UK could quit EU drug regulation system – minister

UK life sciences minister George Freeman has set up a working group to decide the post-Brexit shape of the industry, which could lead to the country breaking away from the European drugs regulation system.

At a press briefing in London, Freeman said the immediate task of the working group was to reassure business that there would be no immediate change to Britain’s status as a fully paid-up member of the EU for “at least” another two years while Brexit terms are negotiated.

The working group will be co-chaired by GlaxoSmithKline CEO, Sir Andrew Witty, and AstraZeneca CEO, Pascal Soriot, with representation from the UK’s pharma and biotech trade bodies and regulators.

Freeman said the working group will ensure the life sciences industry’s voice is heard in these negotiations over the UK’s relationship with the EU.

But crucially a third priority is to “begin to think about the opportunities for the UK life sciences sector outside of the EU regulatory environment.”

Under further questioning, Freeman said no firm decision had been made about whether the UK should be “in” or “out” of the EU medicines system, which is administered by the London-based European Medicines Agency (pictured).

But his comments suggested that he considers the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to be capable of managing the country’s regulatory affairs in the longer term.

This runs contrary to the thinking of some in the pharma industry, who would prefer the UK to remain integrated into the European drugs regulation system following official Brexit.

They view a separate UK regulatory system as an unnecessary cost, which could prevent the latest drugs from reaching the country’s patients.

When questioned whether he wanted the MHRA to remain part of the EMA’s regulatory network, Freeman said he had not ruled anything in, but he has also not ruled anything out.

Freeman said “there is a commitment to continue to be influential – equally there is an ambition if we are outside the formal EU regulatory process to make sure that we exploit that freedom.”

The thesis of his argument is that the UK is uniquely placed for life sciences research because of the National Health Service and the wealth of clinical data it generates.

With the vast amount of clinical data that the NHS can generate, the MHRA can become a “leader in the European life science network”, said Freeman.

Further details are likely to be included in the Accelerated Access Review, Freeman’s flagship project scheduled for publication in the autumn, which will set out how to bring innovative therapies to patients in the UK, encompassing clinical research, regulation and pricing.

The AAR will provide a “powerful vision of how the UK can harness the NHS as a research platform,” said Freeman, suggesting that the MHRA could work closer with cost-effectiveness body NICE to create a more joined up pricing and regulatory system.

But Freeman said he hoped a negotiation period, lasting “at least” two years, would give the opportunity to resolve issues such as the future of the drug regulatory system.

He said: “In the immediate period following the referendum (we want to) reassure the global investment community the UK is still a life science powerhouse.”

Echoing comments from his colleague, the science minister Jo Johnson in a briefing last week, Freeman said the UK is still an EU member until it chooses to invoke article 50 of the Lisbon Treaty and officially quit the EU.






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