This paper examines one nascent entrepreneurial endeavour intended by Canada's Stem Cell Network to catalyze the commercialization of stem cell research: the creation of a company called "Aggregate Therapeutics". We argue that this initiative, in its current configuration, is likely to result in a breach of public trust owing to three inter-related concerns: conflicts of interest; corporate influence on the university research agenda; and the failure to provide some form of direct return for the public's substantial tax dollar investment. These (...) concerns are common to many efforts to commercialize academic science but are rendered particularly acute in this case given the therapeutic promise of stem cell research and the considerable number of resources related to stem cell research in Canada, which Aggregate Therapeutics is expected to pool. We do, however, believe that the company can be altered to guard against a violation of the public's trust, and so we present concrete modifications to its structure, which we contend should be given immediate consideration. (shrink)

In December 2006, Indonesia decided to stop sending influenza virus specimens to the World Health Organization’s Global Influenza Surveillance Network (GISN). Indonesia justified its actions by claiming that they were in protest of the injustice of GISN. Its actions stimulated negotiations to improve the workings of GISN by developing and implementing a more just framework for ‘sharing influenza viruses and other benefits’. These negotiations eventually led to the adoption of a new framework for virus and benefit sharing in May 2011, (...) at the World Health Assembly meeting. In this article, we critically evaluate Indonesia’s claims about the unjustness of GISN. We show that arguments based on the values of ownership, contribution and reciprocity work together to support Indonesia’s claim that it was owed an equal share in the benefits of GISN and, in turn, that GISN was unjust because of its failure to ensure this. We also use these values to evaluate the newly agreed upon framework for virus and benefit sharing. We suggest the new framework fails to give proper consideration to the values of ownership, contribution and reciprocity and, as a result, that it is fundamentally unjust. (shrink)

The US Food and Drug Administration’s controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer’s disease, has motivated multiple policy reforms. Drawing a case series of other drugs granted accelerated approval and interviews of senior FDA officials, I argue that reform should be informed but not defined by aducanumab. Rather, structural reforms are needed to reshape FDA’s core priorities and restore the regulatory system’s commitment to scientific rigor.

Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021.

The scientific challenges and ethical controversies facing human embryonic stem cell (hESC) research continue to command attention. The issues posed by patenting hESC technologies have, however, largely failed to penetrate the discourse, much less result in political action. This paper examines U.S. and European patent systems, illustrating discrepancies in the patentability of hESC technologies and identifying potential negative consequences associated with efforts to make available hESC research tools for basic research purposes while at same time strengthening the position of certain (...) patent-holders' rights. Differences between the U.S. and the European contexts may in part explain why the course of hESC research in those jurisdictions ultimately diverges. Nevertheless, questions about whether and how patenting, related agreements, and licensing practices progress and shape the field of hESC research in both the U.S., Europe, and elsewhere must no longer be marginalised. These questions are fundamentally important in determining what benefits are likely to result from hESC research. Assuring these benefits is the moral issue with which patent systems are most intrinsically concerned, and that governments must begin to directly address rather than assume or ignore. (shrink)

Efforts to ensure greater transparency in the regulation of “drugs” are well underway. For example, laws in the United States and Europe now require registration of most clinical trials beyond phase 1. Yet instances of avoidable harm to patients continue to arise. In response, calls for disclosure of clinical trial data in the form of “clinical study reports,” not just trial designs and basic results, are growing. In this paper, I argue that disclosure of clinical trial data is necessary but (...) insufficient. Rather, the regulatory decisions that flow from those trial data —whether positive or negative —should also be open to outside scrutiny provided they are final in nature. (shrink)

This article is the first in a two-part review of policy design for human embryo research in Canada. In this article we explain how this area of research is circumscribed by law promulgated by the federal Parliament (the Assisted Human Reproduction Act ) and by guidelines issued by the Tri-Agencies (the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans and Updated Guidelines for Human Pluripotent Stem Cell Research ). In so doing, we provide the first comprehensive account of the (...) rules currently governing human embryo research in Canada. In this article we also provide a chronological description of relevant policy initiatives and outcomes related to these policy instruments over the past 20 years, with particular attention to public involvement in policy design. This sets the stage for the second article (scheduled to appear in vol. 6 issue 3) in which we critically analyse the history of policy design for human embryo research in Canada, applying a typology of modes of public consultation developed by Eric Montpetit. Our goal is to carefully explain the various episodes of policy development and their corresponding outcomes, in order to more effectively address emerging questions about the legitimacy of future policy initiatives for human embryo research in Canada. (shrink)

This article is the second in a two-part review of policy design for human embryo research in Canada. In the first article in 6(1) of the JBI , we explain how this area of research is circumscribed by law promulgated by the federal Parliament and by guidelines adopted by the Tri-Agencies, and we provide a chronological description of relevant policy initiatives and outcomes related to these two policy instruments, with particular attention to the repeated efforts at public consultation. This second (...) article analyses the history of policy design for human embryo research in Canada, applying a typology of modes of public consultation developed by Eric Montpetit to better understand the various episodes of policy design and their corresponding outcomes. On this basis, we suggest that the degree to which the views of Canadian residents and citizens on human embryo research have been solicited as part of the policy-making process has diminished significantly over time. We also suggest that this diminished participation is likely to continue given the presence of powerful interest groups and policy communities “speaking for” Canadians. This raises interesting questions about the legitimacy of future policy initiatives for human embryo research in Canada. (shrink)