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This annex provides an overview of the main aspects linked to

the procurement, supply and dispensing of opioid medicines and A1
their status as controlled medicines under the United Nations

Single Convention on Narcotic Drugs, 1961. It outlines the
main requirements set by the Convention and their impact on

operational and policy planning. This annex addresses policy-
makers, managers, officers and health-care providers who A2

are involved at different levels and in different functions with
improving the availability of opioid analgesics for medical needs.

It provides the principal references for further action and some
general guidance on main regulatory aspects to be considered A3

while improving access to opioid analgesics in the health system.


The World Health Organization published the policy guidelines Ensuring balance in national policies
on controlled substances: guidance for availability and accessibility of controlled medicines, to guide
countries how to optimize access to all controlled medicines and to prevent harm from substance misuse
(95). The World Health Organization (WHO) encourages governments, civil society and other interested A4
individuals to strive for the maximum public health outcome of policies related to these medicines. WHO
considers the public health outcome to be at its maximum (or “balanced”) when the optimum is reached
between maximizing access for rational medical use and minimizing hazardous or harmful use. It is
strongly recommended that countries implement these guidelines for achieving this outcome.


A6.1 UN drug conventions and their governance system
A5
There are three international drug control treaties: the United Nations Single Convention on Narcotic
Drugs, 1961, as amended by the 1972 Protocol (94); the United Nations Convention on Psychotropic
Substances, 1971 (119); and the United Nations Convention against Illicit Traffic in Narcotic Drugs
and Psychotropic Substances, 1988 (120). These conventions represent a global effort to prevent drug
abuse, while enabling access to these substances as medicines for the relief of pain and suffering. By
signing these treaties, countries have made a commitment to implement a number of drug control
measures in their territories without unduly restricting medicines access. A6

The Commission on Narcotic Drugs (CND), which represents the States that are Parties to these
international drug conventions, has the authority to decide, upon a recommendation from the World
Health Organization, whether a substance should be scheduled as a narcotic drug or a psychotropic
substance. The process for developing the recommendations for scheduling drugs under these
two conventions is described in the Guidance for the WHO review of psychoactive substances for
international control (121). The International Narcotics Control Board (INCB) is charged with monitoring A7
governments’ compliance with the above international treaties, and ensuring, on the one hand, that
controlled substances are available for medical and scientific use and, on the other hand, that the drugs
are not diverted from licit sources to illicit markets.










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