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Report sounds alarm about Brexit risks to UK clinical trials environment

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While the UK’s Parliament and general public debate how to implement the country’s withdrawal from the European Union and how to define its relationship with the bloc, a new report highlights one area in which the nation is already seeing a decline: its attractiveness as a destination for clinical trials.

Fitch Solutions released the report this week about the risks that Brexit, set to take place on March 29, 2019, poses to the UK’s clinical trials environment. While it stated that the likelihood of a deal with regulatory continuity – a so-called “soft” Brexit – was on the rise, a no-deal “hard” Brexit continues to pose significant risks. “The rigid negotiating stance of the EU, and refusal to offer any form of concession to the UK government has made the prospect of the two extreme ends of Brexit, these being a very soft ‘Brexit in name only’ or a ‘no-deal’ hard Brexit, more likely,” read the report, which came out Monday.

Already, the report found, the number of clinical trials taking place there has fallen by more than 25 percent, from an average of 806 between 2009 and 2016 to 597 last year. One high-profile case came earlier this month when the BBC reported that San Francisco-based Recardio would suspend clinical trial activities in the UK of the drug heart drug dutogliptin due to concerns about how medicines will be approved after Brexit and whether the European Medicines Agency would accept data generated in the UK. The BBC cited a Sept. 17 email from the company to trial sites, and the Phase II study’s ClinicalTrials.gov page – last updated Oct. 2 – still lists the UK sites, albeit as “Not yet recruiting.”

The BBC reported that the company was concerned data it generated in the UK would not be acceptable to the European Medicines Agency after Brexit, though in a statement the agency said it would continue to accept such evidence after Brexit as long as it met its standards.

On the one hand, the UK’s Medicines and Healthcare products Regulatory Agency, or MHRA, has said it will keep its regulations aligned with those of the EMA. But the Fitch report noted there are two parts of certain EU regulations regulations – participation in the EMA’s single-assessment model and shared use of a centralized IT portal for tracking trial progress – that the MHRA cannot implement outside of the bloc. In addition, the EMA has not provided formal guidance for how it will view clinical trial data from the UK and has directed drug companies to prepare for the likelihood that the UK will not be part of the EMA because it will have a “third-country” relationship with the EU.

The EMA regulates medicines in all the EU as well as the European Economic Area nations of Norway, Iceland and Liechtenstein. Switzerland is the only major Western European country outside the EMA’s authority and has its own agency, Swissmedic. Currently headquartered in London, the EMA is preparing to move to Amsterdam ahead of Brexit.

Photo: Christopher Furlong, Getty Images

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