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

For brevity, I will use the term “knowledge production,” or where appropriate, “pharmaceutical knowledge production,” particularly when discussing in more detail the pharmaceutical context.Google Scholar

I previously explored this idea in Lemmens, T., “Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene,” Journal of Law, Medicine & Ethics 32, no. 4 (2004): 641–657 [hereinafter cited as Lemmens, Leopards in the Temple].Google Scholar

The fundamental international nature of research is emphasized in Science as an Open Enterprise, The Royal Society Science Policy Centre report 02/12 (London, UK: Royal Society, 2012): at 9 and 17–19. See in general also the interesting discussion in the report of the current-day practice of science and the emphasis on transparency of data. Thanks to Graeme Laurie for pointing this out.Google Scholar

See Kaye, J., “From Single Biobanks to International Networks: Developing E-Governance,” Human Genetics 130, no. 33 (2011): 377–382; Kaye, J. Gibbons, S. M. C. Heeney, C. Parker, M., and Smart, A., Governing Biobanks: Understanding the Interplay between Law and Practice (Portland, OR: Hart Publishing, 2012). For some examples of biobanks, see UK Biobank, available at <http://www.ukbiobank.ac.uk/aboutbiobank-uk/>; Generation Scotland, Health Science Scotland, available at <http://www.healthsciencescotland.com/114_GenerationScotland.html>; the Ontario Health Study, available at <https://ontariohealthstudy.ca/>; the Canadian Longitudinal Study on Aging, available at <http://www.clsa-elcv.ca/>; the Estonian Genome Centre, available at <http://www.geenivaramu.ee/en> (all last visited February 15, 2013). There are also numerous initiatives designed around specific diseases, exposures or populations. See, e.g., Ontario Tumour Bank, available at <http://oicr.on.ca/oicr-programs-and-platforms/technology-platforms/ontario-tumour-bank>, Autism Genetic Resource Exchange, available at <http://agre.autismspeaks.org/site/c.lwLZKnN1LtH/b.5002149/k.E3CE/Overview.htm>; and Manchester Cancer Research Centre Biobank, available at <http://www.mcrc.manchester.ac.uk/biobank/> (all last visited February 15, 2013).Google Scholar

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See, for example, the funding initiative between Genome Canada and the California Stem Cell Initiative which partly funded research for this paper: Genome Canada, “Corporate Plan 2007–08,” available at <http://www.genomecanada.ca/medias/PDF/EN/CorporatePlan2007-08-english.pdf> (last visited February 15, 2013).+(last+visited+February+15,+2013).>Google Scholar

According to a June 2011 report on biobanking, “Private sector biobanks will experience the greatest increase with growth of 64%, at a 5-year CAGR [compound annual growth rate] of 10.4% and [the private sector biobank market]is expected to reach $69.6 billion by 2015.” See Biobanking: Technology and Global Markets, BCC Research website, available at <http://www.bccresearch.com/report/biobanking-technologies-markets-bio084a.html> (last visited February 15, 2013).+(last+visited+February+15,+2013).>Google Scholar

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See Petryna, A., When Experiments Travel: Clinical Trials and the Global Search for Human Subjects (Princeton: Princeton University Press, 2009). An interesting collection of papers can be found in Petryna, A. Lakoff, A., and Kleinman, A., eds., Global Pharmaceuticals: Ethics, Markets, Practices (Durham: Duke University Press, 2006). See also Glickman, S. W. McHutchison, J. G. Peterson, E. D. Cairns, C. B. Harrington, R. A., and Califf, R. M. et al., “Ethical and Scientific Implications of the Globalization of Clinical Research,” New England Journal of Medicine 360, no. 8 (2009): 816–823.Google Scholar

In Canada, see for example the Canada Vigilance Programme, Health Canada website, available at <http://www.hc-sc.gc.ca/dhp-mps/medeff/vigilance-eng.php> (last visited February 15, 2013).+(last+visited+February+15,+2013).>Google Scholar

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See, for example, the recent initiative by Dr. David Healy: Rxisk – Making Medicine Safer For All of Us, RxISK.org, available at <https://www.rxisk.org/default.aspx> (last visited February 15, 2013).+(last+visited+February+15,+2013).>Google Scholar

See, in general, Matheson, A., “Corporate Science and the Husbandry of Scientific and Medical Knowledge by the Pharmaceutical Industry,” BioSocieties 3, no. 4 (2008): 355–382; Moffatt, B. and Elliott, C., “Ghost Marketing: Pharmaceutical Companies and Ghostwritten Journal Articles,” Perspectives in Biology and Medicine 50, no. 1 (2007): 18–31; for a critical discussion of the regulatory and legal options to deal with the practice, see Stern, S. and Lemmens, T., “Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles,” Public Library of Science Medicine 8, no. 8 (2011): E1001070 (1–5); and Bosch, X. Esfandiari, B., and McHenry, L., “Challenging Medical Ghostwriting in US Courts,” Public Library of Science Medicine 9, no. 1 (2012): e1001163 (1–4).Google Scholar

See Sismundo, S., “Ghosts in the Machine: Publication Planning in the Medical Sciences,” Social Studies of Science 39, no. 2 (2009): 171–198; and Sismundo, S., “Ghost-Management: How Much of the Medical Literature Is Shaped behind the Scenes by the Pharmaceutical Industry?” Public Library of Science Medicine 4, no. 9 (2007): e286 (1429–1433).Google Scholar

Examples of such soft governance include: (1) good clinical practices, such as the ICH GCP and the World Health Organization, Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products, WHO Technical Report Series, No. 850, Annex 3 (1995); (2) research ethics guidelines such as World Medical Association, Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (1964); (3) standards of peer review and authorship established by international organizations of biomedical journals such as International Committee of Medical Journal Editors, Uniform Requirements for Manuscripts Submitted to Biomedical Journals, ICMJE website, available at <http://www.icmje.org/> (last visited February 15, 2013); and (4) governance models of international biobank conglomerates, e.g., Public Population Project in Genomics, P3G website, available at <http://www.p3g.org> and Dove, E. S. Joly, Y., and Knoppers, B. M., “Power to the People: A Wiki-Governance Model for Biobanks,” Genome Biology 13, no. 5 (2012): 158. With respect to the most directly relevant pharmaceutical governance systems at a global level, see the interesting discussion in Spina, A., “The Regulation of Pharmaceuticals beyond the State: EU and Global Administrative Systems,” in Chiti, E. and Mattarella, B.G., eds., Global Administrative Law (Berlin: Springer Verlag, 2011): At 249–268. Spina discusses in detail the ICH/GCP system and the firmer regulatory intervention at a transnational level in the context of the European pharmaceutical regulations. See in particular the discussion at 256–258.Google Scholar

A good example of this is the use of scientific publications based on data collected in one state, published in another, for indirect publicity purposes in multiple other jurisdictions. Note, however, that there are initiatives by national regulatory agencies to exercise tighter control of foreign clinical drug sites, to promote the integrity of these data. See, e.g., the U.S. FDA's establishment of an office in India in 2008: <http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/OfficeofInternationalPrograms/ucm243680.htm> (last visited February 14, 2013). (last visited February 14, 2013).' href=https://scholar.google.com/scholar?q=A+good+example+of+this+is+the+use+of+scientific+publications+based+on+data+collected+in+one+state,+published+in+another,+for+indirect+publicity+purposes+in+multiple+other+jurisdictions.+Note,+however,+that+there+are+initiatives+by+national+regulatory+agencies+to+exercise+tighter+control+of+foreign+clinical+drug+sites,+to+promote+the+integrity+of+these+data.+See,+e.g.,+the+U.S.+FDA's+establishment+of+an+office+in+India+in+2008:++(last+visited+February+14,+2013).>Google Scholar

This argument has been made with respect to hormone replacement therapy and antiarrhythmic drugs. See the discussion in Lemmens, T. and Telfer, C., “Access to Information and the Right to Health: The Human Rights Case for Clinical Trials Transparency,” American Journal of Law and Medicine 38, no. 1 (2011): 63–112 [hereinafter cited as Lemmens and Telfer].Google Scholar

See, in general, Evans, D., Big Pharma's Crime Spree, Bloomberg Markets, December 2009, available at <http://www.bloomberg.com/apps/news?pid=nw&pname=mm_1209_story2.html> (last visited February 15, 2013); Light, D., ed., The Risks of Prescription Drugs (New York: Columbia University Press, 2010); Healy, D., Pharmageddon (Berkeley: University of California Press, 2012); and Moynihan, R. and Cassels, A., Selling Sickness: How the World's Biggest Phrmaceutical Companies Are Turning Us All into Patients (Vancouver: Greystone Books, 2005). For accounts zooming also in on specific controversies, see Young, T., Death by Prescription (Toronto: Key Porter Books, 2009); Bass, A., Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial (Chappil Hill: Algonquin Books, 2008); Nesi, T., Poison Pills: The Untold Story of the Vioxx Drug Scandal (New York: St. Martin's Press, 2008).Google Scholar

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See Thomas, K. and Schmidt, M. S., “Glaxo Agrees to Pay $3 Billion in Fraud Settlement,” New York Times, July 2, 2012, available at <http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all> (last visited February 15, 2013).+(last+visited+February+15,+2013).>Google Scholar

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Topol estimates myocardial infarction or stroke in 160,000 of every ten million people taking Vioxx. Topol, E. J., “Failing the Public Health – Rofecoxib, Merck, and the FDA,” New England Journal of Medicine 351, no. 17 (2004): 1707–1709, at 1708; see also Graham, D. J. et al., “Risk of Acute Myocardial Infarction and Sudden Cardiac Death in Patients Treated with Cyclo-Oxygenase 2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs: Nested Case-Control Study,” The Lancet 36, no. 9458 (2005): 475–481, at 480.CrossRefGoogle Scholar

Combined HRT is associated with an increased risk of coronary heart disease, breast cancer, and stroke. Millions of women have been treated with combined HRT around the world. See Hersh, A. L. Stefanick, M. L., and Stafford, R. S., “National Use of Postmenopausal Hormone Therapy: Annual Trends and Response to Recent Evidence,” JAMA 291, no. 1 (2004): 47–53.CrossRefGoogle Scholar

For detailed discussions of these controversies, see references supra note 19.Google Scholar

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Note how the judicialization of the right to health has in some jurisdictions distorted more complex questions of equity in health care and resource allocations. See Backman, G. Hunt, P., and Khosla, R. et al., “Health Systems and the Right to Health: An Assessment of 194 Countries,” The Lancet 372, no. 9655 (2008): 2047–2085.Google Scholar

See, for example, Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), GA Res. 2200A (XXI), U.N. GAOR, 21st Sess., Supp. No. 16 at 49, 993 U.N.T.S. 3, U.N. Doc. A/6316 (1966) [ICESCR], which defines the right to health as the right to “the highest attainable standard of physical and mental health.”.Google Scholar

See, for example, the overview in Kinney, E. D. and Clark, B. A., “Provisions for Health and Health Care in the Constitutions of the Countries of the World,” Cornell International Law Journal 37, no. 2 (2004): 285–355.Google Scholar

See, for example, U.N. Committee on Economic, Social and Cultural Rights, Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights: General Comment No. 14, U.N. Doc. E/C.12/2000/4, August 11, 2000, at para. 33 [hereinafter cited as General Comment 14]: The Committee recognizes the connection between the right to health and other human rights such as: the right to food, housing, work, education, human dignity, life, privacy, and – interestingly for the purpose of this discussion – access to information (at para. 3). See also: U.N. Special Rapporteur on the Highest Attainable Standard of Health, “Promotion and Protection of Human Rights: Human Rights Questions, Including Alternative Approaches for Improving the Effective Enjoyment of Human Rights and Fundamental Freedoms,” U.N. Doc. A/61/338, September 13, 2006, para. 18. The essential links between the right to health and the right to information is clearly also reflected in the approach taken by the Framework Convention on Tobacco Control. See the detailed discussion in Cabrera, O.A. and Gostin, L. O., “Human rights and the Framework Convention on Tobacco Control: Mutually Reinforcing Systems” International Journal of Law in Context 7, no. 3 (2011): 285–303.CrossRefGoogle Scholar

See Dhir, A. A., “Corporate Selective Reporting of Clinical Drug Trial Results as a Violation of the Right to Health,” in Basser, L. A. Jones, M., and Rioux, M., eds., Critical Perspectives on Human Rights and Disability Law (Leiden: Martinus Nijhoff Publishers, 2011): 341–366, in particular at 356–64; and Lemmens, and Telfer, , supra note¹⁸.Google Scholar

For a general overview of legislative and regulatory initiatives regarding clinical trials registration and results reporting, see Ghersi, D. and Pang, T., “From Mexico to Mali: Four Years in the History of Clinical Trial Registration,” Journal of Evidence-Based Medicine 2, no. 1 (2009): 1–7. See also, for an overview and discussion of international initiatives with a focus on the Americas, Krleža-Jeriç, K. and Lemmens, T. et al., “Prospective Registration and Results Disclosure of Clinical Trials in the Americas: A Roadmap toward Transparency,” Pan American Journal of Public Health 30, no. 1 (2011): 87–96.Google Scholar

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

The Sunday Times v United Kingdom (Series A No 30), European Court of Human Rights (1979–80) 2 EHRR 245, April 26, 1979.Google Scholar

Id., at para. 66. Freedom of speech is protected by article 10 of the European Convention on Human Rights.Google Scholar

See, e.g., also Társaság a Szabadságjogokért v. Hungary, No 37374.05, Eur. Ct. H.R. 618 (2009), in which the ECHR ruled that a human rights organization involved in the promotion of democracy had to be able to exercise their function as “public watchdog” and that States should be prevented from exercising “censorial power of an information monopoly.”.Google Scholar

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

Guerra and Others v. Italy, 26 Eur. Ct. H.R. 357 (1998) at para. 60. I am indebted to Alessandro Spina for alerting me to the relevance of this case and some relevant literature. See also Roche v. United Kingdom, 43 Eur. Ct. H.R. 30 (2006) where the court also decided that the government's failure to provide adequate information about the potential impact of the testing of chemical weapons in which the claimant had been involved was a violation of article 8, not article 10. In the 2006 case of Sdružení Jihočeské matky v. Czech Republic, [2006] Eur. Ct. H.R. 1205, however, the court recognized that a refusal to grant access to information regarding a nuclear power plant was a restriction of article 10, although it considered the refusal justified. Wouter Hins and Dirk Voorhoof prudently suggest that the case opens new perspectives, even though, as they recognize, it clearly does not imply a recognition of a duty to create information. See Hins, W. and Voorhoof, D., “Access to State-Held Information as a Fundamental Right under the European Convention on Human Rights,” European Constitutional Law Review 3, no. 1 (2007): 114–126, at 123–125.CrossRefGoogle Scholar

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See, for example, the recent challenge by Public Citizens of the FDA's decision to approve a higher dosage version of Eisai/Pfizer's Alzheimer's drug Aricept, notwithstanding the primary reviewer and statisitician's recommendation to reject the application based on the serious side-effects of the higher dosage. Public Citizen's petition to the FDA to ban the higher dosage version was rejected. Public Citizen's director of Health Research Wolfe, Sidney M. asked in his editorial in the organization's newsletter whether “[w]ith close to $700 million in drug industry money directly funding FDA drug review each year, …the FDA, in this instance, is protecting the public health or…colluding with the drug industry” (“Did Drug Companies and the FDA Collude to Harm Patients with Alzheimer's Disease?” (editorial) Worst Pills, Best Pills 18, no. 12 (2012): 2 at 2. See also the discussion of some of the pressures on and flaws of the drug regulatory review structure in Lemmens, Leopards in the Temple, supra note 3 at 650–652, and references there.Google Scholar

See, for example, Chaoulli v. Quebec (Attorney General), [2005] 1 S.C.R. 791, 2005 SCC 35. Dhir discusses the right to health claims specifically in the context of Canadian law. See Dhir, , supra note 39 at 356–364.Google Scholar

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See also the interesting discussion in the Explanatory Report ETS No. 164 (Council of Europe, December 17, 1996, available at <http://conventions.coe.int/Treaty/EN/Reports/Html/164.htm> [last visited February 15, 2013), at paras. 63–70 of the individually focused right to information protected by Article 10 of the Convention on Human Rights and Biomedicine (available at <http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm> [last visited February 15, 2013]). Article 10 provides: “1. Everyone has the right to respect for private life in relation to information about his or her health. 2. Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed. 3. In exceptional cases, restrictions may be placed by law on the exercise of the rights contained in paragraph 2 in the interests of the patient.”.+[last+visited+February+15,+2013),+at+paras.+63–70+of+the+individually+focused+right+to+information+protected+by+Article+10+of+the+Convention+on+Human+Rights+and+Biomedicine+(available+at++[last+visited+February+15,+2013]).+Article+10+provides:+“1.+Everyone+has+the+right+to+respect+for+private+life+in+relation+to+information+about+his+or+her+health.+2.+Everyone+is+entitled+to+know+any+information+collected+about+his+or+her+health.+However,+the+wishes+of+individuals+not+to+be+so+informed+shall+be+observed.+3.+In+exceptional+cases,+restrictions+may+be+placed+by+law+on+the+exercise+of+the+rights+contained+in+paragraph+2+in+the+interests+of+the+patient.”.>Google Scholar

For an interesting discussion of the ECHR developments in access-to-information case law, see Hins, and Voorhoof, , supra note 46. See also Hilson, C., “Risk and the European Convention on Human Rights: Towards a New Approach,” in Barnard, C. and Odudu, O., eds., The Cambridge Yearbook of European Studies Volume 11, 2008–2009 (Oxford: Hart Publishing, 2009): at 353–375, in particular at pages 355–365.Google Scholar

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Id., at para. 167. Interestingly, the applicant also claimed that the State had a duty, under art. 10, to conduct a “long-term follow-up study” as part of its positive obligation. The Court considered it was not necessary to examine this claim (at para. 168). The court referred among other cases to Guerra, and to McGinley v. the United Kingdom, where it ruled that “[w]here a Government engages in hazardous activities,…respect for private and family life…requires that an effective and accessible procedure be established which enables…persons to seek all relevant and appropriate information.” See McGinley and Egan v. the United Kingdom, [1998] Eur. Ct. H.R. 51.Google Scholar

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Jean-Francois Akandji-Khombe invokes these cases to suggest that the ECHR recognizes the “right to a healthy environment” in Akandji-Khombe, P.-F., Positive Obligations Under the European Convention on Human Rights: A Guide to the Implementation of the European Convention on Human Rights. Human Rights Handbook no. 7 (Strasbourg: Council of Europe Director General on Human Rights, 2007): at 47–48.Google Scholar

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Article 7 states that “No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.” See International Covenant on Civil and Political Rights, G.A. Res. 2200A (XXI), U.N. GAOR, 21st Sess., Supp. No. 16, 999 U.N.T.S. 171, U.N. Doc. A/6316 (1966) [ICCPR]. For an interesting discussion, see Rosenthal, E., “The International Covenant on Civil and Political Rights and the Rights of Research Subjects,” Accountability in Research 4, nos. 3–4 (2008): 253–260.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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I am indebted for some of the discussion here to Kelly Tai and her research as part of a 2012 summer internship organized by the University of Toronto International Human Rights Clinic with the Open Society Foundations, which resulted in a draft background document, “The Right to Drug Safety and Efficacy Information: A Human Rights Approach.” (Copy on file with author).Google Scholar

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See, for example, General Comment 14, supra note 38, at para. 33: “The right to health, like all human rights, imposes three types or levels of obligations on States parties: the obligations to respect, protect and fulfil. In turn, the obligation to fulfil contains obligations to facilitate, provide and promote. The obligation to respect requires States to refrain from interfering directly or indirectly with the enjoyment of the right to health. The obligation to protect requires States to take measures that prevent third parties from interfering with article 12 guarantees. Finally, the obligation to fulfil requires States to adopt appropriate legislative, administrative, budgetary, judicial, promotional and other measures towards the full realization of the right to health.” (Citation omitted.).Google Scholar

See Hilts, P. J., Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (North Carolina: University of North Carolina Press, 2003).Google Scholar

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See, for example, Healy, , supra note 19; Young, , supra note 19; Angell, M., “The Clinical Trials Business: Who Gains?” in Stein, D. G., ed., Buying In or Selling Out? The Commercialization of the American Research University (Piscatawnay, NJ: Rutgers University Press, 2004): at 127–132; Kassirer, J. P., On The Take: How Medicine's Complicity with Big Business Can Endanger Your Health (New York: Oxford University Press, 2004).Google Scholar

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See, for example, Angell, , supra note 123; Ray, W. A. and Stein, C. M., “Reform of Drug Regulation – Beyond an Independent Drug-Safety Board,” New England Journal of Medicine 354, no. 2 (2006): 194–201; Lemmens, , supra note 3. This also rejoins the Public Goods Approach defended by commentators such as Reichman, J. H., “Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Public Goods Approach,” Marquette Intellectual Property Law Review 13, no. 1 (2009): 1–68.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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Weeks, C., “Medical Association Takes Heat for Pfizer Funding,” Globe and Mail, December 3, 2009, available at <http://www.theglobeandmail.com/life/health-and-fitness/medical-association-takes-heat-for-pfizer-funding/article568583/> (last visited February 18, 2013). For the media announcement of the initiative, see <http://www.pfizer.ca/en/media_centre/news_releases/article?year=2009&article=303> (last visited February 18, 2013). Interestingly this controversial initiative was announced shortly after an editorial in the Canadian Medical Association Journal strongly criticized corporate control over continuing medical education and argued for a major overhaul of the CME system. See Hébert, P. C. Editorial, , “The Need for an Institute of Continuing Health Education,” Canadian Medical Association Journal 178, no. 7 (2008): 805–806, available at <http://www.cmaj.ca/content/178/7/805.short> (last visited February 18, 2013).Google Scholar

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The fact that these campaigns can be extraordinarily successful is evidenced by the paradigm example of disease-creation in the context of Paxil, a leading antidepressant. The manufacturer GlaxoSmithKline greatly expanded its markets by promoting the drug for a range of new psychiatric conditions such as Social Anxiety Disorder (shyness) and Generalized Anxiety Disorder (constant worry). “The proliferation of diagnoses has contributed to a dramatic rise in anti-depressant sales, which increased eightfold between 1990 and 2000.” See Koerner, B. I., “First, You Market the Disease… Then You Push the Pills to Treat It,” The Guardian, July 30, 2002, available at <http://www.guardian.co.uk/news/2002/jul/30/medicine-andhealth> (last visited February 18, 2013). For GlaxoSmithKline's 2003 campaign to promote awareness about restless legs syndrome, see Woloshin, S. and Schwartz, L. M., “Giving Legs to Restless Legs: A Case Study of How the Media Helps Make People Sick,” Public Library of Science Medicine 3, no. 4 (2006): e170 (0452–0455). For strategies used by Pfizer to promote Viagra as a legitimate therapy for erectile dysfunction for all men, see Lexchin, J., “Bigger and Better: How Pfizer Redefined Erectile Dysfunction,” Public Library of Science Medicine 3, no. 4 (2006): e132 (0429–0432).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