WRITTEN QUESTION E-0786/03

by Alexander de Roo (Verts/ALE) to the Commission

(14 March 2003)

Subject: Avoiding duplication of animal experiments

What do 478 719 mice and rats, 113 990 chickens and quail, 47 382 fish and 74 358 other animals have in common? They were used in 2001 in the Netherlands for animal experiments in fundamental research and/or product development. This is the fate of about 10 million animals in the EU every year (Financieel Dagblad, 29.1.2003). The numbers cited are correct. The official source is the report Zodoende by the Food Inspection Department.

The statistics are taken from the annual reports to the Food Inspection Department of the establishments that carry out animal experiments. About half of them relate to drug trials. This is not correct. In the year in question 46,7 % of the animals were used in scientific experiments (mainly at university institutes), 8,1 % for toxicity trials, 1,8 % for teaching and training, 0,5 % for diagnostic purposes and 43,1 % for the development, manufacture, control or official verification of serums, vaccines, medicines and medical or veterinary products for the benefit of humans and animals. Serums and vaccines were not, strictly speaking, classed as medicines. In previous years there was further classification into the subcategories biological products (including serums and vaccines) and medicines. The percentage at the time was approximately 40 % of the category for biological products and 60 % for medicines (i.e. about 25 % of total use).

Is the Commission aware that medicines and biological products such as vaccines which have been tested in the United States and licensed for the American market are retested on animals in order to gain admission to the European market?

Is the Commission aware that producers of generic medicines have to submit a new safety dossier if they wish to market a generic medicine in Europe, even if the active constituent is identical with the active constituent of the original medicine?

How many animal experiments could be avoided if this kind of duplication of animal experiments did not take place in the European Union?

Answer given by Mr Liikanen on behalf of the Commission

(22 April 2003)

Manufacturers producing for the European market need to fulfil the requirements of the European Pharmacopoeia. Most of the safety and potency requirements for e.g. vaccines are different in the United States and Europe; i.e. potency tests might be carried out with a different animal model (for example, animal strain, number, test design, reference product) or additional safety tests might be required in the United States or Europe. Therefore, duplication of animal experiments is not the right term in this context.

Article 114 of Directive 2001/83/EC of the Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(1) specifies that, where it is necessary in the interest of public health, Member States may examine each batch of a medicinal product, such as vaccines, human blood and plasma derivatives, before being released on the market. The testing of each batch may be necessary to ensure for the European citizens the consistency of the quality and the potency of the medicinal product indicated in the marketing authorisation.

Under the framework of the European Directorate for the Quality of Medicines (EDQM)(2) the Official Medicines Control Laboratories (OMCLs) guarantee that correct procedures for the quality control of medicinal products take place. This is one of the measures to avoid the duplication of control test in the Member States. The OMCL may also limit in vivo potency re-testing, provided that sufficient data are available showing consistency of potency of the component concerned. The OMCL network involves 17 Member States in the Union/European Economic Area (EU/EEA) and is primarily aimed at supporting mutual recognition of quality control tests.

Besides this co-operation between Member States which is supported by the Commission, the European Centre for the Validation of Alternative Methods (ECVAM) of the Joint Research Centre is successfully validating alternative test methods also in the area of batch potency testing. Furthermore, as a partner of the International Conference for Harmonisation of requirements for the development of medicinal products (ICH) the Commission promotes and accepts new alternative testing methods in order to replace tests on animals at international level (European Union, United States, Japan). International harmonisation for the development and batch testing of medicinal products such as immunobiologicals, hormones and blood products could be increased as soon as new alternative methods become available.

The development of alternative methods will be funded in the Sixth Framework Programme of the European Community for research, technological development and demonstration activities, contributing to the creation of the European Research Area and to innovation (2002-2006). Two specific parts of the Framework Programme will support the development of novel alternative, non-animal testing methods: Development of new in vitro tests to replace animal experimentation (Thematic Priority 1 Life Sciences, Genomics and Biotechnology for Health, more information is available from the following http://www.cordis.lu/fp6/lifescihealth.htm) and Development of alternative in vitro testing methods and strategies for chemical substances (Specific activities covering a wider field of research Policy support and anticipating scientific and technological needs, more information is available from the following http://www.cordis.lu/fp6/support.htm)

For generic medicinal products, for which no batch testing is necessary, no additional pre-clinical animal studies are requested for a marketing authorisation in Europe.

There are no data available to which extent the different European and American test requirements increase the total number of animals used. As mentioned above, in addition to the development of alternatives methods, international harmonisation of testing requirements would significantly reduce this number.

(1) OJ L 311, 28.11.2001.

(2) established by the Council of Europe.