This study, conducted by visits, interviews, and literature search, analyzes how vaccine manufacturers in Brazil and India access technologies for innovative vaccines: through collaborations with academia and research institutions, technology transfer agreements with multinational corporations, public sector, or developing country organizations, or by importation and finishing of bulk products. Each has advantages and disadvantages in terms of speed, market, and ability to independently produce the product. Most manufacturers visited are very concerned about avoiding patent infringement, which might result in undeveloped or delayed products because of a lack of mastery of the patent landscape. Disregarding the patent picture could also threaten the market of a potential product. Although it is too soon to assess the effects of TRIPS on vaccine technology access in Brazil and India, a good understanding of intellectual property management will be useful. A case study on development of a new combination vaccine illustrates these findings.
Bibliographical noteFunding Information:
In recent years there has been a significant increase in both R&D activity and expenditures in this area by Bio-Manguinhos. R&D activities are mostly funded from their own budget but some funds come from the Ministry of Health and from the Ministry of Science and Technology. Bio-Manguinhos has many collaborative activities with different universities. They have more than 15 vaccine R&D projects, including one on a dengue vaccine and one in collaboration with the Hookworm Vaccine Initiative, through their parent organization, FIOCRUZ. With technology transfer from Glaxo SmithKline (GSK) for Hib, and using DTP from Butantan, they have already developed a DTP–Hib vaccine and are now working on a pentavalent product which will include hepatitis B vaccine from Butantan. They have several agreements with GSK for bulk filling as well as transfer of technology (OPV, measles–mumps–rubella, Hib).
R&D spending has also increased at Butantan, financed by research grants, mainly from Sao Paulo's state science and technology support agency. A number of new R&D projects have been started, as follows: (1) Hib (said to be for export only); (2) hookworm vaccine (in collaboration with FIOCRUZ: Butantan will produce the antigens for the vaccine to be formulated at FIOCRUZ); (3) a combination rabies leishmania vaccine; (4) dengue vaccine (Butantan has obtained a non-exclusive license from the NIH to evaluate the technology); (5) HPV (loose agreement with University of Colorado); (6) rotavirus through a clone licensed from NIH for vaccine development; (7) cellular pneumococcal vaccines (in collaboration with Children's Hospital at Harvard Medical School). They were expecting the rotavirus, dengue, pneumococcal cellular and the rabies–leishmania combination products to enter clinical trials in 2008. They are completing a technology transfer arrangement with Pasteur-Merieux (now Sanofi Pasteur) for influenza vaccine, which started with importation of bulk vaccine but will eventually be their own production.
- Intellectual property rights
- Technology transfer
- Vaccine innovation