The author identifies key ethical and legal issues, their divergence, and the link between that divergence and the federal government’s current stance towards stem cell research. The author also recommends steps research institutions must take to narrow the ethics gap, particularly with respect to preserving access to research data and the materials and addressing ethicist’s profound concerns about making the benefits of stem cell research publicly available.
Winickoff DE, Governing stem cell research in California and the USA: towards a social infrastructure. Trends in Biotechnology. 2006 Sept;24(9): 390-4.
The author addresses three emerging ethical and political problem areas in the field of hESC research in California, and a possible solution. The areas identified are funding priorities, intellectual property, and the governance of egg donation. Winickoff suggests that the creation of a public stem cell bank would create a social infrastructure that would improve efficiency and create a pragmatic opportunity to construct an ethical and legal architecture for long-term public return. It would also provide flexibility and foster trust between scientific institutions and society.
Martin PA, Coveney C, Kraft A, Brown N, Bath P. Commercial development of stem cell technology: lessons from the past, strategies for the future. Regenerative Medicine. 2006 Nov;1(6): 801-7.
The authors review the development of stem cell technology since the 1990s and consider the current terrain in light of this historical context. Additionally, the authors analyze the stem cell technology market and recommend public-oriented policies to revitalize it, specifically highlighting innovative public-private collaborations.
Daley et. al. The ISSCR Guidelines for Human Embryonic Stem Cell Research. Science. 2007 February; 315: 603-604.
The author outlines the role of the ISSCR in regulating stem cell research. The ISSCR is a board which encompasses the values and guidelines of several institutions in the U.S. and other countries. He outlines the major principles, such as permissible and impermissible research, proper use of materials. The future goal of the ISSCR is to promote more internationally standardized ethical policy within stem cell research.
*Scott CT, McCormick JB, Owen-Smith J. And then there were two: use of hESC lines. Nature Biotechnology. 2009 August; 27(8):696-697.
The authors analyze the status and use of currently available hESC lines. They argue that in order to create an efficacious policy, one must address both scientific and social pressures on material selection by targeting the diversity of lines in the banks and at the bench. The first step required to use NIH funds more broadly across all the cell lines. The second step is to highlight which cell lines have the most possible downstream public contribution, and fund these accordingly. The authors suggest that new NIH policies focus on both rules for standards and derivation of stem cell lines, as well as the need to develop and disperse these materials to spur innovation.
*Winickoff DE, Saha K, Graff GD, Opening stem cell research and development: a policy proposal for the management of data, intellectual property, and ethics. Yale Journal of Health Policy, Law, and Ethics. 2009 Winter;9(1): 52-127.
“The need to strike a better balance between free sharing and proprietary and regulatory restraint in the life sciences is becoming an important policy concern in the fields of health policy, law, and bioethics.” The authors explore these issues in stem cell research. “Expanded funding for stem cell research and development holds unique promise for advancing medicine and human welfare. However, technical, proprietary, and regulatory conditions are not ideal: closed information, congested intellectual property, and regulatory complexity are likely to slow innovation, skew attention towards large markets, and prevent ethical settlement.” The authors propose a new form of collective action among funding agencies, scientific journals, and research institutions to centralize data, cell lines, and technologies and to design and disseminate research tools with a goal of increasing technology exchange efficiency, orienting product development towards pressing public health needs, and promoting ‘best ethics’ in R & D.
*Bubela T, Strotmann A, Adams R, Morrison S. Commercialization and Collaboration: Competing Policies in Publicly Funded Stem Cell Research? Cell Stem Cell. 2010 July 2; 7(1): 25-30.
The authors examine the effect of commercialization on the ability for scientists to engage in new collaborative innovation models in stem cell research. Their results show that scientists in stem cell research show a high level of collaboration through a pattern best described by institutional affiliation. The authors argue that results have shown policies directed at enhancing collaborative networks and polices directed at commercialization are moderately antagonistic. Patents tended to negatively impact the degree of collaboration. With the existing pressures for commercialization, and the need for collaboration for the development of future clinical applications, the authors advocate balancing incentives for interdisciplinary collaboration with commercialization. [view supplement here]
*So AD et al. Is Bayh-Dole good for developing countries? Lessons from the US experience. Public Library of Science Biology. 2008. 6(10): e262.
While the goal of the Bayh-Dole act (BD) was to encourage commercialization and economic growth from government-funded research, the author points out that the extent to which BD has contributed to increase in patents, technology transfer, or commercialization may be lower than expected, as many researchers have taken advantage of exclusive licenses to create spin-off biotech companies; the patent as a source of revenue for universities is small overall; patents on basic research tools have become a tax on commercialization and decrease incentives to R&D; patents can interfere with university-industry collaborations, causing companies to find other partners, often outside of the US; patent can also interfere with information exchange and conflicts of interest when researchers become involved with companies. The author also enumerates several safeguards for protecting public interest: limiting exclusive licensing only to uses that are necessary for commercialization; transparency; government authority to issue additional licenses; government use rights; and access to end products.
Bahadur G, Morrison M. Patenting human pluripotent cells: balancing commercial, academic and ethical interests. Human Reproduction. 2010 Jan;25(1): 14-21.
The authors discuss the ethics and patentability of hESCs, including moral issues, the monopolistic scope of some patents, impact of iPS technology on these issues, and ways to redress some of these concerns (e.g. patent pools and patent clearinghouses).
*Scott CT, McCormick JB, DeRouen MC, Owen-Smith J. Investement, Uncertainty, and Intertia: Policy Impacts and the Use of Human Pluripotent Stem Cells. Forthcoming in December 2010.
The authors use information taken from a June 2010 ISSCR meeting to show how policies impact the trajectory of a scientific field. In analyzing their data, the authors argue that inconsistency in policy implementation has largely negative effects in stabilizing a growing stem cell research field. There needs to be more stable policy and funding arrangements in order to provide enough incentives for scientists to expand the volume and diversity of research. Lastly, they argue that only an explicit judicial refutation or swift legislation supporting stem cell research will allow for an environment that fosters growth in the field.
Kawakami M., Sipp D., Kato K (2010). Regulatory Impacts on Stem Cell Research in Japan. Cell Stem Cell. 6(5), 415-418.
In this report, the authors provide an overview of Japan’s centralized approach to regulation and analyze its policy implementation. The authors argue that although Japan took an initially positive step in establish early regulations for stem cell research that these policies may have actually help the country back in numerous areas. The areas discussed in the paper include (1) the regulation of human SCNT, (2) hESC guidelines, (3) germ cell differentiation, and (4) somatic stem cells and clinical research. The authors also discuss the impacts of stem cell research and how the international context effects Japanese stem cell science.
*Mathews, D., Graff, G., Saha, K., & Winickoff, D. (2011). Access to stem cells and data: persons, property rights, and scientific progress. Science (New York, NY) , 331 (6018), 725-7.
Many fields have struggled to develop strategies, policies, or structures to optimally manage data, materials, and intellectual property rights (IPRs). There is growing recognition that the field of stem cell science, in part because of its complex IPRs landscape and the importance of cell line collections, may require collective action to facilitate basic and translational research. Access to pluripotent stem cell lines and the information associated with them is critical to the progress of stem cell science, but simple notions of access are substantially complicated by shifting boundaries between what is considered information versus material, person versus artifact, and private property versus the public domain.
*Regenberg, A., & Mathews, DJH (2011). Promoting justice in stem cell intellectual property. Regenerative Medicine. 6(6), 79-84.
The authors argue that while proprietary issues related to stem cell science are not unique, there exists a series of factors that make the discussion of intellectual property rights and models of innovation policy particularly important in the context of stem cell science. In addition to exploring new ways to spur innovation outside traditional patents, the authors point to reasons why stem cell science is especially hindered by patent thickets and a system that inefficiently shares essential data and materials—namely that regulations and policy around stem cell science varies greatly from country to country and the tree-like nature of stem cell lines allows for patent trolls to restrict progress at strategic points. There is a rich discussion of the stakeholders that exist in stem cell science and how the products of such research will be difficult to distribute fairly if those involved cannot figure out a more efficient and organized way for innovation and property management in stem cell science. The paper draws on the Manchester Manifesto and the recent Hinxton Group meeting in Manchester to conclude that ethically informed policy models in stem cell science should help to promote social justice.
Sengoku, S., Sumikura K., et al (2011). Redefining the concept of standardization for pluripotent stem cells. Stem Cell Rev and Rep. 7, 221-226.
The authors review the concept of standardization and the propose an exhausting framework for the proper management of technology on pluripotent stem cells based on studies of global and regional initiatives. Countries included in this analysis are the UK, the US, and Japan. The authors identify two fundamental issues: (1) initiatives and attempts tend to be limited to each of currently existing categories of pluripotent stem cells, whereas the technological opportunity to enable clinical/commercial application is equally open to all stem cell types; (2) the subject to be examined for standardization is set to a quite narrow range compared to precedent practices in other industrial sectors. To address the aforementioned issues the authors propose a strategic framework for standardization.
Levine, A (2011). Access to human embryonic stem cell lines. Nature Biotechnology. 29, 1079-1081.
Levine investigates the claim made by the Hinxton Group that access to cell lines, data, and materials related to stem cell science are often hindered by proprietary issues. By looking at two survery studies, Levine argues that access issues are only one of several factors affecting scientists’ choices regarding which or how many cell lines to use. Other considerations, such as suitability for a specific project, familiarity with specific lines, a desire to reduce complications in the laboratory, cost, the extent of relevant literature and the preferences of scientists’ colleagues also affect these choices. To address this issue the author asked each hESC scientist respondent to list the major reasons they chose to use a particular cell line.
*Note: entries are presented in chronological order within each category. Entries marked with an asterisk are those that we found to be particularly helpful as we developed materials for this project.
Proprietary Challenges in Stem Cell Research 