State’s task force preparing guidelines
The San Diego Union-Tribune
Companies that want to develop new drugs or therapies using science developed under California’s $3 billion stem cell initiative would have to promise to make those drugs available to Medi-Cal at the lowest commercial price under a proposal the project’s leaders will consider next month.
The companies would also have to show the state a plan for making the therapies available to the uninsured, according to the proposal approved yesterday by a task force that has been working on guidelines for handling Proposition 71-funded discoveries.
As requested by two consumer watchdog groups, the task force’s proposed policy includes provisions that would make drugs available to under-served Californians and also try to recoup some of the taxpayers’ investment.
“I saw a very definite response to the notion that this is public money and the taxpayers’ investment needs to be returned, said John Simpson, a spokesman for The Foundation for Taxpayer & Consumer Rights, one of the consumer groups.
The proposed intellectual property policy will be presented to the 29-member committee overseeing implementation of Proposition 71 at its Feb. 10 meeting at Stanford University.
Overall, the proposed policy is similar to the federal policy known as the Bayh-Dole Act of 1980.
Under the federal law, scientists at research institutions around the country receive taxpayer support grants to conduct research. Any money that is made from patenting discoveries make with taxpayer dollars is returned to the research institutions to fund further education and research.
The California task force felt it was important to develop a policy that would complement the federal rules because many researchers who receive Proposition 71 funds may also be using federal money on other projects.
Meanwhile, the task force had to remain mindful of the millions of dollars of private investment money ‘ from venture capital, biotechnology companies and pharmaceutical companies ‘ that will be needed to turn Proposition 71 discoveries into marketable products.
Task force members talked frequently of not wanting to modify Bayh-Dole so much that it would deter that investment.
Under the proposed California policy, if the research institution makes money by licensing discoveries it made using Proposition 71 funding, it will have to return 25 percent of any revenue it receives over $500,000.
The task force also proposed that every research institute that patents a discovery with Proposition 71 funds must send the state a 500-word summary explaining the discovery in plain English.
“You can’t have full transparency if the public doesn’t understand what you are doing, task force Chairman Ed Penhoet said.
Under the policy, any patented research from Proposition 71 funds must be shared at no cost with researchers from any nonprofit California research institution.
The proposed policy also gives the state “march-in rights.” If a company licenses a Proposition 71-funded discovery and then fails to do the work it said it intended to do, the state has the right to march in and take back the science.”
