Editorial Drug Companies Should Be Held More Accountable for Their Human Rights Responsibilities

The PLoS Medicine Editors*

Almost ten years ago, activism and upon an extensive and consultative process and works against the duty to promote public protest resulted in a landmark with multiple stakeholders—include re- human rights—as the company that holds victory for the access to medicines move- sponsibilities for transparency, manage- the patent is basically the only entity that ment, when 39 of the world’s leading ment, monitoring and accountability, pric- can legally do so’’ [8]. At the same time pharmaceutical companies dropped their ing, and ethical marketing. They identify that the 825 billion dollar global pharma- collective lawsuit against the South African best practice as including access to med- ceutical industry operates as society’s chief government for attempting to legalize the icines, differential pricing between and developer and purveyor of life-saving importation of cheaper generic versions of within countries, commercial voluntary medicine, two billion people around the drugs [1]. Following a settlement, medica- licensing that allows for the production of world lack access to essential medicines. tion prices—including those for antiretro- cheaper generics, investment into research Such a persistent perversity demands more virals to treat the millions of South and development (R&D) of neglected outrage. Africans with HIV/AIDS—dropped, and diseases, and engagement in public–pri- Unfortunately, the pharmaceutical com- public pressure on the pharmaceutical vate partnerships. The Guidelines also panies that now do acknowledge the industry was hailed a success [2]. A decade recommend against lobbying for more importance of principles related to human later it’s time again for action—to hold protection in intellectual property laws, rights tend to blunt their own responsibil- drug companies accountable for their applying for patents for trivial modifica- ities by instead emphasizing their corporate human rights responsibilities to make tions of existing medicines, inappropriate social responsibility initiatives, employment medicines available and accessible to those drug promotion, and excessive pricing. standards, global health programmes, and in need. Indeed, a most notable aspect of the Hunt participation in drug donation schemes, As part of this effort, PLoS Medicine Report is its revelation that many of the voluntary price reductions, or international publishes three unique perspectives on the obstacles States face in delivering the right business groups like the UN Global Com- question of whether drug companies are to health to their citizens are created by pact and the Business Leaders Initiative on living up to their human rights responsi- these very drug company practices [7]. Human Rights (BLLIHR) [9–12]—not bilities. Sofia Gruskin and Zyde Raad The chief proposition in the Guidelines explicitly human rights activities. Indeed, from the Harvard School of Public Health is that pharmaceutical companies, by there is danger in pharmaceutical compa- say more assessment is needed of such virtue of being granted by society the nies’ persistent assertions that the primary obligations [3]; Geralyn Ritter, Vice monopoly and power to develop medi- responsibility for delivering the right to President of Global Health Policy and cines, hold that power (the patent) with health lies with the State and that their role Corporate Social Responsibility at Merck express conditions. And these conditions is merely supportive—as reflected in the & Co., argues that multiple stakeholders include human rights responsibilities to Merck perspective published today in PLoS could do more to help States deliver the make medicines available and accessible. Medicine [4]—as this argument allows the right to health [4]; and Paul Hunt and As Hans Hogerzeil, WHO Director of industry to exculpate itself from its own Rajat Khosla offer their reflections [5] on Essential Medicines and Pharmaceutical human rights responsibilities. Mr. Hunt’s work as the UN Special Rapporteur on the right to the highest Policies, was quoted recently as saying, not Klaus Leisberger, President of the attainable state of health (2002–2008), providing new drugs available to those Novartis Foundation for Sustainable which culminated in the first ‘‘Human who need them ‘‘breaks the social contract Development, is a leading advocate of Rights Guidelines for Pharmaceutical Companies’’ [6]. This PLoS Medicine De- Citation: The PLoS Medicine Editors (2010) Drug Companies Should Be Held More Accountable for Their bate comes two years after the release of Human Rights Responsibilities. PLoS Med 7(9): e1000344. doi:10.1371/journal.pmed.1000344 the Guidelines and a year after Mr. Hunt’s Published September 28, 2010 report [7] on his invited mission to review Copyright: ß 2010 PLoS Medicine Editors. This is an open-access article distributed under the terms of the the policies and practices of GlaxoS- Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any mithKline (GSK) was submitted to the medium, provided the original author and source are credited. UN Human Rights Council. Together Funding: The authors are each paid a salary by the Public Library of Science, and they wrote this editorial these perspectives and reports make clear during their salaried time. that the responsibilities of pharmaceutical Competing Interests: The authors’ individual competing interests are at http://www.plosmedicine.org/static/ editorsInterests.action. PLoS is funded partly through manuscript publication charges, but the PLoS Medicine companies go beyond stakeholder value to Editors are paid a fixed salary (their salary is not linked to the number of papers published in the journal). encompass human rights. What is also Abbreviations: GSK, GlaxoSmithKline; R&D, research and development. clear is that more accountability is now needed. * E-mail: medicine_editors@plos.org The Guidelines on human rights re- The PLoS Medicine Editors are Virginia Barbour, Jocalyn Clark, Susan Jones, and Emma Veitch. sponsibilities of drug companies—based Provenance: Written by editorial staff; not externally peer reviewed.

PLoS Medicine | www.plosmedicine.org 1 September 2010 | Volume 7 | Issue 9 | e1000344 corporate social responsibility among Pfizer and Gilead emerging as the most monitor and publicly document their own pharmaceutical companies, but neverthe- improved since 2008. The Index concludes activities. We agree. Beyond an add-on or less writes that ‘‘no private enterprise has that many more companies are participat- peripheral activity, the acknowledgement the societal mandate or the organizational ing in initiatives to improve access to and promotion of human rights must capabilities to feed the poor or provide medicines and are becoming more trans- become a regular, integrated aspect of health care to the sick’’ [13]. ‘‘Enlight- parent and cooperative in sharing informa- the work of pharmaceutical companies. ened’’ pharmaceutical companies, he says, tion but that the need for medicines across a Better yet would also be an external, can respect and even protect the right to range of infectious and non-communicable international body charged explicitly with health of their employees, for example. diseases remain substantial and is growing. monitoring the policies and practices of But beyond that, in terms of delivering the (Notably, the Index does not examine pharmaceutical companies and reporting right to health, he argues that this company performance against best practic- publicly on the discharge of their right-to- responsibility ‘‘cannot be more than a es, but instead against other companies.) health responsibilities. very limited contribution to overcoming Other analyses, by the George Institute, The challenge for the pharmaceutical the challenges that we all face on a global the UK Department of International industry is to develop viable business level.’’ And indeed major companies in Development, and others [5] demonstrate models that allow for profit whilst respect- their responses to the Guidelines argued some progress in access to medicines and ing and promoting human rights. Phar- that their role and human rights respon- many areas where improvement is needed. maceutical companies are tremendously sibilities are not adequately defined But none of these audits, including the innovative entities that abhor bad public- [14,15]. In contrast, independent observ- Access to Medicine Index, ‘‘frame the ity, so the incentive is there for stimulating ers have stated that these expectations are performance indicators in human rights creative thinking under public pressure. in fact well delineated [16]. terms’’ and none ‘‘explicitly advocate a The human rights guidelines and respon- So how well are drug companies doing? requirement for accountability against sibilities are now clear; the monitoring and Several exercises are available that shed human rights standards,’’ emphasised Paul accountability must step up in earnest. some light on the question. The most Hunt in an interview with PLoS Medicine. important of these, the Access to Medicines What type of accountability is needed? Index (http://www.accesstomedicineindex. The importance and significance of Acknowledgments org/), provides an unprecedented and accountability in this area cannot be Many thanks to Paul Hunt and Gavin Yamey independent comparative analysis of 27 overstated. As Helen Potts argues, ac- for useful discussions on this topic. top drug companies on measures of com- countability is not merely ‘‘responsiveness, mitments, performance, transparency, and responsibility, answerability or evaluation’’ Author Contributions R&D in relation to access to medicines. Its [17]. Where the pharmaceutical industry 2010 Report ranks companies in several and access to medicines intersect, account- ICMJE criteria for authorship read and met: JC VB SJ EV. Agree with the manuscript’s results areas and details improvements since ability is something much more than that and conclusions: JC VB SJ EV. Wrote the first 2008—this year GSK topped the list again, and must go to the core of the business draft of the paper: JC. Contributed to writing of and appears to be a consistently viewed activity. Paul Hunt’s work [5] highlights the paper: VB SJ EV. industry leader. Merck & Co. and Novartis the critical step of companies creating were ranked two and three in 2010, with independent, transparent mechanisms to

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PLoS Medicine | www.plosmedicine.org 2 September 2010 | Volume 7 | Issue 9 | e1000344