‘Almost automatic opt-out’ – Hunt pledges £10m to speed up access to new medicines

Chancellor Jeremy Hunt announced £10m will be given to the UK regulator – the Medicines and Healthcare Products Regulatory Agency (MHRA) – to streamline the approval of new medical products.

Under the plans, medicines already approved by “trusted regulators” could be given an accelerated green light for use in the UK.

The first regulatory partners with whom the MHRA wants to build new “recognition routes” are authorities in the United States and Japan, it said.

The MHRA said it will remain responsible for approving all “recognition route applications.”

The money announced in the spring budget will also be used to develop a “thorough but condensed process to speed up the approval process for top-of-the-line treatments developed in the UK,” the MHRA said.

In his budget speech, Mr Hunt said: “We are fortunate to have one of the most respected drug regulators in the world in the MHRA, indeed the very first to have licensed a Covid vaccine.

“Starting in 2024, they will switch to a different model that allows rapid, often near-automatic approval for drugs and technologies that have already been approved by trusted regulatory bodies in other parts of the world, such as the United States, Europe or Japan.

“At the same time, they will put in place a fast-track new approval process for the most advanced medicines and devices from next year to ensure the UK becomes a global hub for their development.

“And with an additional £10m in funding over the next two years, they will introduce the fastest and easiest regulatory approval in the world for companies looking to get to market quickly.”

Commenting on the announcement, Richard Torbett, Chief Executive Officer of the Association of the British Pharmaceutical Industry (APBI), said: “Chancellor has announced welcome support for the MHRA.

“Increased long-term funding, action to accelerate the approval of new medicines and a commitment to stepping up collaboration with global regulators will help pharmaceutical companies bring new medicines to UK patients.”

Before Brexit, the UK was a member of the European Medicines Agency (EMA), which meant medicines approved in Europe could be quickly available in the UK.

Alison Dennis, life sciences expert at international law firm Taylor Wessing, said: “The MHRA had to recognize that the UK is a relatively small market outside the EU and for which a separate regulatory regime would pose a barrier to drug and device placement on the market.

“By recognizing the decisions of other authorities (both for medicines and devices), the MHRA can ensure that regulation does not constitute a barrier to entry into the UK market.”

dr June Raine, Chief Executive of MHRA, said: “We warmly welcome the £10m funding announced today by HM Treasury, which will be used to fund our ongoing innovation work and to accelerate the development of groundbreaking global recognition pathways, which will be the case To give British patients faster access to the world’s most advanced medical products.

“This cash injection will ensure we have access to the best resources, talent and infrastructure to deliver this ambitious vision for patients across the UK.”

Health Secretary Steve Barclay added: “This new funding will accelerate the delivery of cutting-edge treatments, including cancer vaccines and new artificial intelligence technologies that make therapy more accessible to people with mental illness.

“It will also accelerate access to medical devices approved in other countries by trusted regulatory partners and ensure we continue to provide the best, most innovative and safest treatments in the UK.”

Commenting on the announcement, Sir Martin Landray, Professor of Medicine and Epidemiology at the University of Oxford, said: “I am delighted that the MHRA has the additional resources it needs to attract, retain and develop the expertise it needs.

“In terms of timely approval of treatments approved by other regulatory bodies, the UK is a small market for new products and is therefore a lower priority for developers than many other territories, including the US, EU and Japan.

“The MHRA’s job is to evaluate the safety and efficacy of medicines.

“There are very few issues so specific to the UK that they warrant special consideration.

“Hence, a default of adopting an approval granted by another demanding regulatory agency, such as the U.S. FDA or the European Medicines Agency, makes sense — and frees up resources to focus on drugs that address particular scientific or clinical problems.” have or where approvals in other countries appear unreasonably slow for non-scientific reasons.”