Brexit: Europe drug regulator unplugs from UK

Bloomberg

Europe’s medicines watchdog is bracing to make do without one of its most trusted partners. The European Medicines Agency (EMA) stopped assigning work to the UK’s pharmaceutical regulator earlier this year, unsure whether the two organisations will need to stop collaborating after Britain leaves the European Union in March. Preparing for a potential split, the EU body has also handed over responsibility for about 370 drugs that were overseen by the British authority to other countries.
The EMA stands to lose hundreds of staff in its move to Amsterdam from London, and looming lack of access to British scientists adds to the pressure. PM Theresa May brought back a divorce deal from Brussels that will be put to UK lawmakers to accept or reject at a vote on December 11. Approval looks unlikely, opening up the possibility the country will crash out of the bloc without an agreement.
“We have to work toward the worst-case scenario,” EMA Executive Director Guido Rasi said in interview in London. That would mean UK experts “are not part of the system. They cannot be given any role. We cannot share official data. We have to unplug.”
Europe’s equivalent of the US Food and Drug Administration appoints teams from different nations to assess new products, and the UK has typically shouldered at least 15 percent of the work. The prospect of the two regulators diverging has sparked concerns about a slower process that might hinder UK patients’ access to new drugs.
“A significant diversion of the UK and EU frameworks in the future will translate into a duplication of regulatory efforts, with extended time frames and cost increases,” said Liz Cohen, a
life-sciences lawyer at Bristows.
The UK’s planned divorce has also forced the EMA into a difficult relocation. The agency is seeking to limit losses among its 900 staff to about 24 percent, said Rasi, a physician and former head of Italy’s drug regulator. While that would be better than the earlier estimate of 30 percent, the impending shift has slowed training and technology improvements, he said.
It’s still unclear what kind of ties the UK regulator, called the Medicines and Healthcare Products Regulatory Agency, will have with the EMA, which oversees the safety of medicines in a market of 500 million people.