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The government has allocated an extra £10m to the Medicines and Healthcare products Regulatory Agency (MHRA) to help speed up patient access to new medicines, as part of its spring budget.
Delivering the budget on 15 March 2023, chancellor Jeremy Hunt said the additional funding, which the MHRA will receive over two years, was part of plans “to reform the regulations around medicines and medical technologies”.
From 2024, Hunt said the MHRA’s model for approving medicines would allow “rapid, often near automatic sign-off” for those already approved by regulators in other parts of the world, such as in the United States, Europe and Japan.
“At the same time from next year they will set up a swift new approval process for the most cutting-edge medicines and devices to ensure the UK becomes a global centre for their development,” he added.
In a statement published on 15 March 2023, the MHRA said that the funding would support development of a “thorough but shortened” approval process for cutting-edge treatments developed in the UK, such as cancer vaccines and artificial intelligence (AI)-based therapeutics for mental illnesses.
“It will also support the establishment of an international recognition framework, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners and provide patients with fast-track access to best-in-class medical products that have been approved in other countries,” the statement said.
The MHRA also highlighted that it would still ensure that all products approved in this way are of sufficient quality to be licensed in the UK and would operate a “robust process” promoting patient safety.
“Using the MHRA’s pre-existing international partnerships developed through the Access Consortium and Project Orbis, the first regulatory partners MHRA intends to build new recognition routes with are the US Food and Drug Administration in the United States, and with the Pharmaceuticals and Medical Devices Agency in Japan,” it added.
June Raine, chief executive of the MHRA, said: “[The funding] will ensure that we have access to the best resources, talent, and infrastructure to deliver this ambitious vision for patients across the UK.”
Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry (ABPI), said: “An increase in long-term funding, measures to speed up approvals for new medicines, and a commitment to increase collaboration with global regulators will all support pharmaceutical companies bringing new medicines to UK patients.”
However, Torbett added that to “further unlock this potential, it is essential that a new voluntary scheme is agreed between industry and government, which will help build on the chancellor’s vision for a globally competitive, high growth UK”.
On 1 March 2023, the ABPI proposed a fixed 7% levy on manufacturers’ profits to replace the existing voluntary pricing and access scheme, which is due to end on 31 December 2023. However, the Department of Health and Social Care said the proposals were “completely unaffordable”.
Parastou Donyai, chief scientist at the Royal Pharmaceutical Society, said she was “delighted” that £10m funding had been set aside to support the MHRA to “accelerate its approval processes”.
“This has to be seen as good news on many fronts but of course patient safety is also paramount so it is reassuring to know that the MHRA will draw on existing international partnerships and will remain responsible for the overall approval of applications via any new routes,” she said.
Mark Samuels, chief executive of the British Generic Manufacturers Association, welcomed the additional funding from the government. “We have had substantial concerns about delays to the routine approvals of medicines,” he said.
“These not only impact patient access to important treatments but also suspends the onset of competition meaning the NHS is not saving as much money as it could from generics and biosimilar medicines.”
VAT changes to community pharmacy services
In the spring budget on 15 March 2023, chancellor Jeremy Hunt also announced two VAT changes related to community pharmacy services.
From 1 May 2023, the government will extend the VAT exemption on healthcare to include medical services carried out by pharmacy staff directly supervised by pharmacists.
The government also plans to extend the zero rate on prescriptions to medicines supplied to patients through patient group sirections in autumn 2023.
HM Treasury said in the budget these measures were being introduced to “ensure the tax system keeps pace with changes to healthcare delivery, and is in line with the government’s commitment to ease pressure on GP services”.
Janet Morrison, chief executive of the Pharmaceutical Services Negotiating Committee, said it had been “fighting for changes to these VAT rules for many years so it’s great to see this work finally come to fruition”.
“The change to VAT exemption related to the provision of services being supervised by a pharmacist is a critical step if pharmacies are to make headway in making best use of the skill mix that they have, so while small in impact in the context of the current challenges, this is a very welcome development.”
Mark Lyonette, chief executive of the National Pharmacy Association, said: “These measures don’t touch the sides as far as the massive hole in pharmacy funding is concerned, but we should acknowledge that the government has listened to the sector on these specific VAT matters.
“Although this is a positive signal, it is pennies rather than pounds and another opportunity to fundamentally address the funding crisis in community pharmacy has been missed in this latest Budget.”
