Brexit would delay patients access to drugs, regulators warn

Regulators and pharma have warned again that a “Brexit” would have dire consequences for the industry, delaying drug approvals in the UK and starving its regulator of cash.

The senior figures made their comments shortly before a poll by ORB showed the Remain campaign has a 13-point lead over the Leave campaign.

According to press reports, GlaxoSmithKline’s president of pharma R&D, Patrick Vallance, said splitting the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) from the European regulator would mean delays getting drugs to market.

The MHRA, which officially does not have a viewpoint on Brexit, has a close relationship with the European Medicines Agency and both regulators are based in London.

Vallance noted at a press conference in London that the Swiss regulator takes 157 days longer on average to approve drugs and Canada 140 days longer.

Sir Mike Rawlins, chairman of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) said at the conference he was “hoping and praying” that Britain would remain in the EU.

According to the Guardian, Rawlins said: “There is no question about it, if we were to leave the European Union, the EMA would go.”

He added that the MHRA would have to grow in order to take on regulatory work currently performed by the EMA. “Not only that, but I don’t know how it would be paid for,” he added.

MHRA board member Vincent Lawton told pharmaphorum earlier this month that the regulator would lose £12-15 million in annual funding from Europe in the event of a Brexit.

Rawlins added Brexit would mean Britain would be unable to access rapid alerts warning of dangers in drugs and healthcare devices.

The Daily Telegraph reported that Professor Bruce Campbell, non-executive director at the MHRA, said there are around “half a million” medical devices that will need to be regulated.

At the moment this work is covered by the EMA’s system of licensing and surveillance.
He said the UK would have difficulty dealing with the “sheer number” of such devices.

Campbell said: “If things went well we could continue to collaborate with other agencies but I think doing everything to do with medical devices alone would be very difficult.”

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