Ensuring balance in national policies on controlled substances: Guidance for availability and accessibility of controlled medicines

The central principle of “balance” represents a dual obligation of governments to establish a system of control that ensures the adequate availability of controlled substances for medical and scientific purposes, while simultaneously preventing abuse, diversion and trafficking. Many controlled medicines are essential medicines and are absolutely necessary for the relief of pain, treatment of illness and the prevention of premature death. To ensure the rational use of these medicines, governments should both enable and empower healthcare professionals to prescribe, dispense and administer them according to the individual medical needs of patients, ensuring that a sufficient supply is available to meet those needs. While misuse of controlled substances poses a risk to society, the system of control is not intended to be a barrier to their availability for medical and scientific purposes, nor interfere in their legitimate medical use for patient care (16). (…)

This document provides 21 guidelines for working on the improvement of availability, accessibility and affordability of controlled medicines from a policy perspective. They relate to seven aspects of policy and legislation:

• content of drug control legislation and policy (Guidelines 1 and 2);
• authorities and their role in the system (Guidelines 3 to 6);
• policy planning for availability and accessibility (Guidelines 7 to 10);
• healthcare professionals (Guidelines 11 to 14);
• estimates and statistics (Guidelines 15 to 17);
• procurement (Guidelines 18 to 20);
• other (Guideline 21).” (…)

The obligation to make controlled medicines available for medical purposes finds its legal basis in the international drug control conventions, which state that “the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and that adequate provision must be made to ensure the availability of narcotic drugs for such purposes” (11). Human rights principles supporting the duty to ensure adequate availability of controlled medicines for medicinal purposes are also contained in international legal instruments expressing the international right to health. (…)

Several MDGs affect essential medicines either directly or indirectly, including controlled medicines that are also listed as essential medicines. In particular, MDGs include:

To encourage the pharmaceutical industry to make essential drugs more widely available and affordable for all who need them in developing countries” (MDG 8e); (…)

Drug control should not be approached as an objective in itself, but as a tool to optimize public health. Untreated pain may cause losses to society in the form of incapacity to work, caregivers becoming unproductive in society due to their caring role, and pain patients needing further attention if they do not receive adequate pain management.