Applications for the 3R Science Prize of the European Partnership for Alternatives to Animal Testing (EPAA) can be submitted until 12 noon on October 5, 2020.

No Myth: The Netherlands´ exit plan

Thursday, 17 September 2020 15:22

In August 2020, the initiative "Tierversuche verstehen" TVV (Understanding Animal Experiments) published their background paper "A model for Europe? Exit from animal testing in the Netherlands - myth and reality". TVV is an initiative of the leading German scientific organisations. Its aim is to gain a greater understanding of animal testing by conducting public relations in favor of animal experimentation. For this purpose, a total of 200,000 euros per year is available to TVV. On the basis of this background paper, Julia Merlot's article "Alternative methods will never completely replace animal experiments" was published on Spiegel-Online on 25.08.2020.


https://pixabay.com/get/52e0d44b4d54ae14ead08775cf29337b083ed8e55352744c71297c.png

Gryphon.
Illustration: Gordon Johnson, Pixabay.


 
The NGO People for Animal Rights Germany (PARG) - The Federal Association Against Vivisection has analyzed the background paper as well as the mirror article. The upshot: both texts tend to be one-sided. Especially the article by Julia Merlot lacks thorough research. In addition, information is not fully presented, which distorts the facts. The aim seems to be to devalue the importance of the Netherlands' exit plan and to defame the animal welfare and animal rights organizations that refer to it as dream dancers.
 
However, both texts do not change the fact that the determination and commitment of the Netherlands to change the current status quo is exemplary. Germany should take this as an example and support the initiative to the best of its ability. A prospective exit can only be achieved together, and with a structured and differentiated exit strategy. Otherwise, the withdrawal from animal testing envisaged in the preamble to the European Directive on the protection of animals used for scientific purposes (EU/63/2010) will remain lip service only. That is why we and other animal welfare and animal rights organizations will continue to work for an exit strategy along the lines of the Netherlands.
 
The Federal Association has contacted the scientific editors of “Der Spiegel” and called for more journalistic diligence.
 
Examples from the referred texts
Right on the first page of TVV's paper, the introduction (1) suggests that the exit plan is a myth. It is noticeable that immediately after the introduction comes the summary. This could tempt the reader to skip the following elaborations. Indeed, it is clear from those that the Netherlands has certainly been concerned with the possibility of an exit from animal experiments – beyond the recommendation of the National Committee for the protection of animals used for scientific purposes (NCad-Opinion) of 2016.
 
Model for a possible exit from animal experimentation
In her article based on the TVV paper, Julia Merlot ignores why the Dutch opinion is indeed revolutionary. After the USA (see, for example, Toxicology in the 21st Century, the concept was already elaborated in 2009 (2) and, as a result, the definitive exit plan (3) as well as the Directive to Prioritize Efforts to Reduce Animal Testing (4)), it is the first expert opinion in Europe to propose a possible roadmap for a structured and differentiated exit strategy. This is why the Netherlands is being used as an exemplary model for a possible European exit from animal testing.
 
The NCad report (5) describes how, step by step, and with the targeted use of resources and taking into account individual fields of science, fewer animal experiments can be "necessary". Nowhere in the opinion does it say that animal testing should be stopped without adequate animal-free procedures being available beforehand – on the contrary, this is explicitly recommended as a prerequisite. Animal rights and animal welfare organizations have perceived and communicated this accordingly.
 
The Cornerstone: promotion of animal-free procedures
Merlot goes on to say that the government has not changed the regulations and has only promoted alternative methods. But exactly the promotion of these new approaches with the aim of developing missing methods is one of the cornerstones of the report. At this point, it is not a question of legislative changes, but first of all of a political objective: to prioritize and develop missing methods in a targeted manner. Both Europe- and worldwide implementation only works through international validation studies (6) and panel work (7) in order to make new, animal-free procedures mandatory. For this reason, the Netherlands, as a single country, could achieve nothing at all by amending the law. In this respect, the author's argumentation misses the point.
Julia Merlot also fails to mention in her article that since the publication of the national committee for the protection of experimental animals in science (NCad), there has been a change of government and that the commissioning minister (Martijn van Dam, Labour Party) has not been able to follow up on the recommendations politically.

The Netherlands promotes the transition to animal-free innovation
Furthermore, Merlot writes: "However, there are no legislative initiatives or other projects that follow from the repeatedly quoted passage of the report, according to TVV. That is simply wrong. The paper of TVV itself states that several further steps have been taken following the NCad report. But for this, you would have to finish reading the TVV paper. It says: "However, the Netherlands is still striving to accelerate the transition to animal-free innovation." These are supported by considerable sums of money.

Laws have not been changed so far because, in the government's view, they are not the problem (if animal-free methods are available, animal testing may no longer be carried out; this is determined by the above-mentioned European Directive EU/63/2010 which had to be transposed into the national law of all Member States), but indeed the bottleneck ist to be found in the development and validation of alternative methods.

Should animal rights activists be defamed as dream dancers?
On page 3 of the TVV paper it says: "... Soon, animal welfare organizations announced that the Netherlands reportedly wants to phase out all animal experiments by 2025 and have a concrete roadmap for this." In the report´s summary as well, opponents of animal testing are presented as dream dancers: "... was presented by opponents of animal experiments as a general master plan to stop animal testing by 2025..." TVV thus suggests that animal welfare organizations have not read the original publications and are not properly informed.
 
However, animal rights organizations have read the original documents very carefully, attended congresses in Brussels, interviewed Herman Koëter, the then head of NCad, several times, and participated in lectures by NCad. Regards language, the choice of the term "master plan" was maybe slightly unfortunate, although the Netherlands demonstrably is currently in a process of assessing the possibilities of such a plan - also according to TVV (see below). The planning can be understood as, "the process of setting goals and formulating methods, strategies, and procedures (…) "in order to achieve them" (8). In this respect, the precise wording would be: the Netherlands was in the process of exploring the available possibilities.

Background on the NCad report
The 2016 NCAd opinion already set the goal of a phase-out from legally mandatory testing by 2025, while maintaining safety levels, and gradually reducing animal testing in applied research (6). Dr. Herman Koëter responded to our request on April 26, 2017 (9), as follows:

"In our advisory report, the NCad states that it should indeed be possible to phase out animal procedures in the areas of regulatory required safety testing by 2025, provided that all parties involved in the safety assessment of chemicals work closely together. Furthermore, the Ministries with responsibilities with respect to the use of experimental animals must all support the program both politically and financially. We are aware that our ambition is unprecedented but strongly believe it can be done. It won't be easy or straightforward and requires combined efforts of European member states and regulatory authorities. In the Netherlands, we are more than willing to do our share and to facilitate that cooperation."

NCad: the exit strategy is a mutual task
Dr. Herman Koëter responded to our request on April 26, 2017: "In our advisory report, NCad states that it should indeed be possible to phase out animal testing in these areas of regulatory required safety testing by 2025, provided that all parties involved in the safety assessment of chemicals cooperate closely. In addition, all ministries responsible for the use of experimental animals must support the program both politically and financially. We are aware that our ambition is unprecedented, but we firmly believe that this is possible. It will not be easy or straightforward and requires joint efforts by European member states and regulators. In the Netherlands, we are more than willing to do our part and facilitate this cooperation”.

TVV also admits this on the back pages: "In fact, the NCad's December 2016 recommendation merely provides for the possibility that animal testing in the area of "legally required regulatory safety testing" could be phased out by 2025." (TVV page 4). This refers in particular to official safety tests of chemicals, food ingredients, pesticides, and medicines (human and veterinary medicine). “Since the NCad considers it possible to phase out such animal experiments, it recommends that the Ministry define this as a clear political objective (national and international)." (TVV page 9). We are not aware of any animal rights/animal welfare organization that has not explicitly understood it this way.

Major progress: Exit from legally required tests
This is, after all, a great step forward, even though in recent years the number of animal tests in the legally required tests has decreased as a result of the development of animal-free methods. The prerequisite, of course, is that all parties involved are cooperating closely (Koëter 2017, see above). This was not disputed by TVV:

"... There, the Academy notes that innovations over the next ten years may well help to carry out fewer or more refined animal experiments. At the same time, however, the KNAW expressly points out that these methods and techniques would still contain serious limitations at the moment..." (TVV page 4).

Animal experiment reduction in applied research, basic research as well as education, training, and further education
Excerpt from the interview with Herman Koëter 26. April 2017: "... The advisory report on the transition to non-animal research was published last December. The Minister of Economic Affairs, to whom this advisory report was addressed, will assist (sub)domains in the fundamental and applied science in setting realistic animal-free research objectives for the next 10 years. It is our intention that these animal-free research targets will be published and the progress will be monitored. In each of these areas, the international context will be taken into consideration."

Potential for reducing animal testing in basic research
TVV also does not deny that NCad also sees potential for reducing animal testing in basic research (page 9, emphasis by us):

"... On the contrary, the possibilities for reducing animal testing varied from subject area to subject area. The National Committee, therefore, recommends that individual 10-year plans be developed for each scientific subject area in order to reduce the number of animal experiments, without jeopardizing scientific objectives..."

"... NCad comes to a similar conclusion for applied research. Again, complete elimination of animal testing by 2025 is not possible; however, the Committee recommends that more emphasis be made on animal-free methods and innovations..."

Further developments in the Netherlands
Behind the scenes, a lot has happened since 2016, as TVV itself admits and also performs on the back pages:

The secretaries of state of the two ministries called for "... a scenario with "ambitious but concrete achievable objectives" to "develop a target for basic scientific research over the next ten years, with the aim of reducing the use of animals in experiments". (TVV Page 10)

Even if the current conservative government under Mark Rutte does not want to end animal testing in basic research (which NCad has not proposed), "... The 2025 deadline, which was initially formulated, has been completely removed from the agenda – and one hopes for greater (international) acceptance and support." (TVV Page 15)

Undisputed: No exit without an exit strategy
Why does the Dutch Government even need an agenda and strategy with which it wants international acceptance and support, if not for an eventual exit from animal testing? Even if a specific exit date for the legally required toxicity tests is currently frivolous, this does not change the correctness of the Dutch plan. The U.S. is aiming for a 2035 date and is initially limited to mammals in the toxicity tests.

On one very important point, the report on 'understanding animal experiments' is quite wrong. The will and commitment of the Netherlands to change the current status quo is exemplary. Germany should take this as an example and support the initiative to the best of its ability. The Dutch say quite clearly that the abandonment of animal testing is a joint task. It requires efforts by all European member states and regulators. In addition, all ministries responsible for the use of experimental animals must support this politically and financially.

A prospective exit can only succeed together and with a structured and differentiated exit strategy. Otherwise, the planned exit from the animal experiment will remain only lip service. That is why we and other animal welfare and animal rights organizations will continue to work for an exit strategy along the lines of the Netherlands.
https://www.tierversuche-verstehen.de/wp-content/uploads/2020/08/Vorbild-f%C3%BCr-Europa_Tierversuchs-Ausstieg-in-den-Niederlanden_Mythos-und-Wirklichkeit.pdf

Literature:
(1) Understand animal testing (2020). Role model for Europe? Animal testing exit in the Netherlands - myth and reality. https://www.tierversuche-verstehen.de/wp-content/uploads/2020/08/Vorbild-f%C3%BCr-Europa_Tierversuchs-Ausstieg-in-den-Niederlanden_Mythos-und-Wirklichkeit.pdf
(2) https://ncats.nih.gov/tox21
(3) https://www.epa.gov/sites/production/files/2020-06/documents/epa_nam_work_plan.pdf
(4) https://www.epa.gov/sites/production/files/2019-09/image2019-09-09-231249.txt
(5) National Comité advies dierproevenbeleid (2016). NCad opinion Transition to non-animal research. https://www.ncadierproevenbeleid.nl/documenten/rapport/2016/12/15/ncad-opinion-transition-to-non-animal-research
(6) https://ec.europa.eu/jrc/en/eurl/ecvam
(7) OECD (2015). DRAFT GUIDANCE DOCUMENT ON AN INTEGRATED APPROACH ON TESTING AND ASSESSMENT (IATA)FOR SERIOUS EYE DAMAGE AND EYE IRRITATION. https://www.oecd.org/env/ehs/testing/IATA_Eye_Hazard_Draft_v16Dec15.pdf
(8) https://www.onpulson.de/lexikon/planung/
(9) https://www.tierrechte.de/2018/02/13/interview-mit-dr-koeter-wir-glauben-fest-daran-dass-der-ausstieg-machbar-ist/

The University of Veterinary Medicine Hannover (TiHo) and the Hannover Medical School (MHH) create digital teaching and learning materials about animal protection and alternatives to animal experiments. They make them freely accessible to other teachers.

The Hesperos company has published a second study that confirmed its previous study on physiological and functional muscle fiber deficits in ALS patients.

SARS-Cov-2 attacks the CNS

Monday, 14 September 2020 11:00

Researchers at the Heinrich-Heine-University of Düsseldorf have, in cooperation with scientists from Paris, Cologne, Münster and Bonn proved that the coronavirus SARS-Cov-2 affects cells of the central nervous system.

A team of researchers from the 3d Bioprinting Laboratory at the University Hospital of Innsbruck has printed a three-layer human skin model that is capable of forming the tiniest vascular cells. With this model, scientists want to help avoid animal experiments.

For the first time, scientists have succeeded in creating neural networks with functions of the human brain from human induced pluripotent stem cells.

For the third time, the city-state of Hamburg is awarding a research prize for the development of alternatives to animal experiments. The prize is endowed with 50,000 euros and is awarded every two years.

The project R2U-Tox-Assay is funded by the European Institute of Innovation and Technology (EIT). With its innovation projects, EIT aims to provide answers to some of the major healthcare challenges facing Europe. The project R2U-Tox-Assay aims to develop innovative toxicity assays for drug discovery based on human cell systems. The aim is to better predict undesired side effects of drug candidates in preclinical phases and to reduce animal testing in pharmaceutical research.

The Hybrid Systems Laboratory at the University of Central Florida (UCF) has developed a human-on-a-chip model to study therapeutics against amyotrophic lateral sclerosis, which provides much faster and more reliable results than using an animal model.