WRITTEN QUESTION E-2764/00 by Chris Davies (ELDR) to the Commission. Medical research involving primates.
Date: 2000-09-01
Institutions: European Parliament, Provisional data
Subjects: EU financing, EU programme, animal experimentation, animal welfare, medical research, research body, research programme, vaccine

C 136 E/86

Official Journal of the European Communities

EN

8.5.2001

Petition No 987/97 was discussed at a meeting of the Parliament(cid:146)s petitions committee on 1 December
1998 and it was decided that as Regulation (EEC) No 1408/71 of the Council of 14 June 1971 (1) did not
apply to schemes in favour of war victims,
it would address the Petitions Committee of the German
Bundestag to try to improve the situation of these victims.

(1) Last consolidated version: Council Regulation (EC) No 118/97 of 2 December 1996 amending and updating
Regulation (EEC) No 1408/71 on the application of social security schemes to employed persons, to self-employed
persons and to members of their families moving within the Community and Regulation (EEC) No 574/72 laying
down the procedure for implementing Regulation (EEC) No 1408/71 (OJ L 28, 30.1.1997).

(2001/C 136 E/098)

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)

the Commission funded the
In the fourth framework programme for research and development,
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
(OECD) principles of good laboratory
the Organisation for economic cooperation and development
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 organisa-
tions. This ethical review panel assesses both quantitative and qualitative aspects of the animal experi-
ments. 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.

8.5.2001

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Official Journal of the European Communities

C 136 E/87

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 (cid:145)3 R(cid:146) principle of replacement, reduction and refinement
under key actions 1, 2, 3 and 4 and infrastructures. The key action (cid:145)Cell factory(cid:146) 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(cid:146)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.

(2001/C 136 E/099)

WRITTEN QUESTION E-2765/00

by David Bowe (PSE) to the Commission

(1 September 2000)

Subject: Integrated Coastal Zone Management Programme

Can the Commission comment on the progress of the Integrated Coastal Zone Management Programme
and indicate when it intends to adopt it?

Answer given by Mrs Wallstr(cid:246)m on behalf of the Commission

(10 October 2000)

The Commission(cid:146)s Demonstration programme on integrated coastal zone management
(ICZM) was
completed last year. Its final phase included a broad consultation concerning a possible European strategy
for ICZM. Respondents were asked, in particular, to address the question of what actions needed to be
undertaken at the European level.

A summary of this consultation, as well as all of the technical outputs of the demonstration programme, is
available on the Commission(cid:146)s Web page at: europa.eu.int/comm/environment/iczm/home.htm

On the basis of the lessons of the demonstration programme, and the responses received during the
consultation, on 27 September 2000, the Commission adopted a communication to the Parliament and
the Council describing the conclusions of the demonstration programme and outlining a European strategy
for ICZM (1).

As a component of this strategy, on 8 September 2000, the Commission also adopted a proposal for a
Parliament and Council recommendation to the Member States, concerning the implementation of ICZM in
Europe (2).

(1) COM(2000) 547 final.
(2) COM(2000) 545 final.