International Trade and Emerging Genetic Regulatory Regimes

By Pepa, Stevan M. | Law and Policy in International Business, Spring 1998 | Go to article overview

International Trade and Emerging Genetic Regulatory Regimes


Pepa, Stevan M., Law and Policy in International Business


I. OVERVIEW

In recent years, the development of genetic engineering techniques has resulted in unprecedented interest in industrial applications using living organisms. Human tissue and by-products, uses for new drugs, foods, chemicals, and agricultural products are immediate examples. Within the biotechnology industry, a battle is being waged to secure the massive profits these products will potentially generate. This interest is not limited to private commerce. Increases in government funding of genetic research have attracted intense political attention.(1)

In terms of international trade, the genetics field is still, for the most part, underdeveloped. Although there has been significant world market capitalization, genetic engineering today remains mainly at the research phase of product development and government planning. Continuing government inaction will have deleterious effects. Countries must move now to structure regulatory regimes based on existing trade paradigms. Invariably, trade will follow the commercialization of genetic products in terms of industrial application. The stage is being set as industry begins to consolidate research operations for cost and strategic purposes,(2) and as patent acquisitions of genetic material become country-specific.(3) These developments necessarily lead to the application of domestic legal regimes (such as antitrust, intellectual property (IP), and patent law) to genetic research. They will also require a revamping of existing national laws to create a genetic regulatory regime that will buttress a particular country's comparative and strategic advantage in terms of trade and industrial development.

How, then, can countries take into account relevant ethical considerations when structuring these regimes? As evidenced by the eugenics movement, there are potential problems. The implications of human genetic research have been the subject of much concern throughout the twentieth century. Although genetic research today may affect possible medical solutions to almost every conceivable human ailment, it has a darker side. History records how genetic engineering studies have been used to justify governmental action and judicial pronouncements ranging from mandatory sterilization policies of the mentally incompetent to genocide in the name of perfecting the human condition.(4) This unsavory history--and fears of more awesome manipulation of human biology--underlie the present debate over the implications of human genetic research and technological development.

While this legacy is arguably important, from a trade perspective it cannot be allowed to dictate a government's policy calculations. Industrial strategy, both on the national and international level, will not be arrested by moral difficulties. The full extent of commercial productivity and profit that genetic engineering may generate in terms of both human research and other derivative applications is yet to be quantified. Government regimes designed to limit or eliminate certain biotechnology research are shortsighted when viewed through the wider lens of trade considerations. In the end, anti-genetic regulatory regimes will achieve little in the way of maintaining the moral high ground if industry simply moves elsewhere.(5) Biotechnology firms are increasingly multinational because of the enormous expense associated with genetic research. Trade disputes are likely to arise out of the unique concentration and strategic outlook of various corporate interests engaged in national and international commerce. Forced corporate movement may spark international trade disputes and may compromise a country's international position vis-a-vis its trading partners.

In light of the above argument concerning the primacy of trade considerations, several issues arise. Countries can and should look to past multilateral trade negotiations in order to establish a regulatory model for genetic research.

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