An overview of strategies in the Netherlands, USA, UK, Norway, Sweden, and the EU

For years, the German government has affirmed that everything is already being done to reduce the number of animals suffering in laboratories, that everything is already being done to ensure that animal-free methods are used, and that the law only allows essential animal experiments anyway.

For years, Doctors Against Animal Experiments has been pointing out that the practical implementation of these statements is pending quite obviously.  -The high number of animals used in experiments, which has been stagnating for years, makes a mockery of these statements (1). On top, virtually no animal experiment is rejected by the authorities. The nationwide rate of rejections in no higher than a shameful average of 0.75% (2). The claim  that human-based methods are already adequately funded also proves to be baseless when looking at the facts: human-based research is funded with less than 1% compared to the sum  of funding that goes into animal-based research (3). Real commitment and honest interest in avoiding animal experiments? No.  

In contrast to Germany, other countries are already farther ahead and have drawn up plans, which are largely politically motivated, on how to gradually transition from the animal experimentation system to an animal-free one. In addition to animal welfare, the reasons given for phasing out are always increased safety for humans and higher (research) efficiency, since the new methods work in the correct system, i.e. are relevant to humans. Thus, the results are not only faster to generate, but also more reliable; drugs and therapies can be developed more quickly.

The Netherlands

In 2016, the Dutch State Secretary for Economic Affairs Martijn van Dam commissioned the National Committee for the protection of animals used for scientific purposes (NCad) to draw up a (time-based) plan for the gradual elimination of animal testing. The vision: to be a global leader in innovation without the use of animal testing by 2025.

The first step is to end regulatory (i.e. legally required) animal testing. Those are proceduresthat use animals to test medical devices, pesticides, food additives, and chemicals. All branches of research that have their special requirements (e.g., basic research) are to be addressed in a ten-year plan.

The recommended strategy includes international networking and multidisciplinary collaborations, retrospective evaluation on the efficiency of animal experiments, and faster validation of non-animal methods. Policy makers have a responsibility to strengthen and promote knowledge of and confidence in animal-free, modern methods (4).

In November 2020, the current status was assessed and some changes in wording were made (5). For example, there is no more mentioning of a target year. The focus should be on establishing animal-free methods and innovations. Instead of a phasing-out, is it now more of a change (transition). Critics of the adjusted plan see this as proof of failure – but that is not the case at all: from the very start, the NCad emphasized that the ambitious plan can only succeed if all efforts are aimed at promoting animal-free methods strongly also at international level and by governmental agencies  (6). The targeted change still heads far beyond the usual 3Rs, i.e., simply reducing, improving, and replacing animal testing within the existing system. The original plan, and even the revised one, is still ground-breaking because it shows that a change towards non-animal methods is possible if, in the case of the Netherlands, there is a strong political will

This is also demonstrated by the professorship "Evidence-Based Transition to Animal-free Innovations" at Utrecht University, which was established in spring 2022.In contrast to the usual 3R efforts, its aim is to specifically drive the paradigm shift from animal experiments to human-based methods on a scientific basis (7).

USA

In 2020, the USA, initiated by the chairman of the US Environmental Protection Agency (EPA) Andrew Wheeler, presented a concrete work plan. The motivations cited are faster and less expensive acquisition of data through new animal-free methods that, unlike animal test results, are relevant to humans. The transition will be done while maintaining all necessary levels of safety for humans and the environment, of course.

Mammalian toxicity testing is to be banned by 2035. Part of the strategy to achieve this goal is to develop and promote animal-free methods while reducing tax-based funding for animal testing. Starting in 2025, these funds are to be reduced by 30% and will be eliminated completely by 2035 (8).

A unique milestone: In December 2022, Joe Biden passed the FDA's (Food and Drug Administration) Modernization Act, which includes the regulatory acceptance of animal-free, human-based methods in the approval of new drugs. The word “animal” is replaced by “preclinical” and human mini-organs ("organoids"), multi-organ chips and computer-based methods are explicitly mentioned. This paves the way for completely animal-free drug development - and it shows that this step is obviously already feasible (9).

Great Britain

UK Roadmap

The UK Roadmap, a strategic plan set up by a government-associated agency (called Innovate UK) of more than 60 experts from science and industry, has been launched in 2015. The crucial factor here also is that results from animal experiments often do not reflect human reactions. The animal-free, new methods should enable faster discovery and development of drugs, (agro)chemicals, and other consumer products. The scientific pioneering position in animal-free methods should also lead to increased investment from abroad as well as create a new market in the commercial sector.

Financial investment in research into these methods is crucial, and potential scepticism must be reduced within the scientific sector as well. National and international collaborations and networks need to be addressed, as well as interdisciplinary exchanges, since many different industry sectors can benefit from the application of these methods (10).

Alliance for Human Relevant Science

The Alliance for Human Relevant Science is a collaboration of companies, organizations, and individuals that published the 2020 strategy paper "Accelerating the growth of human relevant sciences in the United Kingdom." In addition, the topic will be introduced to Parliament through an Assembly of Parliamentarians Group (APPG).

Current costs and the impact on health due to irrelevant research results as well as the ineffectiveness of the prevailing system of drug development will be presented. The numerous species differences between humans and animals are the main argument. Human-based, new research methods are presented and shown how they can improve the existing system and current output. It will be argues that, in order to achieve this, strategic funding of animal-free methods, implementation of multidisciplinary infrastructures and collaborations, methodological training for (prospective) scientists, and regulatory changes are needed (11).

Norway

In 2020, the National Committee for Laboratory Animals in Norway reviewed the Netherlands' phase-out concept and made a recommendation to the Minister of Agriculture and Food, Olaug Vervik Bollestad. A Norwegian public study is to be initiated with the aim of limiting animal experiments in favour of animal-free research. A concrete phase-out plan, adapted to Norwegian conditions, should be developed and the establishment of a governmental 3Rs centre, which currently does not exist in Norway, should be initiated (12,13).

Sweden

Shortly after the Swedish government announced that it could become a world leader in the field of non-animal research (14), the Karolinska Institute, one of the largest and most prestigious medical universities in Europe, issued a discussion paper on new non-animal methods in 2021. This clearly aims at a paradigm shift where animal testing is no longer considered the "gold standard". The 114-page paper interviewed several stakeholders from research, government, politics, and industry (e.g. L'Oréal and AstraZeneca). It calls for placement, not replacement, meaning an establishment of animal-free procedures rather than 1-to-1 replacement of animal testing. Also, the word "alternatives" is not chosen; instead, "new methods" are mentioned. These are neither a mere replacement nor an alternative, since they offer many more possibilities than animal testing. The authors are convinced that the new techniques hold great potential for science, the human environment and health, as well as for innovation in the industry sector (15).

European Union

In September 2021, the EU Parliament passed a resolution with 97% of the votes of a total of 687 MEPs calling the EU Commission to present an action plan on how to succeed in phasing out animal testing. This should contain concrete measures and targets to achieve progress in replacing animal experiments with non-animal methods. Responsibility for the action plan is to be assumed by a task force consisting of various Directorates of the Commission and EU agencies, as well as the Member States, and relevant stakeholders. Targeted financial support for animal-free methods and specific training are also part of the call. According to the European Parliament, there has been a lack of active, coordinated effort to reduce and ultimately completely eliminate animal testing (16).

Unfortunately, the EU Commission rejected the almost unanimously supported motion a few months later, tersely stating that the requested measures were already being processed. Regarding the constantly high number of animals suffering in EU-labs without any recognizable downward trend, this is an absurd decision.

Conclusion

Visionary research nations are already on the way to modern, animal-free science and research, and the German government must act urgently if Germany wants to maintain its reputation as a country of cutting-edge research. Due to the numerous advantages, animal-free, human-based methods are clearly the future. Our NAT database, a unique public database for animal-free methods, shows (despite insufficient funding) what is already possible today in the field of animal-free research.

Dipl.-Biol. Julia Radzwill 
Edited on: 23 June 2022

References

1. Bundesinstitut für Risikobewertung (BfR) Verwendung von Versuchstieren im Jahr 2021
2. Strittmatter S. Applications for animal experiments are rarely rejected in Germany. ALTEX - Alternatives to animal experimentation 2019; 36(3):470–471
3. Ärzte gegen Tierversuche e.V. Förderung von Tierversuchen und tierversuchsfreier Forschung
4. Ministerie van Landbouw N. en V. NCad opinion Transition to non-animal research - Rapport - Nationaal Comité advies dierproevenbeleid, 15.12.2016
5. Ministry of Agriculture, Nature and Food Quality, Niederlande. Review of TPI 2018-2020, 11.11.2020
6. Menschen für Tierrechte – Bundesverband der Tierversuchsgegner e.V. Interview mit Dr. Koëter: „Wir glauben fest daran, dass der Ausstieg machbar ist!“, retrieved on 16.3.2023
7. Ärzte gegen Tierversuche e.V. Niederlande erneut innovativ beim Ausstieg aus dem Tierversuch. 
8. US Environmental Protection Agency O. EPA New Approach Methods Work Plan: Reducing Use of Vertebrate Animals in Chemical Testing, 17.6.2020
9. H.R.2617 - Consolidated Appropriations Act, 2023. Sec. 3209. Animal Testing Alternatives.
10. Innovate UK. Non-animal technologies in the UK: a roadmap, strategy and vision, 10.11.2015
11. Alliance for Human Relevant Science Accelerating the Growth of Human Relevant Life Sciences in the United Kingdom , retrieved on 16.3.2023
12. Ärzte gegen Tierversuche e.V. www.aerzte-gegen-tierversuche.de: Norwegen: Ausschuss empfiehlt Ausstiegsplan, 14.10.2020
13. Forsøksdyrkomitéen. Behov for utredning om forskning uten forsøksdyr og et nasjonalt 3R-senter , retrieved on 16.3.2023
14. Riksdagsförvaltningen. Forskning, frihet, framtid - kunskap och innovation för Sverige Proposition 2020/21:60 - Riksdagen
15. Karolinska Institut. Mattias Öberg & Monica Björklund. Att kommunicera om nya metoder utan djurförsök, 2021, (PDF >> http://www.imm.ki.se/rapporter/nya%20metoder%20utan%20djurforsok.pdf)
16. Europäisches Parlament. Pläne und Vorgehen zur Beschleunigung eines Übergangs zu Innovationen ohne die Verwendung von Tieren in der Forschung, bei vorgeschriebenen Versuchen und in der Bildung. 16.09.2021