EMA’s Relocation Poses Serious Threat to Pharmacovigilance Experts

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-06-01-2017, Volume 26, Issue 6

European experts in postmarking safety surveillance have the most to loose from impending EMA move post-Brexit.

Qualified persons in pharmacovigilance (QPPVs) have the most to lose when the European Medicines Agency (EMA) relocates from London, according to a feature article posted by TheBMJ online last month.

Most QPPVs in the European Union (EU) work in the U.K., and there are probably more than 500 of them in the country, Vicki Edwards told a forum held in London in April by the Drug Safety Research Unit (DSRU).

“The directive says that pharma companies are obliged to have a QPPV ‘who shall reside and work in the EU,’” said Edwards, who works as a QPPV for AbbVie. “So what about those who live in the U.K.? Will our roles be terminated? I’ve been a QPPV for 12 years and had a very varied career, with never a dull moment. Could my career be taken away? The Brexit vote was a shock to me and I could hardly believe it.”

The referendum on June 23, 2016, in which a narrow majority of the U.K. public voted to leave the EU, effectively meant that the EMA would have to relocate from London after Brexit, or ‘British exit’, and this will have serious consequences for the future of drug regulation, noted TheBMJ article. 

The system set up to monitor the adverse effects of drugs in Europe was created by the EU, with all its attendant rules, and the relevant directive obliges all companies to employ a QPPV, either on the staff or under contract.

“It would be a total waste-and, bluntly, wrong-to move away from the system that has been created,” said Prof. Saad Shakir, director of the DSRU, an independent academic unit and registered charity, as well as an associate department of the School of Pharmacy and Biomedical Sciences, University of Portsmouth, U.K. “Whatever complaints people may have about the EU, nobody seriously complains about medical regulation and pharmacovigilance. It may need a little tweaking here and there, but there are no major criticisms. We shouldn’t be trying to fix a system that isn’t broken.”

Hundreds of staff to quit?

Thomas Lönngren, PhD, a former executive director of the EMA, told the DSRU forum that he expects half of the 850 people who work at the EMA headquarters in Canary Wharf, London, to quit when the EMA departs. “For the EU, the impact will be huge and damaging,” he said. “The EMA has been one of its most successful agencies.”

He foresees a political battle over its new location. “There’s a long queue-Sweden, Denmark, Hungary, France, and several others have declared an interest. It’s got to be somewhere close to an international airport with daily flights to European capitals. The commission will make a shortlist, and the heads of state will decide. I hope they will reach a sensible decision.”

The future relationship between the U.K. and the EMA remains unclear, but at least there is goodwill on both sides, Shakir said.

“It’ll all work out, people say, but how?” asked Dr. Virginia Acha, executive director of research, medical and innovation at the Association of the British Pharmaceutical Industry. “New systems take decades to put in place. We need the government to be a bit more vocal or we’ll just be seen as an industry trying to look after itself. Our preference post-Brexit is for close regulatory engagement, but there is no existing model for how that might work.” 

Continued membership of EMA is not an option, U.K. Health Secretary Jeremy Hunt conceded, according to The BMJ report.

The U.K. Medicines and Healthcare Products Regulatory Agency will need to be “beefed up,” Lönngren said, but its continued role as part of the European regulatory system would depend on negotiation. “I hope the U.K. system will remain harmonized,” he said. A divorce could mean a separate application would be needed for drug approvals in the U.K., discouraging companies from launching drugs there and disadvantaging those based in the U.K.

“There is a lot to play for and a clear danger of collateral damage if the talks get tough. The industry and its dependents are praying it doesn’t come to that,” concluded The BMJ article.