WRITTEN QUESTION E-2764/00

by Chris Davies (ELDR) to the Commission

(1 September 2000)

Subject: Medical research involving primates

Can the Commission indicate the extent to which the Biomedical Primate Research Centre in Rijswijk, Netherlands, is being funded by the EU?

Have steps been taken to ensure that primates are treated in an acceptable manner within that institution?

How has the Commission been supporting efforts to validate alternative testing methods for the development of vaccines which are currently tested on primates throughout the EU?

Answer given by Mr Busquin on behalf of the Commission

(6 October 2000)

In the fourth framework programme for research and development, the Commission funded the biomedical primate research centre (BPRC) in Rijswijk, the Netherlands, to a total amount of approximately 7,2 million. The funding encompasses a number of three-year projects started between 1995 and 1998 and covering a broad spectrum of research areas, including vaccine and drug development for Human immunodeficiency virus (HIV), tuberculosis, malaria and hepatitis C as well as research on immunological and neurological diseases. Financing in the fifth framework programme has only started, but amounts so far to approximately 3,3 million.

Significant improvements in animal housing conditions at BPRC have been made. Many of the animals previously housed in single cages are now kept in outdoor facilities for social housing. The aim is to house all stock breeding macaques in social outdoor configuration. Larger cages have recently been bought for singly housed animals. During the experiments, the animals are individually housed in cages fulfilling the requirements under Community legislation. The animal department is licensed to perform studies under the Organisation for economic cooperation and development (OECD) principles of good laboratory practice (GLP). Chimpanzees housed at BPRC are not engaged in experiments where serious complications resulting in their death can be foreseen. Animals are retired after experiments.

Since the launch of the fifth framework programme in 1999, all projects involving experiments on non-human primates in the quality of life programme are subject to a careful ethical evaluation by an independent and multidisciplinary review panel that includes representatives from animal welfare organisations. This ethical review panel assesses both quantitative and qualitative aspects of the animal experiments. It takes account of the overall benefit of the research proposed in relation to possible suffering of animals. The contractor has to follow strictly the recommendations of the ethical panel.

The quality of life programme is strongly encouraging research on the development of alternative animal models and in vitro systems. However, no alternatives have yet been developed that could safely replace the testing of vaccine candidates in primates before proceeding to clinical trials in humans. Nevertheless, the programme supports research that applies the 3 R principle of replacement, reduction and refinement under key actions 1, 2, 3 and 4 and infrastructures. The key action Cell factory in particular, aims at exploiting the advances made in the life sciences, making cell cultures available as models for medicine, pharmacology, toxicology, environmental monitoring and pre-normative purposes as substitutes for animal testing. Interaction with the European centre for the validation of alternative methods (ECVAM, located at Ispra, Italy) of the Commission's Joint research centre ensures information flow on supported projects and transfer of results obtained, for further validation activities.

Specifically about vaccines, ECVAM collaborates in and co-ordinates efforts with the main Community national control agencies and the European Pharmacopoeia on the pre-validation and validation of serological methods and other advanced in vitro methods for the potency testing and safety evaluation of vaccines and immunosera, and on the application of more humane endpoints in essential animal tests.