WRITTEN QUESTION E-2823/01

by Jaime Valdivielso de Cué (PPE-DE) to the Commission

(11 October 2001)

Subject: Transgenic salmon

On 18 July this year the European Patent Office for the first time registered a patent for a transgenic animal for human consumption a genetically modified species of salmon originating in Canada.

How can this move be compatible with the ban on the patenting of animal species contained in the European Patent Convention?

What steps will be taken to protect natural species of salmon from any contact with transgenic salmon and prevent the latter from escaping into open water?

Answer given by Mr Bolkestein on behalf of the Commission

(21 December 2001)

The Honourable Member has drawn the Commission's attention to the fact that the European Patent Office has issued a patent for a transgenic fish obtained by incorporating a chimeric gene of non-human origin.

It should be noted that the European Patent Organisation, whose Office issues European patents which are intended to become national patents, is an independent international organisation over which the Community has no direct control.

Directive 98/44/EC authorises the issue of patents on animals provided that the technical implementation of the invention is not confined to a particular animal variety. A patent can therefore be issued only if the claimed invention can be applied to all types of existing fish.

From this point of view, the patent in question seems to comply with the relevant provisions of patent law and, in particular, with the law concerning biotechnological inventions.

The Commission intends to closely monitor developments in the field of biotechnology and will not fail to report on these to the Parliament, especially in the annual report stipulated by Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions(1).

It has to be underlined that the granting of a patent does not by any means authorise its use for deliberate release of fish. The question of deliberate release into the environment of genetically modified salmon has been raised previously and the Honourable Member is referred to the answers it gave to Written Questions E-2223/00 by Mrs Patrie(2), E-1627/00 by Mr Maat(3) and E-1489/00 by Mr Meijer(4).

A legislative framework exists to protect non-genetically modified organisms (GMOs) from adverse effects. A comprehensive assessment of risk to human health and the environment is required under Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(5) and authorisation would only be granted on the basis that there is no reason to believe that adverse effects would occur under the conditions of consent. The Environmental Risk Assessment required under this Directive has to take into account potentially harmful effects such as: effects on population dynamics within the receiving environment; the uncontrolled spread of the GMO(s) in the environment and the interaction between the non-modified organism and the GMO. There have been no applications for releases of genetically modified salmon under the above Directive.

The biotechnology consultation document available at: http://europa.eu.int/comm/biotechnology contains a detailed review of GMO regulations in Chapter 7.1. This outlines the existing and planned horizontal legislative framework comprising Directive 2001/18/EC of the Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC Commission Declaration(6) which will replace Directive 90/220/EEC in October 2002. Even more prescriptive requirements will be introduced for Environmental Risk Assessment under Directive 2001/18/EC. Under the legislative proposals adopted more recently by the Commission(7) a one-door-one key procedure is planned for evaluation of GMO applications intended for food or feed uses, including deliberate release into the environment. This procedure would consist of a single scientific assessment, carried out by the scientific committees of the future European Food Authority, followed by a single decision by the Community.

(1) OJ L 213, 30.7.1998.

(2) OJ C 136 E, 8.5.2001.

(3) OJ C 103 E, 3.4.2001.

(4) OJ C 113, 18.4.2001.

(5) OJ L 117, 8.5.1990.

(6) OJ L 106, 17.4.2001.

(7) OJ C 304 E, 30.10.2001 (COM(2001) 182 final and COM(2001) 425 final.