Cross-Jurisdictional Study of the 3Rs:
A Comparative Legal Analysis of
Animal Research Governance in Finland
and Switzerland

Rosa Maria Cajiga1,3, Charlotte Blattner2, Birgitta Wahlberg3, Markku Suksi3, Fabrice Jotterand1,4 and Bernice Simone Elger1,5

Abstract

The 3R principles (Replacement, Reduction, Refinement) have become a widely used regulatory framework for governing animal research worldwide. While widely endorsed as a moral baseline, its actual capacity to protect animals and to support a transition toward animal-free research remains contested. This article examines how Switzerland and Finland embed and operationalise the 3Rs in law, and asks whether these legal frameworks meaningfully advance responsibility toward animals beyond procedural compliance, within their distinct legal, cultural, and societal frameworks for regulating the use of animals in research. Through a comparative legal analysis, the paper explores how different normative foundations are articulated in the regulation of animal research: Switzerland grounds protection in the constitutional concepts of animal dignity and welfare, whereas Finland, under EU law, relies on animal sentience and intrinsic value, combined with an explicit long-term objective of full replacement of live-animal procedures when scientifically possible. Drawing on an ethics of care perspective, the study examines not only formal legal standards, but also how legal structures frame and allocate responsibility, recognise animal vulnerability, and address continuity of care before, during, and after experiments. The analysis reveals that although both systems incorporate the 3Rs extensively, they remain largely confined to regulating experimental procedures and only partially address breeding, surplus animals, and post-study responsibilities. The paper argues that without clearer legal hierarchies, stronger institutional accountability, and an explicit transition strategy toward non-animal methods, the 3Rs risk functioning primarily as a refinement tool rather than as a genuine framework for structural change, that enables a transition beyond animal-based research.

Keywords

3R principles, animal research, animal welfare, comparative legal analysis, legislation

Suggested Citation Style:

Rosa Maria Cajiga, Charlotte Blattner, Birgitta Wahlberg, Markku Suksi, Fabrice Jotterand and Bernice Simone Elger (2026). Cross-Jurisdictional Study of the 3Rs: A Comparative Legal Analysis of Animal Research Governance in Finland and Switzerland. Journal of Animal Law, Ethics and One Health (LEOH), 62-98. DOI: 10.58590/leoh.2026.012

 

1 University of Basel, Switzerland

2 University of Lausanne, Switzerland

3 Åbo Akademi University, Turku, Finland

4 Center for Ethics in Health Care, Oregon Health and Science University, Portland, OR, USA

5 University of Geneva, Switzerland

 

Content

 

I. Introduction

The 3Rs initiative was born out of a significant multi-year task sponsored by the Universities Federation for Animal Welfare, a UK-registered scientific and educational charity, to track the progress of humane techniques in the laboratory. They commissioned zoologist William Moy Stratton Russell to write a report on the progress of humane research in the laboratory, a task of utmost importance during that time. Russell was assisted by another biologist, Rex Burch, who travelled the country to interview hundreds of researchers for the report (Burch 1995). Russell and Burch’s examination culminated in the 1959 Principles of Humane Experimental Techniques, which set up the 3R principles encompassing Replacement, Reduction, and Refinement. According to Russell and Burch,

  • "Replacement means the substitution for conscious living higher animals of insentient material.
  • − In relative Replacement, animals are still required, though in the actual experiment they are exposed, probably or certainly, to no distress at all.
  • − In absolute Replacement, animals are not required at all at any stage.
  • Reduction means reduction in the numbers of animals used to obtain information of a given amount and precision.
  • Refinement means any decrease in the incidence or severity of inhumane procedures applied to those animals which still have to be used." (Russell and Burch 1959)

The 3Rs have become widely accepted as a moral baseline of animal research[1] among scientists (Hubrecht and Carter 2019). Today, they form the structural basis for performing high-quality scientific experiments and evolving alternative means for improving animal welfare. The 3Rs are embedded in laws and guidelines governing the use of animals in biomedical research (henceforth research) and testing in Europe (Grimm et al. 2023), the USA (Locke et al. 2024), Australia (National Health and Medical Research Council 2019), Africa (Hau et al. 2018), South America and Asia (Bayne et al. 2015). Despite the near-universal adoption of the 3R principles over the past decades, their definition and implementation continue to pose challenges in safeguarding animals from negative impacts of research (Flecknell 2002). These include a range of negative experiences and states animals experience in research, such as animal death, pain, suffering, stress, anxiety, distress, harm or impairment of welfare (Gerritsen 2022).[2] Distress in animals arises from a failure to adequately adapt to their surroundings, where the resulting non-coping behaviours negatively impact their overall welfare (Broom 1991). Although the integration of the 3Rs in current legislation, aimed to reduce or avoid distress in animals used in research is laudable, their contribution to the improvement of animal welfare, and more importantly, to bring about the full and sustainable replacement of animal models is debatable. Müller has, in this sense, convincingly argued that the 3Rs primarily constrain the design and conduct of individual studies and do not, by their internal logic, function as a governance strategy that ensures a reduction in total animal experimentation numbers. He notes that overall numbers may remain stable or rise because innovation also occurs in animal-based methods and because total numbers are shaped by factors outside the scope of the 3Rs (Müller 2023). In a related critique, Blattner has pointed to the 60-year-old existence of the 3Rs and the fact that the number of animals used in experiments has not shown a sustained overall decline since the 1980s – showing that 3R-based regulation is limited in its systemic effects and may indeed amount to a form of regulatory failure (Blattner 2019). Rather than confronting the root drivers of animal experimentation, 3R-based regulation thus largely confines itself to optimising a system whose underlying logic remains intact.

Newest research strengthens these hypotheses: even though the 3Rs have been broadly accepted for decades, the number of animals used in research worldwide has not markedly decreased in the last 20 years (Taylor 2024). For example, in Switzerland, the number of animals used in research has remained at around 600.000 animals per year since 2014.[3] In the EU, the number of animals used on average has been stable at 7.000.000 per year since 2015 (Taylor 2024), including around 80.000 used in Finland (RSAA 2015-2024). In these jurisdictions, the public continuously expresses concern about this issue.[4] In Switzerland, four Popular Initiatives have been launched since 1985[5] and in the EU, the European Citizens’ Initiatives "Stop Vivisection"[6] and "Save Cruelty Free Cosmetics – Commit to a Europe Without Animal Testing"[7] have been at the forefront of public discussion. The European Commission responded to the latter initiative by reassuring the public that it will accelerate the phasing out of animal testing (European Commission 2023). In Switzerland, the Federal Council set up the National Research Program 79 (NRP79) "Advancing 3R – Animals, Research, and Society" in 2021 to address these societal concerns.[8]

This article is part of a research project financed by NRP79 and is dedicated to uncovering, from a legal perspective, the factors that hinder or promote effective implementation of the 3Rs. Although the 3Rs originated as ethical and scientific guidelines, their legal and regulatory effectiveness as legal governance tools largely depends on how they are operationalised in legal frameworks. This includes whether legal definitions are sufficiently clear, who is required to report on practices and results, whether compliance is mandatory or merely encouraged, also whether there are gaps and loopholes, how liberally exceptions are handled, and how strong or weak regulatory oversight is. Overall, a comparative legal analysis can show how far a country’s animal welfare commitments in research are translated into concrete legal duties, oversight mechanisms, and accountability structures (Siems 2018). Accordingly, this article undertakes a comparative legal analysis of how the 3Rs are implemented in the Swiss and Finnish legal contexts. Both Switzerland and Finland operate under civil law systems, relying primarily on codified statutes rather than judicial precedent,[9] unlike common law jurisdictions such as the United Kingdom. Both countries are signatories to the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes (ETS No.123),[10] henceforth Animal Experimentation Convention, which articulates key objectives aligned with the 3Rs (Animal Experimentation Convention 1986). In addition to legal similarities, both countries consistently perform well in global innovation and healthcare indices, such as the Global Innovation Index 2025[11] and the World Index of Healthcare Innovation 2024.[12] Yet despite these parallels, there is a notable divergence in the use of animals in research: Finland uses overall approximately 85% fewer animals in research than Switzerland. Since 2023, the number of animals used for the first time in Finland dropped by approximately 15% (RSAA 2015-2024), but the drivers of this change cannot be inferred from the statistics alone.

Both countries demonstrate an ongoing commitment to animal welfare through regular legal updates that respond to the growing societal awareness. Switzerland updated the Animal Protection Ordinance in 2025, while Finland revised its Animal Welfare Act in 2024. Notably, a proposal drafted by Wahlberg and her colleagues at the Finnish Animal Rights Law Society for the recognition of fundamental rights for animals within the Finnish Constitution[13] has been brought to the Finnish parliament twice. The first time in 2022 by means of a legislative motion driven by MP Kivelä,[14] and the second time by a Citizens initiative proposed by animal law experts of the Finnish Animal Rights Law Society, which gathered at least the required minimum of 50.000 signatures.[15] Furthermore, analysing legislation of an EU member state such as Finland allows for a meaningful analysis of Directive 2010/63/EU, one of the most advanced pieces of legislation for the protection of animals used for scientific and educational purposes.

In addition to the comparative legal analysis, this study is informed by an ethics of care perspective. As Fischer and Tronto argue, caring is a species activity that encompasses "everything we do to maintain, continue, and repair our world", including our bodies, selves, and environments. Although developed for human-to-human contexts, they also note that care can be directed toward things and other living beings (Fisher and Tronto 1990). On this view, attentiveness, responsibility and responsiveness[16] can also guide how we relate to non-human animals, who are vulnerable and depend on others for care. Four practical care processes guide this study: moral attention, sympathetic understanding, relationship awareness, and harmony/accommodation. In practice, this involves paying attention to the specific features of a situation before deciding. It includes trying to see what those affected want and what would be in their best interests, noticing the roles and ties at stake (including when one has caused harm and how wider networks are affected), and seeking responses that include those affected without settling for a superficial peace that leaves the vulnerable worse off (Manning 2009). These ideas remind us that animals used in research are not only subjects of regulation, but beings affected by the institutions around them. Using this lens, the paper assesses not just what the law requires, but whether it supports an ethic of care or undermines it. The evaluative question in Part III and the recommendations in Part IV follow these care criteria.

To contribute to a deeper understanding of animal protection in research, this study offers a comparative legal analysis of animal experimentation legislation in Switzerland and Finland (as an EU Member State, including Directive 2010/63/EU as transposed into national law). In particular, it employs a comparative legal analysis based on the systematic examination of binding legal instruments and their functional alignment across jurisdictions, with a focus on how the 3Rs are defined, prioritised, and operationalised in each legal system (Siems 2018). The analysis is guided by two central research questions: first, an expository question, aimed at describing and understanding: How do the current legal frameworks in both countries embed the 3R principles (Replacement, Reduction, Refinement) in legislation? This question aims at describing, analysing, and understanding the inclusion of the 3Rs in the Finnish and Swiss legal contexts within the evolving nature of animal protection (Parts II and III). The second, an evaluative question, is as follows: How legally and regulatory effective are these legal systems in protecting animals used in research, and how far do they advance an ethic of care approach? This question addresses both strengths and weaknesses that can inform future policies (Parts III and IV).

In answering these questions, this study undertakes a detailed examination of the following key legislative instruments. In Switzerland, it examines the Animal Welfare Act (SR 455) and the Animal Protection Ordinance (SR 455.1); and in Finland, as an EU Member State, Directive 2010/63/EU, as implemented through national legislation, including the Animal Welfare Act (693/2023), the Act on the Protection of Animals Used for Scientific and Experimental Purposes (497/2013) and the Government decree on the protection of animals used for scientific or educational purposes (564/2013).[17] These represent the primary and most relevant legal texts governing animal experimentation in each jurisdiction. The comparison is structured along analytical categories derived from the 3Rs, which serve as the main framework for organising and evaluating the legal material (see Annex).

The study’s best practices section (Part IV) addresses how the implementation of the 3Rs can be more effectively optimised within existing legal frameworks. It also highlights areas where legislation could better support the transition to animal-free research, the highest level of legal protection possible for these animals, particularly in research domains where the use of animals is no longer scientifically needed. In concluding (Part V), this paper synthesises the factors that foster cross-jurisdictional learning by comparing approaches and offering recommendations to strengthen the legal implementation of the 3Rs in both countries, supporting the evolving and more effective protection of animals in research.

II. The Protection of Animals Used in Research in Swiss and Finnish Contexts

1. Finland

a) Finland’s EU Legal Framework: Directive 2010/63/EU

Europe has long demonstrated a growing recognition of animals as sentient beings rather than mere property, a shift that has increasingly been reflected in the development of dedicated legislation (Browning and Veit 2022). An early example is the 1974 law introduced to address public concern and market demand regarding animal welfare through requirements on stunning before slaughter (Council Directive 74/577/EEC 1974).[18] This legislation, which is no longer in force, focused particularly on the requirement to stun animals before slaughter, and marked a significant step toward more humane treatment of animals within the European Union.[19] Another milestone is Article 13 of the Treaty on the Functioning of the European Union (TFEU 2016), which formally recognises animals as sentient beings and obliges EU institutions and member states to pay full regard to animal welfare requirements. This provision has laid the foundation for ongoing advancements in animal welfare law and policy across the EU.[20]

Regarding the use of animals in research, a significant milestone was reached in 1986 when the Council of Europe[21] introduced the Animal Experimentation Convention.[22] This was the first document to establish a common European framework for protecting animals used in scientific procedures. Both Switzerland and Finland signed and ratified this treaty, thereby committing to incorporate its provisions into their national legislation. The Animal Experimentation Convention strongly aligns with the 3R principles, even though it does not explicitly use that terminology, focusing on the use and promotion of alternative methods, choice of species, minimisation of pain and distress, reuse, and euthanasia (Animal Experimentation Convention 1986).

Appendix A of the Animal Experimentation Convention is one of the most important documents of the European framework due to its recommendations on housing, environmental enrichment, and care. On this basis, the EU in 1986 set up its first Directive regarding the protection of animals used for experimental and other scientific purposes: Directive 86/609/EEC (Council Directive 86/609/EEC 1986). This Directive included guidelines for the accommodation and care of animals in Annex II, which were replaced in 2010 by Directive 2010/63/EU (Directive 2010/63/EU 2010) with more detailed guidelines to take due account of the Animal Experimentation Convention. Directive 2010/63/EU establishes minimum EU standards for the protection of animals used for scientific purposes and sets requirements on, among other things, the 3Rs, project authorisation and oversight, accommodation and care, and transparency and reporting. For EU Member States, the Directive is legally binding as to the results to be achieved and therefore requires transposition into national law, while leaving discretion as to the form and methods of implementation. Some elements, including longer-term objectives and recitals, are programmatic and primarily guide interpretation and policy development rather than creating standalone, directly enforceable duties. This EU baseline provides the reference point for assessing how Finland’s national provisions implement and operationalise the Directive’s minimum standards later in the analysis. Directive 2010/63/EU recognises the international importance of the 3R principles in governing the care and use of animals in research. By embedding these principles into EU law, the Directive aims to ensure that the care and use of animals in scientific procedures are consistent with international and national standards beyond the European Union.

b) Finland’s National Legal Framework

The binding sources of law in Finland are EU law, including Directive 2010/63/EU, the Constitution of Finland (731/1999), Parliamentary Acts on the ordinary law level, decrees[23] given by the president, government, or ministries, and other orders based on an Act. The Finnish Constitution has a lex superior status[24] and is at the highest level in the national hierarchy of legal norms. The Constitution of Finland (731/1999) Section 20[25] protects nature and its biodiversity, the environment and the national heritage (Constitution of Finland 1999). According to the preparatory work of the section, animals are part of nature.[26] Therefore, some indirect protection, at least for wild animals, is considered in the Finnish Constitution. This may have significant implications for animal protection, particularly in the context of research involving wild animals (Wahlberg 2011).

Although the 1934 Animal Protection Act is recognised as Finland’s first comprehensive legislation in this area, animal welfare has a longer legal tradition in the country. Already in 1864, a decree prohibiting animal cruelty, particularly in slaughter and transport, was enacted and later incorporated into the 1889 Penal Code (Wahlberg et al. 2024). Since then, Finland has periodically revised and expanded its legal framework for animal protection, reflecting a continued societal concern for the issue. Notably, the Animal Protection Act of 1996 (247/1996) replaced the 1934 Act, and more recently, the Animal Welfare Act (693/2023) has replaced the 1996 Act. Section 1 of the Animal Welfare Act includes the statement: "The purpose of the Act is also to increase respect for and good treatment of animals."[27] The inclusion of the term "respect" in Finnish legislation reflects an intention, as explained in the preparatory materials, to uphold the concept of the animal’s intrinsic value. As written: "The idea underlying respect for animals is that an animal has intrinsic value that is independent of the animal’s value to humans" (The Government Bill to Parliament on an Act on Animal Welfare and related Acts (186/2022)).[28] The Government Bill further clarifies that respect based on intrinsic value does not in itself prevent currently accepted uses of animals, including as laboratory animals; rather, the use and treatment of animals require an assessment of benefits and harms to determine whether they are justified (Government of Finland 2022). This is consistent with the ethical framework set out in Recital 12 of Directive 2010/63/EU.

2. Switzerland’s National Legal Framework

Switzerland has a long-standing and deeply rooted commitment to animal protection. This was first demonstrated in 1893, when a nationwide referendum led to a constitutional amendment prohibiting slaughter methods that did not include pre-slaughter stunning of livestock (Bolliger 2016). Further progress came in 1973, when an animal welfare clause was added to the Constitution, formally recognising animal welfare as a constitutionally protected interest (for the history of the new Article 25bis of the former Federal Constitution that goes back to 1963, see Steiger and Schweizer 2008). Today, Article 80 of the Federal Constitution[29] places the responsibility for animal protection legislation at the federal level.[30] It mandates the Confederation to enact laws governing the protection of animals, including animal experimentation and procedures performed on living animals. This constitutional framework established animal protection as a state obligation, elevating it from a public order concern to an independent constitutional principle and a recognised public interest, on equal footing with other state objectives (Bolliger et al. 2019). Article 80 marked a fundamental shift in values, embedding animal welfare deeply into Switzerland’s legal landscape. In addition, Article 120(2) of the Federal Constitution introduces the concept of the dignity of living beings, which underpins the Swiss legal approach to animal protection alongside welfare. Switzerland’s main legal instruments governing animal experimentation are the Animal Welfare Act (SR 455) and the Animal Protection Ordinance (SR 455.1) and the Animal Experimentation Ordinance (SR 455.163).

Another key constitutional provision was introduced in 1992 by popular vote. Article 120 of the Federal Constitution, though titled "non-human gene technology", posited animal dignity as a constitutional principle that must be observed not only in the context of genetic engineering but throughout the legal system, and every legal application procedure that affects the human-animal relationship (Bolliger et al. 2019). Importantly, the constitutional status of animal protection in Switzerland means that, in certain cases, it can limit other fundamental rights, such as the right to academic freedom enshrined in Article 20 of the Swiss Constitution. While the Finnish Constitution also protects freedom of science in Section 16, the indirect nature of animal protection it offers via its biodiversity mandate, Section 20, means its ability to override or limit other constitutional guarantees is rare, unlike the more direct implications observed in Switzerland.

III. Comparative Legal Analysis Concerning the Implementation of the 3R Principles in Switzerland and Finland

A general legal commitment to protecting animals, even on the constitutional level, rarely suffices to bring about meaningful change. To assess how such commitments are operationalised, this study turns to the concrete legal regulation of the 3R principles in both Switzerland and Finland. The following analysis first describes how the 3Rs are embedded in legislation and then evaluates their regulatory capacity to implement the 3Rs and the extent to which they advance animal protection from an ethics of care approach. It examines how these principles are enshrined and operationalised within the key legislative instruments of each jurisdiction, taking into account their respective aims and objectives. These main legislative instruments include:

Switzerland: Animal Welfare Act[31] (SR 455) – henceforth AniWA, and the Animal Protection Ordinance[32] (SR 455.1) – henceforth AniPO.

Finland: Directive 2010/63/EU – henceforth Directive, Animal Welfare Act[33] (693/2023) – henceforth FAWA, Act on the Protection of Animals Used for Scientific and Experimental Purposes[34] (497/2013) – henceforth FAPA and Government decree on the protection of animals used for scientific or educational purposes[35] (564/2013) – henceforth FADA. These instruments differ in scope, including which animals are covered; these differences are set out in the Scope subsection below.

1. Method

This study adopts a comparative legal approach that examines how the 3Rs are embedded, structured, and operationalised within the respective legal frameworks of Switzerland and Finland. The comparison is organised around analytically aligned categories derived from the 3Rs themselves, enabling a functional assessment of how similar regulatory objectives are pursued through different legal concepts, institutional designs, and normative assumptions. The analysis is based primarily in text and focuses on binding legal instruments mentioned above, interpreted in light of their legislative context and underlying normative commitments in order to identify both structural convergences and points of divergence that are relevant for evaluating the regulatory capacity of the 3Rs. In addition to the statutory wording, the interpretation of these instruments in this article is supported by preparatory materials and official explanatory guidance. Furthermore, in the Finnish case, Directive 2010/63/EU is analysed as part of the national framework through its transposition into Finnish law (via FAPA and FADA), and not as a separate comparator.

To structure the analysis, a preparatory step involved the creation of comparative tables to categorise how each jurisdiction regulates different aspects of the 3R principles. This categorisation enabled a systematic examination of the legal provisions relevant to animal research in both Switzerland and Finland. The categories used in this study include general remarks, such as the recognition of the intrinsic value of animals and the scope of the legislation. The analysis also considers the general objectives underlying the 3Rs, particularly how each jurisdiction defines and prioritises the principles.

In relation to Replacement, the analysis addresses the general legislative objectives aimed at replacing the use of animals in research, as well as the notion of partial replacement, which is grounded in the animal’s capacity to experience pain, suffering, and distress. It also includes an assessment of how actively each legal framework promotes the development and adoption of alternative methods.

The Reduction category considers how legislation encourages minimising the number of animals used, the reuse of animals in subsequent procedures, and broader strategies for systematically reducing overall animal use in research.

With respect to Refinement, the analysis explores legal limits on pain levels that animals may endure, requirements for anaesthesia and analgesia, and the designation of individuals responsible for overseeing animal welfare. It also considers legal provisions concerning the rehoming of animals after use in research and comprehensive standards for their care and housing. These standards include core requirements on husbandry conditions, monitoring, and humane endpoints, as specified in the respective laws.

The analysis that follows focuses specifically on the legal areas where notable differences were observed between the Swiss and Finnish frameworks. Categories where the jurisdictions demonstrated substantial similarity in implementing the 3Rs were not examined in detail, in order to maintain a clear focus on meaningful points of divergence. The similarities observed between jurisdictions originate from adhering to the Animal Experimentation Convention and a general interpretation of the 3Rs. Given that English is neither the official language of the Swiss Confederation[36] nor Finland,[37] some translations had to be made by the authors; these are provided as unofficial translations and are marked as such in the text and the Annex. Native speakers verified them for errors. Other translations are sourced from governmental websites[38] and are cited accordingly.

This study is confined to a comparative legal analysis of the law and therefore does not assess empirically how these laws are implemented, enforced, or experienced in institutional practice. It does not examine decision-making within licensing authorities, ethics committees, or research institutions, nor does it analyse compliance, inspection data, or behavioural responses by researchers. The comparison is likewise limited to national-level instruments and does not attempt to provide a comprehensive account of sub-state laws, soft-law instruments, administrative guidelines, or internal policies that may shape everyday regulatory practice. The findings should therefore be understood as reflecting the normative design and internal logic of the legal frameworks, rather than their empirical effects.

2. General Remarks

a) Recognition of Animal Sentience and Intrinsic Value

In Finland, the preamble of the Directive, as implemented through the national transposing framework (FAPA/FADA), establishes its legal and ethical foundation by affirming that animals have intrinsic value that must be respected (Directive, Recital 12). It further acknowledges the existence of widespread public ethical concern regarding the use of animals in research (Directive, Recital 3). As such, the Directive emphasises that animals should always be treated as sentient creatures, and that their use in research should only be permitted when no alternatives are available (Directive, Recital 6). Besides, it acknowledges the importance of the protection and welfare of animals at an international level (Directive, Recital 3) and calls for ongoing improvements in the protection of research animals in line with advancements in scientific knowledge. This includes a commitment to progressively raising minimum welfare standards (Directive, Recital 6). In Finland, similar commitments are embedded in national legislation. FAWA’s purpose is to promote animal welfare and to protect animals in the best possible way from harm to their welfare. It also aims to increase respect for animals and to promote their good treatment, reflecting the legislative rationale that animals have intrinsic value independent of their value to humans (FAWA, Ch. 1, Sec. 1) (Government of Finland 2022). FAWA is a general animal welfare act that applies to all animals; however, the use of animals for scientific or educational purposes is regulated specifically by FAPA (and FADA) as the sector-specific framework. Complementing this, FAPA stipulates that animals may be used in research only for necessary and justifiable reasons (FAPA, Ch. 1, Sec. 1(1)), consistent with the Directive’s long-term orientation towards full replacement (Directive, Recital 10).

In Switzerland, baseline commitments to animal protection are grounded in both statutory and constitutional law. The Animal Welfare Act sets out a dual objective to protect both the dignity and the welfare of animals (AniWA, Art. 1). Dignity is defined as "the inherent worth of the animal that must be respected when dealing with it" (AniWA, Art. 3a), and is constitutionally anchored in Article 120(2) of the Federal Constitution, which requires respect for the dignity of living beings. This orientation is also emphasised in the Federal Council’s Message on the revision of the Animal Welfare Act, which framed the law as moving beyond purely human-centred protection by recognising that animals are protected not only for the benefit of humans but also for their own sake ("um ihrer selbst willen") (Swiss Federal Council 2002).

The legal recognition of animal dignity is distinctive in comparative perspective. Unlike welfare, which is primarily concerned with preventing suffering and harm, dignity functions as an independent normative constraint that may render certain forms of instrumentalisation unlawful even where no measurable welfare impairment occurs. As a constitutional principle, animal dignity is capable, at least in principle, of limiting other fundamental rights, including economic freedom and academic freedom (Bolliger 2016).

For later evaluation, note that "dignity" (Switzerland) and "respect" (Finland) position animals as bearers of value in different ways, which matters for interpreting relational responsibilities of care (Manning 2009).

b) Scope

Not all animal species fall under the protective radar of animal laws. In Finland, the Directive extends its scope beyond vertebrates to include cephalopods and foetal forms of mammals in the final third of their development, as well as independently feeding larval forms. These inclusions are based on scientific evidence indicating the capacity for sentience in these animals (Directive, Recital 8/9; Art. 1(3)). The Directive also includes similar provisions for non-human primates and endangered species (Directive, Arts. 7-8). FAPA adopts the Directive’s wording on this matter, to reflect the Directive’s mandatory minimum scope for Member States. This, as part of Finland’s transposition, therefore mirrors these scope provisions for animals used for scientific or educational purposes (FAPA, Ch. 1, Sec. 2). It also includes specific regulations concerning the use of stray and feral animals of domestic species and animals taken from the wild, which may only be used in research under strict conditions (Directive, Arts. 9 and 11; FAPA, Ch. 4, Sec. 16(2)). Section 20 of the Constitution of Finland sets out a general responsibility to everyone for nature and biodiversity and requires public authorities to work to secure a healthy environment, but it does not define the scope of the animal research legislation.[39]

In Switzerland, the scope of protection is comparably broad. AniWA applies to all vertebrates and empowers the Federal Council to extend its protection to invertebrates (AniWA, Art. 2 para. 1). AniPO expands on this by regulating handling, housing, use, and interventions on vertebrates, cephalopods and decapods (AniPO, Art. 1). Additionally, Chapter 6 introduces protections for mammals, birds, and reptiles in the last third of the gestation period before birth or hatching, as well as for freely feeding larval stages of fish and amphibians (AniPO, Art. 118 para. 2). Moreover, AniPO allows for the use of domestic animals in experiments even when they do not originate from Swiss or foreign-approved animal facilities. This provision, however, does not apply to dogs, cats and rabbits, which are subject to stricter "sourcing" requirements (AniPO, Art. 112). The use of non-human primates is permitted only if the animals are bred in captivity (AniPO, Art. 118 para. 4).

3. Definitions and Hierarchy of the 3Rs

The 3Rs form the foundational framework for animal research legislation worldwide. Although widely accepted, current legislation often lacks clarity regarding the overarching aim or endpoint of the 3Rs. As noted by Rodriguez, a return to the original intent of Russell and Burch reveals that the 3Rs were primarily designed to minimise animal suffering while still enabling scientific and medical advancement (Rodriguez Perez et al. 2023).[40] Russell and Burch did not originally contemplate the goal of eliminating or reducing animal use in research. Therefore, using their original principles in the law may lead to incongruences when pursuing the goal of fully replacing animal experiments, for example, the one set in the preambular Recital 10 of the Directive. Moreover, the frequent inclusion of the phrase "without compromising scientific and medical progress" in legal formulations may introduce tension between research goals and animal welfare objectives, suggesting that the pursuit of scientific progress may take precedence over efforts to reduce or eliminate animal use.

In terms of explicit legal definitions, both the Directive and FAPA define the 3Rs at the textual level. FAPA does so through a single definition of "the principle of replacement, reduction and refinement" (FAPA, Ch. 1 Sec. 5(1)(8)), while the Directive sets out the three components within the principle in Article 4 (Directive, Art. 4).

Swiss legislation applies the 3R principles, but no law explicitly uses the terms 3Rs, nor defines its elements. Instead, the law mandates that, in collaboration with universities and industry, the federal government shall promote the development, accreditation and application of methods that replace animal experiments (meaning Replacement). Also to enable fewer animals to be used (meaning Reduction) or result in less strain for the animals (meaning Refinement); in particular, it shall promote research projects aimed at eliminating pain, suffering or anxiety in interventions (meaning also Refinement) (AniWA, Art. 22 para. 2). However, to reiterate, the Swiss framework does not provide formal legal definitions of the 3Rs. By contrast, even if Finland’s transposition of the Directive offers definitions of the 3Rs, the Directive is unique in stipulating not only that the 3Rs should be considered systematically, but also that their application when choosing methods must follow a strict hierarchy, prioritising the use of alternative methods (Replacement), and only then, if no such alternatives are recognised by Union legislation, shifting focus to strategies for Reduction and Refinement (Directive, Recital 11 and Art. 4). Yet, this hierarchy is not made explicit in the Finnish national framework after implementation of the Directive.

Such basic definitions and establishment of hierarchies matter. The absence of precise definitions and an articulated hierarchy, as within Swiss legislation, opens the door to inconsistent interpretations, potentially creating loopholes that weaken the overall legal protection of animals. The ambiguity in how the 3Rs are framed – especially the lack of clarity surrounding their relative legal weight – may also undermine institutional efforts to develop, validate, and adopt alternative methods. In practice, this can result in a disproportionate focus on Refinement, often considered the most immediately actionable of the three, thereby slowing progress toward broader implementation of Reduction and ultimately Replacement. Consequently, the total number of animals used in research may not significantly decrease over time.

4. Replacement

a) General Objectives Towards Replacement

The principle of Replacement is embedded in all the legislation analysed in this study. Replacement can generally take two forms: (i) total Replacement, which involves selecting methods that do not involve the use of live animals at all, and (ii) partial Replacement, where animals with lower capacity to experience pain and distress are used instead of species with higher capacities or greater sentience (Russell and Burch 1959). The law does not always strictly stick to this distinction.

Swiss law operationalises Replacement primarily through an indispensability standard for authorisation and a duty to promote alternative methods (AniWA, Art. 17 and Art. 22 para. 2). In Finland, Replacement is framed through Directive as implemented through the national transposing framework (FAPA/FADA), including the requirement to use non-animal methods where a scientifically satisfactory alternative exists (Directive, Art. 4) and the longer-term objective of "full replacement" (Directive, Recital 10). So, Finland’s framework carries an explicit "full replacement" trajectory via the Directive, whereas Swiss law relies on indispensability and promotion duties without framing Replacement as an explicit endpoint.

In what follows, the Directive is discussed only insofar as it binds Finland and informs the interpretation of Finland’s transposing framework. Within the Directive, the concept of Replacement is presented with some variation in interpretation. Article 4 provides a definition consistent with the 3Rs framework, focused on the use of non-animal methods where possible. However, Recital 10 articulates a more ambitious vision: the "full replacement" of procedures on live animals for scientific and educational purposes (Directive, Recital 10). As an EU Member State, Finland is required to transpose and apply the Directive’s Replacement requirements through national law, and this objective guides the interpretation of those rules. Viewed through a care lens, the Directive displays an aim that aligns with institutional attentiveness and responsibility for looking after and supporting our shared world, with care conceived as encompassing people, other living beings, and the non-human world of things (Fisher and Tronto 1990). In the Finnish context, the Directive remains the only legal instrument among those analysed that explicitly states the goal of full replacement and mandates the development and promotion of alternative approaches to achieve this goal "as soon as it is scientifically possible". Furthermore, the Directive underscores the importance of facilitating scientific progress in this direction and calls for the periodic review of the legislation in light of emerging scientific knowledge and animal welfare standards (Directive, Recital 10).

There is a shared understanding that the objective of the 3Rs is primarily to ensure that animal experiments are designed and conducted with greater attention toward animals’ welfare. This involves using an appropriate number of animals, avoiding unnecessary duplication of studies, and promoting the development and use of alternative methods that do not use live animals. Based on this understanding, there is often, at least in an implicit manner, an expectation that the implementation of the 3Rs will, over time, reduce the overall number of animals used for research purposes (Müller 2023). However, this assumption has been increasingly challenged. Müller argues that empirical evidence does not support the idea that the 3Rs have significantly reduced animal use in practice. Similarly, Eggel and Würbel contend that the 3Rs "are not a strategy for eliminating animal research, for reducing the total number of animals used in research or for reducing the overall suffering imposed on them" (Eggel and Würbel 2021). Their critique highlights a key tension in the application of the 3Rs: while the principles may mitigate the suffering of individual animals, they do not necessarily address the collective ethical concerns posed by the continued large-scale use of animals in scientific studies. This point is reinforced by Louis-Maerten, who draws attention to the broader systemic inhumanity experienced by all animals involved in research, regardless of refinements to individual procedures (Louis-Maerten et al. 2024).

Where legal definitions of the 3Rs remain general, or where the hierarchy of principles is not made explicit, there is a risk of misinterpretation and inconsistent application of the 3R principles. In particular, "Replacement" may be misunderstood as substituting one animal model for another, for example shifting from mammals to fish. Indeed, recent trends show a marked increase in the use of zebrafish in research compared to traditional rodent models (Summary Report EC 2024). However, this shift raises concerns, as growing scientific evidence indicates that fish are sentient beings capable of experiencing pain and exhibiting complex cognitive behaviours (Brown 2015).

This kind of species substitution, framed as Replacement, can occur when legislative definitions remain vague or when outdated assumptions about animal sentience persist. As a result, what is presented as "Replacement" may, in fact, constitute a mere species shift rather than the substitution of animals by alternative methods. In this regard, Recital 10 of the Directive is notable, as it explicitly affirms the long-term goal of fully replacing animal use in scientific procedures. By clearly stating this objective, the Directive sets an important ethical and policy benchmark that distinguishes it from the more limited aims of the original 3R framework. In conclusion, where definitions remain general and a clearly articulated hierarchy among the 3Rs – especially concerning Replacement – may enable inconsistent application and enforcement and may weaken the extent to which regulation advances under an ethics of care approach. For the 3Rs to fulfil their transformative potential, they must be framed within a coherent legal structure that supports, rather than obscures, the transition toward animal-free research, a legal objective proposed by the Directive. As Smith observes, the Directive explicitly identifies full replacement of live animals as the "ultimate aim" of European animal research legislation (Smith 2020). At the same time, it anticipates that some scientific disciplines will continue to rely on animal models until scientifically valid alternatives are available.

b) Promotion of Alternative Methods

In the Finnish framework, the Directive clearly establishes the goal of developing alternative methods and underlines the importance of support and coordination in their development and validation (Directive, Recital 46/47). It obliges both the Commission and the Member States to actively contribute to advancing alternative approaches capable of delivering the same – or higher – scientific value as procedures involving animals. To this end, Finland – and other Member States – are required to assist the Commission in identifying and nominating suitable specialised and qualified laboratories for validation studies. Furthermore, they must promote alternative methods at the national level, including the dissemination of relevant information, and designate a single point of contact to advise on the regulatory relevance and suitability of proposed alternatives for validation. This type of centralisation reflects moral attention and responsiveness, since it allows the full range of options to be considered and makes viable alternatives visible and usable in practice (Manning 2009). The Directive also mandates the Commission to take the necessary steps to achieve international acceptance of alternative approaches validated by the Union (Directive, Art. 47 (6), Annex VII). Despite being an EU member state, Finland’s national legislation lacks explicit provisions regarding the development and validation of alternative methods. This absence of explicit statutory provisions does not necessarily mean that Finland has not implemented the Directive’s obligations, since transposition can also be effected through administrative arrangements. However, where responsibilities are not clearly set out in binding national instruments, transparency and legal certainty about responsibility allocation may be reduced. Nevertheless, Finland remains bound by its obligation under the Directive and has demonstrated engagement by submitting a voluntary report detailing national activities up to 2016 related to the development, validation, and promotion of alternative approaches (Bastos and Walder 2022).

The Swiss AniWA instructs the federal government, universities, and industry to promote 3R methods, including the accreditation and application of methods that replace animal experiments (AniWA, Art. 22 para. 2). AniWA places particular emphasis on promoting research projects aimed at eliminating pain, suffering, or anxiety in interventions, indicating a potential prioritisation of Refinement over Replacement. Unlike Finland through the EU Directive, Swiss legislation does not provide a similarly detailed framework for how alternative methods should be developed or supported at the institutional level. This lack of detail and of actor-specific allocation of responsibility risks fragmented implementation and may slow progress toward wider uptake of alternative methods. Establishing clear rules and duty on responsibility and support could facilitate uptake and contribute to reducing animal use. From a care perspective, such clarity is part of the political dimension of care, which not only guides practice but also calls for reforms of existing institutions (Manning 2009). A concrete, publicly funded transition plan with clear milestones and duties would follow from this orientation, as argued by Müller (Müller 2025) and in recent university roadmap proposals (Deckha et al. 2025).

5. Reduction

a) Considerations for Reduction

In this comparative legal analysis, the principle of Reduction has a twofold meaning. First, as one of the core 3Rs, Reduction refers to the obligation to use the minimum number of animals necessary in any given experiment, without compromising scientific validity (Eggel and Würbel 2021). Second, it also refers more broadly to the overall reduction in the number of animals used in research. Achieving the latter goal often relies on the concurrent implementation of other principles, such as Replacement.

Both jurisdictions studied, Finland and Switzerland, formally incorporate the principle of Reduction into their binding frameworks. As part of Finland’s transposition of the Directive (Directive, Art. 4(2)), Finnish legislation clarifies that the number of animals should be reduced to the lowest level necessary to achieve the scientific objectives (FAPA, Ch. 3 Sec. 11(2)). Finland goes further, requiring that facilities and procedures be designed with sufficient infrastructure, equipment, and planning to ensure minimal animal use (FAPA, Ch. 2 Sec. 6(2)). Swiss legislation also embraces this principle by requiring that experiments and their component parts be planned so that the fewest animals possible are used, particularly in cases involving stressful or constraining procedures (AniPO, Art. 137 para. 4 lit. a).

Both jurisdictions allow for the reuse of animals, albeit under specific conditions that align with the principle of Refinement (Directive, Art. 16; FAPA, Ch. 2 Sec. 9/Ch. 4 Sec. 19; AniPO, Art. 135 para. 8). While reuse may contribute to a reduction in overall animal use, it may also impose cumulative strain on individual animals. Therefore, reuse is permitted only when it does not result in significant harm or distress. From an ethic-of-care perspective, these limits reflect attentiveness to context and awareness of the cumulative burdens placed on individual animals (Manning 2009), since they make visible how repeated procedures weigh on an animal’s life beyond what numbers alone reveal.

Despite the apparent clarity of the Reduction principle, its practical implementation is often underdeveloped in legislation. Most notably, there is a lack of emphasis on experimental design and the role of biostatisticians (Zapf et al. 2020), both of which are essential to ensuring that studies use the appropriate number of animals to yield reliable and replicable results (Mead et al. 2012). FADA mandates that project proposals demonstrate sound statistical planning to minimise animal use (FADA, Sec. 28 (2.3)), reflecting the Directive requirement that project evaluation authorities consider expertise in experimental design and statistics (Directive, Art. 38.3(b)). In Switzerland, no such provisions are found in the studied instruments. Some cantonal committees on animal experiments already include statistical review in their authorisation practice,[41] but writing this requirement into federal law would improve consistency and legal certainty. From an ethic-of-care perspective, this kind of rule sets a basic minimum and creates clear institutional expectations where individualised attention is not always possible (Manning 2009).

b) Reducing Numbers by Reusing and Avoiding Duplication

Besides implementing the principle of Reduction as one of the 3Rs, strategies were found for reducing the overall number of animals used in research. Within the Finnish framework, the Directive proposes strategies such as reusing tissue and organs for in vitro methods (Directive, Recital 27), reutilising organs and tissue (Directive, Recital 25) and avoiding the duplication of experiments (Directive, Art. 46). These strategies, however, are not explicitly codified in the Finnish legislation reviewed here. While Finland may voluntarily engage in such initiatives – for example, by participating in EU research databases or organ and tissue-sharing programs – its national laws do not formally require them. Swiss legislation introduces an important development through Article 118a AniPO, added in 2025. This provision mandates that research facilities breed and maintain only the smallest number of animals not intended for procedures, with the express aim of preventing the proliferation of surplus animals. The article also seeks to control the overbreeding of genetically modified animals, requiring prior authorisation for such practices, and signals a shift towards addressing Reduction not only in procedural contexts but also at the colony management level. When seen through a care ethics lens, such measures matter because effective responses require ability factors – such as time, resources, and knowledge – to be in place; regulating breeding and surplus directly addresses those preconditions (Fisher and Tronto 1990).

When it comes to strategies for reducing the total number of animals used in research, Swiss and Finnish legislation fall short in key areas. They do not provide national legal frameworks for tissue or organ sharing, leaving individual laboratories to breed more animals than might otherwise be necessary.[42] Moreover, aside from Article 46 of the Directive, there is a lack of binding legal strategies (at either the national or EU level) to prevent the duplication of experiments, which remains an underutilised yet potentially powerful tool for decreasing the number of animals used in research. Neither jurisdiction requires the pre-registration of animal studies or the creation of public registries for negative or neutral results.[43] Introducing these measures, together with national networks for tissue and organ sharing, would make the principle of Reduction more effective without compromising scientific aims. This would be a caring step that reflects moral attention, harmony and accommodation, since they prevent additional animals from being used in avoidable procedures (Manning 2009).

6. Refinement

The Directive, as implemented in Finland through FAPA and FADA, sets out detailed requirements for the keeping and caring of animals used in research, alongside specific refinement strategies to minimise distress during procedures. In Switzerland, AniPO establishes minimum requirements for keeping laboratory animals, including enclosure size and quality (AniPO, Annex 3). Additional provisions in the Swiss Animal Experimentation Ordinance address operational refinements, such as the frequency of animal checks and permitted identification methods for rodents (Animal Experimentation Ordinance 2025).

a) Severity Degree and Upper Limit of Pain

Both jurisdictions analysed mandate that researchers obtain official authorisation prior to conducting procedures on animals (Directive, Art. 1(1)/36(1); FAPA, Ch. 6 Sec. 24(1); AniWA, Art. 18 para. 1). This licensing process requires submission of detailed project information, including the anticipated severity of procedures, which is an essential component of Refinement (Directive, Art. 36/37/38; FAPA, Ch. 6 Sec. 24(1); FADA, Ch. 5 Sec. 27; AniWA, Art. 34; AniPO, Art. 139).

In Finland, procedures must be classified into one of four severity categories: non-recovery, mild, moderate, or severe (FAPA, Ch. 3 Sec. 15(1)), reflecting the Directive wordings (Directive, Art. 15). In Switzerland, the Federal Food Safety and Veterinary Office (FSVO) defines severity using a 0-3 scale (FSVO 2022). The FSVO’s guidance, similar to Annex VIII of the Directive. It provides guidance for assigning severity categories (using a plethora of examples), to facilitate harm-benefit analysis (Directive, Art. 38(2); FAPA, Ch. 6 Sec. 25(1); AniPO, Art. 140 para. 1; AniWA, Art. 19 para. 4). This "helps to establish whether, in view of the anticipated gain in knowledge, it is appropriate to subject the type and number animals in question to the strains envisaged" (ECAE 2022).

Additionally, for the purpose of transparency, Swiss law mandates that the severity degree of animal experiments be communicated to the public in AniPO Art. 145a and in AniWA Art. 20a para. 1 and 20 lit d. Finland has similar provisions to strengthen transparency in FAPA, Ch. 2 Sec. 10(3) as indicated in the Directive, Recital 22 and Art. 54(2).

The scale of severity establishes levels of harm to guide the licensing process through the harm-benefit analysis, but other provisions set an upper limit to the harm researchers are allowed to inflict to animals. FAPA prohibits performing procedures that involve severe pain, suffering, or distress that are likely to be long-lasting and cannot be alleviated in Ch. 3 Sec. 13, reflecting Recital 23 of the Directive. Exceptions can be made for experiments that surpass the upper limit, and FAPA refers to the Directive regarding these exceptions, which require Member States to adopt provisional measures (Directive, Art. 55(3)). Swiss law does not expressly prohibit such procedures, but mandates that they be reduced to the indispensable minimum in AniPO, Art. 17.

In emergencies, exceptions to the upper pain limit might be necessary. The possibility of granting such exceptions raises the question of who should have the authority to approve them. In both jurisdictions, licensing authorities decide in the first instance, and judicial involvement comes only through appeals. In Finland, project authorisations can be challenged before the Administrative Court according to FADA, Ch. 11 Sec. 56. In Switzerland, the canton of Zurich also extends the right of appeal (Zurich Animal Welfare Act [Tierschutzgesetz] 1991),[44] but there is no comparable mechanism at the federal level. These safeguards show that exceptions can be subject to judicial review, but the pathways are indirect and not always easy to use.

Relying on exceptions, as seen in the Directive, or resorting to the "indispensable minimum" as done in Swiss law, is not a sustainable approach to safeguarding animal welfare. A clearly defined legal threshold for pain is needed to ensure consistent and robust protection, moving beyond subjective interpretations and towards a more ethically sound and legally reliable approach to animal research (Beauchamp and Morton 2015).

b) Housing and Care of Animals

In Finland, general housing principles are provided in FAPA, Ch. 2 Sec. 6 for operators[45] and in FADA, Ch. 1 Sec. 1 for facilities.[46] These include the requirement that physical structures and materials be appropriate to the animals’ physiological and behavioural needs and maintained to ensure ongoing suitability, as well as the mandate that design and construction must not compromise animal health. These provisions are a direct transposition of Directive, Annex III Sec. A1.

Under Finnish law, care includes regular health checks by competent personnel and the prompt identification and treatment of sick or injured animals (FADA, Ch. 4 Sec. 23). Furthermore, the Directive prescribes a daily health check for the animals (Directive, Annex III Sec. A3.1), which was transposed into FADA, Ch. 1 Sec. 5(1). Similarly, under Swiss law, Art. 121 AniPO makes health checks mandatory, and daily welfare checks are mandated by virtue of Article 2.2 of the Animal Experimentation Ordinance (Animal Experimentation Ordinance 2025).

Taking care of animals used in research is the shared responsibility of researchers, research institutions, and animal care personnel. This is a continuing process: caring about, taking care of, caregiving, and care-receiving, rather than a one-off duty (Fisher and Tronto 1990). Given the high risk of health and welfare issues arising from experimental procedures and housing conditions, their well-being must be monitored daily. In this spirit, some authors call for a fourth R to be added to the 3R principles, which stands for Responsibility (Banks 1995; Arora et al. 2011). This concept emphasises the ethical duty of all individuals involved in animal research to uphold a culture of care,[47] ensuring animals are treated with respect and compassion beyond regulatory compliance (ECAE 2022).

Both jurisdictions offer species-specific provisions regarding cage dimensions. Notably, in Finland, the Directive and FADA include a broader range of species in their annexed tables than Switzerland’s AniPO, whose Annex 3 (Minimum requirements for keeping laboratory animals) omits several common research animals such as rabbits, cats, dogs, ferrets, farm animals, birds, amphibians and reptiles. Nonetheless, AniPO compensates for this omission through its general requirements for the housing of both wild (AniPO, Annex 2)[48] and domestic animals (AniPO, Annex 1),[49] covering many of the species excluded from the Annex mentioned above.

Despite these provisions, serious concerns persist regarding whether minimum cage sizes truly support animal welfare. Blattner highlights that such regulations often reflect the lowest acceptable standards rather than conditions that promote optimal well-being. Legally adequate cages may still fail to accommodate animals’ behavioural and psychological needs (Blattner 2019). To genuinely advance welfare, a more refined approach is needed – one grounded in scientific knowledge of species-specific requirements and supported by the legal promotion of enrichment strategies. This relates to relationship awareness and sympathetic understanding, since designing environments that meet animals’ actual needs requires sensitivity to their behavioural and psychological lives (Manning 2009). While AniPO addresses further aspects of refinement, such as the marking of animals and permanent tethering, FAWA regulates these aspects with a different scope. For instance, FAWA, Ch. 3 Sec. 15 permits marking with methods causing only short-term and mild pain, and FAWA, Ch. 3 Sec. 15 requires checking for existing markings on found animals. In contrast, AniPO Art. 120 mandates the use of the least stressful method for laboratory animal identification and specifies permanent marking for particular species before weaning. Similarly, regarding tethering, while FAWA, Ch. 3 Sec. 13 prohibits it if it causes unnecessary pain or suffering, AniPO, Art. 3 para. 4 explicitly states that animals must not be kept permanently tethered. These varying specificities in regulation, particularly when comparing the detailed requirements in AniPO with the more general provisions in FAWA and the Directive's lack of explicit detailed provisions on these matters, signal differences in regulatory depth within the broader European framework for ensuring animal welfare.

c) Killing of Animals

The EU Directive obliges Member States in Article 6 to ensure animals are killed with minimum pain, suffering, and distress and therefore, euthanasia should be performed at a humane endpoint (Directive, Recital 14). To guide this, the Directive includes in Annex IV a table specifying approved methods of euthanasia (anaesthetic overdose, decapitation, etc.) for certain types of animals (fish, birds, rodents, etc.). These provisions have been transposed to the FADA in Annex II. Additionally, FAPA mirrors the wording of the Directive on this subject, such as who is allowed to euthanise the animals, what competence this person must have, and where the animals shall be killed, namely in the establishment, unless the experiment is conducted in the field (Directive, Art. 6; FAPA, Ch. 4 Sec. 20). These documents further stipulate that animals must be euthanised if they experience pain, suffering, or distress not foreseen in the project authorisation, and if such conditions cannot be alleviated.

In Swiss law, AniPO Art. 177 para. 1 stipulates that only qualified persons are permitted to carry out the killing of animals – a requirement limited to vertebrates and decapods. AniPO further mandates that animals must be stunned before being killed, and if stunning is not feasible, every effort must be made to minimise distress. If an animal continues to experience pain, suffering, or distress after the procedure, it must be euthanised, not later than when the humane endpoints are met (AniPO, Art. 135 para. 7). Besides, euthanasia must be performed reliably and swiftly according to AniPO, Art. 179 and may not be performed in rooms where other animals are housed (AniPO, Art. 135 para. 9) since witnessing such acts can cause substantial stress and fear, negatively impacting their well-being (Ferdowsian et al. 2022). This particular safeguard does not exist in the Finnish instruments. While the Swiss instruments studied here do not include detailed, species-specific euthanasia protocols, the FSVO has issued a guidance document (FSVO 2022) outlining killing methods for mice, rats, hamsters, guinea pigs, rabbits, zebrafish, and clawed frogs. An additional publication provides guidance for the humane killing of decapods and long-tailed crustaceans (FSVO 2020).

While both jurisdictions include numerous provisions aimed at ensuring the humane killing of animals used in research, concerns remain regarding the distress caused by some legally permitted methods. For instance, the use of carbon dioxide CO2, though widely accepted, has been shown to cause significant suffering in animals (Axiak Flammer et al. 2019). Furthermore, a critical observation is that neither of the assessed legislations explicitly protects the lives of animals. Instead, they allow for the killing of animals in research settings, provided specific legal and ethical conditions are fulfilled. This permissive stance includes the possibility of exceptions when sufficient justification for euthanasia is presented. Nevertheless, the Directive does include a noteworthy safeguard in Art. 17(2): it mandates that a veterinarian or another competent person must decide to allow an animal to live after a procedure, which is reflected in FAPA, Ch. 4 Sec. 20(4).

d) Rehoming

After the conclusion of a research project, animals used or intended to be used in procedures may be rehomed or set free under the conditions established in the Directive and regulations applied in Finland. These animals can be released into the wild, rehomed or returned to a suitable husbandry system (Directive, Art. 19; FAPA, Ch. 6 Sec. 28). Swiss legislation does not foresee the possibility of rehoming animals previously used in procedures or releasing them into the wild. At least, researchers are required to define the responsibilities for animal housing (also after the experiment is concluded) and provide information on the further use of animals after an experiment in their application for a license (AniPO, Art. 140 para. 1 lit. h and Art. 141 para. 4 lit. f).

A few Swiss Universities[50] have, in a voluntary fashion, initiated programs for rehoming certain animal species, mainly mice and rats in collaboration with the Swiss Animal Protection (SAP). Unfortunately, these programs face budgetary challenges and lack governmental support. So overall, as stated by Jirkof, "for Switzerland, there is currently no national recommendation on the rehoming of laboratory animals" (Jirkof 2019), which presents a significant gap in animal welfare considerations. In Finland, there have also been a few rehoming attempts with rodents and some companion animals, but no permanent national framework exists. The first systematic rehoming project in Finland, involving 16 laboratory beagles, showed that with proper socialisation training and cooperation with animal welfare organisations, animals can adapt successfully to family homes, even when older or initially shy (Hänninen and Norring 2020). Yet, such cases remain isolated, and both countries lack binding structures to make rehoming a standard option.

It is essential to mention that under Article 19(b) of the Directive, as transposed to FAPA, Ch. 6 Sec. 28(2), rehoming genetically modified animals is only permitted where it can be ensured that such animals pose no danger to human health, animal health, or the environment. Similarly, in Switzerland, Chapter 2 of the Federal Act on Non-Human Gene Technology (Gene Technology Act 2003) establishes legal safeguards aimed at protecting human beings, animals, the environment, and biological diversity from potential harms associated with genetically altered organisms. Rehoming extends the responsibility of care beyond data collection into the animals’ later lives. Institutions must ensure that time, resources, knowledge, and skills are in place to meet these responsibilities (Fisher and Tronto 1990).

IV. Best Practices and de lege ferenda Recommendations

This chapter identifies key practices and legal mechanisms that offer meaningful guidance for improving the implementation of the 3Rs across jurisdictions. Drawing on the comparative legal analysis of Finnish and Swiss frameworks, with Directive 2010/63/EU considered only insofar as it is implemented in Finland through FAPA/FADA, it begins by highlighting the importance of clearly defining the 3Rs in law and establishing a legal hierarchy that prioritises Replacement. Such legal precision effectively mitigates ambiguity and promotes a more uniform application. The chapter then turns to the longer-term goal of transitioning to animal-free research, examining how institutional support, public funding, and centralised knowledge-sharing can help move this objective forward. In addition, it considers broader systemic measures to reduce animal use, such as avoiding unnecessary duplication of research and legislative mechanisms that can encourage more efficient and ethical research design. Concerning Refinement, the chapter outlines how legal provisions can better safeguard animal welfare by limiting distress and by promoting care practices that account for animals’ physical and psychological well-being. Finally, the discussion explores how legal responsibilities for the care and post-research fate of animals can be broadened, particularly through practices like rehoming, which reflect a more comprehensive and ethically grounded approach to animal protection in the context of research.

The recommendations use care ethics as a guide, translated into concrete standards. Attentiveness requires structured opportunities to notice animals’ needs, such as daily checks and meaningful enrichment. Responsibility calls for clear assignment of duties, time, and resources. Responsiveness involves mechanisms to act on what is observed, including dynamic humane endpoints, veterinarian authority to intervene, and systems for tracking cumulative severity. Care also continues after data collection, requiring plans for rehoming, retirement, or sanctuary placement. Finally, Replacement must mean non-animal methods, not the mere shifting of burdens to other species. Together, these criteria reflect Manning’s four care processes and they depend on institutions providing the necessary time, resources, knowledge, and skill (Fisher and Tronto 1990; Manning 2009).

a) Establishing a Foundation for the 3Rs

At the core of progressive jurisdictions’ implementing the 3Rs is a clear definition and determination of a legal hierarchy. Swiss law, in particular, relies on Russell and Burch’s 3R principles, but neither explicitly references nor defines the "3Rs" or the "3R principles". This can lead to vagueness when interpreting and applying the 3Rs, resulting in significant leeway, often to the disadvantage of protecting animals and securing their welfare.

Compared to Switzerland’s less precise and potentially more variable interpretation, the inclusion of clear definitions of the principle of Replacement, Reduction and Refinement in Finnish legislation, as mandated by the Directive, is a good example of how to foster the 3Rs implementation. The clarity with which the EU and Finland define the 3Rs as a cohesive framework represents best practice by eliminating ambiguity in their practical application (which is also desirable for researchers and members of committees on animal experiments), directly contributing to a higher standard of animal protection (e.g., total replacement preferred over partial replacement). Clear definitions put moral attention and responsiveness into practice by helping actors recognise relevant options and act on them (Manning 2009).

Although incorporating the 3Rs into law has improved laboratory animal conditions over time, a hierarchy has emerged in practice. Refinement tends to be prioritised, as it is perceived as more readily achievable by researchers, whereas Replacement is less commonly pursued (Franco et al. 2018). This imbalance is particularly evident in Switzerland, where Refinement appears to dominate the hierarchy (Blattner 2019). In contrast, the Directive instructs Member States, such as Finland, to apply the 3Rs with an emphasis on Replacement, compelling the use of alternatives to animal methods wherever scientifically possible (Directive, Recital 11). This forward-looking orientation aligns more closely with best practices by incentivising the development and validation of non-animal methodologies. To preserve the integrity of the 3R framework, it is essential that legislation clearly prioritises Replacement and supports it with concrete legal and financial mechanisms. Without this, there is a risk of reducing the 3Rs to mere refinements – valuable but insufficient to meaningfully reduce animal use or suffering.[51]

The definitions of the 3Rs in the Directive and their transposition in the Finnish legal instruments closely follow Russell and Burch’s original 1959 formulation. However, several limitations have been identified in these initial definitions (Louis-Maerten et al. 2024), including their inherent vagueness, broadness, and inconsistencies in interpreting concepts like Replacement, particularly regarding its scope of application and differentiation from ultimate animal-free objectives. However, the goal of full replacement of procedures on live animals expressed in recital 10 of the Directive is of particular significance when interpreting the 3Rs. It frames the 3Rs within a broader normative trajectory, guiding their implementation toward a clear aim. This forward-looking orientation ensures that the 3Rs are interpreted not merely as a tool for minimising harm within existing research paradigms, but as a mechanism for facilitating the transition toward animal-free research (Blattner 2019; Otto 2021). Switzerland could align with this vision by explicitly adopting a similar interpretative framework, embedding in its legislation a commitment to the full replacement of animal procedures when scientifically feasible. Such a provision would clarify that the 3Rs are not an end in themselves, but a means to achieve the eventual discontinuation of live animal use, and more importantly, would support policy development through a clear transition plan, specifying intermediate goals, timelines, interim reduction targets, and financing mechanisms.

Finland demonstrates best practice by mandating the establishment of a national Council on the Protection of Animals Used for Scientific or Educational Purposes. This body supports the continuous development and implementation of the 3Rs as mandated by FAPA in Ch. 11 Sec. 53(1). In contrast, responsibility for this function in Switzerland is shared among the government, universities and industry (AniWA, Art. 22). This approach appears promising by including the main stakeholders involved in animal research. However, ultimate responsibility for implementation is not clearly defined, which risks that no stakeholder fully assumes responsibility for the 3Rs’ development and implementation. Taking care requires a clear assignment of responsibility and accountability, along with the authority to provide the necessary resources (Fisher and Tronto 1990). If responsibility is not clearly assigned, it is likely that no actor takes full ownership, and the development and implementation of the 3Rs will be weakened.

b) Driving the Transition Toward Animal-Free Research

This section examines the varying degrees to which the goal of full replacement of animal experiments is prioritised and addressed in the compared instruments. Recital 10 of Directive 2010/63/EU explicitly describes the Directive as "a step toward 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". Including a clear end goal for animal experiments signals institutional attentiveness to long-term responsibilities and recognises that care extends not only to people but also to other living beings and the environment (Fisher and Tronto 1990). Setting a future goal for animal-free research, as the Directive does, is the best practice to incentivise the development and validation of alternative methods and to reduce the total number of animals used in research. As an EU Member State, Finland is bound to pursue this objective, even if it is not yet fully embedded in its national legislation (Chlebus et al. 2016; Brønstad and Sandøe 2020). By contrast, such a commitment is absent in Swiss law. Indeed, in response to popular initiatives, the population has consistently voted for continuing animal research.[52]

Even though the EU remains committed to the goal of full replacement, no concrete strategy or deadline for phasing out the use of live animals in experiments has been adopted or even proposed since its adoption in 2010. This lack of strategic planning limits the Directive’s potential to drive sustained progress toward animal-free research (Marshall et al. 2022). To move beyond aspiration, the EU should require Member States, in this case Finland, to develop a phase-out plan, with clear aims, milestones, and timelines for reducing and ultimately replacing the use of animals in research. This plan should be developed under EU pre-established terms in accordance with the nature of directives. The European Commission is working on a roadmap towards phasing out animal testing (Walder et al. 2025).[53] Partner programmes have been launched to foster collaborations between governmental and other organisations to accelerate the transition to animal-free innovation, such as the Transition Programme for Innovation without the Use of Animals (TPI) in the Netherlands.[54] Similar programmes should be incentivised across jurisdictions and supported through sustained public investment. By fostering collaboration and providing structural support, governments can help realise the Directive’s vision and accelerate the transition toward scientifically and ethically superior research practices (Müller 2024).

c) Replacement – Boosting Institutional Support for Animal-Free Research

The Directive's approach – centralising knowledge on alternative methods and ensuring its accessibility to researchers and licensing authorities – represents a best practice in advancing the 3Rs. Centralisation supports moral attention by helping actors see the full range of alternatives, and strengthens responsiveness by making it easier to act on them (Manning 2009). By enabling stakeholders to remain informed about the latest scientific developments and to apply validated alternatives more readily, this model fosters a dynamic and progressive regulatory environment. The Joint Research Centre’s EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) plays a key role in this effort, issuing regular reports on advances in the field (European Commission et al. 2023). Both Switzerland and Finland support institutions dedicated to the promotion and implementation of the 3Rs: the Swiss 3R Competence Centre[55] and the Fin3R Centre, respectively.[56] These bodies facilitate collaboration among various stakeholders, including research institutes, universities, authorities, and industry, to advance the 3Rs in research and education. However, beyond establishing the aforementioned dedicated centres, governmental bodies have a crucial responsibility to actively support the development and validation of alternative methods. This crucial responsibility is increasingly recognised at the policy level, with various governments worldwide demonstrating their commitment through palpable initiatives. For example, through targeted public funding programs for non-animal research, such as the US EPA’s ToxCast Programme[57] or the Swiss Federal Council’s National Research Programme Advancing 3R;[58] tax incentives for companies investing in alternative technologies; fostering inter-institutional research consortia; and developing national roadmaps with clear objectives for phasing out animal use where feasible, like those seen from UK Research and Innovation[59] and the US EPA. Furthermore, regulatory bodies like the US FDA[60] have begun relaxing animal testing requirements, allowing non-animal methods for drug approvals (Deckha et al. 2025). Care theorists warn that responsibility without power is fragile; naming who funds, validates, and recognises alternatives, and with what resources, addresses the asymmetry between responsibility and power (Fisher and Tronto 1990).

Universities, in particular, hold a pivotal role in accelerating the transition to animal-free research. They can contribute towards the transition by clarifying their position, formulating a clear strategy, creating transition units, re-directing curriculum, and fostering a cultural shift in research values (Deckha et al. 2025). A centralised, comprehensive database for alternative methods is also essential to facilitate progress. Such a platform would not only streamline the development and validation of alternative methods but also enhance their adoption across research sectors. Switzerland, with its substantial research output, is well-positioned to contribute to and benefit from the EU’s existing database infrastructure, such as EURL and ECVAM.[61] By establishing collaboration and adjusting legislation to mandate the use of a centralised database, Switzerland could help accelerate the development and validation of alternative approaches.

d) Reduction – Enhancing Reduction and Minimising Overall Animal Use

The principle of Reduction, as defined in the 3Rs framework, aims to minimise the number of animals used in individual experiments. Even though reducing the overall number of animals in research is not an explicit target of the 3Rs, its effective step-by-step implementation may nonetheless contribute to that outcome. Both Finnish and Swiss legislation reflect a commitment to reducing animal numbers in individual experiments. However, to strengthen the implementation of the Reduction principle, legislation should mandate the use of state-of-the-art, reproducible experimental designs and require research institutions to consult with biostatisticians when determining sample sizes. On the other hand, regarding the overall reduction of animal use, significant differences remain in how comprehensively these jurisdictions address reduction on a systemic level. Finland’s framework (FAPA/FADA) implements Directive 2010/63/EU and supports broader strategies that aim to reduce the total number of animals used across the research landscape, such as tissue and organ sharing programs and avoidance of duplication of procedures, such as sharing of research data and results, and the use of centralised databases for non-technical summaries of completed studies. However, these strategies are not specified as clearly in Finland’s implementing provisions. By contrast, Swiss law lacks such strategies. The Directive exemplifies best practice by promoting the reuse of biological materials through tissue and organ-sharing initiatives. However, for such strategies to be effective, Member States must implement this mandate in their legislation and provide the necessary infrastructure and funding. This may include establishing centralised tissue banks and organ-sharing programs at the national level, such as the Primate Tissue Bank of Biomedical Primate Research Centre[62] in the Netherlands, which facilitates the reuse of materials and reduces the need for additional animals.

Furthermore, the Directive mandates EU Member States, including Finland, to avoid the duplication of animal research procedures by recognising data generated from previously conducted experiments across the EU. ALURES[63] is a central database that contains the non-technical summaries of all the experiments conducted at the EU level. Even though researchers do not generally rely only on information obtained from a single database, developing such a tool and making it available to researchers is a clear example of best practices to contribute to reducing the overall use of animals in research. Similarly, Swiss researchers may request access to the FSVO data repository[64] to explore data generated from studies collected or funded by the FSVO for further research. Establishing formal agreements for Switzerland to share data via ALURES, as Norway does, would be a more integrated approach to enhance cross-border collaboration and reduce redundant animal use. Although Norway is not an EU Member State, its participation in ALURES as part of the European Economic Area sets a strong precedent for such cooperation. Complementary to the right to access information on already conducted animal research, these instruments could introduce respective duties to consult the databases for research committees evaluating the legitimacy of a proposed project.

The promotion of the principle of Replacement is key to achieving a substantial reduction in the overall use of animals in research. Using alternative methods such as organoids,[65] organ-on-a-chip systems,[66] or other in-vitro methods is rapidly gaining traction as viable substitutes for live animal experimentation, particularly in toxicity testing and biomedical research. These technologies offer scientifically robust and ethically preferable options and should be actively supported through targeted funding schemes, research grants, and innovation awards (Fausch et al. 2025).

A key area of concern is the regulation of animals bred for research but ultimately not used, commonly referred to as "surplus animals" (Persson et al. 2024). These animals are bred for experiments but not ultimately used because of genetic breeding outcomes, specific experimental requirements, research plan changes, or overproduction. This practice raises ethical concerns due to the frequent euthanasia of these animals (Wewetzer et al. 2023). To tackle the issue of surplus animals, legislation should impose legal limits on breeding surplus and mandate the sharing of bred animals between institutions. This could help minimise unnecessary animal use and improve animal welfare while scientific research moves away from animal models. Swiss AniPO provides a noteworthy example of best practice in this area by limiting the breeding of experimental animals in Art. 118 lit. a and placing the responsibility on the heads of research facilities in Art. 114 para. 2 lit. f, a model that could be adopted more widely to improve accountability across jurisdictions. It is crucial to understand that while these specific measures may improve the welfare of animals currently bred for research and reduce unnecessary animal use, their role is as an interim solution, if the ultimate goal is moving towards entirely animal-free research.

e) Refinement – Optimising Animal Care and Well-Being

The analysed instruments demonstrate variations in their emphasis and the specificity of their requirements regarding different aspects of Refinement. These variations highlight potential inconsistencies in the level of protection and care afforded to animals in the laboratory. This comparative legal analysis underscores the importance of implementing a clearly defined upper threshold for pain in research legislation (Beauchamp and Morton 2015; Olsson et al. 2020). Following the EU, Finland shows best practice by prohibiting procedures that involve severe pain, suffering, or distress that are likely to be long-lasting and cannot be lessened. To ensure consistent protection, the legal threshold for permissible pain should be defined as precisely as possible, based on expert consensus. Although exceptional cases may arise, decisions to exceed this threshold should not rest with licensing authorities but be determined by a court, ensuring independent oversight and ethical accountability.

While it is essential to acknowledge the potential conflict with the constitutionally guaranteed scientific freedom in Switzerland (Federal Constitution of the Swiss Confederation, Art. 20) and Finland (The Constitution of Finland, Sec. 16), it is equally crucial to recognise that constitutional mandates for animal protection, respect, and dignity must also be given substantial weight in this debate. Indeed, as shown earlier, many of these freedoms are recognised to be in principle on par with the state’s objective or constitutional mandate to animal protection. Consequently, adequate aids to weigh these differing interests should be established (Eisen 2018; Le Bot 2018).

f) Responsible Keeping and Care for Animals

Effective animal protection in research settings depends largely on clearly defined and practically implemented responsibilities, both at the institutional level and among individual personnel. Taking inspiration from the ethics of care approach as discussed in the context of One Health, responsibility is understood not simply as fulfilling regulatory duties but as an active, responsive engagement with the needs of others, including animals. This framework situates care as a foundational moral impulse and positions responsibility in terms of attentiveness and relational responsiveness (Anthony and De Paula Vieira 2022).

In terms of animal housing and care, Swiss legislation illustrates several strong practices that extend the scope of responsibility beyond the prevention of physical suffering to a more comprehensive view of animal well-being. It seeks to prevent forms of excessive instrumentalisation, degradation, or significant alterations to an animal’s natural form or capacities, principles rooted in the legal protection of animal dignity. These provisions highlight both a legal and ethical obligation to respect the intrinsic value of animals. Notably, Swiss law also prohibits performing euthanasia and other potentially distressing procedures in view of other animals, acknowledging the psychological toll such experiences may have and affirming the duty to reduce emotional distress.

Both Finland and Switzerland would benefit from mutually adopting each other’s legislative strengths in implementing the principle of Refinement. Incorporating non-pathocentric harms into the Finnish harm-benefit analysis, preferably through the EU, would provide a more holistic approach to animal welfare, reflecting a broadened institutional responsibility for more than physical but also psychological well-being. Similarly, legally prohibiting euthanasia and painful procedures in the presence of other animals in EU Member States, including Finland, would align with psychological welfare considerations. These actions will help institutionalise the duty of care, enhancing accountability and reinforcing the ethical responsibility to minimise distress.

As previously discussed, minimum cage sizes do not inherently guarantee adequate animal welfare. Therefore, both jurisdictions should review their housing requirements to ensure they meet species-specific behavioural and psychological needs. Legislation should promote cage standards that go beyond minimal compliance, informed by contemporary ethological research. Furthermore, enrichment strategies, vital for mental stimulation and behavioural expression, should be updated accordingly with the latest species-specific knowledge.

This analysis highlights that both jurisdictions include numerous provisions aimed at ensuring animals used in research are killed humanely, without unnecessary pain or suffering. However, a critical gap remains: the absence of clear legal obligations regarding the fate of animals that remain healthy following experiments or are bred for research but ultimately not used, commonly referred to as "surplus animals". Current legislation does not provide sufficient guidance to institutions on how to address the continued care or rehoming of such animals, representing a significant area where institutional responsibility needs to be more explicitly defined. Care ethics emphasises that caring is a continuing process (Fisher and Tronto 1990). In the research context, this means recognising relational continuity: responsibilities do not end when the experiment is concluded but should extend to what happens to animals afterwards. Institutions should be required to provide a basic standard of post-study care, while enabling more supportive solutions such as rehoming or sanctuary placement.

Legislation should require that research facilities develop and implement protocols for the post-research placement of animals (i.e., shelters, sanctuaries, etc.), provided they are in good health and can successfully adapt to new environments. From a care ethics perspective, the preferable course of action is to prioritise the animals’ best interests. In Manning’s terms, this reflects sympathetic understanding, which requires attending to what those affected would want and what is best for them (Manning 2009). In the research context, this supports rehoming or sanctuary to enable animals to live out the rest of their natural life spans. In this regard, Finnish legislation is comparatively "advanced" by permitting rehoming, transposing the Directive’s mandates. A true best practice would be to mandate rehoming, rather than just allow it (Van Loo and Janssens 2023). As stated in the FELASA recommendations on rehoming, "The purpose of rehoming is to offer an animal a life worth living beyond its use as a research animal". This principle should guide decisions concerning animals used or intended to be used for scientific purposes, provided that rehoming occurs only where it is in the best interest of the animal (Ecuer et al. 2023). In Switzerland, some universities operate voluntary rehoming initiatives; a national legislative mandate supported by public funding would ensure broader and more consistent implementation. It is important to note, however, that current regulations exclude genetically modified animals from rehoming due to potential risks to public and environmental health. To address this, the establishment of dedicated sanctuaries for research animals – including genetically modified ones – could offer a viable alternative consistent with care ethics, by recognising relational continuity and extending responsibility to these animals beyond their use in research (Fisher and Tronto 1990). In recent years, more attention has been given to the ethical treatment of research animals, including the transition of non-human primates (NHPs) from research environments to sanctuaries or other non-research facilities, often referred to as retirement (Maxwell et al. 2024). This aligns with a wider discussion in the animal welfare field, where increasing attention is being paid to whether and how long-term care facilities for research animals – also those that are genetically modified – can and should be developed. Although such facilities would require significant financial investment, they would align with a more responsible and forward-looking model of animal research governance.

V. Conclusion

This study examined how Switzerland and Finland embed the 3Rs in their legal frameworks for animal research. It compared constitutional provisions, statutory requirements, and detailed regulations to assess how far the law protects animals and implements the 3Rs. The analysis also considered whether these legal tools enable responsibilities toward animals that go beyond procedural compliance, drawing on care ethics as a guiding perspective. In answer to these questions, the analysis shows that both jurisdictions have legal frameworks designed to protect animals, but they rest on different underlying concepts and implement the 3Rs in distinct ways. Moreover, the protections offered by these jurisdictions, appear not to fully meet the standards of attentiveness, responsibility, and continuity required by an ethic of care.

Deciding on the normative ethical approach for this analysis required weighing competing realities. On the one hand, society demands improvements in our relationships – with one another, with the environment, and with animals. On the other, the use of animals in research remains deeply embedded in systems, institutions, the economic sector, and education. Ethics of care was chosen, since it speaks directly to responsibility, which is perhaps one important missing piece in this puzzle. Although it does not mention animals explicitly, it does not exclude them either. It is about improving relationships in general, and this can clearly be applied to animals, especially in terms of attentiveness, responsibility, and continuity.

Even though the 3Rs are embedded in legislation, they alone are unlikely to create the significant changes that are needed in our evolving relationship with animals. Their value lies in providing a concrete language to engage researchers, who might otherwise struggle with abstract concepts such as dignity or intrinsic value. At the same time, the 3Rs need to be reinforced by stronger principles and constitutional protections in order to serve as drivers of change. From the perspective of the ethics of care, their integration into law must be framed as part of a wider effort to reshape relationships and extend responsibility. This reorientation could first be pursued at a theoretical level, for instance, by exploring how the ethics of care might be explicitly incorporated into animal law. Ultimately, however, doctrinal and conceptual changes are needed to move beyond incremental welfare improvements and to reconsider how animals are positioned within our educational, economic, and political systems.

Both jurisdictions have legal frameworks designed to protect animals, but they are built on different concepts, approaches, and tools. Switzerland grounds protection in the constitutional principles of animal dignity and animal welfare. Finland, under the EU framework, grounds protection in animal sentience and a legal duty to respect animals as sentient beings with intrinsic value as reflected in the Directive’s recitals and Finland’s implementing framework. In both, constitutional-level commitments are framed at a high level of abstraction. Greater doctrinal clarification, including through implementing legislation and authoritative guidance, could help specify how animal dignity, sentience, welfare, and intrinsic value are to be balanced against competing human interests, and could support more consistent interpretation and application in downstream legislation and authorisation practice. In both systems, animal research is permitted only when strictly necessary and justified, and the 3Rs function as guiding principles to conduct animal research to a high standard and in a humane way. This, however, does not mean that welfare is fully guaranteed; moreover, it creates a tension with the principles above that recognise the intrinsic value of animals. While both countries integrate the 3Rs in comparable ways, this analysis has shown that they diverge in important aspects.

The analysis shows complementary strengths but also structural weaknesses in both jurisdictions. Finland, through the Directive, benefits from explicit legal definitions of the 3Rs, a statutory hierarchy that places non-animal methods first, and a declared trajectory toward full replacement. Switzerland embeds the principles of dignity and welfare in its Constitution and has adopted detailed duties of refinement that address the day-to-day conditions of animals in laboratories. Yet in both jurisdictions, the overarching objectives of the 3Rs remain under defined in law, leaving them less effective as guiding principles. Blind spots also persist across the systems: efforts to reduce animal use are weakly developed; limits on severe, long-lasting and unalleviable suffering are not framed and operationalised in a fully consistent and enforceable way across both systems, post-study responsibilities remain limited; and although Switzerland has recently introduced provisions to limit surplus breeding, controls in both systems remain incomplete. The reason for the 15% reported drop in animal use in Finland between 2022 and 2023 remains unclear. While this may reflect improved implementation of reduction strategies, latest analyses suggest that recent decreases in the EU often stem from reductions in regulatory testing rather than from systemic reform (Taylor 2024). Finding the reasons behind this decline in Finland would be an interesting subject for further study, as it would help to find out if the implementation of the 3Rs played a role.

Fundamentally, the 3Rs continue to apply mainly to the experimental phase itself, without extending to the breeding of animals beforehand or their rehoming afterwards. This problem emerges from the conceptual design of the 3Rs, developed over 60 years ago, and from their implementation, which continues to apply the framework faithfully while disregarding the continual evolution of science and society. Addressing these shortcomings requires targeted reforms. As a matter of policy design, in Switzerland, statutory definitions of the 3Rs and a legal hierarchy that facilitates the validation of non-animal methods would provide greater clarity and consistency. Finland, by contrast, already benefits from the Directive’s framework but needs stronger national structures to also promote and validate alternatives beyond what EU law requires. In both countries, reduction could be made effective only through concrete tools such as preregistration of studies, independent statistical review, registries of results including negative findings, and national networks for the sharing of organs and tissues. Refinement should also be reinforced by adopting enforceable upper limits on pain, housing standards directed towards welfare, and by prohibiting euthanasia or painful procedures in the presence of other animals. Finally, responsibility for animal welfare in research must not be limited to the experimental phase: it should include a strategy for mandatory rehoming or retirement and, wherever possible, the consideration of the creation of sanctuaries where rehoming is not feasible, and binding measures to minimise the breeding of surplus animals.

To make real progress toward animal-free research, the law must establish a clear pathway with milestones and objectives for transition. Within such a framework, the 3Rs can support change – especially by fostering the development and uptake of alternatives – but they should not be mistaken for an endpoint of regulation. The analysis shows that the 3Rs, while valuable, remain limited in scope. They mitigate harm within research by guiding replacement where possible, minimising numbers, and reducing suffering, but their application is largely confined to the experimental phase, and it does not guarantee animal welfare.

Read through the lens of care ethics, the proposed reforms gain added depth: they foster attentiveness to animals’ needs, assign responsibility with clarity and resources, and extend obligations beyond the experimental phase to breeding, rehoming, and retirement. More importantly, they frame legal change not only as a matter of compliance but as part of a broader effort to reshape our relationship with animals. In this perspective, reforms become steps toward a legal order that embodies attentiveness, responsibility, and continuity, and that acknowledges animals not merely as instruments of research, but as beings toward which we bear ongoing responsibilities.

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[1] Animal research refers to "procedures" as defined in Directive 2010/63/EU, Art. 3 and to "animal experiment" as defined in the Swiss Animal Welfare Act, Art. 3.

[2] As defined in Gerritsen’s book, death itself is not classified as a welfare impairment if it occurs instantaneously and without pain or distress (e.g., under deep anaesthesia). However, the manner and context of death (e.g., anticipation of killing, handling stress, failed stunning) can constitute significant welfare concerns. Pain is an unpleasant sensory and emotional experience that is associated with actual or potential tissue damage or is described in terms of such damage. It is always a subjective experience that must be considered from the perspective of the affected individual. Suffering encompasses all negative emotional experiences and is often used as an umbrella term for states such as pain, anxiety, fear, or depression. It implies a subjective negative experience that significantly affects the animal’s well-being. Stress refers to an acute or chronic physiological state triggered by internal or external stressors that disturb the organism’s homeostasis and initiate adaptation responses. It is not negative per se, but becomes problematic when stress responses are excessive, prolonged, or ineffective, potentially leading to damage or disease. Anxiety in animals is defined as a negative emotional state in response to an anticipated threat. It differs from fear, which is a reaction to an immediate danger. Anxiety is often associated with behavioural signs such as restlessness, increased vigilance, or avoidance behaviour, and can be measured indirectly through physiological indicators (e.g., cortisol levels). Distress (Belastung) is defined as a state in which an animal’s adaptive capacity is overwhelmed, leading to maladaptation or harm. This term is often used in legal or regulatory contexts to assess the severity of experimental procedures. It includes both physical and psychological strain. Harm (Schaden) is considered a lasting, irreversible impairment of an animal’s physical or psychological integrity. It goes beyond temporary suffering and includes, for example, permanent injury, chronic illness, or long-term behavioural disorders. Impairment of Welfare refers to any negative impact on an animal’s physical and psychological well-being. It includes transient suffering as well as lasting harm and is the central criterion in ethical evaluation and harm-benefit analysis of animal experiments.

[3] <https://www.blv.admin.ch/blv/de/home/tiere/tierversuche/bericht-tierversuchsstatistik.html> (accessed: 08.02.2026).

[4] A poll by Savanta for Eurogroup for Animals reflected that 77% of European citizens want a transition to non-animal science. <https://savanta.com/knowledge-centre/press-and-polls/animal-research-poll-eurogroup-for-animals-31-march-2023/> (accessed: 12.08.2025).

[5] Swiss federal popular initiatives on animal experimentation include: 1) Popular initiative of 1985 "for the abolition of vivisection", 2) Federal popular initiative of 1992: "for the drastic and gradual restriction of animal testing (away from animal testing!)", 3) Federal popular initiative of 1993: "for the abolition of animal testing", and 4) popular initiative 2022: "Yes to the ban on animal and human testing – Yes to research paths with impulses for safety and progress". <https://www.bk.admin.ch/ch/d/pore/va/vab_2_2_4_1.html> (accessed 22.01. 2025).

[6] <https://citizens-initiative.europa.eu/initiatives/details/2012/000007/stop-vivisection_en> (accessed: 12.08.2025).

[7] <https://citizens-initiative.europa.eu/save-cruelty-free-cosmetics-commit-europe-without-animal-testing_en> (accessed: 12.08.2025).

[8] <https://www.nfp79.ch> (accessed: 12.08.2025).

[9] The Nordic and Finnish legal systems are built upon the Germanic legal culture; in other words, they are part of the civil legal family, similar to Switzerland, even though the Finnish legal system is not based on a systematic collection of statutes, i.e., codes as in many other civil law countries.

[10] The European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes (ETS No. 123) was ratified by Finland in year 1990 and Switzerland just a few years later in 1993. <https://www.coe.int/en/web/conventions/full-list?module=signatures-by-treaty&treatynum=123> (accessed: 01.09.2025).

[11] Switzerland has ranked first for 14 years in a row in the Global Innovation Index. Finland just moved up to number 6 in 2023 and 7 in 2024. <https://www.wipo.int/web-publications/global-innovation-index-2025/en/gii-2025-results.html> (accessed: 08.02.2026).

[12] While Switzerland ranked first in the World Index of Healthcare Innovation, Finland moved up from number 23 in 2020 to number 14 in 2024. <https://freopp.org/whitepapers/key-findings-from-the-2024-world-index-of-healthcare-innovation> (accessed: 12.08.2025).

[13] Proposal in English: <https://ecojurisprudence.org/wp-content/uploads/2024/05/English-Finland-Constitution-Rights-of-Animals-.pdf> (accessed: 12.08.2025).

[14] <https://www.elaintenvuoro.fi/finland-mp-proposes-inclusion-of-animal-rights-in-the-constitution> (accessed: 12.08.2025).

[15] At the time this paper was written, the proposal was pending before the Finnish Parliament and under committee consideration. <https://ecojurisprudence.org/initiatives/finland-citizens-initiative-constitutional-amendment-on-animal-rights/> (accessed: 12.08.2025). See also the Finnish Parliament record for KAA 8/2023vp <https://www.eduskunta.fi/FI/vaski/Esityslista/Sivut/PeVE_16%252B2026.aspx> (accessed: 20.03.2026).

[16] Attentiveness means noticing needs and risks in context and focusing on what matters for an animal’s welfare; responsibility, taking ownership to initiate and sustain care, with the requisite judgement, time and resources; and responsiveness, remaining answerable to how animals actually fare and adjusting practice accordingly. Fisher, B. and Tronto, J. (1990). Toward a feminist theory of caring. Circles of care: Work and identity in women’s lives 7, 35-92.

[17] In this article, the Directive is analysed as part of Finland’s legal context through transposition and interpretative relevance, and not as a separate jurisdiction for comparison.

[18] Council Directive 74/577/EEC is no longer in force (end of validity 01.01.1995) and was repealed and replaced by Council Directive 93/119/EC. Directive 93/119/EC was later repealed and replaced by Regulation (EC) No. 1099/2009 on the protection of animals at the time of killing, which is currently in force.

[19] The European Union is a supranational economic and political partnership between 27 European countries. The EU can develop its activities on the treaties that are approved by all the Member States. The European Commission is responsible for proposing new legislation to the European Parliament and the Council of the European Union under the EU treaties. The European Commission is also responsible for ensuring that the Member States implement the adopted legislation correctly.

[20] By acknowledging the sentience of animals, this document sparked the revision of other documents such as was later reflected in reforms including the replacement of Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes, to give way to by Directive 2010/63/EU.

[21] Two political organisations are responsible for the general framework encompassing the European continent: The Council of Europe and the European Union. The Council of Europe is an intergovernmental organisation that covers almost the whole continent. It has 46 member countries, including Switzerland. It seeks to develop common and democratic principles based on the European Convention on Human Rights and other agreements. The Council of Europe has no legislative power and seeks voluntary cooperation within the member countries through recommendations, agreements, and conventions. Member countries can sign and ratify the conventions. If they do, they are bound to implement the conventions into their national legislation.

[22] The European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes (Animal Experimentation Convention) is designed primarily to reduce both the number of experiments and the number of animals used for such purposes. It encourages Parties not to experiment on animals except where there is no alternative. All research into alternative methods should be encouraged. Animals to be experimented on should be selected on the basis of clearly established quantitative criteria and must be well cared for and spared avoidable suffering whenever possible. To this end, the Convention lays down a number of principles which are to be considered only as a starting point. The Parties meet regularly to examine the application of the Convention and, if appropriate, to extend or strengthen its provisions.

[23] In both Finland and Switzerland, detailed implementing rules are often laid down in delegated legislation. In Finland this takes the form of Government Decrees (asetukset) issued under constitutional or statutory authorisation (Constitution of Finland (731/1999), Sec. 80). In Switzerland, Federal Council ordinances (Verordnungen) adopted when empowered by the Constitution or a federal act (Swiss Federal Constitution (SR 101), Art. 182 para. 1 fulfils a comparable implementing function.

[24] The lex superior principle refers to the hierarchical ordering of legal norms, according to which a higher-ranking norm (e.g., the Constitution) prevails over lower-ranking norms (e.g., statutes or regulations) in the event of conflict.

[25] Constitution of Finland, Section 20: "Responsibility for the environment Nature and its biodiversity, the environment and the national heritage are the responsibility of everyone. The public authorities shall endeavour to guarantee for everyone the right to a healthy environment and for everyone the possibility to influence the decisions that concern their own living environment."

[26] According to the preparatory work of Section 20 of the Constitution of Finland, the protection of nature has its starting point in nature’s intrinsic value. Thereby, one can claim that at least wild animals, living in and from nature, have an indirectly recognised intrinsic value and constitutional protection.

[27] Translated by authors.

[28] Government Bill to Parliament on an Act on Animal Welfare and related Acts (HE 186/2022), Section 4.1.2 "Respect for Animals" (eläinten kunnioitus). Translation made by authors.

[29] The Federal Constitution (BV) is the highest decree of the Swiss legal system. All federal, cantonal and municipal laws, regulations and other Decrees are subordinate to it. It, consequently, shapes the basis on which all regulations are built. This also applies to the exterior since Switzerland, as a sovereign state, can only participate in international legislation when this does not contradict its Constitution.

[30] Swiss Constitution, Art. 80 Protection of animals:

1 The Confederation shall legislate on the protection of animals.

2 It shall in particular regulate:

a. The keeping and care of animals;

b. Experiments on animals and procedures carried out on living animals;

c. The use of animals;

d. The import of animals and animal products;

e. The trade in animals and the transport of animals;

f. The killing of animals.

3 The enforcement of the regulations is the responsibility of the Cantons, except where the law reserves this to the Confederation.

[31] In German: Tierschutzgesetz.

[32] In German: Tierschutzverordnung.

[33] Since the entry into force of FAWA 693/2023, the Animal Welfare Act of 1996 is no longer in force.

[34] In Finnish: Laki tieteellisiin tai opetustarkoituksiin käytettävien eläinten suojelusta – 497/2013 – of 28 June 2013.

[35] In Finnish: Valtioneuvoston asetus tieteellisiin tai opetustarkoituksiin käytettävien eläinten suojelusta – 564/2013 – of 18 July 2013.

[36] Article 4 of the Constitution of the Swiss Confederation states: "The national languages are German, French, Italian and Romansch". According to Article 70 of the Constitution, only German, French, and Italian are full-fledged "official languages of the Constitution". Federal Laws are published in these official languages: German, French and Italian, and the three versions are equally binding. Romansch is only an official language of the confederation when communicating with persons who speak Romansch. This means that Federal laws are only issued in German, French and Italian.

[38] Fedlex (<https://www.fedlex.admin.ch/en>) is the official Swiss federal legal information platform, managed by the Federal Chancellery, providing free public access to statutes, ordinances, consolidated legislation, federal gazettes, consultation documents, and associated open-data services. Finlex (<https://www.finlex.fi/en>), operated by Finland’s Ministry of Justice, is the official Finnish legal database offering free public access to legislation, case law, treaties, government bills, translations, and open-data services.

[39] Constitution of Finland (731/1999) Sec. 20.

[40] "In their analysis, Tannenbaum and Bennett (2015) demonstrate that the way Russell and Burch introduce and define the 3Rs (i.e., replacement, reduction and refinement) makes it clear that the purpose of each of the Rs is the diminution, and when possible removal, of animal distress without compromising scientific and medical progress."

[41] In Switzerland, cantonal committees on animal experimentation (Tierversuchskommissionen) may include members with statistical expertise or consult external biostatisticians. However, this practice is not uniform across cantons, and federal law does not mandate statistical review, which leads to inconsistencies in evaluation.

[42] There are provisions about reuse of animals in both jurisdictions, but these are meant to protect animals from reuse when it causes them more distress. Therefore, these provisions can be considered refinement.

[43] Preregistration involves submitting a study protocol before data collection to ensure transparency and reduce duplication. Registries of negative or neutral results make such findings publicly accessible, helping to prevent unnecessary repetition of experiments.

[44] In Zurich, three members of the cantonal animal experiment commission may appeal an approval decision to the Cantonal Executive Council (Regierungsrat) and, ultimately, to the Administrative Court (Verwaltungsgericht): Cantonal Animal Welfare Act (Kantonales Tierschutzgesetz) 1991 (ZH) § 12(2), No. 554.1

[45] An operator means a breeder, supplier and user according to FAPA - Ch. 1 - Sec. 1.

[46] An establishment means any installations, buildings, groups of buildings or other facilities in the possession of the operator relating to the activity referred to in this Act, FAPA - Ch. 1 - Sec. 5(7)

[47] The term "Culture of Care" refers to institutional practices that promote responsibility, transparency, and support for staff in animal research. It should not be confused with the ethics of care framework used in this study, which is a normative ethical theory focused on attentiveness, responsibility, responsiveness, and relationships.

[48] Minimum requirements for keeping wild animals.

[49] Minimum requirements for housing domestic animals.

[50] University of Basel, University of Zurich, University of Bern and the École Polytechnique Fédérale de Lausanne.

[51] This critique does not seek to diminish the importance of Refinement, which remains essential for animals currently used in research. Rather, it highlights the need to update the 3Rs through interdisciplinary input – including animal advocates – and to ensure that their definitions remain current and meaningful.

[52] <https://www.news.admin.ch/de/nsb?id=104194> (accessed: 12.08.2025)

[53] <https://single-market-economy.ec.europa.eu/sectors/chemicals/reach/roadmap-towards-phasing-out-animal-testing_en>.

[54] Transition Programme for Innovation without the use of animals (TPI) <https://www.animalfreeinnovationtpi.nl/> (accessed: 12.08.2025).

[55] <https://swiss3rcc.org> (accessed: 12.08.2025).

[56] <https://fin3r.fi/en> (accessed: 12.08.2025).

[57] <https://www.epa.gov/comptox-tools/toxicity-forecasting-toxcast> (accessed 18.07.2025).

[58] <https://www.nfp79.ch/en> (accessed: 12.08.2025).

[59] <https://www.ukri.org/publications/non-animal-technologies-in-the-uk-a-roadmap-strategy-and-vision/> (last accessed: 11.08.2025).

[60] United States Food and Drug Administration.

[61] EURL: EU Reference Laboratory. ECVAM: European Centre for the Validation of Alternative Methods.

[62] <https://www.bprc.nl/en/primate-tissue-bank> (last accessed: 18.07.2025).

[63] ALURES – AnimaL Use Reporting EU System: <https://webgate.ec.europa.eu/envdataportal/content/alures/section1_number-of-animals.html> (accessed 18.07.2025).

[64] <https://www.studydata.blv.admin.ch/home> (accessed 18.07.2025).

[65] Organoids are organ-like structures derived from self-organizing stem cells in 3D cell cultures. They exhibit organ-specific characteristics and originate from stem cells undergoing self-organization.

[66] Organoid chips represent a blend of biological principles and microtechnology, functioning as small-scale cell culture systems within microfluidic devices. Their capacity to simulate the natural cellular surroundings makes it simpler and more convenient to study how cells interact with each other.