Human Rights Responsibilities of Pharmaceutical Companies in Relation to Access to Medicines

The right's full formulation is “the right of everyone to the highest attainable standard of physical and mental health,” from article 12, International Covenant on Economic, Social and Cultural Rights. As shorthand, we adopt either “the right to the highest attainable standard of health” or “the right to health.”

For an introduction to the growing literature, see Clapham A. Robinson M. , Realising the Right to Health (Geneva: Swiss Human Rights Book Series, Rufer & Rub, 2008).

Department for International Development (U.K.), Increasing Access to Essential Medicines in the Developing World: U.K. Government Policy and Plans, June 2004, at 8.

See the Special Rapporteur on the Right to the Highest Attainable Standard of Health, UN Doc. A/61/338, September 13, 2006.

Unless otherwise indicated, references in this chapter to the UN Special Rapporteur on the right to the highest attainable standard of health are to Paul Hunt, the first person appointed to this mandate. One of the authors of this article, he held the post between 2002–2008.

For example, see the Special Rapporteur on the Right to the Highest Attainable Standard of Health, supra note 4 (human right to medicines); UN Doc. E/CN.4/2006/48/Add.2 (Uganda), January 19, 2006; E/CN.4/2005/51/Add.3 (Peru), February 4, 2005; and E/CN.4/2004/49/Add.1 (World Trade Organization), March 1, 2004.

UN Millennium Development Goals, Target 8(e).

Committee on Economic, Social and Cultural Rights, General Comment 14: The Right to the Highest Attainable Standard of Physical and Mental Health, UN Doc. E/C.12/2000/4, at para. 42.

Special Representative of the Secretary-General on the Issue of Human Rights and Transnational Corporations and other Business Enterprises, Ruggie John , “Protect, Respect and Remedy: A Framework for Business and Human Rights,” A/HRC/8/5, April 7, 2008, at para. 60.

See supra note 4.

Special Rapporteur on the Right to the Highest Attainable Standard of Health, UN Doc. A/63/263, August 11, 2008; and R. Khosla and P. Hunt, Guidelines for Pharmaceutical Companies in Relation to Access to Medicines: The Sexual and Reproductive Rights Context (Colchester: University of Essex, 2009).

Special Rapporteur on the Right to the Highest Attainable Standard of Health, Mission to GlaxoSmithKlein, UN Doc. A/HRC/11/12/Add.2, May 5, 2009.

For a review of these debates and initiatives, see Clapham A. , Human Rights Obligations of Non-State Actors (New York: Oxford University Press, 2006).

See supra note 4, at paras 92–93.

Sections 3 and 4 have extensively drawn upon Hunt P. Khosla R. , “Holding Pharmaceutical Companies to Account: A UN Special Rapporteur's Mission to GlaxoSmithKline,” in Gilbert G. , eds., The Delivery of Human Rights (Oxon and New York: Routledge, 2011): At 39–67; and Hunt P. Khosla R. , “Human Rights Responsibilities of Pharmaceutical Companies in relation to Access to Medicines,” in Forman L. , eds., Access to Medicines as a Human Right: What Implications for the Pharmaceutical Industry (Toronto: University of Toronto Press, 2012): At 25–45.

The mandate of the Special Representative was created by the UN Commission on Human Rights in its resolution 2005/69 (April 20, 2005) and John Ruggie served the mandate from July 2005 to June 2011.

See supra note 9, at para. 3.

See supra note 9.

Human Rights Council Resolution 17/4, “Human Rights and Transnational Corporations and Other Business Enterprises,” UN Doc. A/HRC/RES/17/4, June 16, 2011; The Guiding Principles on Business and Human Rights are annexed to the Report of the Special Representative of the Secretary-General on the Issue of Human Rights and Transnational Corporations and Other Business Enterprises, John Ruggie, UN Doc. A/HRC/17/31, March 21, 2011.

See supra note 9, at para. 24.

Id., at para. 55.

Id., at para. 54.

Id.

Report of the Special Representative, “Business and Human Rights: Further Steps toward the Operationalization of the ‘Protect, Respect and Remedy’ Framework,” UN Doc. A/HRC/14/27, April 9, 2010, at para. 55.

See supra note 9, at para. 25.

Id., at para. 24.

See supra note 9, at para. 55.

See Human Rights Council, Resolution 8/7, Mandate of the Special Representative of the Secretary-General on the Issue of Human Rights and Transnational Corporations and other Business Enterprises, adopted without a vote on June 18, 2008.

See the Guiding Principles, supra note 19, at para. 11.

Id., at para. 15.

Id., at para. 18.

Id., at para. 19.

Id., at para. 20.

Id., at para. 21.

Special Representative of the Secretary-General on the issue of human rights and transnational corporations and other business enterprises, John Ruggie, Business and human rights: Towards operationalizing the “protect, respect and remedy” framework, UN Doc. A/HRC/11/13, April 22, 2009, at para. 64.

Id., at para. 64.

Institute for Human Rights and Business, Setting Boundaries: Clarifying the Scope and Content of the Corporate Responsibility to Respect Human Rights, Submission to the UN Special Representative on Business and Human Rights, available at <http://www.ihrb.org/pdf/Setting_Boundaries-Clarifying_Scope_and_Content_of_Corporate_Responsibility_to_Respect_Human_Rights.pdf> (last visited May 16, 2012).

Id., at 5.

Id., at 9.

Id., at 5, 6, 9.

Id., at 8.

See supra note 24, at para. 63.

Id., at para. 64.

See Human Rights Council Resolution 17/4, supra note 19. For the work of the working group on Human Rights and Business, see <http://www.ohchr.org/EN/Issues/Business/Pages/WGHRandtransnationalcorporationsandotherbusiness.aspx> (last visited May 16, 2012).

See supra note 9, at para. 55.

See supra note 35.

See supra note 37, at 5.

See supra note 9, at para. 60.

Id., at para. 54.

See supra note 8; numerous reports of the Special Rapporteur on the right to the highest attainable standard of health have sought to apply the right-to-health analytical framework to specific health issues (e.g., E/CN.4/2005/51 on mental disability) and countries (e.g., A/HRC/4/28/Add.2 on Sweden).

Pharmaceutical companies have responsibilities arising from other human rights, such as the labour rights of their employees, but this article focuses on pharmaceutical companies' right to health responsibilities.

See supra note 9, at paras. 60–62.

See Special Rapporteur on the Right to the Highest Attainable Standard of Health, Mission to Uganda, UN Doc. E/CN.4/2006/48/Add.2, January 19, 2006; Hunt P. Steward R. Mesquita J. Oldring L. , Neglected Diseases: A Human Rights Analysis, WHO-TDR Special Topic 6, 2006; and Molyneux D. H. , “Neglected Tropical Diseases – Beyond the Tipping Point?” The Lancet 375, no. 9708 (January 2, 2010): 3–4, at 3.

WHO, Good Manufacturing Practices for Pharmaceutical Products: Main Principles, WHO Technical Report Series, No. 961, 2011.

See Potts H. , Accountability and the Right to the Highest Attainable Standard of Health (Colchester: University of Essex, 2008); generally, Health and Human Rights Journal 10, no. 2 (2008), with particular reference to Yamin A. E. , “Beyond Compassion: The Central Role of Accountability in Applying a Human Rights Framework to Health,” at 1–20 and Freedman L. , “Human Rights, Constructive Accountability and Maternal Mortality in the Dominican Republic: A Commentary,” International Journal of Gynaecology and Obstetrics 82, no. 1 (2003): 111–114.

GSK, Corporate Responsibility Report, 2007, especially chapter 5.

See Access to Medicine Index, available at <http://www.accesstomedicineindex.org/> (last visited May 16, 2012).

UN High Commissioner for Human Rights, The Impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights on Human Rights , UN Doc. E/CN.4/Sub.2/2001/13, June 27, 2001, at paras. 42–43; The Special Rapporteur on the Right to the Highest Attainable Standard of Health, Mission to the World Trade Organization, UN Doc. E/CN.4/2004/49/Add.1, 1 March 2004, at para. 43; and The Special Rapporteur on the Right to the Highest Attainable Standard of Health, Access to Medicines and Intellectual Property Rights, UN Doc. A/HRC/11/12, March 31, 2009, at para. 19.

WHO Commission on Intellectual Property Rights, Innovation and Public Health, Public Health, Innovation and Intellectual Property, Geneva, 2006, at 20; and Commission on Intellectual Property (UK), Integrating Intellectual Property Rights and Development, London, 2002, at 34.

Pharmaceutical Shareowners Group, The Public Health Crisis in Emerging Markets, London, 2004.

See supra note 9, at para. 54.

See the Guiding Principles, supra note 19, at para. 11.

There are ways of ensuring that only social group E accesses these not-for-profit medicines, e.g., by only making these medicines available via designated health clinics in the public health system unfrequented by social group A.

Special Rapporteur on the Right to the Highest Attainable Standard of Health, “Mission to the World Bank, the International Monetary Fund, and Uganda,” UN Doc. A/HRC/7/11/Add.2, March 5, 2008, Mesquita J. Hunt P. , International Assistance and Cooperation in Sexual and Reproductive Health: A Human Rights Responsibility for Donors (Colchester: University of Essex, 2008); and Mesquita J. Hunt P. Khosla R. , “The Human Rights Responsibility of International Assistance and Cooperation in Health,” in Gibney M. Skogly S. , eds., Universal Human Rights and Extraterritorial Obligations (Philadelphia: University of Pennsylvania Press, 2010): 104–129.

See supra note 12; and Hunt P. Khosla R. , “Holding Pharmaceutical Companies to Account: A UN Special Rapporteur's Mission to GlaxoSmithKline,” in Gilbert G. , eds., The Delivery of Human Rights (Oxon and New York: Routledge, 2011): At 39–67.

See supra note 56, at 49–50.

Oxfam International, Investing for Life: Meeting Poor People's Needs for Access to Medicines through Responsible Business Practices, Oxford, 2007.

Innovest Strategic Value Advisors, Access to Medicine Index 2008 (Haarlem: Access to Medicine Foundation, 2008); and RiskMetrics Group, Access to Medicine Index 2010 (Haarlem, The Netherlands: Access to Medicine Foundation, 2010).

GSK, Annual Report, 2003.

GSK, GSK Statement on Human Rights, 2007, available at <http://www.gsk.com/responsibility/reports-resources.htm> (last visited May 16, 2012).

See Special Rapporteur, supra note 11, at 18–19; and supra note 12, at para. 107.

Anand Grover orally presented the report following his appointment as Special Rapporteur in August 2008. In accordance with protocol, Paul Hunt stepped down as Rapporter on completion of his second three-year term in July 2008.

GlaxoSmithKline Statement in Response to Paul Hunt's Report on GSK, June 2009, on file with authors.

The Lancet, “Editorial: Right-to-Health Responsibilities of Pharmaceutical Companies,” The Lancet 373, no. 9680 (June 13, 2009): At 1998.

On file with authors.

See Special Rapporteur, supra note 11, at 18–19; see supra note 12, at paras. 30–33.

See Human Rights Council Resolution 17/4, supra note 19.

See <http://www.oecd.org/document/28/0,3746,en_2649_34889_2397532_1_1_1_1,00.html> (last visited May 16, 2012).

Commission on Information and Accountability for Women's and Children's Health, Keeping Promises, Measuring Results, WHO, Geneva, 2011, at 9, available at <http://www.everywomaneverychild.org/images/content/files/accountability_commission/final_report/Final_EN_Web.pdf> (last visited May 16, 2012).

See Every Woman, Every Child, available at <http://www.everywomaneverychild.org/resources/independent-expert-review-group> (last visited May 16, 2012).

See, for “non-legal” enforcement means, Reinisch A. , “The Changing International Legal Framework,” in Alston P. ed., Non-State Actors and Human Rights (Oxford: Oxford University Press, 2005): 37–89, at 68.