What do legal texts say about 3Rs?

Link to Constitution

a) Art. 80 FC

Since 1973, animal welfare has been enshrined in the Federal Constitution as a state responsibility (today it is Art 80 of the Federal Constitution).

What does this article mean/what can we conclude from it for animal testing?

Considering that previously, animal welfare was only regulated at cantonal level – in cantonal laws - we can conclude that this codification (at that time in the form of Art. 25 FC, now Art. 80 FC) expressed the legislative will that animal welfare should be an independent constitutional principle, a matter of public interest and a state objective (Bolliger/Richner/Rüttimann/Stohner, Schweizer Tierschutzstrafrecht, p. 43 f; Michel, Rechtsgemeinschaft mit Tieren, p. 274).

The legislative process (i.e., the history of the article's creation) additionally reveals relevant facts about the intention behind the creation of this article.

In 1972, the Federal Council's message on the article, among other things: "In this area [animal testing] too, laboratory animals run the risk of suffering unnecessary and unjustifiable torment as mere objects. On the other hand, many people are developing a growing sense of responsibility for animals as fellow creatures. In recent years, the concept of animal welfare has gained considerable importance both nationally and internationally, and the recognition of the need to advocate for a “humane” existence for animals entrusted to humans is now widespread."

The intention of the legislature behind the creation of the animal welfare article in the constitution was, among other things, to ensure that laboratory animals are not treated as mere objects and are not subjected to unnecessary and irresponsible suffering. When creating Article 80 of the Federal Constitution (formerly Article 25), legislators had a pathocentric protection concept in mind: animals, as beings capable of suffering, should be protected for their own sake (St Galler Kommentar BV-Errass, N 14; Michel, Rechtsgemeinschaft mit Tieren, 275).

This legislative intention, which is reflected in the written text of the Constitution, must be taken into account in the application (interpretation) of ordinary animal welfare law.

b) Art. 120 FC

In 1992, the dignity of creatures was enshrined in Swiss constitutional law.

The legislator intended the dignity of creatures to be understood as a concept open to development, whereby biological findings on the one hand and ethical considerations on the other should be incorporated into this development (Michel, Rechtsgemeinschaft mit Tieren, p. 298).  It certainly includes the prohibition of complete instrumentalization of nonhuman living beings. Consequently, the purpose of enshrining the dignity of creatures is also to set limits on the ruthless and complete exploitation of animals by humans (Michel, Rechtsgemeinschaft mit Tieren, 298).

The Swiss Federal Court stated in it’s decision from 2009: "Even though it [the dignity of creatures] cannot and must not be equated with human dignity, it nevertheless requires that living beings in nature be reflected upon and valued in the same way as humans, at least in certain respects." (Read the Court's decision here.)

Link to the Animal Welfare Act

http://Link to the Animal Welfare Ordinance

a) Art. 18 para 1 AniWA: The authorisation requirement

What does this article mean/what can we conclude from it?

Animal testing can only be legally permitted if an authorisation has been applied for and granted. Unauthorised animal testing is prohibited and illegal.

From a research perspective, however, this also means that actions that would otherwise be prohibited (the intention of Art. 80 FC that carries the pathocentric protection concept means that no unnecessary suffering shall be caused) are permitted in exceptional cases if a licence has been granted.

From an administrative law perspective, the authorisation under Art. 18 AniWA is classified as a police authorisation. It formally legitimises the actions of a researcher under certain circumstances that no other citizen would ever be allowed to perform.

Art. 18 AniWA therefore also has an authorising/legitimising character.

The competent authority (veterinary office) has no discretion with regard to granting a licence. If the requirements are met, it must grant the licence; if they are not met, it may not grant the licence. It only has discretion in assessing whether the requirements are met (Hehemann, Genehmigung von Tierversuchen im Spannungsfeld von Tierschutz und Forschungsfreiheit, p. 244).

b) Art. 139 AniWO: The authorisation procedure

After being entered into the Animex program, applications are processed by the competent cantonal authority (usually the veterinary office of the canton in which the experiment is to take place).

As a first step, the cantonal authority decides whether the animal experiment is non-stressful or stressful.

The authority itself decides on the approval of non-stressful animal experiments.

Only in the case of stressful animal experiments does it consult the Animal Experimentation Commission.

The animal experimentation commission then reviews the application to ensure that it meets the legal requirements (listed in Art. 140 AniWO). Only if the animal experimentation commission considers these requirements to be met does it submit an application for approval to the cantonal authority.

c) Art. 140 AniWO: The requirements

Art. 140 AniWO specifies the requirements that the cantonal animal experimentation commission must examine when reviewing an application for a stressful animal experiment.

Eight criteria are listed (a-h).

The most relevant and most complex requirements to examine are the first two:

-             Art. 140 (1) a.: Indispensability

-             Art. 140 (1) b.: Balancing of interests

d) Art. 17 AniWA: The indispensability

The indispensability requirement.

What does this article (this principle) mean/what can we conclude from it?

Only animal experiments that are indispensable are legally permitted. Conversely, this means that all animal experiments that are not indispensable are legally prohibited (illegal).

The legislature hereby declares (also in conjunction with 137 (2) AniWO) animal testing to be a method of last resort (ultima ratio) (as pointed out by the Federal Court in 2009, BGE 135 II 384 p. 394, 3.2.3, writing “It [animal testing] should remain a method of last resort.”).

This principle in Swiss law addresses all three Rs of the 3Rs principle. This means that any experiment that is not essential, i.e. that can be replaced or dispensed with (replacement), or any experiment that exceeds the essential level in terms of number or stress (reduction and refinement), may not be carried out.

Who checks whether the indispensability requirement has been met? The cantonal animal experimentation commission (Art. 139 (4) AniWO).

Criteria that help to examine the indispensability are written down in Art. 137 (2 – 4) AniWO.

e) Art. 137 para 2 AniWO

What does the article mean?

The principle of ‘replacement’ is clearly stipulated.

Alternative methods scientifically equivalent to animal experiments shall be given priority (Hehemann, Genehmigung von Tierversuchen im Spannungsfeld, 252). Applicants are obliged to provide evidence that the experiment’s aim cannot be achieved using methods that do not involve the use of animals. The applicant must demonstrate a detailed search of the current data pools, databases, and journals. The ECVAM and ZEBET databases and those of SNCAT and SAMW must also be consulted. Alternatively, a biometric expert opinion can proof the indispensability of conducting animal testing. The competent cantonal animal experiment commission then comprehensively reviews the information provided (Hehemann, Genehmigung von Tierversuchen im Spannungsfeld, 252).

Researchers must be aware of: It is their responsibility to find out whether animal testing could be replaced. Only if researchers come to the conclusion that this is demonstrably not the case they should continue planning and submit an application.

Authorities must be aware of: An application that does not prove irreplaceability must be rejected. The authority is bound by law and would create unlawful conditions if it approved replaceable animal experiments. However, its task is to ensure lawful conditions.

Politics/University policies must be aware of: framework conditions must be created in which compliance with the legally binding replacement principle is possible.

On the one hand, it must be made easy to obtain information about alternative ways of gaining the desired knowledge, e.g. through high quality and well managed databases on animal and alternative methods. On the other hand, it must be ensured that researchers are already informed about alternative methods through their training/early stage curriculum so that they can think and plan in an open-minded way.  Otherwise, the principle of last resort intended by the legislator would be undermined.

Art. 137 para 4 a AniWO

Reduction and refinement are clearly prescribed as mandatory and not optional requirements.

Like replacement, the principles of reduction and refinement are not ethical ideals, but applicable law. If they are not consistently applied, an experiment is unlawful.

g) Art. 19 para 4 AniWA: The weighing of interests (harm benefit analysis)

What does this paragraph mean / what can we conclude from it:

An experiment is only lawful if a weighing of interests between the expected gain in knowledge and the burden on the animal caused results in favour of the expected gain in knowledge (i.e. if the latter outweighs the suffering caused and the latter therefore appears proportionate).

All other experiments in which the suffering outweighs the expected gain in knowledge are unlawful and may not be approved.

Already in the planning stage of the experiment, it should be weighed up whether the expected gain in knowledge justifies the suffering.

In case of stressful animal experiments the weighing of interests (in the authorisation process) is carried out by the cantonal animal experimentation commission (Art. 139 (4) AniWA).

Although the applicant must carry out a comprehensive weighing of interests and provide detailed justification in it’s application, this only forms the basis for the commission’s decision.  The deciding commission is not bound by this justification. Instead the commission may and must investigate completely independently and come to its own and independent conclusion (Lüthi, Prüfungsbefugnis der Bewilligungsbehörden im Bereich Tierversuche, Journal of Animal Law, Ethics and One Health (LEOH), 13-14).

What is weighed against each other and how?

It is not correct to do an abstract weighing of the constitutional goods as the freedom of research (fundamental right) versus animal welfare (state responsibility).

Instead it must be weighed the very concrete expected knowledge gain against the expected harm to the animal (in the form of pain, suffering, damage, fear and non-pathocentric harms).

So, first, both interests involved must be determined and weighed.

The determination of both interests involves forecasts.

As a first step, the expected damage must be determined (Hehemann, Genehmigung von Tierversuchen im Spannungsfeld, 256).

Not only the stress caused during the experiment, but also all preparatory and follow-up measures that cause pain, suffering, fear, or harm, or otherwise impair the well-being and dignity of the animal, must be evaluated as well as the duration of the experiment, type and number of animals used and the conditions of husbandry (Hehemann, Genehmigung von Tierversuchen im Spannungsfeld, 255.).

All these criteria lead to a classification of severity degree 0-3 according to Art. 24 FSVO Ordinance on Laboratory Animal Husbandry, the Production of Genetically Modified Animals and Methods of Animal Experimentation.

As a second step, the expectable knowledge gain must be determined.

On the benefits side, the expected gain in knowledge, the probability of the benefits occurring, and the time it will take for the benefits to occur must be determined.

Now that two more specific and weighted interests have been identified, they must be weighed against each other. And how:

The guidelines developed by the Swiss Federal Commission for Animal Experiments (EKTV) describe the weighing of interests in such a way that an infringement of animal dignity – and thus the harm caused – must be assessed more strictly the more serious the infringement is for the animal concerned and the more insignificant or dispensable it is for humans, and vice versa: the more significant the expectable knowledge is, the more harm may be justified (Hehemann, Genehmigung von Tierversuchen im Spannungsfeld, 259).

If there is a disproportion between intensity of harm and the expected knowledge gain, the experiment may not be authorised and may not be carried out.

The weighing of interests must be carried out on two levels.
The first level is that of planning/submission of the experiment: In the national application form (Form A) all applicants are required to weigh up the interests and may for this use the self-evaluation tool, developed by SAMW and SCNAT (Gerritsen, Güterabwägung, 6.2.3., p. 308). The second (new and independent from the first one) weighing of interests happens at the level of decision in the cantonal auhtority (the commission).

h) Art. 24 FSVO Ordinance on Laboratory Animal Husbandry, the Production of Genetically Modified Animals and Methods of Animal Experimentation