WRITTEN QUESTION E-0786/03 by Alexander de Roo (Verts/ALE) to the Commission. Avoiding duplication of animal experiments.
Date: 2003-03-14
Institutions: European Parliament, Provisional data
Subjects: EU market, animal experimentation, consumer protection, marketing, pharmaceutical legislation, pharmaceutical product, product quality, public health, research body, scientific research

C 280 E/88

Official Journal of the European Union

EN

21.11.2003

(2003/C 280 E/094)

WRITTEN QUESTION E-0786/03

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

Subject: Avoiding duplication of animal experiments

(14 March 2003)

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.

21.11.2003

EN

Official Journal of the European Union

C 280 E/89

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 (cid: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 (cid:1) 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.

(2003/C 280 E/095)

WRITTEN QUESTION E-0809/03

by Konstantinos Hatzidakis (PPE-DE) to the Commission

(17 March 2003)

Subject: Violation of Community environmental legislation in Greece

Could the Commission give a figure for the number of presumed violations of Community environmental
legislation in Greece and say which areas are affected? In which cases has it referred Greece to the
European Court of Justice and in which other cases is it preparing to do so?

Answer given by Mrs Wallström on behalf of the Commission

(15 May 2003)

On 10 April 2003, the Commission had 94 cases open against Greece relating to suspected or confirmed
violations of Community environmental legislation. Of the 94 cases, 25 related to Community legislation
on waste management, 22 to nature conservation and 21 to Directive 85/337/EEC (1), as amended by
Directive 97/11/EC (2). Eleven cases related to atmospheric pollution, 10 to water protection, and 5 to
other sectors of Community environmental legislation. The Commission has already initiated infringement
procedures against Greece in 39 cases.