Guiding Access and Control: WHO’s 2025 Blueprint for Controlled Medicines Policy

The 2025 WHO guideline on balanced national controlled medicines policies to ensure medical access and safety lays out a vital new blueprint for governments to ensure that life-saving controlled medicines are accessible for legitimate medical and scientific uses, while safeguarding societies from the harms of misuse. This comprehensive framework was developed with contributions from leading academic institutions, including McMaster University, the Norwegian Institute of Public Health, and the University of California, San Francisco, among others. These guidelines reflect WHO’s ongoing commitment to resolving one of global health’s most complex dilemmas: how to ensure that essential medications like opioids, benzodiazepines, amphetamines, and cannabinoids reach those in need without being diverted into harmful non-medical use.

These medicines serve a critical role in treating a vast range of conditions, including acute and chronic pain, seizures, palliative care, anxiety, substance use disorders, and mental health crises. However, access remains uneven across the globe, especially in low- and middle-income countries where outdated legal frameworks, weak procurement systems, and the stigma around controlled substances continue to deprive patients of essential care. WHO argues that access to such medicines is not only a matter of good clinical practice, but a fundamental human right, essential to both health and life.

From Policy Blueprint to Public Health Priority

This updated guidance replaces WHO’s 2011 recommendations and is aligned with the WHO Roadmap for Access to Medicines, Vaccines and Health Products (2019–2023). It calls on governments to develop and routinely update national controlled medicines policies that are responsive to changing needs, grounded in the latest evidence, and tailored to country-specific contexts. Policymaking, the guideline insists, should be inclusive and participatory, involving patients, caregivers, civil society, academia, regulatory authorities, and health professionals in every stage of development.

While the policies apply to all age groups, special attention is given to vulnerable populations, including neonates, children, elderly patients, and individuals affected by humanitarian emergencies like natural disasters, conflict, or epidemics. These are the people most likely to suffer from unmet medical needs in contexts where controlled medicines are either too tightly regulated or simply unavailable. Countries are advised to pursue reforms that balance access and safety through well-planned national strategies.

Efficient Supply Chains and Smart Procurement

One of the key recommendations from the 2025 guideline revolves around supply chain management. WHO urges countries to base their medicine procurement and forecasting processes on reliable, up-to-date epidemiological and clinical data. Quantification should consider disease prevalence, mortality rates, clinical service capacity, and consumption trends. Countries must also be prepared to adjust estimates dynamically and communicate with the International Narcotics Control Board to prevent supply shortages or oversupply.

Supply chains should be reinforced using simple, context-appropriate technologies that improve traceability, reduce stock-outs, prevent waste, and mitigate diversion risks. Governments are encouraged to invest in local and regional manufacturing hubs to ensure cost-effective and sustainable supply. Importantly, the guideline advises that procurement policies should not only be legally compliant and economically sound but also designed to ensure equity in geographical coverage and affordability.

Legal Reform and Safe Clinical Practice

In a bold set of legal and regulatory recommendations, WHO highlights the need for reform in laws governing the possession, prescribing, and scheduling of controlled substances. Health professionals from a wide range of disciplines should be permitted to prescribe and dispense these medicines without facing undue regulatory or legal barriers. Moreover, legal protection must extend to patients carrying prescribed medicines to avoid criminalization for medically justified use.

The guideline urges governments to ensure that drug scheduling decisions are grounded in scientific evidence and made with input from stakeholders, including healthcare associations, patients, and regulatory bodies. Fast, efficient trade and import-export mechanisms are also vital, particularly in emergencies. WHO strongly supports the digitalization of authorization systems, especially in trade and prescription monitoring, to facilitate faster and more transparent processes.

On the clinical front, WHO calls for robust prescription monitoring systems and pharmacovigilance networks to identify misuse while safeguarding patient privacy. Policies should protect caregivers, patients, and clinicians from unwarranted scrutiny while ensuring that any adverse effects or safety concerns are promptly addressed.

Knowledge, Training, and Research Gaps

Another cornerstone of the guideline is education and public awareness. WHO calls for mandatory, comprehensive training in the appropriate use of controlled medicines to be incorporated into the core curricula of healthcare professionals and included in ongoing professional development programs. The general public, patients, and families must also receive balanced, accurate, and culturally sensitive information about the risks and benefits of these medicines. Public education campaigns, when well designed, can counteract stigma, misinformation, and fear-driven narratives, particularly on social media.

Finally, the document flags significant research gaps, particularly in low-income countries. These include the need for studies on local production models, strategies for managing waste and substandard products, and the long-term effects of drug scheduling changes. There is also limited data on how healthcare provider attitudes and system-level barriers affect prescribing behavior. WHO calls for investment in inclusive, context-sensitive research to support evidence-based policy development.

The 2025 WHO guideline provides governments with a powerful, structured approach to advancing public health through the balanced regulation of controlled medicines. It urges them to recognize access as a right, not a privilege, and to shape policies that reflect empathy, scientific rigor, and shared responsibility. The vision is clear: no patient should suffer needlessly due to policy failure, and no community should be harmed by unregulated drug use. The way forward, WHO insists, is through transparency, accountability, and global solidarity.