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)
https://www.flickr.com/photos/usaid_images/5163775269/
New Era for International Health Law? Health Security vs. Equity
In Human Rights & IHL
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)
https://www.flickr.com/photos/usaid_images/5163775269/