WRITTEN QUESTION E-0597/97 by Undine-Uta Bloch von Blottnitz (V) to the Commission (27 February 1997)

Subject: BSE and experiments with primates

The Commission published the call for proposals for research activities on transmissible spongiform encephalopathies in the C series Official Journal of 17 December 1996 and called for appropriate proposals to be submitted to DG VI. This call for proposals is based on the Weissman report. Plans include tests using primates which are to be fed BSE-infected brains or infected directly by means of injections.

The experiments on monkeys called for by Weissmann and supported by the Commission are highly controversial among scientists.

1. If dose/effect/transmission experiments on macaque monkeys and chimpanzees were to be started in 1997 results would be available at the earliest by 2008. If no monkey had developed the disease by that stage it would be necessary to wait even longer. How does the Commission respond to this objection and how does it justify its call for proposals for these experiments in the Official Journal?

2. In this connection, how does the Commission view the following aspects:

a) by that date the BSE epidemic will more or less have subsided;

b) by that date virtually all infected beef will already have been eaten;

c) it will then no longer be possible to influence the extent of infection in humans;

d) the impact of BSE on humans will then be visible in the statistics;

e) these experiments do not offer any assistance in decision-making for politics or medicine?

3. What are the Commission's grounds for assuming that any knowledge obtained through tests on monkeys can be transferred to humans?

Answer given by Mr Fischler on behalf of the Commission (5 May 1997)

The Commission believes in general that the use of animals for experimentation should be kept to a minimum. In particular, the Commission takes this approach for the use of non-human primates. Nevertheless, as the Honourable Member is aware, certain experiments using primates were called for by Professor Weissman in his report to the Commission on the needs for research activities on transmissible spongiform encephalopathies.

The Commission recognises that results from such studies will not be available for some time. Nevertheless, this does not argue against carrying out studies the results of which may give useful information particularly for the risk assessment for the population as a whole which may be valuable for health programme planning.

To date and in particular in the call for proposals for research projects published in December 1996, only one experiment has been proposed which uses primates. In any case, all proposals will as usual be evaluated by experts and the Commission will take particular account of the ethical aspects of such work. It will only accept proposals using primates where there is an absolute need for the work to be done, where there is no alternative way of obtaining the information, and where the research complies with ethical and safety provisions applicable in the country where the research is carried out as well as with Directive 86/609/EEC concerning the protection of animals used for experimental and other scientific purposes ((OJ L 358, 18.12.1986. )).

The Commission recognises that data obtained from trials on non-human primates cannot automatically extrapolated to humans. For this reason, the Commission will ask the evaluators of any projects which are proposed using primates to make a thorough assessment of this aspect, as part of their overall considerations.