HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Monday, June 6, 2011

Guest Blogger Lindsay F. Wiley: World Health Assembly Adopts a New Influenza Preparedness Agreement on Virus Sample Sharing and Access to Vaccines

Wiley I want to thank Katharine Van Tassel and everyone else at Health Law Prof Blog for allowing me to join them this month as a guest blogger.  I’m new to the academy – having just taken a position as Assistant Professor of Law at American University less than a year ago – and so I truly appreciate the opportunity to join the ongoing discussion here about recent developments in health law news and scholarship.

My current projects include a book chapter on international and comparative legal frameworks for addressing natural disasters and the global health impacts of environmental degradation; a law review article tentatively titled Uncovering a Collective Right to Health in Public Nuisance Jurisprudence; and early research on what legal theory might contribute to an emerging ethical debate over the use of stigma as a public health tool.  So it’s a summer of disaster, nuisance and stigma for me.  I’ll be starting my guest blogging stint with some recent developments in global health law.  I’d also like to post about the process of developing a health law survey course, something that’s very much on my mind as I wrap up my first year of full-time teaching.

At the end of last month, the Sixty-fourth World Health Assembly concluded an historic session in Geneva that included discussion of several hot-button issues.  Though it has received little attention from the press, arguably the most significant new development from the perspective of international health law was the WHA’s adoption of a new Pandemic Influenza Preparedness Framework agreement (the PIP Framework).  The lack of fanfare is perhaps understandable given that pandemic influenza is so 2009.  Indeed, WHO’s own press release gave the new agreement lower billing than the declaration by an independent Review Committee that “the pandemic (H1N1) 2009 was indeed a real pandemic” and that it “found no evidence WHO was influenced by industry in its decision making” as the events of 2009 unfolded.

The rather bland reporting of the new PIP Framework belies its status as the culmination of four years of negotiation among WHO’s 193 Member States that included some of the most contentious debates in the organization’s recent history.  The controversy began in 2006 when Indonesian officials refused to share samples of avian influenza collected within their borders.  At a time when fear over the pandemic potential of H5N1 avian flu was significant, Indonesia’s refusal to share samples elicited strong reaction from diplomats and commentators in the U.S. and elsewhere. 

Essentially, Indonesian officials argued that they would not be willing to share further avian flu samples until they received assurances that they would also be able to share in the benefits of vaccine research made possible by the samples.  WHO collects virus samples and ultimately makes them available to private companies for vaccine research and development.  Indonesia argued that such a system was equivalent to biopiracy – the exploitation of resources found in developing countries for the benefit of companies (and ultimately populations) in wealthy countries. 

As David Fidler outlined in a 2008 article in Emerging Infectious Diseases, both sides of the controversy framed their arguments using international law.  The WHA passed a resolution in 2007 asserting that the International Health Regulations (as revised in 2005) included an obligation to share virus samples.  Indonesia maintained that the IHR requirements applied only to information sharing, not the sharing of physical material like virus samples.  Moreover, Indonesia argued that the Convention on Biological Diversity, adopted to combat biopiracy, applied to virus samples and mandated prior informed consent and provision for fair and equitable sharing of benefits.

Ensuing negotiations over virus sample and benefit sharing were described by William Aldis in a 2008 article in Health Policy and Planning as revealing a growing rift between developing countries’ and developed countries’ competing conceptions of “health security.”  Policymakers in developing countries, Aldis argued, tend to view health security as something akin to human security – an idea rooted in health equity and human dignity.  At the same time, those in wealthy countries conceive of health security as something akin to national security – an idea rooted in protection of populations from disease threats that know no borders. 

Ultimately, the agreement endorsed last week by the WHA claims to settle the dispute by including a statement that WHO Member States “should” share samples of influenza viruses with pandemic potential.  By doing so, they agree to the onward transfer of such materials to other entities as set forth in the Standard Material Transfer Agreements, included in an annex to the PIP Framework.  The Framework also directs the WHO Director General to put into place a traceability mechanism to track and report the movement of virus samples within and out of the WHO’s system.  The reporting obligation can be temporarily modified in an emergency.  The Director General is also directed to further develop and maintain a stockpile of antivirals, vaccines, and related supplies to be used in the event of an influenza outbreak with pandemic potential.  The agreement includes establishment of a PIP Benefit Sharing System that aims to “prioritize … antiviral medicines and vaccines against H5N1 and other influenza viruses with human pandemic potential … to developing countries, particularly affected countries, according to public health risk and needs and particularly where those countries do not have their own capacity to produce or access influenza vaccines, diagnostics and pharmaceuticals.”

Disease outbreaks with pandemic potential highlight the mutual interdependence between rich and poor when it comes to threats that “know no borders.”  Historically, however, our response to these threats has fallen far short of fully respecting the goals of health equity and social justice that Larry Gostin, Jennifer Prah Ruger, and others have argued should underpin the emerging field of global health law.  Whether this new agreement is a meaningful step in the right direction remains to be seen.  At a time when global health resources are becoming dangerously scarce – to such an extent that the WHA’s main focus during the recent meeting was to undertake a massive reform effort in response to this year’s budget shortfall – it is hard to imagine that our commitment to global health equity will be substantially strengthened in coming years. 

Lindsay F. Wiley

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