Alan Shatter (Dublin South, Fine Gael)

I propose to take Questions Nos. 9, 15, 18, 20, 22 and 25 together.

Malaria is a serious disease which can cause severe complications and death. It is estimated by the World Health Organisation that approximately 1 million people die every year from the disease in sub-Saharan Africa alone. It has long been recognised as a serious threat to any military force operating in a malarious area.

Lariam is a malaria chemoprophylactic agent first authorised for use in 1989 by the Irish Medicines Board, IMB, which is the statutory regulatory body charged with regulating the use of medicines in Ireland to ensure their quality, safety and efficacy. Research has shown that it is one of the most effective medications for protection against the type of malaria prevalent in sub-Saharan Africa. While certain risks associated with the use of the drug were highlighted in FDA drug safety newsletters in 1996 and 2003, the IMB remains of the view that the benefit-risk profile for the product was acceptable. The IMB continues to review the safety of this and all medicines on an ongoing basis and updates the product information as appropriate. Lariam remains the medication of choice for the Defence Forces for missions to sub-Saharan Africa and continues to be certified by the IMB.

In accordance with best international practice in prescribing Lariam, and taking account of the contraindications, warnings and side effects highlighted by the IMB, the Defence Forces screen all personnel for medical suitability. The screening system rules out staff with certain conditions, including depression, anxiety and neurodegenerative disorders, from overseas services. These are the conditions which, as has been indicated by the IMB and other regulatory bodies worldwide, are more likely to precipitate serious adverse reactions to Lariam. In addition, personnel who are found suitable for Lariam are obliged to commence their medication three to four weeks in advance of their travel. This precaution allows a slow build-up of the medication in the bloodstream and also permits assessment by the person of his or her individual reaction to the medication while still in Ireland. Personnel are screened both before and after deployments and all necessary actions are taken to ensure that those with contraindications to Lariam use are not prescribed the medication.

It should be noted that the primary area of operations for United States forces is currently Afghanistan. Neither the United States army nor the Irish Defence Forces recommend Lariam as a first-line malaria chemoprophylaxis for Afghanistan. Another factor to consider is that while the United States military engaged in mass prescribing, the Defence Forces, in accordance with the prescribing instructions, consider each individual case.

I am advised by the military authorities that three members of the Defence Forces displayed a serious symptomatology which may have been caused or contributed to by Lariam, although there is nothing conclusive in this regard. I am also advised that all three personnel made a full recovery and their cases were reported to the IMB. I am further advised by the director of the Defence Forces medical corps that he is unaware of any suicide by a member of the Defence Forces linked to Lariam.

No personnel have been discharged because they were below Defence Forces medical standards as a result of taking Lariam. I am informed that the number of personnel deemed unsuitable for Lariam due to contraindications cannot be quantified without an examination of every medical file, which would be impractical. Likewise, the number of personnel to whom Lariam was administered cannot be accurately established without an examination of every file. I have asked the military authorities to provide an estimate of this number based on the number of personnel who served on certain missions.

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