Directive 2010/63/EU of the European Parliament and of the Council from September 22^nd 2010 on the protection of animals used for scientific purposes (abbreviated as the Animal Experiments Directive) regulates animal experiments in the EU. The revised directive replaced the outdated 1986 regulations. The 27 member states had to transpose the EU requirements into national law by November 2012.

What are the main amendments?

• Extension of the scope of the directive
• Full replacement of all animal experiments set as goal
• Upper limit for pain and suffering
• Fear of animals recognized as suffering
• Authorization requirement for all animal experiments mandatory
• Protection for fetal forms of mammals
• Classification into severity levels introduced
• Retrospective assessment introduced for certain experiments
• Harm-benefit analysis / ethical consideration introduced / strengthened/…
• Authorities‘ review power strengthened
• Publication of experimental projects
• More comprehensive recording of animal numbers required.
• No stricter national regulations / Existing higher animal welfare standards retained

What are the practical consequences of these innovations?

After years of negotiations, the EU Animal Experiments Directive has undergone a major overhaul that strengthens animal welfare in many fields. With the extension of the scope, basic research and training are now also covered by the directive. Previously, it only applied to commercially oriented animal experiments.

• What has to be emphasized positively is that the replacement of animal experiments is formulated as the ultimate goal. Recital 10 of the Animal Experiments Directive states, "[...] However, this Directive represents an important step towards achieving the final goal of full replacement of procedures on live animals for scientific and educational purposes as soon as it is scientifically possible to do so." While this approach is still a long way from the urgent phase-out of animal testing we have long been calling for, it at least formulates the goal of moving away from animal testing.

• It is also a major achievement that there is an upper limit for pain and suffering above which an animal experiment should not be conducted. Recital 23 of the Directive states: " From an ethical standpoint, there should be an upper limit of pain, suffering, and distress to which animals can be subjected in scientific procedures. To that end, the performance of procedures that result in severe pain, suffering, or distress, which is likely to be long-lasting and cannot be ameliorated, should be prohibited." What is also new in this area is that the fear experienced by animals in the laboratory is explicitly taken into account as suffering. However, with a so-called safeguard clause, the EU leaves a loophole that allows member states to permit animal experiments above the pain-suffering threshold in justifiable exceptional cases.

• A project authorisation now applies to all animal experiments. The Animal Experiments Directive is particularly important for EU countries that previously had no approval procedures for animal experiments. Such project authorisations existed only in a few countries such as Germany, Sweden, and Denmark. Other countries now have had to introduce such procedures, which at least promises a certain degree of control and a regulation of procedures. With regard to Germany, animal experiments that previously had to be notified to the authorities, i.e. merely reported, such as legally required experimental projects as part of drug approval, will in future be subject to a simplified administrative procedure. This results in a potentially stronger possibility of examination by the authority. Animal experiments for training and further education, which were previously only subject to a notification procedure, are now subject to authorization.

• The Directive states that fetal forms of mammals from the last third of their development onwards, and cephalopods should potentially be protected.

• Animal experimentation procedures must be categorized into severity classifications based on the likely degree of pain, suffering, distress, and lasting harm inflicted on the animals. Severity classifications include "non-recovery [of vital functions (death under anaesthesia)]," "mild," "moderate," and "severe." It should be noted, however, that experimenters the severity classifications for their experiments themselves, which leads to suffering often being classified too low.

• A retrospective assessment has also been introduced. This does not apply to all animal experiments. Only experiments on primates and those that are categorized as "severe" must be subjected to a retrospective assessment. This involves checking whether the suffering of the animals (severity classification) was correctly classified and whether the intended benefit was fulfilled.

• The authorities' evaluation powers in the authorisation process for animal experiments have been strengthened. The EU directive stipulates that a comprehensive project evaluation, in which ethical considerations relating to the use of animals are taken into account, should form the core of the project authorization. For the project assessment, the EU stipulates that the authority may evaluate in detail appropriate to the type of project whether, for example, the project justifies the use of animals. An essential component of this is a harm-benefit analysis of the project, which assesses whether harm to animals in the form of suffering, pain, and distress is justified by the expected outcome, taking into account ethical considerations, and whether this expected outcome could potentially benefit humans, animals, or the environment.

• Some transparency is provided by the publication of project summaries. In Germany, these so-called Non-Technical Project summaries (NTP) of the experimental projects are published in a central database of the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) in anonymized form. These contain information on what happens to the animals as well as the severity of the experiments.

• The numbers of those animals, who are bred but not used in animal experimentation procedures and are therefore killed without use (so-called surplus animals including genetically modified animals) are recorded. For the first time in 2018 and every five years thereafter, the Member States had to submit the numbers of so-called surplus animals to the European Commission, which then publishes these data.

• One criticism is that the EU directive does not allow member states to enact stricter regulations than those of the directive. However, it does create a basis for a uniform, improved animal welfare standard across the EU. Existing, higher regulations may also be retained nationally.

History

Tug-of-war on the Animal Experiments Directive

In November 2008, the European Commission initially presented a draft for the Animal Experiments Directive which, although far away from our demands, such as phasing out of all animal experiments, at least contained positive aspects that would have represented further improvements. For example, it was originally planned to prohibit particularly painful animal experiments without exception and to at least restrict experiments on monkeys. The Commission also envisaged that so-called alternative methods be used if available, whereas now they would first have to be incorporated into international regulations, a process that takes many years. However, during the negotiations between the Commission, the Parliament, and the EU Council of Ministers, and under the influence of Germany (see section on "The German government as a proponent of animal experiments"), some plans were watered down.

The German government as a proponent of animal experiments

During the negotiations on the Animal Experiments Directive up to its implementation in German law (see section "Implementation of the Animal Experiments Directive in Germany"), the German government aided that some specifications were changed to the disadvantage of animal protection.

The draft originally submitted by the Commission demanded a project authorisation for all animal experiments, for example. Germany, however, introduced a simplified administrative procedure for legally required animal experiments and the production of substances (e.g. vaccines) in line with the German notification requirement, which represents a significant weakening of the draft. In relation to Germany, however, it represents an improvement of the former mere obligation to notify.

The Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF) exerted influence on the responsible Federal Ministry of Agriculture (Bundesministerium für Ernährung und Landwirtschaft, BMEL) and demanded that all experiments on monkeys - including great apes - and protected animal species, as well as experiments that cause prolonged, severe suffering and pain to the animals, be permitted, as such restrictions were incompatible with the freedom of research enshrined in the German constitution. Instead of a ban on such experiments, they are now, in principle, possible (see section "What do the innovations mean in practice?").

Implementation of the Animal Experiments Directive in Germany

The EU Directive should have been implemented in German law by November 2012. In January 2012, the German government had submitted drafts for a new Animal Welfare Act and for an Animal Experimentation Regulation. The Animal Welfare Act was completely inadequate but came into force after a long struggle and with a delay in July 2013.The new Animal Experiments Regulation came into force in August 2013. In some places, the animal welfare requirements set by the EU had been implemented to the disadvantage of the animals and the existing German animal welfare law had been undermined.

In 2018, the European Commission initiated an infringement procedure against Germany for the incorrect implementation and demanded appropriate corrections (see section "Infringement procedure"). Our association had already submitted a comprehensive complaint to the European Commission about two years earlier, in March 2016, for the inadequate implementation of the directive in Germany, which was contrary to animal protection. As early as 2012, together with five other animal rights organizations, we had commissioned an expert opinion from the renowned Basel lawyer Prof. Dr. iur. Anne Peters, which confirmed that the German government was not implementing the requirements of the EU Animal Experiments Regulation to the required extent and that the state objective of animal protection was being disregarded. Another expert report submitted by the German Bündnis 90/Die Grünen parliamentary group in 2016 also reveals serious violations in implementing the EU Animal Experiments Directive in Germany.

Due to the EU Commission's lengthy notification of deficiencies and the obvious animal welfare violations, Germany had to bow to the pressure, amend significant improvements in some areas, and eliminate animal welfare deficits. In 2021, with a delay of around 8 years, the responsible Federal Ministry of Food and Agriculture (BMEL) submitted a revised draft of the Animal Welfare Act in order to comply with the EU's request. In some fields, improvements were still lacking. Since 2021, a revised Animal Welfare Act and an Animal Experiments Regulation have been in force that have been improved in response to pressure from the EU, but they still contain deficiencies in terms of animal welfare - despite better knowledge of the German federal government.

Thus, the possible margin in favour of the animals, which the EU directive grants, is still not used. Experiments on great apes could be prohibited and research on non-human primates restricted. In addition, according to the EU's will, there should be an upper limit for pain, suffering, and distress from an ethical point of view, which may not be exceeded in scientific procedures. Germany, however, does not make use of the advantage of tightening the animal protection law and does not consider any restriction even for such experiments that are particularly heavily criticized. The sense of fear that the EU attributes to animals and that is to be taken into account in the approval of animal experiments is also still missing in the German implementation.

Our cooperation partner, the German Legal Society for Animal Protection Law e.V. (Deutsche Juristische Gesellschaft für Tierschutzrecht, DJGT), concludes that the federal government is obviously vehemently trying to make animal experimentation law as lax as it is actually no longer legally possible and is deaf to recommendations and demands from society, politics, and even the EU. DJGT therefore considers improvements to be necessary.

The new regulations have also made it necessary to revise the 1999’s Ordinance Notification of Laboratory Animals. It obliges institutions that conduct animal experiments to report certain data to the authority, such as the number of animals and the intended use of those animals. The BMEL presented a draft for this in August 2013, which came into force in 2021 after further amendments. Here, too, it is clear that the sole aim is to manage animal experiments and make them as convenient as possible for the experimenters' lobby. For example, fish and cephalopods can be reported on the basis of estimated numbers instead of specifying the exact number of animals. In the future, it will also no longer be possible to trace whether an animal comes from a breeding facility inside or outside of Germany, but only whether it comes from the EU or not.

Infringement procedure against Germany

In 2018, the EU Commission had initiated an infringement procedure against Germany for incorrect implementation of the European animal testing requirements. An EU Commission communication (1) from July 19, 2018 indicates that the EU has initiated infringement procedures against six member states, including Germany, for inadequate implementation of EU rules on the protection of animals used for scientific purposes into national law (Directive 2010/63/EU). In the case of Germany, the EU points to deficiencies in inspections, staff expertise, and the presence of veterinarians. One year later, the EU Commission (2) still criticized numerous deficits. German law remained inadequate, amongst others, in the fields of inspections, expertise, and administrative procedures to authorize project applications. Moreover, some provisions were missing altogether.

The EU Commission had listed more than twenty implementation errors and demanded their elimination. One of the most glaring errors, which the EU sharply criticized: the authority that has to approve an animal experiment is not allowed to check whether it is really essential and ethically justifiable. Under the previous German legal situation, the authorities’ hands were tied as they were not allowed to check the content of the information provided by the experimenter. The scope to which the authority was allowed to check was limited to a purely formal plausibility check.

 Another major shortcoming, which was clearly criticized by the EU, was that, contrary to the requirements of the Animal Experiments Directive, animal experiments required by law in Germany continued to be subject only to the obligation to notify. This means that they were merely to be reported to the authority, whereas the EU prescribes an authorization process for all animal experiments. After tough negotiations, some of the most serious errors were corrected in line with EU requirements. One can only speculate why the EU Commission discontinued the proceedings against Germany in 2022 despite ongoing animal welfare deficiencies.

Various activities

Demo in front of the EU Parliament in Strasbourg on March 9^th, 2009

From the very beginning, we have worked intensively with our European umbrella organization ECEAE and other animal rights organizations to ensure that the highest possible animal protection standards are enacted at the EU level and that these are not undermined in Germany. For as long as there is a lack of political will to completely phase out animal testing, it is important to at least limit the suffering of animals. Right from the start, we have clearly positioned ourselves on the design of the EU Animal Experiments Directive and its implementation in German law in a variety of ways. Our activities at the EU level in the context of our participation in the ECEAE as well as at the federal level include:

• Numerous statements, including to the Federal Ministry of Food, Agriculture and Consumer Protection (BMEL) and the state ministries
• On-site actions in Strasbourg, Brussels, and Berlin, among others
• Letter and postcard campaigns to all German Members of the European Parliament, among others
• Support of the citizens' initiative stopvivisection.eu
• Signature collections and handovers
• A campaign to end the forced swim test, demanding a ban on particularly painful animal experiments
• Commissioning of legal expert opinions
• Detailed discussion and handing over of signatures at the EU-Commission
• Two petitions in the Bundestag (German Parliament) for the correct implementation of the directive and for a ban on experiments with high severity resulting in a Bundestag hearing

...and many more!

Conclusion

With the Animal Experiments Directive, the EU has created a statement that in some points reveals the modern spirit of the times. It should not remain a mere administration of animal experiments - it is necessary to initiate concrete steps to reach the main goal of the EU to completely replace animal experiments. In order to turn this goal into practice, the EU must develop a phase-out plan for animal testing. The fact that the phase-out is not only scientifically required, but can also be politically motivated, is shown by some countries that have already developed strategies, such as the Netherlands, Sweden, and the USA. In September 2021, the EU Parliament passed a resolution calling on the EU Commission to present an action plan to phase out animal experiments with an overwhelming majority of 97 %. This resolution must now be followed by concrete action. A European Citizens' Initiative initiated by five European animal protection umbrella organizations, to which our NGO belongs, underlines this necessity, and demands a roadmap to phase out animal experimentation from the EU.

After a long period of hesitation of the German Federal Government, at least some positive specifications of the EU Directive were transferred into the German animal experimentation law. This was due to pressure from the EU, which is a result of tireless and long-standing demands of our NGO and numerous other organizations.

However, there is still a need for improvement. Particularly serious is the missing of a clear upper limit for pain and suffering in animal experiments in German law, which makes even the cruellest animal experiments possible.

A further revision of the German animal experimentation law is necessary in this respect. All the requests made in the infringement procedure must be implemented fully and correctly, and, in addition, the margin granted by the EU must be used with regard to animal protection. We will push for the new federal government to finally commit itself to animal protection and initiate action. With our targeted activities at all levels, we are committed to the highest level of animal protection and ultimately to an end to all animal experiments.

Dipl. Biol. Silke Strittmatter
28.02.2023