The World Health Organization (WHO) has released the full edition of its guideline on balanced national controlled medicines policies, the first comprehensive global framework aimed at ensuring access to controlled substances for medical and scientific purposes, while reducing the risks of misuse and diversion. This follows an initial rapid communication presented at the Seventy-eighth World Health Assembly, which introduced the guideline.
Controlled medicines such as opioids, benzodiazepines, barbiturates, and amphetamines are vital for pain relief, surgery, seizure management, palliative care, and the treatment of mental health and substance use disorders. Yet, millions of patients around the world remain unable to obtain them.
WHO estimates that up to 98% of patients in low-income countries lack adequate pain relief. In contrast, weaker safeguards in some regions have fueled opioid-related epidemics. Across the globe, many adults and children with advanced cancer or HIV/AIDS suffer without morphine, while epilepsy patients in numerous countries go untreated due to restrictive regulations, inadequate training, and poor awareness of the clinical benefits of these medicines. Meanwhile, in settings where regulations are insufficient, over-prescription and rising demand for strong opioids have led to significant public health harms, including dependence, overdose, and substance use disorders.
The new guideline emphasizes the need for balanced national policies that guarantee continuous and affordable access to controlled medicines while safeguarding against harmful, non-medical use. It seeks to help countries create systems that ensure safe, equitable, and sustainable access to these essential drugs, which are critical for treating acute and chronic pain, mental health conditions, substance use disorders, and other serious illnesses.
WHO’s recommendations span seven key areas: policy design, financing and pricing, medicines selection, procurement and supply, regulation, prescribing and dispensing practices, and education for both health professionals and the public.
Among the central recommendations are:
- Needs-based national planning to prevent both shortages and oversupply, using the best available epidemiological and consumption data.
- Affordable pricing and financing strategies, including the use of generics and biosimilars to ensure access without compromising quality.
- Strict bans on unethical marketing practices, preventing commercial interests from driving inappropriate promotion.
- Evidence-based decision-making, ensuring that access policies prioritize scientific data and safety considerations.
- Modernized supply chain systems that use digital tools and simple technologies to prevent shortages, strengthen traceability, and reduce diversion.
- Legal protections that safeguard patients’ rights to possess prescribed controlled medicines.
- Training and education, both for health professionals and the public, to ensure safe and informed use.
- Robust monitoring systems that balance accountability with the protection of patient privacy.
Together, these measures aim to make controlled medicines widely available, affordable, and safely used for legitimate medical and scientific needs, so that no patient suffers or dies needlessly due to lack of treatment.
Developed through years of systematic reviews and international consultations, the guideline replaces WHO’s 2011 guidance on controlled substances. It will be published in all six official UN languages and is expected to shape policy reforms worldwide, particularly in low- and middle-income countries where treatment gaps are most severe.
As the guideline concludes: “Access to controlled medicines is not just a technical issue — it is a matter of equity, dignity, and the right to health.”
(WHO, Relief Web)