Brexit will put British patients at the “back of the queue” for vital new drugs, the Government has been warned – forcing them to wait up to two years longer
A medicines regulator has raised the alarm over a likely decision to pull out of the European Medicines Agency (EMA), as well as the EU itself.
Health Secretary Jeremy Hunt dropped the bombshell last month, when he said he expected the UK would quit the EMA – because it is subject to rulings by the European Court of Justice.
Sir Alasdair Breckenridge, a former chairman of the UK's Medicines and Healthcare products Regulatory Agency (MHRA), said companies would be forced to pay for a separate assessment to clear new drugs for use in this country.
He told BBC Radio 4's Today programme: “The UK market compared to the European market of course is small and they may decide not to come to the United Kingdom.
“So, therefore, there will be delay in getting new drugs - important new drugs, anti-cancer drugs, anti-infective drugs - for patients in the UK.”
The comments echo an unreported warning by the current MHRA chairman, Professor Sir Michael Rawlins, who said Japan, the US and the EU would be put ahead of Britain.
He told peers, last month: “One of the biggest worries I have about Brexit and standing alone as a regulator is that we are only three per cent of the world market for new drugs and if we are not careful we are going to be at the back of the queue.”
David Jeffreys, the vice-president of Eisai - a Japanese drugs firm that employs 450 people in the UK - said British patients could face delays of up to two years.
“The early innovative medicines will be applied for in the USA, in Japan and through the European system and the UK will be in the second, or indeed the third, wave - so UK patients may be getting medicines, 12, 18, 24 months later than they would if we remained in the European system,” he warned.
Mr Jeffreys, who also speaks for the trade body the Association of the British Pharmaceutical Industry (ABPI), said it wanted the UK to agree a co-operation deal with the EMA, even if it did not remain part of the EU system.
Dr Philippa Whitford, the SNP’s health spokeswoman and a breast surgeon, said Theresa May had looked “utterly blank” about the benefits of the EMA, when she raised the issue.
Last month, Mr Hunt told a Commons committee he was “hopeful” of being able to continue working closely with the EMA, promising “separate regulatory arrangements”.
And the Department for Health said Brexit offered new opportunities to bring forward new drugs faster from other markets, insisting it remained a priority.
A spokeswoman added: “In fact, Brexit brings opportunities in this area, and we will be focused on whether we can secure even faster access to the latest innovations for British patients.
“So we are already taking action to ensure the UK continues to be a world leader and our cross-agency Brexit taskforce is considering the future regulatory roles the MHRA could adopt."
However, medicines experts fear that efforts to reach a solution will be blocked if they become part of a much bigger political row with the EU during the Brexit negotiations.
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