UK pharma sector braced for regulatory shake-up after Brexit
The UK’s pharmaceutical regulator would lose influence over the European Medicines Agency (EMA) if Britons vote to leave the EU in a June referendum. As a result, it could well consider aligning itself with its US equivalent, sector advisors have told EurActiv.com.
Experts say it is looking increasingly clear that the UK would lose the now London-based EMA if Britons vote to leave the EU in the looming 23 June referendum.
Sweden and Denmark have both expressed interest in hosting the regulator if the UK cannot keep it.
he European Commission declined to comment on what would happen to the EMA in case of a Brexit scenario. But experts believe the UK could still, subject to negotiations, remain part of the EMA if it leaves the EU, although its influence on the body would likely wane.
“The pharmaceutical industry benefits from very harmonised regulation in Europe,” Jo Pisani, pharmaceutical and life science consulting leader at PwC in the UK, told EurActiv. “We could still benefit from this regulation under the EEA model, but we’d have less influence over it. In case of a full exit, we’d be put in a difficult position where we might be in the EMA but not have a say.”
If this happens, the UK could potentially try to join the US Foods and Drugs Agency (FDA), she said. “There’s been a lot of talk of a ‘superpower’ global regulatory body,” Pisani said.
This was echoed by another pharmaceutical and life science consultant who declined to be named because of the firm’s decision not to comment on the referendum. He said: “There’s no reason why we couldn’t work with the FDA in the US rather than the EU. This could benefit the market more generally as more and more countries are beginning to follow [the regulation of] the FDA.”
Others questioned the likelihood of the UK aligning itself with the FDA.
Susie Middlemiss, a partner at Slaughter and May, an international law firm, said it “would be challenging as it is a very different system”.
She added that it is “more likely that the UK would try to participate in the EMA regime as it would need to boost the capabilities of its own regulator”, the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
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If the UK leaves the EU, there will undoubtedly be consequences for the National Health Service and public health ― and mostly for the worse, warn a cross-party selection of British MEPs.
A spokesperson for the FDA would not comment specifically on a potential linkage with MHRA but said the two regulators already have a “strong relationship” and that the FDA “would work with MHRA as it does with them today [in case of a Brexit], but also as it does with regulators such as Swissmedic, which is not part of the EU or EMA”.
“It is important to be aware that the EMA model is not identical to ours for medical product regulation, with the FDA’s remit being much broader,” the spokesperson added. “For example, clinical trials and pre-market development are regulated by individual countries, not EMA.”
MHRA declined to comment.