Tag Archives: Directive 2010/63/EU

EU Directive ‘cannot be implemented in isolation’ Brussels roundtable agrees

At a roundtable discussion on the use of animals in scientific research there is overwhelming agreement that Europe has appropriate and detailed legislation regulating the use of animals in scientific research, that adapts to and encourages scientific progress.

Conclusions also show that successful implementation of the Directive is a shared responsibility. The round table identified opportunities to join forces and work together, as the Directive 2010/63/EU cannot be successfully implemented by organisations or individuals working in isolation.

At the meeting in Brussels, representatives from the diverse sectors within the biomedical community (academia, industry, research organisations, medical charities, etc.) and policy-makers discuss the recommendations of the European Commission review report of the Directive 2010/63/EU on the protection of animals used for scientific purposes.

The objective of the roundtable was to  inform policy discussion in EU institutions and to identify recommendations for the users’ community on this basis. Topics under discussion were: the implementation of the Directive; improving openness and transparency; ideas for further areas to be tackled. Continue reading

Scientists in Europe must take more responsibility for openness, says EARA executive director

Openness and transparency surrounding the use of animals in research is ‘still an Achilles Heel’ for the biomedical sector, a roundtable hosted by the Federation of European Academies of Medicine (FEAM) last week has heard.

Speaking at the meeting, EARA Executive Director, Kirk Leech, said: “The zeitgeist is openness and transparency for the biomedical sector, but this is still an Achilles Heel for many European institutions.” Continue reading

European scientific community welcomes EU review of the Directive for the protection of animals used for research


LONDON, UK – 10 November, 2017

The European scientific community supports the view of the EU Commission, that the Directive on the protection of animals used in biomedical research is bringing significant benefits in animal welfare and a sound foundation for future best practice in the sector.

The European Animal Research Association (EARA), which represents more than 60 organisations across Europe in the biomedical research sector, has welcomed the Commission report, published today. The report reviews the requirements of Directive 2010/63/EU – all uses of live animals for research or education and testing must be carried out in compliance with the Directive.

In particular, the EU recognised that measures to improve transparency to the general public on the performance of research establishments in the areas of animal use and welfare are starting to have an effect. Requirements to publish non-technical summaries of the objectives and benefits of research projects, as well as annual statistical data, are also seen to have greatly improved openness in Member States. Continue reading

Recommendations on the report of the European Commission Scientific Conference ‘Non-Animal Approaches – The Way Forward’

The European Commission published in April 2017 the report of the conference ‘Non-Animal Approaches – The way forward’ that they organised in Brussels on 6 and 7 December 2016. The Conference’s presentations and video recordings can be viewed on DG Environment website.

The conference was announced in the Commission’s response to the Europeans Citizens Initiative ‘Stop Vivisection’ as one of four actions that should contribute towards the goal of, ultimately, phasing out animal testing.

The key recommendations outlined in the report are extracted here for simplicity:

Recommendations Session 1 – Animal Testing Today
There is a need for on-going investment in public and private funding in non-animal alternatives. However, consideration is required to ensure the proposed research is appropriate, addresses areas of need, and is of high quality with appropriate statistical design. To achieve these goals, the following are required:
1. A thorough gap analysis of where alternatives are still lacking and how to improve the current alternatives to be fit for purpose
2. The investigation of more “human” testing e.g. using human cell-based systems
3. Consideration of whether there should be a more stringent scientific peer review of methodology before starting any project using animals or developing alternatives
4. A need for systematic use of ARRIVE, and other relevant guidelines to stimulate a culture of scientific excellence.
5. Improvements in study design and data analysis for all animal experimentation as well as for non-animal studies.
6. More standardisation, e.g. in design, analyses, statistics and publication
7. The need to publish negative results systematically – start with all publicly funded studies using animals

Recommendations Session 2 – Biomedical Research: Strengths and Limitations of Non-Animal Alternatives
1. There is a need for a continued and organised research agenda within Europe to co-ordinate the short-term and longer-term uptake of alternatives based around in silico and in vitro approaches in the short term and human-on-chip and microphysiological approaches in the longer term. Some more strategic top-down or central steering of this research agenda might be beneficial.
2. Fundamental biological research, from sequencing of human genomes to tissue and organ level biology, should not be discontinued as this will support the better development of the next generation of alternatives to animal testing.
3. Effort is required to speed up and possibly simplify the process of validation (also covered in a later session) leading to acceptance of alternatives and therefore greater uptake.
4. Greater resources should be made available for data sharing, including consideration of greater access to confidential data – or knowledge being made available from it. Resources such as patient DNA databases should be created for research purposes.
5. Education and training of all researchers using animals is mandatory in the EU, enforcement of compliance is necessary to ensure respect for animals and their correct, ethical use.

Recommendations Session 3 – Regulatory Testing: Strengths and Limitations of Non-Animal Alternatives
1. New approaches for the validation of complex alternatives need to be developed now, i.e. moving away from the one-to-one replacement paradigm, to ensure acceptance and uptake.
2. Regulators should lead the way whilst working closely with industry and other stakeholders.
3. The process should start with a common problem definition.
4. Work is required on defining, understanding and agreement on acceptable risk to human safety on using non-animal data – as a result regulation may need to be adapted.
5. Progress in the area of acceptance of alternatives must be collaborative at a number of levels and will require resources to achieve this:
a. International collaboration e.g. EU, US, Japan etc.
b. Stakeholders e.g. regulators, industry, developers etc.
6. Dates and targets for the phasing out of animal tests, where possible, should be considered. Although not all panellists considered that helpful.
7. Additional barriers to the acceptance of alternatives, beyond those already known, should be identified and strategies to remove them be defined.
8. There should be support for internationally led case studies to evaluate and demonstrate the acceptance of new alternative approaches. In this context, it could be helpful to carefully map out uncertainties of current animals tests.
9. An in vitro Mode of Action-based classification system like today’s GHS will be required.

Recommendations Session 4 – Reporting on European Commission Actions 1 – 3
1. The European Commission should continue its role to monitor compliance with Directive 2010/63/EU and to increase the vision of using alternatives to animals wherever possible.
2. Consideration could be given as to how the Three Rs could further be promoted through Directive 2010/63/EU e.g. through the use of dedicated information officers.
3. Access to knowledge sources should be reviewed and improved, for instance by their quality assurance and the provision of an (internet) one-stop-shop to access all resources using an improved search engine.
4. Support should be provided for dissemination events, such as conferences and workshops, to increase outreach especially for non-scientists.
5. Consideration should be given to require publication of Three Rs methods where possible.
6. Assistance should be provided to compile and publish negative data where possible, interoperable databases of information are one approach that should be investigated.
7. A funding strategy to promote knowledge sources for the Three Rs and access to them should be developed, including commitments from the European Commission and private industry.

Recommendations Session 5 – Responsible Research
1. The European Commission should continue (and increase) funding of research in alternatives in specific areas that will stimulate their uptake and implementation.
2. All EU agencies such as ECHA, EMA and EFSA and initiatives such as EPAA and IMI should further encourage the uptake of alternatives and the implementation of the Three Rs principles.
3. Science must make efforts to understand and remove all elements of bias from the experimental design and reporting of results.
4. The use of tools such as the NC3Rs Experimental Design Assistant should be mandatory in the design of experiments and be required by grants funding agencies.
5. The implementation of the NC3Rs ARRIVE guidelines should be mandatory in grant proposals as well as publication of results, starting with all publicly funded research using animals.
6. Greater efforts should be made to ensure results are openly available e.g. using data repositories such as European Open Science Could, allowing access to all results including negative results, and enabling free and easy data reuse; especially results derived from publicly funded research using animals.
7. Journal editorial policies should more fully embrace the Three Rs principles ensuring the ARRIVE guidelines have been respected.
8. The peer-review process should be assessed as to whether it is fit for purpose with regard to transparency and implementation / review of the Three Rs.
9. The assessment of research impact should be revised to remove the emphasis from highly significant “headline” results to ensuring quality and relevance.
10. 2020 should be designated the “Year of Systematic Review”.
11. Each Member State should be encouraged to have a Science Media Centre, such as that in the UK, which helps the general press with the correct reporting of research outcomes.

Recommendations Session 6 – The Future: The Way Forward
1. Harmonisation of all new methodologies is required; there is good progress for metabolomics as one example which should be supported.
2. There is a need for a large-scale evaluation of metabolomics to demonstrate its utility to identify mechanisms of action relating to chemical safety for a number of species.
3. Support is required to complete the development of technologies such “human-on-a-chip”, in readiness for industry adoption and validation.
4. There is a need to widen the Adverse Outcomes Pathway type approach to areas outside regulatory toxicity e.g. in disease modelling.
5. Human tissue should be made more readily available and this should be addressed at EU level.
6. All new technologies require some form of validation to demonstrate their fitness of purpose. Further efforts in developing validation schemes and strategies may be required.
7. iPS and related technologies should be developed to address specific organ level effects and disease treatments.
8. Further understanding of the limitations of the new technologies is necessary, especially how to scale up cellular based techniques to in vivo.
9. Patient groups should be informed about the new technologies, their advantages and risks.
10. Efforts to show how to combine all new technologies e.g. for drug safety are required which may need a new way of thinking both about the technology itself and the means of combining information.
11. There is a continued need for education and training in all aspects of animal-free science and the Three Rs; this is required at all levels from school and university students to established researchers in academic, industrial and contract laboratories. Proper and full dissemination of knowledge will be key to this. This will require the promotion of the new techniques and approaches and raising awareness of resources through well-designed internet resources and, preferably, a single search engine from which all information can be accessed. There is also a need to inform and educate the public more effectively including through Scientific Conferences and to maintain an open and constructive dialogue between stakeholders.

The European Animal Research Association (EARA)
June 2017

Scientists’ engagement in animal research policy-making – Lab Animal Europe column

The November issue of Lab Animal Europe magazine features an Outreach article written by Emma Martinez, EARA’s Communications and Policy Officer. In this article, also published in Lab Animal (US), Emma discusses how the European Citizens’ Initiative ‘Stop vivisection’ and the review of Directive 2010/63/EU converge on the European Commission scientific conference ‘Non-Animal Approaches – The Way Forward’ and the need for scientific engagement. Continue reading

Commission announces infringement procedure against restrictive Italian animal research law

The European Commission has announced the start of an infringement procedure against Italy, whose animal research law it calls ‘too restrictive’. The Commission has sent a letter of formal notice to the Italian government, as the first step in the infringement procedure. Earlier this year, EARA’s partner organisation Research4Life asked the European Commission on behalf of 37 public and private Italian research institutions for the law to be reassessed. Continue reading

Declaração de apoio à Diretiva Europeia 2010/63/UE

Declaração de apoio à Diretiva Europeia 2010/63/UE (“Diretiva”) relativa à proteção dos animais utilizados para fins científicos

A utilização de animais na investigação tem facilitado os maiores avanços na medicina que transformaram a saúde humana e animal. Apoiamos a utilização de animais na investigação quando não existam métodos alternativos disponíveis, quando os potenciais benefícios para a saúde sejam imperativos e quando as normas aceitáveis de ética e bem-estar possam ser cumpridas.

A Diretiva Europeia 2010/63/UE melhorou as normas relativas ao bem-estar dos animais e introduziu os conceitos de refinamento, substituição e redução (“3Rs”) em toda a UE, garantindo ao mesmo tempo que a Europa continua a ser líder mundial em investigação biomédica. Nos termos desta Diretiva, os animais podem ser utilizados na investigação quando os potenciais benefícios médicos, veterinários e científicos sejam imperativos e não exista um método alternativo viável.

Para que a investigação com utilização de animais seja ética e cientificamente rigorosa e autorizada nos termos da Diretiva, tem de cumprir normas de bem-estar exigentes e incorporar os 3Rs. Os 3Rs são:

  • Replacement (substituição) – métodos que evitam ou substituem a utilização de animais;
  • Reduction (redução) – métodos que minimizam o número de animais utilizados por experiência;
  • Refinement (refinamento) – métodos que minimizam qualquer sofrimento e melhoram o bem-estar animal.

Os desenvolvimentos de métodos alternativos à utilização de animais na investigação, como o uso de modelos de células humanas e modelação informática, continuam a progredir e os cientistas devem continuar a impulsioná-los. Contudo, os métodos alternativos não conseguem, atualmente, substituir integralmente a utilização de animais. Em muitas doenças, incluindo estados complexos como cancro, doença cardíaca e diabetes, que afetam vários órgãos, temos que entender como é que todo o organismo interage, o que significa que a investigação com a utilização de animais inteiros continua a ser essencial.

A investigação utilizando animais possibilitou grandes progressos no entendimento da biologia e contribuiu para o desenvolvimento de quase todos os tipos de tratamento utilizados atualmente na prática médica e veterinária. Atualmente, a investigação em animais continua a ser necessária para entender a saúde e a doença humana e animal, e para o desenvolvimento e melhoria de tratamentos para benefício de doentes a nível mundial.

The Italian Research Community asks the European Commission to amend Italian transposition of Directive 2010/63/EU


London, UK – 8th February 2016

Over 37 private and publicly funded Italian organisations, coordinated by EARA’s Italian partner Research4life, have addressed the European Commission in a letter last Friday requesting it to reassess the Italian law on the protection of animals used for scientific purposes.

The Italian legislative decree No. 26 of 4th March 2014 transposes to the Italian law the European Directive No. 63 of 22nd September 2010. The legislative decree 26/2014 introduced unprecedented provisions regarding to 1) the use of animals for xenotransplantation and substances of abuse research (Art. 5, part 2. letter d. and e) 2) the use of animals for training and education in universities (Art. 5, part 2. letter f), 3) breeding cats, dogs and non-human primates (Art. 10, part 5). Continue reading

Заявление в поддержку Директивы 2010/63/EU

Заявление в поддержку Европейской Директивы 2010/63/EU (Директива) о защите животных, используемых в научных целях.

Использование животных в научных исследованиях способствовало основным прорывам в медицине, которые обеспечивают здоровье людей и животных. Мы поддерживаем исследования на животных в тех случаях, когда альтернативные методы недоступны, когда потенциальная польза с точки зрения здоровья несомненна, и когда приемлемые этические стандарты и благополучие животных могут быть обеспечены.

Директива 2010/63/EU ужесточает требования к  благополучию животных и распространяет действие концепций улучшения (refinement), замещения (replacement) и уменьшения (reduction) (3R) на всю Европу, при этом ясно обозначая Европу в качестве мирового лидера биомедицинских исследований. В соответствии с Директивой животные могут быть использованы в исследованиях только в том случае, если медицинские, ветеринарные или научные достижения очевидны и не существует никаких действенных альтернатив. Чтобы исследование с использованием животных было приемлемо с этических и научных позиций и разрешено в соответствии с Директивой, оно должно отвечать высоким стандартам и концепции 3R:

  • Replacement (замещение) – методы, которые позволяют избежать или вовсе отказаться от использования животных;
  • Reduction – методы, которые позволяют уменьшить количество животных, используемых в эксперименте;
  • Refinement – методы, позволяющие избежать страданий животных и улучшить их благополучие.

Продолжается развитие методов, альтернативных использованию животных в экспериментах, таких как использование культур человеческих клеток и компьютерное моделирование, и ученые должны стимулировать этот процесс. Несмотря на это, в настоящее время альтернативы не способны полностью заменить животных в научных исследованиях. Для многих комплексных заболеваний, таких как рак, сердечно-сосудистые заболевания и диабет, которые затрагивают множество органов, мы должны понимать реакцию всего организма, как единого целого, что делает исследования на животных все еще необходимыми.

Исследования с использованием животных обеспечили появление основных достижений в области понимания биологических механизмов и внесли вклад в разработку едва ли не всех методов лечения, используемых в медицине и ветеринарии сегодня. В настоящее время исследования с использованием животных продолжают оставаться необходимыми для понимания здоровья человека и животных и для разработки и улучшения методов лечения пациентов по всему миру.

Statement in support of European Directive 2010/63 features in Lab Animal Europe

The European Animal Research Association (EARA) has published a statement on behalf of leading biomedical research organisations, learned societies, industry representatives, universities and patient groups in Europe in support of Directive 2010/63/EU.

With the Directive being reviewed in 2017 as part of the standard European legislative process, this statement illustrates the continued need for the responsible use of animals in medical, veterinary and basic research and the importance of communicating about the topic.

The statement has been featured in the news section of Lab Animal Europe December’s issue. Lab Animal Europe is the biggest and most widely read magazine in this sector of the research industry.