Maureen O'Sullivan (Dublin Central, Independent)
Link to this: Individually | In context

Question 825: To ask the Minister for Health if the two Certificate Gs listed in the 2010 statistics for the number of animals used in experimental and other scientific purposes are the same ones as recorded in the 2009 Statistics; if the G Certificates cover all LD50/LC50 procedures as enumerated at column 7.2.1 of the Statistics in 2009 and/or 2010; if other types of procedures are permitted under these G certificates; in relation to approving the Certificate Gs listed in the 2009/2010 statistics, what was the argument accepted by his Department as to the reason the object of any such experiment will be necessarily frustrated unless the animal may experience pain that is likely to be prolonged; will Certificate G procedures, which are defined as potentially causing animals severe and prolonged pain, be prohibited as a result of the transposition of Article 15(2) of Directive 2010/63/EU which forbids procedures that involve severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated; and if he will make a statement on the matter. [26779/12]

James Reilly (Dublin North, Fine Gael)
Link to this: Individually | In context

I can confirm that the two "G" certificates referred to in the 2010 statistics are the same ones listed in the 2009 statistics. Typically, licences are held for 5 years so these certificates will also be recorded in subsequent years.

"G" certificates are issued on a case-by-case basis and are issued only in exceptional circumstances where the project is of sufficient importance for meeting the essential needs of human beings or animals.

All LD50/LC50 tests would not necessarily require a "G" certificate. The two certificates that have been issued relate to two current licences in respect of the same project. The aim of this project is to develop substances to improve neuromuscular transmission for therapeutic purposes.

Directive 2010/63/EU will be transposed into Irish law by the end of 2012 and from that date onwards, the existing certification process will no longer operate. Article 15 of the 2010 Directive, as you have pointed out, forbids procedures that involve severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated. In addition, under the new national legislation, the National Competent Authority will perform a project evaluation including a harm/benefit analysis of the project, to assess whether the harm to the animal in terms of suffering, pain and distress is justified by the expected outcome taking into account ethical considerations and may ultimately benefit human beings, animals or the environment.

I would like to advise the Deputy that I have informed the Chairman of the Irish Medicines Board of my intention to designate the Board as the National Competent Authority for Directive 2010/63/EU and to have responsibility for those other functions of the Directive necessary for its implementation.