Tuesday, June 07, 2005

SCA13: Current and Planned Amendments

The following is from Sen. Ortiz' office and is not available on her website:


SCA 13 (Ortiz) – Current and Planned Amendments
Issue
SCA 13 as Amended 5/31/05
Planned Amendments
Open Meetings
--ICOC and Institute
Meetings of Institute and ICOC subject to California open meeting laws, with exceptions permitted under the Bagley-Keene open meeting act, consistent with Prop. 71 as drafted.
Clarify that the ICOC may consider matters involving patient information, confidential intellectual property or work products, matters involving prepublication, scientific information or data, and matters involving personnel, and that records including such information are exempt from public disclosure.
--Working Groups
Allowed to conduct closed sessions to conduct peer review, including to evaluate and score individual projects, and to consider matters involving intellectual property, proprietary information, and prepublication scientific information.
Grants working group required to produce a written summary of its reasons for funding or not funding any project as well as how each project recommended for funding will benefit California residents. it would also be asked to conduct an open public meeting to solicit public comments before submitting recommendations to the ICOC.
Written summaries could be posted on the Institute’s website, with an opportunity for the public to post comments, in lieu of holding a public meeting to invite public comment.
Public summaries of projects limited to a short description of the project, the disease category addressed by the project, the geographic region represented by the project, and the general reasons for the decision to fund or not fund the project. Intent is not to identify individual applicants or to publicly air the specific weaknesses of their proposals.
Conflicts of Interest
--ICOC members, Chair, Vice Chair, President of Institute
Required to file form 700’s and disclose their economic interests in the manner set forth in the Political Reform Act, as currently required in prop. 71
Required to divest or place in blind trust any financial or real property interest in any organization that applies for funding or that has substantial interests in stem cell therapy, defined as greater than 5 percent of its research budget.
Delete the divestiture requirement for ICOC members, Chair, Vice Chair, and President, and instead rely on the existing PRA disclosure and recusal requirements, or narrow the divestiture requirement to financial investments in designated entities.
--Working group members
Required to file form 700s and disclose their economic interests to the ICOC.
ICOC would provide the State Auditor with the disclosure statements. Auditor would be required to annually review disclosure statements as well as decisions or recommendations of each working group member and report findings to the Legislature regarding whether working group members have complied with requirements.
Apply the NIH requirement that members must recuse themselves from deliberation on any proposal if they or a close relative or professional associate has a financial interest in the proposal, including a direct benefit of any type deriving from the proposal itself, or a financial benefit of any type from an applicant institution of over $5,000 per year, including honoraria, fees, stock, or other benefits.
Narrow the scope of disclosure for working group members, perhaps to reporting interests (investments and income) in entities doing business with the institute and in biotech and pharmaceutical companies.
Intellectual Property
Requires grants and contracts to ensure that clinical treatments resulting from the research are made available at affordable costs to low-income residents and that the state is provided with a share of the royalties or revenues derived from the development of the treatments or services.
Delete the “except as otherwise provided in this article” language in section 6 of the bill, to make it clear that any conditions imposed by the bill are not conditions on the sale of the bonds themselves.
Delete the specific criteria in section 9 in favor of a broader policy statement requiring the ICOC, in negotiating intellectual property agreements, to ensure that therapies and treatments resulting from research funded by Prop. 71 dollars are affordable and accessible to California residents, particularly those eligible for state and county funded programs. This will remove grounds for litigation of individual projects and focus IP agreements in areas that produce the greatest benefits for taxpayers and do not jeopardize the ability to use tax-exempt bonds. Sphere: Related Content

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