ABSTRACT
Almost all medical innovation originates in publicly funded research environments, yet most innovation prioritizes private commercial interests over and above public-health concerns. Decades of industrial policy choices have promoted patenting and licensing of government-backed research for privately developed innovation. Key amongst these were the National Institutes of Health (NIH) patent agreements that in the 1970s shaped university research agendas away from open science and the Bayh-Dole Act of 1980 that further catalyzed patenting by encouraging university-industry collaborations, entrenching the role of the private sector in setting priorities in medical research. Those who defend the patent-centric model of innovation argue that giving private patents to universities and firms optimizes innovation by creating a profit incentive. However, critics have argued that private patents may not always accelerate innovation and misdirect public investment from public health. In many ways, this debate has reached an impasse, with both sides reiterating arguments that have been present since the enactment of Bayh-Dole. One potential way out of the patent debate is to reconsider the use of conditionalities, a tool that formerly figured in NIH research agreements in the early 1990s, but which fell out of favor as a result of industry pressures. As contractual provisions of public funding at the earliest stage of research, grant conditionalities can surmount problems associated with the wider privatization of medical innovation, ensuring that public investment is directed toward public-health priorities. ‘Profit discouragement’ and ‘use-it-or-lose-it’ provisions could be used to encourage access plans and shape competitive behaviors of private actors in medical innovation for public investment returns. Moreover, grant conditionalities could benefit by soliciting advice from other stakeholders, such as individual patients and medical providers, whose knowledge could resolve conditionalities’ uncertainty and risks of enforcement, while demanding increased transparency from private actors. Finally, grant conditionalities can bolster the quality and reliability of research by securing long-term sustainable innovation goals and reducing opportunities for capture. In revisiting the role of the state as an equitable developer of innovation rather than just a regulator and large provider of subsidies, the Article illustrates how disciplining public funding can be used to subject commercial interests to greater public accountability, advancing medical innovation and the values of health justice.
Benavides, Ximena, Beyond Patents: Resetting Medical Research Priorities with Grant Conditionalities (August 19, 2024).
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