Thursday, 20 December 2012

CIRM grants, Bayh-Dole and stem cells: should one size fit all?

Last Thursday IP Finance welcomed a guest post by Mike Mireles on the current performance of the United States' Bayh-Dole Act.  Today we are happy to host a follow-up from the same author, also on Bayh-Dole but this time addressing the conflict between the opposed values of flexibility and certainty when funding R&D in the field of stem cells  Mike writes:

California Institute for Regenerative Medicine funding and the Bayh-Dole Act

In addition to federal resources, state funding in the United States may also be available to support the development of intellectual property.  In 2004, the voters of the state of California voted by proposition to allocate $3 billion to finance stem cell research.  The funding is distributed by the California state agency, the California Institute for Regenerative Medicine or CIRM.  After hearings concerning the administration of the funding, regulations were adopted to govern CIRM grants that generally follow the Bayh-Dole Act, but include some changes such as revenue-sharing with the State of California, the requirement of the creation of "access plans" for Californians that cannot afford the CIRM funded drug, and pricing for drugs developed from CIRM funding through the California Discount Prescription Drug Program.  
After funding many projects (see here), a recent Institute of Medicine of the National Academies report has called for numerous changes to regulations concerning CIRM grants including suggesting that the regulations are modified to follow the Bayh-Dole Act more closely -- apparently for reasons associated with consistency that will lead to more certainty.  Should concerns with certainty trump the interest in experimenting with modifying Bayh-Dole Act type legislation, perhaps leading to a Bayh-Dole Act that better benefits the public?  Shouldn't local conditions and concerns warrant changes in Bayh-Dole type legislation?  Does a one-size fits all approach make sense -- let alone for states, but even for different countries adopting Bayh-Dole Act type legislation?  

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