Santa Monica, CA — Proposed regulations that would govern who owns and controls discoveries resulting from California stem cell research grants to for-profit organizations fail to ensure affordable access to the drugs and cures for California taxpayers paying for the research, the Foundation for Taxpayer and Consumer Rights (FTCR) said today.
“To ensure that the people who have paid for the research to develop these drugs have this affordable access, there must be a provision allowing for intervention by the state attorney general if the drugs are priced unreasonably,” wrote John M. Simpson, FTCR Stem Cell Project director, in comments filed with the California Institute for Regenerative Medicine (CIRM).
Click here to read FTCR’s comments.
The regulations are being reviewed through the state’s Office of Administrative Law and will have the full force of law when completed. The most recent proposal was open for public comment and those comments must be considered before the regulations can be implemented.
FTCR also said that a provision in the proposed Intellectual Property (IP) Regulations for For-Profit Organizations that would have tied some stem cell cure prices to the California Prescription Discount Drug Program, (Cal-Rx) was rendered meaningless by Gov. Arnold Schwarzenegger‘s action on the state budget. In the deal that allowed the state budget to be approved, Schwarzenegger line-item vetoed the money that would have implemented Cal-Rx.
“Clearly, any provisions in the IP policies that intend to implement favorable pricing must rely entirely on the IP regulations under CIRM‘s auspices and not on some outside scheme that is highly subject to political whim,” wrote Simpson.
Simpson wrote that the revised regulations were clearer and less ambiguous than an early version. He added, “Sadly, however, if the proposed regulations lack an essential provision — in this case a provision that guarantees affordable access for all Californians — it matters little how clear they are.”
Proposition 71, passed in 2004, creates a $6 billion stem cell research program and the California Institute for Regenerative Medicine to oversee it. So far CIRM‘s oversight committee has approved about $210 million in research, training and facilities grants. Last week the state sold the first $250 million in bonds to finance the research program.
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The Foundation for Taxpayer and Consumer Rights is California’s leading non-profit and non-partisan consumer watchdog group. For more information visit us on the web at: www.ConsumerWatchdog.org and www.OilWatchdog.org.
