Consumer Watchdog: Affordable Access to CIRM -Financed Therapies Threatened

The California stem cell agency is proposing a “tremendous loophole” that will allow biotech companies to escape requirements to ensure affordable access to stem cell therapies generated by taxpayer dollars, the Consumer Watchdog group said today.

The group also complained that the regulations are being rushed through a meeting this week of the CIRM board in San Francisco.

The comments were filed by John M. Simpson, stem cell project director of the Santa Monica, Ca., group, who has been deeply involved in the development of CIRM IP regulations. The changes, however, caught him by surprise.

In remarks filed as part of the official regulatory process, he said the proposed alteration in the definition of exclusive licensee is “a substantive change that fundamentally alters the IP regulations.”

Simpson wrote,

“This proposed new definition creates a tremendous loophole that potentially allows companies to escape the IP regulation’s access requirements for products developed with CIRM funds. This was never the intent of the IP task force during its thorough, deliberative process in developing the IP regulations.”

Simpson said,

“It merits a full hearing and thoughtful discussion. Sadly it now appears that there is, for what reason I do not know, an effort to sneak this major change in policy through virtually unnoticed. If that is allowed to happen, it would be truly sad. Developing the IP policies had been one of CIRM’s most inclusive and transparent processes with all stakeholders represented at the table. This change would completely undermine all of those efforts.”

Here is how Simpson described the proposed change:

“The access requirements for products developed by CIRM grantees apply only to grantees, collaborators and exclusive licensees. Under the new proposed definition an entity that purchased a company holding a license would not be obligated to meet the modest access requirements because they would not have received the 'license directly from a Grantee, Grantee Personnel, or Collaborator.' Presumably a licensee could also assign rights to another entity and that entity would not be held to the access requirements, again because it would not have received the 'license directly from a Grantee, Grantee Personnel, or Collaborator.'”

Simpson asked that the proposed changes be referred back to the CIRM IP Task Force before they are acted on by the full board.

We have asked CIRM if it has any comments on Simpson's letter. We will carry the full text of the agency's comments if it responds.

You can read the full text of Simpson's remarks below.