92002E1365

WRITTEN QUESTION E-1365/02

by Charles Tannock (PPE-DE) to the Commission

(14 May 2002)

Subject: Animal experiments involving chimpanzees and other primates

In its very clear and helpful answer to my Written Question E-0291/02(1), the Commission states that the Biomedical Primate research Centre (BPRC) in the Netherlands is, to the knowledge of the Commission, the only institution in the Community which currently conducts experiments involving chimpanzees. Can the Commission confirm that the Centre is partly funded by the Commission and indicate the level of funding? Can the Commission also confirm that that funding is conditional upon the Centre complying with all appropriate Directives and future Directives pertaining to animal experiments?

The Commission also stated in its reply that it has become clear that Directive 86/609/EEC(2) does not provide sufficient controls to safeguard the welfare of non-human primates and that, in consequence, the industry was taking stock of the current situation, with discussions between Member States, industry and non-governmental organisations in the field of animal welfare having already begun. Can the Commission indicate whether, in cases involving primates, it is mandatory and consistent with the principle of replacement, reduction and refinement for those wishing to carry out experiments to issue advance notification to the national authorities of the nature of the experiments, together with an explanation of the reason why other animal models or alternative testing methods cannot be used, the relevance of the experiments and the maximum levels of pain which will be permitted? If not, does the Commission agree that a requirement of this kind is necessary if monitoring of the Directives is to be effective and that the monitoring process would be enhanced further if such requests for authorisation, once approved, were to become public documents? Finally, does the Commission know how many experiments involving primates were conducted at the BPRC last year?

(1) OJ C 172 E, 18.7.2002, p. 176.

(2) OJ L 358, 18.12.1986, p. 1.

Answer given by Mr Wallström on behalf of the Commission

(1 July 2002)

The Biomedical Primate Research Centre (BPRC) in Rijswijk, the Netherlands, is participating in several three-year research projects under the Fifth Framework Programme for Research and Technological Development (RTD) (1998-2002). The Commission has so far funded the BPRC to a total amount of approximately EUR 5,4 million under the 5th Framework Programme for RTD. These projects cover research areas such as vaccine and drug development for human immunodeficiency virus (HIV), tuberculosis, malaria and hepatitis C.

The Biomedical Research Primate Centre (BPRC), which is situated in the Union but independent of the Union, has engaged itself contractually to fulfil all legal and ethical requirements at national as well as at Union level.

As indicated in the 6th Framework Programme for Research and Technical Development, adopted by the Parliament and the Council, fundamental ethical principles including animal welfare requirements are to be respected and furthermore research activities must respect the Amsterdam Protocol on Animal Protection and welfare. The Commission's amended proposals concerning the specific programmes implementing the 6th Framework Programme(1) stipulates that the research activities must respect the protection of animal in accordance with Community law and participants in research projects must conform to current legislation and regulations in the countries where the research will be carried out.

Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes, sets out that an experiment entailing the use of an animal shall not be performed if another scientifically satisfactory method of obtaining the result sought is reasonably and practicably available. It also states that, when an experiment has to be performed the choice of species shall be carefully considered and, where necessary, explained to the authority. In a choice between experiments, those which use the minimum number of animals, involve the animals with the lowest degree of neurophysiological sensitivity, cause the least pain, suffering, distress or lasting harm and which are most likely to provide satisfactory results shall be selected. The Directive obliges the Member States to establish procedures whereby experiments themselves or the details of persons conducting such experiments shall be

notified in advance to the authority. Where it is planned to subject an animal to an experiment in which it will, or may, experience severe pain which is likely to be prolonged, that experiment must be specifically declared and justified to, or specifically authorised by, the authority. On the basis of requests for authorisation and notifications received the authority in each Member State shall collect, and as far as possible periodically make publicly available, the statistical information on the use of animals in experiments in respect of the number and kind of animals used in experiments (the confidentiality of commercially sensitive information shall be protected). Whether a general mandatory requirement to give advance notification to the authority for experiments involving the use of non-human primates should be introduced will need to be examined carefully during the in-depth revision of the Directive.

The Commission has no information regarding the number of experiments conducted at the BPRC in 2001, which involved non-human primates.

(1) COM(2002) 43 final.