WRITTEN QUESTION No. 2877/96 by Hiltrud BREYER to the Commission. Gene laboratories and genetic engineering in Europe
Date: 1996-10-31
Institutions: BREYER, European Parliament
Subjects: EU Member State, animal experimentation, exchange of information, experiment on humans, genetic engineering, genetically modified organism, marketing, medicinal product, research body, research project













EUR-Lex - 91996E2877 - EN






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91996E2877

WRITTEN QUESTION No. 2877/96 by Hiltrud BREYER to the Commission. Gene laboratories and genetic engineering in Europe  


Official Journal C 096 , 24/03/1997 P. 0030 





WRITTEN QUESTION E-2877/96 by Hiltrud Breyer (V) to the Commission (31 October 1996)Subject: Gene laboratories and genetic engineering in Europe1. How many gene laboratories and genetic engineering activities are there currently in Europe?2. What are the safety levels of these laboratories or genetic engineering activities, broken down by country?3. Under what titles are these activities pursued, particularly those at safety level 3?4. What genetically engineered pharmaceuticals are currently marketed in Europe, broken down by country?5. Are experiments being carried out or planned involving genetic therapy on human beings and animals? If so, what experiments, broken down by country?Answer given by Mrs Bjerregaard on behalf of the Commission (13 January 1997)1., 2. and 5. Under Article 18 of Directive 90/219/EEC ((OJ L 117, 8.5.1990. )) on the contained use of genetically modified micro-organisms, the Member States are only required to send an annual summary report on notifications received for group II type B operations (in effect, industrial or commercial operations). Therefore the Commission does not have the information requested in questions 1 and 2 which may be available from the Member States. The Commission does not hold any complete information on Member States using genetic therapy on human beings and animals. However, the Commission has funded a database, Biorep, which is a permanent inventory of biotechnology research projects in the Community and would include gene therapy projects (available from the library of the Royal Netherlands academy of arts and sciences).3. Under Directive 90/219/EEC on the contained use of genetically modified micro-organisms there is no obligation for users involved in type A, group II operations (safety level 3 is included in group II) to submit a report to the Commission.4. Medicinal products produced by genetic engineering such as recombinant DNA technology are included in Part A of the Annex to Regulation(EC) no 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing an European agency for evaluation of medicinal products ((OJ L 214, 24.8.1993. )). Such products, authorized by the Community and which can thus be marketed in all the Member States since 1 January 1995 (entry into force of Regulation (EC) no 2309/93) are:>TABLE>Prior to 1 January 1995, the provisions of Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology ((OJ L 15, 17.1.1987. )) applied - the annex was similar to that of Regulation (EC) no 2309/93. This 'concertation' procedure coordinated national applications submitted in Member States. Companies were not obliged to apply in all Member States although in most cases applications covered all 12 Member States at that time. A list of genetically engineered medicinal products considered in this procedure is forwarded direct to the Honourable Member and to the Secretariat general of the Parliament.