Conflicts in the Biotechnology Industry

Author:

Greely Henry T.

Abstract

True revolutions turn the entire world upside down, in ways expected and surprising, profound and mundane. The revolution spawned by advances in molecular biology is no exception. Most of the attention has gone, deservedly, to the possible effects of these advances on medicine, on society, and on our understanding of what it means to be human. But the revolution has already had effects—large and small, good and bad—in other areas. This paper analyzes one aspect of the industry created by that revolution in molecular biology–biotechnology. Specifically, it surveys the various kinds of conflicting interests, both real and perceived, that develop among commercial enterprises, government, and institutions in biotechnology; and it examines the legal implications and public policy concerns of these conflicting interests.The paper focuses on three different kinds of conflicting interests that confront private and public enterprises competing or collaborating in the biotechnology industry: (1) those among businesses involved within the industry; (2) those in relationships between industry and government; and (3) those in relationships between industry and universities. These types of conflicts raise very different issues, but each stems from circumstances unique to the young biotechnology industry.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference23 articles.

1. 2 The paper deals largely with conflicting interests rather than “conflicts of interest.” Although some of the discussion concerns conflicting interests that give rise to conflicts of interest, full discussion of such conflicts of interest awaits another paper.

2. 4 See, for example, Ortho Pharmaceutical Corp. v. Amgen, Inc., 882 F.2d 806 (3d Cir. 1989); and Re Joint Ventures Between Baxter International Inc. and Nestle SA, [1992] 5 C.M.L.R. M33.

3. “Benefit vs. Risk: How FDA Approves New Drugs,”;Farley;FDA Consumer,1987

4. “Nucleosides. V. The Monomesylates of 1-(2′-Deoxy-beta-lyrofuranosyl)thymine,”;Horwitz;Journal of Organic Chemistry,1964

5. 6 Pub. L. No. 96–517 (1980) (codified at 35 U.S.C. § 200, et seq. (1994)). The act was amended in 1984 to extend its coverage to national laboratories operated by universities or nonprofit organizations. Pub. L. No. 98–620 (1984).

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