and Healthcare products Regulatory Agency (MHRA) assume the responsibilities the EU has with regard to the U.K. medicines market. Such a switch would require reworking U.K. law through the Human Medicines Regulations 2012 legislation.
Unless regulations remain explicitly tied to those in the EU, this raises the concern that companies may not find it economically viable to develop drugs for the U.K. market, as it is small compared with that of the rest of Europe.
Another worry is that those companies might not continue to use the U.K. as a location for clinical trials. The country's National Health Service works with commercial sponsors in clinical trials, and these studies brought in an average of £6,658 ($8, 816) in revenue per patient, or £176 million of income for the 2014-2015 financial year, according to an NHS report last year.
Losing that income could be a major blow to the cash-strapped health service. The MHRA has plans for a public consultation later in 2018 on some of the key proposed legislative changes.
It's not just clinical trials that could be disrupted either. No deal, or a hard Brexit, could also disrupt the supply of critical medical products. The EMA has had doubts about whether U.K. companies are sufficiently prepared for the exit, and has also raised concerns about potential drug shortages and the stockpiling of drugs as a contingency plan.