I can confirm that Directive 2010/63/EU on the protection of animals used for scientific purposes has been transposed into Irish law during December 2012 by the European Union (Protection of Animals Used for Scientific Purposes) Regulations 2012, which considerably strengthens the protection of animals still needed for research and safety testing, that came into operation on 1 January, 2013.
Significant changes that are provided for in the transposition of this Directive include a requirement to perform detailed project evaluations prior to authorisation of projects using animals and higher standards of animal care, welfare and accommodation. The Directive plays a significant role in minimising the number of animals used and requires that alternatives to animal testing be used where possible, whilst ensuring a level playing field for EU industry and enhancing the quality of research conducted in the EU.
The Directive also strongly promotes the principles of the three R’s (replacement of the use of animals to the greatest extent possible with alternative testing methods, refinement of scientific procedures to improve animal welfare, and reduction in numbers of animals used). It should be noted that many of the provisions set out in Directive 2010/63/EU are mandatory. The European Environment Commissioner affirmed that the European Union will, once the Directive is transposed, have the highest standards of experimental animal welfare in the world.
In the aforementioned Regulations, I decided not to transpose Article 42 which provides for a simplified administrative procedure for certain types of projects. My decision in this regard is based on my determination to ensure a high level of protection for all animals that still need to be used for scientific purposes. A simplified procedure along the lines of Article 42 would, in effect, have introduced a two-tiered system, one requiring full project authorisation and another which would undermine that authorisation system. As a consequence of my decision not to introduce any such simplified system all projects using animals for scientific purposes are subject to the full project approval and authorisation requirements set out in the Directive.
The approval of projects and of key individuals involved in those projects and of the establishments where they are carried out is a matter for the Irish Medicines Board (IMB) which I have designated as the Competent Authority (CA) for the purposes of the Directive. My decision to assign CA functions to the IMB takes into account the fact that replacement and refinement of experimental studies to minimise the use of animals is a central tenet of the Directive. This requires an up-to-date knowledge of such alternative methods and tests as well as the authority to require the use of such alternatives, where possible, by those currently using animals. This work requires the employment of persons with veterinary expertise specialising in laboratory animal welfare to evaluate scientific projects and to oversee compliance with Directive requirements. Such specialists are also expected to be able to offer detailed regulatory advice to those involved in the industry. The IMB has the relevant expertise in relation to both human and veterinary medicine to assist it in undertaking this regulatory work and in ensuring that the three R’s remain central to this area of work in the years ahead.
I should also point out that any project involving severe pain or suffering is automatically subject to a full retrospective assessment by the competent authority. It is also open to the IMB to retrospectively assess any other project carried out under this Directive. Significant enforcement powers have been included in the transposing statutory instrument to enable the IMB to examine any possible breaches of the legislation and the transposition also provides for significant penalties where serious infringements are identified.
