Guide on Estimating Requirements for Substances under International Control

26 March 2012

The International Narcotics Control Board (INCB) is launching the Guide on Estimating Requirements for Substances under International Control on the occasion of the centennial of the first international drug control treaty, the International Opium Convention signed at The Hague on 23 January 1912, which was the cornerstone of international drug control. Drug abuse was a scourge that was widespread, affecting most regions of the world, when the 1912 Convention was adopted. Subsequently, an international drug control system was established. The current system is based on the three international drug control conventions: the Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol; the Convention on Psychotropic Substances of 1971; and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988. The international drug control system endeavours to prevent the abuse of drugs, as well as the harm caused by such abuse, while ensuring adequate availability of drugs for the treatment of pain and mental illness.

The problem of inappropriate levels of consumption of internationally controlled substances (too high in some countries and too low in others) has been a matter of concern to INCB for many years. In January 2011, the Report of the International Narcotics Control Board on the Availability of Internationally Controlled Drugs: Ensuring Adequate Access for Medical and Scientific Purposes1 was published. The Report contained a detailed analysis of the global situation with regard to the availability of internationally controlled drugs for medical and scientific purposes and showed the disparity in that availability among the various regions of the world. Australia, Canada, New Zealand and the United States of America, in addition to several European countries, account for 90 per cent of global consumption of analgesics. In some of these countries, there is overconsumption of certain controlled substances, which may cause additional health problems or further compound existing conditions.

In contrast, 80 per cent of the world’s population has limited or no access to these medicines, meaning that many individuals suffer unnecessarily. Many medical conditions cannot be adequately treated without access to the narcotic drugs used, for example in the treatment of pain, or to the psychotropic substances used in the treatment of mental and neurological conditions.

Impediments to the adequate availability of internationally controlled substances vary between countries, and it is the responsibility of national authorities to identify these impediments and take appropriate measures to remove them. However, INCB is of the opinion that the first step that needs to be taken is the identification of a country’s actual requirements for internationally controlled substances in order to overcome underconsumption and, at the same time, prevent overconsumption.

The importance of identifying actual national requirements was reiterated by the Commission on Narcotic Drugs in its resolution 54/6 on promoting adequate availability of internationally controlled narcotic drugs and psychotropic substances for medical and scientific purposes while preventing their diversion and abuse. In the resolution, the Commission encouraged INCB to continue its efforts, in cooperation with the World Health Organization (WHO), to develop guidelines to assist Member States in estimating their medical and scientific requirements for internationally controlled narcotic drugs and psychotropic substances.

Countries that are in a position to adequately estimate and assess their requirements for narcotic drugs and psychotropic substances are usually the ones that are able to take the steps required to improve availability. The process of establishing the mechanism and developing the expertise to make adequate estimates and assessments of legitimate requirements leads to improved supply of internationally controlled substances. Obtaining accurate information about the legitimate requirements for such substances is a prerequisite to ensuring their availability.

INCB is aware that the success of such efforts depends, to a large extent, on a well-functioning drug control system. Without an effective drug control system, countries will find it much more difficult to assess their present consumption levels, identify the additional quantities required for existing treatment facilities and define the improvements required in the health-care infrastructure and the drug distribution system so that patients can be given the medications they need.

Unfortunately, many countries still find it difficult to identify their actual requirements of narcotic drugs and psychotropic substances and are therefore unable to provide adequate estimates and assessments or, in some cases, to provide any estimates at all. In order to support these countries, a working group comprising representatives of INCB, WHO and the WHO Collaborating Centre for Pain Policy and Palliative Care, together with several independent experts, developed the present Guide. The national regulatory agencies of countries at different stages of development were asked to provide their comments, with a view to ensuring that the Guide would be as widely applicable as possible.

The Guide is meant to assist Governments of countries with low levels of consumption of controlled substances in calculating their requirements so that they can then submit to INCB estimates and assessments that accurately reflect those requirements. It could also be useful for Governments of countries in which the consumption levels for some substances are disproportionately high. It is hoped that the Guide will be widely used by competent national authorities and will ultimately help them to arrive at estimates and assessments that reflect their actual requirements for internationally controlled substances.

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