I am informed by the departments of Health and National Defence as follows:
(a) The Canadian Forces did not indicate on the order forms for the mefloquine to be used on the Somalia deployment that it was for use under the Food and Drugs Act Lariam Safety Monitoring Study or on the Somalia deployment. This type of statement is also not on the initial order form that was addressed to the Ottawa Civic Hospital for the procurement of mefloquine earlier in the safety monitoring study. The order dates were September 9, 11, 14, 15 and 28, 1992 and the drugs were delivered within three working days of the order being placed.
(b) At the time of the transaction, the manufacturer was not required, nor did they inform Health Canada that the mefloquine was being ordered under the authority of the Lariam Safety Monitoring Study, and that this mefloquine was apparently purchased for the Somalia deployment.
Health Canada was informed only after the allegations arose in the media in October 1994, and after investigation and consultation with the manufacturer subsequently.
(c) Health Canada
Health Canada records reveal that the manufacturer did indeed request fast tracking of the new drug submission for Lariam.
Health Canada issued a notice of compliance for Lariam on January 22, 1993. Health Canada is not privy to significant dates related to Canadian Forces activity in Somalia and is therefore unable to comment on the date of approval of Lariam—January 22, 1993, in relation to the end of the Canadian Forces deployment in Somalia.
National Defence
Health Canada's response indicates January 22, 1993, as the date of approval for Lariam. Licensing approval for Lariam was therefore granted prior to the end of the Canadian Forces deployment in Somalia.
(d) The last submission of the safety monitoring study results received by Health Canada prior to marketing approval was on July 17, 1992. The final results of the Lariam Safety Monitoring Study were received from the manufacturer on July 30, 1993 and in August/September 1993, subsequent to marketing approval.
(e) An advisory note was prepared for and passed to the Minister of National Defence in October 1997 which states, with regard to the approval of mefloquine, “there was no intention to mislead the Commission”. However, this document goes on to explain, “Until very recently, it was believed that the Surgeon General Branch had informed Health Canada that mefloquine was being dispensed without the consent of individuals—even the directorate which authorized the use of mefloquine in Somalia was under this misconception”. Consequently, any information the department may have passed to the Somalia commission of inquiry related to the approval of mefloquine would have been based on the assumption that Health Canada and the drug manufacturer had been informed that the Department of National Defence was administering mefloquine outside the boundaries of the manufacturer's study.
Since the advisory note was prepared some four months after the publication of the Somalia commission of inquiry report in June 1997, no action was taken to advise the commission. However, as a result of the misunderstanding experienced with the administration of mefloquine in Somalia, the department implemented several corrective actions to improve monitoring and recording procedures relating to the use of unlicensed products. A regulatory affairs position has been established to serve as a single contact point with Health Canada regarding unlicensed products; procedures for acquisition, distribution, use and recording of unlicensed medical products have been promulgated; detailed drug and vaccine information sheets for health care providers and Canadian Forces members are being prepared; and an adverse effects monitoring and reporting database is being developed.