Revised Directive 86/609/EEC on animal experiments: read the Dr Hadwen Trust's reaction to new draft

Escrito por Dr Hadwen Trust/ECEAE.


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The European Commission has today (Nov 5th) finally adopted its long-delayed legislative proposal1 to revise the now 20-year-old Directive 86/609/EEC2 on the protection of animals in experiments. Scientists from ethical research charity the Dr Hadwen Trust3 cautiously welcome the proposals but warn the new Directive must be about more than ‘token gestures and bigger cage sizes’. The charity says this is a ‘once in a lifetime opportunity for Europe to lead the world in replacing animal experiments’.

More than 12 million animals are used in EU labs each year4 however, over twenty years of scientific developments, including non-animal alternatives, are not reflected in the existing legislation. Additionally, animals used for basic medical research, education and training, have been left unregulated, and hundreds of thousands of sentient fetal and invertebrate animals are experimented on each year without any legal protection at all.

There is also no harmonised process to ethically review and prospectively authorise animal research in the member states, meaning many experiments are likely to have been duplicated or could have been replaced by non-animal alternative test methods.

The Commission first acknowledged in 2001 that the Directive was outdated and in need of improvement. Progress on producing a draft has been painfully slow. Today’s draft legislation does include a great ape test ban (with exceptions), but as no apes are used in EU research at the moment, this is considered by many animal advocates as something of a token gesture. Mandatory prospective and retrospective ethical review of some (but not all) animal experiments has also been proposed.

Non-animal medical research charity the Dr Hadwen Trust has cautiously welcomed the proposals but says much more must be done to speed up the replacement of animals with non-animal methods.

Emily McIvor, Dr Hadwen Trust Policy Director, says: “It is regrettable that animals in laboratories have had to wait so long for this inadequate law to be updated. Far too many animals have no protection from even the very highest levels of suffering, and we must act to change that. The Dr Hadwen Trust welcomes today’s draft legislation and some of the positive measures it contains such as the ban on use of great apes in experiments. However, it is vital that the revision of Directive 86/609 is about more than token gestures and bigger cage sizes. To make this law fit for a morally and scientifically progressive 21st century, the ultimate goal of replacing animals with alternatives must be right at the heart of the legislation. This is a once in a lifetime opportunity for Europe to lead the world in ending animal experiments and replacing them with the most technologically advanced non-animal techniques science can offer.”

The Dr Hadwen Trust is leading the campaign for an EU-wide strategy to vastly increase investment in new non-animal replacement methods through Directive 86/609. In July this year the charity brought world renowned primatologist Dr Jane Goodall DBE5 to the European Parliament to hand in a 150,000 signature petition from citizens in thirteen member states calling for greater action on alternatives including the creation of an EU Centre of Excellence in replacement research.

What will the Dr Hadwen Trust be lobbying for in Brussels?

  • Establishment of an EU Centre of Excellence to prioritise development of non-animal replacement methods across all current animal uses including basic medical research. Current EU activity focuses just on regulatory toxicology which only constitutes around 10% of EU animal use.
  • Extension of the scope of the Directive to include all sentient animals used by the research industry incl. invertebrates and fetal forms, as well as animals used in basic research, in education and training, and those killed for their tissues or used in the production and maintenance of genetically modified strains
  • A complete immediate ban on experiments causing severe or prolonged pain, suffering or distress
  • Clear targets for decreasing animal use through application of replacement techniques as part of a properly funded EU-wide strategy

In a related development, an EU Science Committee6 will tomorrow (Nov 6) hold a public hearing on Europe’s primate research in order to produce a scientific opinion for legislators working on Directive 86/609. The Committee was asked by the EU Commission to produce an independent scientific Opinion. However the Dr Hadwen Trust has condemned the Committee’s draft Opinion, which avoids almost any criticism of primate research despite well known failings and seriously underplays the immense potential of more relevant non-animal techniques.

The Dr Hadwen Trust now calls on the European Parliament and the Council to take up discussions of the new Directive as a matter of priority. If it is not discussed in the EU Parliament by the June 2009 European elections, the legislation and hence better protection for animals, will be significantly delayed.

Dr Hadwen Trust experts in Brussels and London are available for interview, comment and analysis. For further information contact Communications Director Wendy Higgins on mobile 07989 972 423 or email: Esta dirección de correo electrónico está siendo protegida contra los robots de spam. Necesita tener JavaScript habilitado para poder verlo.


Notes to Editors

1 The draft proposal has been adopted by the Commission and announced at a press briefing today Nov 5 at 13.00hrs, Berlaymont Building, 200 Wetstraat/Rue de la Loi, 1040 – Brussels.

2 Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes.

3 The Dr Hadwen Trust for Humane Research is the UK’s leading non-animal medical research charity.

4 12.1 million animals were used in EU experiments in 2005; Fifth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union published 5/11/2007 (these are the most recent EU wide statistics available).

5 Jane Goodall PhD, DBE is the founder of the Jane Goodall Institute and a UN Messenger of Peace. www.janegoodall.org

6 The Scientific Committee on Health & Environmental Risks (SCHER), European Commission, Brussels, Nov 6th, 10am – 4.30am.

7 EU citizens have indicated strong support for more ambitious laws to protect animals. A 2005 EUROBAROMETER survey recorded that 82% of EU citizens believe we have a duty “to protect the rights of animals whatever the cost”. A 2006 EU Commission survey showed that 93% of respondents believe more needs to be done to improve the welfare/protection of experimental animals and 79% believe there is not EU funding for alternative methods to replace animal experiments.

 

POSITION OF THE ECEAE

 

Statement on the European Commission’s proposals on the
revision of Directive 86/609/EEC on the protection of
animals used in experiments
November 2008
The ECEAE welcomes the fact that the European Commission has at
last published its proposals to revise Directive 86/609/EEC. The
proposal should represent some improvement for the welfare of
millions of animals but the ECEAE is disappointed with the lack of
ambition of the Commission on a number of issues. This is an historic
opportunity for the EU to make a real difference to animal protection
and in the process reflect the clearly-expressed views of EU citizens.


Positive points


• The enlargement of the scope of the Directive is a positive step forward. A number
of species and procedures are now expected to be covered by the legislation, as is
fundamental research and the use of animals for educational purposes. We also
welcome the Commission’s proposal to protect animals specifically bred for their
organs and tissues1.


• The introduction of a requirement that research projects are authorised in advance
with a harm-benefit test which, if applied properly, should ensure that few
experiments causing a high level of suffering are allowed to take place, along with
the prohibition of many others which currently take place2. More detail is, however,
needed from the Commission about how the test is to be applied in practice.

 

The ECEAE is disappointed with:


I - The Implementation of the Three Rs Principles:
Provisions related to the implementation of the 3Rs principle have been included; however
the European Commission has prioritised the Refinement principle at the expense of the
Reduction and, most important, Replacement principles.


• The lack of binding targets on the reduction of animal use. While the European Commission
states that the implementation of the 3Rs principle is a priority, and says that it expects to see a
reduction in the number of experiments under the revised Directive, we are disappointed not to
see the EU leading the way with proposing a targeted strategy to progressively phase out the use
of animals for experiments. The current provisions are based on an assumption – not shared by
the public – that researchers have the right to use animals almost whenever they wish to whereas
the protection of animals should be the primary purpose of this Directive.


• As for the implementation of the Replacement principle, we are disappointed to see that no
funding or incentives are proposed to accelerate research on alternative methods of testing.


II - The weak restrictions on the use of some species and types of experiments:


The European Commission hasn’t been ambitious enough to include immediate and absolute
bans on the use of some species as expected and supported by public opinion.


• The Commission has ignored the call of the European Parliament to phase-out the use of nonhuman
primates (NHP) in experiments. Their use should be restricted3 according to the
Commission, but that will not satisfy public opinion. According to the Commission, NHP could still
be used for a number of procedures listed in Article 5, including basic research. The use of NHP
should be banned.


• Exceptions to the ban on the use of Great Apes are simply unacceptable4. From an ethical point
of view, no type of procedure should be allowed on those highly sensitive animals.


• The exemption to the ban on the use of wild-caught animals is unacceptable because of the
considerable additional suffering inevitably experienced by such animals (competent authorities
may grant exemption on the basis of scientific justification that the purpose of the procedure
cannot be achieved by the use of an animal which has been bred for use in procedures)5.


• We consider that the Commission should have proposed a ban on the use of domestic animals,
and especially cats and dogs, due to the high level of concern expressed by European citizens6.


3See Recital 16
4Article 50
5Article 9.2
6More than 73% of the European citizens who participated to the public consultation launched by the European Commission in 2006
considered that the use of cats and dogs in experiments is unacceptable: question 23 of the , http://ec.europa.eu/environment/
chemicals/lab_animals/pdf/results_citizens.pdf

 

III - The vague wording of the proposals and the lack of guidelines for interpretation:
Guidelines for interpretation of some provisions are (intentionally) missing, making the
Parliament’s and Council’s task of assessing the merits of the proposal more difficult.


• No detailed definition of the “severity” of the suffering an animal would be allowed to experience
during a procedure was proposed. Moreover performing procedures classified as severe would still
be possible if the pain and suffering are not “likely to be prolonged” which is unjustifiable7. An
absolute and immediate ban of those experiments is essential. In any event, ‘prolonged’ is far too
vague a concept.


• The proposals don’t expressly mention the possibility for Member States to apply or adopt stricter
measures for the protection of animals used in experiments, despite the Commission saying they
would be able to in the explanatory memorandum. A specific Article was included in Directive
86/609/EEC8.


• The European Commission proposes a ban on the use of stray and feral animals of domestic
species, without proposing an actual definition of this category of animals. The Commission
should at least propose a list of animals belonging to this category or should establish the criteria
to classify animals as domestic.


• The exception to the requirement to use only purpose-bred animals for procedures is
disappointing9. Providing a “scientific justification” to competent authorities in order to experiment
on non-purpose bred animals is unacceptable.


• Regarding the possibility to “re-use” animals in procedures10, the Commission has failed to
indicate the timeline for this process, and especially the length of time during which an animal
could be held in an establishment or when it could be re-homed11. In addition, the proposed
exception allowing animals to be re-used even if they have already experienced ‘moderate’ (i.e.
significant) suffering is unacceptable.


7Article 15.2
8See Article 24 of Directive 86/609/EEC, and Explanatory memorandum of the draft revision, page 14.
9Article 10.2
10Article 16
11Article 19

 

IV - The lack of transparency deriving from the implementation of the Directive:
Even though the European Union adheres to the concept of transparency, this commitment
is often lacking in the proposals. The European Commission has failed to introduce
provisions encouraging Member States to be more transparent with their citizens.
Furthermore, no provision refers to the participation of stakeholders in the process of
implementation, and revision of the legislation.


• The Commission’s provisions on a retrospective assessment of suffering experienced by
animals used in procedures are inadequate as well as vague12.


• Regarding the application for a project authorisation to carry out a procedure, the
Commission proposes that the application “shall include non-technical project summary”13 with a
view to this being the only information to be published. Even then, there are exceptions.
Stakeholders and public alike need to see far more information than this. In addition, it is
essential that, whilst paying due deference to genuine confidentiality, there is a public comment
period before projects are authorised to give expert groups the opportunity of arguing that
non-animal alternatives could be used or that the procedures have already been done elsewhere,
and the members of the public to argue that the claimed benefit does not justify the animal
suffering. REACH provides a precedent.


• The duplication of animal experiments (which results from lack of transparency) are not clearly
banned, as they should be14.


• The review and implementation provisions for this Directive are far too long15; a review of the
essential elements of the Directive as well as the deadlines for its implementations should be
carried out with Parliament’s involvement within five years at the most.


12Article 38
13Article 40
14Article 44
15Article 52 and 53