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 | | WHO Regional Committee for AfricaAddis Ababa, Ethiopia
Statement by Dr. Philip O. Emafo,
8.5 Medicines regulatory authorities: current status and the way forwardMr. Chairperson, Excellencies, Ladies and Gentlemen, The provisions of the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol, the Convention on Psychotropic Substances, 1971 and the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 form the basis for international drug control. The main objective of these international drug control treaties is to limit the manufacture and use of narcotic drugs and psychotropic substances to an adequate amount required for medical and scientific purposes, to ensure their availability for such purposes and to prevent their illicit manufacture, trafficking and use. The international drug control treaties have been ratified by very many countries. However, a few countries have yet to ratify them. In Africa, Equatorial Guinea is not a party to any of the international drug control conventions. Liberia is not yet a party to the 1971 Convention and Chad is party to the 1961 Convention but not to the Convention as amended by the 1972 Protocol. Gabon, Namibia and Somalia have not yet ratified the 1988 Convention. The International Narcotics Control Board (INCB) urges those countries to take steps to become party to the Conventions as soon as possible, so as to assist the international community in its drug control efforts. In addition to ratifying the 1961, 1971 and 1988 Conventions, Governments are required to take appropriate legislative and administrative measures to give effect to and carry out the provisions of those treaties. A pre-requisite for the rational use of narcotic drugs and psychotropic substances in any country is the existence of a well-managed health care system that is complemented by an efficient drug regulatory authority. Such a system ensures that the right patient receives the right drug in the right dose at the right time and that the medication is prescribed by an appropriate professional. It also ensures that drugs are not diverted from licit sources Mr. Chairperson, The INCB monitors the control of narcotic drugs and psychotropic substances at the national level through the analysis of reports submitted to it by Governments, in accordance with their treaty obligations, as well as by United Nations Economic and Social Council (ECOSOC) resolutions. The timely submission, the comprehensiveness and accuracy of reports submitted to the Board by Governments reflect to a large extent the commitment of Governments to drug control measures at the national level. The Board is concerned that out of the 53 countries in Africa, 20 countries failed to submit for confirmation by the Board their estimates of annual medical requirements for narcotic drugs for 2006. In such circumstances, the Board establishes estimates for essential narcotic drugs for those countries. A situation that is not entirely satisfactory. Several African countries also appear to be experiencing difficulties in submitting mandatory statistical information on narcotic drugs to the Board. For example, 11 countries failed to furnish their annual statistics on narcotic drugs for 2004 to the Board. The cooperation of countries in Africa with the Board in respect of submission of annual statistical reports on psychotropic substances remains poor. 26 countries did not submit such reports for 2005. In addition, many African countries have not regularly updated their assessments of requirements for psychotropic substances. This information is crucial to ensure that an adequate supply of psychotropic substances for medical requirements is available and to avoid delays of consignments to the concerned countries. The inability of several countries in Africa in providing mandatory information on controlled substances to the Board, such as estimates and statistics, may be a reflection of weaknesses in their drug control systems, which require urgent corrective measures. However, several countries have resumed submitting annual statistical reports to the Board after many years of non-submission, indicating that the situation may be improving. Mr. Chairperson, The international drug control treaties recognize that the use of narcotic drugs and psychotropic substances for medical and scientific purposes is indispensable and that these drugs should be available for such purposes. It is one of the core responsibilities of the Board to ensure that narcotic drugs and psychotropic substances are available for medical and scientific purposes. The Board is concerned that narcotic drugs, in particular opioid analgesics are not available in sufficient amounts for the rational treatment of pain, in developing countries including many countries in Africa. While in South Africa and Seychelles, the average consumption of opioid analgesics is comparable to those of some developed countries; most countries in Africa consume only small amounts of opioids, giving the impression that pain management is poor in such countries. However with adequate human resources development in pain management the rational use of opioid analgesics in such countries is likely to increase. Mr. Chairperson, The Board and WHO continue to cooperate in addressing the shortage of narcotic drugs in some countries. Pursuant to a request contained in the World Health Assembly resolution WHA58.22 and the United Nations Economic and Social Council resolution 2005/25, INCB and WHO are jointly examining the feasibility of a possible assistance mechanism that would facilitate the adequate treatment of pain using opioid analgesics. The mechanism should address the main impediments to rational use of opioid analgesics for the management of pain. Governments should examine the extent to which their health care system and laws and regulations permit the rational use of opioids for medical purposes, identify impediments to such use and develop action plans for proper pain management. In this regard, I would like to draw your attention to the WHO guidelines for national drug control policy for pain management entitled "Achieving balance in national opioids control policy: guidelines for assessment", which were developed in close cooperation with INCB. Mr. Chairperson, While ensuring that narcotics drugs are available for the treatment of pain, Governments must also take steps to ensure that such substances are not diverted into illicit channels. In several African countries, medicines including controlled drugs have found their way into outlets that operate outside the established or legally authorized distribution channels. These cases have provided an insight into how traffickers have attempted to or succeeded in circumventing the national and international controls in place, facilitating their abuse or misuse with grave public health consequences. A recent negative development has been the targeting of the African continent by traffickers for the diversion of large amounts of ephedrine and pseudoephedrine, both of which are precursors frequently used in the illicit manufacture of the stimulant methamphetamine. In the past, there were reports that ephedrine and pseudoephedrine were also being abused in the region. It is possible that these substances are still abused in the region. Governments are therefore invited to take appropriate action to prevent the diversion and abuse of ephedrine and pseudoephedrine. The Board urges all countries on the continent to exercise their utmost vigilance and to thoroughly check any import of those precursors into their country. It is also important that Governments provide timely replies to pre-export notifications from exporting countries. In view of the seriousness of the situation, the Board urges all Governments to assess and to inform the Board of their legitimate medical needs for the two substances, both as raw material and in the form of pharmaceutical preparations. As you may be aware, in the case of psychotropic substances, countries may invoke article 13 of the Convention on Psychotropic Substances of 1971 that prohibits the importation of specific substances in Schedules II, III or IV of the 1971 Convention into their country, as a tool to prevent the diversion of controlled substances. To date, six countries in Africa have invoked article 13. Mr. Chairperson, The Board also believes that with proper training the rational use of narcotic drugs and psychotropic substances will be promoted among health care professionals. It is for this reason that the Board wrote to all Governments in April of this year, requesting them to take measures to include the subject of the rational use of drugs for medical purposes and the risks associated with substance abuse and addiction to drugs in the curricula of the appropriate faculties in their universities. The Board trusts that action is been taking by Governments in Africa in this regard. Mr. Chairperson, On behalf of the Board, I thank you most sincerely for the opportunity to address this Committee and look forward to a future of greater collaboration between the INCB and WHO in Africa. | |