Tag Archives: international health

Reasons to Support a Binding Treaty on Health R&D for Developing Countries

The 65th World Health Assembly of the WHO is currently considering a treaty that will fund and coordinate research for diseases affecting developing countries. The proposal was put forward by the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), a body created in 2010 to develop the efforts of previous committees established to consider health R&D. In a report last month, the CEWG concluded that “a binding instrument on R&D is necessary to secure appropriate funding and coordination to promote R&D needed to address the diseases that disproportionately affect developing countries and which constitute a common global responsibility” (p. 120).

Economic and moral justifications for the treaty

The economic justification provided by the CEWG frames the treaty as a response to a market failure resulting from the inability of intellectual property (IP) rights to incentivize companies to invest in drug development for diseases affecting the developing world. The treaty’s funding mechanism is designed to address this economic barrier to research investment.

The moral justification contains two arguments. The first is based on the problem of access: the international community has medical resources and the capacity to distribute them, and yet a multitude still suffers and dies from lack of medicines. The CEWG deems this preventable gap between means and needs as morally unacceptable. The CEWG urges that the moral argument for equitable access to existing medicines be extended to drugs not yet developed, a goal reflected in the proposed R&D treaty. Of particular interest is the second moral argument, which is based on health-related human rights responsibilities that governments have assumed toward their citizens as a matter of international law. A multilateral treaty requiring governments to spend money in their health sectors would mark a departure from the practice of the last sixty years.

A return to post-WWII international ethical principles

Although the treaty would mark a change in practice, it would represent a return to ethical principles agreed to by the international community after World War II. The Universal Declaration of Human Rights (UDHR), a nonbinding legal document, was adopted by the United Nations in 1948. It embodied an ethical vision based on the principle that “[a]ll human beings are born free and equal in dignity and rights.” Moreover, it sketched a blueprint for realizing that vision in a legally binding document. The UDHR described rights and obligations for governments to respect and assume so that the freedom, dignity and equality of all people could be ensured.

However, competing visions of human rights tussled during the drafting of the UDHR, and intensified further during the Cold War. When it came time for a binding legal instrument, the single vision and framework was split into two treaties: the International Covenant on Civil and Political Rights (ICCPR, 1966) and the International Covenant on Economic, Social and Cultural Rights (ICESCR, 1966). The ICCPR was spearheaded by the US-led Western, capitalist bloc and focused on negative rights, i.e. rights fulfilled by governments refraining from actions that interfered with citizens’ rights (e.g. freedoms of expression, religion, movement, etc.). The ICESCR was championed by the USSR-led Communist bloc and focused on positive rights, i.e. rights realized by government action (e.g. rights to education, health, housing, etc.).
Over time, rights in the ICCPR were prioritized over those in the ICESCR. This was partly because the latter were harder to enforce in law courts, but also because they were much costlier (a point relevant to the proposed treaty). This imbalance resulted in reduced health spending among governments, particularly among developing countries. However, as the Cold War waned, the tension between the treaties subsided and the international community reaffirmed in the Vienna Declaration and Program of Action (1993) the indivisibility, interrelatedness and interdependence of human rights. This has allowed for greater international cooperation in the area of health, perhaps most visibly with the HIV/AIDS epidemic. Governments, private organizations and philanthropists have since combined efforts to address various health challenges from malaria to tuberculosis. These laudable efforts notwithstanding, there has not been a broad-based legally binding health-related treaty containing an explicit funding obligation.

Three reasons to support a binding treaty for health R&D

First, it ensures a source of sustainable funding for health R&D in the developing world. Global health today involves many actors, including governments, nongovernmental organizations, corporations and philanthropists, all able to act alone or in partnerships. Of these actors, however, governments are able to make funding commitments least susceptible to market trends, waning voluntary donations, or shifting public interests. A binding treaty would keep R&D funding from slipping off the global health agenda.

Second, a binding treaty ensures, not just funding, but public accountability for health R&D. Of the global health actors listed above, governments are accountable to the broadest constituencies. Particularly if they are democratic, governments can provide a means for diverse sectors of society – beyond stockholders and donors – to inform, criticize and influence funding decisions.

Third, a binding treaty recognizes that the commoditization of health is an inadequate approach for addressing health needs in developing countries. As the CEWG Report noted, a health R&D market failure has created, among other things, the need for public action through the concerted legal commitments of governments. The CEWG’s proposal recognizes the critical role governments will need to play in global health.

Funding sustainability, policy accountability and public engagement constitute three grounds for a health R&D treaty. By involving governments in funding health R&D, such a treaty would begin to restore the split vision of the UDHR. Of greater importance, it will encourage research addressing needs of those with the least access to health.

— Ibrahim Garba

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Are Clinical Trials in the Developing World Safe and Ethical? Research Ethics in the News

The Association of Clinical Research Organizations (ACRO) recently released a report asserting “Clinical trials conducted in the developing world meet the same safety, ethical and quality standards as those conducted in the developed world.” ACRO represents “companies whose focus is clinical research. The association provides an active voice for the global CRO industry, which provides specialized services that are integral to the development of drugs, biologics and medical devices”.

If the ethical issues are properly addressed, ACRO sees many benefits to encouraging globalized clinical trials. These include: the increased speed of drug development, improving local economies, and finding new markets for products. To avoid incidents like the 1996 Trovan debacle, ACRO recommends increasing the FDA’s resources, encouraging local government measures to protect research subjects while facilitating globalization, and ensuring equity in ethics:

“All participants in clinical research — no matter where they live or the environment in which research takes place — be protected by the same level of safety and ethical considerations, and that they be afforded the same standard of care, including adherence to the GCP principles promulgated by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)”.

Reference:

Clinical Research Safety and Ethical Standards in Developing World Up to U.S. Levels, Report Says. Association of Clinical Research Organizations (ACRO), PRNewswire-USNewswire. July 21, 2009.

Related:

“Enormous” improvement in emerging-country trials, claims ACRO. Peter Mansell, PharmaTimes. July 22, 2009.

The International Conference on Harmonisation  – http://www.ich.org/

Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, Schulman KA. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009 Feb 19;360(8):816-23. PMID: 19228627.

ACRO Comments on NEJM Article on Globalization of Clinical Research. Association of Clinical Research Organizations, Reuters. February 20, 2009.

Other News

NHLBI Stops Study of Treatment for Pulmonary Hypertension in Patients with Sickle Cell Disease Due to Safety Concerns. National Heart, Lung, and Blood Institute (NHLBI), NIH News. July 28, 2009.

Are clinical trials risky or dangerous? ABC Action News. July 27, 2009.

Chinese Research Teams Build Mice from Reprogrammed Cells, Raising New Bioethical Questions. Michael Rugnetta, Science Progress. July 27, 2009.

A Peek Inside NIH Peer Review. Vivian Cheng, Science Progress. July 27, 2009.

Manimal Planet: Anti-Mermaid Legislation Rises from the Deep. Jonathan D. Moreno, Science Progress. July 24, 2009.

Financial Conflicts of Interest 101: How Money Shapes Research and How Policy Can Protect Patients. Vivian Cheng, Science Progress. July 20, 2009.

Context counts when assessing the social value of research. Nancy Walton, The Research Ethics Blog. July 19, 2009.

Data Bank: Public Support for Stem Cell Research On the Rise. Vivian Cheng, Science Progress. July 16, 2009.

Obama’s Guidelines on Human Stem Cell Research: Expanding Funding, Improving Oversight. Robert Streiffer, Bioethics Forum. July 16, 2009.

Merck and Schering-Plough settle investigation. Marley Seaman (AP), The Washington Post. July 15, 2009.

Obama and the President’s Council on Bioethics: An Insider’s View. Ryan M. Antiel, Bioethics Forum. July 13, 2009.

Public Praises Science; Scientists Fault Public, Media. The Pew Research Center for the People & the Press, Survey Reports. July 9, 2009.

Jesus Goes to Bethesda: Just how religious is Obama’s nominee for director of the NIH? Chris Wilson, Slate. July 9, 2009.

‘Synthetic sperm’ from stem cells raises hope for male infertility. Mark Henderson, The Times. July 8, 2009.

Related: Transforming Stem Cells into Sperm Cells Yields Unexpected Bioethical Questions. Andrew Plemmons Pratt, Science Progress. July 13, 2009.

— J.O.

Otmar Kloiber, M.D. – Ethical Perspectives in Medicine, Health and Science

Join us at the Center for Bioethics this Tuesday at 3:00 p.m. for this event. Dr. Kloiber Otmar Kloiber, M.D.will address a number of critical ethical and policy issues in international health and health research, including: global efforts in TB resistance, health and human rights, and the next revisions to the Declaration of Helsinki.