U.K. commits to adopt EU trial regulation, minimize divergence after Brexit

The U.K. regulatory agency has detailed how it expects Brexit to affect its clinical trial regulations. Officials reiterated their intent for the U.K. to implement the incoming European Union Clinical Trials Regulation (CTR) and expanded on the long-term effects of Brexit on research approval processes.

How, if at all, CTR will apply to the U.K. after Brexit is one of many questions that have occupied drug developers since the 2016 referendum on European Union membership. CTR is broadly supported by the industry, which would like the U.K. to adopt the law and remain closely tied to EU institutions after Brexit to simplify the initiation and running of clinical trials in the region. However, the U.K.’s priorities look likely to prevent its ongoing involvement in the European Medicines Agency (EMA).

The government outlined its preferred path through this tricky situation in April when it committed to implementing CTR regardless of the outcome of the Brexit negotiations. That commitment headed off a political rebellion but left aspects of the U.K.’s intentions unclear.

Now, the Medicines and Healthcare products Regulatory Agency (MHRA) has reaffirmed the plan to implement CTR and added further details. If Brexit negotiations and the implementation of CTR go as planned, the regulations will come into force during the 21-month period in which the U.K. will be out of the EU in name only. That would see the government transpose CTR into U.K. law, ensuring that the rules remain harmonized when the transition period stops at the end of 2020.

However, forces outside of the government’s control could cause the CTR implementation date to fall after the U.K. has fully split from the EU. That could happen if Brexit negotiations collapse—forcing the U.K. into a hard, no-deal Brexit in March—or if the EMA delays implementation of CTR again. If that happens, the U.K. will "remain aligned with parts of the EU’s CTR legislation that are within [its control]."   

In both scenarios, the U.K. is trying to hew closely to the EMA’s rules, but it can only do so much on its own. As the government and now MHRA acknowledge, the U.K. cannot implement the shared clinical trial IT portal or participate in the single assessment model without the agreement of the EU. The U.K. would have access to these systems during the Brexit transition period, but the situation beyond 2020 is uncertain.

The U.K. wants to stay in the initiatives and other EU-wide programs, ideally as a nonvoting member of the EMA, but the EU has downplayed this prospect. Unless the U.K. compromises further, the EU will treat it more like Canada than Norway after 2020.

That means the U.K. will likely need its own regulatory process for clinical trial approvals. The MHRA addressed how it will handle this requirement in its CTR advice to drug developers.  

"It will still be possible for sponsors to run multistate trials involving the U.K. Sponsors would have to apply to MHRA, as well as to the EU concerned states; but MHRA would take every effort to ensure this parallel submission is as streamlined and efficient as possible (for example by using the same application dossier)," the MHRA wrote. The MHRA has committed to providing assessment outcomes within the EU timeframe. 

Officials published the CTR position to calm the nerves of biopharma executives, who are worried about the prospect of supply chains and regulatory processes collapsing in March in the event of a no-deal Brexit. The CTR document touches on this prospect without providing details about how the MHRA would mitigate the fallout.

"The government recognizes that in the unlikely scenario of no deal between the U.K. and the EU, it would be important to reach a suitable resolution to the supply chain questions that would arise, particularly regarding investigational medicinal products," the MHRA wrote.

--------------------------------------------------------------------------------------------------------------------------

Editor's Note:

To apply for becoming a contributor of en-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.