MGL c.111L Biotechnology
Law says, in part, "it shall be the policy of the Commonwealth to actively foster research and therapies in the life sciences and regenerative medicine by permitting research and clinical applications involving the derivation and use of human embryonic stem cells..."
105 CMR 960: Biotechnology. As amended, to implement the law above
Dickey-Wicker Amendment, P.L. 104-99 , sec.128
Prohibits use of Federal funds for "(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero..."
21st Century Cures Act, P.L. 114-255
Includes sections requiring timely regulatory review of regenerative therapies, including therapies enabled by stem cell therapy research.
Federal executive orders and guidelines
Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells , March 9, 2009
"For the past 8 years, the authority of the Department of Health and Human Services, including the National Institutes of Health (NIH), to fund and conduct human embryonic stem cell research has been limited by Presidential actions. The purpose of this order is to remove these limitations on scientific inquiry."
National Institutes of Health Guidelines for Human Stem Cell Research , 74 Fed Register 32170, July 7, 2009
Selected case law
Sherley v. Sebelius , 689 F.3d 776 (2012), cert. den. 133 S.Ct. 847 (2012)
The last in a series of cases on federal funding of embryonic stem cells. Affirms the decision of the US District Court (see below) which granted summary judgment to the government and allows the federal funding to go forward. "NIH may not simply disregard an Executive Order.... Bound as it is to carry out the President's directives, NIH thus reasonably limited the scope of its Guidelines to implement the Executive Order. And because the Executive Order's entire thrust was aimed at expanding support of stem-cell research, it was not arbitrary or capricious for NIH to disregard comments that instead called for termination of all ESC research (including research that the executive branch has permitted since 2001)."
- Sherley v. Sebelius, 776 F.Supp.2d 1 (July 2011)
United States District Court for the District of Columbia reconsiders its 2010 temporary injunction against federal funding of embryonic stem cell (ESC) research, and concurs with the U S. Court of Appeals for the District of Columbia Circuit (see below) that the National Institutes of Health’s interpretation of the law was based on a permissible construction of the statute.
- Sherley v. Sebelius, 644 F.3d 388 (April 2011)
Vacates the decision in Sherley v. Sebelius,704 F.Supp.2d 63 (2010), which had temporarily blocked federal funding for embryonic stem cells (ESC) research. On appeal, the circuit court of appeals held that Dickey-Wicker Amendment was “ambiguous” and that the National Institutes of Health (NIH) had "reasonably concluded" that although federal funds could not be used to directly destroy an embryo, the amendment does not prohibit funding a research project using embryonic stem cells. This is an important distinction under the law. The preliminary injunction is vacated.
|Last updated:||September 4, 2018|