Study on the impacts of different options for the Revision of the Directive 86/609/EEC on the Protection of Laboratory Animals Draft summary

Basle, Berlin, Utrecht June, 2007

Client: European Commission DG Environment

Prognos AG Kai Gramke Dr. Joachim Beck Marc Biedermann Martin Klemm In Co-operation with Marie-Jeanne Schiffelers Utrecht School of Governance Utrecht University

Prof. L.F.M. van Zutphen, Utrecht University

1

Prognos AG CEO Christian Böllhoff

Basle Aeschenplatz 7 CH-4010 Basel Telefone +41 61 32 73-200 Telefax +41 61 32 73-300 info@prognos.com www.prognos.com

Berlin Karl-Liebknecht-Straße 29 D-10178 Berlin Telefone +49 30 52 00 59-200 Telefax +49 30 52 00 59-201 info@prognos.com

Bremen Wilhelm-Herbst-Straße 5 D-28359 Bremen Telefone +49 421 20 15-784 Telefax +49 421 20 15-789 info@prognos.com Brussels 39, Avenue des Arts B-1040 Brussels Telefone +32 2 513 22 27 Telefax +32 2 502 77 03 info@prognos.com Düsseldorf Schwanenmarkt 21 D-40213 Düsseldorf Telefone +49 211 887 31 31 Telefax +49 211 887 31 41 info@prognos.com

2

Content

1. Executive Summary 3

2. Procedural Issues and Consultation of Interested Parties 4

3. Problem Definition 6

4. Objectives 8

5. Policy Options 10

6. Assessment of Specific options 13

7. Level Playing Field Analysis 26

8. Overview 28

3

1. Executive Summary

To be completed by the commission.

4

2. Procedural Issues and Consultation of Interested Parties

Preparatory work for the revision of Directive 86/609/EEC started in 2002 when the European Commission’s Directorate-General for Environment (DG ENV) requested an opinion on the welfare of non-human primates used in experiments from the Commission’s Scientific Committee on Animal Health and Animal Welfare, SCAHAW. This Opinion was adopted by SCAHAW on 17 December 2002.

In 2003, DG ENV organised a Technical Expert Working Group, TEWG, to collect scientific and technical background information for the revision of the Directive. The experts from Member States, acceding countries (which are now Member States), industry, science and academia as well as from animal welfare organisations worked through a set of questions prepared by DG ENV. The results of the TEWG provide an important input for the revision of the Directive.

In 2004, the Animal Health and Animal Welfare Panel, AHAW, of European Food Safety Authority was mandated to give a scientific opinion on four further questions in relation to the revision; whether the scope should include some invertebrate species and foetal/embryonic forms, which animals should be purpose bred and identifying humane methods of euthanasia.

The input from TEWG, SCAHAW and AHAW Panel has provided a broad basis for different policy options for the revision. DG ENV decided in 2005 to perform a voluntary impact assessment to be able to critically review and assess these policy options and their impacts, to test the conclusions and to provide justifiable and (where possible) quantitative indications as to the related benefits and costs.

In December 2005 Prognos AG was assigned to carry out a study to provide input to the Commission’s Impact Assessment according to the revised Impact Assessment guidelines of the Commission’s Secretariat General (SEC(2005)791).

During the study all relevant material concerning the revision of the Directive was screened to gather as much information as available. Then, baseline information was collected from stakeholders, national authorities and other sources. To close the remaining gaps and to detect which other important aspects would have to be covered, a survey among experts was launched. This survey was conducted by means of two questionnaires. One questionnaire was sent to all major stakeholders who were expected to be able to provide detailed and important information on the status quo of the situation of laboratory animals, the research and testing process, the current state of the

5

Directive and challenges arising from its implementation. This includes representatives of private and public users of animals (e.g. industry and academic institutes), industry, academic and professional associations, non-governmental organisations etc. A second questionnaire was sent to the national authorities in the Member States (also referred to as “national contact points”) that are responsible for the legislation concerning laboratory animals and consequently for the implementation of Directive 86/609/EEC.

The results of this survey were by far not as complete, detailed and fact-based as expected. It became evident that only very limited cross-national data is available and it was therefore necessary to design a series of comprehensive models to be able to quantify impacts of policy changes.

Based on existing baseline information and the data received from Member States and stakeholders, a qualitative screening of possible impacts associated with each policy option was done. Based on the evidence gathered, specific hypotheses on the respective costs and benefits for each regulatory element were developed. Where possible, the hypotheses already presented quantitative figures.

The results of this preliminary impact assessment became the basis of an internet consultation which was a major element of the study. The consultation was open to participation for a period of nine weeks and consisted of two separate questionnaires, one for the general public and one for experts and stakeholders. The purpose of the public consultation was to get an impression of public opinion relating the use of animals for experimental and other scientific purposes.

The expert questionnaire served to verify, correct and complete the preliminary findings of the assessment of the options to revise the existing Directive. The questionnaire was addressed to experts in the area of animal welfare, animal testing, animal science, natural sciences (especially biology, medicine, pharmacology and toxicology), legal and economic affairs related to these areas and who were in the position to either confirm the identified impacts or provide factual, quantifiable information to the contrary.

The arguments and the scoring have been taken into account in the final qualitative and quantitative evaluation of each impact.

6

3. Problem Definition

Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes is the main piece of community legislation in place today to protect animals used in experiments and to avoid distortions of the internal market in this field.

The Directive seeks to set controls on the use of laboratory animals, recommends minimum standards for housing and care as well as for the training of personnel handling animals and supervising the experiments. It also aims at reducing the numbers of animals used for experiments by requiring that an animal experiment should not be performed when an alternative method exists, and by generally encouraging the development and validation of alternative methods to replace animal methods.

The Directive was adopted in 1986 and has not been significantly changed since. However, the EC Treaty now formally recognises the welfare requirements of animals since 1997. The protocol on the protection and welfare of animals, annexed to the Treaty, provides that

"In formulating and implementing the Community's agriculture, transport, internal market and research policies, the Community and the Member States shall 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."

In recent years, it has become increasingly apparent that the Directive needs to be revised. The current Directive is open to interpretation and does not mirror important progress that has been made in science over the last two decades. New techniques have become available, such as use of transgenic animals, xeno-transplantation and cloning. These require specific attention, which the current Directive does not provide for, nor is the use of animals with a higher degree of neurophysiologic sensitivity, such as non-human primates, specifically regulated.

An initial problem analysis has shown four main problem dimensions across the three areas mentioned in the Commission Impact Assessment guidelines (economic, social and environmental aspects). These main problem dimensions can be described as follows:

7

a.) Economic problems: Competitive disadvantages of countries with high animal welfare standards resulting primarily from price differences (due to different minimum requirements for housing) , diverging regulatory and authorisation procedures in the Member States leading to delays of projects and different authorisation criteria (e.g. inclusion/exclusion of ethical evaluation) across Europe, unsatisfactory (working) conditions of researchers, obstacles to horizontal mobility, increasing activist criminality.

b.) Environmental problems/Animal welfare: Different levels of animal welfare resulting from a high number of animals not protected and from different standards that are in force.

c.) Scientific problems: Low innovation / low quality science resulting from delays of projects, potentially unnecessary testing and duplication, low incentive to develop and use alternative methods, risk of variable research results due to non-consistent scrutiny of study design and implementation of refinement (leading to higher stress levels for animals) and obstacles to free movement of researchers due to different standards.

d.) Public/societal problems: Increasing dissociation between weak legislation and strong public concern, evolving from changed ethical and societal values and increased public interest about the acceptability of animal testing.

8

4. Objectives

The overall aim of the revision is to achieve a harmonised, controlled use of animals in scientific procedures with transparent practices across all Member States. The Directive should ensure a level playing field within the EU for establishments, for those carrying out procedures or breeding and/or supplying animals for procedures, taking into account animal welfare considerations on the one hand and the Community’s desire to stay in the leading edge of research on the other. It should also reflect relevant developments since the adoption of the Directive in 1986, including the Protocol to the Treaty referred to above, as well as ethical and other relevant concerns.

According to the Impact Assessment guidelines the Commission has developed general and specific objectives for the revision of Directive 86/609/EEC:

General objective 1: Strong convergence of standards that ensures a level playing field for industry and researchers

Specific objectives

Reduce unfair competition and distortion of internal market for companies, research institutes and universities by

• harmonising the minimum requirements in areas such as scope, authorisation and ethical review for carrying out animal experiments

• levelling the cost and time factors of experiments

• encouraging research into alternative approaches and improve conditions for innovation

General objective 2: A significant improvement in animal welfare and protection over the life time experience of experimental animals.

Specific objectives

Improve animal welfare by ensuring a minimum scrutiny and standards of all animal keeping and use for experimental purposes by

• Implementation of ethical evaluation of projects and ethical review process in establishments to ensure full compliance with the Three Rs.

• Minimum criteria for housing and care, and inspections

9

• Ensure protection of all sentient animals (invertebrates, foetal forms, basic research, bred for tissue) used within the competence of the Community.

These policy-objectives have been the analytical starting point for the development of the following policy options.

10

5. Policy Options

Taking into account the preliminary analysis, the problems that have emerged with the existing legislation, and the objectives to be achieved by the EU, three policy-options have been developed:

1.) No Policy-Change: One option could be to keep the current situation unchanged. This would mean that the existing Directive 86/609/EEC would not be revised and that the given standard of European legislation and national implementation would be continued.

This option could be justified by the observation, that since 1986 all Member States have implemented the minimum standards set out by the existing Directive and that some Member States in their national legislation have even gone far beyond this. The overall level of the protection of laboratory animals can be assumed as high in the EU 15. The new Member States had to implement the Directive at the latest by the time of accession, with the consequence that in some of these Member States the overall number of laboratory experiments has already decreased significantly.

2.) Reinforcement of the EU-regulation: A second option could be to enforce the EU-regulation by revising the existing Directive. This would mean that in specific areas, where evidence shows that an EU-wide harmonisation could considerably contribute to the enhancement of the welfare of laboratory animals and to a reduction of existing obstacles to the functioning of the internal market, a revised Directive could set clearer and more harmonized standards.

This option could be justified by the fact that both the scientific context and the policy-problems have significantly changed since 1986. Although, for instance, the level of animal protection in Europe has increased during last years, the statistics are showing a small increase of the total number of animals used per year in most Member States. In many relevant policy dimensions, such as scope, education and training, authorisation or housing and care, the absence of a level-playing field leads to unfair competition and distortion of internal market for companies, research institutes and universities. Good practice examples of selected Member States could be used as a starting point to develop a higher level of legal and procedural convergence throughout Europe.

11

3.) Deregulation:

A third option could be to abort the existing Directive and transfer the regulatory competence fully to the Member States, with the EU-level remaining to provide only recommendations and playing an active part in exchanging information on good practices and alternative methods.

This option could be justified by the observation that the regulatory setting throughout Europe has not been sufficiently harmonized by the existing Directive and that many Member States have shown that national legislation can successfully even go far beyond EU standards. Industry and science have adapted to these different standards. Action of Member States, adapted to the specific national regulatory and institutional environment and the respective public awareness in each country could possibly by more effective and efficient than an EU-wide regulatory approach. Variance of regulatory settings across Member States do not necessarily have to be considered as negative but could even strengthen the competitiveness of Europe as a research place due to innovative regulatory approaches being implemented by some Member States.

5.1. Discussion of the three basic options

In this impact assessment, the option of deregulation was not pursued further because all Member States have existing national legislation that fully implements the original Directive. Some Member States exceed the requirements of the Directive. Furthermore, the impact of deregulation would be to fail to address the calls from many experts, stakeholders, Member States and policy makers who have achieved a broad consensus during the last few years on the fact that a revision of the current Directive is necessary. Finally, deregulation is not an option due to the international commitments (Council of Europe) of the European Union. The question therefore is not whether the EU should regulate but how she should regulate.

The no policy change (status-quo) option would not be able to address the existing problems and trends of concern described in the previous section. It is therefore not a viable option. [Just moving this paragraph upfront, instead of leaving it as a paragraph further down in the text]

The no policy change option was therefore only considered as the baseline for quantifications of impacts. The calculations of these impacts were done to identify the change concerning benefits and costs in comparison to the status-quo. Therefore the no-policy change option was not considered as an option in itself, but rather as

12

a methodological tool to estimate the impacts of legislative changes. The different regulatory options of a possible revision are being analysed on the basis of the status-quo/no policy change option.

The second basic option (revision of Directive 86/609/EEC) was the only viable one and was developed further. Using the policy-option-matrix method, specific options for each policy dimension were defined.

13

6. Assessment of Specific options

During the problem analysis a number of specific policy problems have been identified. These were classified according to twelve policy dimensions. Within these policys dimensions a total of 24 specific options were analysed and evaluated. In most cases these options were also quantified and monetarised. In some cases the contractor recommended the revision of the original options and provided arguments and calculations in support.

I. Scope The options could include extending the scope of animals and procedures covered under the current Directive to create a uniform regulatory environment within the EU for at least 2.7 Mio animals currently not covered by the Directive. This would result in a more competitive level playing field in this respect. Option 1: Extend the scope to cover animals used in basic

Research

The extension of the scope would moderately improve the welfare of up to 500’000 animals (15% of all animals used for basic research) in 5 Member States not currently covering basic research while only creating moderate administrative costs. Total costs of implementation would amount to 6.6 Mio Euro for additional authorisation and ethical evaluation procedures but will only affect 5 Member States. Total costs could increase to 10 Mio Euro if most projects in basic research were of very individual nature and more complex than standard projects.

Option 2: Extend the scope to cover animals bred for the primary

purpose of their tissue and organs to be used in experiments or for other scientific purposes (but without requiring a project authorisation for the euthanasia if it is performed by competent person using a method appropriate to the species)

The extension of the scope would significantly improve the welfare of the 1.8 Mio. animals involved, due to better breeding; housing and care and euthanasia. Only minor additional costs should occur if, as planned for the revision of the Directive, euthanasia is performed by a competent person.

14

Option 3: Extend the scope to cover selected invertebrates species (Cyclostomes, Cephalopods and Decapod crustaceans)

The extension of the scope would moderately improve the welfare of the animals involved, whereas the costs to public authorities and additional administrative burden for user establishments are estimated to be moderate due to their low share in total project costs but cannot be quantified.

Option 4: Extend the scope to cover mammalian foetal forms from the last third of gestation until birth

The extension of the scope would moderately improve the welfare of the animals involved, whereas the costs for Member States (public authority) would be low with an estimated total amount of 846.000 Euro. Additional administrative burden for user establishments is estimated to be 12.6 Mio. Euro.

Option 5: Extend the scope to cover animals used in education and training

The extension of the scope would moderately improve the welfare of 200.000 animals involved, whereas the costs to Member States (public authority) will be low, due to the fact that only 158 projects will come under the scope causing yearly additional costs of around 35.000 Euro. Additional administrative burden for user establishments is estimated to be 1.4 Mio. Euro.

II. Authorisation of projects

Regarding the large differences in authorisation practices in Europe, a level playing-field should be established to guarantee comparable minimum requirements for the authorisation of projects.

The introduction of compulsory authorisation for individual projects could be a highly effective instrument for enhancing animal welfare but only if minimum requirements are defined and implemented by all Member States. These minimum criteria could include:

1. Compliance check systematically assessing elements such as - the authorisation of the establishment is valid - the authorisation of the personnel is valid - the competence of personnel is demonstrated - housing and care standards are complied with

15

- an animal welfare officer works in the establishment - a veterinary surgeon is named and available on request - the latest inspection report confirmed compliance - the statistical reporting obligations have been complied with during the previous reporting period - a scheme for local ethical review process throughout the project lifetime is in place

2. Supporting opinion by a detailed ethical evaluation of the respective project

3. Setting a deadline during which the authorising body is required to reply to an application.

The elements of authorisation and ethical review can be designed not to overlap but to complement one another (see section on Ethical Review). The specific way in which authorisation would be granted in relation to ethical evaluation (e.g. centralised, decentralised, parallel, and subsequent) could be determined by Member States taking into account their current infrastructure.

Option 1: Authorisation of individual projects with compliance check

Authorisation of individual projects can increase animal welfare for about 950.000 animals significantly, due to an assurance that minimum legal requirements are met by the applicants. A reduction of unnecessary experiments may occur. No increase in project delays is to be expected if the authorisation procedure is implemented in an efficient way and the elements are harmonised throughout the EU Member States.

The implementation of project authorisation in four countries combined with the implementation of a compliance check in all Member States would lead to an increase in yearly costs on user level of 23 Mio Euro. Yearly costs on Member States level are estimated to be 450.000 Euro.

Option 2: Authorisation of a group of projects for regulatory testing

Authorisation of groups of projects would have high positive impacts on the competitiveness of user establishments and on public expenditure due to a reduction of authorisation procedures. Compared to project authorisation (114 Mio Euro per year), this option compares favourably and would lead to costs of 92 Mio Euro per year.

16

III. Ethical Review (A): Ethical Evaluation of projects

Most stakeholders agree that an effective ethical evaluation for scientific uses of animals should be mandatory in every European country. An important option for the revision of the Directive could be to make ethical evaluation of projects mandatory.

The revised Directive could contain a list of minimum requirements for ethical evaluation such as:

(i) Implementation of the Three Rs in which every project has to be critically evaluated to see if the concepts within the Three Rs framework have been sufficiently taken into account. Minimum elements could include:

• Justification of the scientific objectives

• Justification of the proposed use of animals and procedures

• Origin, numbers, species and life-stages of animals with justification

• Demonstration of lack of alternative replacement methods

• Demonstration of competence of persons involved in the project

• Use of anaesthesia, analgesia and other pain relieving methods

• Reduction, avoidance and alleviation of any other form of animal suffering from birth to death

• Housing, husbandry and care conditions in the context of procedures

• Use of early and humane endpoints

• Experimental strategy and statistical design to minimise animal numbers and animal suffering

• Assessment of life time experience, including the re-use of animals

• Avoidance of unnecessary duplication of procedures

(ii) Severity classification of procedures which aims at categorising the procedures by the level of physical pain, physiological perturbation, or mental distress the procedures may inflict on an animal, and their duration.

17

Whereas some Member States systematically apply severity classification, most Member States have little or no experience in this area. Consideration could therefore be given to minimum requirements. In addition, it could be beneficial to give practical guidance for this severity assessment.

(iii) Harm-benefit analysis at a project level aims at quantifying, not in mathematical terms, the harm to the individual animal in terms of suffering, pain, distress etc and the likely benefit of the experiment to humans, animals and the environment.

(2) An additional option would be to require retrospective reporting of the benefits and harms in all projects.

Option 1: Compulsory ethical evaluation of projects with minimum requirements

The introduction of a compulsory ethical evaluation has a substantial positive impact on animal welfare (via implementation of the Three Rs) and scientific standards (via the prior evaluation of the research design). Model calculations show the potential for an EU-wide reduction of animal use to be more than 371.000 animals or 8% of the animals used in Member States where the ethical evaluation has not yet been (fully) implemented. Total additional yearly costs in those countries currently lacking an ethical evaluation system amount to 9 Mio Euro in the short-term (7 Mio Euro mid-term) and associated yearly savings of 70 Mio Euro.

Option 2: Introduction of retrospective analysis of all projects to record deviations and evaluate factual harm and realized benefit

Retrospective analysis has the potential to verify which types of animal tests have really been useful for the progress of science and which have been rather unreliable. This may help animal welfare but also drive innovation to areas where animal tests could be relatively easily replaced. Introduction of retrospective analysis for all projects would lead to an increase in costs by almost 20 Mio Euro in the short and medium term while it is yet uncertain if the objectives of "learning from mistakes" and achieving more accurate data collection on severity and benefits are met. Potential benefits can be expected to become visible only after several years.

18

IV. Ethical Review (B): Ethical review process and National Body

The revised Directive could aim at a higher level of harmonisation within and between Member States, creating an improved level playing field for research and industry, and at the same time aiming at improved welfare for animals.

A combination of a national body for co-ordination of ethical review matters within the Member States and a local ethical review process at an establishment level may be worthwhile. This could ensure a solid implementation of ethical review requirements.

The tasks of a national body could include:

• Establishment and publication of requirements for ethical evaluation of projects and local ethical review process

• Act as an appeal body

• Promotion and co-ordination of Three Rs approach at a national level to help ensure good animal welfare and good science

Option 1: Introduction of a national ethical review body with a minimum harmonised remit

The introduction of a national ethical review body with a minimum harmonised remit can increase transparency, due to an assurance that guidelines are set for all local ethical review bodies. Public accountability and objectivity also may be improved. Although there will be costs in setting up such a body these costs are considered low. Having a national body in place is especially valuable to give guidance to the system that is doing the actual review.

Option 2: Introduction of a compulsory ethical review process in each establishment

The introduction of a compulsory ethical review process in each establishment, especially also at breeder and supplying establishments has a high potential to increase animal welfare, the level of awareness and debate. Introduction of a compulsory system of ethical review at establishment level could also improve the level of work satisfaction especially for animal care takers/animal welfare officers. Furthermore; a compulsory procedure will get better recognition within the establishment. The costs seem therefore acceptable in relation to overall research costs.

19

V. Housing and care standards

The revised Directive could incorporate elements of the Council of Europe’s revised Appendix A to Convention ETS 123 as compulsory minimum standard with a transitional period for implementation. This would bring the Directive in line with current scientific and technical knowledge, increase animal welfare and create a competitive level playing field within the EU (and between EU and non-EU countries who are Parties to the Convention).

Many of the general provisions and recommendations of the revised Appendix A for health, transport, quarantine, acclimatisation, isolation, watering, feeding, cleaning, records and identification are procedures that are already in place in many establishments, as these are integral parts of good scientific/laboratory practice to obtain reliable and reproducible scientific results. Major changes required are mostly related to the new cage sizes, the mandatory use of environmental enrichment, and the mandatory group housing and socialising of animals.

Option 1: Requiring as a minimum standard compliance with the revised Appendix A to the Council of Europe Convention ETS 123

Compliance would significantly increase the welfare of 12.1 Mio. animals through better housing and care standards thus leading to better and more reliable scientific results as well as to improvements in the mental wellbeing of personnel. Total one-time investment costs for new cages to reach full compliance with ETS 123 guidelines have been estimated for rodents, (mice and rats) and monkeys. These costs would amount to 27.8 Mio. Euro, or 5.6 Mio. Euro yearly, assuming a 5 year depreciation period. Preliminary findings indicate that 35% of establishments in private sector and 20% in public sector have already adapted with investments of 8.3 Mio Euro. This would reduce the total amount of future investments to reach full compliance to 19.5 Mio. Euro. The calculated total additional yearly costs for purchase/caging/care amount to 37 Mio Euro. These costs include investment costs in caging of 5.6 Mio. The calculated total additional costs would, therefore, amount to 6% of the total costs for purchase/caging/care (or 1.3% of total animal research costs). Investment costs for new buildings have not been calculated, but may be substantial, in particular for breeders of laboratory animals.

20

VI. Transparency / Access to information

The revision of the Directive would incorporate minimum requirements on transparency and public accountability by requiring non-confidential information on ethical evaluations and project authorisation decisions to be made publicly available.

Option 1: Relevant, non-confidential information from the ethical evaluation reports and project authorisation decisions to be made publicly available

This option has been revised due to the high costs associated. Total costs for the implementation of a slightly revised option based on non-technical summaries drafted by the applicant would amount to 520.000 Euro per year. Making these non-technical summaries publicly available would substantially improve accountability and the public image of the sector and would contribute to the need to increase understanding of the public as to why animal experimentation is still carried and its justifications. Personal safety issues and intellectual property rights would be adequately considered direct and indirect costs for user establishments and authorities would be low.

VII. Non-human Primates

The main options for the revised Directive could be to reinforce the ban on wild-caught NHPs and to allow only very limited exemptions. For macaques (cynomolgus and rhesus monkeys) a gradual switch to only allowing use of F2 (second-generation) and following generations of purpose-bred animals could be desirable. The use of Great Apes could be highly restricted.

Option 1: Shift to only use of F2 and subsequent generations of purpose bred NHP

A shift to F2 animals is possible but is associated with the several consequences if not carefully planned and executed. Breeders will be forced to increase their breeding programmes by decreasing the number of animals to be sold. Consequently, supply may decrease significantly or be offset by additional wild caught animals, which would not be beneficial to animal welfare.

Currently world demand for macaques is higher than world supply. Breeders would be able to sell their wild caught animals and their F1 production to non-EU countries instead of putting resources into the production of F2 animals. This could effectively lead to a supply-stop of

21

macaques into the EU and consequently a stop of respective research programmes.

Prices for F2 animals would be higher because of increased breeding colony size and the fact that close to part of the production (surplus males) cannot be sold.

Option 2: Transitional period for the shift to F2 and subsequent generations 2.1 Transitional period of 0 years 2.2 Transitional period of 5 years

2.3 Transitional period of 10 years

A transitional period for a shift of wild caught/F1 animals to F2+ animals is not needed for marmosets since this species has already been bred in captivity for many years and all marmosets used in research are in fact F2+ animals. For species that are not frequently being used (like baboons and vervets) a transitional period is not relevant since the limited use of these species would not justify the establishment of a facility for breeding F2 animals for research purposes. For macaques a transitional period of at least seven years seems to be needed.

Option 3: Ban of the use of Great Apes with very limited exceptions

The assessment shows an overall positive impact of this element: The only real necessity for experiments with Great Apes is the development of treatments for new diseases that might occur. For this purpose, one limited but well equipped centralised facility at global level would be sufficient. Given that several third countries maintain such facilities, there is currently no need to establish an additional one in Europe.

VIII. Inspections

The revision of the Directive could harmonise the minimum requirement for annual inspections at the level of two, one of which could be unannounced. A system of EU inspections could also be envisaged.

22

Option 1: Minimum twice yearly inspections by national authorities of which at least one unannounced

The option would have positive impacts in terms of increase in animal welfare for the 12.1 Mio. animals concerned, as well as positive impacts on public perception and transparency. The costs for establishments are relatively low with 615.000 Euro and confined to the day of inspection. The disruption of very sensitive projects may lead to additional costs of 265.000 Euro. Total costs for Member States depend on the implementation level of the inspection system. A fully centralised system would lead to total costs of 3.1 Mio. Euro, whereas decentralised systems would produce lower costs of 2.5 Mio. Euro.

Option 2: EU inspections

The overall assessment shows that EU inspections would not result in a significant increase in animal welfare unless disproportionately high resources were invested to render these inspections efficient and sufficiently frequent. An EU inspection system would lead to total costs of 4.2 Mio. Euro per year. A revised option modelled on the Food and Veterinary Office quality check would cost 240.000 Euro a year, but must be seen in combination with either national or decentralised inspection costs. This would increase costs to 3.33 Mio Euro in combination with national inspections or 2.73 Mio Euro in combination decentralised inspections.

IX. Education and training

The revised Directive could incorporate some minimum requirements for education and training to achieve basic competence for the different categories of personnel. In addition, it could set requirements for maintaining and demonstrating competence and life-long learning.

Option 1: Requirement for competence combined with minimum elements for education and training

Appropriate education and training would improve the implementation of all Three Rs and ensure respect of their welfare requirements of animals before, during and after procedures. This would improve the welfare of 12.1 Mio. animals concerned. Furthermore, this would substantially assist in reducing existing obstacles to horizontal mobility and would lead to a high job satisfaction of those having direct contact with animals on a daily basis. Defining the requirements for achieving the initial competence would

23

create a level playing field and contribute to the free exchange of personnel between Member States. The costs for this option are moderate since the education and training can, for a great deal, be integrated in the formal educational programmes for students in Member States. Total yearly costs for a revised option which requires mandatory refreshment courses every five years would amount to 38 Mio. Euro.

X. Avoiding unnecessary duplication of animal experiments

A significant reduction of duplication in regulatory testing would require changes in numerous legislative requirements at Member State level. This policy approach, however, cannot be addressed by a revision of the given horizontal Directive. Compulsory authorisation of projects and ethical evaluation is partly meant to address this problem.

In view of this situation, the general approach of a revised Directive regarding the reduction of duplication could be setting-up a centralised EU-wide database collecting information on project authorisation and scientific results in each Member State.

The database could also provide a discussion platform where scientists and inspectors could exchange their experiences, problems and good practices. As far as possible, information on 3rd countries could also be collected. This could contribute to increasing the knowledge, especially in basic research, and provide more transparency on “negative results”, not systematically published so far.

The database would not be made public but be restricted to scientists and inspectors only.

Option 1: Setting up a centralised EU-wide database

An EU database covering only a minor share of relevant information in a problematic way would hardly contribute to a general improvement in animal welfare but rather enhance the bureaucratic burden and decrease scientific competitiveness of the EU. Nevertheless, a minor improvement for animals used in basic research could be expected due to a lower risk of unnecessary duplication. Total yearly costs for maintaining and using an EU-wide database would amount to 6.5 Mio Euro with one-time development and installation costs of 30.000 Euro.

24

XI. Use of CO2 for euthanasia For animal welfare reason, the revised Directive could incorporate a list of humane methods of euthanasia to be used for experimental animals. Within such a list of methods, the use of CO2 could be prohibited unless the animal is rendered unconscious prior to its exposure to the CO2.

Option 1: Prohibition to use CO2 unless the animals are first rendered unconscious by exposure to anaesthetic gases such as halothane

The overall assessment shows that this option may increase animal welfare but would most likely be associated with much higher costs. Due to the ongoing scientific debate about CO2 and replacements, more research may be required and the welfare effect cannot be quantified. Total costs for all establishments in the EU would amount to 46 Mio Euro.

XII. Statistical Reporting

The revised Directive could increase the quality and usability of annual statistical reporting of the Member States by introducing elements covering:

− the number of genetically modified animals and of certain invertebrate species and foetal forms (excluding larvae)

− numbers of animals killed for the primary purpose of their organs and tissues to be used in scientific procedures

− numbers of projects and types of establishments − severity classes of the experiments to which animals have

been subjected

Option 1: Inclusion of genetically modified animals, some invertebrate species and foetal forms (excluding larvae) in the statistical reporting

An inclusion would provide more detailed information and thus be highly beneficial to a better monitoring of their use at Member States and EU level. Consequently, a moderately positive impact on the enhancement of national and European policy-making can be expected. Total costs for establishments concerning statistical reporting for transgenic animals and foetal and embryonic forms amount to 7.4 Million Euro.

25

Option 2: Inclusion of animals killed for the primary purpose of their organs and tissue to be used in experiments

An inclusion would provide more detailed information and thus be highly beneficial to a better monitoring of their use at Member States and EU level. Consequently, a moderately positive impact on the enhancement of national and European policy-making can be expected. Total costs for establishments for the reporting of 1.8 Mio. animals killed for their organs and tissue amount to 4 Million Euro pr year.

Option 3: Inclusion of numbers of projects and types of establishments in the statistical reporting

The inclusion would provide a more comprehensive picture on the overall number and structure of animal experimentation in Europe, thus contributing to a better monitoring at Member State and EU level. The associated costs would be negligible.

Option 4: Inclusion of severity classes to which animals have been subjected to in the statistical reporting

A better statistical reporting system including severity classification would contribute to better informed policy-making both at EU and national level. Since user establishments and Member States have no experience, cost quantification is not possible.

26

7. Level Playing Field Analysis

One of the key tasks of the Commission is to ensure that establishments are competing on an equivalent basis if they choose to operate beyond the limits of a national market. In the case of the revision of Directive 86/609 the challenge is twofold. On the one hand the Commission must attempt to create a level playing field by minimising existing obstacles, on the other hand the Commission must ensure that the revision does not create new obstacles.

Several options for the revision of the directive include measures to ensure a more level playing field within the European Union.

− Scope - The extension of the scope to cover animals used in basic research would bring associated costs in 5 Member States to the level of the remaining Member States, thus creating a level-playing field for all establishments in the EU.

− Authorisation - A requirement to respond to authorisation applications within a fixed period of time would converge processing times and project delays to a level playing field for all applicants in Europe.

− Ethical review – minimum requirements for Ethical evaluation and the introduction of a national review body would result in a less diverse competitive environment between different Member States.

− Housing and care - minimum standards would ensure a level playing field in the EU by reducing unfair competitive advantages for establishments in Member States which are not bound by the same standards.

− Education and training - requirements for competence combined with minimum elements for education and training would assist in reducing existing obstacles to cross-border mobility.

Currently the diverse requirements for education and training can be considered the most important obstacle to a level playing field in terms of the free movement of personnel. Different requirements for authorisation and ethical evaluation have a major impact into the costs as well as delays establishments are faced with depending on the Member State in which they operate. However, in the coming years the most challenging obstacle will be the potentially non-harmonised implementation of the ETS-123 housing and care guidelines. ETS-123 itself is not binding for Member States and implementation of the guidelines can be rather diverse among Member States. This would result in further distortion of the level playing field. Due to the high costs involved with the implementation,

27

the Commission should ensure that an adequate implementation through the directive is achieved.

The questionnaires that were distributed to stakeholders during the project did not provide further insight into the situation. Most stakeholders contacted could not identify additional obstacles to a level playing field from their personal experience. However, it remains undisputable that establishment operate today in a vastly variable regulatory environment which is catered for by additional resource allocation resulting in highly diverse cost structures and time delays.

28

8. Overview

Opt

ions

/Impa

cts

Ani

mal

Wel

fare

Impa

cts

Scie

ntifi

c Im

pact

s Pu

blic

/Soc

ieta

l Im

pact

s Ec

onom

ic Im

pact

s

Scop

e S

igni

fican

t pos

itive

wel

fare

effe

ct fo

r up

to 2

Mio

ani

mal

s

Incl

usio

n of

ani

mal

s br

ed fo

r org

ans

and

tissu

e ha

s sl

ight

pos

itive

impa

ct o

n th

e up

date

of a

ltern

ativ

e te

chni

ques

N

o di

rect

effe

ct

The

exte

nsio

n of

the

scop

e w

ould

le

ad to

13

Mio

Eur

o ad

ditio

nal c

osts

fo

r pub

lic a

utho

ritie

s

Aut

horis

atio

n N

o di

rect

effe

ct

Mod

erat

e po

sitiv

e im

pact

on

com

petit

iven

ess

of th

e E

urop

ean

rese

arch

/ in

dust

ry c

ompa

red

to th

ird c

ount

ries

Shi

ft fro

m in

divi

dual

to g

roup

aut

horis

atio

n w

ould

hav

e a

slig

htly

neg

ativ

e im

pact

on

the

publ

ic im

age

of re

sear

ch/ i

ndus

try

Ethi

cal R

evie

w

Com

puls

ory

ethi

cal e

valu

atio

n of

pr

ojec

ts w

ould

lead

to b

ette

r im

plem

enta

tion

of 3

Rs,

incl

udin

g a

redu

ctio

n of

371

.00

anim

als

used

Pos

itive

impa

ct d

ue to

add

ition

al

scru

tiny

of e

xper

imen

tal d

esig

n an

d st

atis

tical

ana

lysi

s

Sta

ndar

dise

d cr

iteria

wou

ld h

ave

a m

oder

ate

posi

tive

impa

ct o

n tra

nspa

renc

y an

d pu

blic

imag

e of

re

sear

ch/in

dust

ry

Hou

sing

and

C

are

Sig

nific

ant p

ositi

ve w

elfa

re e

ffect

for u

p to

12

.1 M

io a

nim

als

Impr

oved

hou

sing

and

car

e co

nditi

ons

wou

ld le

ad to

mor

e pr

ecis

e an

d re

liabl

e re

sults

of e

xper

imen

ts

Wou

ld c

ontri

bute

to p

ublic

imag

e of

es

tabl

ishm

ents

E

TS-1

23 w

ould

lead

to a

dditi

onal

yea

rly

cost

s of

37

Mio

. Eur

o fo

r est

sblis

hmen

ts

Tran

spar

ency

No

dire

ct e

ffect

N

o di

rect

effe

ct

Pub

licly

ava

ilabl

e N

on-te

chni

cal-s

umm

arie

s w

ould

sub

stan

tially

impr

ove

acco

unta

bilty

Cos

ts fo

r dra

fting

non

-tech

nica

l-sum

mar

ies

at e

stab

lishm

ent l

evel

wou

ld a

mou

nt to

52

0.00

0 E

uro

Non

-Hum

an

Prim

ates

Effe

ct n

ot a

sses

sed

Mov

e to

F2

gene

ratio

n an

d ba

n of

Gre

at

Ape

s w

ould

con

tribu

te to

pub

lic im

age

of th

e re

sear

ch/in

dust

ry

Ani

mal

cos

ts w

ould

incr

ease

Insp

ectio

ns

Mod

erat

e po

sitiv

e w

elfa

re e

ffect

for u

p to

12

.1 M

io a

nim

als

No

dire

ct e

ffect

S

tand

ardi

sed

insp

ectio

ns w

ould

cou

ntrib

ute

to th

e M

embe

r Sta

tes

(and

EU

) kno

wle

dge

of fu

nctio

ning

of t

he D

irect

ive

sta

ndar

dise

d in

spec

tions

wou

ld e

nsur

e a

leve

l-pla

ying

fiel

d fo

r all

acto

rs

Educ

atio

n an

d Tr

aini

ng

Mod

erat

e po

sitiv

e w

elfa

re e

ffect

for u

p to

12

.1 M

io a

nim

als

Min

imum

requ

irem

ents

for i

nitia

l com

pete

nce

wou

ld c

ontri

bute

to fr

ee e

xcha

nge

of

pers

onne

l bet

wee

n M

S a

nd q

ualit

y of

sci

ence

Wou

ld c

ontri

bute

to p

ublic

imag

e of

es

tabl

ishm

ents

Man

dato

ry re

fresh

men

t cou

rses

eve

ry

five

year

s w

ould

am

ount

to 3

8 M

io E

uro

for e

stab

lishm

ents

yea

rly

Dup

licat

ion

Slig

ht p

ositi

ve e

ffect

for a

nim

als

used

in b

asic

re

sear

ch, d

ue to

less

pub

licat

ion

bias

. N

o di

rect

effe

ct

No

dire

ct e

ffect

C

osts

for e

stab

lishm

ents

and

Mem

ber S

tate

s of

6.4

Mio

Eur

o pe

r yea

r.

CO

2 Th

e ef

fect

s ca

nnot

be

qual

ified

and

qu

antif

ied

due

to la

ck o

f inf

orm

atio

n ab

out

alte

rnat

ives

to C

O2

No

dire

ct e

ffect

N

o di

rect

effe

ct

Tota

l one

-tim

e in

vest

men

t cos

ts w

ould

am

ount

to 4

6 M

io E

uro

Stat

istic

al

Rep

ortin

g N

o di

rect

effe

ct

No

dire

ct e

ffect

W

ould

pro

vide

info

rmat

ion

for p

oliti

cal

deci

sion

mak

ing

and

cont

ribut

e to

pub

lic

imag

e of

est

ablis

hmen

ts

Cos

ts fo

r est

ablis

hmen

ts w

ould

am

ount

to

11.4

Mio

Eur

o pe

r yea

r

Impa

ct S

cale

S

igni

fican

t pos

itive

M

oder

ate

posi

tive

S

light

pos

itive

N

eutra

l S

light

neg

ativ

e M

oder

ate

nega

tive

S

igni

fican

t neg

ativ

e

Less

wild

ca

ught

ani

mal

s

Incr

ease

in s

ize

of b

reed

ing

colo

ny

Com

puls

ory

ethi

cal e

valu

atio

n of

pro

ject

s w

ould

cos

t 9 M

io

Eur

o bu

t avo

id u

njus

tifie

d pr

ojec

ts

and

rela

ted

cost

s of

70

Mio

Eur

o an

d w

ould

leve

l adm

inis

trativ

e co

st d

iffer

ence

s be

twee

n m

embe

r sta

tes R

etro

spec

tive

revi

ew

wou

ld c

ost 2

0 M

ioE

uro

Gro

up

auth

oris

atio

n w

ould

redu

ceco

sts

b y 2

1 M

io E

uro

Indi

vidu

al p

roje

ct a

utho

risat

ion

wou

ld in

crea

se c

osts

by

23.6

Mio

Eur

o

Cos

ts o

f up

to 4

Mio

Eur

o pe

r yea

r fo

r est

ablis

hmen

ts a

nd

Mem

ber S

tate

s