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1 1 (March 18, 2020)

handle is hein.crs/govcjvz0001 and id is 1 raw text is: Resarh Servi kM- COVID-19 Medical Countermeasures: Intellectual Property and Affordability March 18, 2020 Federal agencies and private industry have begun efforts to develop and test medical countermeasures (such as antiviral treatments and vaccines) to combat COVID- 19, the disease caused by the novel coronavirus SARS-CoV-2. For example, Gilead Sciences has begun clinical trials, both in China and in the United States, to test whether its experimental antiviral drug remdesivir is safe and effective against COVID- 19. In February 2020, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Department of Health and Human Services (HHS), entered into agreements with two pharmaceutical companies-Johnson & Johnson and Sanofi-to develop vaccines for COVID- 19. BARDA has also partnered with Regeneron Pharmaceuticals to develop a monoclonal antibody treatment for COVID- 19. (See this CRS report for further detail on these and other potential countermeasures against COVID-19.) Members of Congress have raised concerns about whether these medical countermeasures, if shown to be safe and effective, will be affordable and accessible to the public-especially if federal funds contribute to their development. The Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSA), enacted into law on March 6, 2020, contains two provisions relating to affordability of COVID- 19 countermeasures. First, products purchased by the federal government using funds appropriated by CPRSA, including vaccines, therapeutics, and diagnostics for COVID- 19, shall be purchased in accordance with Federal Acquisition Regulation guidance on fair and reasonable pricing. Second, CPRSA states that the Secretary of HHS may take such measures authorized under current law to ensure that vaccines, therapeutics, and diagnostics developed from funds provided in this Act will be affordable in the commercial market. This Sidebar reviews several intellectual property (IP) rights provisions under current law that the federal government could use to ensure that COVID- 19 countermeasures are accessible and affordable. Other actions that the federal government might hypothetically take-such as additional spending, production by federal agencies, governmental negotiation, or direct price controls-are beyond the scope of this Sidebar, in that such measures do not implicate IP rights and may require additional legislative action beyond the current law referenced in CPRSA. Congressional Research Service https://crsreports.congress.gov LSB10422 CRS Lega Sidebar Prepaed for Membeivs and Cornm ittees o4 Cor~qress ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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