The Foreign Service Journal, July-August 2020

36 JULY-AUGUST 2020 | THE FOREIGN SERVICE JOURNAL tions under which the product would be made available. But there are some principles that might influence these deci- sions or agreements. WHO convened a conference in April to develop an “Access to COVID-19 Tools Accelerator” agreement— a global collaboration to accelerate the development, produc- tion and equitable access to new diagnostics, therapeutics and vaccines—and the European Commission and United Kingdom co-chaired a follow-on conference in May to raise billions of dol- lars to implement it. Governments, such as the European Union, and nongovernmental sources, such as the Gates Foundation, pledged to fund a mechanism, possibly a pooled purchasing agreement, to, they hope, guarantee that when a vaccine or cure is developed, there will be global access to it based on need, reasonable cost and evidence of greatest potential impact. The United States, India and Russia were not involved in these efforts, and China participated only at a low level. China subsequently announced that vaccines it develops would be treated as a “global public good,” implying collaboration with these ad hoc arrangements; but details are unclear. The U.S. National Institutes of Health finances about 50 percent of the publicly funded biomedical research in the world. And the U.S. pharmaceutical and bioresearch industry pays for an equal disproportion of private-sector research and develop- ment (R&D) for drugs and vaccines. The grant and partnership model on which this research depends does not align with a global top-down product development and distribution blue- print proposed by WHO and the ACT Acceleration project. So the United States’ hesitancy to join such grand schemes is understandable. In the past, however, other stakeholders have recognized the centrality of U.S. efforts and accommodated them. Agreements on information sharing about our parallel processes, product-sharing formulas or foreign manufacturing based on royalties have been reached, either by formal negotia- tion or private-sector initiatives. Can We Avoid the Coming Train Wreck? The stakes in the coronavirus case are unusually high and, at the same time, there is an unprecedented refusal by the U.S. government to engage in the kind of planning, negotia- tions and problem-solving that has characterized global health collaboration in the past. Without some sort of agreement or formula, there are formidable obstacles to scaling up vaccine use around the world. These include, in particular: (a) governments’ power to “nationalize” and thus hoard production of scarce vaccines and the reciprocal power of countries where the initial outbreak occurs to, in the future, declare “viral sovereignty” and refuse to share pathogen samples fromwhich vaccines or countermeasures can be developed; and (b) the intellectual property and market exclusivity rights of the vaccine’s developer and/or manufac- turer, recognized by regulatory bodies such as the Food and Drug Administration, that allow pricing of in-demand, life-saving cures beyond the reach of the majority of the world’s population. Rules governing international trade and intellectual property (TRIPS) allow countries unable to access medicines needed for health emergencies to issue a “compulsory license” requiring the manufacturer to permit their local firms to produce the patented product, in principle based on a fair royalty payment. If the United States should succeed in developing the first successful SARS-CoV-2 vaccine, and no other global agreement is in place, the compulsory licensing scenario could be night- marish. The COVID-19 pandemic surely meets the definition of a health emergency in every country. But there would be a finite supply of an initial FDA-approved vaccine, with virtually infinite demand. Countries will insist on compulsory licensing to manu- facture the vaccine, even to the extent of pirating versions if the patent holder does not offer generous terms. If the NIH or U.S. government paid for a major part of the vaccine’s development, the question of price and availability in low- and middle-income countries will be even more challenging and politicized. The lack of any “command and control” system for global health and the weakened state of WHO as a convenor, arbiter or facilitator of access to scarce health products is likely to produce chaos, ill will and, most importantly, barriers to vaccine access for those who badly need it. This is not unsolvable. But to reach a solution, the United States needs to engage quickly and fully with the global com- munity. That means the World Health Organization, the Group of Seven and other major powers, the private sector, large philanthropies and other multilaterals, such as, in the vaccine space, the Global Vaccine Safety Initiative and the Coalition for Epidemic Preparedness Innovation. Even more than in other sectors, a large number of countries have looked to the United States for technical and operational Without some sort of agreement or formula, there are formidable obstacles to scaling up vaccine use around the world.