Dáil question addressed to the Minister for Health (Deputy Stephen Donnelly)
by Deputy Neasa Hourigan for WRITTEN ANSWER on 28/11/2023

To ask the Minister for Health when the harm/benefit analysis of proposed animal experimentation projects are conducted, whether his Department considers the utility of the product to be tested on animals, or the utility of the product a component substance of which is to be tested on animals, as a factor in that harm/benefit analysis; and if he will make a statement on the matter.

Written Answer:
The Health Products Regulatory Authority (HPRA) is the competent authority in respect of the use of animals for scientific purposes within Ireland. Any project on animals conducted in Ireland must be evaluated by the HPRA in accordance with Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes. This legislation is transposed into Irish law by the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 (S.I. No. 543 of 2012).

The Regulations specify that a project can only be authorised:

In accordance with Directive 2010/63/EU the HPRA conducts a harm/benefit analysis on each project application within 40 working days of receipt. The HPRA publishes the results of its analysis of project applications on the European Commission ALURES (Animal Use Reporting - EU System) Non-Technical Summary (NTS) database which has been developed for this purpose.

Dáil question addressed to the Minister for Health (Deputy Stephen Donnelly)
by Deputy Neasa Hourigan for WRITTEN ANSWER on 07/11/2023

To ask the Minister for Health whether his Department will conduct an inquiry into the Royal College of Surgeons in Ireland use of a US institute to conduct animal research not in accordance with Irish or EU regulations; and if he will make a statement on the matter.

Written Answer:

Dáil question addressed to the Minister for Health (Deputy Stephen Donnelly)
by Deputy Neasa Hourigan for WRITTEN ANSWER on 11/09/2023

To ask the Minister for Health the steps taken to ensure batches of botulinum toxin products destined for either non-medical use (i.e. aesthetic purposes) or medical use are identified as such by applicants for animal testing project authorisations and the Health Products Regulatory Authority, in order to ensure accurate harm-benefit analyses and evaluations of proposed projects to test such products on animals under Directive 2010/63/EU and SI No.543 of 2012 (as amended); and if he will make a statement on the matter.

Written Answer:

Dáil question addressed to the Minister for Health (Deputy Stephen Donnelly)
by Deputy Paul Murphy  for WRITTEN ANSWER on 25/04/2023

To ask the Minister for Health his views on the continued use of the LD-50 test on animals given the availability of alternative tests that do not cause suffering to animals; and if he will make a statement on the matter.

Written Answer:
My Department has liaised with officials in the Health Products Regulatory Authority (HPRA) with regard to this question. The HPRA is the relevant government agency with responsibility for the implementation of the legislation on the protection of animals used for scientific purposes.

The validation and regulatory acceptance by EU medicines regulators of non-animal tests as an alternative to the use of the LD-50 test for quality control and safety tests of some medicinal products is welcomed. In line with the legal obligations laid down in Articles 4 and 13 of Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes, approval to use animals for LD-50 testing of certain medicinal products is granted strictly on the basis of robust justification that no non-animal method is available and recognised under EU legislation.

However, there are medicinal products on the market for which as yet, no alternative tests have been successfully validated or been granted regulatory approval as a replacement for the LD-50 test.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Seán Kyne for WRITTEN ANSWER on 11/06/2013

To ask the Minister for Health his stance on measures to ensure that the regulatory framework for Horizon 2020 EU research programmes provides essential funding to advance methods of biomedical research which do not involve the use of animals.

Written Answer:
As the Deputy will know, Ireland is implementing Directive 2010/63/EU on the protection of animals used for scientific purposes which includes the principles of replacement, reduction and refinement. I understand that the recitals to the Framework Regulation for Horizon 2020, as proposed by the Commission, contain the following in paragraph 24 "Research and innovation activities supported by Horizon 2020 should respect fundamental ethical principles. The opinions of the European Group on Ethics in Science and New Technologies should be taken into account. Research activities should also take into account Article 13 TFEU and reduce the use of animals in research and testing, with a view ultimately to replacing animal use. All activities should be carried out ensuring a high level of human health protection in accordance with Article 168 TFEU". Negotiations on the Horizon 2020 Programme are still ongoing between the European Council , the Commission and the European Parliament. It is hoped to have an agreement reached by end June under the Irish Presidency.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Seán Kyne for WRITTEN ANSWER on 11/06/2013

To ask the Minister for Health if he will confirm which national laboratory has been nominated, under Article 47(2) of the EU Directive 2010/63/EU, to assist the European Centre for the Validation of Alternative Methods.

Written Answer:
I would like, at the outset, to clarify that the development and validation of alternative approaches to procedures using animals is a matter that must be addressed on a an EU wide basis. The Irish Medicines Board (IMB) is currently working with the European Commission regarding the identification and validation on alternative approaches that might be developed in the future. In this regard, one area that is being examined by Member States in co-operation with+ the EU Commission is the identification and nomination of suitable, specialist and qualified laboratories to carry out such validation studies. This work is on-going at present.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Seán Kyne for WRITTEN ANSWER on 11/06/2013

To ask the Minister for Health if he will confirm that amount of funding allocated to the development and validation of alternative bioscience research method approaches in 2013 with reference to Article 47 (1) of the EU Directive 2010/63/EU.

Written Answer:
I would wish to draw to the attention of the Deputy that what is proposed under Article 47 (1) is that the Commission and the Member States shall contribute to the development and validation of alternative approaches which could provide the same or higher levels of information as those obtained in procedures using animals, but which do not involve the use of animals or use fewer animals or which entail less painful procedures, and they shall take such other steps as they consider appropriate to encourage research in this field. ~~

A specific amount of funding is not required to be allocated for this purpose in 2013. The recently appointed Competent Authority for the purpose of Directive 2010/63/EU on the protection of animals for scientific purposes, the Irish Medicines Board (IMB) is currently working with the European Commission regarding the identification and validation on alternative approaches that might be developed in the future.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Seán Kyne for WRITTEN ANSWER on 11/06/2013

To ask the Minister for Health if he will confirm that funding amount provided towards the development of non-animal alternative bioscience research methods, knowns as the 3 Rs, replacement, reduction and refinement - in the years 2010, 2011 and 2012 and if he could confirm the proportion allocated to each method.

Written Answer:
The Deputy may wish to note that all project applications in the period referred to in the Deputy's question, that is, 2010 to 2012, involving the use of animals required the application of replacement, reduction and refinement considerations. It would not have been possible for research projects to be licensed by my Department in the absence of such considerations. However, there was no dedicated budget line provided by Government for this purpose.

Dáil question addressed to the Minister for Health (Mr White)
by Deputy Maureen O'Sullivan for WRITTEN ANSWER on 26/03/2013

To ask the Minister for Health further to Parliamentary Question No. 636 of 12 March 2013, which does not include a reference to any specific enforcement activities undertaken by the Irish Medicines Board or his Department to ensure compliance with the EU marketing ban on animal tested cosmetics, the number of cosmetic products that have been surveyed by the IMB in conjunction with Environmental Health Services to ensure their compliance with cosmetics regulations, in particular the prohibitions on the marketing of animal tested cosmetics in regulation 9 of S.I. No. 870 of 2004, since 11 March 2009; the number of reports of EU cosmetics surveillance programmes that have been brought to the Government or IMBs attention since 11 March 2009; the number of cosmetics products to which they refer; if he will describe the detailed protocol for any active surveillance programmes to be performed by the IMB or in conjunction with other agencies to ensure compliance with the full marketing ban on animal tested cosmetics that came into force on 11 March 2013; and if he will make a statement on the matter.

Written Answer:
The European Communities (Cosmetic Products) (Amendment) (No. 3) Regulations 2010 (S.I. 440 of 2010) nominated the Irish Medicines Board (IMB) as competent authority for cosmetics on 1 October 2010. Since then 292 separate cosmetic products have been surveyed by the IMB in conjunction with the HSE, Environmental Health Services. There have been no incidences of breaches of the animal testing ban detected.

Since the IMB assumed the role as competent authority for cosmetics on 1 October 2010, 354 cosmetic products have been brought to the attention of the IMB from EU surveillance reports and there have been no reported instances of breaches of the animal testing ban.

The IMB, in conjunction with the EU Commission and other European Member States, takes a risk-based approach with respect to enforcement of cosmetics legislation, including surveillance programmes, to ensure a high level of public safety. As a notification system operates and there is no pre-approval of cosmetic products in Europe, the regulation of these products primarily involves post-marketing surveillance programmes which are both pro-active and reactive in nature. There is a requirement for a Responsible Person to be designated for each cosmetic product placed on the European market and the Responsible Person must maintain a Product Information File (PIF) relating to each product. This PIF contains all information relating to testing and can be requested for review by the IMB both proactively, as part of a pre-planned surveillance programme, and reactively if there are grounds to suspect a non-compliance.

The PIF must also contain the cosmetic product safety report as specified in Annex I of Regulation (EC) 1223/2009 on cosmetic products, this includes information on the toxicological profile of the substance for all relevant toxicological endpoints and a clear identification of the source of the information. The IMB will be pro-actively reviewing PIFs over the next 12 months for compliance with the implementation of the full animal testing ban as part of a pre-planned surveillance programme. Prior to October 2010 the HSE, Environmental Health Services was responsible for enforcement activities in relation to cosmetics and my Department has requested the Parliamentary Affairs Division of the Executive to arrange to have the statistic compiled for the period March 2009 to October 2010 and to have a reply issued directly to the Deputy.

Dáil question addressed to the Minister for Health (Mr White)
by Deputy Maureen O'Sullivan for WRITTEN ANSWER on 12/03/2013

To ask the Minister for Health the mechanisms and procedures his Department and or the IMB have in place to ensure enforcement of Regulation 9 of SI. 870 of 2004 (European Communities (Cosmetic Products) Regulations 2004) which prohibits the sale of all animal-tested cosmetics here and the rest of the EU from 11 March 2013.

Written Answer:
Regulation 9 of S.I. No. 870 of 2004 which prohibits the marketing of cosmetic products and ingredients that have been tested in animals has been in force for four years, since 11 March 2009, except for a derogation relating to three toxicity checks. On 11 March 2013, this derogation ends, and no further testing on animals of cosmetics or ingredients can take place.

It has been the policy of the Department of Health not to licence the use of live animals for testing of cosmetics in Ireland and this is confirmed by the statistical information provided by the Department to the European Commission under Article 13 of Directive 86/609/EEC, as amended.

Furthermore, there have been no incidences of breaches of this ban detected in ongoing European cosmetic surveillance programmes brought to the attention of the Irish Medicines Board (IMB) or my Department to date.

The relevant Regulations require the manufacturer of the product, the manufacturer’s agent, the person to whose order the cosmetic product is manufactured for, or the person who first supplies the cosmetic product in the European Union, to ensure that cosmetics imported, distributed or retailed in Ireland or the EU comply with the legislation. Enforcement of the legislation is provided for in Regulation 12 of S.I. No. 870 of 2004 and the IMB is the Competent Authority responsible for ensuring that the legislation is complied with.

On 11 March 2013 the EU Commission published a Communication on the animal testing ban. This Communication concluded that the marketing ban should enter into force, be coherently implemented throughout the EU and that the research and development of alternative testing methods for toxicity of cosmetics should be prioritised as part of the EU's trade and international cooperation agenda.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Clare Daly for WRITTEN ANSWER on 12/03/2012

To ask the Minister for Health the number of times his Department authorised concussion and or percussive blow to the head as a permitted method of euthanasia for new-born puppies, kitten, fox cubs and or ferret kits, between 2002 and 1 January 2013; if it occurred without explicit authorisation, the number of young animals that were killed by this method.

To ask the Minister for Health his Department's position in relation to concussion and or percussive blow to the head as a humane method of killing new-born puppies, kitten, fox cubs and or ferret kits; his policy and or that of the Irish Medicines Board on the use of this killing method under SI 543 European Union (Protection of Animals used for Scinetific Purposes) Regulations 2012.

Written Answer:
The Deputy's first question relates to the European Communities (Amendment of Cruelty to Animals Act 1876) Regulations 2002 which were revoked by the European Union (Protection of Animals Used for Scientific Purposes) Regulations 2012. These revised Regulations, which transposed Directive 2010/63/EU on the Protection of Animals Used for Scientific Purposes, came into operation on 1 January 2013 and considerably strengthened the protection of animals still needed for research and safety testing. They also play a significant role in terms of minimising the number of animals used and require that alternatives to animal testing be utilised whenever possible.

The 2002 Regulations transposed Directive 86/609/EEC into Irish law. Under these Regulations, it was a requirement that where an animal was killed, it was done by a humane method. In this context "humane method" is defined as "the killing of the animal with the minimum of physical and mental suffering, depending on the species". From 2007 onwards account was taken of Commission Recommendation (2007/526/EU) on guidelines for the accommodation and care of animals used for experimental and other scientific purposes. This Recommendation set out requirements in relation to humane killing in respect of all species and, where appropriate, more specific requirements were outlined in relation to certain species.

Individual statistical information in relation to the specific humane methods of killing for individual projects was not a requirement under Directive 86/609/EEC and was not, therefore, included in the consequential transposing Regulations. My Department is not aware of any method of killing done as part of a scientific experiment which was conducted without explicit authorisation. If the Deputy is in possession of information that might indicate that this is the case, I would urge you to provide such information to the IMB, which is the Competent Authority in this area.

The new legislation, now in force, sets out a comprehensive range of measures that must be complied with in relation to methods of killing. It requires that where an animal (used or intended to be used in a procedure, or bred specifically so that their organs or tissues may be used for scientific purposes) is killed, the person responsible for the killing shall ensure that the method of killing with the minimum pain, suffering and distress is used, and the animal is killed by a competent person in the establishment of the breeder, supplier or user, as appropriate. Additionally it requires that in the case of the killing of an animal covered by Annex IV to the Directive, the breeder, supplier or user, or other person responsible, shall ensure that the appropriate method of killing as set out in that Annex is used.

The IMB believes that it would be unlikely that newborn puppies or kittens would have been euthanised by way of the methods outlined in the Deputy's question. Any such euthanasia would more likely have been carried out by injection of a lethal dose of barbiturate (i.e. anaesthetic overdose). The IMB policy in relation to the euthanasia of animals used for scientific purposes in establishments that have been authorised in accordance with EU Directive 2010/63/EU is that only those methods that are set out in the Directive should be used. In accordance with Regulation 8(1) of SI No 543 of 2012, which came into effect on 1 January 2013, the method for euthanasia of animals that is used shall be the method where the minimum pain, suffering and distress is experienced.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Clare Daly for ORAL ANSWER on 8/11/2012

To ask the Minister for Health if he will agree to animal welfare advice not to directly transpose a loophole in the ban on inflicting severe and prolonged pain on animals in experiments, article 55.3 of the Animal Experimentation Directive, and instead require the passage of secondary legislation for the licensing of such high levels of harm.

Written Answer:
The matter the Deputy is referring to are the Safeguard Clauses set out at Article 55 of Directive 2010/63/EU on the protection of animals used for scientific purposes. These Safeguard Clauses cover exceptional circumstances in which Member States may, on scientifically justifiable grounds, provisionally authorise applications for derogations relating to a number of restrictions set out in the Directive including authorisation of procedures involving severe pain, suffering or distress that is likely to be long lasting and cannot be ameliorated.

Under Article 55(3), such exceptional provisional measures could, for example, be required to deal with an unexpected outbreak of a life threatening or debilitating clinical condition in humans or an outbreak of an highly infectious pathogenic disease. The Safeguard Clauses would also allow for emergency measures in the event of a natural disaster that resulted in, for example, the contamination of land and livestock.

It will only be possible to introduce any such provisional measure by way of Ministerial Order after consultation with the Irish Medicines Board (the Competent Authority for the purposes of the Directive) and any such measure will be subject to EU Member State and Commission scrutiny and approval. The European Commission, assisted by an Advisory Committee (composed of Member State representatives and chaired by the Commission) must, subsequently, authorise or disallow any such provisional authorisation.

It is clear from the Directive that the replacement, refinement and reduction of animal testing is at the core of this legislation and I strongly endorse this objective. Nevertheless, and even if difficult to foresee, it is my considered view that it is both reasonable and correct to make provision for exceptional emergency situations that might arise, if only to ensure that the necessary legislative tools are available to deal with such an eventuality. The Directive provides Member States with the legislative tools needed to respond in an effective way to such situations. Not to incorporate such tools in our transposition of the Directive might prove to be most regrettable if fate were to take a hand.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Seán Kyne for WRITTEN ANSWER on 13/11/2012

To ask the Minister for Health if he will outline the progress made on the implementation of the EU Directive 2010/63/EU on the use of animals for scientific and medical research purposes; and if he will confirm if the existing Irish primary legislation, which is in many aspects stronger than the provisions of the EU Directive, will be retained ion the process of incorporating the Directive.

Written Answer:
I do not accept that existing measures relating to the protection of animals used for scientific purposes set out in the 1876 Cruelty to Animals Act as amended provide a higher level of protection to those set out in Directive 2010/63/EU. Indeed, I am very much of the view that the new Directive will considerably strengthen the protection of animals still needed for such research and safety testing.

The Directive needs to be considered in its entirety to appreciate the full scope of the protections afforded to animals. These include mandatory provisions that will minimise the number of animals used and require alternatives to be used wherever possible, while ensuring a level playing field for EU industry and enhancing the quality of research conducted in the EU. The "Three Rs" principle of replacing, reducing, and refining animal testing is firmly anchored in the new legislation and I endorse this development.

The new Directive will be transposed into Irish law during November and will become operational from 1 January 2013. I would also like to advise the Deputy that the Irish Medicines Board is to be designated as the Competent Authority for Directive 2010/63/EU. The transposing regulations will set out enforcement provisions, including penalties, that will apply when the provisions of the Directive are not complied with. These penalties will be effective, proportionate and dissuasive.

I would, finally, like to draw the attention of Deputies to the comments of European Environment Commissioner Potocnik who has said that the European Union will, once the Directive is transposed, have the highest standards of experimental animal welfare in the world.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Maureen O'Sullivan for WRITTEN ANSWER on 23/10/2012

To ask the Minister for Health the date on each of the current Certificate Gs, which permit severe and prolonged pain in animal experiments, setting the end of the period in which each Certificate G will be in force; and if he will make a statement on the matter.

Written Answer:
Irish legislation governing the protection of animals used for scientific purposes only allows for the issue of a “G” Certificate in very exceptional circumstances. An application for a “G” Certificate must be signed by statutory signatories and must certify that the proposed experiment is of sufficient importance in terms of meeting the essential needs of human beings or animals to justify issue of such a Certificate.

Both of the “G” Certificates referred to by the Deputy are in respect of research experiments to develop substances to improve neuromuscular transmission for therapeutic purposes – the outcomes of this research will help to develop treatments to improve motor and sensory functions in humans. One of the “G” Certificates expires on 10th July, 2013 and the second “G” Certificate expires on 1st December, 2014.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Patrick Nulty for WRITTEN ANSWER on 16/10/2012

To ask the Minister for Health if he will publish the advice he stated on 3 July 2012 in reply to a previous Parliamentary Question by this Deputy, that he has received from the Department of Health Bioethics Unit regarding transportation of Directive 2010/63/EU relating to animal experimentation; and if he will make a statement on the matter.

Written Answer:
The Bioethics Unit and the Environmental Health Unit in my Department are working together on an on-going basis on the transposition of Directive 2010/63/EU on the protection of animals used for scientific purposes and will continue to do so. As both of these Units are within my Department, this engagement is an on an on-going day-to-day basis and this will continue until the transposition is completed. The Directive is required to be transposed into Irish law by November, 2012 and its provisions will take effect from 1 January, 2013.

It would point out to the Deputy that many of the provisions set out in Directive 2010/63/EU are Mandatory. The Directive strongly promotes the principles of the three Rs (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). The provisions of the new Directive also strengthen the protection of animals still needed for research and safety testing. Significant changes in this regard are requirements to perform ethical evaluations prior to authorisation of projects using animals and higher standards of care and accommodation.

The European Environment Commissioner Janez Potočnik said: "it is vital to improve the situation for animals still needed in scientific research and safety testing, whilst maintaining a high standard of research and improving the focus on finding alternative methods to animal testing”. The Commissioner has also affirmed that the European Union will soon have the highest standards of experimental animal welfare in the world. As indicated by the Commissioner, the transposition of Directive 2010/63/EU will considerably enhance the protection of animals used for scientific purposes.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Clare Daly for WRITTEN ANSWER on 23/10/2012

To ask the Minister for Health if he will consult with experts and stakeholders prior to tabling new regulations in relation to animal testing in view of the fact that the directive gives considerable discretion to national Governments in some key areas such as how animal pain, suffering and distress will be measured.

Written Answer: (with IAVS comments in red)
Directive 2010/63/EU will considerably strengthen the protection of animals still needed for research and safety testing. The Directive will also minimise the number of animals used and require alternatives to be used wherever possible, while ensuring a level playing field for EU industry and enhancing the quality of research conducted in the EU. The "Three Rs" principle of replacing, reducing, and refining animal testing is firmly anchored in the new legislation and I strongly endorse this development.

IAVS comment: With this Directive, the devil will be in the detail. Whether the Directive’s aims are realised will depend on the specific wording of the transposed regulations and how they are implemented in practice. For example, the Directive requires member states to ‘promote’ the 3Rs, but doesn’t specify how. Whether any effective 3Rs promotion takes place in Ireland will depend on whether the Department of Health adopts a strategy, in conjunction with research funders, for the replacement of animal tests, or sets targets for reduction that would drive change. These are discretionary policy decisions that will have a fundamental impact on the outcomes of the new legislation. Verbal endorsements are all well and good, but they must be backed up with tangible policies.

The Irish Anti-Vivisection Society (IAVS) has raised concerns about the level of consultation and scrutiny on the new Directive and about the transposition of Article 55 (Safeguard Clauses).

I cannot accept that consultation on and scrutiny of the Directive has been minimal. My Department sought the views of the public and interested parties in July, 2009 on the proposed Directive and again in October, 2011 in order to inform our transposition of the provisions of the Directive into Irish law. In both cases these public consultations were advertised in the National media and key stakeholder groups were also directly advised of the consultation process. Officials of my Department have met with a range of interested parties (including the IAVS on two occasions) on the Directive.

IAVS comment: The relevant phase is after the finalised Directive text was adopted by the EU – 22nd September 2010. Over a year later, the Department held a consultation, with the request for submissions consisting of a list of ten or so subject headings. Until recently, the Department has given little indication of its detailed proposals of these consultations. The Department is now being more open in the final weeks of drafting, and we welcome this.

On the matter of scrutiny of the Directive, in July 2009, my Department provided an information note to the Joint Committee on European Scrutiny on the then proposed Directive and indicated that the transposition of the Directive would be done by Statutory Instrument in order to ensure that this transposition would be implemented within the allowed timeframe. Failure to do so could delay the considerably enhanced protections the new Directive provides for animals - a circumstance which animal protection organisations would, quite correctly, take issue with. It could also result in EU infringement proceedings against the State during the Irish Presidency of the European Union.

The Joint Committee, after consideration of the proposed Directive, agreed that no further scrutiny was required, given that the aim of the proposal is to improve the existing 1986 Directive and in view of the scope allowed in the Directive for Member States to decide on practical transposition measures.

IAVS comment: Whether the Directive really does deliver enhanced animal protection will depend on the quality of the transposition process. Given the enormous complexity of the Directive, the significant difference each country can make to its effectiveness, and the historic changes it brings to Irish animal experimentation regulation, the IAVS believes that it would have been preferable for the Directive to have been transposed as primary legislation. We continue to call for maximum scrutiny in the Oireachtas, within the limits imposed by the SI process.

Many of the Directives provisions are mandatory. The discretionary Safeguard Clauses set out at Article 55 cover exceptional circumstances in which Member States may, on scientifically justifiable grounds, provisionally authorise applications for derogations relating to a number of restrictions set out in the Directive, including the use of on non-human primates set out in Article 8 and authorisation of procedures involving severe pain set out in Article 15. The European Commission, assisted by an Advisory Committee (composed of Member State representatives and chaired by the Commission) must, subsequently, authorise or disallow any such provisional authorisation.

Such exceptional provisional measures could be required to deal with an unexpected outbreak of a life threatening or debilitating clinical condition in humans or to allow for experiments necessary for the preservation of species. The Safeguard Clauses would also allow for emergency measures in the event of a natural disaster that resulted in, for example, the contamination of land and livestock or the outbreak of an infectious pathogenic disease.

It is clear from the Directive that the replacement, refinement and reduction of animal testing is at the core of this legislation and I strongly endorse this objective. Nevertheless, and even if difficult to foresee, it is my considered view that is both reasonable and correct to make provision for exceptional emergency situations that might arise, if only to ensure that the necessary legislative tools are available to deal with such an eventuality. The Directive provides Member States with the legislative tools needed to respond in an effective way to such situations. Not to incorporate such tools in our transposition of the Directive might prove to be most regrettable if fate were to take a hand.

It will only be possible to introduce any such provisional measure by way of Ministerial Order after consultation with the Irish Medicines Board (the Competent Authority for the purposes of the Directive) and any such measure will be subject to EU Member State and Commission scrutiny and approval.

IAVS comment: Firstly we need to clarify that the Safeguard Clauses are specifically not mandatory for Member States, because of their extreme and controversial nature. The Directive says that countries “may” include this provision. We are disappointed that the Irish Government currently intends to adopt a relatively weak approach to transposition of this most critical of clauses.

We are also concerned that the Minister’s stated intention could inadvertently reverse Ireland’s long-standing ban on the use of non-human primates. This is the first time this has been proposed by the Department throughout the entire transposition process. The IAVS believes the existing ethical prohibition enhances Ireland’s international reputation, we are not aware of any demand within Irish biosciences for such a dramatic weakening of welfare policy, and this is not required by the Directive. We are concerned that careless transposition of Article 55 could re-introduce primate experimentation into Ireland by the back door, and urge the Minister to look again at the matter.

A major problem is that the safeguard clauses actually represent wider loopholes than the Minister suggests: “Scientifically justifiable” is meaningless as an additional threshold as it is supposed to be an essential condition for any animal experiment.

The definition of “exceptional circumstances” is potentially highly subjective, and we’re not sure what it adds to the overall threshold for allowing painful experiments on animals – they are only supposed to be authorised in exceptional circumstances anyway. That’s why there is a special regulatory system for them over and above other methods of research which don’t directly inflict pain and suffering.

The IAVS is opposed, in principle, to the infliction of severe and prolonged pain on any animals in any circumstances. However, we would like to propose, as a practical compromise, a more thorough process for such extreme authorisations.

We note that the UK Government has stated: “There is no requirement to transpose Article 55 as such. If in future it was considered appropriate to invoke any of its provisions it would be necessary to bring forward further secondary legislation and seek the approval of Parliament.”

This is more appropriate because it means there is an extra hoop to jump through – new legislation – before an application to the European Committee to inflict severe and prolonged pain is can be submitted. This provides an essential layer of democratic accountability. In contrast, the Minister indicates that the Irish Government intends to set up a system where they can authorise severe and long-lasting pain prior to an application to the European Union for retrospective permission, without reference to the Dail.

The IAVS therefore requests that the Irish Government adopts a similar approach to the UK Government in this particular matter.

I would, finally, like to draw the attention of Deputies to the comments of European Environment Commissioner Potocnik who has said that the European Union will, once the Directive is transposed, have the highest standards of experimental animal welfare in the world.

IAVS comment: Overall, this is probably the case, but there will be considerable variation between countries because of the considerable room for interpretation in crucial measures such as the ethical evaluation of projects and support for the 3Rs. Where Ireland ranks will depend on the detail of the legislative text and the practical commitment of implementers and Inspectors under the auspices of the Irish Medicines Board.

The new Directive will be transposed into Irish law during November and will become operational from 1 January 2013.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Seán Kyne for WRITTEN ANSWER on 06/03/2012

To ask the Minister for Health if he will consider, within the context of the transposition of Directive 2010/63/EU, to introduce an obligation to use the new non-animal alternatives (details supplied*) for the testing of chemicals and for which the EU granted approval for use last month.

*Details Supplied: Allergan and the non-animal testing alternative, the in-vitro, cell-based assay for use in the stability and potency testing of chemicals

Written Answer:
Directive (2010/63/EU) on the protection of animals used for scientific purposes will strengthen the protection of animals still needed for research and safety testing. The Directive will also play a significant role in minimising the number of animals used and require alternatives to be used where possible, whilst ensuring a level playing field for EU industry and enhancing the quality of research conducted in the EU. The "Three Rs" principle of replacing, reducing, and refining animal testing is firmly anchored in the new legislation and this is something that I strongly support.

I am pleased to be able to inform the Deputy that the IMB has advised the Department that a new non-animal cell-based test method has been approved for the testing of Botox. The test replaces the animal-based LD50 assay for testing of botulinum neurotoxins, an assay method which has been the standard up to now. They further advise that the new test has been validated for use to determine the potency of product for release onto the market and in stability studies and it will result in a significant reduction in the use of animals in testing of Botox. The change in test methods is in line with the overall ‘3Rs’ principles of replacement, refinement and reduction in the use of animals in research testing which is enshrined in the Directive.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Patrick Nulty for WRITTEN ANSWER on 18/04/2012

To ask the Minister for Health the position regarding the regulations covering animal testing for scientific purposes; if he will outline the enforcement regime for said regulations; and if he will make a statement on the matter.

Written Answer:
The use of animals for scientific purposes is strictly controlled in accordance with Council Directive 86/609/EEC and the Cruelty to Animals Act 1876, as amended by the European Communities (Amendment of Cruelty to Animals Act, 1876) Regulations 2002 and 2005. Under this legislation, experiments on animals can only be performed by persons licensed by the Minister for Health and in premises registered for that purpose. Both the licensees and the registered premises must meet specific requirements and standards. The Department of Agriculture, Food and the Marine carries out the necessary inspections of breeders, suppliers and users of animals and their establishments to verify compliance with the regulations. A Memorandum of Understanding has been signed by both Departments formalising arrangements in this regard.

While it is desirable to replace the use of animals in scientific procedures it remains the case that such procedures continue to be necessary to protect human and animal health and the environment. In this regard, a new Directive 2010/63/EU on the protection of animals used for scientific purposes will further strengthen the protection of animals still needed for research and safety testing. The Directive will also play a significant role in further minimising both the number of animals used and the requirement that alternatives be used where possible, whilst ensuring a level playing field for EU industry and enhancing the quality of research conducted in the EU. The "Three Rs" principle of replacing, reducing, and refining animal testing is firmly anchored in the new legislation and this is something that I strongly support. The new Directive will be transposed into Irish law by the end of 2012.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Maureen O'Sullivan for WRITTEN ANSWER on 06/06/2012

To ask the Minister for Health if he amended or withdrew relevant licences to prohibit the animal LD50 assays for testing of botulinum neurotoxins, potency and stability determinations for which the new non-animal cell based test method has been approved by the Irish Medicines Board as a replacement; the date such prohibitions came into force, as required by Section 2 (2)(b) of S1555 (2002); and if he will make a statement on the matter.

Written Answer:
I take it that the Deputy is referring to Section 2(2)(b) of the Cruelty to Animals Act, 1876 which was inserted by Regulation 2(c) of the European Communities (Amendment of Cruelty to Animals Act 1876) Regulations 2002 (S.I. No. 566 of 2002). This sub-section states that “an experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practicably available”

As you will be aware a new non-animal cell based test method has been approved by the Irish Medicines Board (IMB) for the testing of Botox. The IMB advised us that the data submitted by the applicant is confidential and that if another company proposed a similar change, it would need to submit its own variation application with supporting data.

As the new non-animal cell based test method is not available to other companies, the issue of withdrawing current licences involving LD50 tests does not arise. We have informed other companies in this area, however, that such a test exists and encouraged them to develop other similar models.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Maureen O'Sullivan for WRITTEN ANSWER on 06/06/2012

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.

Written Answer:
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.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Maureen O'Sullivan for WRITTEN ANSWER on 03/07/2012

To ask the Minister for Health if he will publish all of the Irish Medical Boards advice to him regarding the replacement non-animal cell-based test for botulinum neurotoxins; and if he will make a statement on the matter.

To ask the Minister for Health if and when Allergan's authorities will carry out animal-based LD50 assays for testing botulinum neurotoxins were amended and withdrawn following confirmation that this represented an alternative to the LD50 assays; and if he will make a statement on the matter.

To ask the Minister for Health what proportion of animal-based LD50 assays for testing of botulinum neurotoxin in Ireland that have ceased as a result of Allergan's switch to a non-animal replacement; and if there were any withdrawal of authorities; and if he will make a statement on the matter.

To ask the Minister for Health if he has explored the possibility of Allergan making their non-animal botulinum neurotoxin test available to companies who continue to perform the animal-based test in Ireland, through licensing of the technology, for example; and the response has he received from other companies still carrying out animal botulinum neurotoxin LD50 tests to his Department's encouragement to develop similar models; and if he will make a statement on the matter.

Written Answer:
A new non-animal cell based test method has been approved by the Irish Medicines Board (IMB) for the testing of Botox. As the Deputy will be aware, this new marketing variation sought by Allergan will enable that company to replace the existing animal based test method with a non-animal method. I welcome this development.

The Deputy also asks if and when Allergan's authorities to carry out animal-based LD50 assays for testing botulinum neurotoxins were amended and withdrawn following confirmation that the non-animal test represented an alternative to the LD50 assays. In this regard, I should point out that the company involved is not a establishment registered under the existing legislation for the performance of scientific experiments on animals. I have no doubt, however, that Allergan will look to have this new non-animal test method with regard to botox testing widely used given the considerable investment involved in the development of the test.

A reduction of LD50 animal testing assay should initially become evident on the publication of the 2012 statistics. It should be noted that as the new non-animal cell based test method is not available to other companies, the issue of withdrawing current licences involving LD50 tests does not arise.

On the matter as to whether Allergan could make their non-animal botulinum neurotoxin test available to companies who continue to perform the animal-based test in Ireland, the IMB has advised my Department that the data submitted by the applicant is confidential and that, if another company proposed a similar change, it would need to submit its own variation application with supporting documentation. It is open to companies in this area to approach Allergan in this regard but I do not consider that it would appropriate for me, as Minister for Health, to intervene in this matter. We have informed other companies in this area, however, that such a test exists and encouraged them to develop other similar models.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Patrick Nulty for WRITTEN ANSWER on 03/07/2012

To ask the Minister for Health the legislative measures, policy actions and targets he intends to implement in order to ensure that the 3 Rs principles of reduction, replacement and refinement of animal experiments are achieved in practice when transposing Directive 2010/63/EU; and if he will make a statement on the matter.

Written Answer:
The new Directive requires that all EU Member States adhere to the principles of the three Rs (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). These provisions are mandatory.

My Department is continuing work on the transposition which will be completed by November 2012. I would also like to advise the Deputy that I have decided that the Irish Medicines Board is to be designated as the Competent Authority for Directive 2010/63/EU. The transposing regulations will set out enforcement provisions, including penalties, that will apply where the provisions of the Directive, including requirements relating to the "Three Rs", are not complied with. These penalties will be effective, proportionate and dissuasive.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Patrick Nulty for WRITTEN ANSWER on 03/07/2012

To ask the Minister for Health the advice he and or his officials have received from the Department of Health Bioethics Unit regarding meeting Ireland's ethical obligations when transposing Directive 2010/63/EU relating to animal experimentation, and any other animal experimentation policy issues; if will he publish such advice; and if he will make a statement on the matter.

Written Answer:
The Bioethics Unit advises on a number of issues across various policy areas in my Department, including the protection of animals for scientific purposes. The Bioethics Unit has engaged with and will continue to engage with officials in my Department who have been assigned the task of transposing Directive 2010/63/EU on the protection of such animals. Directive 2010/63/EU will be transposed into Irish law by the end of the year and the improved protections for animals set out in the Directive will take effect from 01 January 2013.

It should be noted that many of the provisions set out in Directive 2010/63/EU are Mandatory. The Directive strongly promotes the principles of the three Rs (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). The provisions of the new Directive also strengthen the protection of animals still needed for research and safety testing. Significant changes in this regard are requirements to perform ethical evaluations prior to authorisation of projects using animals and higher standards of care and accommodation.

Dáil question addressed to the Minister for Health (Deputy James Reilly)
by Deputy Patrick Nulty for WRITTEN ANSWER on 04/07/2012

To ask the Minister for Health his views on the submissions made to the public consultation exercise held by his Department in October-November 2011 regarding transposition of Directive 2010/63/EU relating to animal experimentation; and if he will make a statement on the matter.

Written Answer:
My Department undertook two public consultations with regard to the Directive on the protection of animals used for scientific purposes. The first consultation took place in July 2009 following the publication of the proposed Directive in November 2008. Responses to that public consultation informed Ireland's position in the subsequent negotiations at EU level. The second public consultation took place in October 2011 following the adoption by the European Parliament and the Council of Directive 2010/63/EU on the protection of animals used for scientific purposes. Responses to this second public consultation are informing my Department's ongoing work on the transposition of the Directive into Irish law. This task must be completed by November of this year.

Directive 2010/63/EU strengthens the protection of animals still needed for research and safety testing. Significant changes in this regard are requirements to perform ethical evaluations prior to authorisation of projects using animals and higher standards of care and accommodation. The Directive also strongly promotes the principles of the three Rs (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). Many of the provisions are mandatory.

I appreciate the time and effort devoted by individuals and organisations in their response to both public consultations. The submissions received in response to the first consultation were particularly welcome as the Directive was still under discussion at that stage. The second public consultation, of necessity, had a different focus given that the Directive was already finalised at that stage and most of its provisions are mandatory. The responses to the second public consultation are, consequently, primarily focused on the nuts and bolts of the transposition process itself and are of particular assistance to the Department in this regard.