Stem Cell Research and Economic Promises

However, see generally the interesting paper by Winickoff D. E. Saha K. Graff G. D. , “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 9, no. 1 (2009): 54–126. See also Herder M. Brian J. D. , “Canada's Stem Cell Corporation: Aggregate Concerns and the Question of Public Trust,” Journal of Business Ethics 77, no. 1 (2008): 73–84.

See Zarzeczny A. Caulfield T. , “Emerging Ethical, Legal and Social Issues Associated with Stem Cell Research and the Current Role of the Moral Status of the Embryo,” Stem Cell Reviews and Reports 5, no. 2 (2009): 96–101.

Salter B. , “State Strategies and the Geopolitics of the Global Knowledge Economy: China, India, and the Case of Regenerative Medicine,” Geopolitics 14, no. 1 (2009): 47–78, at 54. See also Silversides A. , “Merchant Scientists: How Commercialization Is Changing Research in Canada,” Walrus Magazine, May, 2008, available at <http://www.walrusmagazine.com/articles/2008.05-science-and-commercialization-ann-silver-sides/> (last visited March 5, 2010).

Weinstein B. L. Clower T. L. Seman M. , Economic Impact of Stem Cell Research in Texas, Prepared for The Alliance for Medical Research Houston, Texas, January 2009, available at <http://www.unt.edu/cedr/StemCell.2009.pdf> (last visited March 5, 2010).

Id., at IV.

Id., at V.

Goodman A. C. Berger S. , Michigan Stem Cell Economics Study, a report prepared for The Michigan Prospect, September 15, 2008, available at <http://www.michiganprospect.org/files/stem_cell.pdf> (last visited March 5, 2010).

Id., at 6.

Seneca J. J. Irving W. , The Economic Benefits of the New Jersey Stem Cell Research Initiative, Prepared for the Office of the Governor Trenton, New Jersey, September 2005, at I, available at <http://policy.rutgers.edu/News/press/stemcell.pdf> (last visited March 5, 2010),

See, for example, Longaker M. T. Baker L. C. Greely H. T. , “Proposition 71 and CIRM – Assessing the Return on Investment,” Nature Biotechnology 25 (2007): 513–521; Gilbert R. J. , “Dollars for Genes: Revenue Generation by the California Institute for Regenerative Medicine,” Berkeley Technology Law Journal 21, no. 3 (2006): 1107–1142; and, most recently, Hiltzik M. , “California Stem Cell Program Needs a New Treatment,” Los Angeles Times, March 30, 2009, at B1.

Baker L. Deal B. , Economic Impact Analysis; Proposition 71 California Stem Cell Research and Cures Initiative, September 14, 2004, available at <http://www.stlr.org/html/Staff_archive/Herder/Source_List+SourceUpload+3+0/Source_037.pdf> (last visited September 2, 2009; access restricted).

Id., at 2.

UK Stem Cell Initiative, available at <http://www.dh.gov.uk/ab/UKSCI/index.htm> (last visited March 5, 2010).

UK Stem Cell Initiative ; Report & Recommendations , November 2005, at 9, available at <http://www.advisorybodies.doh.gov.uk/uksci/uksci-reportnov05.pdf> (last visited March 5, 2010).

Keng Yam T. , Deputy Prime Minister and Minister for Defence, speech at the Opening Ceremony of the Conference on “Beyond Determinism and Reductionism: Genetic Science and the Person,” at 2, July 17, 2002, at the Trinity Theological College, reprinted in Singapore Government Press Release, Media Relations Division, Ministry of Information, Communication and the Arts, available at <http://www.a-star.edu.sg/speech/attachment/150/893_312_Speech_by_DPM_Tan_on_Beyond_determinism_and_reductionism.pdf> (last visited April 14, 2009).

Japan Ministry of Education, Culture, Sports, Science and Technology, White Paper on Science and Technology (Provisional Translation), May, 2008, at 2 and 100, available at <http://www.mext.go.jp/english/wp/1260270.htm> (last visited March 5, 2010).

Japan Council for Science and Technology Policy, Cabinet Office, Strategy for Innovative Technology (Provisional Translation), May 19, 2008, available at <http://www8.cao.go.jp/cstp/english/doc/innovative_technology/innovative_technology.pdf> (last visited March 5, 2010).

For a critique of the Stem Cell Network's commercialization strategy, see Herder , supra note 1.

Stem Cell Network, available at <http://www.stemcellnet-work.ca/> (last visited March 5, 2010).

See National Stem Cell Centre, Press Release, Australian National Stem Cell Centre Secures Additional Funding, May 6, 2004, at 1, available at <http://www.stemcellcentre.edu.au/PDF/nscc_secures_funding.pdf> (last visited April 14, 2009).

Mandel M. , “The Stem Cell Scandals and Economic Growth,” BusinessWeek, December 17, 2005, available at <http://www.businessweek.com/the_thread/economicsunbound/archives/2005/12/the_stem_cell_s.html> (last visited March 5, 2010).

As noted, the ethos occurs in other realms of research, an issue I have noted elsewhere (see, for example, Caulfield T. , “Sustainability and the Balancing of the Health Care and Innovation Agendas: The Commercialization of Genetic Research,” Saskatchewan Law Review 66 [2003]: 629–645. See also Downie J. Herder M. , “Reflections on the Commercialization of Research Conducted in Public Institutions in Canada,” McGill Health Law Publication 1, no. 1 [2007]: 23–44).

Interestingly, both the Michigan and Texas reports (the two most recent) characterize the situation as a “race.” The Michigan report notes: “But, in the race to find cures using embryonic stem cell research, Michigan is at a serious disadvantage.” See Goodman Berger , supra note 7, at 5. The Texas analysis states, “Nonetheless, in the race among the states to find cures using embryonic stem cell research, Texas is currently a minor player and is at a serious disadvantage.” See Weinstein , supra note 4, at iii.

See Salter B. Harvey O. , “Stem Cell Innovation in the USA: The Benefits of the Minimal State,” Regenerative Medicine 3, no. 4 (2008): 597–610, at abstract.

For example, the enabling legislation that created the Canadian Institutes of Health Research, Canada's primary biomedical research funding entity, states that “commercialization of health research” and “economic development through health research” to be central goals of the agency. See, Canadian Institutes of Health Research Act, RS. C. 2000, c.6.

For example, the field of induced pluripotent stem cells has moved forward at a startling pace. See Baker M. , “Fast and Furious,” Nature 458, no. 7241 (2009): 962–965. But even in this promising area, significant challenges remain.

Neergaard L. , “Analysis: Stem Cell Payoff Will Take Decades, Not Days,” Seattle Times, March 16, 2009, available at <http://seattletimes.nwsource.com/html/health/2008866055_apmedstemcellsanalysis.html> (last visited March 5, 2010); see also Halcom C. , “Economic Benefits of Stem Cell Research Years Away,” Crain's Detroit Business, November 10, 2008.

In addition, the track record of big science delivering on therapeutic promises is not great. See, for example, Little M. Hall W. Orlandi A. , “Delivering on the Promise of Human Stem-Cell Research: What Are the Real Barriers?” EMBO reports 7, no. 12 (2006): 1188–1192, at 1190: “there is skepticism about the likely success of stem-cell research, on the basis of the historical experience of the hyperbole surrounding gene therapy since the early 1970s. As a result, the market has become more cautious about the promises of new technologies.” See also Giebel L. B. , “Stem Cells – A Hard Sell to Investors,” Nature 23 (2005): 798–800.

See, for example, Hamilton D. , “The Biotech Bubble: Why Stem-Cell Research Won't Make States Rich,” Slate Magazine, February 6, 2007, available at <http://www.slate.com/id/2159153/pagenum/all/> (last visited March 5, 2010).

In fact, many stem cell companies (such as industry leaders like Advanced Cell Technology and Novocell) are struggling. Some companies have shifted their focus from the development of therapies to the more modest – but immediately relevant – area of research support (e.g., developing the tools, ingredients and supplies necessary for stem cell research); see, Dolgin E. , “Profiting from Pluripotency: How Companies Plan to Make Money (Really) Off of Embryonic Stem Cells,” The Scientist 23, no. 2 (2009): 60, available at <http://www.the-scientist.com/article/display/55372/> (last visited March 5, 2010).

See Little , supra note 28, at 1191.

Rowley E. Martin P. , Barriers to the Commercialisation & Utilisation of Regenerative Medicine in the UK, Institute for Science and Society, University of Nottingham, April 2009, available at <http://www.nottingham.ac.uk/iss/research/Current-Research-Projects/Staff_projects/regenmed/Barriers_report.pdf> (last visited March 5, 2010).

Science News, “Stem Cell Innovation at Risk in UK, Studies Find,” Science Daily, April 6, 2009, available at <http://www.sciencedaily.com/releases/2009/04/090406073547.htm> (last visited March 5, 2010).

See Longaker , supra note 10.

For a discussion of the importance of public trust in the context of research, see House of Lords Select Committee on Science and Technology, Science and Technology – Third Report, February 23, 2000, at 1.19 (introduction, available at <http://www.publications.parliament.uk/pa/ld199900/ldselect/ldsctech/38/3801.htm> (last visited March 5, 2010).

Petersen A. , “The Ethics of Expectations: Biobanks and the Promise of Personalised Medicine,” Monash Bioethics Review 28, no. 1 (2009): 5.1–5.12.

Id., at 5.9–5.10.

See, for example, Blumenthal D. , “Academic-Industrial Relationships in the Life Sciences,” New England Journal of Medicine 349 (2003): 2452–2459; Lemmens T. , “Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene,” Journal of Law, Medicine & Ethics 32, no. 4 (2004): 641–657; see Downie Herder , supra note 22; Bekelman J. E. Li Y. Gross C. P. , “Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review,” JAMA 289, no. 4 (2003): 454–465; see Caulfield , supra note 22; Caulfield T. Williams-Jones B. , eds., The Commercialization of Genetic Research: Ethical, Legal and Policy Issues (New York: Kluwer Academic/Plenum Publishing, 1999): At 200; Caulfield T. , “The Commercialization of Human Genetics: A Discussion of Issues Relevant to Canadian Consumers,” Journal of Consumer Policy 21, no. 4 (1999): 483–526; Silversides , supra note 3.

For a good review of the evidence associated with many of these issues, see id. ( Bekelman )

Some of the stated economic benefits, such as a reduction in the burden of disease and the attraction of top researchers, are not directly related to the commercialization process.

See supra note 19.

See Herder Brian , supra note 1.

See Rowley Martin , supra note 32; see also Resnik D. , “The Commercialization of Human Stem Cells: Ethical and Policy Issues,” Health Care Analysis 10, no. 2 (2002): 127–154.

Blumenthal D. Campbell E. G. Gokhale M. Yucel R. Clarridge B. Hilgartner S. Holtzman N. A. , “Data Withholding in Genetics and the Other Life Sciences: Prevalences and Predictors,” Academic Medicine 81, no. 2 (2006): 137–145.

Critchley C. R. , “Public Opinion and Trust in Scientists: The Role of the Research Context, and the Perceived Motivation of Stem Cell Researchers,” Public Understanding of Science 17, no. 3 (2008): 309–327.

The California Stem Cell Research and Cures Initiative (2004) (Proposition 71). Cal Legis Serv Prop 71 (West). Enacted.

For a review of much of the relevant literature, see Caulfield T. , “Human Gene Patents: Proof of Problems?” Chicago-Kent Law Review 84, no. 1 (2009): 133–145.

See Bergman K. Graff G. , “The Global Stem Cell Patent Landscape,” Nature Biotechnology 25 (2007): 419–424, at 420, where it is reported that there are over 10,000 applications and granted patents related to stem cells technologies.

Id., at 422.

Loring J. F. Campbell C. , “Intellectual Property and Human Embryonic Stem Cell Research,” Science 311, no. 5768 (2006): 1716–1717, at 1716. See also Winickoff , supra note 1.

Caulfield T. Ogbogu U. Murdoch C. Einsiedel E. , “Patent, Commercialization and the Canadian Stem Cell Community,” Regenerative Medicine 3, no. 4 (2008): 483–496, at 485.

Id.

Lei Z. Juneja R. Wright B. D. , “Patents versus Patenting: Implications of Intellectual Property Protection for Biological Research,” Nature Biotechnology 27 (2009): 36–40.

For example, Genomic Research and Accessibility Act, H.R. 977, 110th Cong. (2007).

Holman C. , “Trends in Human Gene Patent Litigation,” Science 322, no. 5899 (2008): 198–199; Caulfield T. Cook-Deegan B. Kieff S. Walsh J. , “Evidence and Anecdotes: An Analysis of Human Gene Patenting Controversies,” Nature Biotechnology 24 (2006): 1091–1094; Murdoch C. J. Caulfield T. , “Commercialization, Patenting and Genomics: Researcher Perspectives,” Genome Medicine 1, no. 2 (2009): 22.1–22.5; Walsh J. P. Cohen W. M. Arora A. , “Patenting and Licensing of Research Tools and Biomedical Innovation,” in Cohen W. M. Merrill S. , eds., Patents in the Knowledge-Based Economy (Washington: National Academies Press, 2003): At 285; see also Directorate for Science and Policy Programs American Association for the Advancement of Science, International Intellectual Property Experiences: A Report of Four Countries , Project on Science and Intellectual Property in the Public Interest, Directorate for Science and Policy Programs, American Association for the Advancement of Science, Washington, D.C., 2007, available at <http://sippi.aaas.org/Pubs/SIPPI_Four_Country_Report.pdf> (last visited March 5, 2010). This study looked at technologies more broadly and concluded at page 15: “IP-protected technologies remain relatively accessible to the broad scientific community, and not as constrained by IP protections as many have cautioned.”

Holman C. M. , “The Impact of Human Gene Patents on Innovation and Access: A Survey of Human Gene Patent Litigation,” University of Missouri-Kansas City Law Review 76 (2007): 295–361, at 300; also see Caulfield , supra note 47.

In the U.S., one could argue that the WARF patents have already had an adverse effect. For example, Lee P. , “The Evolution of Intellectual Infrastructure,” Washington Law Review 83 (2008): 39–122, at 95, has argued that “several years of exclusive rights have no doubt prevented some downstream research and development from occurring.” Others, however, disagree. See, for example, Vom Wege Dovi J. , “Speaking Words of Wisdom: Let It Be. The Reexamination of the Human Embryonic Stem Cell Patents,” Marquette Intellectual Property Law Review 12, no. 11 (2008): 107–130, at 120: “It can hardly be true that the WARF patents stifle research. Quite the opposite is true. Scientific progress is accelerated because researchers can use the WARF cells, rather than having to establish their own ES cell lines. Furthermore, the patents act as incentives for scientists to explore other avenues to design around the patents.” For a detailed review of the WARF story, see Golden J. M. , “WARF's Stem Cell Patents and Tensions between Public and Private Sector Approaches to Research,” Journal of Law, Medicine & Ethics 38, no. 2 (2010). The author notes that while the WARF situation may have caused undue expense, “[f]or those who believe in the value of a robust public sector for scientific research, it might be particularly reassuring that the story of WARF's stem cell patents reaffirms that biotechnology's public sector can work to reclaim research areas even when, whether due to conscious policy decision or unconscious mistake, public funding has initially vacated the field.” Further, Golden notes: “Whether or not one believes that WARF or Geron should be blamed for managing rights or claims of right in a way that has failed to optimize progress in HESC science, it seems undeniable that the United States patent system has helped to get the ball rolling in the first instance.”

See, for example, Vrtovec K. T. Scott C. , “Patenting Pluripotence: The Next Battle for Stem Cell Intellectual Property,” Nature Biotechnology 26 (2008): 393–395; and Plomer A. Taymor K. Scott C. , “Challenges to Human Embryonic Stem Cell Patents,” Cell Stem Cell 2, no. 1 (2008): 13–17.

See, generally, Bergman Graff , supra note 48; see also Lee , supra note 41, at 95: “In a sense, stem cells are the quintessential infrastructure, for they retain the ability to differentiate into a wide array of particularized cells and have shown immense promise as the basis for a broad variety of regenerative therapies. Despite only being about half-way through the term of the original patent, consensus has already developed that these assets are critical to a broad range of basic experimentation and applications” (footnotes omitted.)

See supra note 38.

See, generally, Winickoff , supra note 1.

For e.g., see The Hinxton Group, An International Consortium on Stem Cells, Ethics & Law, Consensus Statement, February 24, 2006, available at <http://www.hinxtongroup.org/docs/Hinxton%202006%20consensus%20document.pdf> (last visited March 5, 2010): “Insofar as hESC lines are a precious resource and replication and scientific collaboration are vital to scientific advancement, we encourage scientists conducting stem cell research to submit any stem cell lines they derive to national or international depositories that subscribe to internationally accepted standards of quality and make cell lines and data (e.g. DNA fingerprinting and microsatellite data) publicly available” (at para. 8); see also International Society for Stem Cell Research, Guidelines for the Conduct of Human Embryonic Stem Cell Research, December 21, 2006, available at <http://www.isscr.org/guidelines/ISSCRhESCguidelines2006.pdf> (last visited March 5, 2010), at 10–11; see also Interstate Alliance on Stem Cell Research (IASCR), “Objectives,” available at <http://www.iascr.org/about.shtml> (last visited March 5, 2010): “IASCR objectives include the development of mechanisms for data and material sharing.”

See Caulfield , supra note 51.

Campbell E. G. Clarridge B. R. Gokhale M. , “Data Withholding in Academic Genetics: Evidence from a National Survey,” JAMA 287, no. 4 (2002): 473–480; Blumenthal D. Campbell E. G. Anderson M. S. Causino N. Louis K. S. , “Withholding Research Results in Academic Life Science: Evidence from a National Survey of Faculty,” JAMA 277, no. 15 (1997): 1224–1228.

Hong W. Walsh J. , “For Money or Glory?: Commercialization, Competition, and Secrecy in the Entrepreneurial Universities,” Sociological Quarterly 50, no. 1 (2009): 145–171, at abstract, where the authors conclude thus: “Our research highlights the central role that scientists' competition for priority plays in the system of science and that, while such competition spurs effort, it also produces negative effects that recent trends toward commercialization of academic science seem to be exacerbating.”

Id. Also, thank you to John Walsh for his assistance in the interpretation of the research; personal communication with author, April 28, 2009.

Bubela T. Strotmann A. , Designing Metrics for Impacts and Social Benefits of Publicly Funded Research , Working Paper: The International Expert Group on Biotechnology, Innovation and Intellectual Property, 2008, available at <http://www.theinnovationpartnership.org/data/ieg/documents/cases/TIP_Innovation_Metrics_Case_Study.pdf> (last visited March 5, 2010). See specifically, “Collaboration and Commercialization in Stem Cell Research: A Case Study,” at 5–17. Bubela and Strotmann conclude that “a culture of commercialization (measured by numbers of patents held) had a significant negative impact on collaboration patterns as measured by at least two network statistics, including the number of distinct collaborators that a researcher has. These effects were observed even after a number of other variables were taken into account that are highly predictive of collaborative behaviour,” at 17.

Id., at 17. The relatively recent push for open access to stem cell lines is an indication of both the research community recognition of the importance of collaborative interactions and the fact that there might be a problem brewing. See, for example, Taylor P. L. , “Research Sharing, Ethics and Public Benefit,” Nature Biotechnology 25 (2007): 398–401; this paper notes the importance of the guidance issued by the ISSCR regarding the sharing of data.

Chalmers D. Nicol D. , “Commercialisation of Biotechnology: Public Trust and Research,” International Journal of Biotechnology 6 (2006): 116–133.

See, generally, Caulfield T. Einsiedel E. Merz J. Nicol D. , “Trust, Patents, and Public Perceptions: The Governance of Controversial Biotechnology Research,” Nature Biotechnology 24 (2006): 1352–1354.

Canadian Biotechnology Secretariat, International Public Opinion Research on Emerging Technologies: Canada-US Survey Results (Ottawa: Industry Canada, 2005).

See, for example, Williams C. , “Australian Attitudes to DNA Sample Banks and Genetic Screening,” Current Medical Research and Opinion 21, no. 11 (2005): 1773–1775, at 1774 where it was found that “75% indicated concerns over commercialization and access to information by health insurance companies”; and Hoeyer K. , “Informed Consent and Biobanks: A Population-based Study of Attitudes towards Tissue Donation for Genetic Research,” Scandinavian Journal of Public Health 32, no. 3 (2004): 224–229, at 227, where it is reported that avoiding the influence of “corporate interest” was one of the most important issues for the public. See also Levitt M. Weldon S. , “A Well Placed Trust?: Public Perceptions of the Governance of DNA Databases,” Critical Public Health 15, no. 4 (2005): 311–321, at 315.

See Critchley , supra note 45.

Id., at 324. See also a recent study by Liu H. Priest S. , “Understanding Public Support for Stem Cell Research: Media Communication, Interpersonal Communication and Trust in Key Actors,” Public Understanding of Science 18, no. 6 (2009): 704–718, at 716. They found that “trust in university scientists is making a very positive contribution to the benefit perception.”

It should not be forgotten that conflicts of interest tied to industry involvement in research are another closely related issue. Such conflicts can also jeopardize public trust (see DeAngelis C. , “Conflict of Interest and the Public Trust,” JAMA 284, no. 17 [2000]: 2237–2238).

This relationship is, no doubt, complex. See, for example, Ten Eyck T. A. , “The Media and the Public Opinion on Genetics and Biotechnology: Mirrors, Windows, or Walls?” Public Understanding of Science 14, no. 3 (2005): 305–316; Williams C. Kitzinger J. Henderson L. , “Envisaging the Embryo in Stem Cell Research: Rhetorical Strategies and Media Reporting of Ethical Debates,” Sociology of Health and Illness 25, no. 7 (2003): 793–814; and Nisbet M. , “Framing Science: The Stem Cell Controversy in an Age of Press/Politics,” The Harvard International Journal of Press/Politics 8, no. 2 (2003): 36–70. For an example of the impact of media on policy development see Caulfield T. Bubela T. Murdoch C. J. , “Myriad and the Mass Media: The Covering of a Gene Patent Controversy,” Genetics in Medicine 9, no. 12 (2007): 850–855.

Einsiedel E. Premji S. Geransar R. Orton N. Thavaratnam T. Bennett L. , “Diversity in Public Views Toward Stem Cell Sources and Policies,” Stem Cell Reviews and Reports 5, no. 2 (2009): 102–107, at 103.

Peddie V. L. , “‘Not Taken In by Media Hype’: How Potential Donors, Recipients and Members of the General Public Perceive Stem Cell Research,” Human Reproduction 24, no. 5 (2009): 1106–1113, at 1111.

See Reis R. , “How Brazilian and North American Newspapers Frame the Stem Cell Research Debate,” Science Communication 29, no. 3 (2008): 316–334; and Kitzinger J. Williams C. , “Forecasting Science Futures: Legitimising Hope and Calming Fears in the Embryo Stem Cell Debate,” Social Science & Medicine 61, no. 3 (2005): 731–740.

See generally, Caulfield T. , “Popular Media, Biotechnology and the ‘Cycle of Hype,’” Journal of Health Law and Policy 5, 2005): 213–233; Caulfield T. , “The Commercialization of Medical and Scientific Reporting,” PLoS Medicine 1, no. 3 (2005): 178–179; see also Cardinal G. , “Commercialization of Genetic Research and Its Impact on the Communication of Results,” Health Law Journal 7, no. 33 (1999): 35–48.

For an interesting critique of media reports on recent stem cell discoveries see: Baker M. , “Stem Cells and Neurodegenerative Disease: Cool Science and Skepticism,” Nature Reports Stem Cells (April 9, 2009), available at <http://www.nature.com/stemcells/2009/0904/090409/full/stemcells.2009.54.html> (last visited March 15, 2010).

Woloshin S. Schwartz L. M. , “Giving Legs to Restless Legs: A Case Study of How the Media Helps Make People Sick,” PLoS Medicine 3, no. 4 (2006): 452–456; Bubela T. Caulfield T. , “Do the Print Media ‘Hype’ Genetic Research?: A Comparison of Newspaper Stories and Peer-Reviewed Research Papers,” Canadian Medical Association Journal 170, no. 9 (2004): 1399–1407; and Holtzman N. A. , “The Quality of Media Reports on Discoveries Related to Human Genetic Diseases,” Community Genetics 8, no. 3 (2005): 133–144.

See Caulfield T. , “Popular Media, Biotechnology and the ‘Cycle of Hype,’” Journal of Health Law and Policy 5 (2005): 213–233.

Hopkins M. M. Martin P. A. Nightingale P. Kraft A. Mahdi S. , “The Myth of the Biotech Revolution: An Assessment of Technological, Clinical and Organisational Change,” Research Policy 36, no. 4 (2007): 566–589.

Indeed, there is a growing literature on the various forces, including intense public expectation, that are pushing researchers toward clinical trials. See for example, Wilson J. , “A History Lesson for Stem Cells,” Science 324, no. 5928 (2009): 727–728, at 728 where the author states “unrealistic expectations have been fueled by relentless media coverage.”

For an interesting and comprehensive proposal that seeks to balance the need for “openness and restraint in biomedical research and innovation,” see Winickoff , supra note 1, at 63. See also Murray F. , “The Stem-Cell Market – Patents and the Pursuit of Scientific Progress,” New England Journal of Medicine 356, no. 23 (2007): 2341–2343, at 2343: “[O]ne can envision an open commons for human embryonic stem-cell research, combined with strong incentives for commercial research investments. Such a scheme would not mean eschewing patent rights. Rather, it would require a commitment by academic institutions to allow a wide-reaching reciprocal exemption for the free exchange of materials for research purposes, with relevant stipulations built into commercial licenses.”

While it is difficult to disentangle the impact of patents from commercialization pressure more generally, many of the concerns would seem likely to exist independent of the patenting process. For example, if patenting was not allowed, would there still be data withholding?

See, for example, Winickoff , supra note 1. For a discussion of important role of governance in the context of biobanking, see Kaye J. Stranger M. , eds., Principles for Biobank Governance (Surrey, United Kingdom: Ashgate, 2009); and Häyry M. Chadwick R. Arnason V. Arnason G. , eds., The Ethics and Governance of Human Genetic Databases: European Perspectives (Cambridge: Cambridge University Press, 2007).

See Baker , supra note 26.