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Blueprint to fast track innovative drugs and devices

Published on 14/07/09 at 04:56pm

A new 'Blueprint' to put innovation at the heart of the NHS and help support the UK life sciences sector has been launched by Lord Drayson and Lord Darzi.

Lord Drayson set up vaccines company PowderJect in the 1990s and has been working as Minister for Science and Innovation since January in a specially created Office of Life Sciences (OLS).

The OLS has now unveiled a wide-ranging action plan which it hopes will inject new life into the UK life sciences sector, encompassing the pharma, biotech, medical devices and diagnostics industries.

The most notable proposal is for medicines and technologies that are judged to be innovative to bypass the NICE appraisal for a few years and be approved for NHS use immediately.

This 'Innovation Pass' would last for three years, after which time the drug would be referred to NICE, giving companies time to generate evidence of products' value to patients and the health service.

The system is planned for launch with a one-year pilot phase starting in 2010/11, and will have a dedicated budget of £25 million. If it proves successful, the scheme would allow products two further years to prove themselves on the market as well as further dedicated funding to pay for their uptake.

Significantly, the Innovation Pass will not just apply to new medicines, but also new medical devices and diagnostics, which tend to have a lower priority in NICE's current appraisal system.

Developing a culture of innovation

Lord Drayson said: ''By placing innovation at the heart of healthcare delivery, we will help create a pioneering NHS, one that responds to patient expectations, and one where the adoption of new ideas and the diffusion of innovation is encouraged and supported.''

He added that establishing a "culture of innovation" in the NHS was a key component of the new Blueprint, and will undoubtedly be one of the greatest challenges.

To help this, NHS chief executive David Nicholson will review the health service's systems of levers and incentives, such as Payments by Results, to help accelerate the uptake of new medical technologies.

At the strategic health authority level, a new Delivery Group will be created to improve the uptake of new medicines and technologies and the engagement between industry and the NHS.

Innovation Pass

The Innovation Pass idea will be put out to consultation shortly. This will help define some of the most important questions about how it will operate, including just how innovative a technology will have to be, to be considered for an Innovation Pass.

NICE has welcomed the new announcement, and is likely to be involved in setting the criteria for the Innovation Pass, but will not oversee the initiative's budget.

Richard Barker, director general of the ABPI, said: ''In January we warned the Prime Minister that the life sciences industry in the UK needed a shot in the arm. Gordon Brown has clearly heeded that warning. The OLS blueprint charts a course of action which is both sound and welcome. Its delivery will require a full sail and steady and determined hand on the tiller. When the ship is steered safely home, it will deliver a truly transformational change for the life sciences industry in the UK.''

Lord Drayson concluded that the NHS needed to not just champion innovation, but to also help generate income for the UK.

''We have got to have a strong economy. Taxes don't just fall out of the sky, they have got to be earned.

"If we can get everybody in the NHS to see it as a generator of wealth as well as delivering the best quality of care, then we can have the best of both worlds."

He acknowledged this was a controversial concept: "I have already seen commentators popping up and saying it is a conflict of interest, but if we can't do this we will be in serious trouble.''

NHS chief executive David Nicholson was present at the launch, and welcomed its objectives, but agreed the plan would represent a shift in thinking for the health service.

The launch of the Blueprint was held at Imperial College in London, and was punctuated by the visit of the Prime Minister to see a demonstration of groundbreaking medical devices developed at the college.

Also speaking at the event was Lord Darzi, health minister for quality and innovation. He said the Blueprint would help place innovation at the heart of healthcare delivery and create a pioneering NHS.

Asked whether there was an explicit link between the aims of promoting innovation and promoting better health outcomes, Darzi indicated that innovation was the means to this end. He also noted that the US has seen rapid uptake of some new medical devices, but without the evidence base to support them, and indicated this would be avoided in the NHS.

The Blueprint's action points fall into four separate categories: the NHS as an innovation champion; building a more integrated life sciences industry; providing greater access to finance and stimulating investment; and marketing UK life sciences.

Venture capital fund: In terms of access to finance, a new UK Innovation Investment Fund was launched on 29 June, with the aim of helping technology-based businesses grow, including biotech companies, many of which are currently struggling to raise funds. The government will put £150 million into the fund, with the aim of finding industry investment to create a £1 billion, 10-year venture capital fund.

Taxes: The government has also declared its ambition to help innovative businesses by creating further tax incentives. It says an announcement will be made ahead of the Pre-Budget report in the autumn.

Supporting clinical trials and science: The Government will reinforce the need for greater emphasis on research and clinical trials in the next NHS Operating Framework.

Other measures include:

* From 2010, the Society of Biology will begin to accredit undergraduate bioscience degrees to help ensure that graduates leave with the core mathematical and practical skills and competencies required by employers.

* The Government will support the formation of a UK Life Sciences Super Cluster to co-ordinate work across industry, higher education and the NHS, and to boost international recognition of UK life sciences.

* The Technology Strategy Board (TSB) will launch an £18 million "RegenMed" programme of investment to support commercial R&D, with additional funding from the Medical Research Council, the Engineering and Physical Sciences Research Council, and the Biotechnology and Biological Sciences Research Council. The TSB is also committed to improving its expertise in the life sciences.

To download the Blueprint visit the Office for Life Sciences website

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