Directive 2010/63/EU

/Tag:Directive 2010/63/EU

Comments on UK Options for Transposition of European Directive 2010/63/EU

Michael Balls and Michelle Hudson

The British Government’s proposals for the transposition of European Directive 2010/63/EU are discussed under five main headings: direct transposition without major effects on the UK legislation, introduction of stricter requirements in the Directive, retention of stricter controls in the Animals [Scientific Procedures] Act 1986, questions requiring further consideration, and matters of concern. The Home Office had published a consultation on the options in 2011, which resulted in 98 responses from organisations and 13,458 responses from individuals. Our main concerns relate to the use of non-human primates, the annual publication of the UK statistics on laboratory animal use, and the provision of greater transparency on how animals are used, and why. Finally, we conclude that the new Directive and its transposition into the national laws of the Member states provide a renewed opportunity for genuine commitment to the Three Rs, leading to progressive and significant Reduction, Refinement and Replacement.
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2017-01-09T06:38:42+00:00 Tags: |

Abstracts of EUSAAT 2012

Various

Progress in 3Rs Research: EU FP6 & FP7 Projects
Chemicals — REACH and Animal Welfare
7th Amendment of EU Cosmetics Directive
Directive 2010/63/EU and Other Legal and Ethical Topics
3Rs Progress in Other Sectors
Inhalation and Nanotoxicology
3R Goes 3D — Implementation of 3D Methods in Toxicity Testing
Free Communications
21st Century Non-animal Tools For Basic and Biomedical Research
Good Cell Culture Practice
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Editorial: The Increasing Use of Genetically-altered Animals Threatens the Credibility of Directive 2010/63/EU

Michael Balls

The new EU Directive and the equivalent legislation in the EU Member States will be of little value, unless they can bring the production and use of genetically-altered animals under control and lead to a progressive and sustained reduction in laboratory animal use
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2017-01-09T06:38:53+00:00 Tags: |

Editorial: Transparency and Public Accountability on the Use of Non-Human Primates as Laboratory Animals Needs Actions, as Well as Words

Michael Balls

Living up to the promise of greater openness in the application of Directive 2010/63/EU will be very demanding, given the conclusions of an analysis of publicly-available information on NHP use in EU FP7-funded projects.
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An Opportunity to Refocus on the ‘Humane’ in Experimental Endpoints: Moving Beyond Directive 2010/63/EU

Vanessa Ashall and Kate Millar

Humane endpoints are a core refinement concept in animal experimentation. This paper identifies an urgent requirement for individuals and institutions to refocus on humane endpoints as part of the transposition of Directive 2010/63/EU into the national laws of the Member States, and to go beyond their legal construction when setting new guidance or applying humane endpoints in practice. It will be argued that requirements for humane endpoints within the Directive appear not to promote recent advances in best practice, but seem reliant on a narrow and potentially outdated definition of the term. We describe progress that has been made in encouraging change in the construction and application of humane endpoints, and suggest that Directive 2010/63/EU does not sufficiently acknowledge the conceptual complexity of this refinement strategy. For example, a useful development representing recent consensual views of best practice has been proposed by an EU consortium (in 2012). A complex approach to humane endpoints may place additional demands on institutions and raise challenges that would, unfortunately, not need to be overcome in order to remain within the Directive’s current requirements regarding humane endpoints.

We argue that there is now a need for a practical tool to help structure appropriate ethical reflection during research planning and experimentation, in order to facilitate best practice in the application of this important refinement concept.

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Ethical Review of Projects Involving Non-human Primates Funded Under the European Union’s 7th Research Framework Programme

Ursula G. Sauer, Barry Phillips, Kirsty Reid, Véronique Schmit and Maggy Jennings

Internet searches were performed on projects involving non-human primates (‘primates’) funded under the European Union (EU) 7th Research Framework Programme (FP7), to determine how project proposals are assessed from an ethical point of view. Due to the incompleteness of the information publicly available, the types and severity of the experiments could not be determined with certainty, although in some projects the level of harm was considered to be ‘severe’. Information was scarce regarding the numbers of primates, their sourcing, housing, care and fate, or the application of the Three Rs within projects. Project grant holders and the relevant Commission officer were consulted about their experiences with the FP7 ethics review process. Overall, it was seen as meaningful and beneficial, but some concerns were also noted. Ethical follow-up during project performance and upon completion was recognised as a valuable tool in ensuring that animal welfare requirements were adequately addressed. Based upon the outcome of the survey, recommendations are presented on how to strengthen the ethical review process under the upcoming Framework Programme ‘Horizon 2020’, while adequately taking into account the specific requirements of Directive 2010/63/EU, with the aim of limiting the harms inflicted on the animals and the numbers used, and ultimately, replacing the use of primates altogether.

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