Legal aspects of research on animals

II. Legal aspects of research on animals

1. Legally prescribed animal experiments

Before certain products - such as drugs and pesticides - can be licensed for marketing their provider must demonstrate that they are not harmful to human health or the environment. Similar testing regulations exist for production processes, waste substances etc. Animal experiments are prescribed by law in some instances as an integral component of such safety checks.
A number of German laws contain regulations as to which products must be tested and how this is to be done before they can be brought to market. Yet many products are sold not only throughout Germany but also internationally, and they must therefore satisfy the safety standards of various countries. In order to avoid safety checks having to be repeated in every country where a particular product is sold, the countries agree upon testing procedures in accordance with which the safety checks are to be performed. The providers can then establish the product's safety under such a standard procedure and market it in all the countries that accept this procedure without having to conduct additional safety testing. Many EU-wide accepted testing procedures for the harmfulness and environmental compatibility of substances and production processes are contained in Annex V of the Directive on Classification, Packaging and Labelling of Dangerous Substances (67/548/EEC). The Organisation for Economic Cooperation and Development (OECD), an international trade organisation currently comprised of 32 member states, has also adopted recommendations for testing substances (OECD Guidelines for the Testing of Chemicals). Safety verification furnished in accordance with OECD standards is accepted in all OECD member states.

1.1. Legally prescribed animal experiments in Europe

On the European level there are a number of directives and regulations requiring animal experiments as part of the testing of substances and processes (Module 8). EU law takes precedence over national law in such cases. Providers may therefore be compelled by EU legislation to conduct animal experiments as part of safety checks, even if national laws do not require them.

1.2. Legally prescribed animal experiments in Germany

Animal experiments are also required by various German laws (see module National Laws). In addition, there are laws that require safety verification without defining the procedure under which such proof is to be furnished. In these instances regulations setting out such procedures are adopted by government or administrative agencies. Regulations may also specify animal experiments. Some legally prescribed animal experiments do not need any further approval (see below) but merely require declaration - in other words, they must be reported to the competent authority. Animal experiments for research purposes, on the other hand, are always subject to approval.

2. Legal provisions to protect laboratory animals

Both in Germany and in many other countries - and indeed on the EU level - there are not only regulations governing when animal experiments must be performed, but also regulations that serve to protect laboratory animals. Such regulations define who may conduct animal experiments, the purposes for which they may be performed, how the laboratory animals must be kept and how they are to be treated during and after the experiment.

2.1. Council of Europe and European Union

On the European level both the European Union (EU) and the Council of Europe have adopted provisions to protect laboratory animals.

2.1.1. Council of Europe

Created in 1949, the Council of Europe is an organisation of European states currently numbering 47 members. The goals of the Council of Europe include: protecting human rights, safeguarding the rule of law, and harmonising social and legal practices in the member countries.

European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes

On March 18, 1986 the Council of Europe adopted the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes (see module Convention of the Council of Europe). The Convention invokes the conviction that man has a "moral obligation" to respect all animals and to show "due consideration for their capacity for suffering and memory", yet at the same time it accepts that "man in his quest for knowledge, health and safety has a need to use animals" (see Preamble).
The Convention requires, for example, that animal experiments should only be performed if no alternative methods are available, i.e. if the goal of the experiment cannot be achieved without using laboratory animals (Art. 6). At the same time it calls upon the member states to promote research into other methods that could be used as an alternative to animal experiments (Art. 6, on the definition of alternative methods see below), thereby making it possible over time to increasingly replace animal experiments with alternative methods.
A specific authorisation or declaration is required for experiments that are likely to cause the animal considerable enduring pain (Art. 9). In order to avoid unnecessary repetition of multiple experiments the parties to the Convention further undertake (wherever possible) to recognise the results of procedures carried out by another contracting party (Art. 29). The Convention was signed by Germany on June 21, 1988 and it entered into force in Germany on November 1, 1991. 

2.1.2. European Union

The European Union is a grouping of European countries that currently numbers 27 member states. The member states transfer part of their sovereignty to the common organs of the EU. These are thereby empowered to take binding decisions for the member states in defined areas. The EU is authorised only to a limited extent to adopt animal welfare regulations: animal welfare is not - in contrast to environmental conservation - a community objective of the EU and it is therefore handled by the member states themselves. The EU may only adopt animal welfare regulations that are binding on all member states, if this serves to prevent trade barriers and distortions of competition arising in the Single European Market. For if the different EU countries were subject to regulations of differing severity regarding the keeping of production animals and laboratory animals, providers from countries with stricter requirements would be disadvantaged in the Single European Market due to the higher costs of production and keeping animals. In order to counter such disadvantages the EU may adopt animal welfare regulations that are binding upon all member states. However, not all the animal experiments performed have such "internal market relevance". For example, whether or not animal experiments are conducted in accordance with EU-wide standards as part of (further) education or in basic research at universities has no influence on the Single European Market. For this reason the EU cannot adopt regulations in these areas.

Directive 86/609/EEC

Directive 86/609/EEC (see module Directive 86/609/EEC) of November 24, 1986 is important for the subject "animal experiments". With respect to the provisions governing the origin, housing and care of laboratory animals, the requirements placed on persons and institutions that perform animal experiments and the standards for the conduct of experiments, the directive is based heavily on the Convention of the Council of Europe (see above). The directive similarly requires the reciprocal recognition of test results by the member states (Art. 22) and the non-use of animal experiments if alternative methods can yield the desired outcome (Art. 7). The contracting parties further undertake to promote the development and evaluation of alternative techniques (Art. 23, see below). The animal welfare standard prescribed by the EU is below the level of various national provisions. The contracting parties therefore retain the option of applying more rigorous national standards (Art. 24). The directive has been translated into national law: the German Animal Protection Act (Tierschutzgesetz) satisfies the requirements of the directive.

Resolution 86/C 331/02

Taking up the idea of ensuring that animals enjoy protection, the representatives of the governments of the member states of the European Union, meeting within the Council, published a resolution at the same time as Directive 86/609/EEC. This is intended to ensure that no less rigorous standards are applied to the conduct of animal experiments that do not fall within the scope of the Directive on Animal Experiments (for example as part of further education and training). In addition, the resolution requires that animal experiments in the member states should only be permitted for certain purposes and that animal experiments carried out as part of further education and training should principally be conducted at universities or other educational institutions of an equivalent level. Unlike the directive, the resolution has no legally binding force.

Reduction in the number of legally prescribed animal experiments

The member states of the European Union are obliged by both the Directive on Animal Experiments, Directive 86/609/EEC (Art. 23), and the corresponding Convention of the Council of Europe (Art. 6) to support research into the development of alternative methods. To this end centres exist on both the national and European level for the assessment of alternative and complementary methods (see module Alternative Methods). The reduction of unnecessary multiple tests through the re-use of test records from safety checks (see module Re-use of Test Documentation) is also intended to help minimise the number of legally prescribed animal experiments

European Constitution

On October 29, 2004 the heads of state and government of the EU member states signed a Treaty establishing a Constitution for Europe. The Protocol on Protection and Welfare of Animals dated October 2, 1997 (see module Protocol on Protection and Welfare of Animals dated October 2, 1997) was incorporated into the draft European Constitution as Article III-121. In the Protocol and Article the member states and the Community commit to "paying full regard to the welfare requirements of animals" when formulating and implementing Community policy, while respecting the legislative or administrative provisions and customs of the member states ("relating in particular to religious rites, cultural traditions and regional heritage"). It was originally envisaged that the European Constitution would come into force in 2006. However, following the draft constitution's rejection by the citizens of France and the Netherlands, the ratification process (i.e. the process by which the member states accept the treaty) has initially been extended until mid-2007.

2.2. Germany

As has already been mentioned, both the Convention on Animal Experiments of the Council of Europe and the EU Directive on Animal Experiments permit the contracting parties to adopt more rigorous national provisions governing the conduct of animal experiments in research. By international standards the corresponding provisions of the German Animal Protection Act (TierSchG) (see module Animal Protection Act) - principally §§ 7-9 - are considered relatively restrictive. The Act defines animal experiments as "procedures or treatments for experimental purposes" either "on animals, if they may entail pain, suffering" or "harm for such animals or on the genetic make-up of animals, if they may entail pain, suffering or harm for the genetically modified animals or their carriers" (§ 1 Para. 1).
Animal experiments are prohibited in Germany for certain research purposes, for example "for the development or testing of weapons, munitions and associated devices" (§ 7 Para. 4) or "for the development of tobacco products, detergents and cosmetics" (§ 7 Para. 4). On the other hand, they are permitted (1) for research into diseases, (2) for the identification of environmental hazards, (3) as toxicity tests and (4) in basic research (§ 7 Para. 2). In these research fields experiments on vertebrate animals are subject to approval (§ 8), meaning that an application for every single animal experiment must be filed with an approval agency. Experiments on invertebrates (see module Experiments on Invertebrate Animals), on the other hand, do not require approval but are merely subject to mandatory declaration in certain cases.
Two requirements, in particular, are scrutinised as part of the approval procedure: (1) the planned animal experiment must be indispensable for the attainment of the declared goal of the experiment (§ 7 Para. 2, § 9), and (2) the stresses on the laboratory animals must be ethically acceptable in view of the higher-order status of the experiment's purpose (§ 7 Para. 3).

Indispensability and ethical acceptability

An animal experiment is considered to be indispensable if a declared experimental goal cannot be achieved without it. The various aspects of the indispensability of an animal experiment are illustrated on the basis of the so-called 3R principle of experimental research (see module 3R principle of Russel and Burch) with animals: Replacement, Refinement, Reduction. If an experimental goal can also be achieved without recourse to animal experimentation, e.g. through the use of cell cultures or computer simulations, or through the use of animals that are lower on the phylogenetic family tree, the requirement for indispensability is not satisfied (replacement); animal experiments that could be avoided through improved statistical design of the research project (reduction), or that could be structured in such a way as to inflict less stress on test animals (refinement), are similarly not considered indispensable.
The second requirement, namely that the planned animal experiment must be ethically acceptable (see module Ethically Acceptable), is geared to the high-order status of the experiment's purpose. Experiments on vertebrates that lead to "protracted or repeated considerable pain or suffering" for the test animals are only considered to be justified if they are of "outstanding importance for vital needs of humans or animals, including the solving of scientific problems" (§ 7 Para. 3)

Approval procedures

Researchers planning an experiment involving vertebrate animals must submit a corresponding application for approval to the responsible medium-level authority (regional government, regional council) (§ 8, § 15 Animal Protection Act). Since 1986 the agency for expert assessment of experimental projects has been supported by a local Animal Protection Committee (§15 Animal Protection Act). It is envisaged that this should be composed predominantly of researchers who are able to arrive at an informed evaluation of the indispensability and ethical acceptability of animal experiments on the basis of their experience. One-third of the members must come from the recommended lists of animal welfare organisations. The verdict of the Animal Protection Committee is not binding on the approval agency.

Animal Protection Act and freedom of research

Although the Animal Protection Act prescribes mandatory approval for animal experiments in research, the legality of this provision has often been doubted in the past. Such doubts are founded on the fact that freedom of research is a fundamental right granted without qualification (Art. 5 Para. 3 Sentence 1, Basic Law [GG]). Unqualified fundamental rights cannot be restricted by simple laws, but only for the sake of other objects of constitutional protection.
Prior to 2002 animal welfare was not under constitutional protection and hence the Animal Protection Act was merely a simple law. In accordance with constitutional logic, it was therefore not possible to incorporate into it provisions aimed at restricting unqualified fundamental rights such as freedom of research (or equally religious freedom or artistic freedom). The question thus presented itself as to whether the legally prescribed approval practice might be unconstitutional. The question was not resolved by the courts, although in 1994 a corresponding question was brought before the Federal Constitutional Court (see module Federal Constitutional Court). In view of these concerns the authorities practised a "constitutionally compatible interpretation" of the Animal Protection Act, meaning that the approval agencies did not review applications on the basis of objective criteria (which would have been unconstitutional), but merely checked whether the applicant had demonstrated the indispensability and ethical acceptability in a scientifically plausible manner ("qualified plausibility check"). The opinion expressed in pertinent commentaries on the Animal Protection Act is that the task of the approval agencies changed with the adoption of animal protection as a constitutional goal. 

Animal protection as a constitutional goal

Constitutional goals are goals that a state sets for itself. Just like basic rights they constitute objects under constitutional protection, yet they differ from the former inasmuch as they do not establish a subjective right and are not enforceable.
Animal protection has been a constitutional goal since 2002. Art. 20a of the Basic Law states:
"Mindful also of its responsibility toward future generations, the state shall protect the natural bases of life and the animals by legislation and, in accordance with law and justice, by executive and judicial action, all within the framework of the constitutional order. "
The words "and animals" were only included in the existing article in 2002. Prior to this, i.e. from 1994 to 2002, Art. 20a was merely concerned with "protect[ing] ... natural resources" (environmental protection as a constitutional goal). The Joint Constitutional Commission of the Federal Parliament and Federal Council (Gemeinsame Verfassungskommission von Bundestag und Bundesrat), which was initiated in the context of constitutional reform following German reunification and ultimately spoke out in favour of environmental protection as a constitutional goal, had already contemplated animal protection as a constitutional goal (see module Animal Protection as a Constitutional Goal). However, it rejected a corresponding constitutional amendment. Its rejection was based upon the concern that animal protection as a constitutional goal would exceed the bounds of a constitution otherwise geared exclusively to humans and that this "shift in values" could have consequences more far-reaching than desired (module 21). The decisive factor in the constitutional amendment - eight years after this negative stance - was exclusively the striving "[to] strengthen the animal protection already standardised by simple law", since this could hitherto "scarcely be effectively enforced against other objects of legal protection with constitutional status, such as the freedom of research and academic freedom" (Parliament Printed Materials [BT-Drucks.] 14/9090).

Animal protection as a constitutional goal and animal experiments

Since animal protection has enjoyed constitutional status in Germany, legal provisions on animal welfare intended to restrict freedom of research are possible from a constitutional perspective. Yet there is dispute as to whether the already existing provisions governing the approval practice of agencies are automatically reinterpreted following the constitutional amendment. Two opposing positions are put forward.
Commentaries on the Animal Protection Act (and the court practice of Giessen Administrative Court (see module Court Practice of Giessen Administrative Court)) assume that with the designation of animal protection as a constitutional goal the temporary device of a "constitutionally compatible interpretation" of the Animal Protection Act was rendered superfluous. It is their supposition that it should therefore now be possible to interpret the corresponding paragraphs - even without amendment of the Act's wording - as a more far-reaching intervention in freedom of research. It would thus be incumbent upon agencies to subject the indispensability and ethical acceptability of animal experiments for which applications are submitted to objective scrutiny and no longer merely to check whether the applicant had demonstrated them in a scientifically justified manner. If this understanding establishes itself in approval practice, it is conceivable that in the future a considerably larger number of animal experiments will not be authorised.
The objection raised against this understanding is that the wording of the Act (now as before) states that an animal experiment is to be approved in those cases where the applicant has demonstrated its indispensability and ethical acceptability in a scientifically justified manner. Whilst it is true that after the constitutional amendment lawmakers can adopt more rigorous provisions governing animal welfare in research, it is not possible to interpret the existing text of the Act contrary to its wording.
It remains to be seen whether and if so to what extent the existing approval practice will change as a consequence of animal protection acquiring the status of a constitutional goal. In 2003 and 2004 a total of 16 applications to conduct experiments were rejected throughout Germany; in these cases the pain, suffering or harm to the test animals was categorised as ethically unacceptable in view of the research objective or the indispensability of the experiments was deemed not to have been sufficiently substantiated (cf. Tierschutzbericht 2005: 80). In 2001 and 2002 altogether 2 applications for experiments were rejected (see Tierschutzbericht 2003: 67).

2.3. Switzerland

Worldwide, Switzerland is the only country, which assigns a constitutional protection to the dignity of animals and which also ascribes dignity to plants. Article 80 of the Swiss federal constitution (see module Swiss federal constitution) contains regulations concerning the protection of animals. In 1992, the term “dignity of living beings” (see module Dignity of living beings) was integrated into the federal constitutions by means of article 120 (non-human gene technology), which refers to animals and plants. Section 2 of this article says that the “Confederation shall legislate on the use of reproductive and genetic material from animals, plants and other organisms. In doing so, it shall take account of the dignity of living beings as well as the safety of human beings, animals and the environment, and shall protect the genetic diversity of animal and plant species.” This article was codified for the first time in the Act on Genetic Engineering (see module Act on Genetic Engineering) of March 21, 2003 which, amongst others, is to “guarantee the dignity of living beings” (unofficial translation). The breeding of genetically modified animals is considered under the definition of animal experiments and is subject to authorization.
The term “dignity of living beings” has also been specified in the Protection of Animals Act (TSchG) (see module Protection of Animals Act and Protection of Animals Ordinance) of December 16, 2005, which was enacted in 2008, as well as in the Protection of Animals Ordinance (TSchV) (see module Protection of Animals Act and Protection of Animals Ordinance) of April 23, 2008; both of these almost exclusively refer to vertebrates. The Protection of Animals Act reads that the dignity was the “intrinsic value of the animal, which has to be respected in the handling of the animal. The dignity of the animal is being disrespected if a burdening of the animal cannot be justified by outweighing interests. A burdening is at hand if the animal is, in particular, being exposed to pain, suffering or damages, if it is being put into a state of fear or being humiliated, if its outer appearance or its capabilities are being intervened substantially or if it is being instrumentalized excessively.” (unofficial translation)
It is questionable how an animal detects whether it is being humiliated when it is not being afflicted with pain, suffering or damages and when it does not fear anything. Critics also put into question the intrusion into the outer appearance as additional human-subjective approach to the burdening. Animal experiments allow for restricted breaches of dignity: “Animal experiments, which cause the animal pain, suffering or damages, frighten it, substantially impair its well being or may disrespect its dignity in another manner, are to be constrained to the indispensible measure.” (Article 17) (unofficial translation).

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