WASHINGTON, D.C. (May 21, 2020)—The National Association for Home Care & Hospice announced full support of the COVID-19 Emergency Manufacturing Act, a bicameral bill introduced by Elizabeth Warren (D-MA) in the Senate and Rep. Jan Schakowsky (D-Ill) in the House of Representatives, to authorize the federal government to manufacture medical products, including by contracting with existing manufacturers, to ensure the nation has an adequate supply of critical materials to avoid rationing during the coronavirus Public Health Emergency.
Medical tools and therapeutics urgently needed to diagnose, treat, mitigate and prevent COVID-19 should be accessible and available to all without delay. But health care providers throughout the country have already faced shortages of personal protective equipment like N95 masks, medical devices like ventilators, and prescriptions drugs for patients on ventilators. Drug corporations’ estimates show that if and when COVID-19 treatment and vaccine candidates are shown to be safe and effective, they still will not have sufficient production capacity to rapidly meet unprecedented global need. Public manufacturing could help ensure adequate supply and avoid rationing.
The COVID-19 Emergency Manufacturing Act:
- Establishes an Emergency Office of Manufacturing for Public Health within the Department of Health and Human Services.
- Requires the Office to begin public manufacturing of:
- Drugs (including active pharmaceutical ingredients) in shortage necessary for the treatment of severe COVID-19 cases as soon as practicable;
- Diagnostic materials for COVID-19 within one month of the date of enactment of the Act;
- Personal protective equipment used to protect against coronavirus transmission within one month of the date of enactment of the Act; and
- Authorizes the Office to manufacture or enter into contracts with other entities to manufacture:
- Drugs, biological products, medical devices, and personal protective equipment used to help diagnose, mitigate, prevent, treat or cure COVID-19 or limit the harm of COVID-19; and
- Drugs, biological products and medical devices in shortage.
- Requires the Office to prioritize manufacturing of products, drugs, biologics and devices that have the greatest impact on the COVID-19 response, addressing shortages, reducing public health program costs, and alleviating demographic disparities in COVID-19 outcomes.
- Requires the Office to construct manufacturing facilities for a range of vaccine platform technologies and therapeutics after clinical data demonstrates strong positive indications of safety and efficacy.
- Requires the Office to issue and publicly disclose licenses, as useful for performing its duties under the Act, in exchange for reasonable royalties, allowing the Office to practice or have practiced patented inventions, including referencing or relying upon regulatory test data, and accessing and using otherwise confidential information relating to the manufacturing of COVID-19 products, including know-how.
- Requires the Office to provide drugs, biological products, medical devices, and personal protective equipment used to help diagnose, mitigate, prevent, treat or cure COVID-19 or limit the harm of COVID-19 at no cost domestically, and to sell them at cost to other entities, including internationally.
- Requires the Office to sell drugs, biological products and medical devices produced by the Office in response to a shortage at a fair price.
- Requires the Inspector General of the Department of Health and Human Services to review no fewer than one out of three contracts entered into the by the Office under the Act and for the Director of the Office to submit regular monthly reports to Congress with respect to the activities of the Office.
NAHC supports this legislation and urges the full Congress to take up consideration in a timely fashion.
Visit nahc.org for more information.