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Pharmaceutical Knowledge Governance: A Human Rights Perspective

Published online by Cambridge University Press:  01 January 2021

Trudo Lemmens
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In recent years, the development process of pharmaceuticals, medical devices, and related products and the overall market of these products have become increasingly global. This paper discusses the need for better governance of one aspect of this market: the production, distribution, and use of pharmaceutical knowledge. Various controversies, some of which will be described in this paper, highlight how industry control over pharmaceutical data production has resulted in very serious threats to public health. Different practices and regulatory fields that affect what I will refer to in this paper as “pharmaceutical knowledge production” are all too often artificially separated and dealt with in isolation, which seriously affects the quality of the available information on the safety and effectiveness of products. I will examine here how a human rights-based approach should inspire us to look more carefully not only at the significant human rights-related interests that are at stake, but also at the relations between the different interwoven regulatory, cultural, and social factors and how these play out at the various stages of knowledge production.

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Symposium
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Journal of Law, Medicine & Ethics , Volume 41 , Issue 1 , Spring 2013 , pp. 163 - 184
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Copyright © American Society of Law, Medicine and Ethics 2013

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References

The discussion in this article will primarily focus on pharmaceutical products, but it should be recognized that related arguments can be made in the context of medical devices and in the context of novel therapeutic products (e.g., companion products, nanotechnology devices, and biologics). Since I will primarily invoke examples from the pharmaceutical context, I will generally only refer to “pharmaceuticals” or “pharmaceutical products” in the text. There are differences between the pharmaceutical, medical device markets, and other health product markets, but those differences are beyond the scope of this paper. The core of what is being argued applies to the other sectors.Google Scholar
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The first case involved the state's interference with two Irish NGOs, Open Door Counselling and Dublin Well Woman Centre, which provided information to women about reproductive choices, including the identity and contact information of abortion clinics operating in the United Kingdom. The Irish Supreme Court had prohibited the organizations from providing information about the latter. Without ruling about the right to abortion itself, the ECHR considered the restrictions on the freedom of expression disproportionate. Open Door and Dublin Well Woman v. Ireland, No. 14234/88, Eur. Ct. H.R. 68 (1992), available at <http://www.unhcr.org/refworld/docid/3ae6b7020.html> (last visited February 15, 2013). See in general also the interesting discussion of the connection between access to information and abortion in Erdman, J., “Access to Information on Safe Abortion: A Harm Reduction and Human Rights Approach” 34 Harvard Journal of Law and Gender 34, no. 2 (2011): 413–462.Google Scholar
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This seems in line with Alicia Ely Yamin's emphasis on inter-sectoral collaboration in promoting human rights. Yamin, A. E., “Will We Take Suffering Seriously? Reflections on What Applying a Human Rights Framework to Health Means and Why We Should Care,” Health and Human Rights 10, no. 1 (2008): 45–63, at 49–50. There are, in fact, some interesting and fruitful examples of collaboration between the legal community, the media, and professional organizations in promoting access to information about pharmaceuticals. A case in point is how the New York Times and the medical journal PLoS Medicine recently joined forces as public interest interveners in litigation against Merck for its alleged failures to adequately warn the public about the potential side effects of hormone replacement drugs. The goal of the intervention was to obtain access to the substantial clinical trials data and company documents associated with the product. The court granted their request and PLoS made all documents available on its website. Motion granted on July 24, 2009, by U.S. District Judge William Wilson, Jr. See Wyeth Ghostwriting Archive, Public Library of Science Medicine Website, available at <http://www.plosmedicine.org/static/ghostwriting.action> (last visited February 15, 2013).Google Scholar
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Some constitutions contain detailed provisions related to the right to health and at least some of them indicate specifically that the state's obligations to protect and fulfill the right to health include the obligation to ensure the safety and effectiveness of pharmaceutical products. It would be worth exploring if this could provide a basis in these countries for a direct legal claim against the state based on a failure of knowledge governance. See e.g. art. 64 (3) of the Portuguese Constitution (Constituição da República Portuguesa), which indicates that the right to health protection includes an obligation for the state “to control and monitor the production, distribution, commercialization and use of chemical, biological and pharmaceutical products and other treatment and diagnostic methods.” (“Para assegurar o direito à protecção da saúde, incumbe prioritariamente ao Estado: … e) Disciplinar e controlar a produção, a distribuição, a comercialização e o uso dos produtos químicos, biológicos e farmacêuticos e outros meios de tratamento e diagnóstico.”) I am indebted to Joana Mendes for pointing this out and for providing the basis of the translation.Google Scholar
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In light of this complexity, it would appear all too easy to rely completely on publication of data as a means to protect consumers. Data have to be interpreted, contrasted, debated, and translated through expert intermediaries; see the discussion in Jasanoff, S., “Transparency in Public Science: Purposes, Reasons, Limits,” Law and Commentary Problems 69, no. 3 (2006): 21–45. It is also worth mentioning that several recent publications highlight problems with the reliability of the evidence cited in much of the published scientific literature, which receives little attention outside of the scientific community. See in particular Ioannidis, J. P. A., “Why Most Published Research Findings Are False,” Public Library of Science Medicine 2, no. 8 (2005): e124 (0696–0701), and references therein; see also Ioannidis, J. P. A., “Contradicted and Initially Stronger Effects in Highly Cited Clinical Research,” JAMA 294, no. 2 (2005): 218–228.Google Scholar
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The driving forces behind the meeting include, among others, the public and professsional debate following the Doshi et al. paper on Tamiflu (see supra note 28) and subsequent editorials in leading medical journals and media reports (see, for example, Godlee, F., Editorial, “Clinical Trial Data for All Drugs in Current Use” British Medical Journal 345[2012]: e7304; and two 2012 inquiries by the European Ombudsman into the access to information procedures of the European Medicines Agency (EMA). The first involved a citizen's complaint about the EMA's refusal to provide access to adverse event reports in its EudraVigilance data base on Roaccutane, a product to treat severe acne. In his recommendations, the Ombudsman explicitly recognized a duty to provide access to such reports and emphasized the importance of access to data in the context of democratic accountability. See Decision of the European Ombudsman closing his inquiry into complaint 2493/2008/(BB)(TS)FOR against the European Medicines Agency (available at <http://www.ombudsman.europa.eu/en/cases/decision.faces/en/11360/html.bookmark> [last visited February 18, 2013]). The second case involved a complaint from two pharmaceutical companies about the fact that the EMA failed to justify why they could not also benefit from the waiver to conduct certain paediatric trials for the approval of their products, as two competitors did. While the Ombudsman concluded that the decision was defensible in substance, he criticized the EMA for failing to ensure transparency of the process and of its decision-making, and for failing to provide adequate reasons. See Draft recommendation of the European Ombudsman in his inquiry into complaint 2575/2009/(TS)(TN)RA* against the European Medicines Agency (available at <http://www.ombudsman.europa.eu/en/cases/draftrecommendation.faces/en/11553/html.bookmark> [last visited February 18, 2013]).CrossRefGoogle Scholar
European Commission, Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC, COM(2101) 369 final, 2012/0192, more specifically art. 78.3 (imposing public accessibility of the EU clinical trials database, with exceptions) and art. 25.6 (obligation to register clinical trials in a primary registry of the WHO platform). The proposal has been criticized for various reasons, including the vagueness of various requirements, the absence of stringent requirements related to ethics review, and the open-ended exception to the transparency requirements. Amendments, including many focusing on strengthening the transparency requirements, have been proposed by European Parliamentary Rapporteur on Clinical Trials Regulations Glenis Willmott and are currently being discussed at the level of the European Parliament. See particularly on the transparency issue and the proposed regulation, Gotzsche, P. C., “Deficiencies in Proposed New EU Regulation of Clinical Trials” BMJ 345 e8522 (2012): 1–3 available at <http://dx.doi.org/10.1136/bmj.e8522> (last visited March 12, 2013).CrossRefGoogle Scholar
See Gostin, et al., supra note 133; see also Kickbusch, I. Hein, W., and Silberschmidt, G., “Addressing Global Health Governance Challenges through a New Mechanism: The Proposal for a Committee C of the World Health Assembly,” Journal of Law, Medicine and Ethics 38, no. 3 (2010): 550–563.Google Scholar
See my earlier criticism of the reorganization at WHO and its apparent impact on the results reporting initiatives in Lemmens, and Telfer, , supra note 18, at 75–76.Google Scholar