It explains that, whilst the Commission does share the conviction that animal testing should be phased out in Europe, it does not intend to submit a proposal to repeal Directive 2010/63/EU on the protection of animals used for scientific purposes and is not intending to propose the adoption of a new legislative framework. In a nutshell, the reasons given are the following:
The complete replacement of animal testing is currently not possible while needing to ensure a high level of protection of human and animal health and the environment.
The Directive is needed to ensure a high level of protection of the animals used in research.
At the same time, Directive 2010/63/EU is the catalyst for the development and uptake of alternative approaches. The use of animals in research actually provides a mechanistic understanding of the biology of animals and humans, which enables the development of more ethical, cost-effective, predictive and faster alternative methods.
The Communication sets out a number of actions that the Commission will take towards the goal of phasing out animal testing. These include the development, validation and implementation of new alternative approaches.
The Commission reiterates its intention to continue to promote the development and implementation of alternative approaches for regulatory and research use. This will include close cooperation between the Commission, Member States and international organisations and be supported, as appropriate by EU programmes.
When talking about the alternatives, the report refers to “computational tools to analyse biological processes and to simulate the complex mechanisms involved in health and disease” as “technological advances have revolutionised biomedical research” and may contribute to reduce animal testing.
Phasing out animal testing – Other foreseen actions
1. Accelerating progress in the Three Rs (the requirement to Replace, Reduce and Refine the use of animals wherever possible) through knowledge sharing: The Commission will analyse technologies, information sources and networks from all relevant sectors with potential impact, and will present by end 2016 an assessment of options to enhance knowledge sharing among all relevant parties.
2. Enforcement of compliance with the Three Rs principle and alignment of relevant sector legislation: The Commission will actively monitor compliance with the Directive, in particular the Three Rs principle, and with the relevant obligations in sector legislation to use available alternatives. The Commission will also actively monitor the correct enforcement by all Member States.
By end 2016, the Commission will examine regulatory requirements in the relevant sector legislation mandating animal testing to assess if the legislative text enables an efficient up-take of available alternative approaches and the Commission will ensure that future proposals for relevant sector legislation will reflect the rules on the protection of animals used for scientific purposes.
The Commission plans to review it in 2017 and will emphasize the availability of alternative approaches. In addition, the Directive requires an implementation report in 2019. These reports will be the first assessments of the extent to which the Directive is reaching its objectives.
3. Engaging in a dialogue with the scientific community: By end 2016 the Commission will organise a conference engaging the scientific community and relevant stakeholders in a debate on how to exploit the advances in science for the development of scientifically valid non-animal approaches and advance towards the goal of phasing out animal testing. On that occasion it will present a progress report on the actions taken.
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