Carlota Saorsa / HIDDEN / We Animals

22 September 2024

The European Pharmacopoeia Commission took a historic step by removing the rabbit pyrogen test from the European Pharmacopoeia in favour of the use of non-animal methods. This decision will not only spare the lives of tens of thousands of rabbits in the EU every year, but will also better ensure the safety of medicines and vaccines.

This long-debated method, which raised ethical concerns and had limitations in accuracy and reproducibility, now belongs to the past. 

Pyrogens are fever-inducing substances that can unintentionally contaminate injectable medicines, and their detection is crucial to ensure the safety of these products.

Developed in the early 1900’s, the rabbit pyrogen test was the predominant method for detecting pyrogens. It involves injecting the test substance intravenously into a vein of the rabbits’ ears and observing their reaction, mainly an increase in body temperature. These injections can be repeated until their ears are severely damaged and can no longer be used, or until they show a reaction. In all cases, rabbits are killed at the end.

The limitations of the rabbit pyrogen test are widely recognized, including limited sensitivity and reproducibility. Repeated injections can lead to the development of pyrogen tolerance, while the inherent stress of the test can also affect results.

Alternative non-animal methods with improved sensitivity and relevance have been available for more than 20 years.

Despite many years of efforts to promote the use of non-animal methods for both ethical and scientific reasons, the rabbit pyrogen test remained the standard for detecting pyrogens, resulting in the suffering and death of approximately 25,000 rabbits annually in the EU.

In June 2024, the European Pharmacopoeia Commission, a regulatory body responsible for overseeing the safety of medicines, adopted 57 revised texts in the European Pharmacopoeia. Drug developers will now be required to choose non-animal methods for assessing the pyrogenicity of their products. Among the available methods, the Monocyte Activation Test (MAT) has emerged as a highly reliable and accurate solution for pyrogen detection. This test is based on the response of human immune cells to pyrogens, offering greater sensitivity and reproducibility than the rabbit assay.

This decision marks a significant milestone in the transition away from animal-based testing methods. It is hoped that it will pave the way for the adoption of more innovative and reliable non-animal approaches across various scientific fields.

Regards Mark

Story: https://www.msn.com/en-gb/news/world/animal-rights-activists-scale-roof-of-building/ar-AA1oi4WA?ocid=BingNewsSerp

Regards Mark

5 August 2024

Directive 2010/63/EU establishes common EU measures for the protection of animals used for scientific purposes, but the way the Directive is implemented differs between EU Member States. A new implementation report highlights this heterogeneity, particularly in areas where the Directive lacks specific, detailed provisions.

Member States are required to send information on the implementation of Directive 2010/63/EU to the European Commission every five years. Following the first report in 2019, the second report, covering the period 2018-2022, has just been published.

Education and training

The Directive requires appropriate education and training for staff carrying out procedures, caring for animals, killing animals and designing procedures and projects. However, implementation rests largely with Member States, which can decide independently how competence should be demonstrated.

Most Member States mentioned that they follow the EU Education and Training Framework document, but did not explicitly explain how competence should be demonstrated beyond having obtained the required education. 

Project evaluation and authorisation

During project evaluation, applications must be carefully considered to ensure that animal use is justified, the principles of the 3Rs (replacement, reduction and refinement) are applied, and that the benefits are expected to outweigh the anticipated harms. 2 Member States use individuals to evaluate projects, whereas the others use a panel.

Around 15 000 projects involving the use of animals are authorised across the EU and Norway annually. The number of projects has remained reasonably constant throughout the five-year reporting period, and only around 4.5% of applications are rejected each year.

Competence of project evaluators is assured in different ways. However, it seems that there may be scope for improved training to ensure a consistent approach across the Member States. Many Member States discussed the required qualifications of project evaluators, but only Ireland mentioned expertise in the area of non-animal methods.

It is surprising that there was no explanation on how to achieve harmonisation when project evaluation is carried out by multiple competent authorities from some Member States.

Only one Member State confirmed that applicants are never involved in the project evaluation of their own work.

Animals bred and killed but not used in procedures

This category includes animals killed for their organs and/or tissues, animals used for breeding when they reach the end of their breeding life, animals which were ill and humanely killed before being used, and animals killed in order to protect the health and scientific integrity of the colony. They are not reported in the annual statistics.

In 2022, 9.5 million animals were bred and killed but not used in procedures. This means that there are more animals that fall into this category than the number of animals that are actually used in procedures. Mice, zebrafish and rats account for more than 90% of the animals reported.

Inspections

20 Member States complied with the requirement to inspect at least 1/3 of the user establishments each year. Greece, Croatia and Portugal appear not to have met this criterion for any of the years reported.

According to the Directive, an appropriate proportion of inspections must be carried out without a prior warning. Across the Union, around 1/3 of inspections were unannounced. However, the proportion of unannounced inspections varied between Member States from 0-100%. This suggests that different criteria are being applied to determine “an appropriate proportion.”

8 Member States performed no unannounced inspections which is the same number as in the first report. Cyprus and Portugal performed no unannounced inspections over the ten years covered by the two implementation reports.

18 Member States acknowledged that they did not meet the minimum requirements for inspection in any of the reporting years.

Penalties

Nearly 3/4 Member States reported infringements, and 21 Member States have used administrative actions. Infringements which were dealt with by administrative action were due to failings in animal welfare, staff, records, environment, and facilities.

Almost half of the Member States used legal actions, of which two-thirds were fines.

Structure of competent authorities

The Directive requires that the authorisation of establishments, inspections, project evaluation, project authorisation and retrospective assessment are performed by a competent authority. 7 Member States have only one competent authority for each of the five tasks (Denmark, Ireland, Cyprus, Malta, Portugal, Slovenia, Norway), while other Member States have very large numbers of competent authorities (for example, 112 in Spain; 245 in Italy, 328 in Poland and 573 in Germany).

It may be challenging to provide a consistent approach where there are multiple competent authorities responsible for the same individual tasks. Large numbers of competent authorities for any or all tasks increase the risk of inconsistencies.

Summary

The implementation reports are an opportunity to show how Member States have been working since the implementation of the Directive, understand where they encounter difficulties, but also highlight best practices so that they can learn from each other. 

The lack of harmonisation across Member States continues to have a negative impact on the objective of creating a level playing field across the EU, but also, and importantly, on animal welfare. 

Regards Mark

29 July 2024

Long-awaited statistics on the use of animals for scientific purposes in the 27 EU Member States and Norway during 2021 and 2022 have been published. We dive into the figures to see how many animals were used, which species, and in which ways, to explore how the data can inform the transition away from animal use.

For the first time, a systematic trend analysis was included to make direct comparison with previous years data available in order to monitor the objectives of Directive 2010/63/EU.

2021 Statistics

In 2021, after three years of consecutive decrease, the total number of animals used for the first time increased significantly to 9.41 million. This is 18.5% higher than in 2020, and 6.6% higher compared to 2018.

This increase is mainly due to three research projects, two using salmon in Norway and one using larval form of sea bass in Spain, accounting for over 1.3 million animals. Part of the increase can also be attributed to projects that were either cancelled or postponed in 2020 due to COVID-19 lockdowns and carried out in 2021.

Positively, 13 Member States reduced the number of animals used for the first time in 2021 compared to 2020.

2022 Statistics

In 2022, the total number of animals used for the first time decreased to 8.39 million, 10.9% lower than 2021, and 5% lower than 2018. 

This confirms the exceptional nature of the increase reported in 2021, and highlights a longer-term decreasing trend.

Species

In both years, mice continue to be the most used species, followed by fish, rats, domestic fowl and rabbits.

Fish saw a dramatic increase in use in 2021, whilst 2022 saw an increase in the proportion of reptiles used.

Disappointingly, the total number of non-human primates used for the first time increased. Most non-human primates were imported from Africa and Asia, shifting more prominently towards Africa after the Chinese export ban introduced in 2020. The percentage of those that came from self-sustaining colonies (from parents bred in captivity) increased from 58.8% in 2021 to 74.4% in 2022, a positive shift towards eliminating capture of wild primates for breeding purposes. 

Genetic alteration

In 2022, 24.8% of animal uses were carried out on animals that were genetically altered, an increase of 4.3% compared to 2021. Of these, 17.5% were carrying a harmful phenotype. Zebrafish and mice continue to be the most genetically altered species. 

In addition, 852,145 animals were used in 2022 for the creation and maintenance of genetically altered animal lines, an increase of 28.1% on 2021. 

Severity of suffering

The proportion of ‘severe’ uses continues a downward trend since 2018, but this still represents 918,202 animals in 2021, and 784,048 animals in 2022.

However, it is worrisome that the proportion of ‘moderate’ uses has been increasing since 2019, reaching over 42% of uses in 2022. 

Types of use

As in previous years, most animal uses were conducted for research purposes.

The number of uses of animals used for regulatory purposes continued to decrease by 6.2% in 2021, and 16.2% in 2022. This is mainly due to continuous reductions in animal uses related to legislations on medicinal products for human use and food legislation, amongst others. This can be attributed to combined efforts from EU regulators, including the EDQM and the European Commission and industry via EPAA, as well as changes in legislation. This includes the decision in 2021 to completely replace the rabbit pyrogen test within five years, and the replacement of the use of mouse bioassay for the purposes of shellfish toxin testing by the so-called Lawrence method.

Unfortunately, this trend is not reflected in other legislation, including medical devices legislation and industrial chemicals legislation, where the number of animals used to satisfy regulatory requirements has been increasing since 2018. 

Routine production saw an increase of 1.5% in 2021 and 15.7% in 2022. This category includes monoclonal antibody production by the mouse ascites method, one of the most severe procedures. In 2022, only 3 Member States reported the use of the mouse ascites method, with France representing 99.5% of that, using 49,038 mice. Germany stopped the use of animals for this purpose in 2022. The Commission itself mentions in the 2022 report that the use of mouse ascites method which results in high severities and has alternative production methods available should be discontinued. 

What do the statistics tell us? 

The statistics indicate that policies to promote the development and use of non-animal technologies and approaches require a further push in order to significantly reduce animal experiments in Europe.

Although a positive trend is now seen in the replacement of a small number of methods, this took decades to achieve after the development of non-animal alternatives. Likewise, the mouse ascites method continues to be accepted in some EU countries despite its near ban in most Member States, and the existence of valid alternatives.

The upward trends in the use of some species like the ones belonging to groups of non-human primates are also worrying in an era where human-based methods have been thriving.

It will be important to take lessons from the social, economic, regulatory and technological factors that influenced the slow transitions that are now taking place, in order to plan more effective transitions moving forward.

Regards Mark

We have a new government in the UK now.

Cruelty Free International

Animal protection NGO, Cruelty Free International, is calling on the UK’s new Labour government to honour its manifesto pledge to “partner with scientists, industry, and civil society as we work towards the phasing out of animal testing”.

This commitment must lead to the end of the use of animals in UK laboratories, through the development of a roadmap with clear targets, milestones and actions, led by a new minister to co-ordinate plans across all departments.

The government must also provide further detail to expand on earlier commitments by senior members of the Labour Party that included a board of experts to be established in the first year and tasked with drafting a plan to phase out the use of dogs, minipigs and rabbits in testing, including medical testing.

Cruelty Free International stands ready to offer its expertise to ensure these policies are delivered in an ambitious but achievable way.

The organisation’s ‘Pledge Cruelty Free’ campaign in the build-up to the General Election asked all parliamentary candidates to make a commitment to put the 1998 ban on testing cosmetics on animals, covering ingredients used either primarily or exclusively in cosmetics, into law; make our homes safer by modernising the system for testing the chemicals that go into the products we use every day, such as food, clothes, household cleaning, furniture, electronic goods, paints and dyes, and removing animals from those tests; and ask that the government create a plan to phase-out animal testing forever, with a minister dedicated to delivering this target across all government departments.

Home Office statistics show that there were over 2.76 million uses of animals in laboratories in Great Britain in 2022. Ten per cent of those are tests required by regulators to assess the safety or effectiveness of chemicals, medicines and other products.

Cruelty Free International Head of Public Affairs, Dylan Underhill, said: “Sir Kier Starmer and his new government must honour their manifesto pledge to phase-out animal testing, and reflect both the views of the public and the strength of feeling that there is on this issue. With such a strong majority they can and must be bold to reflect the promise of change on which Labour built their campaign. Animal testing is simply not good science, yet inexplicably continues as the default method for testing the safety of products. We know that, as a country, we can do so much better in our protection of the millions of animals that suffer and die in laboratories every year.

“Their commitment must lead to the end of the use of animals in UK laboratories, through the development of a roadmap with clear targets, milestones and actions, led by a new minister to co-ordinate plans across all departments. The government must provide further detail on commitments that included a board of experts to be established in the first year and tasked with drafting a plan to phase out the use of dogs, minipigs and rabbits in testing, including medical testing. Cruelty Free International stands ready to offer its expertise to ensure these policies are delivered in an ambitious but achievable way.

“We know that there is so much for a new government to do in its first few days and weeks in office, but this is long overdue and cannot be forgotten or delayed any longer. The government must develop a roadmap with clear targets and milestones to phase out the use of all animals in experiments as soon as possible. We stand ready to offer our expertise in service of this ambition.

“A greater increase in funding, in line with the levels for similar ground-breaking technologies in the UK, needs to be accompanied by innovative incentives to encourage scientists and industry to move away from the current use of animals. Non-animal testing methods, in many cases, have already proven themselves to be faster, cheaper and more accurate than animal testing.

“Animal testing touches our lives in many ways that most of us don’t appreciate, from cosmetics and household products to clothes, furniture, plastics, electronic and white goods, paints, dyes, and food – all these things can be associated with animal testing on their way to our homes. We need Labour to take bold steps forward – without this, we will be condemned to a never-ending cycle of small reductions rather than the transformative step forward which is needed to meet the aspirations of the public.”

Regards Mark

https://www.dailymail.co.uk/news/article-13580329/Animal-Rising-activists-charged-burglary-break-animal-testing-beagle-puppies.html

Animal Rising claims MBR Acres of holding ‘bleeding licences’ which allow them to bleed healthy dogs to death to harvest their blood and organs

Regards Mark

In a landmark decision, the Department of Justice and Environmental Protection Agency have imposed a hefty $35 million penalty on a company for serious violations of animal welfare and environmental laws. This fine marks the largest in history under the Animal Welfare Act, highlighting a significant step towards stricter compliance and respect for animal rights and environmental safety.

Animal Breeding: A Harrowing Discovery at Virginia Dog Breeding Facility

The fine stems from a distressing situation uncovered in 2022 at a Virginia-based dog breeding facility operated by Envigo Global Services. The facility, which bred dogs primarily for research purposes, was found severely lacking in meeting the humane standards required by law. Over 4,000 beagles were living in deplorable conditions, prompting a forced surrender by the Department of Justice.

Continue reading https://www.msn.com/en-us/news/us/massive-35-000-000-fine-hits-dog-breeding-giant-for-animal-neglect-and-environmental-harm/ar-BB1nLecW?ocid=BingNewsSearch

Mark

As part of research, pregnant baboons were given varying combinations of estrogen and an estrogen inhibitor, and their fetuses were delivered via C-section at different stages of pregnancy, according to documents provided to The Virginian-Pilot. The placenta and fetal tissue were collected for study, according to the protocol objective for the experiment submitted by EVMS to the school’s Institutional Animal Care and Use Committee.

A total of 156 baboons were requested for the experiment over three years. Death of the mother, the fetus or both were accepted outcomes of the study as described in the documents.

Read the full article at  Animal rights group files complaint against Eastern Virginia Medical School citing abuse in baboon research (msn.com)

Today, 24^th April, is the World Day for Lab Animals.

24 April 2024

Every year on 24 April, World Day for Animals in Laboratories serves as a stark reminder of the millions of animals used in scientific research around the globe. At present, we are faced with a critical decision: whether to perpetuate existing policies that neither incentivise the development and uptake of innovative non-animal technologies nor lead to significant reductions in the number of animals used for scientific purposes, or to implement coordinated and concrete policies and mechanisms that empower stakeholders to embrace non-animal technologies.

In response to growing calls from Members of the European Parliament, EU agencies, citizens, academia and industry for a transition towards more biologically-relevant non-animal approaches, the European Commission took action in 2023. It committed to develop a roadmap to phase out the use of animals for chemical safety assessment, and to explore the possibility of a European Research Area (ERA) action to accelerate the development, validation and uptake of non-animal approaches in biomedical research and testing of pharmaceuticals.

These two initiatives represent significant opportunities to establish the necessary policies and mechanisms at EU level to accelerate the transition to non-animal science. The roadmap will serve as a framework for coordinating concrete actions  to move away from animal testing in the context of the EU chemicals legislation. In doing so, it will set a precedent for other policy areas that still rely on the use of animals. 

An ERA action has the potential to foster increased collaboration and coordination between Member States, and to identify specific areas where animal use can be avoided and where investments should be directed to advance non-animal technologies. It can also improve access to essential infrastructure for non-animal research, and facilitate the development of harmonised education and training programmes. This will ensure that students, educators, researchers and regulators are equipped with the necessary knowledge and skills to effectively advance innovative non-animal approaches to address scientific challenges. 

Eurogroup for Animals and its member organisations call on all stakeholders, including policy makers, scientists, industry, regulators and funders, to join forces to develop and implement forward-looking policies and mechanisms in order to move towards a future where humans, animals and the environment are better protected.

Today, we also take the opportunity to shine a spotlight on the recent achievements of several of our member organisations in advancing human-based science:

• LAV is currently involved in legal proceedings against a contract research organisation in Italy which carries out tests on animals, including dogs and non-human primates. Following complaints from LAV, the Italian authorities carried out an inspection which revealed numerous irregularities. As a result, the former director and veterinarian were charged with mistreatment and unnecessary killing. The authorities seized all the dogs and non-human primates. 

• Proefdiervrij inaugurated the 3rd edition of the Proefdiervrij Venture Challenge. Moreover, the Dutch Government allocated 125 million to an initiative aimed at establishing a Center for Animal-Free Biomedical Translation, with Proefdiervrij playing a crucial role as a member of the project team.

• Doctors Against Animal Experiments (DAAE) engaged with 800 political decision-makers to request the correct transposition of Directive 2010/63/EU on the protection of animals used for scientific purposes into German law. Furthermore, DAAE granted two Herbert Stiller Research Prizes to advance animal-free research. 

• The RSPCA ran an event with the European Federation of Pharmaceutical Industries and Associations (EFPIA) to discuss steps that the industry is taking to avoid, replace and reduce animal use, and opportunities for further progress. The RSPCA also launched their AWERB Directory, collating key resources to help institutional Animal Welfare (and Ethical Review) Bodies effectively challenge whether and how animals are used in research and testing. Furthermore, the RSPCA organised its third annual Focus on Fish event to share knowledge and ideas for reducing the suffering and improving the welfare of fishes used in science, as well as their fifth international meeting promoting practical approaches for avoiding and reducing ‘severe’ suffering. 

• GAIA contacted the Brussels and Walloon Ministers for Animal Welfare to encourage the establishment and implementation of an action plan to replace and reduce animal testing, similar to the Flemish Action Plan, in their respective regions. In its response, the Brussels Minister announced that a five-year strategy to reduce animal experimentation will be included in the Brussels Animal Welfare Code. 

• Djurens Rätt submitted 27,847 signatures to urge the Swedish government to reinstate dedicated funding for the Swedish 3R Centre.

• Deutscher Tierschutzbund presented their work on non-animal-derived materials at the 2023 JRC Summer School and at the 12th World Congress on Alternatives and Animal Use in the Life Sciences. Moreover, Deutscher Tierschutzbund has been campaigning against the interim order issued by the Bremen Administrative Court which allows research on non-human primates to continue at the University of Bremen beyond the expiry of the authorisation licence. 

• Humanimal Trust published an updated edition of Humanimal, a children’s book focusing on the similarities between humans and animals. Moreover, Humanimal Trust also launched the First Global Creative Awards for children and young minds in order to captivate a broad audience with the concept of One Medicine via creative media, as well as online One Medicine Webinar series showcasing where collaboration between human and veterinary medical professionals can deliver better health for all species.

• Menschen für Tierrechte (People for Animal Rights Germany, PARG) joined forces with the Berlin Greens to make “Animal-free Research Methods Development” a mandatory component of all relevant undergraduate courses offered at universities in Berlin. In addition, PARG also published an extensive University Guide that provides comprehensive information for studying life science subjects without the use of animals. PARG’s initiative “Exit from Animal Testing. NOW!” lead a government action plan and a commitment of two million euros for the development of a strategy aimed at reducing animal testing.

• Animalfree Research launched a petition calling on the Swiss Parliament and the Federal Council to make a binding commitment and establish a concrete plan to gradually phase out harmful animal experiments, and take measures to systematically evaluate the benefits of state-funded research involving animal experiments and publish these results on a regular basis. Furthermore, Animalfree Research organised a forum on advancing personalised medicine with animal-free research.

See also:

https://www.msn.com/en-gb/health/other/beyond-animal-testing-the-rise-of-ethical-alternatives-in-clinical-research/ar-BB1kDKjj?ocid=msedgdhp&pc=DCTS&cvid=a9c869c6c1834150c18c298de147fbb2&ei=45