Paul Kehoe (Wexford, Fine Gael) | Oireachtas source

I propose to take Questions Nos. 8 and 26 together.

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

Lariam is a malaria chemo-prophylactic 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 to ensure the quality, safety and efficacy of medicines available in Ireland. Research has indicated that it is one of the most effective medications for protection against the type of malaria prevalent in sub-Saharan Africa. Whereas certain risks associated with the use of the drug were highlighted in drug safety newsletters in 1996 and 2003, the IMB remained of the view that the benefit-risk profile for the product remained 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 contra-indications, warnings and side-effects highlighted by the IMB, the Defence Forces screen all personnel for medical suitability. The screening system rules out personnel from overseas service with certain conditions, such as depression, anxiety and other disorders which, as has been indicated by the IMB and other regulatory bodies worldwide, are more likely to precipitate serious adverse reactions to Lariam.

In the case of overseas missions to malarious areas, the medical screening involves a one-on-one assessment of the individual’s suitability to be prescribed the selected anti-malarial agent in line with current IMB guidelines. 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 those conditions which have been identified as precipitating serious side-effects in association with the medication. In addition, blood tests are carried out to ensure the liver is healthy, as liver disease is an accepted contra-indication to the use of Lariam.

It is the policy of the Defence Forces medical corps that personnel found suitable for Lariam should 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 it also permits assessment by the person of the 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 those with contra-indications to Lariam use are not prescribed the medication.

To date, legal proceedings have been served against the Minister for Defence in five cases concerning the prescription of Lariam. These claims are being managed by the State Claims Agency in conjunction with the Chief State Solicitor's office. Given that legal proceedings have been served, the Deputy will appreciate that it would not be appropriate to comment further on individual cases.

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