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Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: NICE

Bailout Update: New UK Life Sciences Blueprint Aims to Promote Innovation

world_map_2002The UK has a new Life Sciences Blueprint that sets as a goal the creation of an internationally-recognized life sciences cluster.  Here’s the press release and here’s the full report (pdf). 

Innovation Pass and Changes at NICE:

The Blueprint kicks off an “Innovation Pass” program under which certain novel medicines (criteria TBD) will be available for a 3-year period without the otherwise mandatory predicate of review by the National Institute for Health and Clinical Excellence (NICE).  A further report is due from Sir Ian Kennedy next week (July 22) that aims “to identify the aspects of value and innovation which NICE should take into account in its work.”  If innovation stimulus is considered a part of the comparative effectiveness analysis, who knows how widely the door may open even after the Innovation Pass. 

Between these changes and the recent report on genomic medicine from the House of Lords Science and Technology Committee, which recommends that the purview of NICE be extended to “include a programme for evaluating the validity, utility and cost-benefits of all new genomic tests for common diseases, including pharmacogenetic tests,” big changes may be heading NICE’s way.

Also notable:

  • The Government will invest £150 million alongside private sector investment, with the aim of leveraging enough private investment to build a £1bn, 10-year Venture Capital Fund.  This is Lord Drayson’s idea that we held up at the time as a model for technology-agnostic lobbying;
  • Along with a variety of educational initiatives and programs, the Society of Biology will begin to accredit undergraduate bioscience degrees to help ensure that graduates leave with the core skills and competencies required by employers;
  • A reassessment of the UK’s various R&D tax incentive programs (A little tax joke for you there as a prize for making it this far down the post.);
  • An £18 million program for regenerative medicine R&D; and of course
  • A marketing initiative to make sure everyone knows all the great stuff they’re doing.

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Allocating Spending to Support R&D: UK, U.S. and Canadian Approaches

The U.S., Canada and the UK have all acknowledged the central importance of R&D even in these recessionary times.  However, the three national governments have decided to focus their spending on different steps of the R&D equation:

  1. Education: UK Takes the Long View
    British PM Gordon Brown, in a speech this week, identified three priorities: research, education and training, and public discourse.  However, only one of the three, education, was the subject of specific increased targets and spending:  retraining to increase the number of science teachers, a goal to double the number of pupils in state schools taking ‘triple science’, and a new Diploma program.  The U.S. and Canada have increased funding for graduate studies, but the UK effort is focused at an earlier stage, to rebuild the interest and capabilities of domestic graduates. 
  2. Publicly-Funded Research: U.S. Takes the Lead
    The focus of the U.S. R&D spending increases has absolutely been on research.  The increases for the NIH and NSF in the stimulus and the budget will go largely to increasing the volume of publicly-funded research.  PM Brown’s speech also vowed to protect funding for science from competing demands for Government support during the downturn, but did not propose increases over the existing 10-year plan.  Canada’s budget actually cut research funding across the three main granting agencies.
  3. Commercialization: Canada Takes Off 
    Canada’s focus was on commercialization.  The 2009 budget included $200 million allocated to the National Research Council’s IRAP program — $170 million to double the program’s contributions to companies, and $30 million to help companies hire over 1,000 new post-secondary graduates.  It also provided significant additional funding to BDC.  The only comparable spending in the U.S. was the $400 million for ARPA-E, which is allocated to energy programs, and supports research as well as commercialization.  PM Brown’s speech recognized the importance of maintaining the country’s struggling start-ups, and he has reached out to big pharma, but promised no specific action.

What’s still missing:  Stimulating Output

  • Despite calls in the UK, the U.S. and Canada, there have been no major tax policy changes enacted in this round of budgets and bailouts that ease the burden on, or return money to, early-stage technology companies.  Ontario has actually taken some steps in this direction with the Ontario Venture Capital Fund and the Ontario Tax Exemption for Commercialization.
  • Nor have there been many changes that increase the value of outputs: in the bio/pharma area, the UK has probably moved farthest in this direction, with upcoming reforms of the National Institute on Comparative Effectiveness (NICE), while the U.S. has seen decreasing FDA approvals and is allocating new comparative effectiveness funds.  On the other hand, approvals of GE animals, support for personalized medicine and big spending on electronic medical records will provide support to specific industry initiatives.

Stay tuned to our Bailout Page for updates.

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Wednesday Brain Dump: February 4, 2009

Some good news on the gene therapy front in adenosine deaminase-deficient SCID patients and in rheumatoid arthritis.

But mostly bad news on the job front at GSK, AstraZenecaAbbott,  GenVecPatheon, and others.

Other good news on the approvals front for Parusgel (despite process concerns), KapidexLamictalGelnique and Taxus Liberte.

Really small news: Nanomaterials may be heading for increased regulation in Canada, with a mandatory reporting program reportedly pending and a new guide from IRSST in Quebec (pdf) (although the IRSST guide doesn’t mention bio-materials).

Just NICE news: Comparative Effectiveness may be headed for some changes in the UK, where NICE is working on a review.

Positively Biblical news: The lion lies down with the lamb (or something equally unlikely)

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