Report 2006-108 Recommendation 2 Responses

Report 2006-108: California Institute for Regenerative Medicine: It Has a Strategic Plan, but It Needs to Finish Developing Grant-Related Policies and Continue Strengthening Management Controls to Ensure Policy Compliance and Cost Containment (Release Date: February 2007)

Recommendation #2 To: Regenerative Medicine, California Institute for

The committee should ensure that it follows through with its plan to identify the appropriate standard for providing uninsured Californians access to therapies developed using institute funds and to convey clearly to grantees its expectations for providing access in its intellectual property policies. In addition, the committee should identify practical benchmarks to use as a standard for discount prices for therapies and apply the standard to its policies for grants to nonprofit and for-profit organizations.

Annual Follow-Up Agency Response From January 2010

By the time of last year's update, CIRM had adopted its "Intellectual Property Requirements for Non-Profit Organizations" (17 Cal. Code Reg. 100300 et seq. ) and "Intellectual Property and Revenue Sharing Requirements for For-Profit Organizations" (17 Cal. Code Reg. 100400 et seq.), and embarked on the process of combining them into a single, updated set of comprehensive regulations. CIRM's governing board, the Independent Citizens Oversight Committee (ICOC) has adopted the new regulations, "Intellectual Property and Revenue Sharing Requirements for Non-Profit and For-Profit Grantees" (17 Cal. Code Reg. 100600 et seq.). The regulations include requirements for discount pricing and access ( 100607). (See 2009-041 p. 30)

California State Auditor's Assessment of Annual Follow-Up Status: Fully Implemented

All Recommendations in 2006-108

Agency responses received after June 2013 are posted verbatim.