By Steven Knievel, Access to Medicines Advocate
The U.S. House Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce will hold a hearing Tuesday, July 21, 2020 to discuss efforts to develop a vaccine for the novel coronavirus. Executives from pharmaceutical corporations Moderna, Pfizer, Merck, Johnson & Johnson and AstraZeneca are expected to testify.
The public is spending billions of dollars to support vaccine development, yet the contracts and pharmaceutical corporations’ plans are shrouded in secrecy. The people need answers to critical questions about affordability and supply. Here are the burning questions that committee members should ask the pharma execs, in order to stand up for the public interest in timely access to safe, effective and reasonably-priced vaccines for all.
What measures are each of your corporations taking to ensure equitable access to COVID-19 vaccines across the globe, regardless of nationality, race or wealth?
- When you anticipate the vaccine candidate which your corporation is helping to develop will be available in countries and regions around the world;
- any and all advanced purchasing commitments you have entered; and
- any measures you have taken or intend to take to ensure people in rich countries at lower risk of serious health problems resulting from COVID-19 do not receive preferential or more timely access to vaccines than people who are more vulnerable to the disease in lower- and middle-income countries.
Has your corporation conditioned receipt of government support on the U.S. restricting its rights to ensure competition and affordability?
- For example, has your corporation conditioned receipt of BARDA or other government support on the U.S. government restricting its rights over related patents beyond as provided under Bayh-Dole?
Has your corporation conditioned receipt of a license relating to a COVID-19 vaccine candidate on such a license being exclusive?
- Please be inclusive in your response both of licenses your corporation has accepted and any potential licensing deals it has rejected due to the rights holder not offering exclusivity.
Will your corporation commit to sharing technologies it owns or has been licensed, data, know-how and other information necessary to produce the vaccine candidate or candidates you are helping to develop with the World Health Organization COVID-19 Technology Access Pool? If not, why?
- If not, please explain how not doing so better facilitates timely access to the vaccine candidate or candidates you are pursuing around the world.
Some of the corporations you represent have pledged to offer your vaccine candidate at not-for-profit prices for the duration of the pandemic. What does that mean?
- How will your corporations define that time period?
- How will you determine what constitutes a not-for-profit price?
- How do you intend to price your vaccine once that period has expired?
How will you ensure the price of vaccines you are helping to develop does not inhibit access for anyone throughout the world, and does not otherwise inhibit a country’s COVID-19 response by drawing scarce resources away from other urgent public health priorities?
Will your corporation publicly disclose detailed R&D and manufacturing costs?
- Will you disclose detailed information relating to investments in COVID-19 vaccines in research and development, manufacturing costs, and other associated costs, disaggregated and itemized by each expense, so as to help the public assess whether pricing of your vaccine candidate, once set, is fair and appropriate?
Have you agreed to or been party to any conversations pertaining to federal R&D investments impacting pricing determinations for the vaccine candidate your corporation is helping to develop? Please detail any such agreements or conversations.
- Earlier this month while testifying before the Senate Appropriations Committee, Acting Director of BARDA, Dr. Gary Disbrow claimed that in future vaccine procurement, that the U.S. government will seek consideration for the U.S. government’s previous investment in developing such vaccine, and emphasized that this would take the form of “more than just a dollar for dollar investment; it is also the cost of capital because the U.S. government took the risk to make that investment.” Have the corporations you represent entered into any contracts with the federal government under which this is articulated, or under which you understand such considerations to have been taken into account?
- Please provide any further clarification that you have knowledge of with respect to how U.S. government investments in research and development will impact the price at which your vaccine candidate is sold in the United States, to the U.S. government or to private entities, and outside of the United States.