WRITTEN QUESTION E-3774/98

by Hiltrud Breyer (V) to the Commission

(11 December 1998)

Subject: Feeding genetically modified substances to patients by tube without their consent

1. Is the Commission aware that preparations containing genetically modified substances (eg sandalis and salvimusin) are widely administered to tube-fed patients in hospitals, old people's and nursing homes and by outpatients' services?

2. How, in the Commission's view, is it possible to protect the rights of patients receiving care in establishments of this kind (eg by requiring written consent or the provision of prior information in writing)?

3. What is the Commission's opinion of previous practice in the abovementioned establishments, whereby patients are not explicitly informed and no alternative products that do not contain genetically modified substances are offered, thus raising the possibility of forced feeding?

4. Does the Commision agree that an alternative product that does not include genetically modified substances should always be offered, to restore patients' right to make choices and decisions of their own free will despite their relatively helpless state?

5. Does the Commision agree that, as a general rule, preparations for feeding by tube should be labelled in accordance with the regulation on novel foods (and subsequent regulations)?

6. Does the Commision intend to conduct a general information campaign aimed at the establishments concerned?

Answer given by Mr Bangemann on behalf of the Commission

(1 February 1999)

As a rule "special foods" means diet foods for specific purposes. Therefore "special foods" containing genetically modified ingredients are also covered by the provisions of food law, such as Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer, and to the advertising of these(1) (labelling directive), European Parliament and Council Regulation (EC) 258/97 of 27 January 1997 concerning novel foods and novel food ingredients(2) and the rules governing diet foods for specific medical purposes.

The Commission drafted a Commission directive and, within the "modus vivendi", Parliament was informed on 24 November 1998. This draft directive was examined by the standing committee for foodstuffs on 17-18 December 1998. That committee gave a favourable opinion on this draft. It is expected that the draft directive will be adopted by the Commission.

According to information received by the Commission the products at issue will be identified. In other words information concerning the use of genetically modified substances will be available to carers and patients. This is in line with consumers' expectations.

The Commission is not planning to take any particular action concerning a special information campaign for industry.

As far as the rights, protection and informed consent of patients receiving care in hospitals, outpatients' services, old people's and nursing homes are concerned, the standards of provision, organisation, and operation of hospitals and other health-care services within the Community are a national matter to be dealt with by the Member States and their institutions.

(1) OJ L 33, 8.2.1979.

(2) OJ L 43, 14.2.1997.