Lords: ‘Simplify pharma regulation’
pharmafile | July 1, 2013 | News story | Sales and Marketing | Lords, NICE, pharma, regulation
Investors are not putting their money into the UK’s regenerative medicine sector because of the high failure rate when it comes to developing widely-used treatments out of bench research.
That is the stark view of the House of Lords science and technology committee, which has urged the government to simplify the regulatory system around this area – which involves replacing or regenerating cells, tissues or organs in the body – in a report issued today.
The report focuses on translation and commercialisation and suggests the government should beef up support for clinical trials in cell and gene therapy, and tissue engineering, and to put its backing behind innovative funding models to allow more cash into projects.
It is an area the government has already identified as one with great potential, putting £20 million of new funding into the UK Regenerative Medicine Platform last year to provide imaging and cell manufacture technologies.
But the Lords suggest much more is needed in Westminster and Whitehall: “They must take action now to ensure that the UK does not fall behind other countries, such as Japan and the US, who are already taking steps to streamline their processes.”
The science has the potential to provide new treatments – or even cures – for diabetes and neurological conditions, and to allow such procedures as the repair of faulty hearts, thus increasing the wellbeing of patients and helping the country’s economy.
“There is growing concern that despite positive progress so far the UK could fall behind in this area and miss out on opportunities to translate basic science to commercially viable treatments as the science develops,” the report says.
The committee took soundings from organisations including the Medical Research Council, Department of Health, NICE, Human Tissue Authority and the Wellcome Trust before making its recommendations.
In essence it believes the building blocks are in place: “Excellent basic science base, potential access to hundreds of thousands of patients in a unified healthcare system, and experienced blood and transfusion services, clinicians and scientists.”
To press home the advantage, it wants the Health Research Authority to streamline the regulation of regenerative medicine over the next 18 months, providing an additional advice service to help researchers navigate what it calls a ‘labyrinthine’ system.
The Technology Strategy Board and Economic and Social Research Council should look at ‘innovative’ funding models, both here and abroad, and recommend one to the Treasury, the report adds.
Meanwhile the National Institute for Health Research should set up a regenerative medicine stream of its clinical research network to help design trials, identifying patients and clinicians who might take part.
At the same time the Department for Business, Innovation and Skills should put cash into manufacturing facilities to support mid- to late-stage clinical development.
While all this is going on, the DH should develop a strategy to ensure the NHS is ready to provide regenerative treatments
NICE should also build into its evaluation process the fact that the high initial cost of regenerative medicine-based drugs should turn into considerable savings for the NHS in the long run.
The report’s final recommendation is that the government should appoint an independent chair of a group whose job will be to co-ordinate and drive the delivery of these medicines.
“This opportunity must not be missed,” the committee concludes. “The UK could and should be a world leader in this field.”
Adam Hill
Related Content
NICE recommends migraine treatment for NHS use
The National Institute for Health and Care Excellence (NICE) has shared draft guidance recommending AbbVie’s …
GSK’s Jemperli recommended by NICE for endometrial cancer treatment
GSK has announced that the National Institute for Health and Care Excellence (NICE) has recommended …
NICE recommends SC treatment of AbbVie’s Tepkinly for patients with DLBCL
AbbVie has announced that the National Institute for Health and Care Excellence (NICE) has recommended …
