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Patents or Commercialisation Pressure? A (Speculative) Search for the Right Target
TIMOTHY CAULFIELD[*]
Biomedical researchers are under intense pressure to commercialise their work. And the pressure is growing in strength and coming from new directions. If you are a biomedical researcher operating in today’s research environment, the successful commercialisation of your work is not, as it was once perceived, a fortunate and coincidental by-product of blue-sky science. It is an expectation.
In Canada, this reality has recently become part of the national debate on how best to fund and govern research. It has raised questions about whether this trend is having an adverse impact on the research environment and whether it has caused the erosion of independent science.[1] It has also stimulated a growing body of empirical research on its impact.
In this brief comment I seek to: (1) highlight the degree to which, in Canada, commercialisation pressure has become institutionalised as a formal funding policy; and (2) argue that, given this reality, more attention — and, for that matter, more ethical, legal and social issues (ELSI) research resources — should be focused on the complex issues associated with this trend. I suggest that many of the issues so often attributed to patents (eg, data withholding and a breakdown in collaborative relationships) are just as likely the result of commercialisation pressure. In fact, it is commercialisation pressure, as an umbrella phenomenon under which the patenting process sits, that deserves the harshest critique. It is this social phenomenon — not patents, which are merely a legal tool to facilitate commercialisation — that seems the more genuine threat to both scientific inquiry and, in the long term, the public good.
The term “commercialisation” has, in recent times, come to refer to both links with industry and efforts to turn university-based research into marketable products and services. The concept of commercialising research is also closely tied to the politically palatable idea of using university research to stimulate economic growth. In other words, “commercialisation pressures” refers to a suite of demands and incentives. It is not one thing, but a general ethos. Still, despite its amorphous nature, it is a concept that many feel comfortable articulating as an identifiable phenomenon.[2] When you speak of commercialisation pressure in the halls of academe, people know what you mean.
It is also important to recognise that the idea that commercialisation pressure is escalating is more than just speculation. It is more than just a subjective perception held by the research community. While there is no doubt that researchers have long been encouraged to commercialise — indeed, this is the theoretical rationale for the enactment of Bayh-Dole Act in the United States[3] — numerous studies have found that commercialisation pressure has been intensifying over the past decade.[4] Those working with technology transfer offices (TTOs), the focal point of much of the university commercialisation activity, have also noted the increase in pressure. Our study of Canadian TTOs found near universal agreement about the presence of the trend.[5]
Perhaps most important, this pressure has become increasingly institutionalised within the public funding research entities. It has evolved well beyond mere political rhetoric or an informal institutional policy designed to encourage closer ties with industry. It is now embedded in the research grant process. Researchers are now explicitly encouraged — or, in some cases, required — to demonstrate either commercial potential or, at least, economic impact.
For example, Genome Canada, a federally supported, non-profit, research-funding agency, states that its explicit goals are, inter alia, to support “genomic sciences that create economic wealth and social benefit” and to “translate discoveries into commercial opportunities.”[6] Naturally, the agency’s request for proposals reflects this mandate. For example, the grant guidelines for Genome Canada’s Large-Scale Genomics Research Projects (2010) noted that the agency was putting explicit emphasis on “economic benefits” and, as such, required applicants to demonstrate, “with supporting evidence”, “job creation and economic growth,” the “development of a product or a service,” or, inter alia, “intellectual property” that might lead to new “licenses and/or new start-ups.”[7] The most recent Genome Canada competition, launched in 2012, states that “[s]ocio-economic benefits should be attainable within as short a time as possible” and proposals that promise “significant benefits will be realized within a short time-frame ... will have an advantage in the review process.”[8] To be fair, this competition has broad vision of “benefit” — indeed, a focus is cost-effectiveness of the health-care system. Still, it serves as an example of the pressure on the research community to produce tangible and economically relevant outcomes.
While one could argue that it is unfair to single out Genome Canada — it is, after all, a funding body that was created to achieve specific goals, including economic growth — similar language permeates most of Canada’s biomedical funding agencies. The Canadian Institutes of Health Research, the country’s principle biomedical funding agency, was created with in the hope of “promot[ing] growth and job creation” and has a legislated mandate to facilitate “the commercialisation of health research” and to promote “economic development”.[9] The homepage for The Networks of Centres of Excellence (NCE), another federal funding agencies, notes that the program was created to cultivate “economic competitiveness” by “funding research partnerships between academia, industry, government, and not-for-profit organizations” in order to turn “turn Canadian research and entrepreneurial talent into economic and social benefits for all Canadians”.[10]
We see the same trend at the provincial level[11] and within government in-house research institutions, like the National Research Council.[12] Given this pressure, it is not surprising that research initiatives — indeed, entire areas of research — are now justified on the grounds of economic growth. The lobbying for funds for fields such as stem cells and genetics is often accompanied by claims that they will help to stimulate the economy or promote job creation.[13]
The dominance of the commercialisation ethos is, in the context of health research, all but absolute.[14] There is almost no space within the Canadian university biomedical research infrastructure where its reach cannot be felt. Virtually every source of funding contains, to a lesser or greater degree, a commercialisation theme.
There have been many public assertions about the social harm caused by patents. These pronouncements have been made for decades[15] and have come from NGOs, judges,[16] health professional organisations,[17] policy makers, scientists and, even, celebrities.[18] Often the claims of harm have been dramatic and devoid of any doubt.[19] The general thrust of these cautions is that patents hurt science, clinical practice, patients and, ultimately, the general public.
But despite decades of research on the potential impact of patents on both the research environment and the clinic, the evidence of actual harm is, at best, equivocal.[20] This is not to say that patents play an ideal role in the innovation process and in the realm of biomedical research. On the contrary, there is evidence that reveals the presence of inefficiencies and hints that patents may, among other things, slow or reduce academic output.[21] But there is little to support the-sky-is-falling scenarios so often associated with gene patents.[22] While this brief comment is not the place to revisit the existing evidence and debates about benefits and harms,[23] I believe it is fair to say that despite a significant amount of academic inquiry that has utilised a range of methods, what has been revealed is not a not a clear engine of social harm, but the reality that the issues associated with patents are much more subtle, complex and uncertain than often portrayed.[24]
While one could argue that the data on the impact of patents is still accumulating, it seems a reasonable time to consider turning our gaze to a larger, and more appropriate, target: commercialisation pressure. There have, as noted, been many articles and studies on the commercialisation phenomenon,[25] but this critique has, until recently,[26] had far less public and policy profile than the patenting debate.[27] Why this has happened is unclear. It could be due to a number of factors including the amorphous nature of the commercialisation phenomenon, the public sector position of the commercialisation advocates (government, funding agencies, etc), the high profile of several gene patent cases,[28] and the easily quantifiable nature of patents (ie, they are something to point at and count). But given the degree to which commercialisation has become institutionalised — and, as such, a formal policy worthy of scrutiny — there seems merit in considering the challenges linked to commercialisation and their relationship to the issues so often associated — often solely — with patents.
As noted above, an issue that is often tied to the patents is the idea that the patenting process erodes the research environment by increasing secrecy (particularly in the early stages of the research process),[29] leads to data withholding behaviour, and corrodes collaborative relationships. But, of course, all of these concerns can also be attributed to commercialisation pressure. Indeed, there is at least some evidence that, in the context of data withholding[30] and a reduction of collaborative behaviour,[31] it is commercialisation pressure, and not patenting, that might be the most significant factor. And, as suggested by numerous commentators, the problem of secrecy could intensify without the existence of patent protection. Secrecy would be the only viable options for the protection of commercialisable university-derived inventions. Dobson and Evans, for example, have noted that “[s]ecrecy is sometimes an alternative to patenting, but one that conveys less benefit to the public than the protection of technology investment through granting of patents.”[32]
There are many additional issues associated with commercialisation pressure that justify further policy attention, such as the potential impact on public trust.[33] Several studies have shown, not surprisingly, that when researchers are involved with industry, public trust declines.[34] A recent survey of Albertans undertaken by our team at the University of Alberta found that while 45.1 per cent of the public trusted publically funded researchers a “great deal”, only 19.5 per cent felt the same way about university researchers funded by industry.[35] In addition, those that did not trust them at all rose from 6.2 per cent to 26.9 per cent.
Other areas of social concern that warrant further attention in this context include, inter alia, the potential role that commercialisation pressure has had on the rise in academic fraud,[36] the hype generated in research institutions,[37] the direction of research,[38] and the possible premature application and marketing of technologies. Finally, commercialisation pressure also creates interesting tensions with the concomitant push toward open science.[39]
I could, of course, speculate about the impact of commercialisation pressure on a range of other areas, including the teaching environment and the cost of healthcare. But this is not meant to be an exhaustive survey. The point is simply to highlight a convergence of three trends: the increasingly pervasive nature of commercialisation pressure in the context of health research; the equivocal quality of the evidence regarding the harms of patents; and the emerging evidence on the impact of the commercialisation push. To date, gene patents have grabbed much of the policy and research attention; especially in the territory of biotechnology. But given this convergence, a refocusing seems warranted. I am not suggesting that we abandon research on the impact of patents. Nor am I trying to position this as a “patents” versus “commercialisation pressure” debate. But, at a minimum, a moment of reflection seems appropriate. We could, for example, start by asking ourselves the following two questions: If we removed patents but did little to alter the current commercialisation ethos, how many of the frequently suggested harms would go away? (Few.) How many would intensify? (Many.)
Naturally, in making policy choices about the role of commercialisation in the context of university-based research, we must also consider the positive attributes of commercialisation. We must balance risks and benefits. The push to commercialise is being done for a reason. Numerous benefits have been attributed to the move toward commercialisation and university partnerships with industry, including additional revenue, more rapid knowledge translation, and, of course, economic development.[40]
In addition, as with the patent debate, we need to take an honest assessment of what the evidence says about many of the proposed harms associated with the commercialisation of university research. It isn’t all bad news. A 2009 study from Germany, for example, found “there is no evidence indicating that inventive [commercially focused] activities of academic researchers are associated with decreases in research output.”[41] Indeed, the researcher found a slight increase in publication. “There does not seem to be a fundamental incompatibility between engaging in technology transfer and being a prolific author of relevant scientific work.”[42] This conclusion is consistent with past research done in Canada that found that academic publications remain, for most academics, the central goal of their academic career and “that involvement in partnership projects with industry does not appear to influence the number and quality of publications.”[43]
This kind of research reminds us to be careful not to condemn commercialisation pressure as being somehow inherently evil. As with patents, its impact on the research environment is likely complex and context dependent. But given the ascendancy commercialisation as a core theme in health research funding policy, and given the unique role that university-based research plays as a trusted and independent source of health evidence, a careful, critical and public analysis is warranted.
[*] Canada Research Chair and in Health Law and Policy, Professor, Faculty of Law and School of Public Health, and Research Director, Health Law and Science Policy Group, University of Alberta. I would like to thank Lisa Belanger, Sarah Burningham, Ubaka Ogbogu and Amy Zarzeczny for the help and comments and the Stem Cell Network and the CCSC for their funding support. I would also like to thank Dianne Nicol for the invitation to contribute to this collection. Portions of this article informed a commentary in the magazine Policy Options.
[1] Anne Silversides, “Merchants of Science: How Commercialization is Changing Science in Canada” (May 2008) The Walrus
<http://walrusmagazine.com/articles/2008.05-science-and-commercialization-ann-silversides> Hannah Hoag, “Canadian Budget Hits Basic Science: Innovation Wins over Basic Research and the Environment” (30 March 2012) Nature, doi: 10.1038/nature.2012.10366. Hoag writes that Canada’s latest budget “push[es] for more collaboration between basic researchers and industry”.
[2] In a recent study that included interviews with individuals involved with university technology transfer, all seemed comfortable with the concept. See Tania Bubela and Timothy Caulfield, “Role and Reality: Technology Transfer at Canadian Universities” (2010) 28 Trends in Biotechnology 447; See also C J Murdoch and Timothy Caulfield, “Commercialization, Patenting and Genomics: Researcher Perspectives” (2009) 1(22) Genome Medicine 1.
[3] Charles R McManis and Sucheol Noh, “The Impact of the Bayh-Dole Act on Genetic Research and Development: Evaluating the Arguments and Empirical Evidence” (Washington University in St Louis Legal Studies Research Paper Series Paper No 11-05-04, 2 March 2011) <http://ssrn.com/abstract=1840639> .
[4] See, eg, Manuel Crespo and Houssine Dridi, “Intensification of University–Industry Relationships and Its Impact on Academic Research” (2007) 54 Higher Education 61; Don Chalmers and Dianne Nicol, “Commercialisation of Biotechnology: Public Trust and Research” (2004) 6 International Journal of Biotechnology 116; Joanna Poyago-Theotoky, John Beath and Don Siegel, “Universities and Fundamental Research: Policy Implications of the Growth of University-Industry Partnerships” (2002) 18 Oxford Review of Economic Policy 10. A recent study of the international stem cell research community found that 87 per cent of those surveyed thought commercialisation pressure was either moderate or intense: see Timothy Caulfield, Christen Rachul and Amy Zarzeczny, “The Evolution of Policy Issues in Stem Cell Research: An International Survey” (2012) Stem Cell Reviews and Report. The study also found that researchers generally viewed the issues associated with commercialisation (eg, patenting, ownership of tissue, etc.) to be more contentious now than ten years ago. There is also evidence that biomedical research has become a larger component of the government’s economic policy. For example, Silversides notes that “[h]ealth research has become a key plank in Canada’s industrial policy, and now accounts for nearly 25 per cent of all R&D expenditures in Canada, up from just 14.3 per cent in 1989”: Silversides, above n 1, 1.
[5] Bubela and Caulfield, above n 2.
[6] Genome Canada, About Genome Canada (2012)
<http://www.genomecanada.ca/en/about> .
[7] Genome Canada, Genome Canada is Pleased to Announce the Launch of Its 2010 Large-Scale Applied Research Project Competition (2010)
<http://www.genomecanada.ca/en/about/news.aspx?i=349> .
[8] Genome Canada, 2012 Large-Scale Applied Research Project Competition (2012) <http://www.genomecanada.ca/en/portfolio/research/2012-competition.aspx> .
[9] Canadian Institutes of Health Research Act, SC 2000, c 6, s 4(i). Recent moves by the CIHR to restructure their funding model has caused some leading Canadian researchers to voice concern that “the CIHR would direct of funds away from the kind of basic, curiosity-driven research that can lead to important discoveries”: Anne McIlroy, “Proposed streamlining of Ottawa’s lab-funding system worries researchers”, The Globe and Mail (Toronto), 29 March 2012. Whether such concerns are justified is unclear, but it highlights the degree to which science policy changes that have pushed commercialisation have sensitised the research community toward these kinds of issues.
[10] Networks of Centres of Excellence of Canada, About the Networks of Centres of Excellence (2011) <http://www.nce-rce.gc.ca/About-APropos/Index_eng.asp> .
[11] Alberta Innovates Health Solutions (AIHS), which replaced the Alberta Heritage Foundation for Medical Research, is the province’s primary health research-funding agency. The mandate of AIHS is to “support research and innovation activities to improve the health and well-being of Albertans and create, through innovation, health related social and economic benefits for Albertans”: Alberta Innovates Health Solutions, Mandate and Roles Document (2010) 1 <http://www.aihealthsolutions.ca/docs/mandate%20and%20roles.pdf> . It also seeks to create value by, inter alia, “[e]nhancing the potential to support and facilitate private sector health research and innovation in the province”: at 1. The creation of AIHS is, to quote the chairman of the Alberta Innovates, “geared to products, services and outcomes with value-added”: Sheila Pratt, “New Order Rules Medical Research”, Edmonton Journal (Edmonton), 7 November 2010. This approach is also emphasised in the relevant enabling legislation, The Alberta Research and Innovation Act, SA, 2009, A-31.7, which states, in s 2, the purpose of Alberta Innovates is, inter alia, the “development and growth of new and existing industries.”
[12] “National Research Council to ‘refocus’ to serve business”, CBC News (online), 6 March 2012,
[13] For example, research communities ask for funding based on the promise of economic growth and, thus, create pressure on themselves to deliver. See, for example, Timothy Caulfield, “Stem Cell Research and Economic Promises” (2010) 38 Journal of Law, Medicine and Ethics 303; See also Rupert Neate, “Stem cell centre gets green light from UK government”, The Observer (online), 2 October 2011, <http://www.guardian.co.uk/business/2011/oct/02/stem-cell-centre-government-investment> where it is suggested that the funding of stem cell research will “help drive Britain’s recovery.”
[14] In Canada, scholars in the social sciences and humanities can apply to the Social Science and Humanities Research Council (SSHRC). But according to 2009 SSHRC eligibility criteria, any research that touches on the subject of health must go to the CIHR (see SSHRC, Subject Matter Eligibility (2011) <http://www.sshrc-crsh.gc.ca/funding-financement/apply-demande/background-renseignements/selecting_agency-choisir_organisme_subventionnaire-eng.aspx#af3> ), thus requiring virtually all scholars working on health issues to work within the rules and ethos of the CIHR or the other biomedical funding agencies.
[15] Scott Veggeberg, “Controversy Mounts Over Gene Patenting Policy”, The Scientist (27 April 1992)
[16] Association for Molecular Pathology et al v United States Patent and Trademark Office et al, No 09 Civ 4515 (29 March 2010).
[17] J Richer et al, “CCMG statement on gene patents” (2012) 82 Clinical Genetics 405.
[18] One of the best examples of celebrity pontification is Michael Crichton’s New York Times editorial that started with this assertion: “You, or someone you love, may die because of a gene patent that should never have been granted in the first place. Sound far-fetched? Unfortunately, it’s only too real.” Michael Crichton, “Patenting Life”, The New York Times (New York), 13 February 2007.
[19] Ibid.
[20] For a review see Timothy Caulfield, “Human Gene Patents: Proof of Problems?” (2009-2010) 84 Chicago-Kent Law Review 133; See also Dianne Nicol, “Implications of DNA Patenting: A Review of the Evidence” (2011) 21(1) Journal of Law, Information and Science 7, 35 doi: 10.5778/JLLIS.2011.21.Nicol.1.
[21] Kenneth G Huang and Fiona E Murray, “Does Patent Strategy Shape the Long-Run Supply of Public Knowledge? Evidence from Human Genetics” (2009) 52 Academy of Management Journal 1193.
[22] See, eg, Christopher Holman, “The Impact of Human Gene Patents on Innovation and Access: A Survey of Human Gene Patent Litigation” (2007) 76 University of Missouri-Kansas City Law Review 295. See also Nicol, above n 20, 35: “On the available evidence, the detrimental impact of DNA patents appears to be considerably lower than anticipated by many commentators”.
[23] See Caulfield, above n 20.
[24] See, generally, Abigail Lauer, “The Disparate Effects of Gene Patents on Different Categories of Scientific Research” (2011) 25 Harvard Journal of Law and Technology 179. It is interesting to note that even commentators that continue to fear the impact gene patents recognise the lack of explicit evidence of harm. See, eg, Editorial, “Genes—to have and to hold” (2012) 9 Nature Methods 931, 931: “Even though no infringement lawsuits have yet been brought against academic researchers, the uncertainty nonetheless draws the wrong emotions into the lab.” Of course, one could argue the “wrong emotions” this editorial fears could also be elicited by commercialisation pressure. In addition, the increasing commercial push of the institutions adds to the possibility that the use of a patented invention for university research will result in the successful infringement claims that produce the suggested “wrong emotions.” See, eg, Madey v Duke, [2002] USCAFED 222; 307 F 3d 1351 (Fed Cir, 2002). It makes it much more difficult for researchers to argue that a patented invention is being utilised for non-commercial purposes. (Admittedly, the existence of a true research exemption is, in many jurisdictions, unclear. See, eg, Dianne Nicol, “Human Gene Patents: Under Whose Control?” (2003) 179 Medical Journal of Australia 181.
[25] See above n 4 and accompanying text. See also Jocelyn Downie and Matthew Herder, “Reflections on the Commercialization of Research Conducted in Public Institutions in Canada” (2007) 1 McGill Health Law Publication 23.
[26] As noted above, the concerns about commercialisation pressure are starting to appear in Canada’s popular press. But this is a recent phenomenon and, compared to the sustained attention and policy activity associated with patents, relatively mild in tone and profile.
[27] We have studied the ways in which the gene patent debate has been portrayed in the popular media and suggest that the media has played an important role in simplifying, shaping and sustaining the public debate. See Timothy Caulfield, Tania Bubela, and C J Murdoch, “Myriad and the Mass Media: The Covering of a Gene Patent Controversy” (2008) 9 Genetics in Medicine 850.
[28] Ibid.
[29] Australian Law Reform Commission, Genes and Ingenuity: Gene Patenting and Human Health, Report No 99 (2004) 297-310.
[30] See, for example, Wei Hong and John P Walsh, “For Money or Glory? Commercialization, Competition, and Secrecy in the Entrepreneurial University” (2009) 50 The Sociological Quarterly 145.
[31] Tania Bubela et al, “Commercialization and collaboration: competing policies in publicly funded stem cell research?” (2010) 7 Cell Stem Cell 25.
[32] Alison Dobson and James Evans, “Gene patents in the US - focusing on what really matters” (2012) 13 Genome Biology 161, 5. They further note that “[t]he possibility that privately funded ventures will increasingly resort to secrecy to protect new DNA technologies is substantial and could frustrate progress overall”: at 5. It is worth noting, however, that it is far from clear that “secrecy” is even a problem in the context of genetic research. See Milia N et al, “Mine, Yours, Ours? Sharing Data on Human Genetic Variation” (2012) 7 PLoS ONE, e37552, 7: “In conclusion, our study provides evidence that the majority of published data regarding human genetic variation are made openly available to the scientific community.”
[33] See, eg, Chalmers and Nicol, above n 4; Kathinka Evers, Joanna Forsberg and Mats Hansson, “Commercialization of Biobanks” (2012) 10 Biopreservation and Biobanking 45.
[34] Christine R Critchley, “Public Opinion and Trust in Scientists: The Role of the Research Context, and the Perceived Motivation of Stem Cell Researchers” (2008) 17 Public Understanding of Science 309, 321: “[T]he public will be less supportive of controversial scientific research if it is conducted within a private company rather than a publicly funded University.”
[35] Timothy Caulfield, Christen Rachul and Erin Nelson, “Biobanking, Consent and Control: A Survey of Albertans on Key Research Ethics Issues” (2012) 10 Biopreservation and Biobanking 433, 436. The study question focused on trust and the retention of health information and tissue samples.
[36] See Arl Zimmer, “A Sharp Rise in Retractions Prompts Calls for Reform Published”, The New York Times (New York), 16 April 2012. While I am unaware of any research that explores the connection between the rise of retractions and commercialisation pressure, it seems a logical link. Given the importance of maintaining public trust, this is a worthy area of inquiry. See Daniel Sarewitz, “Beware the Creeping Cracks of Bias” (2012) 485 Nature 149, 149: “Nothing will corrode public trust more than a creeping awareness that scientists are unable to live up to the standards that they have set for themselves.”
[37] See, generally, Timothy Caulfield and Celeste Condit, “Science and the Sources of Hype” (2012) 15 Public Health Genomics 209; Lindsay Adams, “How Medical News Become Ridiculous”, The Atlantic (online), 13 September 2012
<http://www.theatlantic.com/health/archive/2012/09/how-medical-news-becomes-ridiculous/262341/> . See also Steven Woloshin et al, “Press Releases by Academic Medical Centers: Not So Academic?” (2009) 150 Annals of Internal Medicine 613, 616: “Press releases issued by 20 academic medical centres frequently promoted preliminary research or inherently limited human studies without providing basic details or cautions needed to judge the meaning, relevance, or validity of the science.” While the authors did not attribute this phenomenon to commercialisation pressure, this seems a likely part of the story worth investigating. Indeed, given the pressure on researchers to produce commercialisable, near future inventions, might this encourage inappropriately “hyped” pronouncements? This possibility is discussed more fully in Caulfield and Condit, above n 37.
[38] Downie and Herder, above n 25.
[39] See, generally, Timothy Caulfield, Shawn H E Harmon and Yann Joly, “Open Science versus Commercialization: A Modern Research Conflict?” (2012) 4 Genome Medicine 1.
[40] See, generally, Poyago-Theotoky, Beath and Siegel, above n 4. It is important to note, however, that the degree to which empirical evidence supports these benefits remains contested.
[41] Guido Buenstorf, “Is Commercialization Good or Bad for Science? Individual-Level Evidence from the Max Planck Society” (2009) 38 Research Policy 281, 290.
[42] Ibid.
[43] See Crespo and Dridi, above n 4, 77.
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