Before engaging with the potential risks of the push to commercialize university research, it is important to acknowledge and highlight some of the benefits and advantages associated with the trend. Commercialization is a primary means through which medical products and services reach the market and consumers, which can, in turn, advance public health. Also, research commercialization initiatives can, in theory, generate interest and investment in emerging areas of research, with consequent gains or improvements in research funding, job creation, scope and quality of innovation, creation and growth of industries, and economic sustainability of universities [3, 18, 19]. Commercialization can also help build university-industry collaborations that are often necessary for the translation of research into beneficial products and therapies for public use. While a critical or extensive engagement with the positive outcomes of commercialization are beyond the scope of this paper, we acknowledge that there are well established and observed impacts of research commercialization that justify its relevance to research/science policy and society in general. In particular, it is worth noting that our analysis neither touches upon nor seeks to diminish any positive effects associated with the “entrepreneurial university” [20, 21], or the established role of commercialization in advancing university-industry-government relationships (i.e., the “triple helix” concept) [22].
While the afore-mentioned benefits are often upheld in policy documents and discussions as justifications for increased commercialization, they are either expressed in broad aspirational terms or as axiomatic endpoints, and often with little or no evidence orreasoned reflection in support [1, 4, 23]. Moreover, evidence of a link between university research and economic growth is tenuous at best [4, 23, 24], and the discussion of some potential benefits, such as increased industry participation in research translation, fail to acknowledge or discuss established and potential risks, such as risks associated with the data reporting and publication practices in industry funded research.
Potential risks
Adverse impacts on research environment
Two distinct impacts on the research environment arise in connection with commercialization pressure, namely impacts on the direction and type of research being done, and impacts on research practices. Regarding the former, recent studies of the impact of commercialization pressure on the research environment suggest that the trend is viewed unfavourably by many in the research community, and is associated with a variety of adverse effects on the conduct, integrity or direction of research [25–27]. For example, a 2014 Pew Research Center survey of members of American Association for the Advancement of Science, which is the world’s largest general scientific association, found that nearly half (47 %) believed that the pressure to develop marketable products was having an undue influence on the direction of their research, while a majority (69%) viewed a focus on projects expected to yield rapid results as having a similar influence on their research [28]. Another study, from 2014, concluded that the “government-initiated emphasis on commercialization” of U.S. university research “may undermine open paths toward novel technologies and hinder explorations of unknown fields” [29]. A small study of members of the Canadian stem cell research community found similar views and concerns, and that a majority of those surveyed (76 %) either agree or strongly agree that commercialization and translation pressure could impact public trust or funding of their research [1]. In relation to impacts on research practices, several studies have found or posited associations between commercialization activity and data withholding [30–32], the erosion of collaborative research relationships [33, 34] and reluctance or unwillingness to engage in certain research trends, such as open science initiatives, which seemingly conflict with the financial considerations that underlie the pursuit of commercialization [29, 35–37].
Science hype
There is growing concern that representations of biomedical research are inappropriately overstated, including in scientific abstracts [38], institutional press releases [39], newspaper coverage of research [40], and in popular culture more broadly. There are, of course, many sources of science “hype” that work in concert to produce exaggerated representations, including publication pressures and public, media and institutional expectations [41]. It is, no doubt, a complex problem involving many actors. But given that the commercialization mandate requires science that can be translated quickly and that will have practical results, it seems likely it is a pressure that is, at least, playing a role in this trend. Some of the concerns associated with science hype include exaggerated public and patient expectations, misinformed science and health policy, and the possibility of loss of public support where promised outcomes do not materialize [42–44]. Science hype can also be exploited by those seeking to market unproven and potentially harmful therapies. Lastly, participation by researchers in promoting or advocating for the commercial potential of their work, especially if tied to success in obtaining research grants, could skew the framing of research questions and outcomes in a manner that compromises their ability to approach the research from a disinterested position.
Premature implementation and use of services
A commonly held view among advocates of the push to commercialize is that research activities, particularly in the biomedical and medical sciences, can and ought to yield near-term commercializable products and services for clinical use [1, 2]. While there is a possibility that this position is mere rhetorical flourish in support of arguments for the increasing policy emphasis on translational research, one thing is clear: the view does not accord with any realistic assessment of the process and duration of translational research. Research results do not materialize according to a set schedule or in response to the expectations and demands of the market. Studies, especially of the biomedical and clinical research context, suggest that moving from bench to market takes decades [45, 46], and only few among many research studies yield more than modest direct returns or useful products or services [2, 46, 47]. Even the process of regulatory scrutiny and approval takes years.
Given this reality, the notion that “fast and successful” translation of research results is possible and desirable, especially when expressed by prominent policymakers, may skew research incentives and public expectations in favour of premature implementation of research results, with consequent risks to research integrity and to the quality, safety or efficacy of research outputs [13, 48]. Indeed, commercialization activities and associated incentives have been linked to premature implementation of gene therapy research programs [49]. In the stem cell research context, a global market for putative, scientifically unproven stem cell therapies has emerged, and appears to be expanding in availability and reach despite evidence of considerable health, financial, regulatory and social risks posed by the phenomenon [50–54]. While it remains unclear how the “near-term translation and commercialization” ethos factors into or drives the market for unproven and unapproved stem cell therapies, the phenomenon is arguably a response to the commercialization message.
Regarding public expectation, the view that near-term translation is possible and achievable, coupled with offerings of premature products and services, may shift public perception of the translational research process or lead to public demand for faster access to research outputs. This may, in turn, create a challenge for regulators both in terms of responding to access demands and justifying regulatory rules and decisions. In the United States, for example, the Food and Drug Administration has recently been forced to use litigation and enforcement orders and notices to deal with premature implementation issues arising in part from consumer demand for stem cell-based products and services [55–58].
Public trust
The effect of the commercialization ethos on public trust is less likely to be direct and more consequential to the materialization of some of the afore-discussed risks, such as where overstated research benefits fail to emerge or premature products and services cause harm to the members of the public. However, there is evidence to suggest that commercial considerations negatively affect public perceptions of research, and may have a role to play in the erosion of public support of research and the acceptance of research results [59–62]. In this regard, several academic commentators and research studies have noted or found associations between commercialization activities and declining public trust in research. For example, a recent Australian study of public views of stem cell research concluded that “the results of this research clearly highlight the importance of trust in public support for stem cell research, and that the commercial research context is a significant threat to this trust” [59]. The study also found that “[r]egardless of where scientists source their cells, public support and trust are eroded when their work is conducted in a private research organisation using private funds” [59]. Similarly, a 2012 study of over 1000 Albertans found that, in the context of tissue research, public trust in university research erodes quickly if there are ties to industry [63]. Whether direct or consequential, the potential for loss of public trust is arguably the most pressing risk associated with the drive to commercialize. Given the role that public trust plays in relation to setting research priorities, agenda and in the allocation of research resources, loss of public confidence and trust will most likely doom an affected area of research, or at least create significant setbacks [49, 64]. Indeed, the push toward commercialization seems to be happening at the worst possible time, when public trust in the traditional sources of science is eroding [65]. The further commercialization of university-based research will only exacerbate this dilemma.
Skewed health policy
The commercialization agenda clearly favours products and services that can generate economic activity, such as marketable tests, interventions and drugs. This approach arguably has little to do with addressing broader socio-economic and behavioural changes that would have broader and more enduring impact on human health [66]. The potential for harm caused by the push toward commercially oriented technological approaches – at the expense of a focus on social change – has been noted by numerous commentators in the context of a range of emerging technologies – including genetic testing [67], personalized medicine [66], nutrigenomics [68], epigenetics [48] and stem cell research [13]. As noted by Petersen and Krisjansen, “[i]ncreasing investment in the promissory life sciences, including the harnessing of the publicly funded resources of universities and other publicly funded research institutions, means that fewer resources are available for social research and policy initiatives in areas of pressing need” [48]. Given that research on prevention, public health and behaviour intervention already receives far less government funding than research aimed toward treatment [69], such pressure can hardly be viewed as constructive.
Other studies have found that the emphasizing a commercializable, technological approach to health problems may also have an adverse impact on the development of social policy. It has been found, for example, that framing health issues, such as obesity, as being a disease associated with genetics – a framing that is more likely when commercialization is the goal – as opposed to a social problem demanding social reforms, leads to less support for government public health policies [70, 71].
In addition, commercialization may result in clinical trends – such as a push toward more testing and screening procedures – that conflict with other, evidence-based, approaches to healthcare, such as the recent push to do less diagnostic screening in an effort to avoid unnecessary harm, anxiety and costs [72]. And, of course, the push to commercialize may also lead to increase healthcare costs, as the introduction of new technologies almost inevitably do – an ironic conclusion, given that economic benefit is one of the stated benefits of the commercialization agenda.
Damage to the long-term economic contributions of university research
The notion that university research should and ought to focus on near-term translational research activities that produce commercializable products and services may obliterate support for other long-term contributions to basic and clinical research that produce both incremental and ground-breaking advances [2, 14]. While this may not in fact be a huge loss if the near-term commercialization strategy is successful (but they rarely, if ever, are), there is little reason to suppose that simply reducing the time for research and development will yield more contributions for the financial or knowledge economies. As one well-known Canadian commentator has noted, for example, the money generated by the intellectual property owned by Canadian universities is minuscule [24]. After accounting for the direct costs associated with the management of commercialization activities, the total surplus for all Canadian universities for 2010 amounted to $2.1 million, and the average income for each university as was only $425,000. This is hardly the kind of money that will drive economies and change the fate of universities. Besides, a focus on near-term commercialization goals may alter research behaviour and incentives and lead to negative impacts on the knowledge economy, such as increased publication and translation of research of diluted value [73, 74] and shifts away from new ideas that require basic research [75].