California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 6 - Intellectual Property and Revenue Sharing Requirements for Non-Profit and for-Profit Grantees › Section 100607 - Access Requirements for Products Developed by Grantees

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A Grantee, a
				Collaborator or an Exclusive Licensee that is commercializing a Drug, as
				defined in Title 17, California Code of Regulations, section
				100601, subdivision (i), that
				resulted in whole or in part from CIRM-Funded Research must submit a plan to
				afford access to such a Drug to Californians who have no other means to
				purchase the Drug. As used in this section, "no other means" means Californians
				who are not covered by a prescription drug benefit provided by any third-party
				payer (private or public) covering the particular Drug, and whose family
				incomes are below 300 percent of the federal poverty level. The access plan
				must be consistent with industry standards at the time of commercialization
				accounting for the size of the market for the Drug and the resources of the
				Grantee, the Collaborator or its Exclusive Licensee. Grantees, Collaborators
				and/or their Exclusive Licensees shall have the burden of establishing that the
				proposed access plan satisfies the requirements of this Section.
(b) A Grantee, a Collaborator or an Exclusive
				Licensee that commercializes a Drug must submit the access plan described in
				subdivision (a) of this regulation to CIRM within 10 business days following
				final approval of the Drug by the federal Food and Drug Administration, unless,
				within that timeframe, the Grantee, Collaborator or Exclusive Licensee seeks an
				extension from CIRM. If CIRM grants an extension, the access plan must be
				submitted no later than 30 business days following final approval of the Drug
				by the federal Food and Drug Administration.
(c) The access plan shall be subject to the
				approval of CIRM after a public hearing conducted by CIRM that provides for
				receipt of public comment. CIRM may adopt appropriate procedures to protect
				proprietary information submitted by Grantees, Collaborators and Exclusive
				Licensees in connection with said public hearing. Approval shall not be
				unreasonably withheld. Overall, CIRM shall not require that proposed Access
				plans exceed industry standards for such plans at the time of commercialization
				in California.
(d) Access plans
				approved hereunder shall make Grantees, Collaborators and Exclusive Licensees
				that commercialize a Drug responsible only for providing the Drug itself.
				Nothing herein shall require the Grantee, Collaborator or Exclusive Licensee to
				be responsible for any costs of administering the Drug nor for any associate
				costs of medical procedures or protocols for the Drug therapy, nor for any
				costs for attendant care.
(e) The
				Independent Citizens Oversight Committee ("ICOC") may waive the requirement in
				subdivision (a) of this section if the ICOC determines, after a public hearing,
				that in the absence of the waiver, development and broad delivery of the Drug
				will be unreasonably hindered or that the waiver will provide significant
				benefits that equal or exceed the benefits that would otherwise flow to the
				state pursuant to subdivision (a) of this section. To invoke this waiver
				provision, a Grantee, Collaborator or Exclusive Licensee must deliver a written
				request to the Chair of the ICOC within 10 business days following final
				approval of the Drug by the federal Food and Drug Administration, unless the
				Chair of the ICOC agrees to an extension. The request must be accompanied by
				materials describing how development and broad delivery of the Drug will be
				unreasonably hindered by compliance with subdivision (a) of this section,
				and/or how the waiver will provide significant benefits that equal or exceed
				the benefits that would otherwise flow to the state pursuant to subdivision (a)
				of this section. The request shall be posted on CIRM's website no fewer than
				ten (10) business days prior to the ICOC's consideration. The ICOC may meet in
				closed session to review confidential or proprietary material, or other
				material as allowed by Health and Safety Code section
				125290.30,
				subdivision (d).
(f) A Grantee,
				Collaborator, or an Exclusive Licensee that is commercializing the Drug must
				provide a Drug, that resulted in whole or in part from CIRM-Funded Research, at
				a price as provided in the California Discount Prescription Drug Program
				(commencing with California Health and Safety Code section
				130500)
				(or a successor statewide prescription drug discount program) to eligible
				Californians under said program.
(g) A Grantee, Collaborator or its Exclusive
				Licensee that is commercializing the Drug must sell a Drug, that resulted in
				whole or in part from CIRM-Funded Research, and which is purchased in
				California with Public Funds (as defined in Title 17, California Code of
				Regulations, section
				100601, subdivision (cc)) at any
				benchmark price described in the California Discount Prescription Drug Program
				or a successor statewide prescription drug discount program.
(h) This regulation is not intended, and this
				regulation shall not be construed, to preempt or prevent any other requirement
				under state or federal law or regulation, or agreement or contract, that would
				result in selling a Drug at a lower price than provided hereunder.
1. New section
				  filed 12-17-2009; operative 12-17-2009 pursuant to Government Code section
				  11343.4
				  (Register 2009, No. 51). For prior history, see Register 2007, No.
				  26.
2. Amendment of subsections (a)-(b), repealer of subsection (c),
				  subsection relettering, new subsection (e) and amendment of subsection (g) and
				  NOTE filed 4-18-2012; operative 4-18-2012 pursuant to Government Code section
				  11343.4
				  (Register 2012, No. 16).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.30
					 and
					 125290.80,
					 Health and Safety Code.