Regulations Approved for Proposition 71-Funded Research
The Independent Citizens' Oversight Committee on Friday approved regulations for stem cell research funded by Proposition 71, including giving California the same discount for new therapies as the federal Medicaid program, the Sacramento Bee reports. State voters approved Proposition 71 in November 2004 to fund stem cell research.
Under the regulations:
- Companies will be able to set their own discount policies for providing new therapies to low-income, uninsured workers;
- The California Institute for Regenerative Medicine will have "march-in" rights to seize licenses from institutions that do not comply with the regulations;
- Researchers will be required to quickly disclose their discoveries, share them with other researchers and write 500-word summaries of discoveries for the general public; and
- Universities must return 25% of royalty revenue exceeding $500,000 to the state.
The regulations also include a number of rules for egg donors. The guidelines state that egg donors must be told they will not receive any payments, except reimbursement for expenses related to the donation, and they must be told about the risks associated with donation (Wasserman, Sacramento Bee, 2/11).
Egg donors also must be told how the eggs will be used. Two review boards must review and approve projects involving the use of eggs (Somers, San Diego Union-Tribune, 2/11).
The rules will be finalized later this year after a 270-day public comment period (Sacramento Bee, 2/11).
CIRM President Zach Hall told the board of directors on Friday that "[i]t will be the spring of 2007 before we will be able to pursue stem cell research on the scale that the voters of Prop. 71 expect" because of legal challenges to the law. Hall said that although it could take 15 more months, he expects Proposition 71 funding will eventually be made available.
In the meantime, ICOC Chair Robert Klein said on Friday he was close to raising $50 million in philanthropic donations to the institute. Donors will be repaid if CIRM wins the lawsuits challenging Proposition 71. The donations, issued as bond anticipation notes, will allow CIRM to begin training stem cell researchers.
Hall also suggested raising more than $2 million in private funds to support collaborations with other scientific organizations (Lin, Los Angeles Times, 2/11).