Selling pharmaceuticals ethically in resource-limited settings: the case of Sofosbuvir

Abstract

In countries without universal health insurance systems, is it ethically acceptable for pharmaceutical companies to sell their products only to the relatively small segment of the population that can afford private insurance coverage or to pay for medications out of pocket? Are there certain drugs that companies should be expected to sell in these economies even if they are unable to do so profitably? Within a human rights framework, this paper identifies these and related ethical challenges and proposes some responses. The paper begins by considering general ethical responsibilities that arise from commitment to the Universal Health Coverage initiative as a Sustainable Development Goal. It then discusses ethical responsibilities on the part of pharmaceutical companies as distinct from those of national governments or the broader international community. Some proposals follow for thinking through specific ethical challenges that arise when making decisions about whether, and on what terms, to introduce a new drug into a particular setting. Finally, the paper considers a number of these issues and responses in the context of the sale of sofosbuvir in the Asia-Pacific region.

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Notes

  1. 1.

    (World Health Organization 2014), at 7.

  2. 2.

    Ibid, at 8.

  3. 3.

    (Evens and Kaitin 2015), at 216.

  4. 4.

    The sections on “Human Rights as Source of Ethical Obligations” and “Breadth of Market Access” are excerpted from a report that was prepared by one of the authors: (Coleman 2017)

  5. 5.

    Constitution of the World Health Organization, 45th edition, Oct 2006.

  6. 6.

    See, e.g., Universal Declaration of Human Rights, G.A. Res. 217 (III) A, Art. 25 U.N. Doc. A/RES/217(III) (10 Dec 1948); International Covenant on Economic, Social and Cultural Rights, G.A. Res. 2200 (XXI) A, Art. 12, U.N. Doc. A/RES/2200(XI) (3 Jan 1976); Convention on the Elimination of All Forms of Discrimination Against Women G.A. Res. 34/180, Art. 12, U.N. Doc. 34/180 (18 Dec 1979); Convention on Rights of the Child, G.A. Res. 44/25, Art. 24, U.N. Doc. 44/25 (2 Sep 1990); International Convention on the Elimination of All Forms of Racial Discrimination, G.A. Res. 2106 (XX), Art. 5, U.N. Doc. 2106 (21 Dec 1965); African Charter on Human and Peoples’ Rights, Art. 16 (June 1981); Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social and Cultural Rights, Art. 10 (17 Nov 1988).

  7. 7.

    (United Nations Secretary-General 2008) (by Paul Hunt).

  8. 8.

    (United Nations Secretary-General 2009) (by Paul Hunt).

  9. 9.

    See id. at paragraph 39.

  10. 10.

    Id. at paragraph 35.

  11. 11.

    See, e.g., (Moon 2013)

  12. 12.

    A meeting on ethical considerations in selling pharmaceuticals in emerging economies was organized by one of the authors (Carl H Coleman) on 6 and 7 October 2016 at the Center for Health & Pharmaceutical Law & Policy, Seton Hall Law School, New Jersey, USA.

  13. 13.

    Professor of Philosophy and Director of the Center for Ethics and Policy, Carnegie Mellon University.

  14. 14.

    See Hunt, supra note 17, at paragraph 41.

  15. 15.

    (Office of the United Nations High Commissioner for Human Rights and World Health Organization 2008) see also U.N. Charter arts. 55–56.

  16. 16.

    Agreement on Trade-Related Aspects of Intellectual Property Rights, 15 Apr 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299; see also World Trade Organization, Declaration on the TRIPS Agreement and Public Health, 14 Nov 2001, WT/MIN(01)/DEC/2, 41 I.L.M. (2002) (the ‘Doha Declaration’).

  17. 17.

    Hunt, supra note 17, at paragraph 37, 41; see also: (Luna 2016)

  18. 18.

    See (Saadj and White 2014)

  19. 19.

    See generally (Mouton et al. 2016)

  20. 20.

    See (Pickett and Wilkinson 2009)

  21. 21.

    See generally (Adamski et al. 2010)

  22. 22.

    See generally Mouton et al., supra note 30.

  23. 23.

    See (Williams et al. 2015), at 1292.

  24. 24.

    See Moon, supra note 21, at 10.

  25. 25.

    Ibid.

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Coleman, C.H., Ho, C.W.L. Selling pharmaceuticals ethically in resource-limited settings: the case of Sofosbuvir. ABR 9, 87–101 (2017). https://doi.org/10.1007/s41649-017-0014-z

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Keywords

  • Pharmaceuticals
  • Developing economies
  • Emerging markets
  • Equity
  • Access to medicines
  • Corporate social responsibility