The government’s plans to speed up the approval of new drugs could change the lives of many NHS patients with life-threatening conditions, according to a leading cancer specialist.
The move could shorten the time people have to wait at least six months for the UK to approve vaccines and other new drugs already approved in the US, Europe or Japan.
And it could save years as the UK requires approval for a new treatment from scratch, given that in Europe, for example, it takes an average of eight years to get approval for a cancer drug, as experts previously suggested.
Medics, meanwhile, welcomed the government’s plans but said it was critical to ensure that safety was not sacrificed.
NHS patients may soon be able to access a range of medicines not yet approved in the UK as part of the government’s plans to automatically approve promising therapies that have already removed regulatory barriers in other key high-safety countries.
It also plans to speed up the approval of new treatments, Chancellor Jeremy Hunt said in the budget.
“Starting in 2024, the Medicines and Health Products Agency (MHRA) will move to a different model that will allow rapid, often near-automated, approval of medicines and technologies already approved by trusted regulatory authorities in other parts of the world, such as the United States. are states. , Europe or Japan.
“At the same time, they will introduce an accelerated re-authorization process for the most advanced medicines and devices from next year to ensure that the UK becomes a global hub for their development and cutting-edge technologies such as cancer vaccines and AI mental health. therapy”.
Lennard Lee, clinical consultant for cancer innovation and diagnostics for the NHS England Cancer Program, told the BBC. I: “This is good news and should give patients a reason to be very positive.”
“The impact on consumers is that our patients can suddenly find themselves in a very unusual situation where they can access the latest and greatest medicines faster than in other countries. You will be at the head of the global queue. It will simply change the lives of patients with incurable diseases like cancer, who need access to life-saving medicines.”
“If successful, our MHRA regulatory system will be the fastest and simplest system in the world. This opens up the opportunity for patients to receive the best treatment from around the world in the shortest possible time, ”said the doctor. Lee.
“Effective regulatory approvals are extremely important. NHS patients want to be the first in the world to have access to new treatments that will change their lives and help many people live better and longer,” said the doctor. Lee, Associate Professor at the University of Oxford and Academic Supervisor of the Indie Sage Science Panel.
Elsewhere, medical professionals welcomed the decision to speed up regulatory approval but said it was critical that it be done safely.
“We welcome this announcement. But we need more details on how the new approval systems will work in practice,” said Mads Thomsen, public health policy adviser at Cancer Research UK. I.
“If these new systems lead to faster regulatory decisions while maintaining current high quality standards, this could mean new treatments reach patients faster and make the UK a more attractive place to launch new drugs and conduct clinical trials,” he said. .
Nicola Perrin, Executive Director of the Association for Medical Research Charities (AMRC), said: “It is encouraging to see the chancellor recognize the importance of accelerating patient access to treatment while maintaining strict safety standards.
“We welcome the MHRA’s announcement of additional resources to develop a sustainable approach. It is critical that patients quickly and safely access new innovative treatments. Looking forward to more details,” she said.
Dr. Li is confident that a faster approval process can be carried out safely.
“Our MHRA stands out as a regulator that always puts safety first. However, security does not mean that verification processes should take months or years. If our regulators have the resources, it is entirely possible to provide patients with early access to safe treatment.”
A government source said: “Patient safety is our top priority and this announcement is no different. People can rest assured that MHRA has a proven track record of developing innovative approaches that reduce the time it takes to bring products to market without compromising our highest standards of safety, quality and efficacy.
Under this new structure, the MHRA reserves the right to reject applications for the commercialization of medicines and medical technologies if it does not consider the evidence presented to be sufficiently reliable.”
Professor Christian Helin, Executive Director of the Institute for Cancer Research in London, said: “We applaud the measures to improve patients’ access to new cancer treatments. Today’s announcement could speed up drug registration in the UK and increase the number of drugs approved here.
“However, MHRA approval is not the only barrier to patients getting new cancer treatments. Once drugs are approved by the MHRA, they still need to be reviewed by authorities such as NICE before they are made available to the NHS.
Sir Martin Landray, Professor of Medicine and Epidemiology at the Oxford Department of Health at the University of Oxford, said: “The default position of accepting approval from another advanced regulatory body such as the US FDA or the European Medicines Agency makes sense – and requires resources. focus on drugs that have specific scientific or clinical problems, or for which approval in other countries seems unreasonably slow for non-scientific reasons.”
The plans are part of a broader healthcare initiative that could also make it easier for life sciences companies to raise the funds they need to develop new drugs.
This includes a £1.8bn “R&D loan” for smaller R&D companies, which means, for example, that a qualifying cancer drug company that spends £2m on R&D will receive more £500,000 to help them discover new opportunities. treatment.
The loan, which could support 20,000 progressive companies, was welcomed by life sciences companies.
Infex Therapeutics is a Northwestern biotechnology company developing drugs to treat infectious diseases and combat the threat of antimicrobial resistance (AMR).
CEO Peter Jackson said: “Today’s announcement gives us the financial flexibility to advance our range of innovative treatments for life-threatening infections. This is especially important as the world faces a growing threat of infectious diseases and drug-resistant infections, which are putting a significant strain on global health systems. There is an urgent need for new anti-infectives and we will continue to support the UK’s leadership in advancing innovation in this area.”
Fiona Lee, founder of VasoDynamics, a Stevenage-based biotechnology company developing drugs to combat the side effects of cancer treatment, said: “We have an exciting line of drugs that are being clinically tested in the UK to prevent and reduce therapy-induced cancers, mouth ulcers . , skin damage and hair loss, which will improve the quality of life for many cancer patients in the UK and elsewhere in the UK’s local industry and society as we move into the next phase of clinical and commercial development.
Hugo Fry, chief executive of RQ Biotechnology, which is developing antibody-based therapies to protect immunocompromised people from COVID-19 and other future pandemic threats, said: “This will help us realize our commitment to producing infectious drugs for vulnerable people at full patient speed. . . This announcement really allows us to grow quickly, build a portfolio, hire local talent and continue our strong investment in the UK biotech sector.”
Source: I News
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