January 1, 1970 (Vol. , No. )
Lisa A. A. Haile J.D., Ph.D. Partner, DLA Piper Co-Chair, Global Life Sciences Sector
While research on stem cells has generated significant public interest, controversy and political debate is unlimited. The progress in the stem cell field is evident from daily news reports worldwide. The regenerative medicine/stem cell sector clearly spans the global playing field with innovative research taking place across the U.S., Europe, and Asia. Technical innovations, legal positions, and regulatory challenges in one country or region can have a profound effect on the regenerative medicine industry worldwide. In the absence of ethical, regulatory, and legal harmonization, it is unclear what the future holds for stem cell collaborations and commercialization strategies globally.
Resources to Support Regenerative Medicine Studies
Key Bush administration restrictions on embryonic stem cell research were lifted by President Obama. It is believed that while under the Bush guidelines only a handful of stem cell lines were available for federal funding, there may now be as many as 700 or more stem cell lines around the world that are eligible for U.S. government funding.
Additionally, the final NIH guidelines took effect July 7, 2009. The bottom line is that stem cells obtained from embryos created solely for research regardless of the technique will not qualify for federal funding. The NIH guidelines also continue to prohibit federal funding for research that:
• uses human embryonic stem cells from embryos other than those donated by fertility clinics and that otherwise would have been discarded (i.e., created through IVF)
• involves embryos derived by other methods such as therapeutic cloning
• involves embryos from donors who were compensated or who failed to give consent in writing
• introduces human stem cell lines into nonhuman primate blastocysts or influences the genetic lines of animals
• violates the Dickey-Wicker Amendment, which prohibits research on human embryos themselves
The ban on federal funds for cell lines created using cloning includes techniques like somatic cell nuclear transfer (SCNT) or parthenogenesis is because they involved not only complex scientific issues but also further ethical issues on which a broad consensus has not yet emerged. It is unclear, though, why these stem cells should be treatment differently, because parthenogenesis does not create nor destroy viable human embryos; it is carried out on unfertilized human eggs. In fact, parthenogenetic stem cell lines have been approved for use in Germany, where the restrictions on embryonic stem cell research were even stronger than they were in the U.S. under the Bush administration.
Further, parthenogenetic stem cells are unique models for the study of immune rejection, cell differentiation, and DNA expression patterns. Several pluripotent human stem cell lines have been produced in privately funded U.S. labs via parthenogenesis. Should we be concerned that U.S. companies developing stem cells through parthenogenesis and SCNT technologies will receive greater funding offers from the governments of Korea, India, and China in the future? Without access to federal funding here in the U.S., it is quite plausible that stem cell technologies could migrate to other countries.
Recently, Senators Tom Harkin (D-IA) and Arlen Specter (R-PA) introduced ‘The Stem Cell Research Enhancement Act of 2009,’ which would allow for the federal funding of embryonic stem cell research permanently. Otherwise there is the potential that the next administration could overturn President Obama’s executive order leaving the industry in a state of flux as administrations pass through office. President Obama’s order and The Stem Cell Research Enhancement Act of 2009 would only allow funding for research on embryonic stem cell lines created from embryos left over from in vitro fertilization treatments and will still exclude SCNT and parthenogenetic methods for creating stem cells.
Is Harmonization of Legal and Regulatory Aspects Possible?
Harmonization of stem cell research, legal issues, ethical concerns, and patent laws worldwide is desirable. Given the cultural and religious differences among countries, though, it may not be possible. Many believe that patents should be available for isolated human embryonic stem cells and methods of production or use as long as they meet the general patent criteria: novelty, utility, nonobviousness, industrial applicability, inventive step, and sufficiency of disclosure, depending on the country.
Most countries have a “morality” clause with respect to patentable subject matter. For example, something cannot be patented in the U.S. if it is contrary to public policy, in Europe if it is against public order/morality, and in Japan if it is against morality. If we are going to approach harmonization, it seems that exclusions to patentability due to the principles of public order or morality, should be limited if possible.
Perhaps the technical solutions to moral dilemmas in the stem cell field would include more technologies such as parthenogenesis and induced pluripotent stem cells. Currently, there is no international concensus on the moral status of human embryonic stem cells. In the USPTO, you cannot patent a human being; in the U.K. and European Patent Offices, you cannot patent totipotent cells. Policies on patenting differ country to country, reflecting a diversity of moral issues and cultures, thus one must ask the question, will patents stifle global commercialization of stem cell therapeutics?
While federal funding of certain stem cell research can now proceed in the U.S. compared to during the Bush administration, the private equity markets continue to be skeptical about viable stem cell business models in the country as well as Asia, India, and Europe. Additionally, the obvious regulatory uncertainties were highlighted by the news on August 18 that the FDA put Geron’s Phase I trial with human embryonic stem cells (hESCs) in spinal cord injury on hold after approving it in January. This would have been the first clinical study of hESCs. Couple those factors with the potential inability to receive patent protection for certain stem cell technologies worldwide, and there will continue to be questions about the development and commercialization of stem cell therapies in the absence of legal and regulatory harmonization globally.