BREXIT could transform access to new drugs and medical technologies for patients in Britain by stripping away red tape and “risk-averse” regulators, according to a leading think tank.
A paper published today by the Adam Smith Institute urges legislators to streamline the approvals process for potentially lifesaving new medicines and health technologies, arguing that the current regime "has become too risk averse" and bogged down by "overly onerous" regulation.
It said that "particularly needy patients" should be able to get new drugs which have only passed early stage safety and efficacy trials if their doctor recommends it, similar to the system in Japan. Brexit could also accelerate the roll-out of 3D organ printing to help meet the demand for transplants, and remove legal barriers to gene editing therapies for a range of diseases including cancer and heart disease. The think tank said patients in Britain should also be able to access treatments already approved by other developed nations' own regulatory bodies, without needing to undergo a separate and lengthy approvals process here first.
Sam Bowman, executive director at the Adam Smith Institute, said: "Britain has a chance to make itself a global hub for medical regulation after Brexit forces us to rethink the old ways of doing things. But we need to balance that innovation against the need for safety.
"This report’s solution to that need is ingenious: continue to require regulatory approval, but outsource some of that to the regulators of Japan, Germany, Canada and other safe, developed countries that also trial and approve medical products. Let’s hotwire the approvals process and unleash a new era of research and development in the field of making people live longer, happier lives."
In some cases, the strict protocols followed by the UK's Medicines and Healthcare Regulatory Authority were "[depriving] patients of tools which would be able to simplify, or even save, their lives", said the paper. It cited the example of a computer program devised in the US which has been shown to identify melanoma skin cancers with the same accuracy as a dermatologist.
It said: "Once developed into an app, such a computer program would offer very low cost methods of early cancer detection, likely saving many lives. Requiring such an app to go through a costly approval process inevitably means delaying the diagnosis for some individuals with melanoma."
The paper also highlighted the potential of gene editing - a cutting edge technique which allows scientists to replace defective genes with normal functioning ones, but which remains largely illegal. A clinical trial of the first gene therapy, Glybera, in 2012 was "poorly designed" by requiring 342 volunteers despite only 250 Europeans actually suffering from the disease it was designed to treat - an ultra-rare condition called lipoprotein lipase deficiency.
Accelerating the introduction of 3D printing - which uses a patient’s own cells to grow an organ for transplant, eliminating the risk of rejection - would also "save 600 lives" a year across the UK.
The paper added: "Each of these technologies is in its early stages of development. Each technology is also new, and substantially different from prior technologies.
"An overly cautious regulator could kill the potential of each technology, while an enlightened, permissive MHRA could adapt and become a beacon for medical innovation."
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