KEI and MSF comments regarding the Notice published in the Federal Register on February 22, 2016, [81 F.R. 8728], entitled ‘Prospective Grant of Exclusive License: Production of Attenuated Respiratory Syncytial Virus Vaccines’ (available here: https://federalregister.gov/a/2016-03486; KEI comments here: /wp-content/uploads/KEI-MSF-NIH-RSV-comments-8March2016-final.pdf).
A KEI press release follows:
KEI Scientific and Technical Advisor
+1 (202) 332-2670
KEI and Doctors Without Borders/MSF Ask NIH to Ensure Fair Price for New RSV Vaccine
Washington, DC, March 9, 2016 — Yesterday evening, Tuesday, March 8, 2016, Knowledge Ecology International (KEI) and Doctors Without Borders/Médecins Sans Frontières (MSF) raised concerns with the National Institutes of Health over the lack of transparency, and the potential for excessive pricing, in the grant of an exclusive license on patents for a new government-developed childhood and senior vaccine.
KEI and MSF submitted comments to the National Institute of Allergy and Infectious Diseases (NIAID) on the prospective grant of an exclusive license to the French company Sanofi on the patents for attenuated strains of respiratory syncytial virus (RSV) — a virus that affects almost every infant — developed over the course of 25 years of research at the National Institutes of Health, primarily in the lab of NIAID scientist Dr. Peter Collins.
A exclusive license would allow Sanofi to set an unreasonable or discriminatory price in the United States, and unaffordable prices in developing countries, KEI and MSF argued. “We are concerned,” the comments said, “that the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and Department of Health and Human Services (HHS) exclusive licensing of patent rights of this promising vaccine candidate to Sanofi will result in:
- Sanofi pricing an important vaccine out of the reach of routine use in pediatric and/or adult populations;
- Sanofi abusing the granted monopoly to charge excessive prices, something the NIH has been loath to address after previous licenses have been issued;
- Sanofi requiring U.S. residents to pay more than other countries for a vaccine developed at public expense (see /xtandi for a petition to the NIH relating to a prostate cancer drug invented at UCLA on federal grants, and priced far higher in the United States than in any other country); and
- Delays in the entry of competitive suppliers for the manufacturing and distribution of the vaccine that will increase affordability and reduce supply shortages,
- Barriers to innovation, including enhancements that make the vaccines more effective in low resource settings.”
KEI and MSF noted the NIAID’s lack of transparency in providing information on the above concerns, after KEI made multiple requests for information. (An additional letter, explaining the NIH’s overall lack of transparency on the grant of licenses, to Nancy Weiss, a senior intellectual property advisor at the White House Office of Science and Technology Policy, is available here: /wp-content/uploads/KEI-letter-OSTP-03-04-16.pdf.)
RSV is one of the most common childhood diseases. In the United States alone, RSV infects over two million children younger than five annually, causing over 57,000 hospitalizations. Worldwide, RSV is associated with the death of about 200,000 children under the age of five every year.
The submission asked the NIH to obtain an agreement from Sanofi that the taxpayer-funded RSV vaccine is sold in the United States at reasonable prices, and not a prices higher than in other high income countries, and that it is affordable in developing countries.
A concluding comment also suggested an alternative method to fund the continued development and commercialization of this vaccine, which would involve either the NIH or third-party payers funding the final stages of trials and registration of the vaccine, and receiving benefits for doing so.
“Even better would be for the NIH to reject the use of exclusive licenses, and to conclude the development of the vaccine either with its own funding, or by approaching third-party payers (in the public and private sectors) to share the costs of the final development of the vaccine. Those providing funding to conclude the vaccine development could be offered access at concessionary prices and possibly share in the eventual licensing income from non-exclusive licensing of the patents.”