Briefing – Position at Trialogue meeting, 7 December 2009 Proposal for a Directive on the protection of animals used for scientific purposes (revising Directive 86/609/EEC)
Priority issues for animal welfare Eurogroup For Animals and Animal Defenders International (ADI) call on you to take into account, the legal obligation to pay full regard to the welfare requirements of animals as stated under the Lisbon treaty, Article 13 TITLE II PROVISIONS HAVING GENERAL APPLICATION Article 13 In formulating and implementing the Union's agriculture, fisheries, transport, internal market, research and technological development and space policies, the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage.
Background Eurogroup for Animals and Animal Defenders International have followed and supported all efforts to ensure the adoption of an improved directive on the protection of animals used for scientific purposes. As discussions intensify and final positions are adopted, we urge you to consider all possible implications that proposed wording may have on animal welfare as required under the treaty. We believe that further discussion of points listed below is essential because in certain cases wording under consideration will have detrimental effects on the welfare of animals, with no clear benefits gained. In this briefing we have highlighted four Articles which we believe merit further urgent consideration, and we have proposed new wording where appropriate. In addition to these issues, our positions on all other points previously discussed remains as before. Article 2A Stricter national measures – The proposed wording is unacceptable as it lays restrictions on Member States, prohibiting them from introducing new measures that are stricter than those contained in the EU Directive. This caps improvement and would be highly detrimental to animal welfare in general. Due to the acknowledged lowering of the level of animal welfare taken up in this dossier, it is imperative Member States can go further. We anticipate widespread concern from EU citizens knowing that in this instance, the EU influence on national legislation is to limit national aspirations to continually improve standards. Member States must not be restricted in implementing
scientific improvements as they are developed. This is even highlighted in the recitals and needs to be explicit in the Articles: (5) New scientific knowledge is available on factors influencing animal welfare as well as the capacity of the animals to sense and express pain, suffering, distress and lasting harm. It is therefore necessary to improve the welfare of animals used in scientific procedures by raising the minimum standards for the protection of those animals in line with the latest scientific developments.
Council wording
proposed amendment
Article 2A
Article 2A
Stricter national measures
Stricter national measures
Member States may, while respecting the general rules laid down in the Treaty, maintain provisions, in force at the time of entry into force of this Directive, aimed at ensuring more extensive protection of animals falling within the scope of this Directive than those contained in this Directive. […].
Member States may, while respecting the general rules laid down in the Treaty, maintain provisions, in force at the time of entry into force of this Directive, or adopt new provisions aimed at ensuring more extensive protection of animals falling within the scope of this Directive than those contained in this Directive. […].
Article 13.1: The requirement to use alternative method – Deletion of the second paragraph of Article 13.1 weakens the requirement (from existing Directive 86/609) to use alternative methods that are ‘reasonably and practicably available’, and undermines full implementation of the 3Rs (replacement, reduction and refinement of animal procedures). The deletion is intended to establish legal certainty by limiting the requirement to use alternatives to those methods that are ‘recognised by Community legislation’. However, recognition by Community legislation is appropriate only in the case of regulatory toxicology and ‘safety’ testing (which accounts for a small proportion of overall animal use). Alternative methods employed in, for instance, the production of antibodies, or in basic research, would therefore no longer be required despite their being readily available and scientifically robust. We believe that the requirement to use available alternative methods should be central to all animal experimentation legislation, and as such cannot be properly addressed only on a ‘case by case’ basis through the project evaluation. At first reading, all of the political groups in the European Parliament supported the requirement to use available alternative methods; the wording was not amended and many group positions relied on explicit support for full implementation of the 3Rs. We urge MEPs to maintain their first reading positions on this point. Council wording
Proposed amendment
Article 13 Choice of methods
Article 13 Choice of methods
1. Without prejudice to national legislation prohibiting certain types of methods, Member States shall ensure that a procedure is not carried out if another method or testing strategy for obtaining the result sought, not entailing the use of a live animal, is recognised by Community legislation.
1.Without prejudice to national legislation prohibiting certain types of methods, Member States shall ensure that a procedure is not carried out if another scientifically satisfactory method or testing strategy for obtaining the result sought, not entailing the use of a live animal, is reasonably and practicably available.
Articles 53: Review - The concept of a regular thematic review of areas of animal research and the availability of alternatives and how these might be implemented (specifically for primate use under Article 8 and to broadly review any areas of research under Article 53) achieved strong support by the European Parliament (ams 59 & 194) at plenary.
Council wording
Proposed amendment
Article 53 Review Sub-paragraph 1
Article 53 Review Sub-paragraph 1
The Commission shall, where appropriate, and in consultation with the Member States and stakeholders, conduct periodic thematic reviews of the replacement, reduction and refinement of the use of animals in procedures, paying specific attention to non-human primates as well as technological developments and new scientific and animal welfare knowledge.
The Commission shall, every 4 years, in consultation with the Member States and stakeholders, conduct thematic reviews of the replacement, reduction and refinement of the use of animals in procedures and set strategies for the development of new replacement methods, paying specific attention to non-human primates as well as technological developments and new scientific, animal welfare knowledge.
Article 8: Non-human Primates - The position to restrict primate experiments to debilitating and potentially life-threatening clinical conditions in human beings is highly preferred to the EP position. Although the Council’s wording has improved on this point, the term ‘debilitating condition’ still needs to be further restricted as a condition having a permanent and substantial impact on person’s day-today functioning. Council wording
Proposed amendment
Recital 16
Recital 16
(16) … Their use should only be allowed for basic research, the preservation of the respective nonhuman primate species or when the work, including xenotransplantation, is carried out in relation to potentially life-threatening conditions in humans or in relation to cases having a substantial impact on person’s day-to-day functioning i.e. debilitating conditions.
(16) ….Their use should only be allowed for basic research, the preservation of the respective nonhuman primate species or when the work, including xenotransplantation, is carried out in relation to potentially life-threatening conditions in humans or in relation to cases having a permanent and substantial impact on person’s day-to-day functioning i.e. debilitating conditions.
Article 8 Non-human primates
Article 8 Non-human primates
[…]
[…]
A debilitating clinical condition for the purpose of this Article shall mean a reduction of a person’s normal physical or psychological ability to function.
A debilitating clinical condition for the purpose of this Article shall mean a permanent and substantial reduction of a person’s normal physical or psychological ability to function.
Contact details Emily McIvor, Policy Consultant Dr Hadwen Trust for Humane Research/ The Humane Society International emily.mcivor@headweb.co.uk Mobile: +44 7812 354144 84a Tilehouse Street, Hitchin, Hertfordshire, SG5 2DY, UK Tel: +44 (0)1462 436 819 www.drhadwentrust.org.uk / www.hsi.org
Kirsty Reid, Policy Officer, Eurogroup for Animals/EWLW k.reid@eurogroupforanimals.org 6 rue des Patriotes, 1000 Brussels Mobile: +32 495 24 23 33 Tel. + 32 (0)2 740 08 93 www.eurogroupforanimals.org
Position during trialogue discussions, December 2009
Helder Constantino Head of Parliamentary Affairs Animal Defenders International HelderConstantino@ad-international.org Mobile: +44 7899 685203 Millbank Tower, Millbank, London SW1P 4QP, UK. Tel. +44 (0)20 7630 3340 www.ad-international.org