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 US Government Role in Biotechnology R&D
By
Richard Lehne and Gerda van Roozendaal
 
Keywords:  Policies/Programmes; United States of America; Relation public-private sector. 
Correct citation: Lehne, R. and G. van Roozendaal (1995), "US Government Role in Biotechnology R&D." Biotechnology and Development Monitor, No. 24, p. 6­8.

Both in absolute terms and in a percentage of its total R&D budget, the USA has made the world's largest commitment to basic research in biological sciences. Through collaboration with the private sector, the government hopes to receive optimal returns from its public biotechnology support.

The federal government funds about half of the biotechnology related research, while private companies take care of the other half. The 1994, budget projections were US$ 4.3 billion for biotechnology research activities, an increase of 0.7 per cent over the 1993 budget. However, from 1992 to 1993 the budget increased by 5 per cent.
The USA has a series of biotechnology policies formulated by various agencies, rather than one single biotechnology policy. Nevertheless, the federal government support for new technologies in the USA has three major components: (1) the direct funding of basic research mostly conducted at university laboratories and research institutes; (2) the funding of R&D activities at federal and state agencies, which use part of these funds for research outside their laboratories; and (3) a series of programmes created in the last 25 years to increase the productivity of US firms by facilitating the use of new technologies. In November 1993, the Clinton administration created the National Science and Technology Council (NSTC), which is responsible for the co­ordination of the whole array of federally­funded research activities.
The main priorities of the federally­funded biotechnology research are in the health area. NSTC's Biotechnology Research Subcommittee (BRS) recently affirmed basic and applied research in health care as a priority area. Additionally, BRS indicated that environmental and agricultural applications of biotechnology require additional efforts. Marine biotechnology is expected to receive increasing attention in the years to come.

University­based research
The US biotechnology industry has its origins in the laboratories of US universities. In no other industry has the dependence on university research been greater, and the participation of professors in the management and direction of start­up firms more evident, than in biotechnology. Extensive university­industry ties in the form of movement of researchers, financial gains sought by the universities and specific arrangements such as long­term private funding of university research are the key ingredients of the technology transfer taking place between US private and public sector.
In 1984 nearly half of all biotechnology companies were funding university research, while in the pre­1984 decade one quarter of all US patents in genetic engineering were granted to universities. In recent years there have been fewer broad, lengthy partnerships between universities and firms and more short­term agreements focused on specific topics. While still a source of dynamism and innovation, universities today occupy a more limited position in a maturing industry than they did when the start­up firms had just emerged.
To circumvent possible conflicts of interests between the researcher having both a financial stake and the need to report the results of his/her publicly­funded research, the National Institutes of Health (NIH) have been trying to 'regulate' the close collaboration between industry and universities through guidelines for those universities receiving federal funds. However, protests from the side of the industry led to the replacement of the guidelines by a recommendation stating that universities should develop conflict­of­interests policies.

Support through agencies
Health. Historically, the NIH has funded basic biological research in the USA. It is the principle biomedical research arm of the Department of Health and Human Services (DHHS). NIH funds biomedical and basic research related to a broad spectrum of diseases and health problems both in its own research facilities and at outside organizations.
Currently, NIH provides about three fourths of the public funds available for biotechnology activities, and its support is almost evenly divided between health care and basic research. Several of the industry's top scientists were trained at NIH, and many companies grew out of university research funded by the NIH. Other firms license patents directly from NIH or indirectly from universities which have conducted NIH­funded research.
Of special interest for developing countries could be the research conducted under the auspices of the Department of Defence (DOD). The DOD is responsible for the health of the armed forces. Since it is expected that many future wars will be fought in tropical areas, and given the likelihood of US involvement (think about Somalia, Haiti, Kuwait, etc.), DOD will continue to conduct many research projects targeting tropical diseases. Research projects aim amongst others at the development of vaccines against dengue and malaria. Another line of research financed by DOD is on the detection, protection and decontamination of chemical and biological weaponry. Since exact information is hard to obtain, it is unclear  whether developing countries will benefit from the results, since DOD may see a restrictive distribution of its research results as strategically important.
Agriculture. Agriculture is a major US export earner. Foreign annual income is estimated at about US$ 40 billion. In this respect, it is surprising that the funding for agriculture only ranks fourth. Some of the accomplishments of the United States Department of Agriculture (USDA) could also be beneficial for developing countries, for example in the field of disease­resistant crops. Additionally, the USDA is co­operating directly with foreign institutes, such as from Israel.
One of USDA's tasks is to develop biosafety regulations. The USDA's I is in charge of the development of US biosafety regulations, and promotes the development and harmonization of biosafety regulation internationally, mainly through the sharing of information. The main motive is to facilitate free trade and remove possible non­tariff barriers that might evolve out of biosafety concerns.
In recent years numerous federal state governments have begun to support biotechnology by sponsoring the creation of a variety of university­based biotechnology research centres and by enacting pro­industry legislative measures. For example, the state of New Jersey established three biotechnology research centres. In 1995 new legislation authorized state agencies to provide financial assistance for the construction of biotechnology research facilities, allowing the use of pension funds to be invested in new firms, and prohibiting local governments from regulating industry activities at all.

Biotechnology research budgets by area (1994, in %)
Health 41 %
General Foundations 39 %
Infrastructure 8 %
Agriculture 5 %
Manufacturing/Bioprocessing 4 %
Environment 2 %
Energy 1 %
Social Impact Research 0.2 %
Total: US$ 4299.3 million


Biotechnology research budgets, 
eight most important agencies  (1994, in %)
Department of Heath and Human Services 78 %
Department of Energy 6 %
National Science Foundation  5 %
Department of Agriculture 4 %
Department of Defence 2 %
Department of Veterans Affairs 2 %
National Aeronautics and Space Administration 1 %
Agency for International Ddevelopment 1 %
Others 1 %
Total: US$ 4299.3 million
Source: FCCSET, Committee on Life Science and Health (1993),
Biotechnology for the 21st Century: Realizing the promise.
Washington DC, USA: US Government Printing Office, p. 77

Programmes
Support to facilitate the commercialization of research results and the transfer of technology between the US public and private sector is seen as an important tool to promote US productivity and its international competitiveness. The Advanced Technology Programme (ATP) has been created by the Department of Commerce to provide partial federal funding to accelerate the development of promising but high­risk technologies that could enhance the general economic productivity. About 10 per cent of 400 industry responses to a recent ATP announcement involved biotechnology.
Another programme encourages the commercial applications of research conducted by federal laboratories through Cooperative Research and Development Agreements (CRADAs). The basic idea is that private firms and government­supported laboratories agree jointly to explore the commercial potential of federal research initiatives, and the federal government covers a part of the costs. Technology transfer is seen as mutually beneficial since it facilitates the sharing of expertise, personnel and material. Patent conditions under the CRADAs are programme specific and determined on a case­by­case basis. An example of a CRADA is the co­operation between the Walter Reed Army Institute of Research and the US company OraVax, resulting in an encapsulated vaccine against a diarrhoea­causing bacterium.

Contradicting proposals
During the election of 1992, present President Clinton addressed the theme of technology policy to highlight the inactivity of the Republican Bush administration in the economic realm. Now the technology policy initiatives of the Clinton administration have become a lightening rod for attacks by the new Republican­dominated Congress, and substantial budget cuts in the Clinton productivity and competitiveness programmes are expected. These programmes, however, constitute only a small part of the federal support for biotechnology activities.
Early actions on rebalancing the budget suggested that funding for basic research would be sustained. While the overall federal R&D spending was expected to increase in 1996 by only 0.2 per cent, the programmes affecting biotechnology R&D would receive a 3­5 per cent increase.
By July 1995, however, the picture had changed significantly. Republican proposals were circulating to reduce or even abolish the funding for different agencies, much ignoring the advice of BRS and other advisory councils. Indeed the budget for NIH, which has always been seen as safe, faced cuts of 5 to 16 per cent at the expense of applied research and development. In August 1995, however, NIH seemed to have won the battle and would see a budget increase of almost 6 per cent.
Richard Lehne*/Gerda van Roozendaal (editor)

*Rutgers University, Department of Political Science, New Brunswick, New Jersey 08903 USA. Phone (+1) 908 9321914; Fax (+1) 908 9327170;
E­mail lehne@gandalf.rutgers.edu

Sources
FASEB (n.d.), Consensus Conference on FY 1996: Federal research funding in the biomedical and related life sciences. USA: Federation of American Societies for Experimental Biology.

FCCSET, Committee on Life Science and Health (1993), Biotechnology for the 21st Century: Realizing the promise. Washington DC, USA: US Government Printing Office.

J. Fox (1995), "Clinton Budget Boosts Biotech R&D Spending." Bio/Technology, vol.13, March, pp.204­205.

GAO (1994), Technology Transfers: Benefits of cooperative R&D agreements. Washington: General Accounting Office/RCED.

C. Macilwain (1995), "NIH Loses Long­Standing Protection from Impact of Heavy Budget Cuts." Nature, vol.375, 18 May, p.168.

Office of Technology Assessment (1991), Biotechnology in a Global Economy. Washington DC, USA: US Government Printing Office.

US Senate, Committee on Commerce, Science, and Transportation, Subcommittee on Science, Technology, and Space (1994), Hearing on Competitiveness of the US Biotechnology Industry. Washington DC, USA: US Government Printing Office.



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