Explanatory Memorandum to COM(2008)543 - Protection of animals used for scientific purposes - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2008)543 - Protection of animals used for scientific purposes. |
|---|---|
| source | COM(2008)543  |
| date | 05-11-2008 |
Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes was adopted to harmonise practices in the area of animal experimentation in the EU. However, due to a variety of weaknesses in the current Directive, a number of Member States have established considerably more far-reaching measures in their national implementation whereas others apply only minimum rules. The present uneven situation needs to be rectified to ensure that the objectives of the internal market are re-established. The current proposal aims at ensuring a level playing field, throughout the EU, for industry and the research community, at the same time strengthening the protection of animals still used in scientific procedures in line with the EC Treaty's Protocol on Animal Welfare i. The proposal supports the Commission’s overall strategy on animal experimentation, including enhanced promotion of the development, validation, acceptance and implementation of alternative methods and provides a solid basis for a full implementation of the principles of the Three Rs i - Replacement, Reduction and Refinement of animals in experiments.
Around 12 million animals are used on a yearly basis in scientific procedures in the EU-27 i. All efforts should be made to reduce the numbers of animals used in experiments to a minimum. The most pragmatic approach to reducing experiments on animals is through the introduction of alternative methods, as with current scientific knowledge, a complete phase-out of animal experimentation is not yet achievable i. Therefore, it is imperative to ensure that those animals that are still used for legitimate reasons receive the highest protection and welfare consistent with the aims of the experiment.
The scientific grounds on which Directive 86/609/EEC was founded dates back over 20 years. A number of provisions are out of date and the Directive therefore does not cater for modern techniques in the field of animal experimentation, nor does it incorporate the latest advancements in the field of animal welfare. Furthermore, the wording of the Directive follows that of an international Convention; the style of some provisions is thus more political than regulatory. A significant number of provisions are open to interpretation and provide guidance rather than harmonisation.
Contrary to the objectives of the Directive, the afore-mentioned factors have resulted in a distortion of the internal market, with significant differences in the level of regulation between Member States. Moreover, the current provisions contain ambiguities and inconsistencies, leading to transposition and compliance problems.
The importance attached to animal welfare is evolving in terms of ethical concerns and this has become a “cultural attitude” for European society. This is acknowledged by the EC Treaty’s Protocol on Protection and Welfare of Animals which recognises animals as sentient beings. It requires the Community, and the Member States, to pay full regard to animal welfare. However, the current provisions of the Directive no longer meet this obligation.
There is an increasing awareness of and concern for animal welfare in the public arena. The participation in recent opinion polls and public consultations gives a strong indication of the public interest in this area – two of the three largest public consultations ever launched by the European Commission amongst any of its various policy activities addressed the subject of animal welfare i. The existing measures do not sufficiently mirror these expectations and fail to provide a sufficient level of transparency in this highly controversial field.
Other Community policies and legislative measures, such as REACH,[6] may have as a temporary negative effect an increased use of animals in regulatory testing, despite the provisions already taken to avoid unnecessary tests. In light of this and the provisions of the Cosmetics Directive,[7] the necessity to reduce our dependency on animal experimentation is compelling. The ultimate goal should be to replace the use of animal experiments all together. In addition to animal welfare benefits, alternative methods also have the potential to provide robust information through quality-controlled, state-of-the-art tests which could be faster and less cost-intensive than classical animal-based tests.
Directive 86/609/EEC has encouraged the development of alternatives to animal testing. For example, in 1991 the Commission created the European Centre for Validation of Alternative Testing Methods (ECVAM) i within the Commission’s Joint Research Centre. To move forward to the next level, the proposal has a specific emphasis on complementing this structure by introducing a number of measures to promote alternative approaches, though recognising that the identification and setting of regulatory testing needs is done and should be done through the use of other pieces of legislation. The measures to promote alternative approaches range from a general requirement to use alternative methods as soon as they become available, to further concrete measures to promote their development, validation and acceptance, also at international level. Generally the proposal requires that the principles of the Three Rs are fully taken into account when developing Community measures to protect the health and safety of human beings, animals and the environment.
The use of animals in scientific procedures today, however, still remains essential for ensuring a level of safety for human beings, animals and the environment and for the advancement of knowledge which will lead to improvements in human and animal health and welfare i,[10]. There are strong arguments for differentiating the use of animals with respect to the species, in particular in relation to their genetic proximity to human beings. Although the proximity of non-human primates makes some of these species the only suitable ones for certain types of testing, this differentiation is supported by science and should be respected.
Therefore, and in line with earlier commitments i, specific provisions have been incorporated to reduce the use of non-human primates to an absolute minimum. A strict case-by-case scrutiny is imposed in cases where non-human primates are still the only suitable species. The proposal limits the use of non-human primates by prohibiting the use of Great Apes and restricting the use of other species of non-human primate to only specific fields of application. Furthermore, there are ambitious requirements on the origins of the animals and specific monitoring mechanisms are foreseen to ensure the effectiveness of the proposed measures, ultimately facilitating the move towards abolishing the use of non-human primates in scientific procedures. It is recognised, however, that current scientific knowledge will not allow us to achieve this goal in the near future i.
In its role as guardian of the EC Treaties, the Commission is also responsible for ensuring that Community legislation is properly implemented and enforced. The current Directive has faced criticism linked to its enforcement, transparency and public accountability. To remedy the situation, the proposal foresees tightening of national inspections, not only to ensure compliance, but as a means to promote the exchange of best practices and implementation of the principles of the Three Rs. Furthermore, the Commission can play a constructive role in assisting where appropriate the national inspection systems in fulfilling their role.
The proposal builds on the current provisions of Directive 86/609/EEC. It seeks to tighten the loopholes, remove ambiguities, make the provisions coherent and align it with the better regulation standards of the Community. The existing provisions that have had the most pronounced impact on the distortion of the internal market, namely authorisation and accommodation and care requirements, have been further developed to specifically ensure harmonised objectives and minimum standards can be applied throughout the EU.
The accommodation and care guidelines annexed to the Council of Europe Convention (ETS 123) were fully revised in June 2006, with the support of the Community. In line with the Community's international obligations to implement the revised guidelines, parts of these guidelines will be implemented as minimum standards through this proposal.
EU context
This proposal, which aims at harmonising and levelling the practices for the breeding, keeping and use of animals in scientific procedures in the EU, is in line with the objectives of Article 95 of the EC Treaty. It is specifically designed to take account of the diversity of infrastructures in different Member States by leaving sufficient scope for implementing measures at a national level, in line with the principle of subsidiarity of the Community. Optimum implementation at the national level through the use of identified best practices will provide ample opportunity to reduce unnecessary red-tape and administrative costs.
In accordance with the Lisbon Agenda objectives, the proposal is based on an analysis of the potential benefits and costs of action or lack of action as well as the respect of the economic and social development of the Community as a whole. Moreover, specific measures have been included to allow smooth administrative procedures in support of the objectives of the Lisbon Agenda. The proposal strikes a balance in promoting European research and competitiveness while at the same time being at the forefront in ensuring that full regard is paid to animal welfare.
The proposal ensures that the necessary harmonised framework is put in place to facilitate EU wide research projects, especially in terms of the mobility of research personnel via establishment of minimum training standards. At the same time, the Community Framework Programmes for Research have put an increasing emphasis on the development and validation of alternative approaches which are echoed strongly in the proposal.
In addition, the Commission has an important responsibility to ensure that new legislation regarding animal welfare standards is based on evolving scientific knowledge and current best practice. As part of this policy, the European Food Safety Authority (EFSA),[13] established in 2002, serves as an independent scientific source of risk assessment and advice, information and risk communication to the European Commission. Scientific questions on animal welfare fall also under the remit of EFSA and these are tackled by the Panel on Animal Health and Animal Welfare (AHAW). A number of specific measures are based on the recommendations provided by AHAW. The incorporation of the latest scientific knowledge will be facilitated through requirements for regular review of these provisions.
The proposal incorporates fully the principles of the Three Rs in line with other Community policies. The requirement to replace, reduce and refine the use of animals in scientific procedures is highlighted in a number of other pieces of Community legislation such as Directive 98/8/EC on biocidal products, Directive 1999/45/EC on dangerous preparations, 7th Amendment to Directive 76/768/EEC and most recently in Regulation (EC) No 1907/2006 (REACH)[14],[15],[16],[17].
In the area of alternative methods, the proposal further facilitates the aims of the European Partnership on Alternative Approaches to Animal Testing, EPAA i which was launched in 2006 between the Commission and industry to promote alternative approaches to animal testing.
Finally, the proposal is fully in line with the recent Community Action Plan on Animal Welfare i which included this proposal as part of its specific actions. The European Parliament reiterated its call for the Commission to come forward as soon as possible with a proposal to revise Directive 86/609/EEC i.
Consultation of interested parties
Consultation methods, main sectors targeted and general profile of respondents
Stakeholder groups have been extensively involved in the development of this proposal from the beginning through a Technical Expert Working Group (TEWG) convened by the Commission, bilateral consultations with different stakeholder groups as well as through public internet consultations. The documents distributed for the TEWG were also widely distributed to the research community and industry to allow maximum input. In 2006, the Commission carried out a public Internet consultation directed at the general public and experts and stakeholders in the field i.
The results of the citizens' consultation are based on the responses of citizens who were interested in the subject and took the initiative to fill in the questionnaire. Therefore, the results are not comparable to those obtained from surveys, such as Eurobarometer. However, the high level of participation gives a strong indication of the public interest in this area. A large majority of the respondents supports measures at EU level to increase the welfare of animals.
The expert consultation received over 12,000 comments on the different options for the revision. These have been analysed in detail and taken into account in the legal drafting as well as in modifying and updating the Commission Impact Assessment.
Domains of scientific expertise concerned
Experts in the area of animal testing and experimentation, laboratory animal science, natural sciences (especially biology, medicine, pharmacology, toxicology and ecotoxicology), animal welfare, ethics, laboratory animal breeders, technicians and veterinarians, animal behaviourists, and experts in legal and economic affairs related to these areas were asked for and provided input.
The proposal is based on the best available scientific and technical knowledge. Such expertise has been gathered through the comprehensive stakeholder consultations including the TEWG, a public internet consultation and by contracting an outside study to assess the socioeconomic and animal welfare impacts of the measures proposed. In addition, specific scientific questions were addressed to the Panel on Animal Health and Animal Welfare of the European Food Safety Authority and to its predecessor Scientific Committee on Animal Health and Animal Welfare (SCAHAW).
The consultation included national administrations, industry associations, animal welfare organisations, patient organisations, science and research institutes, organisations in the field of the principles of the Three Rs and alternative methods, the European Medicines Agency, the Joint Research Centre and other Commission services, national administrations and breeders of laboratory animals in third countries as well as many other associations which had European coverage.
There is a broad consensus that the current Directive is outdated and has led to distortion of the internal market. The technical-scientific advice was used as the basis for a preliminary set of foreseen measures. These measures were then presented for a wide consultation during which they received clear support from stakeholders.
Among the options that were abandoned as a result of feedback received, was a requirement for publication of ethical evaluations and systematic retrospective assessments of all projects using animals. These were replaced by a requirement for non-technical summaries to be produced by the applicant and retrospective assessment based on case-by-case analysis of its necessity. Furthermore, the option to have an EU wide database as a means to combat unnecessary duplication of testing was discarded.
Throughout the consultation, stakeholders supported the approach to ensure a flexible mechanism that allows implementation to be determined at a national level.
There was a broad consensus that the current Directive should be revised to include the main elements presented establishing common objectives and principles throughout the EU, leaving to Member States the adoption of detailed measures at the appropriate administrative level.
The following broad options, from less to more prescriptive, have been considered:
Deregulation
Maintaining status quo
Strengthening the current legislation
Voluntary agreements as an alternative to legislation
The Commission carried out an Impact Assessment, which sets out in more detail the findings as regards the socio-economic impacts and impacts on animal welfare linked to this proposal and the more detailed options therein.
The current situation in the European Community is characterised by a highly diversified, unequal competitive environment for industry and the research community. The main economic actors affected by the functioning of the internal market are:
- Contract research institutes performing animal tests on behalf of other companies for cost or expertise reasons.
- Companies doing product development research in-house (e.g. pharmaceutical, chemical producers). Their cost structure varies across Europe due to differences in the regulatory environment.
Universities are also affected by the functioning of the internal market in the area of animal experimentation, as they compete for industry sponsorship for research, are tendering for public procurement contracts and sometimes create their own commercial off-spring or branches.
The Impact Assessment was reviewed in March 2007 by the independent Commission Impact Assessment Board. The Board issued its Opinion on 16 March 2007 and emphasised the following positive elements: The attempt to quantify and where possible monetise benefits and costs for each specific option, the inclusion of information about third country systems of laboratory animal protection, the examination of links with other Community legislation and the inclusion of a glossary of terms. In light of the Board's recommendations, the following sections have been further improved: internal market problems, the option of self-regulation, the qualitative benefit dimension and the use of the standard model of administrative costs.
The increase in annual costs is estimated to be about 143.7 million € for the EU-25. This figure includes additional administrative costs of about 45 million € annually mainly from increased scrutiny of project applications, covering more animals, more inspections and improved statistics.
These costs should be mirrored against the benefits to animal welfare, innovation and science as well as society in terms of increased public accountability and transparency. Authorisation of groups of projects for regulatory testing would reduce the average costs of this type of project at the establishment level due to economies of scale. Positive impacts would also occur at the level of authorisation bodies in Member States due to more flexible and efficient handling of the procedures. Industry and academia would benefit from deadlines for authorisation decisions.
Some simplification benefits have been taken into account, especially related to group authorisations which will greatly reduce the administrative burden. Expected savings will be about 22 million € per year. The benefits from reduced administrative costs and avoidable unnecessary testing alone were estimated to be 90 million € per year. These, however, are not reflected in the estimated annual cost.
3)
Contents
- LEGAL ELEMENTS OF THE PROPOSAL
- BUDGETARY IMPLICATION
- Grounds for and objectives of the proposal
- General context
- Existing provisions in the area of the proposal
- Consistency with other policies and objectives of the Union
- 2) CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT
- Summary of responses and how they have been taken into account
- Collection and use of expertise
- Methodology used
- Main organisations/experts consulted
- Summary of advice received and used
- Impact assessment
- Summary of the proposed action
- Community context
- Legal basis
- Subsidiarity principle
- Proportionality principle
- Choice of instrument
- 5) ADDITIONAL INFORMATION
- Correlation table
- European Economic Area
- the proposed Directive includes requirements for:
- the acquisition, breeding, marking and keeping of animals, including their accommodation and care requirements;
- the authorisation and functioning of establishments breeding, supplying or using animals and inspections of these establishments;
- the authorisation of persons using or caring for animals, supervising or responsible for designing projects using animals;
- the evaluation and authorisation of projects using animals, including their retrospective assessment;
- the choice of procedures and their conduct;
- the development, validation, regulatory acceptance and implementation of alternative approaches;
- transparency through publication of non-technical information on projects, national implementing rules and guidelines as well as reporting on implementation and statistics.
The basis of the specific measures is anchored in the globally acknowledged principles of the Three Rs (Replacement, Reduction and Refinement). Replacement means the attempt to replace procedures involving live animals by alternatives which do not use live animals; reduction means the attempt to reduce the number of animals used in procedures to the minimum necessary without compromising the quality of scientific results; refinement means the employment of methods to ensure that any possible pain and suffering by the animals are reduced to the minimum, as well as to improve the care, treatment and living conditions of the animals to enhance their well-being, taking into consideration the life-time experience of the animals.
There is Community legislation in place to evaluate and manage potential risks of products and substances for health and safety reasons. In some cases, it is necessary to resort to animal testing to evaluate these risks. The areas include pharmaceuticals, chemicals, pesticides as well as food and feed safety. It is therefore necessary that animal welfare considerations are taken into account, while being balanced against the potentially serious threats to human and animal health, and the environment which need to be tested.
The provisions of this Directive relate to the harmonisation of the internal market in the field of breeding, supplying and use of animals and consequently Article 95 of the EC Treaty was kept as the legal basis.
For the following reasons the proposal complies with the subsidiarity principle:
- The EC Treaty provides the European Community in Article 95 with a legal base to adopt measures to approximate Member State provisions laid down by law, regulation or administrative action, in order to ensure the functioning of the internal market.
- The Protocol on protection and welfare of animals annexed to the EC Treaty requires the European Community and the Member States to pay full regard to the welfare requirements of animals in formulating and implementing the Community's internal market and research policies.
- While some of the identified problems fall under a competence shared by the Community and the Member States, problems such as those resulting from diversified requirements for authorisation and ethical evaluation as well as for accommodation and care of animals, cannot be sufficiently solved by the Member States themselves because action or non-action by the Member States has created the problems of distortion of the internal market in the first place. Without regulatory action at European level, the distortion of the internal market will persist and possibly worsen.
Without Community action to underpin the efforts at national level, the current situation has created an uneven playing field for industry and the research community.
As a result there are competitive disadvantages for establishments in countries with high animal welfare standards resulting primarily from price differences, diverging regulatory and authorisation procedures and criteria in the Member States leading to variable delays and cost of projects, unsatisfactory conditions for researchers and obstacles to horizontal mobility and between academia and the private sector. Similar problems can be identified for the breeders and suppliers of experimental animals.
The proposal aims at achieving common principles, objectives and actions for all Member States to ensure a fair and level playing field in the future.
The proposal complies with the proportionality principle for the following reasons:
The proposed Directive would establish a set of measures to harmonise the practices for the use and the care of animals used or intended to be used in scientific procedures, in line with the animal welfare protocol of the EC Treaty. Much scope is left to the Member States to identify the most suitable specific measures at the most appropriate administrative level and the respective administrative infrastructure. This will ensure that the regional and local specificities as regards socio-economic and ethical aspects can be properly taken into account.
The practical implementing measures are to be decided by Member States, allowing for an efficient use and further development of national administrative capabilities which may also be best suited to support the local industry and research community. As demonstrated by the Impact Assessment, the benefits of the proposed measures to the internal market as well as to animal welfare outweigh the costs. The final measures have been refined to secure a balance between the need for harmonisation, the costs and flexibility for local implementation.
The Member States will be entitled to take more stringent measures than those laid down in the proposed Directive, where they satisfy the requirements of Article 95 i EC.
Proposed instrument: Directive.
Other means would not be adequate for the following reason:
A more prescriptive instrument, such as a Regulation, would be too rigid to encompass all the existing regulatory systems that have developed over the last 20 years in the Member States. Deregulation or a non-binding instrument would not address the problems identified with the current Directive and could not prevent the further distortion of the internal market.
4)
The proposal has no implication for the Community budget.
Review/revision/sunset clause
The proposal includes a review clause.
The Member States are required to communicate to the Commission the text of national provisions transposing the Directive as well as a correlation table between those provisions and this Directive.
The proposed act concerns an EEA matter and should therefore extend to the European Economic Area.