Animal research is under threat in Germany. It’s time for the government to take charge!
German legal experts* Klaus Gärditz and Matthias Dombert, say animal protection laws in Germany are applied in a confusing and fragmented way, which is seriously hampering research studies using animals. Here they explain why and suggest how things can be improved.
The official system of handling approval for animal experiments in biomedical research in Germany is in disarray. Due to faults in the German federal system, uniform law enforcement is proving impossible with project approvals unlawfully delayed due to political moves, leading to the risk of research studies being abandoned altogether.
In Germany, part of the problem is the way that EU law on animal research is being implemented. EU Directive 2010/63, defines the measures necessary for the protection of animals used for scientific purposes. To this end, it formulates guidelines for avoiding and reducing the use of animal experiments, or demands improvements in the conditions for the breeding, housing or use of laboratory animals:
The EU defines the target, but it is up to individual countries, the Member States, to adopt their own legislation to implement this goal. From the point of view of the European Commission, the responsibility lies with the respective Member State, i.e. from the German perspective the Federal Republic of Germany, which fulfils its regulatory mandate with the Federal Animal Welfare Act and recently made adjustments to the EU legal framework at the end of 2021. So far so good? However, anyone who thinks this way has not considered German federalism.
Confusion on animal protection laws
In Germany, it is up to the individual states to apply the federal animal protection law and this means, in the best case, a harmonious diversity, but unfortunately, as a rule, confusing fragmentation. Because in Germany, the authorities of 16 federal states decide on the interpretation of the Animal Welfare Act.
The European Commission has reported that 26 different authorities are responsible for approving animal experiments in Germany, and 285 authorities for inspections and has identified the problem by saying: ‘It is recognised that the more competent authorities in a Member State involved in the implementation of the Directive, the more difficult it is to ensure a coherent approach and a uniform result’.
The consequences of German federalism can be reduced if uniform administrative enforcement is ensured across the federal states. However, this is not the case - a fact that one becomes painfully aware of when the competent authorities present their scientists with new application forms. These have been necessary, since the end of 2021, due to the legislative changes implemented in line with European Union law. Scientists have been asked ‘how environmental concerns should be taken into account’ and to provide information ‘on the statistical design to minimise the impact on the environment’.
The consequences of German federalism can be reduced if uniform administrative enforcement is ensured across the federal states.
There would be no objection to these added specifications if it were clear which response structure the standard-setter had in mind. However, this remains obscure and it is difficult for researchers and authorities alike to ascertain. In this respect, both researchers and regulators are in the same boat. If neither national, nor European legislative materials can be found on how the new requirements should be met, the state authorities have no choice but to look for a pragmatic application criteria that is open to interpretation.
Animal approvals 'deliberately delayed' It also remains unclear who decides on the acceptance of animal experiments in basic research. Unfortunately, the competent authorities often exceed their competence.
For instance, In November 2021, the Bremen Administrative Court had to temporarily order
the city to allow research using rats and macaques, in the fields of neuroscience and cognitive research, beyond the end of its approval period in order to avoid damaging the studies. This extension of animal testing permits has had to be enforced repeatedly before the administrative courts.
A report on the court judgement, in the publication Forschung & Lehre, said that the impression was created that a decision on the research application had been ‘deliberately delayed’. According to the court, new scientific findings as argued by the city health senator, making the research unnecessary, were ‘by no means clear’.
The decision on whether animal experiments are ‘essential’ for the purposes of basic research, as required by the Animal Welfare Act, in Germany, is an assessment that should be made by the researchers seeking approval under Article 5 Paragraph 3 Clause 1 of the Constitution. The competent authority must check whether the explanation is plausible, but it cannot replace the explanations with its own ‘scientific’ evaluations - animal protection law needs to be interpreted in accordance with the Constitution.
France, the Netherlands, Estonia and Finland have all found a way around similar problems, because only one authority decides on the approval of the animal experiment. This is a finding that should not be underestimated: authorities that work effectively and predictably also attract researchers from other countries. Furthermore, in a single authority a high level of scientific expertise can be put together, which is not necessarily available to all local authorities entrusted with animal welfare tasks.
France, the Netherlands, Estonia and Finland have all found a way around similar problems, because only one authority decides on the approval of the animal experiment.
As required by European law, Germany also has a national committee the German Federal Institute for Risk Assessment. This advises the competent authorities and committees on matters relating to animal experiments and is intended to ensure the ‘exchange of best practices’.
Therefore, there is a solution to some of these problems at national level. The National Committee can and should be an institution that provides valuable assistance for all federal states, especially when it comes to the first-time application of new practical regulations. Of course, this presupposes that this national committee has the personnel to do so. And this is where things are amiss for the Federal Republic, and specifically assistance certainly includes legal expertise with the aim of giving legal certainty through interpretation assistance.
Not only does biomedical research success in Germany depend on this legal certainty, but also the effectiveness of animal protection. If you want to allow for the consequences of the federal system by ensuring uniform law enforcement in Germany, we demand the strengthening of the effectiveness of the National Committee!
Prof. Dr. Klaus Gärditz is chair of public law at Bonn University.
Prof. Dr. Matthias Dombert is honorary professor for public law at the University of Potsdam
Institutions report on damaging delays to research permit permissions
In 2019 EARA published a survey to address concerns, voiced by research institutions in Germany, about the delays experienced in receiving permits from state authorities to conduct biomedical research using animals.
The survey showed that two thirds of respondents did not receive a response to their permit application within statutory 40 days (+ 15 days for administrate purposes). More than half of the institutions said that the delays had had a negative impact on their planned studies.
The average response time, for acknowledgment from authorities that permission was being sought was on average 65 days, some though took up to 106 days. Some responses took up to one year.
The institutions told us that the most common reasons given for delays by the state authorities were staff shortages. The majority of respondents agreed that it was both a lack of resources and probably expertise, leading to many rounds of questions.
The survey was completed by 133 institutions and covered applications made to 13 different German state authorities.
Image: Bremen Town Hall - Alexey Komarov