Dáil debates

Wednesday, 11 December 2013

Ceisteanna - Questions - Priority Questions

Defence Forces Medicinal Products

9:50 am

Photo of Seán Ó FearghaílSeán Ó Fearghaíl (Kildare South, Fianna Fail)
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4. To ask the Minister for Defence if, with regard to the Safety, Health and Welfare at Work Act 2005, the Defence Forces sought or conducted a medical risk assessment of lariam; and if he will make a statement on the matter. [53120/13]

Photo of Seán Ó FearghaílSeán Ó Fearghaíl (Kildare South, Fianna Fail)
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This relates to the issue of lariam, which is an issue that I and other colleagues have raised before and I am sure we will continue to raise it in the period ahead. We are trying to ascertain if medical risk assessments have been carried in respect of those members of the Defence Forces who have had lariam prescribed to them.

Photo of Alan ShatterAlan Shatter (Dublin South, Fine Gael)
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The Safety, Health and Welfare at Work Act 2005 does not apply to Defence Forces personnel when they are on active service. Nevertheless, I am informed by the military authorities that risk assessments are carried out for all mission areas. These risk assessments are intended to identify all hazards that might exist in a mission area, including health risks. Suitable control measures are then put in place to minimise identified risks. Where a health risk is identified, the control measures will include preventative medication where appropriate. Where malaria has been identified as a risk, the choice of chemoprophylaxis is dependent on a number of factors, including the type of malaria in the destination, resistance to particular drugs, the profile of the traveller - contra-indications, underlying health conditions, purpose of travel - the duration of travel and adherence issues. The choice of medication is a medical decision made by medical officers in the Defence Forces on the basis of best international practice having regard to the specific circumstances of the mission and the individual member of the Defence Forces.

As the Deputy knows, the Irish Medicines Board is the statutory authority with responsibility for the quality, safety and efficacy of medicines for use in Ireland. The Defence Forces comply with Irish Medicines Board guidelines on the prescription of medicines, including lariam. I am advised that Lariam is one of the most effective medications for protection against the type of malaria prevalent in sub-Saharan Africa. It continues to be licensed by the Irish Medicines Board. I am further advised the Defence Forces are fully aware of the range of reported side effects attaching to all anti-malarial medications. Protocols are in place to control the risk of side effects in individuals. Malaria is a serious disease that kills approximately 1 million people per year in sub-Saharan Africa alone. It is a serious threat to any military force operating in the area and lariam must remain in the formulary of medication prescribed by the medical corps for Defence Forces personnel on appropriate overseas missions, particularly those in sub-Saharan Africa, to ensure that our military personnel can have effective protection from the very serious risk posed by this highly dangerous disease.

Photo of Seán Ó FearghaílSeán Ó Fearghaíl (Kildare South, Fianna Fail)
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On 9 October 2009 and 6 July 2010, the director of administration wrote to express serious concern about this issue of risk assessment.

Specifically he suggested the Safety, Health and Welfare at Work Act 2005 needs to be adhered to and a medical risk assessment needs to be carried out because of genuine concerns about the use of lariam. A similar concern was expressed on 6 July when he wrote to the Defence Forces Medical Corps. The Minister stated risk assessments have been carried out. Will the risk assessments be published and if so when?

10:00 am

Photo of Alan ShatterAlan Shatter (Dublin South, Fine Gael)
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In the context of the issue raised by the Deputy I want to be absolutely clear. The Defence Forces follow best international practice in prescribing lariam. Personnel are screened for illness and medical suitability for service overseas. This automatically rules out from overseas service personnel with certain conditions, for example, depression, anxiety, pregnancy and neurodegenerative disorders which, as has been indicated by the Irish Medicines Board, are more likely to precipitate serious adverse reactions to lariam. The medical screening also involves an assessment of the individual's suitability to be prescribed the selected chemoprophylactic anti-malarial agent in line with Irish Medicines Board guidelines. These guidelines are available to anyone who wishes to obtain them. This typically involves a review of the individual's previous experience, if any, with the medication. The individual's medical history is also screened for these conditions which have been identified as precipitating serious side-effects in association with the medication. Each individual screened for G6PD status, which is an enzyme required to metabolise primaquine, an agent used on return to Ireland to clear the liver of any dormant parasites. In the case of lariam, blood tests are carried out to ensure the liver is healthy, as liver disease is an accepted contraindication to the use of lariam. Personnel are screened before and after deployment.

Photo of Seán Ó FearghaílSeán Ó Fearghaíl (Kildare South, Fianna Fail)
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The question is very simple. Will the Minister publish the risk assessments? I have a sense of growing concern about this issue. When I initially raised it I wanted to be reassured by the Minister that everything that should be done was done. We have tabled a series of questions which have elicited very little by way of answer. We asked the Minister the medical experts who advised the Minister and the Department of Defence and their qualifications. We were told this information was legally privileged. Any group which comes together to advise a Department can hardly claim privilege in the circumstances. The medical risk assessment is based on the 2005 Act. Is the Minister claiming this is legally privileged and if so, how can he do so?

Photo of Alan ShatterAlan Shatter (Dublin South, Fine Gael)
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The only matter the Deputy knows is legally privileged is the report obtained with regard to lariam in the context of litigation pending before the courts taken against the Department of Defence. My recollection is much of the litigation arises from a time when the Deputy's party was in government and the members of the Defence Forces were serving at that time. It was the Deputy's colleague who was Minister for Defence who explained, as I am explaining in the House, the circumstances in which lariam is prescribed, the assessment necessary of individual personnel prior to the prescribing of lariam and the checks required to be undertaken on their return from duty. The issue of the safety of lariam in the State and the appropriateness of its being prescribed is a matter uniquely within the competence of the Irish Medicines Board. As Minister for Defence I will not second-guess the expertise of the Irish Medicines Board. It would be completely inappropriate for me to do so.

Photo of Seán Ó FearghaílSeán Ó Fearghaíl (Kildare South, Fianna Fail)
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The Minister did not answer the question.