New Era for International Health Law? Health Security vs. Equity
In late 2010, the United Nations' Convention on Biological Diversity (CBD) adopted a new protocol to ensure the fair sharing of benefits derived from the use of genetic resources. As international law, the "Nagoya Protocol" could affect not only trade, but the response to public health emergencies.
By Tomohiko Makino, MD - The 2009 influenza A (H1N1) pandemic tested the global health community. The crisis re-emphasized the importance of a global disease surveillance network that includes timely sharing of pathogen strains for risk assessment and for developing countermeasures such as vaccines. Wealthy countries purchased most of the limited vaccine supply developed by the private sector. The US and eight other countries agreed to donate 10% of their vaccine supplies to the World Health Organization (WHO) for low-income countries, although logistical and supply snags delayed fulfillment of those pledges until well after the pandemic's peak. This gesture acknowledged but did not resolve questions about timely and equitable access to medical countermeasures.
These tensions threaten the global collaboration necessary to respond to emerging infectious diseases, in turn threatening global security. Countries at high risk of emerging infections have raised the stakes (and their own diplomatic leverage) by claiming ownership of pathogens, and thus of benefits such as commercial vaccines derived from their pathogens, in numerous international negotiations. Opponents counter that proposed benefit-sharing schemes may jeopardize swift public health responses and ultimately cost lives.
The issue first surfaced in late 2006. Highly pathogenic avian influenza (A/H5N1) appeared a likely candidate for the next pandemic strain. Indonesia, one of the countries reporting high numbers of human H5N1 infections, declared its refusal to share virus samples from human H5N1 influenza cases with WHO's Global Influenza Surveillance Network. Laboratories in this network share viruses derived locally from patient specimens with WHO Collaborating Centers, enabling WHO to track circulating strains for alarming changes and recommend vaccine formulations - and to make samples freely available to companies that manufacture and market influenza vaccines. Indonesian leaders cited the unfair disconnect between benefit and sample sharing. The pharmaceutical industry developed and sold "pre-pandemic" H5N1 vaccines based on virus strains shared through the network. Indonesian officials contrasted wealthy countries' ability to purchase these vaccines for their national stockpiles against its own immediate domestic public health crisis. Indonesia also claimed that the failure of vaccine manufacturers to share revenues with the countries of virus origin violated the ownership rights of genetic resources - an act of biopiracy under the UN Convention on Biological Diversity (CBD).
The idea of ownership rights clearly originates from outside the public health paradigm. CBD accredits states with ownership rights to genetic resources, and clarifies that access to these resources should be based on mutually agreed terms following prior informed consent (Articles 15.1, 15.4 and 15.5). CBD also endorses appropriate "Access and Benefit Sharing," in Article 15.7, now the most highlighted aspect of the agreement. The original CBD text did not exempt pathogens. The public health community presumed that pathogens, as risks to be averted, would not attract claims of ownership. However, like other genetic resources, pathogens may also generate benefits. For example, influenza virus is definitely a pathogen, but is believed to generate huge vaccine revenues.
Current arguments stem from whether the global public good of surveillance should trump an individual country's ownership. After four years of contentious debate, WHO Member States have not achieved a consensus on the sharing of influenza viruses and access to vaccines and other benefits. International laws do not explicitly mandate biological specimen sharing for the purpose of public health emergency preparedness and response.
On 29 October 2010, the 10th Conference of the Parties to the CBD adopted the "Nagoya protocol," the first binding agreement that appears to describe public health emergencies and pathogen sharing. Article 6 states that "Parties may take into consideration the need for expeditious access to genetic resources and expeditious fair and equitable sharing of benefits arising out of the use of such genetic resources, including access to affordable treatments by those in need, especially in developing countries." This vague statement is neither a breakthrough for the preemption of public health needs over ownership rights nor a clear obstacle to global health security. Some of the proposed mechanisms to establish equitable sharing of benefits - such as tracking every single virus specimen - could delay efficient disease surveillance. Nevertheless, the protocol is a significant step, providing another platform to articulate practical solutions that exempt ownership rights during public health emergencies.
The complexity comes from the coupling of pathogen sharing and benefits sharing. The argument started with the observation that benefits from sample sharing are not equitably distributed. Although there are elements of truth to this, the combination defies solutions. Sample and benefits sharing lie in different spaces. Sample sharing supports the purely technical practice of disease surveillance for public health security. Disease surveillance networks should not have geographic blanks, and should not be imperiled by political disagreements. In contrast, benefit sharing is an issue of equity. If a country has insufficient access to appropriate medical countermeasures, the international community should offer appropriate aid based on real need. Voluntary capacity building that limits the spread of disease satisfies both humanitarian and health security objectives.
The Nagoya Protocol has opened a new diplomatic arena, where efforts to protect natural resources in developing nations could ultimately limit public health options. As one of the few countries not party to the CBD, the U.S. (where ratification has been stalled since 1993, when partisan concerns over sovereignty overrode Clinton administration support and Senate Foreign Relations Committee approval) will only observe this debate. Parallel battles over intellectual property protections and access to pharmaceuticals continue within the World Trade Organization, with developed and developing nations reversing their roles. These arguments reflect the reality that public health success depends on the voluntary commitment of the private sector to develop and manufacture life-saving interventions -- and that arguments over ownership, equity, and security reverberate far beyond any single forum. Recognizing WHO is no longer the sole venue for health diplomacy, public health experts must actively contribute to various negotiations which, while not dedicated principally to global health, could have impact on it.
Photo Credit: Red -Eyed Tree Frog, Nov 2010. By Jerry Bauer, USDA Forest Service (USAID_IMAGES)