Drafting “rules on biotechnological innovations

Proposals of the European Community for an ordered development fo biotechnologies

Abstract

It is well known that the European Community has, among others, the goal of promoting the social and economic development of the member states, of facilitating scientific research, technological innovation, production of goods and their circulation within the Union, of removing law discrepancies and commercial conflicts as much as possible.

In such spirit, the European Parliament and Council issued the Directive 98/44CE of July 6th 1998 concerning the juridical protection of biotechnological inventions, assuming that parts of human, animal of vegetable genome are patentable – according to the traditional theory of patents – as they are deriving from 2inventions” susceptible of industrial applications and not from mere isolation (“discovery”).

The Author – who ahs already examined the ethical aspects of the use of biotechnologies in the vegetable and animal fields (see Medicina e Morale2000, 3: 449-504) – dwells on describing what the Directive 98/44/CE provides, along with other formerly issued international laws, concerning g the protection of environment, of animals and human organisms.

The Authors recognizes how the Directive bans any commercial utilization that is immoral and against the public order, giving actual cases of prohibitions to be applied to: human cloning for reproductive purposes; the modification of human embryos for commercial and industrial uses; the modification of animal genetic identity, such to cause pain to animals with no substantial utility for man or animals.

Nevertheless, as for the juridical aspect, the Directive allows the utilisation of human embryos – though not directly and expressively produced for research purposes, according to the article 18 of the Convention on human rights and biomedicine – for experimentation and for biotechnological applications concerning the production of stem cells of medicines.

The Author examines then the debate that follows the issuing of the Directive, mainly in the Parliamentary Assembly of the Council of Europe (Strasbourg), about the concern in the public opinion as to the so-called “transgenic foods” (Recommendation No. 1389/1998 entitled “consuer saferty and food quality”). A contrariety to patient living organisms was expressed, while admitting the need of an appropriate protection of intellectual property (Recommendation 1417/1999).

These issues were treated but not solved by the International Conference of Oviedo (May 16-19, 1999), organized by the Council of Europe. The Steering Committee on Bioethics of the same Council of Europe. The Steering Committee on Bioethics of the same Council of Europe was given the task of expressing an “advice” on this complex subjects; in the meanwhile, the conferences of Seattle and Montreal took place: there it was signed a Protocol on bio-safety, regulating the international trading of genetically modified seeds and substances for agriculture and farming. The Protocols allows the subscriber countries to ban the importation of genetically modified products which are considered dangerous for environment and health, except for finished products and therefore transgenic food,

When the Directive 98/44/CE will come into force (July 31st, 2000), as the moratorium expires, is is unlikely that the arguments for an invalidation advanced by The Netherlands and Italy will be accepted. For this reason, the Authors insists on supporting the adoption of the “precaution principle” – explicitely included in Community laws concerning protection of health environment – although it needs a better specification of its extension and expected consequences. Another principle, the principle of “transparency”, requires a further refinements of the information addressed to the consumer, through a clearere labelling giving the chance of a really free and consiuos choice of products deriving from genetically modified organisms on sale.

It is necessary to pursue research, excluding the use of human embryos.