Isotopes for Medicine and the Life Sciences (1995) / Chapter Skim
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B Legal Considerations
B Legal Considerations
Pages 113-122
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From page 113... ...
to date have been geared toward fulfilling the research isotope availability objectives of the Atomic Energy Act of 1954. The revenue generation objectives of Public Law 101-101 would seem to require a different approach, one that would make IPDP an effective supplier to commercial customers and that would generate revenue above expenses.
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From page 114... ...
PUBLIC LAW 101-101 In 1990 Title III of Public Law 101-101 (the Energy and Water Development Appropriations Act of 1990) established a revolving fund that required IPDP to finance itself through operating revenues, but there was no financial provision for the production of isotopes made exclusively for research.
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From page 115... ...
The law did not take into account the distinction between supplying isotopes to the research community, characteristically at a financial loss, and supplying commercially used isotopes to the private or clinical sector at "full cost recovery." Subsequent interpretations within DOE have led to isotopes being priced at full cost; the recent Conference Report on the FY95 Energy and Water Development Appropriations included language specifically freeing the Secretary of Energy from the provisions of Public Law 101-101 in setting fees for isotopes and related services, however. Since the outset of the government's isotope production activities, a persistent issue has been when the government should terminate the production of specific isotopes so as not to compete with the private sector.
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From page 116... ...
The private organization's petition or a summary thereof, exclusive of company confidential information, and will designate the place where a copy of the petition, exclusive of company confidential information, may be seen. (The petitioner should identify those portions of his petition which contain company confidential information; however, the information published must be sufficient to permit meaningful public comment.)
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From page 117... ...
1. AEC radioisotope prices will be established to provide reasonable compensation to the Government (which ordinarily will be the higher of AEC full cost recovery or reasonable commercial rates)
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From page 118... ...
THE TECHNOLOGY TRANSFER ACT OF 1986 Also germane to the present considerations of partnership relations and various legal and financial arrangements for isotope production is the Technology Transfer Act of 1986 (Public Law 99-5021. The purpose of the act was to amend the Stevenson-Wydler Technology Innovation Act of 1980 to promote technology transfer by authorizing government-operated federal laboratories to enter into cooperative research agreements and by establishing a Federal Laboratory Consortium for Technology Transfer within the National Bureau of Standards.
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From page 119... ...
A laboratory director, i] n deciding what cooperative research and development agreements to enter into, shall give special consideration to small business firms and consortia involving small business firms and give preference to business units located in the United States that agree that products embodying inventions made under the cooperative research and development agreement or produced through the use of such inventions will be manufactured substantially in the United States.
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From page 120... ...
The latter components of antitrust legislation such as the Clayton Act of 1914 forbid certain tie-in arrangements and exclusive-dealing group policies, whereas the RobinsonPattman Act proscribes predatory pricing and price discrimination. The Federal Trade Commission Act, passed subsequently to the Sherman Act forbids unfair methods of competition.
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From page 121... ...
, determination of the exclusivity and market capture of delivery contracts, and analysis of the fairness of compensation schemes. The central concern embodied in antitrust laws is the fear of exercise or abuse of market power (i.e., the power to control price or to exclude competitors)
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From page 122... ...
It may be that the most appropriate model would be a combination whereby the academic institution would be primarily responsible for the education function in its broadest context, the government agency would be responsible for research (in collaboration with academia) and the facility, and industry would be for marketing, sales, and distribution.
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