[Ip-health] Without A Global Approach to Global Inequities in Access to Possible COVID-19 Treatments and Vaccines, Legislative “Fixes” Won’t Make us Safer

Baker, Brook b.baker at northeastern.edu
Mon May 11 12:00:00 PDT 2020


Brook Baker & Matthew Rose, Without A Global Approach to Global Inequities in Access to Possible COVID-19 Treatments and Vaccines, Legislative “Fixes” Won’t Make us Safer, Health GAO (May 8, 2020), https://healthgap.org/without-a-global-approach-to-deadly-inequities-in-access-to-possible-covid-19-treatments-and-vaccines-legislative-fixes-wont-make-us-safer/


COVID-19 is a global emergency requiring bold new strategies to ensure that the discovery, regulatory approval, pricing, sufficiency of supply, and equitable distribution of COVID-19 health products benefit all people, worldwide. The AIDS crisis has taught us what happens when the benefits of science are withheld from the most vulnerable, in the most impoverished countries – millions suffer and die needlessly. The actions we take now must prevent history from repeating itself.

Global AIDS activists have long known that a virus knows no borders. Protection against COVID-19 in the U.S. can be secured only if other countries can also access COVID-19 health products in needed quantities and at affordable prices. Gross inequities between impoverished and wealthy countries in access to tests, treatments, vaccines, and other health technologies cannot be tolerated as ‘business as usual’ in the COVID-19 response. Attempts to mitigate the deadly effects of big pharma’s greed and price gouging shouldn’t stop with U.S. policy interventions.

On April 30, U.S. Senator Elizabeth Warren and Representative Janice Schakowsky put forth bold legislation<https://www.warren.senate.gov/newsroom/press-releases/warren-schakowsky-to-introduce-legislation-to-publicly-manufacture-personal-protective-equipment-prescription-drugs-other-medical-supplies> that presents an important policy response to overcome existing and projected shortages of essential medical supplies for COVID-19 and to provide public and privately contracted manufacture of adequate quantities be sold at no cost or at cost, depending on the product and the receiving entity. The bill would also tackle the preexisting problem of manufacturing and affordably accessing other medical products facing shortages in the U.S., where products would be sold at “fair cost.”

But global inequities are being exposed and risk being exacerbated by COVID-19, and the Bill should go further to confront and correct these harms.

What’s in the Bill?

The COVID-19 Emergency Manufacturing Act<https://www.warren.senate.gov/imo/media/doc/COVID-19%20Emergency%20Manufacturing%20Act%20of%202020%20bill%20text.pdf> allows the federal government and its contractors under certain considerations to bypass any and all patent, regulatory data, manufacturing know-how, and exclusive rights relating to COVID-19 medical products and other health products in short supply. After gaining access to these rights and conditioned on paying reasonable remuneration, ordinarily a royalty, to right holders, the Emergency Office of Manufacturing for Public Health would be permitted to:
·         Make (or contract with other entities to make) personal protective equipment, medical devices and pharmaceutical products related to COVID-19 and provide them domestically at no cost to Federal, state, local, and Native health programs, and to other domestic health care providers and suppliers, as determined by the Secretary;
·         Sell those same COVID-19 medical products at cost to consumers in the commercial market and to other international entities;
·         Manufacture (or contract with other entities to manufacture) active pharmaceutical ingredients for use by the Office or sale to others;
·         Make (or contract with other entities to make) other non-COVID-19 medical products that are in short supply and sell them at a fair cost;
·         Begin manufacturing personal protective equipment and diagnostic materials related to the coronavirus within one month of the law being enacted;
·         Begin building manufacturing facilities for any COVID-19 vaccine at the earliest clinical signs of it being safe and effective;
·         Give priority to entities manufacturing in the United States and using U.S.-made components;
·         Seek regulatory approval for COVID-19 and shortage medical products produced or procured under the Act.

What’s missing from the Bill?

Although the proposed bill codifies important efforts to accelerate production and assures no-cost or low-cost access to COVID-19 medical products and other medical products in short supply, it could do much more to ensure its intent to safeguard Americans’ health is realized. The bill should be amended to ensure equitable and affordable access for people in the U.S. and around the world. Exclusive rights targeted in the legislation not only lead to insufficient sources of supplies and shortages in the U.S., they produce the same problem globally. To respond quickly and decisively to the COVID-19 pandemic, manufacturing capacity should be expanded everywhere around the globe, both to meet U.S. and global demand. At this point, the statutory priority given to domestic manufacturers could undermine expanding non-domestic manufacturing capacity. We recommend amending the bill to draw on international as well as domestic manufacturing capacity.

The legislation could also be strengthened by clarifying the scope of the Secretary’s authority to sell to international entities, a term that is undefined in the Bill. Although it is likely to include U.N. entities and perhaps other global health initiatives such as the Global Fund to Fight AIDS, Tuberculosis and Malaria and GAVI, it is unclear whether the Bill would allow supply to foreign governments or other foreign health care providers. Although the U.S. cannot issue compulsory licenses to overcome patent monopolies in other countries, it could provide directly that non-predominant quantities of medical products produced to meet U.S. domestic needs could be supplied to foreign countries where patent rights did not exist or were bypassed by compulsory licenses or other means.

An additional “upstream” problem the Bill does not yet address is that fact that pharmaceutical and device manufacturers frequently innovate with substantial government support for product development and clinical trials, with such funding increasing dramatically in response to COVID-19. However, U.S. funding and grant agreements rarely provide that grantees should ensure equitable and affordable access to resulting products both domestically and globally. We recommend that Senator Warren and Representative Schakowsky link expansion of manufacturing capacity and overcoming the harm of monopolies with additional efforts to ensure that public funding results not in monopoly rights and high prices, but rather firm contractual commitments to open licensing to qualified manufacturers who can thereafter increase supplies and improve affordability at home and abroad.

What about equitable access?

A final global issue that requires greater attention is the issue of ensuring equitable distribution of COVID-19 products wherever they are needed. Although it is understandable for U.S. government officials to focus on meeting the pandemic needs of people in the U.S., we are part of a global community where the right to health is held by all. It is deeply problematic for the U.S. to rush to the front of the line, to push other countries in much more dire need of medical products out of the way, and to wave a checkbook to get preferential access to COVID-19 products that are needed globally. A foreign policy appropriate for this and future global pandemics would focus on equitable sharing, mutual systems strengthening and collaboration, and would prevent hoarding initial quantities through advance purchase commitments, grant and co-funding agreements, and other means. This legislation should make it clear that contract manufacturers should not give exclusive, unfair, or preferential access for U.S. purchases at the expense of equitably meeting access needs around the world.

A time of risks – and opportunities

No single nation will defeat COVID-19 until governments tackle containment everywhere. Without doing our part to facilitate an equitable, global response, we risk being trapped in a perpetual cycle of inadequate pandemic response, with widespread needless suffering and death. If COVID-19 is allowed to continue to circulate unprevented and untreated abroad, it will continue to cross out borders and undermine our response. Essential medical supplies must flow freely to where the virus is. In the spirit of important and fundamental structural change, we hope that these two powerful lawmakers will support amendments to the Bill that would promote equity and justice in the U.S. and around the world.
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