Civil Society Concerns Over US Health Service Plan To Give Exclusive Patent Rights To Sanofi

The United States National Institutes of Health’s decision to consider granting an exclusive licence on patents for a newly government-developed vaccine to Sanofi has prompted a strong reaction from civil society warning against potential high prices and requesting transparency in the process.

Knowledge Ecology International and Médecins Sans Frontières (MSF, Doctors Without Borders) in a joint comment [pdf] voiced concerns about the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH) and the Department of Health and Human Services would grant exclusive licensing of patent rights to French pharmaceutical company Sanofi for a vaccine against attenuated strains of respiratory syncytial virus.

This pathology leads to over 57,000 hospitalisations among children younger than 5 years old, and 2.1 million outpatient visits for the same age group, as well as over 170,000 hospitalisations and 14,000 deaths among adults older than 65, in the United States each year, according to the comment.

KEI and MSF are concerned that exclusive licensing of patent rights to Sanofi will result in the company pricing “an important vaccine out of the reach of routine use in paediatric and/or adult populations.”

The French pharmaceutical company might abuse the granted monopoly to charge excessive prices, they said, and Sanofi might require US residents to pay more than other countries for a vaccine developed at public expense. According to the comment, “The NIH has been involved in RSV research for over 25 years.”

The exclusive licensing of patent rights may also delay the entry of competitive suppliers for the manufacturing and distribution of the vaccine, and create barriers to further innovation, including “enhancements that make the vaccines more effective in low resource settings,” they said.

The two signatories said that although they contacted the National Institute of Allergy and Infectious Diseases for comments, as instructed in the Notice published in the Federal Register on 22 February, they receive no answer.

“Having made numerous subsequent efforts to obtain information about the proposed license, we have yet to receive copies of the patent applications or receive any information from the NIAID Technology Transfer and Intellectual Property Office about the proposed licensing terms or the technology that is to be licensed,” they said.

KEI and MSF requested an additional two weeks to submit further comments (the deadline was originally 8 March).

The KEI and MSF comment suggests that the NIH conclude the development of the vaccine “either with its own funding, or by approaching third-party payers … 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,” they proposed.

 

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