What are the international regulations?
The international regulation of controlled substances is governed by:
- Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol
- Convention on Psychotropic Substances of 1971
- United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988
These conventions aim to prevent the illegal trafficking and abuse of controlled substances, while ensuring that they are available for medical and scientific purposes.
Which organizations monitor the narcotics trade?
The International Narcotics Control Board (INCB) is an independent body of the United Nations that monitors State compliance with the international drug control treaties. The World Health Organization (WHO) supports this work by facilitating the creation of treatment guidelines and maintaining the Model List of Essential Medicines.
How are narcotics controlled internationally?
As part of its monitoring function, the INCB administers an ‘estimate’ system (often referred to as a quota) for controlled substances in which competent national authorities provide their annual estimated need for controlled substances. This estimate is reviewed by INCB and once approved, determines the amount of controlled substances that will be manufactured and/or imported into the country.
A correctly calculated estimate provides national competent authorities with information about the quantity of controlled substances required for medical and scientific purposes and helps to ensure that adequate stocks are maintained in country. INCB reviews and confirms each country’s estimate and publishes the information. If a country fails to uphold its obligation to provide INCB with an estimate, INCB may calculate an estimate for the country so that controlled substances may be imported. In such cases, INCB will request that the country review and confirm the estimate to ensure that the quantity is appropriate for the country’s requirements.
How are estimates prepared?
The INCB, with support from the World Health Organization and palliative care experts, created the Guide on Estimating Requirements for Substances Under International Control to assist governments of countries with low levels of consumption of controlled narcotic drugs in calculating accurate estimates that reflect their medicinal needs for these drugs. There are three commonly used methods for quantifying the requirements for controlled substances:
- Consumption based method: based on amounts consumed in previous years
- Service based method: recent consumption based on consumption in a sample of facilities
- Morbidity based method: based on patterns of morbidity and standard treatment schedules
The Guide outlines each of the methods and the data required for each method in order to accurately calculate requirements.
Governments must submit their estimates for narcotic drugs to INCB on an annual basis. The form used for submitting estimates, ‘Form B’, is provided by INCB to national competent authorities, and can be obtained by emailing firstname.lastname@example.org or on the INCB website. Estimates for the following year are usually due by the end of June. Annual estimates confirmed by INCB are valid until 31 December.
Can estimates be amended?
Situations may arise over the course of the year in which the submitted estimate is inadequate for the medical and scientific needs of the country. In these cases, INCB permits governments to increase or decrease their annual estimate by submitting a Supplement to Form B. Supplemental estimates submitted to INCB are typically reviewed within a few days and are also published on the INCB website once approved.
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