Availability of Internationally Controlled Drugs: Ensuring Adequate Access for Medical and Scientific Purposes last Thursday, 4 February 2016.  The new report highlights disparities between high- and low/middle-income countries in availability of and access to controlled medicines.

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International Narcotics Control Board releases new report on Availability of Internationally Controlled Drugs

Friday 12 February, 2016
by Suzanne Zhou

 Cover of INCB ReportThe International Narcotics Control Board (INCB) released its report Availability of Internationally Controlled Drugs: Ensuring Adequate Access for Medical and Scientific Purposes last Thursday, 4 February 2016. The report updates its 2010 report on the same topic.

The new report highlights disparities between high- and low/middle-income countries in availability of and access to controlled medicines, including opioids for the relief of pain from cancer, and contains a number of important recommendations to address barriers to availability and access.

The INCB is the body responsible for monitoring implementation of the Single Convention on Narcotic Drugs, the key international instrument regulating controlled medicines, including opioid analgesics. The Single Convention recognises 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”. However, in many countries, excessive focus on the Single Convention’s other aim – preventing diversion and abuse of narcotic drugs – has led to severe barriers to the availability of opioid analgesics for pain relief and palliation.

The report states that 5.5 billion people have ‘limited or no access to medicines containing narcotic drugs’, and that 92% of the world’s medical morphine is consumed in a small number of high-income countries constituting only 17% of the world’s population, predominantly the US, Canada, countries in Western Europe, Australia and New Zealand. The remaining 83% of the world’s population, predominantly low and middle-income countries, consumes only 8% of the world’s medical morphine. The World Health Organization estimates that each year, 5.5 million terminal cancer patients suffer from moderate to severe pain that is not managed at all. These disparities persist despite global stocks of opiate raw materials that are sufficient to meet global demand.

Barriers to availability and access identified by the INCB through a survey of Single Convention member states include lack of training or awareness among health professionals, fear of addiction, limited financial resources, problems in sourcing from industry or imports, cultural and social attitudes toward the treatment of pain, fear of diversion into illicit channels, fear of prosecution or sanction, international trade control measures, and onerous regulations. Of these, legal barriers highlighted by the INCB include fear of sanctions due to unclear or punitive laws that discourage prescribing or stocking opioids; restrictions on who can dispense and prescribe opioids; limits on dosage amounts or on how long a prescription is valid for; requirements for special patient permits; burdensome bureaucratic and reporting requirements; and disproportionate penalties including penalties for unintentional violations.

The report aims to provide guidance on addressing these barriers. It emphasises that access to controlled drugs for medical purposes is a human right, and reinforces that parties have obligations under the Single Convention not only to prevent diversion and abuse, but to ensure adequate and not unduly restricted availability of internationally controlled drugs for medical purposes. It recognises that opioid analgesics are indispensable for cancer treatment and palliation. The problem is especially urgent in low- and middle-income countries, which currently account for 70% of cancer deaths – a proportion that is projected to increase further by 2030 without sustained action.

The report makes a number of recommendations, including in relation to legislation and regulatory systems, health systems, affordability, training of health care professionals, public education and awareness. Legal recommendations include reviewing laws and regulations to streamline distribution and prescribing processes, removing legal sanctions for unintentional mistakes in handling opioids, broadening prescription validity periods and the classes of professionals who are able to prescribe, improving interagency cooperation, and providing the health and pharmaceutical community with updated information on laws and administrative measures.

The report is another important step in the global move to ensure that access for medical and scientific purposes receives the prominence it deserves within the international drug control regime. These steps began with Commission on Narcotic Drugs (CND) resolutions in 2010 and 2011, and have continued with decisions and reports from the CND, UN Office of Drugs and Crime, INCB, World Health Assembly and WHO. They complement the growing recognition of the importance of palliative care in global health fora, including the World Health Assembly’s 2014 resolution on access to palliative care, and the inclusion of an indicator for access to palliative care in the Global Monitoring Framework for Non-Communicable Diseases. In April 2016, the UN General Assembly will hold a Special Session on the World Drug Problem (UNGASS), which will cover a wide range of drug policy issues including the availability of controlled medicines, prevention and treatment of drug dependence, HIV/AIDS, alternative development, and judicial cooperation. UNGASS represents a critical opportunity to guide international drug policy and national activities to address the lack of availability of opioid analgesics and other controlled medicines.

Download the report

Read about the McCabe Centre’s work on access to opioid analgesics

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