MPs have voted 305-301 that the UK should negotiate to remain part of the European Medicines Agency following Brexit.
“Parliament has sent a clear message that patients and public health should be a top priority for the Government in these negotiations,” said Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, and Steve Bates, chief executive of the BioIndustry Association, in a joint response to the news.
“Every month, 37 million packs of medicine arrive in the UK from the EU and 45 million move the other way. Therefore, it is essential that the UK continues to participate in the EMA after Brexit, as set out in the Brexit White Paper and in the Prime Minister’s Mansion House speech.”
A white paper released earlier this month proposed a role for the UK in EU agencies that provide authorisations for goods in highly regulated sectors – including the EMA – “accepting the rules of these agencies and contributing to their costs, under new arrangements that recognise the UK will not be a Member State”.
Also, the UK would try to ensure that all the current routes to market for human and animal medicine remain available, it said, “with UK regulators still able to conduct technical work, including acting as a ‘leading authority’ for the assessment of medicines, and participating in other activities like ongoing safety monitoring and the incoming clinical trials framework”.
MPs’ decision to have continued involvement in EU medicines regulation after Brexit was also welcomed by the Drug Safety Research Unit.
“The DSRU believes that the overall aim should be to ensure that citizens of the UK and the EU continue to gain access to the best and most innovative medicines. The DSRU will continue to support the MHRA (the UK medicines regulator) and the EMA in their efforts to achieve this aim,” the group said in a statement.
AZ stockpiling meds for no-deal Brexit
Meanwhile, it has emerged that AstraZeneca is increasing stocks of medicines that could be impacted by Brexit by a fifth in case the UK fails to reach an exit deal with the EU.
Juliette White, the company’s vice-president of global external manufacturing, told BBC’s Newsnight that the move was a “safety net” designed to boost the number of medicines ready for pharmacies and hospitals.
“We always have an additional amount of medicines available. We are increasing that by about 20 percent,” she told the programme.