Animal Experimentation in Basic Research – Current Discussion and Implications of the Latest Jurisprudence in Switzerland[1]

Abstract

Keywords

Basic research, animal experimentation law, harm-benefit analysis, case law, approval procedure

Suggested Citation Style

Lüthi, Nicole, Stoykova, Katerina and Michel, Margot (2024). Animal Experimentation in Basic Research – Current Discussion and Implications of the Latest Jurisprudence in Switzerland. Journal of Animal Law, Ethics and One Health (LEOH), 99-112. DOI: 10.58590/leoh.2024.007

Correspondence

Prof. Dr. iur. Margot Michel, Implementation of the 3Rs in Swiss Law, Faculty of Law, University of Zurich, Freiestrasse 15, 8032 Zurich, Switzerland (margot.michel@ius.uzh.ch)

*       M.A. HSG, PhD Candidate, Faculty of Law, University of Zurich, Switzerland

**    lic. iur., PhD Candidate, Faculty of Law, University of Zurich, Switzerland

*** Prof. Dr. iur., Chair of Private and Comparative Law, Animal Welfare Law and Philosophy of Law, Faculty of Law, University of Zurich, Switzerland

Content

• I. Introduction
• II. Harm-Benefit Analysis as a Core Element of Animal Experimentation Law and its Meaning for Basic Research
• III. Court Decision VB.2021.00276 (Zebra Finch Decision)
• 1. Facts of the Case
• 2. Considerations of the Court
• IV. Commentary
• V. Concluding Remarks

I.                Introduction

In recent years there has been an apparent political trend, particularly in Europe and the United States, to phase out or at least significantly reduce the use and harm of animals in research. For instance, the United States Food and Drug Administration established a New Alternative Methods Program in 2022 to advance the development and regulation of animal-free research methods.[2] The European Commission (EC) has recently reaffirmed its desire to modernize science in the European Union (EU) and promote the development of alternatives, with the clear objective “to accelerate the reduction of animal testing”[3] as a response to the European Citizens’ Initiative Save Cruelty Free Cosmetics – Commit to a Europe Without Animal Testing.[4] In Switzerland, the Federal Council initiated the 79th National Research Program “Advancing 3R – Animals, Research, and Society” in 2021 with a comparable objective.[5] Additionally, over 80 motions and proposals have been submitted to Parliament[6] and four popular initiatives[7] regarding animal experimentation have been voted on since 1985.

Despite these political endeavors, the number of animals used in experiments remains high. In Switzerland, these numbers have remained relatively stable over recent years, with a slight increase since 2020.[8] The majority of research animals are used for basic research experiments. In 2022, approximately 60 percent of the 585,991 animals used in experiments were used for basic research.[9] Furthermore, the number of animals subjected to the most severe harm (severity grade[10] 3) has more than doubled over the past decade, with basic research currently accounting for almost 80 percent of these experiments.[11] Notably, the use of animals within severity grade 3 experiments in basic research has been rising continuously for the past ten years.[12] The discrepancy between the political objective of reducing the number of animal experiments and their severity on the one hand, and the current number of animals affected by severe harm on the other hand, is therefore particularly evident in the context of basic research. For this reason, basic research is an ongoing public topic[13] – and, more recently, legal debate in Switzerland and Germany.[14] These discussions predominantly focus on basic research experiments that impose significant harm on laboratory animals without demonstrating concrete benefits.

The following article examines the recent decision of the Zurich Administrative Court regarding a severely harmful animal experiment. Taking this decision as a starting point, this article analyzes and contextualizes recent Swiss case law, assessing its implications for basic research. The concept of the harm-benefit analysis, a key part of animal experimentation law that emerged from a balancing of interests during the democratic legislative process, is of the utmost importance in understanding the Court’s decision. Therefore, this concept will be discussed first in terms of its significance and in the context of basic research.

II.               Harm-Benefit Analysis as a Core Element of Animal Experimentation Law and its Meaning for Basic Research

Swiss animal experimentation legislation and statistics do not define the term “basic research”. In comparison, the EU Directive 2010/63/EU[15] distinguishes between basic research and other types of research in its Article 5 on the permissible purposes of experiments.[16] While the Directive itself does not further explain the meaning of basic research, an extensive definition can be found in the Commission Implementing Decision 2012/707/EU.[17] Therefore, basic research “includes studies of a fundamental nature including physiology, (…) that are designed to add knowledge about normal and abnormal structure, functioning and behavior of living organisms and [the] environment” (Annex II, B.9.i of the Implementing Decision). Similarly, basic research is commonly understood in the literature as research that has no specific purpose and is not conducted for (immediate) practical application but focuses primarily on knowledge gain,[18] for which a later application is possible but not yet foreseeable. As many authors have observed,[19] and has also been reflected in the jurisprudence of the Federal Supreme Court of 2009, it is often difficult to draw a strict distinction between basic and applied research, as there are complex interrelationships between the two. Therefore, the distinction between basic and applied research is mostly considered outdated. However, it remains practically relevant as a reference point.[20] The determining factor in this regard appears to be whether the research primarily aims to achieve a practical application or whether it is undertaken to gain a wider understanding of a certain scientific field.[21]

Swiss animal experimentation law does not make this distinction and applies a uniform understanding of research, treating applied and basic research similarly. Nevertheless, there are references to basic research in other regulations. A legal definition of the term, which is largely consistent with the usage of these terms in both literature and jurisprudence, can be found in the Federal Act on the Promotion of Research and Innovation (RIPA[22]), which defines basic research as research with the primary aim of knowledge gain (Art. 2 lit. a No. 1 RIPA) and applied research as research that aims to find solutions to practical problems (Art. 2 lit. a no. 2 RIPA).

In any case, all research projects involving animals, whether basic or applied research, must be approved by the competent cantonal approval authority (Art. 18 para. 1 AniWA[23]), which is advised by a cantonal animal experimentation committee (Art. 34 para. 2 AniWA).[24] One of the main tasks of the approval authorities and the committees is to conduct a thorough harm-benefit analysis before granting or rejecting a request for an experiment.[25] The harm-benefit analysis, integral to most Western legal and ethical frameworks,[26] is generally understood as the obligation to balance the interests at stake in each individual case. With regards to animal experimentation, it means finding a balance between the suffering of the animals concerned and the benefit of the experiment in question.[27]

In Swiss law, the harm-benefit analysis is enshrined as a legally binding principle, reflecting a democratic process in which various stakeholders were given the chance to express their positions.[28] In Switzerland, a detailed legislative procedure takes place before enacting any federal regulation (Art. 3 lit. b CPA[29] in connection with Art. 164 para. 1 Cst.[30]). This involves a comprehensive consultation process, managed by the competent federal office, in which the views and opinions of a diverse range of stakeholders on a preliminary draft law are consulted and integrated into the final draft. This comprehensive negotiation process, known as the consultation procedure, ensures that the draft law is widely endorsed and supported (cf. Art. 2 CPA). Finally, Parliament must pass the draft in a democratic process. Additionally, all federal laws are subject to an optional referendum (Art. 141 lit. a Cst.).[31] The adoption of laws through this democratic legislative process enjoys broad democratic legitimacy. It is binding for those applying the law, including courts and other authorities (Art. 190 Cst.).

With the legislator acting within the scope of its legislative powers in this field (Art. 80 para. 2 lit. b Cst.), the current legislation on animal experimentation is thus the result of a weighing of the relevant constitutionally protected interests during the democratic legislation process – namely freedom of research (Art. 20 Cst.) and the protection of animal dignity and welfare (Art. 120 para. 2 and Art. 80 Cst.). As a result of this consultation procedure, the criterion of the “indispensable minimum” was introduced into Swiss animal experimentation law (Art. 17 AniWA), limiting the extent to which freedom of research can be exercised to the objectives and further requirements stipulated in Art. 137 AniPO.[32] This initial balancing of interests is fleshed out in the form of a harm-benefit analysis as described in Art. 19 para. 4 AniWA, the centerpiece of the animal experimentation approval procedure. 

As previously stated, federal laws are binding for authorities applying the law (Art. 190 Cst.), which is also true for authorities involved in the approval procedure for an animal experiment. It is crucial to highlight that, at this stage, the relevant constitutionally protected interests are no longer subject to consideration, as the legislator has already weighed them up. Thus, there is no room for a juxtaposition of constitutional interests within the scope of the harm-benefit analysis; rather, the gain in knowledge expected to result from a specific, individually requested experiment – taking into account its societal benefit and the prospect of its realization – is weighed against the level and amount of harm inflicted on the animals involved.[33]

Therefore, an (individual) animal experiment is only permissible if the anticipated benefit resulting from it – which must be defined as precisely as possible – outweighs the pain, suffering, harm, or fear that the animals are expected to experience. Or, vice versa, and in the word of the law, which lays down the harm-benefit analysis as a fundamental principle of animal experimentation law:

“An animal experiment is impermissible in particular if the pain, suffering or harm it involves or anxiety it induces is disproportionate to the anticipated gain in knowledge.” (Art. 19 Abs. 4 AniWA)

From this, it necessarily follows that the more harmful an experiment is, the greater the anticipated benefit must be to justify it.[34] Accordingly, an experiment within the highest severity grade (severity grade 3) must have a more significant, realistic, and useful benefit than an experiment involving only mild stress (severity grade 1).[35]

A methodically correct harm-benefit analysis does not allow for mere speculation about benefit and harm; it requires a realistic evaluation of the benefits and harms of an experiment. The evaluation of the anticipated benefit of a specific experiment can be especially challenging in basic research where their extent and significance are often uncertain and can only be assessed in the long run.[36] But without a quantifiable benefit, there is nothing by which to measure the harm to the experimental animals. However, the legislation lays down the same conditions for both applied and basic research. Therefore, basic research cannot “escape” the harm-benefit analysis provided for in Art. 19 para. 4 AniWA.[37]

III.             Court Decision VB.2021.00276 (Zebra Finch Decision)

1.               Facts of the Case

In its ruling of November 24, 2022,[38] the Zurich Administrative Court dealt with an application for approval of an animal experiment on zebra finches and upheld the appeal of three members of the Zurich Animal Experimentation Committee[39] as it did not grant permission for the experiment. 

The experiment would have consisted of genetically modifying the birds’ brain cells to produce certain proteins that can be activated or deactivated by light, depending on the wavelength. The primary goal of the experiment was to understand the brain mechanisms responsible for the planning, preparation, and production of birdsong. The long-term goal, defined by the researchers, was to gain new insights into human language acquisition.[40]

In the proposed experiment, more than 100 zebra finches would have been subjected to cranial surgery and then connected to a cable via an implant attached to their head for eight to nine hours twice over a period of ten days. In addition, the birds would have been isolated in a “tethering cage” repeatedly, sometimes overnight. After the experiment, most of the animals would have been euthanized.[41]

In its capacity as the licensing authority, the Veterinary Office of the Canton of Zurich classified the experiment under the highest severity category (severity grade 3) and approved it at the request of the Animal Experimentation Committee, albeit with conditions. Subsequently, three members of the Committee appealed to the Health Directorate against the decision and demanded not to grant the permit for the experiment. The Health Directorate rejected the appeal, after which the appellants took the case to the Administrative Court of Zurich.[42] The decision has not been contested and is final.

2.               Considerations of the Court

In its considerations, the Court classified the experiment in question as basic research, as its purpose was to gain new knowledge about fundamental life processes in zebra finches (cf. Art. 137 para. 1 lit. b AniPO). In doing so, the court followed the case law of the Swiss Federal Supreme Court concerning harmful experiments on primates.[43] In these landmark rulings of 2009, the Swiss Federal Supreme Court reaffirmed that animal experimentation is permissible only as a “last resort” (ultima ratio) and must be strictly limited to the “indispensable minimum”.[44] The criterion of indispensability demands that animal experiments that inflict pain, suffering, or harm on animals, induce anxiety in them, substantially impair their general well-being, or may disregard their dignity in any other way, must be limited to the indispensable minimum (Art. 17 AniWA). Indispensability imposes a more stringent restriction on the permissibility of animal experiments than the reference to e.g., necessity, reasonableness, usefulness, or meaningfulness of an experiment.[45] In particular, it also includes the obligation to use alternative methods and procedures, which is anchored in both the Animal Welfare Act (Art. 20 para. 2 AniWA) and the Animal Protection Ordinance (Art. 137 para. 2 AniPO).[46] Considering the indispensable minimum, the weight of knowledge gain is reduced in the harm-benefit analysis – particularly in basic research, where the long-term goals and potential clinical applications are highly uncertain and would require numerous additional animal experiments –, especially if the harm to the animals is significant.[47]

Analogous to the precedents set by the Federal Supreme Court, the Administrative Court first addressed the permissible research objectives (cf. Art. 137 para. 1 AniPO). It ultimately concluded that, although the Animal Welfare Ordinance does not specify a fundamental hierarchy of experimental objectives, it does allow for prioritization.[48] In light of the Swiss Constitution, the protection of human life and health as a research objective must therefore be given priority over the research objective of acquiring knowledge about fundamental life processes.[49] For basic research, this means that an experiment merely designed to gain new knowledge is given less weight than one designed to learn about human health or alleviate human or animal suffering in a clinical setting (“clinical benefit”). Therefore, the benefit of a (basic) research project involving animal experimentation must be determined based on a “subject-specific assessment of the research objective and the scientific nature of the method”.[50]

In principle, the benefit of a basic research project is determined by the potential for future (clinical) application of the experimental findings.[51] However, the Court was aware that, under this premise, it is particularly difficult to assess the benefits of basic research experiments as they are often not yet directly connected to a specific clinical application. However, the Court also held that the potential and future benefits of basic research should be factored into the harm-benefit analysis, as far as they are scientifically substantiated.[52] Thus, this ruling indicates that basic research experiments are not automatically inadmissible.

This becomes evident if the harm-benefit analysis is regarded as a scale. The permissibility of an experiment requires that the scale tips in favor of the expected benefit, meaning that the latter must “weigh” more than the harm. Consequently, the more severe the harm imposed on the animals, the more detailed and substantiated the anticipated benefit must be. As previously discussed, this conclusion is explicitly reflected in the wording of the law, as Art. 19 para. 4 AniWA requires a balancing of the animals’ pain, suffering, harm, or anxiety with the expected gain in knowledge, and only permits animal experiments if the latter outweighs the former. Any deviation from this conclusion would undermine the normative essence of the harm-benefit analysis, effectively allowing any human interest to justify the infliction of severe harm. Therefore, in line with Federal Supreme Court case law, the Court held that the bar for approval (in basic research) must be set very high if, on one end of the proverbial scale, the potential benefits are uncertain and may require numerous additional animal experiments, and, on the other end of the scale, the harm to the animals is very significant.[53]

The Court took the view that sufficient proof had been provided to demonstrate that the knowledge gained from the experiment in question could be potentially extrapolated to humans. However, it noted that no specific timeframe for the realization of an expected clinical application had been given. The Court held that the approval authorities and the Health Directorate (‘lower instance’) had given too much weight to the anticipated benefits of the experiment in question when balancing them against the harm to the zebra finches.[54] The experiment in question was part of a larger project consisting of multiple animal experiments, which was funded by the American National Institute of Health (NIH).[55] The Court criticized the approval authorities and the lower instance for overestimating the potential benefits of the umbrella project, considering the unlawful juxtaposition of the benefits “resulting from a chain of animal experiments” and the animal suffering caused by the specific experiment in question.[56] The Court held that the scientific benefit had been exaggerated and therefore the experiment would cause disproportionate suffering to the zebra finches. Consequently, the experiment was deemed inadmissible.[57]

IV.             Commentary

The most recent case law of the cantonal Administrative Court has confirmed what is already established based on existing legislation and earlier Federal Supreme Court case law: Harmful animal experiments (i.e., severity grades 1–3) must be limited to the “indispensable minimum” (Art. 17 AniWA), which must be examined for each proposed animal experiment individually.[58] To this end, experiments may only serve to pursue one or more of the research objectives listed in Art. 137 para. 1 AniPO: The applicant must demonstrate that the research objective is either related to the preservation or protection of human and animal life and health (lit. a); that it can be expected to provide new knowledge about fundamental life processes (lit. b); or that it serves to protect the natural environment (lit. c). Experiments conducted to gain new knowledge about fundamental life processes are generally considered part of basic research.[59] 

Although these research objectives leave ample room for interpretation, they derive from a binding limitation set by the legislator as to what type of experimental objectives could potentially justify harm to animals. This indicates that not every conceivable gain in knowledge can be a legitimate objective of an experiment. Rather, based on the premise that harmful experiments must be limited to the “indispensable minimum”, animal experimentation must always entail a benefit for society.[60] In other words, the public must derive a benefit from the experiment in question that relates to the protection or improvement of human or animal health and life, e.g., a cure for a certain disease. Thus, while any gain in knowledge is of scientific interest, it does not necessarily translate into a societal benefit.[61] In this sense, the reference to “fundamental life processes” at least hints at eventual application to improve human and animal health and life.[62]

While Art. 137 AniPO does not explicitly establish a hierarchy for research purposes, not all listed purposes are of equal importance. Therefore, in line with the jurisprudence of the Federal Supreme Court in 2009, the Zurich Administrative Court found that it follows from a constitutional interpretation that the objectives cannot be given equal weight. The protection of human life and health as a research objective (Art. 137 para. 1 lit. a AniPO) is therefore of greater importance than the “mere” gain of new knowledge about fundamental life processes.[63] For example, compared to toxicity testing on animals as part of applied research (whereby action is taken to prevent hazards or toxicity in humans, animals, or the environment), basic research lacks this preventive component.[64] In other words, the significance of new insights that are not aimed at protecting human and animal health and life is, relatively speaking, low.[65] The Federal Food Safety and Veterinary Office (FSVO) refers to a “relative weighting” in this context.[66] The same holds for applied research that “only” aims to protect the environment (Art. 137 para. 1 lit. c AniPO). Any other interpretation would contradict the intention of the legislator to only allow animal testing as an “ultima ratio” and very last resort, made clear by imposing a stringent standard requiring indispensability.[67]

In this regard, it is important to note that mere curiosity or a desire for knowledge alone cannot justify animal experiments under current law. Instead, such experiments must always aim to generate “knowledge about fundamental life processes.” In light of the “indispensable minimum” (Art. 17 AniWA), basic research is unjustifiable if it is purely curiosity-driven[68] and only serves to quench a personal thirst for knowledge without any intention of translating the results into a clinical context.[69] As stated above, both basic and applied animal research must aim to produce important societal benefits and serve interests other than gaining knowledge, such as the protection of life and health of humans and animals; there is no other justification for the associated interference with protected legal interests. Otherwise, they do not meet the indispensability criterion and are therefore inadmissible to begin with.[70]

However, the presence of a legitimate research objective and a societal benefit is not sufficient to deem an experiment “indispensable”. Rather, as stated above, a harm-benefit analysis must be conducted on a case-by-case basis.[71] Regarding the benefit, as the Administrative Court astutely points out, it is acceptable to factor in the anticipation of an indirect “clinical benefit” (i.e., a future clinical application) if there is a sufficient scientific basis for doing so.[72] If the latter cannot be proven, the probability of generating a concrete benefit must be denied and the benefit is to be given very little weight.[73]

Furthermore, according to the Administrative Court (as well as the Federal Supreme Court), mediate benefits that are expected to result from a chain of multiple experiments and additional research cannot be directly weighed against the suffering caused by the experiment under assessment. Rather, the harm-benefit analysis is limited to assessing whether there is scientific reason to expect a (clinical) application of the insights gained from the specific experiment in question. It is, therefore, also important to consider whether the potential (clinical) application can be achieved within a foreseeable time frame.[74] In other words, the less clarity is provided as to the chances of a future (clinical) application, the less weight the benefit should be given in the balancing of interests.[75] Additionally, the Court emphasized that the question of how the results of an experiment transfer to humans influence the weight of a certain benefit, which must be scientifically substantiated.[76] Consequently, experiments on and with animals that only aim at new knowledge about fundamental life processes with an uncertain benefit cannot be justified if they cause severe harm to experimental animals (i.e., severity grade 3).[77]

Although the Court remains rather vague in this regard, the ruling indicates that it is at least questionable whether animal experiments aimed at gaining new knowledge about fundamental life processes without a concrete benefit can outweigh (severe) harm to animals. Of course, each experiment must continue to undergo an extensive harm-benefit analysis. However, the threshold for such experiments with only a vague benefit must be set high – or higher, in any case –, than for experiments that promise immediately applicable (clinical) findings.[78] This is already reflected in the 2009 Federal Supreme Court ruling: in the case in question, the benefit expected to result from the gain in knowledge was considered insignificant – both because the experiment was planned in the field of basic research and because of the uncertainty as to a future clinical application of the benefit – and the harm to the animals was relatively high (severity grade 2).[79] The Federal Supreme Court gave additional weight to animal suffering because of the primates' genetic closeness to humans and the legislative hierarchy of animal species (e.g., Art. 2 para 1, Art. 20 para 2 AniWA[80]). However, by finding that the harm to the animals was relatively high and the expected benefit low in comparison, the Court had already tipped the scales in favor of the animals. Since the harm was classified as severity grade 2 – and not the highest severity grade 3 – the fact that the animals were primates tipped the scales just a bit further in their favor, without this being the decisive factor for the outcome of the harm-benefit analysis.

Unlike the Supreme Court, the Administrative Court did not consider the genetic proximity of zebra finches to humans, which was criticized by a minority of chambers in a dissenting opinion. While the species concerned can be considered in the harm-benefit analysis (especially with regard to the harm), it is always a question of whether an anticipated benefit is significant and concrete enough to justify an animal’s suffering, regardless of the species involved.

V.              Concluding Remarks

The latest case law on animal experimentation confirms that the threshold for basic research which does not result in a concrete and foreseeable (clinical) benefit while inflicting severe harm to animals is high, regardless of the species involved. While the Administrative Court’s decision is in no way equivalent to a ban on basic research, it emphasizes that basic research does not enjoy unconditional priority.[81] Basic research experiments as well as all other animal experiments require a rigorous harm-benefit analysis. This is particularly important where animals will certainly be subjected to serious harm, whereas the possible benefits of the experiments remain uncertain and vague. Taking another stance and prioritizing scientific progress per se would render obsolete the harm-benefit analysis. Moreover, the entire approval procedure in basic research would become pointless, and this, in turn, would give unlawful priority to basic research over applied research.[82] This would not only be a step backward from the democratically legitimized harm-benefit analysis established by the legislator but would also be completely incompatible with the equal status of the opposing constitutional interests – such as freedom of research and animal (dignity) protection –, amounting to an unconstitutional prioritization of human interests over animal protection and animal dignity.[83]

Given that basic research accounts for nearly 80 percent of animal experiments categorized as severity grade 3, one cannot help but wonder whether all these experiments meet the criterion of the “indispensable minimum” under the strict legal standards that pertain to basic research, and which were applied by the Administrative Court. At any rate, it shows how important the option of a judicial review of the licensing authorities is to ensure uniform interpretation of the law and legal certainty. While applicants can always apply for a judicial review, the claim that the interests of animals have not been sufficiently taken into account in the approval procedure can only be brought before a court in the canton of Zurich.[84] The importance of this option was recently confirmed by the Cantonal Council: a parliamentary initiative that was submitted by members of the Cantonal Council to abolish the right of appeal was rejected by the majority of the Cantonal Council by 159 votes to 5. The initiators' argument that the committee’s right of appeal – which is unique in Switzerland – makes Zurich less attractive as a research location did not convince the Council, which thus voted in line with national efforts to effectively enforce the current law on animal experiments. With numerous initiatives and political efforts in Switzerland, the European Union, and the United States to phase out animal experiments – or at least to significantly reduce the number of animals used for research and the harm inflicted on them in the process –, consistent enforcement of the current law is all the more crucial.

Copyright (c) 2024 Nicole Lüthi, Katerina Stoykova, Margot Michel

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