Legal and ethical aspects of using animals in research in the EU

Published on December 31, 2015   54 min

Other Talks in the Series: Animal Models in Biomedical Research

0:00
Hello, I'm Judy MacArthur Clark and I'm the Director of the Animals in Science Regulation Unit in the home office in London. My unit is responsible for the regulation of all the use of animals in research in the UK. And as such, we assess people's licenses, we inspect and we have the policy responsibility which relates to the policy in Europe. And today I'm going to talk about legal and ethical aspects of using animals in research in the European Union. Of course, UK is one of 28 member states of the European Union.
0:39
So first of all, I wanted to summarize the European Union regulations very briefly. And the main regulatory piece is European directive 2010/63 and I've given you the reference to the final text of that at the bottom of this slide. This directive replaced the older directive from 1986 and its title is "a directive on the protection of animals used for scientific purposes." It was agreed between member states in November 2010 and as with all European directives, it needed to be accepted by each member state and introduced into the national regulations. So each member state was required to complete that by January 2013. We didn't actually all hit that deadline but all member states now have implemented this directive. So at this stage, this is now applying in all of the European Union. There were three key aims to this new directive which I've listed out here. Firstly, an aim to harmonize the regulations across the European Union, including not just the regulations as to how animals would be used but also the standards of their housing and their care. Secondly, the directive includes very clear promotion of the 3Rs, that is, the replacement, reduction and refinement of the use of animals in research. And thirdly, the directive has an overarching aim of raising standards in animal welfare. So it's not just about harmonizing but also to aiming to raise those standards. And it is now, as I said, effective in all 28 EU member states.
2:20
So, the key elements, very briefly, are that the directive brought in the concept of project authorization in all member states which had not existed previously. And this authorization has to be independently performed. So, it can't just be performed by the establishment where the work's to be done. There has to be a significant degree of independence about how the authorization is done and it has to include a Harm-Benefit Analysis and I'll say a little bit more about that later. The maximum period for authorization is five years. And there is the opportunity for retrospective review, that is, review at the end of project, so at some point during project as to how effectively the 3Rs have been implemented. For certain projects, this is mandatory. The directive also brings in a framework of named persons and committees. And these are really important in terms of how the regulations are being delivered. So there is a named person who's responsible for overall compliance at each institution, there's a veterinarian responsible for advice and animal welfare, named animal care persons and named training and competence officer and a named information officer who has responsibility for ensuring access to relevant information to people working in an institution. So, each institution has to have a structure that provides names for each of those people. Also, each member state has to have a national committee and also each establishment or institution has to have an established animal welfare body. In the UK, we call that an animal welfare and ethical review body. And there are responsibilities for that body laid out in terms of ensuring animal welfare within the establishment. A third component is assurance of training and competence. And the main target here is by setting standards of training competence to achieve free movement within the European Union so that people who've been trained and demonstrated to be competent in one member state can move freely to other member states. There's also standardization of the requirements for statistical collection. And each member state has to report annually on the numbers of animals used within an agreed format and it's quite a detailed format. And it includes the requirement to state the actual severity experienced by each animal used under the regulations during the course of that calendar year. There's also requirement for inspection and a minimum frequency of inspection is specified. So this is inspection of establishments where work is being carried out. So I think that gives you an outline of the key elements. But I think it is also worth mentioning that because the regulations are then detailed into individual member states, there can be quite a lot of variability between the way in which those details work. So it is important to recognize that if you're familiar with the regulations in one member state, that doesn't necessarily provide you with sufficient familiarity of the national regulations in other member states and it's important to familiarize yourself with those national regulations before commencing any work.
Hide

Legal and ethical aspects of using animals in research in the EU

Embed in course/own notes