Medical and Regulatory Affairs

Curves Ahead: What Brexit Means for Drug Development in the UK

If the United Kingdom’s plan to exit the European Union evokes thoughts of a perilous road of steep grades and switchbacks, you’re pretty well attuned to the politically and commercially fraught process known as Brexit.

More than two years after British voters elected to split from the EU, it often seems more questions than answers are still emerging from the complex process leading to “Brexit day” on March 29, 2019, and to the U.K.’s full withdrawal from the EU on the last day of 2020. What this uncertainty portends for clinical drug development remains very much a work in progress, and it’s something we’re watching closely as our customers consider its impact on their future.

A lot is happening, including some recent developments that could fundamentally alter research into new therapies in the U.K. and on the Continent for years to come.

Legislators renew focus on clinical trials after Brexit

In July, British politicians voted to have the U.K. maintain close post-Brexit ties with the European Medicines Agency (EMA), narrowly approving a trade bill that seeks to secure Britain’s right to “fully participate” in the regional regulatory network after the split is complete. But will this actually happen?

While the vote seeks to retain close ties to the EMA, and London has been clear about its desire to stay within the European regulatory network, EU negotiators have downplayed the prospect of the U.K. staying closely involved.

Then in early August, Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) confirmed its desire for the U.K. to implement the European Union’s incoming Clinical Trials Regulation (CTR), an effort to harmonize assessment and supervision processes for clinical trials through the EU via a portal and database the EMA is now developing. The agency seeks to create consistent rules for conducting clinical trials and to make information on the conduct and outcome of those trials available to the public.

But due to timing and other factors, Britain’s embrace of the CTR is far from assured. Forces outside the government’s control could push the regulation’s implementation beyond the final Brexit date. That could happen if Brexit negotiations collapse, forcing a hard, no-deal departure in March 2019, or if the EMA again delays implementation, now targeted for first-quarter 2020.

The MHRA announced its position on CTR in part to assure pharmaceutical executives who are concerned about interruptions to supply chains and regulatory processes in the event Brexit talks fall apart. “The government,” the agency wrote, “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.”

Our commitment to helping you manage the Brexit transition: whatever happens

The life sciences industry is vital to the British economy — supporting nearly a quarter-million jobs and generating £70.3 billion (approximately $89.5 billion) in annual turnover — and to the health of people around the world who benefit from the innovation it generates. Premier Research shares the MHRA’s commitment to maintaining the U.K.’s standing as one of the best places in the world for medical and scientific discovery. These headwinds and crosswinds are creating a lot of uncertainty, and we’re following these developments closely and planning accordingly so that our customers don’t have to focus on every bend on the long road to Brexit’s final conclusion.

In fact, we recently created a Regulatory Services Division upon our acquisition of San Francisco-based Regulatory Professionals Inc., a company that provides regulatory solutions to biotechnology, pharmaceutical, and medical device companies. With this expansion of our regulatory expertise, we’re in an even stronger position to help customers navigate this challenging environment.

If you have questions about how Brexit will affect your current or upcoming trial – and what we’re doing to prepare – contact our team today.