Position Paper on Securing
Efficient Biomedical Research
While Maintaining the Highest
Animal Welfare Standards
Recommendations Proposed by the DFG’s
Permanent Senate Commission on Animal
Protection and Experimentation

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July 2022
Contact:
Dr. Sonja Ihle
Life Sciences 1
Tel.: +49 228 885-2362
E-mail: sonja.ihle@dfg.de
DOI: 10.5281/zenodo.6956898

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Table of Contents
1

Theses........................................................................................ 32	Politically Motivated Activities Seeking to Ban
Animal Research ...................................................................... 53	Legal and Ethical Foundations of Animal Research to
Maintain the Highest Standards of Animal Welfare andEnsure the Highest Quality in Research ................................ 8
4	Use and Promotion of a Diverse Range of Methods
as a Fundamental Requirement .............................................115	The 3Rs Principle in the Context of Scientific Validity
as a Benchmark for Animal Welfare in Research .................16
6	Animal Research in Public and Political Perception........... 21
7	Future Safeguarding of Technological Sovereignty
in Biological and Biomedical Research ............................... 24
8

Appendix ................................................................................. 27

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1

ThesesScience and innovation are cornerstones of progress and prosperity in our society and as such, they also enable resilience and crisis
response capability, as was recently exemplified in the coronavirus
pandemic. In order to continue to safeguard the future viability of bio­
medical research while maintaining the highest standards of animal
welfare, a long-term and sustainable strategy for securing and further
developing free, knowledge-driven research is needed, based on thefollowing theses:
1)

Biomedical research is necessary and ethically required in order to ensure responsible scientific and medical progress. Scientists take theirhigh ethical responsibility seriously when using animals for the purpose of
research. Due to the special need to protect animals – while at the sametime ensuring scientific progress – the use of animal experiments arealways kept to a minimum.

2)

In addition to the freedom of science as enshrined in the German constitution, the necessary resources have to be provided, long-term perspectives have to be secured, and bureaucratic hurdles and administrative
burdens need to be removed in order for excellent research to flourish.

3) Free access to technologies, promotion of methodological development and the technological sovereignty this gives rise to are essential requirements for scientific innovation to meet future challenges forhuman beings, animals and nature.
4)

Full-scale education, training and professional development of thoseworking in human and veterinary medicine, in the life and naturalsciences, and all other persons involved in the handling of laboratory animals requires the use of animals. This ensures responsible handling of laboratory animals with regard to animal welfare and guarantees continuous
improvement in the quality of treatment, a highly reliable patient care aswell as optimal and legally compliant use of new methods and techniques.

4

Theses5)

The choice of method in research is based on the best possible suitabilityof a method or model for answering a scientific hypothesis (scientific validity). The optimal use of a broad, interdisciplinary spectrum of methods
overcomes the limitations of isolated methodological approaches.

6)

The use of animals in research is an essential part of the spectrum of research methods and is therefore an indispensable building block in termsof ensuring outstanding scientific findings and medical applications. In
scientific research, the separation between research “with” and “without”
animals does not exist.

7)

The 3Rs principle (Replacement, Reduction, Refinement) and scientificvalidity are the key guidelines for ensuring the highest level of animal
welfare and quality in research. Without simultaneous consideration of
the progress of scientific knowledge, the number of animals used forscientific purposes does not constitute a benchmark for the quality ofanimal welfare in research.

8) Transparent and fact-based communication about science is an obligation towards society and provides the basis for forming societal andpolitical opinion.
9) Any fundamental ban on animal research does not automatically put
an end to the need for the use of animals in research but endangers
Germany and the EU with regard of their innovation potential and status
as research hubs: it increases dependence on biomedical innovationfrom non-European sources, reduces sovereignty and the ability to act
independently in the face of future challenges, and removes control overanimal welfare from Germany and the EU.

52	Politically Motivated Activities Seeking
to Ban Animal Research
Animal experiments are currently part of the diverse range of techniques
used in life science research. Due to the special protection of animals as enshrined in the German constitution and also at EU level, researchers have aparticular ethical responsibility when conducting animal research, and one of
the ways they assume this responsibility is by engaging in dialogue. Despite
rigorous legal frameworks attaching great importance to animal welfare, animal research remains controversial both socially and politically. Activities
pursued by politicians at national and European level demanding so-calledphase-out plans to end the use of animals in research are viewed with concern by the scientific community. EU Directive 2010/63/EU aims in the longterm at the possibility of abandoning the use of animals in research “as soon
as it is scientifically possible to do so.” 1 The Directive explicitly emphasises
the importance of the scientific feasibility of such a move. At the same time,it deliberately does not formulate any specific timelines or other milestones.2
A fundamental ban on research using animals constitutes a maximum encroachment on the constitutionally protected freedom of research and science, which also includes the free choice of methods. It restricts the agile
use of a broad spectrum of technologies, which is necessary for scientific innovation, in such a rigorous way that the generation of future knowledge andthe progress in the life sciences that this gives rise to, as well as the possible
transfer of science to medical applications, are jeopardised. Thus, the implementation of strategic plans and recommendations for the development ofbiotechnology and health research in Germany as formulated by the Federal

1	Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes;
to document on eur-lex.europa.eu.
2	See also EU Commission response to “Resolution on plans and actions toaccelerate the transition to innovation without the use of animals in research,
regulatory testing and education”, 2021/2784(RSP).

6

Politically Motivated Activities Seeking to Ban Animal Research

Government and currently still in force 3,4 would also be restricted by a ban
on research methods using animal for scientific purposes. One goal of theFederal Ministry of Education and Research’s current High-Tech Strategy is
to make use of innovation potential by promoting key technologies in order
to meet societal challenges and, among other things, to ensure that medical
progress finds its way to patients more quickly. A phase-out scenario for animal research would, for example, run counter to the goals of the “Nationale
Dekade gegen Krebs” (engl. “National Decade against Cancer”) set out inthe High-Tech Strategy, since animal research is a key contributing factor inthis branch of research.
The desire to end the use of animals for scientific purposes by pursuing anaction plan that contains binding timelines and goals with regard to scientificcontent is based on fundamental misconceptions of how knowledge-driven
research works and how essential it is to have a broad, interdisciplinary spectrum of methods that includes both animal experiments and non-animal methods in equal measure. For this reason, there can be no underlying justification
for any such short-term scheduled plan to phase out research with animals as
this would endanger Germany’s science and innovative strength.
When considering the opportunities and limitations of a technology transfer
towards animal-free methods, it is imperative to distinguish between knowledge-driven research5 and research for regulatory purposes6, since the objectives and the development potential are fundamentally distinct. While basic
research serves to generate new findings and increase knowledge, making

3	Federal Ministry of Education and Research (2018): Research and innovationthat benefit the people – the High-Tech Strategy 2025; to document on bmbf.de.
4	Commission of Experts for Research and Innovation (2021): Report on Research,Innovation and Technological Performance in Germany 2021;
to document on e-fi.de.
5	Knowledge-driven research also includes translation, i.e. the transfer of basic
scientific research results to areas of application.
6	Research for regulatory purposes includes the use of animals for regulatorycompliance procedures, for example in statutory safety and risk assessments.

Politically Motivated Activities Seeking to Ban Animal Research7

use of a flexible, creative spectrum of methods, the standardisation of processes and the establishment of fixed technology pipelines play a key role
in research for regulatory purposes. This may also include the validation ofalternative methods to animal testing for standardised processes.
In this paper, the DFG’s Permanent Senate Commission on Animal Protection
and Experimentation (hereafter referred to as the Senate Commission) will
focus on the aspects of knowledge-driven research (including translation andteaching).

There is a legitimate desire in science, society and politics to further
strengthen animal welfare in research. In this paper, the Senate Commission therefore elaborates ideas on how animal welfare in research canbe guaranteed while at the same time ensuring scientific quality in research projects. The paper focuses on information about the framework
conditions that must be in place for efficient biological and biomedical
basic research in order to maintain the innovative strength of researchin Germany and the EU. It describes the link between animal welfare
measures and scientific validity and then goes on to address ideas tothe various stakeholders from science, politics, administration and society. By means of participation and communication, the framework conditions for animal welfare and research are to be improved, and a shift
is to be initiated in the discourse towards a holistic understanding of
biomedical research methods.

83	Legal and Ethical Foundations of Animal
Research to Maintain the Highest Standardsof Animal Welfare and Ensure the Highest
Quality in ResearchComments on Theses 1, 2, 4 and 5
The anchoring of animal protection in German Basic Law 7 and EU Directive
2010/63/EU provides a strict framework for the approval of animal research.
According to this, animal experiments can only be carried out if no non-animal methods are available to answer a scientific question in order to achieve
the same research objective 8. Every animal experiment must be approvedin advance in an extensive procedure carried out by the relevant authorities.
This includes a harm-benefit analysis in which an assessment is carried outof whether an experimental project is suitable, necessary and appropriate toachieve the desired gain of knowledge. The 3Rs principle (Replacement, Reduction, Refinement) serves as a guideline for animal welfare in research, andthe assessment of this forms part of the approval procedure. Here, it is necessary to demonstrate that the desired gain of knowledge cannot be achieved
without using sentient animals (Replace), with fewer animals (Reduce) or using methods causing less harm (Refine). In addition to the use of methods
without laboratory animals (so-called alternative methods), an assessment
has to be made as to whether animals considered to be less sentient can beused (“relative replacement”).
However, consideration of the 3Rs principle in isolation without scientific context can have a negative impact on the quality of research projects. For thisreason, in addition to the 3Rs principle, scientific validity is an important requirement for the planning and implementation of experiments. Measures that
promote animal welfare in accordance with the 3Rs principle must always be

7Art. 20a. Basic Law (GG).

8

Animal Protection Act (TierSchG) § 7 and § 7a (status: 23.03.2022).

Legal and Ethical Foundations of Animal Research

9considered in the light of scientific validity. This applies, for example, to suchaspects as the selection of non-suitable models or insufficient sample sizes inorder to reduce the number of animals used. If animal welfare measures limit
scientific validity, the experimental design and thus also the overall project has
to be questioned from both an ethical and a resource-saving perspective 9.
The 3Rs principle must also be anchored in teaching and training in the fieldof animal research: here it is crucial to ensure full initial education, training
and professional development involving animals so as to ensure responsible,
professional handling of laboratory animals in practice.

Recommendation and notes► Only by interlinking animal welfare measures with simultaneous con-sideration of the different aspects of scientific validity (construct validity, internal validity and external validity) is it possible to ensure soundanimal welfare while maintaining the scientific quality of research projects10.
► Due to the particular ethical responsibility of science in the use ofanimals in experiments, both aspects – animal welfare measures andscientific validity – must be taken into account to the same extent inevery experimental design and execution and be recognised by theauthorities.
► The implementation of animal welfare measures as an intrinsic part ofscientific project planning must be more firmly anchored in the context
of teaching and training.

9	Deutsche Forschungsgemeinschaft (2019): Animal Experimentation in Research:
The 3Rs Principle and the Validity of Scientific Research; to document on dfg.de.
10

Ibid.

10

Legal and Ethical Foundations of Animal Research► In addition to the requirements of the 3Rs, regulatory decisions by theauthorities must take into account the scientific validity of the outcomesto be achieved.
► At federal and state government level, responsibilities for animal wel-fare and research lie with different ministries and authorities. Thus,
within the framework of legislative procedures and/or subsequent
legislative and executive steps, care must be taken to ensure thatboth aspects are given equal consideration through participation,inter-ministerial communication and cooperation.

	114	Use and Promotion of a Diverse Range of
Methods as a Fundamental Requirement
Comments on Theses 2, 3, 4, 5 and 6
The aim of the life sciences is to understand the structures and interrelationshipsof living organisms, including the underlying physiological and pathophysiological processes. The scientific approach is hypothesis-oriented and the choice of
methods and models is based on the scientific question to be answered. The
spectrum of methods used is highly diverse and interdisciplinary. It includes
so-called ex vivo or in vitro methods such as cell cultures and organoids, insilico or theoretical approaches (for example computer-based modelling), in
vivo models (animal models) and human studies. In veterinary medicine andorganismic biology, animals themselves are the focus of scientific interest.
The selection of methods and models is largely based on whether they are
well suited to answering the research question (construct validity). However,
all methods – both animal models and animal-free approaches – are subject
to limitations, and the results require validation by complementary methods.
Generally speaking, a combination of methods – animal models and non-animal approaches – is needed to answer complex questions. It is not uncommon for far-reaching cooperation to take place between different researchgroups in order to make optimal and creative use of methodological expertise.
Non-animal methods are often used at the beginning of a research strategy
to generate fundamental insights. In vivo models are only used if no other invitro methods are available for the further pursuit of the research question. It
is not uncommon for insights gained from animal research to lead to a returnto animal-free methods at a later stage. For example, computer models often
draw on data generated by animal experiments.
Methods and models are thus optimised, improved and newly developed fromthe point of view of which method is best suited to answering a scientific question. In the long run, those methods prevail that prove to be most suitable andfeasible.

12

Use and Promotion of a Diverse Range of Methods as a Fundamental Requirement

Animal-free training methods are available for education, training and professional development. Nevertheless, training on animals is also necessary
because this is the only way to ensure responsible handling of laboratory
animals according to animal welfare standards based on appropriate training,as well as ensuring the optimal use of methods and techniques.
In the course of the great methodological progress achieved in the life sciences, there has also been a significant increase in expertise in the development
and improvement of animal-free technologies, offering new potential for research without the use of animals. This methodological advancement is an
essential part of research. It occurs as new biological/biomedical questions
arise and is intrinsically motivated by them, without these methods being directly classified as alternative methods. In knowledge-driven research, theoften postulated separation into research using alternative methods and research using animals for scientific purpose does not exist.
To forego the possibility of validating results in animal models and of generating new questions that can currently only be addressed by means of animal
research constitutes a massive intervention in the fundamentals of scientificresearch. It limits the agile and creative use of existing technological potential
and prevents new innovations in Germany and the EU. In addition, any suchban could limit scientific validity with regard to reproducibility and generalisability of results in cases were mutual model validation is required.

Use and Promotion of a Diverse Range of Methods as a Fundamental Requirement

13

Recommendations and Notes► In order to be able to conduct research in the life sciences at the high-est international level in the future, it is vital to ensure that the choiceof methods is oriented towards the research question. Here, the mostsuitable method should be prioritised over an adaptation of the question to a less suitable method (construct validity) and this methodshould be freely available.
► The use of less suitable, animal-free methods and of less valid animalmodels or insufficient sample sizes would limit the quality of research
and are therefore not justifiable, whether ethically or in terms of sustainability. For this reason, scientific validity must be a key factor in
fundamental experimental design and implementation and must not be
subject to limitation by authorities.
► At the same time, progress in life science research promotes the devel-

opment of new methods and the innovations that these give rise to. In
knowledge-driven research, however, methodological progress is notrecognised and published in the same way as advancements in theknowledge of biological and biomedical processes.
► Methodological development must receive greater recognition andsupport. Awareness of innovation potential must be trained and enhanced, also with regard to the 3Rs principle.
► Mechanisms for appropriate method transfer in the scientific commu-

nity need to be developed so as to ensure innovations find more widespread practical application.
► The explicit promotion and development of non-animal alternative

methods must be practice-oriented with a view to translation into
everyday research work. Methodological progress should not be allowed to develop in a parallel structure without exploiting the relevant
application potential.

14

Use and Promotion of a Diverse Range of Methods as a Fundamental Requirement► Information networks between individual disciplines must be further

expanded and collaborative participation between more methodologically oriented and knowledge-driven research areas must be intensified so as to improve and accelerate the knowledge transfer andtransformation process.

From Fundamental Research to Application
Based on the Example of Checkpoint Inhibitors
Checkpoint inhibitors (CI) are a new class of drugs that have been revolutionising the treatment of tumour patients for several years. CI workby activating the body’s immune response against the tumour. Without
CI, the immune response against tumours is inhibited, and it can be said
that CI suspend this inhibition.
The development of CI began in the 1980s with the aim of answering
fundamental questions about the immune system: in addition to aspectsof the development of T lymphocytes (a group of white blood cells thatare essential to the body’s immune response), the aim was to clarify
which signals control activation of T lymphocytes.
The researchers used a wide range of methods to answer these questions.
For example, cell culture experiments on T cell activation were used to
first understand more precisely the effect or function of various moleculesthat seemed to be involved here, before subsequently investigating in vivo
– i.e. using animal experiments – whether these molecules function thesame way in living organisms. An important aspect of this was the use ofmice that had been genetically manipulated (gene targeting) such that themolecules to be investigated were not present (so-called knockout mice).

>>

Use and Promotion of a Diverse Range of Methods as a Fundamental Requirement

>>It was found that the knockout mice developed the most severe
signs of autoimmune disease. This meant that without these specificmolecules, the T lymphocytes acted unchecked and uncontrolled, also
triggering unwanted immune responses to organs in their own bodies. Inturn, it was possible to conclude that the molecules under investigation
had an inhibiting effect on the T lymphocytes.
Two complementary strands of translational research emerged fromthese findings: I) the attempt to restrain inhibitory molecules so as toincrease the body’s immune response and target tumours, and II) theattempt to stimulate these inhibitory molecules so as to curb the body’s
immune response and thus be able to treat patients suffering from autoimmune diseases. Here, the research also relied on the use of various
complementary methods, in particular animal models and cell culture experiments, in order to specifically transfer the knowledge gained frombasic research to application. For the inhibitory approach (I), different
tumour diseases were imitated in mice to test the effect of the molecules
in different tumours. Based on these results, it was possible to conductclinical trials that confirmed the effectiveness of the approach, thereby
resulting in its approval as a new clinical application. For some years
now, various drugs have been available that are based on the principle
of inhibitory molecules and have become established as an essential
pillar of therapy for tumour patients. Translational research relating to approach (II) led to the development of a drug to treat rheumatoid arthritis,for example.1111	Kamradt, T. (2017): Wie aus Grundlagenforschung im Tier ein neues
Therapiekonzept für Tumorpatienten entstand. Trillium 1: 18 –23;
to document on trillium.de.

15

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5	The 3Rs Principle in the Context of Scientific
Validity as a Benchmark for Animal Welfare
in ResearchComments on Thesis 7
The annual statistics on the use of laboratory animals are used by politicians
and the public as an important benchmark for the success of animal welfare
measures in research. Any decrease in the numbers of laboratory animals
used is seen as an improvement in animal welfare and vice versa. From ascientific point of view, this view is misguided because it is too short-sighted.
Mere numbers say nothing about the quality of animal welfare and protection
applied within the research projects carried out. The same applies in otherareas of animal use.
The idea of animal welfare in research essentially follows the 3Rs principle,
which in addition to the replacement of animal experiments also includes
reduction (using fewer animals or obtaining more information with the same
number of animals) and refinement (improvements in the handling of theexperimental animals during the experiment and husbandry). 3R strategies
depend fundamentally on the type of experimental animal and the inherent
differences in husbandry, care, physiological and psychological needs, aswell as on the technologies used. The further development of technologies
in the conduct of research (for example, imaging procedures) or improvement of animal husbandry and handling of laboratory animals are important
contributions to animal welfare in the area of refinement and replacement.
Refinement measures in particular cannot be measured based on a decrease in the numbers of animals used. In addition, compliance with theguidelines for ensuring good scientific practice – in particular the aspectsof free data availability (open science, data sharing, FAIR principles) andunbiased reporting – contributes to the implementation of the 3Rs principle.
However, as described above, it is essential for the 3R measures always to
be considered in the light of scientific validity. In principle, an animal exper-

The 3Rs Principle in the Context of Scientific Validity

17

iment is only worthwhile and compliant with animal protection requirements
if the resulting outcomes are scientifically valid and serve to advance knowledge. As such, a 3R strategy cannot be an end in itself: it is only effective
if viewed in the context of scientific validity. So when looking at numbers ofanimals used, as well as other animal welfare measures, it is crucial not todisregard this intrinsic link to scientific quality.
Just as the mere tracking of the number of animals used does not provide
any indication of effective animal welfare measures in research, gain ofknowledge cannot be measured by a simple quantitative benchmark. The
metrics of research achievements (total number of publications and citations for individuals or journal impact factor for journals etc.) to measure
the relevance and quality of research results is an intensely and controversially debated topic in science and science management12. Quantitative
assessment of success in animal welfare and scientific progress is therefore
not possible. Thus, only a few examples of projects can be cited here todemonstrate how key scientific findings have emerged as a result of animal research. These are often based on decades of research: during thistime, a broad spectrum of methods was used and animal research methods also underwent further scientific progress. One current example is the
rapid development of vaccines to combat the coronavirus pandemic, which
resulted from many years of work in the field of cancer research, not least
using animal research. Advances in transplant medicine also vividly illustrate the evolution of animal research – from genetically modified animals
and xenotransplantation research through to medical application in humanbeings. The key point about these examples is not that animal numbers
have increased or decreased, but that animal research has continuously developed and ultimately, after decades of research, has resulted in significant
medical application which benefits people. In addition, examples of research
projects can be mentioned in which 3R measures have led to an increase in12	Deutsche Forschungsgemeinschaft (2022): Academic Publishing as a Foundation
and Area of Leverage for Research Assessment; to document on dfg.de.

18

The 3Rs Principle in the Context of Scientific Validity

animal welfare in experiments and/or a reduction in animal numbers – whileat the same time maintaining high standards of scientific quality.

Recommendations and Notes► The numbers of animals used in experiments cannot be regarded as abenchmark of quality for animal welfare in research without simultaneous consideration of the progress of scientific knowledge.
► The 3Rs principle can only serve as a benchmark for increasing animal

welfare in research in the context of scientific validity.
► Refinement and reduction must be perceived as equally importantanimal welfare measures and must be incorporated in a communication strategy that is not limited to replacement.
► Reduction and refinement approaches must be taken into accountwhen implementing 3R funding measures.
► When promoting new non-animal alternative methods, the verificationof validity must also be considered and promoted. In order to reduce
the risk of transformation failure, it is also important to consider andpromote cooperation between “developers” and “users”.
► Research results must be processed and made available in accord-

ance with the FAIR principles (“Findable, Accessible, Interoperable andRe-usable”).

The 3Rs Principle in the Context of Scientific Validity

19

What is Refinement?
In laboratory animal science, refinement refers to all measures thatlead to an improvement in the living conditions of the animals, thereby
reducing the overall burden they are exposed to when used for research
purposes. Refinement methods are diverse, ranging from simple changes in cage design to the technically complex use of imaging techniques.
As such, refinement is itself an important field of research in which new
improvements are continuously developed and evaluated.
The following areas of refinement are of particular importance:
Improvement of husbandry conditions:
Experimental animals spend most of their lives in housing systems thatare guided by aspects such as hygienic standards and the practical demands of experimental feasibility. Possible improvements for housing
conditions concern cage size, equipment elements and opportunities for
activity to counteract boredom, for example.
Improvement of experimental conditions:Certain experimental designs and test procedures have been scientificallyestablished for many years. However, science is also a constant processof change and progress, so animal experiments, in particular those which
are considered to be severe, are constantly being questioned. For example, modern video analysis systems based on artificial intelligence can record the behaviour of animals in their home cages. This avoids stressors
caused by moving the animals to special experimental apparatus.
Improvement of the handling of laboratory animals:
The health and welfare of laboratory animals is a human responsibility
and includes cleaning of housing systems and daily inspection. The interactions that take place between humans and animals offer great potential

>>

20

The 3Rs Principle in the Context of Scientific Validity>>
for improvement. For example, it has been shown that mice that areremoved from the cage with the help of a tube show less stress thanwhen they are grasped by the tail root. Intensive training and gradual habituation to the experimental apparatus can optimally prepare research
animals for the experiment. This not only improves the welfare of the animals, but also the well-being of the people involved, even leading to better
experimental results.
Reduction of the amount of burden in the experiment itself:
Animal research can involve pain, suffering or harm, for example in surgical procedures. Better procedures of severity assessment and the resulting optimised administration of analgesics and anaesthetics can significantly reduce burden.

21

6	Animal Research in Public andPolitical Perception
Comments on Thesis 8
The use of animals in knowledge-driven research occupies a special positionin the context of the ethical debate on how far the use of animals for humans
can be legitimised. There is frequently no direct link between the scientificgain in knowledge and the resulting benefit to human beings. Scientific breakthroughs which could not be foreseen at the start often arise after decadesof research. In the context of the harm-benefit analysis, the scientific gainin knowledge is weighted against the expected harm on the animals in theexperiment, but in public perception the significance of scientific findings can
be classified as less relevant if no direct progress for humans, animals andnature can be seen. On the other hand, the suffering of animals in research
is obviously a highly emotional factor. Science is therefore faced with thechallenge of communicating the importance of basic research for the future
viability of society while at the same time ensuring acceptance for the justifiability of animal research. In the progress report on its High-Tech Strategy
2025 13, the Federal Government says that “die Partizipation der Gesellschaft
an Erkenntnissen und Erfolgen der Wissenschaft” (engl. “the participation ofsociety in the findings and accomplishments of science”) is one of its strategic guiding objectives under the Research Framework Programme. The aim
is “die Wissenschaftskommunikation zu stärken, um die Aufgeschlossenheit
der Gesellschaft gegenüber der Wissenschaft zu erhöhen und die Basis fürgemeinsame Diskussion um Forschung und Innovation zu verbreitern” (engl.
“to strengthen science communication in order to increase society’s openness
towards science and broaden the basis for joint discussion around researchand innovation”). It was in 2015 that the Alliance of Science Organisations inGermany set up the information platform “Tierversuche verstehen” 14 (engl.
13	Federal Ministry of Education and Research (2019): Fortschrittsbericht zur Hightech-Strategie 2025; to document on bmbf.de.
14

Initiative „Tierversuche verstehen“ (tierversuche-verstehen.de)22

Animal Research in Public and Political Perception“understanding animal research”); this was followed by the launch of the “Initiative Transparente Tierversuche” 15 (engl. “initiative transparent animal research”) in July 2021. The aim of this latest initiative is to call on academic
institutions and research-based industry to provide the public with transparent
information about the research on animals taking place at these institutions
and to engage in dialogue. In addition to the researchers themselves andtheir institutions, a commitment and willingness to engage in transparent dialogue of this kind is also desirable among other stakeholders. For example,
in translational research, in the pharmaceutical industry and in biomedicine(including the medical profession and pharmacy) hardly any information isprovided about the fact that the products, procedures, medication and medical
therapies used are largely based on research outcomes that also involved
the use of animals. Furthermore, media coverage of innovations, scientificawards and research achievements generally tend not to mention the useof laboratory animals. Similarly, the Federal Government’s strategy papers
lack a clear commitment as to the basis and methods to be used in achieving
strategic goals in the field of health research (cf. National Decade against
Cancer and “Wirkstoffe entwickeln, Infektionen bekämpfen und Forschung zu
globaler Gesundheit stärken” (engl. “developing active substances, fighting
infections and strengthening research on global health” 16)). Only by maintaining transparency it is possible to ensure that public and political decision-makers are informed about the widespread use of animals in research and createa knowledge-based foundation that also allows the impact to be assessed ofany possible animal experiment ban on the future of the innovation potential
and status of a research hub.

Recommendations and Notes► Transparent communication about the use of animal in science andresearch should be part of the institutional self-image of all stake-15„Initiative Transparente Tierversuche“ (initiative-transparente-tierversuche.de)16	Federal Ministry of Education and Research (2018): Research and innovationthat benefit the people – The High-Tech Strategy 2025; to document on bmbf.de.

Animal Research in Public and Political Perception

23

holders involved, providing the basis for a dialogue geared towards
facts and for social and political acceptance.
o On the part of science itself, such a cultural change must be supported by the research institutions, with communication strategies to this effect being developed – not least so as to provide
researchers with the necessary support, especially if they personally become the target of animal research critics. The initiative“Tierversuche verstehen” of the Alliance of Science Organisationsin Germany and the “Initiative Transparente Tierversuche” aim tosupport this change.
o On the part of “technology users” in industry and business, medicine and the medical profession, there should be a clear commitment regarding the use of products that have been developed
based on animal research in order to transparently underpin theimportance of animal research, including examples from application and practice.
o In media reporting on research and innovation, the use of animals
in research should also be referred to transparently. In this way,reporting would act as a multiplier, broadening the circle of the informed public.
o Such transparency is called for on the part of politicians and theexecutive, too. For example, strategy papers, planned funding
programmes etc. should mention the use of animal for scientificpurposes to the same extent as other methodological approaches.
In the case of cross-departmental issues, a consensus should bereached concerning strategic orientation and joint communication.
► In addition to communicating the research methods used, a realistic

impression should be provided of the opportunities and limitations of
new scientific findings. This applies to statements about future promises of cures produced by knowledge-driven research, and equallyto the promise that new alternative methods would make animal research obsolete in the near future.

24

7	Future Safeguarding of Technological
Sovereignty in Biological and Biomedical
Research
Comments on Thesis 9
A mandated ban on the use of animals for scientific purposes does not automatically mean the end of the need to use animals in research per se. Rather,a ban endangers Germany and the EU in terms of their innovation potential
and standing as a research location: it increases the potential dependenceon biomedical innovation from other research locations, reduces the ability to
act independently in the face of future challenges, and leads to a relocationof relevant research projects to non-European countries. At the same time,
Germany and the EU would lose sovereignty over the animal welfare standards desired by society. With its directive, the EU has issued strict framework
conditions for research on animals which have been translated into national
legislation and allow the authorities to act in the interests of animal welfare.
In Germany, research involving animals is one of the most heavily regulatedareas of animal use. These legal and regulatory frameworks lose their validity
as soon as Germany or the EU prohibit research using animals and become
dependent on innovations resulting from animal research conducted outside
the EU.
The need for sovereignty in the field of biological and biomedical research wasrecognised by the Federal Government and highlighted in an impulse paper,using the example of vaccine development 17. In order to preserve this sovereignty, it seems counterproductive to no longer allow researchers in Germany
and the EU to conduct research using animals. Rather, the political objective
must be to consider excellent science and animal welfare in research together
and to optimise the framework conditions in such a way that the two consti-

17	Federal Ministry of Education and Research (2021): Technologisch souverän die
Zukunft gestalten – BMBF-Impulspapier zur technologischen Souveränität;
to document on bmbf.de.

Future Safeguarding of Technological Sovereignty in Biological and Biomedical Research25

tutionally protected assets (freedom of science and animal welfare) are safeguarded as effectively as possible, while further promoting sovereignty andinnovative strength in research and method development. A crucial aspect is
to bring about a cultural change in which the perceived contradiction between
animal welfare and animal research is resolved and collaborative strategies
are developed that take equal account of the quality of research and animal
welfare. In view of the distribution of responsibilities in the federal ministries
and the relevant state governments, such an approach requires horizontal
and vertical coordination of policies in order to jointly align future strategies
and optimise administrative and bureaucratic processes with regard to thesetwo valuable assets – freedom of science and animal welfare. In addition tothis call for a shift in discourse, the Senate Commission endorses much of
the Commission of Experts for Research and Innovation (EFI) report18 in its
assessment of the Federal Government’s long-term research and innovation
policy. In particular, it supports the proposed measures and recommendations
to exploit the potential of gene editing and CRISPR/Cas from the perspectiveof animal research. All in all, innovation strategies and funding measures must
therefore be designed in such a way that they always aim to optimise animal
welfare and research quality. Administrative procedures adopted by public authorities should support this process so as to create an ideal foundation for
future innovation. In order to initiate a cultural change towards a holistic viewof animal welfare and research quality and to anchor this in strategic plans,
there is a need for policy coordination that always involves the relevant departments at an early stage and on an equal footing, such as the ministries
concerned and inter-ministerial working groups as well as state, federal andEU stakeholders.

18	Commission of Experts for Research and Innovation (2021): Report on Research,Innovation and Technological Performance in Germany 2021;
to document on e-fi.de.

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Future Safeguarding of Technological Sovereignty in Biological and Biomedical Research

Recommendations and Notes► The reduction in bureaucracy mentioned frequently throughout thecoalition agreement 19 must be noticeably implemented in the areaof science, too: the legally prescribed project authorisation must be
designed in such a way that, while strictly adhering to the ethical justifiability of animal research, the administrative burden for researchers
is reduced. This includes the harmonisation of authorisation procedures across Germany and the EU, thereby providing legal certainty
for researchers.
► With regard to the internationalisation of research and development,

care must be taken to ensure that research remains globally competitive in the area of technology. For example, in spite of the common
EU Directive harmonising animal welfare in research across the EU,
the administrative burden and the duration of approval procedures in
EU countries vary so much that Germany currently suffers a significant competitive disadvantage.
► The “reduction strategy” for animal experiments also proposed in thecoalition agreement must be preceded by an impact assessment report that takes into account the positions of all relevant stakeholders;
this should be coordinated and taken into account by the Federal
Government across departments and ministries.
► Following the recommendation of the EFI report, a German 3R centre

should be set up to take on the role of a competence centre for 3R
measures and their transfer to basic and translational research forthe purpose of advising researchers and promoting networking between the various stakeholder groups.

19

Coalition agreement (bundesregierung.de)

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8

Appendix

Members of the DFG’s Permanent Senate
Commission for Animal Protection andExperimentation (DFG)
Professor Dr. Brigitte Vollmar, Rostock (Chair)
Professor Dr. Anja-Katrin Bosserhoff, Erlangen
Professor Dr. Petra Dersch, Münster
Professor Dr. Klaus Ferdinand Gärditz, Bonn
Professor Dr. Thomas Gudermann, Munich
Professor Dr. Christiane Herden, Gießen
Professor Dr. Thomas Kamradt, Jena
Professor Dr. Lars Lewejohann, Berlin
Professor Dr. Stefan Schlatt, Münster
Professor Dr. René H. Tolba, Aachen
Professor Dr. Stefan Treue, Göttingen
Professor Dr. Hanno Würbel, BernCommission Secretariat
Dr. Cornelia Exner, Marburg
Dr. Valeska Stephan, RostockDFG Head Office
Dr. Sonja Ihle, Bonn

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