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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