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1 1 (August 19, 2021)

handle is hein.crs/goveejr0001 and id is 1 raw text is: C o g r s i o a R e s a r c S e vi c August 19, 2021 Liability Issues Related to COVID-19 Vaccine Manufacturing and Global Distribution Background In March 2021, the United States announced efforts to donate Coronavirus Disease 2019 (COVID-19) vaccines abroad. In many high-income countries, vaccines and other medical countermeasures are playing a critical role in controlling the spread of COVID-19. Vaccine distribution efforts in low- and middle-income countries (LMICs) have been comparatively slow for a variety of reasons, raising concerns about how inequities may hinder pandemic control. Some vaccine manufacturers and others willing to donate COVID-19 vaccines are concerned about legal exposure should there be adverse health events arising from COVID-19 vaccination outside of the United States. In several countries, legal liability issues have slowed or entirely stalled vaccine roll-out. For example, U.S. government vaccine donations to India reportedly remain in a Delhi warehouse because the Indian government has not agreed to indemnify vaccine manufacturers for vaccine-related injuries. Only a relatively small percentage of the Indian population is fully vaccinated against COVID-19; donated doses could potentially increase vaccination rates in the country. This In Focus discusses potential liability issues that vaccine manufacturers and donors may face, and options Congress might consider while deliberating vaccine distribution and liability issues. Vaccine Distribution and Liability Concerns Due to the novelty of the therapeutics used to control the COVID-19 pandemic, liability insurance is generally unavailable for COVID-19 vaccine manufacturers. Many pharmaceutical companies have expressed concern about the costs they may face from vaccine-related injury litigation, with some preventing governments from exporting vaccines to other countries without liability and indemnification agreements in place. In February 2021, the Table 1. Classification of Liability Regimes World Health Organization (WHO) and Chubb Limited, an insurance company, signed an agreement on behalf of COVAX-a multilateral initiative for global COVID-19 vaccine distribution-to create a No-Fault Compensation program for those who suffer serious adverse events associated with a vaccine administered through COVAX. For more on COVAX, see CRS In Focus IF11796, Global COVID-19 Vaccine Distribution. In May 2021, the Task Force on COVID-19 Vaccines, Therapeutics, and Diagnostics for Developing Countries (the Task Force), composed of the International Monetary Fund, the World Bank Group, WHO, and the World Trade Organization, called for $50 billion in additional funding to support efforts to vaccinate 40% of all eligible people worldwide by the end of 2021. The Task Force cited liability issues and insufficient indemnification schemes as among the primary obstacles to achieving this goal. According to COVAX, as of July 31, 2021, approximately 5% of COVID-19 vaccines that were pre-purchased by or for LMICs have been delivered to these countries. The Task Force indicated that the resolution of liability issues and negotiation of indemnification agreements through the No- Fault Compensation Program might incentivize additional donations to COVAX and mitigate acute near-term vaccine supply shortages. Methods of Limiting Liability Manufacturers may secure legal protection through a variety of means, including legislation and contracts (Table 1). Some legislation provides immunity for manufacturers or creates no-fault compensation funds that may apply to injuries related to vaccines. In addition, some governments and manufacturers have negotiated agreements to address distribution of COVID-19 vaccines, which vary by country and manufacturer. The relevant legal regimes involved may also vary depending on how vaccines are acquired and distributed, whether via COVAX or through other channels. Type Description Examples Immunity Prevents entities from being held legally - U.S.: Public Readiness and Emergency Preparedness (PREP) Act liable and generally prevents individuals - Philippines: COVID-19 Vaccination Programme Act from receiving compensation Indemnification Requires a government to compensate - Contractual provision between the EU and AstraZeneca entities for damages the entities owe to - Contractual provision between the Dominican Republic and injured individuals Pfizer No-fault Individuals apply for compensation to a - U.S.: National Vaccine Injury Compensation Program compensation fund, and no liability attaches to the entities - COVAX mechanism ttps://crsreports.congress.