WHO publishes full guideline report to help countries ensure safe, equitable access to controlled medicines

Geneva, 18 September, The World Health Organization (WHO) published the full edition of its guideline on balanced national controlled medicines policies, marking the first comprehensive global framework designed to ensure access to controlled drugs for medical and scientific uses, while minimizing risks to public health that may arise due to misuse and diversion. This publication followed a rapid communication released during the Seventy-eighth World Health Assembly that outlined the new guideline.

Many controlled medicines, including opioids, benzodiazepines, barbiturates and amphetamines, are essential for managing pain, conducting surgeries, treating seizures, supporting palliative care, and managing mental health and substance use disorders - yet millions of patients worldwide still cannot access them.

According to WHO, up to 98% of patients in low-income countries lack access to adequate pain relief, while in other regions, weak safeguards have contributed to opioid-related epidemics. Across the world, adults and children with advanced cancer or living with HIV/AIDS continue to suffer in pain without morphine. In many regions, epilepsy patients go untreated because essential anti-seizure medicines are locked behind restrictive regulations and lack of education and understanding of how these medicines can be used clinically. Meanwhile, in many countries, insufficient regulation of controlled medicines has led to over-prescription and rising demand for strong opioids, driving a surge in health-related harms including substance use disorders, drug dependence and overdose.

The new WHO guideline calls for balanced national policies that both guarantee uninterrupted, affordable access and prevent harmful non-medical use of controlled medicines. It aims to help countries ensure safe, fair, and affordable access to essential controlled medicines that are vital for managing acute and chronic pain, mental health disorders, substance use disorders, and other serious health problems.

The WHO guideline provides governments with evidence-based recommendations covering seven key domains: policy development, pricing and financing, medicines selection, procurement and supply chain, regulation, prescribing and dispensing, and education for both health professionals and the public.

Key recommendations include:

• National needs-based planning to avoid both shortages and oversupply. Governments should use the best available epidemiological data and consumption patterns to forecast demand.
• Fair pricing and financing mechanisms, including the use of generics and biosimilars, to keep medicines affordable without compromising quality.
• Banning misleading and unethical marketing of controlled medicines, such that commercial interests do not influence their promotion.
• Ensuring that robust scientific evidence drives decisions about access to controlled medicines while appropriately balancing safety considerations.
• Supply chain innovations to prevent stock-outs and diversion. WHO urges the use of digital tools and simple technologies to prevent stock-outs, improve traceability, and reduce diversion of medicines from medical to non-medical use.
• Legal reforms to protect patients' rights to possess prescribed controlled medicines.
• Comprehensive training for health professionals, alongside public education campaigns.
• Robust monitoring systems, balancing transparency with protection of patient privacy.

These measures are designed to ensure that controlled medicines are accessible, affordable, and used safely for legitimate medical and scientific purposes, so that no patient is left to suffer or die needlessly from a lack of essential medicines.

The guideline, developed through a multi-year process of systematic reviews and global consultations, replaces the 2011 WHO guidance on controlled substances and will be published in all six official WHO languages.

It is expected to guide policy reforms across Member States in the coming years, especially in low- and middle-income countries where treatment gaps remain stark.

"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.