Ministers are coming under growing pressure to scrap plans to quit Europe’s medicines regulator as part of Brexit, with drug firms saying doing so could force Britons to wait a year longer than patients in the EU to access new drugs.
Labour and leaders of the UK’s pharmaceutical industry fear that patients and the NHS will lose out if Britain gives up its membership of the European Medicines Agency (EMA). The health secretary, Jeremy Hunt, told MPs last week that he did not expect the UK to continue as a member once it left the EU.
Several EU states, including the Netherlands and the Republic of Ireland, have already expressed interest in hosting the EMA’s headquarters if and when it relocates from London with its 890 medical, scientific and managerial staff. Hunt said it was likely the EMA would move as a result of Brexit.
The shadow health secretary, Jonathan Ashworth, has written to Hunt branding departure from the EMA “reckless and unbelievable” and highlighting the “damaging loss of jobs and wealth from our shores” it would involve.
He said that British people would face “longer waiting periods to access life-saving treatments”. He added: “If we leave the EMA we could, like Canada and Australia, have to wait for many months before being able to buy drugs already available in bigger markets like the EU and the United States.”
The Association of the British Pharmaceutical Industry (ABPI), which represents drug firms employing about 220,000 people in the UK, voiced similar concerns. Dr Virginia Acha, its executive director for research, medical and innovation, said that Britain being outside the EMA could lead to patients waiting six to 12 months longer than the rest of Europe to receive newly developed medicines because the UK would be a small market rather than part of a large EU-wide one.
“While there is opportunity in creating a bespoke regulatory framework for the UK, if this operates outside of the EMA, the added time, cost and burden of having to seek additional regulatory approval in a separate system is likely to mean British patients’ access to medicines will face even greater delay,” Acha said.
The EMA currently licenses all medicines that manufacturers want to sell in the 28 EU states and some other countries in the European Economic Area. Its resident population of 500 million people represents 25% of the world’s total drug market. If Britain left the EMA and made its own arrangements to regulate drugs, it would be of much less priority to pharmaceutical firms because it would be as little as 3% of the global market, Acha added.
The prime minister, Theresa May, was non-committal on how drugs regulation would work after Brexit when Philippa Whitford, the Scottish Nationalist MP and an NHS doctor, raised it at last week’s prime minister’s questions.
“Leaving the EMA would be bad for patients and bad for the NHS. We should be doing our damnedest to stay inside the EMA, maybe through some form of associate membership,” Whitford said.
The ABPI is lobbying several Whitehall ministries, including Hunt’s Department of Health and David Davis’s Department of Exiting the European Union, to try to ensure the UK retains some form of membership of the EMA. Britain already has its own drugs regulator, the Medicines and Healthcare products Regulator Agency (MHRA), which is part of an EMA-led pan-European network of 36,000 national regulators and scientists.
The MHRA already plays a disproportionately large role in the EMA’s work, assessing about 20% of all the drugs the EMA evaluates every year. But it would have to increase hugely in size if it became responsible for approving all new drugs aimed at the British market.
Ashworth has asked Hunt to spell out how much it would cost Britain to have a dedicated national drugs regulator and also said that “regulatory divergence between a post-Brexit Britain and the EU” could lead to job losses in the life sciences industry, a sector May has highlighted as central to the UK’s economic prospects after departure form the EU.
Quitting EU regulator "would leave UK waiting longer" for new drugs
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