Developing New Contraceptives Obstacles and Opportunities (1990) / Chapter Skim
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5 Organizational Structure of Contraceptive Development
5 Organizational Structure of Contraceptive Development
Pages 55-74
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From page 55... ...
The World Health Organization's Special Programme of Research, Development, and Research Training in Human Reproduction, established in 1972, has also undertaken significant research and development activities and has helped coordinate the worldwide effort to promote contraceptive development Organizations involved in basic research, product development, clinical testing, and marketing of contraceptives constitute a heterogeneous mix of institutional types. There is a private-enterprise sector, which includes bow very large, multiproduct, multinational firms and a number of smaller firms with limited product lines.
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From page 56... ...
Nonprofit organizations consist of foundations, which provide funding for research, the training of scientists, and other purposes, and operating organizations, such as the Population Council, Family Health International, the Program for Appropriate Technology in Health {PATTI) , as well as universities and university-based programs such as the Contraceptive Research and Development Program (CONRAD)
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From page 57... ...
Anything that decreases profitability for large firms while increasing it for smaller firms will affect the size distribution of firms engaged in contraceptive-related activities. Likewise, whatever the motivation of the individuals' working there may be to serve social and humanitarian goals, nonprofit organizations, including universities, can be expected to be successful only insofar as they obtain funds from individuals, private foundations, or government.
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From page 58... ...
Government funding for research in reproductive biology and contraceptive development increased substantially between 1973 and 1987, while investments in contraceptiverelated research and development by major drug companies declined substantially, although the precise change is impossible to specify. As a result of these changing patterns of funding and research, a small number of private nonprofit organizations have become major forces in contraceptive development.
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From page 59... ...
Also actively trying to develop new contraceptive technology are nonprofit organizations. Three large European pharmaceutical firms and the Human Reproduction Programme of the World Health Organization are also involved in a range of contraceptive development activities.
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From page 60... ...
The growth of new research centers represents an important adjustment to declining pharmaceutical industry support for contraceptive research. Indeed, although increased involvement from large pharmaceutical companies would surely have an effect, that effect might not be immediately evident because of the relatively long time it takes before research leads to new products.
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From page 61... ...
Because small firms have fewer products and have usually invested a great deal of time, money, and research effort into the products they develop, they are more willing to risk the liability and possible adverse publicity associated with contraceptives than many of the larger, more diversified pharmaceutical companies, which stand to lose more financially if there is a public outcry against one of their products. Companies such as Watson Laboratories and Lexis Pharmaceuticals Inc., which produce generic drugs, have also entered the contraceptive business, but their primary goal is to produce generic oral contraceptives rather than to develop new technology.
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From page 62... ...
The Population Council and Family Health International 0;Hp are the most important nonprofit organizations involved in contraceptive research and development in the United States. Together they spend more than $10 million annually studying new contraceptive products (Family Health International, 1988; Population Council, 1988; U.S.
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From page 63... ...
FHI is, for example, supporting some Phase III clinical trials of NORPLANT~ contraceptive implants originally developed by the Population Council. The activities of nonprofit organizations do not end with the development of a new method.
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From page 64... ...
These circumstances have led a mission-oriented federal agency like AID to rely on a funding arrangement such as CONRAD, which provides a mechanism for involving university-based scientists in the agency's contraceptive development program. Several contraceptive products currently being developed commercially in the United States and Europe, such as copper IUDs and contraceptive implants, were originally investigated by nonprofit organizations.
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From page 65... ...
For a time in the late 1970s, for example, researchers were not allowed to use AID money for collaborative contraceptive research projects in Chile, despite the international renown of Chilean contraceptive researchers; during that time, foundations provided funds that could be used to support collaborative work in Chile. The World Health Organization The World Health Organization is involved in the contraceptive development process mainly through the Special Program me in Research, Development, and Research Training in Human Reproduction (HRP)
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From page 66... ...
HRP is working closely with the nonprofit organization, PATH, which is helping WHO introduce these new contraceptives into developing country family planning programs, working with local pharmaceutical companies, drug regulatory officials, government policy makers, donor agencies, family planning program managers, clinicians, and potential users. COLLABORATIVE EFFORTS IN CONTRACEPTIVE DEVELOPMENT International and national organizations, including universities, nonprofit groups, and commercial firms, are increasingly collaborating on specific contraceptive development projects.
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From page 67... ...
Industry-University Collaboration University scientists conducting basic research in biomedical laboratories funded mostly by the federal government often recognize the commercial potential of their studies of reproductive biology and fertility regulation, but they lack the resources needed to develop these ideas and to market innovations. Pharmaceutical companies, by contrast, have the needed resources and are almost always on the lookout for discoveries with commercial potential.
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From page 68... ...
Because many executives fear collaboration will slow development, they opt for doing as much of the research and development as possible within the company itself. Competition also exists among small firms, nonprofit organizations, and scientists involved in contraceptive development.
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From page 69... ...
Through collaborative research grants and contracts, Family Health International and the Population Council have also contributed to the support of scientists active in contraceptive research in developing countries. The Population Council has also provided fellowships for graduate training in fields related to contraceptive development.
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From page 70... ...
However, given the successful collaboration already under way among contraceptive developers and clinical researchers, a more fruitful approach may be to strengthen the already functioning Contraceptive Development Branch of the Center for Population Research at the National Institute of Child Health and Human Development rather than establish either a new national center for research on human reproduction and contraceptive development or a new NIH institute. CONCLUSION The organization of contraceptive research and development in the United States has changed dramatically over the past two decades.
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From page 71... ...
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From page 72... ...
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From page 73... ...
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