WHO Issues Landmark Guideline to Balance Access and Safety of Controlled Medicines
WHO highlights that up to 98% of patients in low-income countries have little or no access to adequate pain relief, despite the availability of medicines such as morphine, oxycodone, or fentanyl.
The World Health Organization (WHO) has released the full edition of its long-anticipated guideline on balanced national controlled medicines policies, offering for the first time a comprehensive global framework to ensure equitable access to controlled drugs for legitimate medical and scientific purposes, while minimizing the risks of misuse, diversion, and public health harms.
The guideline follows a rapid communication presented earlier this year during the Seventy-eighth World Health Assembly. It seeks to address one of the most persistent global health challenges: the dual burden of severe under-access in low-income regions and widespread overuse and misuse in others.
Global Inequities in Access
WHO highlights that up to 98% of patients in low-income countries have little or no access to adequate pain relief, despite the availability of medicines such as morphine, oxycodone, or fentanyl. Patients with advanced cancer, terminal illnesses, or living with HIV/AIDS often suffer needlessly due to regulatory restrictions, lack of training for healthcare professionals, and weak supply systems.
The situation is equally dire for those with epilepsy. Millions go untreated as essential anti-seizure medicines remain out of reach, restricted by outdated laws or misconceptions about their use.
Conversely, in higher-income regions, weak safeguards and aggressive marketing have fueled opioid epidemics, leading to widespread addiction, dependence, and overdose deaths. This imbalance underscores the urgent need for what WHO calls a “balanced” policy approach.
Essential Role of Controlled Medicines
Controlled medicines, including opioids, benzodiazepines, barbiturates, and amphetamines, are critical to modern healthcare. They are used to:
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Manage acute and chronic pain
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Conduct anesthesia during surgery
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Treat seizures and epilepsy
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Provide palliative care
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Support mental health treatments
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Address substance use disorders
WHO stresses that these medicines are indispensable in both emergency and long-term care. Yet restrictive regulations, combined with stigmatization, often prevent doctors from prescribing them even when clinically necessary.
Key Recommendations of the Guideline
The new WHO guideline lays out evidence-based recommendations across seven core domains, designed to help governments reform outdated or unbalanced policies:
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Policy Development – Adopt needs-based planning using epidemiological data to forecast demand and prevent shortages or oversupply.
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Pricing and Financing – Ensure affordability through fair pricing systems, generics, and biosimilars without compromising safety or quality.
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Medicines Selection – Include essential controlled medicines in national formularies, aligned with WHO’s Model List of Essential Medicines.
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Procurement and Supply Chain – Use digital tools to strengthen traceability, prevent stock-outs, and reduce diversion to illicit markets.
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Regulation – Introduce legal reforms that protect patients’ rights to access prescribed controlled medicines, while maintaining safety controls.
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Prescribing and Dispensing – Promote evidence-based clinical decisions free from misleading or unethical commercial influence.
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Education and Public Awareness – Expand training for healthcare professionals and run public campaigns to reduce stigma and promote safe use.
The guideline also emphasizes robust monitoring systems that strike a balance between transparency and patient privacy, ensuring accountability without violating individual rights.
Equity, Dignity, and the Right to Health
Developed through a multi-year process involving systematic reviews and extensive global consultations, the guideline replaces WHO’s 2011 framework and will be available in all six official UN languages.
WHO officials stress that the document is more than a technical manual; it is a moral commitment. “Access to controlled medicines is not just a technical issue — it is a matter of equity, dignity, and the right to health,” the guideline concludes.
Implications for Global Health Policy
The release of this guideline is expected to drive policy reforms across Member States, particularly in low- and middle-income countries where treatment gaps are most acute. If adopted effectively, it could help millions access essential pain relief and treatment, while reducing the devastating public health consequences of misuse and dependence.
WHO hopes that by promoting balanced, evidence-driven policies, no patient—whether battling cancer, living with epilepsy, or enduring a mental health disorder—will be left to suffer or die because of inadequate access to essential medicines.
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