Post by Sadie Blanchard, Research Fellow Yale Law School
This week’s session of the Seminar in Private Law at Yale Law School took up transnational cooperation to combat influenza. Professor Amy Kapczynski spoke together with Dr. Nancy Cox, former Chief of the CDC’s influenza division who was responsible for its cooperation with a global network, operating under the auspices of the WHO, of national flu research labs that shares influenza samples and isolates the strains of the virus used in vaccines.
Dr. Cox described a crisis that erupted in the flu research network in 2006 after decades of peaceable cooperation. The crisis began when Indonesia refused to share samples of the avian flu virus during an outbreak that threatened to become a pandemic. Indonesia explained that it was reacting to the public dissemination by other scientists in the network of research using samples Indonesia had provided without obtaining Indonesia’s permission or giving credit to the scientists who provided the samples, in violation of the network’s guidelines. Its displeasure was compounded when it learned that a corporation had developed a flu vaccine based on a virus strain that Indonesia provided to the WHO and that patents had been sought on modified virus samples without the consent of the countries that had shared the samples through the network. Indonesia and other developing countries complained of the system’s inequity: they shared samples with the WHO network, and then Western pharmaceutical companies were given those samples, patented the resulting vaccines, and sold them at prices developing countries could not afford. In response, Indonesia proclaimed its sovereignty over viruses found in its territory, arguing they were natural resources covered by the Convention on Biological Diversity.
Although other developing countries never refused to share their samples, many supported Indonesia’s position. Shortly after Indonesia’s declaration, countries party to Convention on Biological Diversity reasserted state sovereignty over biological materials, including pathogens, by negotiating the Nagoya Protocol. Moreover, Indonesia’s samples were considered critical for global avian flu surveillance and response. Therefore, its decision to withhold viruses led the WHO to convene a meeting of governments to renegotiate the terms of virus and benefit sharing. As one scholar explained the negotiating positions,
Developing countries want obligatory benefit sharing in return for virus sharing, with binding terms spelled out in a Standard Material Transfer Agreement (SMTA). In contrast, developed countries want to avoid binding obligations to provide benefits (e.g., vaccines, antivirals) in exchange for access to virus samples provided by developing countries. At least one news report indicated that developed countries wanted to avoid losing their ability to place advance orders for influenza vaccine because of a binding SMTA.
The tension between developed and developing countries rose during the swine flu outbreak in 2009, when developed countries placed advance orders for all the vaccine that manufacturers could produce. Developed countries believed they would face shortages and thus largely refused to donate vaccine to developing countries, and prohibited their manufacturers from doing so, until expected domestic demand was met. In the end, the expected shortages never materialized, and the harm to developing countries was small, because the swine flu turned out to have been less virulent than regular seasonal flu. Although countries spent many times more on swine flu vaccines than they did on seasonal flu vaccines, much of the purchased vaccine (nearly half, in the United States) went unused. The WHO endured widespread criticism for its decision to declare a pandemic, which triggered these massive vaccine purchases.
Nonetheless, in 2011, the WHO succeeded in negotiating the Pandemic Influenza Preparedness (PIP) Framework, which required that private and academic partners participating in the flu network undertake binding contractual obligations to make vaccines available to poorer countries. PIP also prohibits recipients of material from seeking intellectual property in its derivatives. The contracts are enforceable through international arbitration. The PIP framework is the only global public health governance framework enforceable by private law mechanisms. Participating private sector companies are required to pay for half of the cost of running the network. Seventy percent of their contributions are distributed to developing countries and 30 percent is set aside within the WHO for vaccine purchases during a pandemic. The PIP Framework transformed a previously technocratic network of scientists governed by formal terms of reference together with informal rules and traditions into a legally formalized cooperative system that uses technology to track the dissemination and use of data.
Amy Kapczynski said the flu network is a case study for the collaboration challenges in international health networks and the formal and informal ways they can be handled. She highlighted the distinction between states and scientists and their different motivations for collaboration. States collaborate, she said, because they believe it is necessary in order to prevent epidemics. But they also face negative repercussions from reporting disease outbreaks—including in international trade and travel and local politics—and grapple over financial contributions. With PIP, developing countries pushed for private-law mechanisms to bind users concerning benefit sharing. From the scientists’ perspective, there appear to be very different motivations for collaborating: there seems to be intrinsic value to cooperating, but scientists also value publication and reputation-building.
Daniel Markovits identified at least six possible frames for this dispute. Indonesia put forward a property frame, arguing that something belonging to it had been taken without reciprocal benefit. A starkly different frame could cast Indonesia as permitting, by its negligence, a dangerous virus to spread beyond its borders and then intentionally withholding from the world the means to protect itself. A distributive justice view that sees Indonesia’s relative poverty as the fault of rich country exploitation might excuse Indonesia’s actions on that ground. A creativity-focused frame might care mostly that proper acknowledgement be given to those producing intellectual material. A diplomatic frame might focus on the Indonesian activists who rallied for a change to the network’s terms, arguing that such people are not legitimate actors in scientific conflicts. Finally, a utilitarian public health frame might place the best possible health outcomes at lowest cost above any other consideration. None of the reading materials discussed a framing agreement among participants in the dispute to settle the dimension on which the battle would be fought.
In Nancy Cox’s view, the WHO, as the convenor of the meetings, sought to take all the different positions into account to maximize the likelihood of reaching agreement. Amy Kapczynski observed Indonesia’s strongly asserted property claim and demand for a quid pro quo. It threatened to cut the WHO out of the process altogether and negotiate directly with the manufacturers. Once the dispute entered the WHO field, the property claim was weakened because the public health logic of that organization favors wide dissemination. A student categorized the different kinds of claims Indonesia made in deciding to withhold biological material. It made a couple of claims about law: that it had a sovereign right to this biological material and that the WHO’s International Health Regulations did not require it to share the material. It also made claims about equity and fairness: that drug companies were making profits, developing countries were satisfying their demand, and developing countries were getting the leftovers. Finally, it made a power statement: it would bypass the WHO and negotiate directly with drug companies unless the terms of cooperation were altered. Could Indonesia have made this power statement without first setting out its legal and equitable claims? What role did those prior claims play in legitimizing Indonesia’s position?
Cox responded that initially Indonesia’s legal claims were important in forming allies with other developing nations. The fairness issue moved the public health community within developed countries and motivated the CDC to provide technical support to U.S. negotiators throughout the process. While Indonesia sought to legitimate its position, the ultimate outcome was decided by power and interest: Indonesia had extraordinary leverage because states were worried that without samples many people would die due to a delay in vaccine production.
Questions were then raised about whether there were other means available to obtain Indonesian virus samples, and it was emphasized that this was not seen as a one-off problem but a negotiation to sustain a long-term surveillance structure.
A student observed that the PIP Framework moved the flu network from a public system to a public-private partnership, giving corporations a seat at the table. He asked how elevating corporations to partner level changes the way norms are created. Does the presence of corporations change the reigning norm from equitable sharing to distribution based on relative contribution? Cox responded that while corporations provide funding and are given access to virus strains, they have no official voice in the network, no technical input on virus selection for vaccine production, and no right to patent viruses. She mentioned the WHO’s efforts to improve transparency, which have gone through several iterations but have not yet proven satisfactory to critics. She believed improving transparency to be important to the establishment of trust. Kapczynski said that during the negotiations there was much concern about potential conflicts of interest, and various controls were put into place to limit corporate influence. On the other hand, during negotiations governments actively consulted with their companies. Cox explained that there was a discernible change in the United States’ negotiating position when the State Department replaced the Department of Health and Human Services (HHS) as the U.S. lead negotiator toward the PIP Framework. The State Department generally brings a stronger emphasis on intellectual property rights and industry interests. It doesn’t have as many regulatory barriers to industry relationships as does HHS and has a very different perspective on its role as negotiator.
Richard Brooks observed that the property and exchange frame was present before corporations were brought in. Indonesia made property claims, and there was a sense during the swine flu epidemic that because Mexico had contributed so much it had a claim to more vaccine than it received. Kapczynski agreed that it was developing countries that advanced the logic of exchange—contract and arbitration—because they saw it as a means of protecting their interests.
The conversation then turned to whether innovation in gene sequencing might render this network obsolete and eliminate the impetus to expand its model to other infectious diseases, as has been suggested by some policymakers. In 2009, scientists at Novartis succeeded in creating a synthetic flu vaccine from gene sequence data more quickly than the vaccine was able to be produced from actual viruses; indeed, before they even received a virus sample from the WHO. They advocate and have begun to develop new technology to produce genome sequences rapidly to replace the existing laborious WHO system, which requires “the isolation of viruses, preparation of high-growth reassortant vaccine viruses, and shipment of viruses and nucleic acids between geographically dispersed sites where vaccines are manufactured.” Novartis scientists collaborated with other private-sector and public-sector scientists to develop a technique for rapid virus synthesis that would produce specimens suitable for mass vaccine production. The team of scientists argues that this method could “enable more rapid pandemic responses and a more reliable supply of better matched seasonal and pandemic vaccines than available at present.” The researchers called on the WHO and nations to eliminate regulatory and bureaucratic barriers to implementing this approach. They want the National Influenza Centers—the flu labs that participate in the WHO network—to sequence genetic material and post the data to the web for free access rather than sending physical viruses exclusively to the WHO.
A student observed that the scientists participating in the flu network, and perhaps also the WHO bureaucracy, seem to exhibit the intrinsic human desire to cooperate identified by Daniel Markovits. He asked whether this might be an instance in which that inherent sociability induces persistent efforts to cooperate that ignore the resulting collapse of valuable arrangements or, I would add, hinder the construction of superior alternatives. Dr. Cox confirmed the experience as a scientist of strong intrinsic motivation to collaborate with other scientists. She spoke of her enduring friendships with scientists with whom she began working based in the then-Soviet Union and China in the 1980s and the great satisfaction of seeing their labs transformed over the years into useful enterprises.
It is not apparent, however, that pharmaceutical companies share that impetus to cooperate in the network. If they manage to create vaccines without material from PIP, their current incentive to participate in PIP will probably erode. Still, it remains to be seen how they will persuade developing countries to provide free, open access to gene sequence data. In addition, the WHO has shown that it is highly motivated to remain involved in flu surveillance, and it has leverage in that is member states are large purchasers of vaccines. In any event, innovation might soon produce conditions that are ripe for a new bargain to be struck.
As in prior sessions of the Seminar, transparency emerged as increasingly important in this field of cooperation. Both insiders and outsiders are asking for more open sharing of information. As regards the flu surveillance network specifically, the challenges to its legitimacy have been largely internal, from developing countries that did not believe benefits were equitably shared. External challenges to legitimacy came soon thereafter from corporations who questioned the value of the network; however, at around the same time—though not obviously because of their challenge—they were brought into the network as official collaborators. More broadly, the WHO’s involvement in global health governance has attracted unprecedented scrutiny since its response to the swine flu outbreak in 2009. External legitimacy challenges continue to push it toward greater transparency.
Next week, the Seminar will consider the role of business elites in negotiating the end of the South African apartheid state. Michael Young, an English business leader who convened secret meetings between the African National Congress and the South African government, will speak together with Ian Shapiro and Itumeleng Makgetla, who have written a paper (available here) about the role of business elites in apartheid’s fall.