Virus Sharing, Genetic Sequencing, and Global Health Security Lawrence O

PERSPECTIVE ruses with pandemic potential. Seasonal influenza viruses are excluded, as are noninfluenza pathogens irrespective of their pandemic potential. In a globalized world, with myriad emerging infec- Virus sharing, genetic sequencing, tions, the framework’s narrow scope excludes the vast majority of future threats. The ownership and and global health security sharing of the Middle East respiratory syndrome 1 1 2 coronavirus (MERS-CoV), for example, has been Lawrence O. Gostin, Alexandra Phelan, Michael A. Stoto, controversial, with Saudi Arabian officials cir- 1,2 3 John D. Kraemer, K. Srinath Reddy cumspectaboutglobalcooperation(4). Countries This Perspective focuses on the future of the Pandemic Influenza Preparedness (PIP) Framework, lack the leverage to withhold pathogens already which was initially established to promote the fair sharing of public health–related pandemic in wide circulation, such as HIV, because scien- influenza samples between countries.We examine the changes that need to be made to address the tists can acquire samples from multiple sources. growing likelihood that genetic sequence data might be shared instead of physical virus samples, as Gaps in global governance well as the need to expand the PIP framework’sscopeandtoimproveitsfairness. The private sector’s incentive to participate is its he Pandemic Influenza Preparedness (PIP) commercial need for viral samples to develop Framework (1) was a milestone agreement pandemic influenza vaccines. But in May 2013, in promoting international sharing of bio- scientists demonstrated that GSD could be used logical samples to develop vaccines, while to rapidly develop synthetic viruses for product T 5 ensuring that poorer countries would have development ( ). If pharmaceutical researchers access to those vaccines. Now genetic sequenc- no longer require access to biological materials ing data (GSD) can allow scientists to develop to develop products, private sector cooperation synthetic viruses rapidly for product develop- in the framework could decline. ment. Electronic transfer of GSD could enable The PIP Framework defines “biological mate- wider access to researchers to innovate and share rials” as influenza viruses with human pandemic findings, speeding development of life-saving tech- potential, including extracted RNA and cDNA, on January 31, 2016 nologies in a time-sensitive global emergency. which appears to exclude GSD. Although the frame- But access to GSD may also have major implica- work also defines genetic sequences, the frame- tions for biosecurity, biosafety, and intellectual work’s sharing and benefits scheme does not property (IP). By rendering physical transfer of explicitlyapplytoGSD.Notingthatsomecoun- viruses antiquated, GSD may also undermine the tries treat the publication of pathogen sequenc- effectiveness of the PIP Framework itself, with ing data as highly sensitive, the PIP Framework disproportionate impacts on poorer countries. left for the future the handling of GSD—which In December 2006, Indonesia challenged the suggests that WHO member states and stake- fairness of the global preparedness system by Fig. 1. By sharing influenza viruses with human holders failed to agree during the negotiations. refusing to share samples of avian influenza A pandemic potential and building financial and The omission of GSD in the PIP Framework’s (H5N1). Concerned that wealthier countries would research partnerships, countries can unite to sharing and benefits scheme is out of step with classic.sciencemag.org gain disproportionate access to vaccines while creat- widen access to vaccines. global preferences for the inclusion of genetic in- ing cost barriers for others, Indonesia invoked formation of global health importance in public sovereign ownership of a virus isolated in its ter- Although it has the potential to be transforma- domain or open access databases, to increase trans- ritory. The government claimed that the Conven- tive, the PIP Framework leaves fundamental parency and to advance social justice. The Na- tion on Biological Diversity prevents exploitation gaps in health security and in equity. tional Institutes of Health’s genetic sequencing of its “biological and genetic resources,” includ- database GenBank, for example, offers an anno- ing novel pathogens (2). Indonesia’s decision— Gaps in equity, research, and security tated collection of publicly available DNA se- supported by many low- and middle-income ThedynamicsbehindthePIPFrameworkwere quences, which enables data exchange. Similarly, Downloaded from countries—risked significantly impeding the capac- unusual because Indonesia had something to the Global Initiative on Sharing All Influenza Data ity to monitor and respond to novel influenzas. leverage—virus samples critical to the functioning (GISAID) platform promotes sharing influenza- It took more than 4 years, but the World Health of the global public health system (Fig. 2). The type virus sequences. Although these sequences Organization (WHO) was able to broker the PIP agreement changed an unfair status quo, where- are publicly accessible, researchers must acknowl- Framework, finalized in May 2011 (Fig. 1). It used by lower-income countries shared viruses, while edge the originating laboratories that contributed a novel strategy to advance global justice by af- relying on ad hoc “charitable” donations of vac- data to the GISAID platform and ensure fair use fording more equitable access to the benefits of cines. For example, during the 2009 influenza (A) of research findings. research. Rather than having governments com- H1N1 pandemic, vaccine donation pledges often mit to providing a share of their vaccine stock- were not fulfilled until high-income countries had Biosafety and biosecurity piles with lower-income countries in exchange for protected their domestic populations (3). In ex- Biosafetyreferstothemaintenanceofsafecondi- access to biological samples, the PIP Framework change for access to biological materials, the PIP tions in biological research to prevent inadvertent created legally enforceable contractual obligations Framework requires researchers and manufac- escape of hazardous materials that could harm on participating private and academic partners turers to fulfill contractual obligations, such as workers, persons outside the laboratory, or the en- that are involved in the manufacture of vaccines providing an agreed percentage of vaccines, di- vironment. Unlike physical virus sharing, sequenc- to make vaccines available to poorer countries. agnostics, or pharmaceuticals to the WHO stock- ing data are not inherently hazardous, and sharing pile or granting developing countries “fair and information instead of physical samples mitigates 1O’Neill Institute for National and Global Health Law, Georgetown reasonable” or royalty-free licenses to manufac- the risk of inadvertent release of the infectious University Law Center, Washington, DC 20001, USA. ture such products. agent by limiting access to biological agents. 2 Department of Health Systems Administration, Georgetown In addition to potential limitations in light of Biosecurity refers to the precautions taken to University, Washington, DC 20057, USA. 3President, Public Health Foundation of India, New Delhi 110070, India. GSD discussed below, the PIP Framework is lim- protect against the spread of harmful biological *Corresponding author. E-mail: [email protected] ited in scope as it applies only to influenza vi- substances. This includes pathogens of dual-use SCIENCE sciencemag.org 12 SEPTEMBER 2014 • VOL 345 ISSUE 6202 1295 likely fall under the scope of “naturally occurring incorporated into existing databases such as the substances” and thus not be patentable as defined GISAID platform. Moreover, allowing free ex- by the World Intellectual Property Organization change of GSD without enforcing the obligations (8). GSD, however, entail additional intellectual owed to the donating country essentially unravels steps from simply isolating the virus. Still, it is the PIP Framework “bargain” after the fact, un- conceivable that GSD might be deemed a non- dermining both the framework’s legitimacy and the patentable “naturally occurring substance” in WHO’s credibility to negotiate future agreements. major jurisdictions such as the United States (9). In the long run, the gaps in the framework that Although the PIP Framework does not dis- we describe open an opportunity to resolve other place the IP regimes of domestic jurisdictions, existing weaknesses by revising the text. A revised extending the framework to cover GSD would framework should be driven by norms of equity contractually prohibit unauthorized assertions and shared global vulnerability, with the vital goals of property rights over GSD, similar to biological of open access to research materials, accessible materials. Such an expansion of coverage would license agreements, and more rapid development further the framework’s objectives of social jus- of therapeutic countermeasures. Note that fairness tice, while encouraging open access to GSD. requires that lifesaving vaccines and pharmaceuticals, as well as the results of research, are Global health governance equitably distributed in low- and middle-income Fig. 2. Bird flu in Indonesia: freewheeling toward The private sector (e.g., pharmaceuticals, for- countries that lack the ability to purchase products a pandemic. Biological samples (poultry and pigs) profit health care providers, food, alcohol, and in the market or produce them

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