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Vol. 137, No. 27 — December 31, 2003 Registration CONTROLLED DRUGS AND SUBSTANCES ACT Order Amending Schedule III to the Controlled Drugs and Substances ActP.C. 2003-1990 11 December, 2003 Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 60 of the Controlled Drugs and Substances Act (see footnote a) , deeming that it is necessary in the public interest, hereby makes the annexed Order Amending Schedule III to the Controlled Drugs and Substances Act. ORDER AMENDING SCHEDULE III TO THE CONTROLLED DRUGS AND SUBSTANCES ACT AMENDMENT 1. Schedule III to the Controlled Drugs and Substances Act (see footnote 1) is amended by adding the following after item 31: 32. Amineptine (7-[(10,11-dihydro-5H-dibenzo[a,d]cyclohep ten-5-yl)amino]heptanoic acid) and any salt thereof COMING INTO FORCE 2. This Order comes into force on the day on which it is registered. REGULATORY IMPACT (This statement is not part of the Order.) Description The purpose of this regulatory initiative is to add the substance amineptine to Schedule III to the Controlled Drugs and Substances Act (CDSA), and to Part I of Part G to the Food and Drug Regulations (FDR) to meet the requirements of the United Nations' Convention on Psychotropic Substances, 1971 (1971 Convention). Amineptine is a synthetic, atypical tricyclic antidepressant with central nervous system (CNS) stimulating effects. The United Nations Commission on Narcotic Drugs (CND), on the recommendation of the World Health Organization (WHO), decided to include amineptine in Schedule II of the 1971 Convention. Notification of this decision was provided to countries in July 2003. Canada acceded to the 1971 Convention in 1988, and as such, has an obligation to control amineptine in accordance with the international requirements set out in this agreement within 180 days of receipt of the notification. Amineptine is not presently approved for market in Canada nor is it marketed in the United States. It has been marketed in 66 countries within Europe, Africa, Asia, and South America, however, during 1999, the manufacturer began to voluntarily discontinue the marketing of amineptine due to its dangerous side effects, which include hepatotoxicity and dependence. In its assessment of amineptine, the WHO concluded that given its significant hepatotoxicity, the degree of risk to public health and society associated with the abuse liability of amineptine is assessed to be substantial. The WHO rated the therapeutic usefulness of amineptine to be from little to moderate, at best. Despite its withdrawal from the market in several countries, amineptine continues to be available in a number of countries. The likelihood of its abuse therefore warrants its placement under international and domestic control to protect the health and safety of Canadians. The 1971 Convention was developed to, among other things, improve global and national measures aimed at curtailing the abuse and trafficking of psychotropic substances, while ensuring that their use for legitimate medical and scientific purposes is not unduly restricted. It contains graded requirements attached to four schedules (Schedules I to IV), each associated with distinct control measures based on the dependence potential and abuse liability of substances and their degree of usefulness in medical therapy. The most stringent requirements pertain to substances in Schedule I that have a high dependance potential or abuse liability, but little or no therapeutic application. Substances in Schedule IV, on the other extreme, have a lower dependance potential and/or a higher degree of usefulness in medical therapy. The CDSA provides a legislative framework for the control of substances that can alter mental processes and that may produce harm to the health of an individual and to society when diverted or misused. Except as authorized under its related regulations, activities including the possession, possession for trafficking, trafficking, importation, exportation, possession for exporting and production of controlled substances are prohibited under the CDSA. The substances controlled under the CDSA are grouped into eight schedules (Schedules I to VIII). Schedules I to VI list the controlled substances. Schedules VII and VIII specify amounts of substances in Schedule II (i.e., Cannabis and Cannabis resin) associated with milder penalties. Each schedule is associated with particular offences and punishments described in Part I of the Act. Schedules I, II and III are subject to the same offences with varying punishments. These offences include: possession, trafficking, possession for the purpose of trafficking, importation, exportation, possession for the purpose of exportation, and production. The offences for Schedule IV are similar to those of Schedules I, II, and III except that there is no offence for simple possession. The offences for Schedules V and VI are: importation, exportation and possession for the purpose of exportation. Part G of the FDR derives its legislative authority from the CDSA, and governs the activities of producers, distributors, importers, exporters, health care professionals, and hospitals related to controlled drugs (e.g., stimulants, sedatives, and androgenic anabolic steroids). Alternatives The 1971 Convention places certain obligations on Canada regarding the control of psychotropic substances. Only placement in the schedules to the CDSA will satisfy the requirements of the 1971 Convention. Failure to meet these international obligations could result in compliance actions under article 19 of the 1971 Convention. Article 19 includes provisions for imposition of trade sanctions in respect of controlled drugs and substances being exported to Canada. Options for CDSA Schedule In determining in which schedule to the CDSA a substance should be listed, Health Canada considers several factors including: international requirements, the dependence potential and likelihood of abuse of the substance, the extent of its abuse in Canada, the danger it represents to the safety of the public, and the usefulness of the substance as a therapeutic agent. Substances listed on Schedule II of the 1971 Convention are generally found in Schedule III to the CDSA. Placement of amineptine in Schedule III of the CDSA is, therefore, consistent with the treatment in Canada of other stimulant drugs which are subject to abuse and listed in Schedule II of the 1971 Convention. For this reason, no alternatives were considered. Listing in Schedule III to the CDSA allows for a simple possession charge to be laid, which serves as an added deterrent to non-medical use, and a tool for law enforcement to address situations of illicit use. Options for Regulatory Control Substances listed in Schedules III and IV of the CDSA are generally regulated under one of three sets of regulations under the CDSA: Part G of the FDR, Part J of the FDR or the Benzodiazepines and Other Targeted Substances Regulations (Targeted Substances Regulations). Different levels of control measures are found within the various regulations which impact on licensed dealers, pharmacists, practitioners, and hospitals. Part J of the FDR regulates the use of controlled substances with no recognized medical use; substances listed in the schedule to Part J of the FDR are defined as "restricted drugs" and include such substances as LSD and mescaline. Controlled substances included in CDSA Schedules III and IV that have some therapeutic use are regulated either under Part G of the FDR or the Targeted Substances Regulations with the former having more stringent controls over distribution. Although limited by its abuse potential and hepatotoxicity, amineptine has been demonstrated to have some therapeutic value; it may, therefore, be overly restrictive to include it in the schedule to Part J of the FDR. It functions as a stimulant, a common characteristic shared by many of the substances listed in the Part I of the schedule to Part G to the FDR. Regulation of amineptine under Part I of Part G of the FDR would therefore be consistent with the existing regulatory framework, provide adequate protection for the Canadian public, and meet the requirements of the 1971 Convention. Benefits and Costs The benefits of this initiative are expected to outweigh any costs by a significant margin. The control measures to be imposed by this amendment will help protect the public and social health of Canadians through reduced risk of diversion. Additionally, the controlled status of amineptine should promote increased awareness of its high dependence potential and abuse liability. There should be no negative impact on the Canadian pharmaceutical industry as a result of this amendment because amineptine is not currently marketed in Canada. With the availability of safer alternatives and the identified risks associated with amineptine, it is unlikely to be marketed in Canada in the future. However, scheduling under the CDSA and Part I of Part G to the FDR will not be an obstacle should, in the future, amineptine be found to have some legitimate scientific or medical benefits that outweigh its risks. Applicable regulatory requirements for licensing, security and record-keeping will ensure that supplies are distributed within legal channels thereby minimizing the risk of misuse and diversion. This initiative will provide enforcement agencies with the tools that are necessary to combat illegal possession, trafficking, production, importation and exportation of amineptine. Enforcement agencies may incur limited additional costs due to enforcement activities. The benefits to society derived from these amendments will, however, clearly outweigh these limited costs. These amendments will allow Canada to fulfill its international obligations thereby avoiding any damage to Canada's international reputation and possible compliance action by the United Nations. Consultation No objections to this regulatory initiative are anticipated. Stakeholders, including the following, will be notified directly of the registration and publication of this amendment in the Canada Gazette: the pharmaceutical industry including licensed dealers, pharmaceutical associations, deans of Pharmacy, Medicine, Dentistry and Veterinary Medicine, Provincial and Territorial Ministries of Health, Registrars of Pharmacy, Medicine, Dentistry and Veterinary Medicine. Compliance and Enforcement This regulatory initiative does not alter existing compliance and enforcement mechanisms under the provisions of the CDSA and its related regulations. A person conducting activities outside of those authorized could be subject to the penalties defined in the CDSA. Should, in the future, amineptine be approved and marketed for therapeutic use, periodic inspections and review of information required to be maintained or submitted under the FDR will be used by Health Canada to monitor compliance of licensed dealers, practitioners, pharmacists and hospitals. Customs officials will be able to assist in monitoring compliance with requirements for import and export of this drug. Failure to comply with the Regulations could lead to administrative sanctions such as revocation of a licence or permit. Contact
Shereen Khan
S.C. 1996, c. 19 S.C. 1996, c. 19 |
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