Geneva, Switzerland, 2025-09-20

The World Health Organization (WHO) has released a comprehensive new guideline designed to help countries ensure safe, fair, and affordable access to essential controlled medicines. The report, titled “WHO guideline on balanced national controlled medicines policies,” is the first of its kind and offers a global framework for governments to manage the delicate balance between guaranteeing access to vital medications and preventing their misuse. The guideline, which aims to address a long-standing global health crisis where millions suffer from a lack of access to pain relief and other essential controlled drugs, provides evidence-based recommendations covering seven key areas of a country’s health system.

A Framework for Action and Affordability

The new WHO guideline calls for national policies that are both balanced and practical. It recognizes that under the United Nations drug treaties, governments have an obligation to provide access to controlled substances for medical and scientific purposes. The new report is a roadmap for how to achieve this goal, while at the same time minimizing the risk of harm from non-medical use.

 * Key Recommendations: The guideline provides concrete recommendations, including a call for national needs-based planning to avoid both shortages and oversupply of controlled medicines. It also emphasizes the importance of fair pricing and financing mechanisms, such as the use of generic and biosimilar drugs, to keep medicines affordable without compromising quality. 

 * Tackling Misleading Marketing: The report also calls for a ban on misleading and unethical marketing of controlled medicines, such as those used for mental health disorders and substance use disorders, to prevent commercial interests from influencing their promotion.

A Growing Global Crisis

The publication of the guideline comes at a critical time. According to the International Narcotics Control Board (INCB), the goals of ensuring access to and the safety of controlled medicines are currently not being met. Millions of people, particularly in low and middle-income countries, suffer needlessly from a lack of access to essential medicines that are vital for managing pain from cancer, for palliative care, and for treating mental health conditions.

 * Addressing Pain and Mental Health: The guideline focuses on medicines that are essential for treating a wide range of conditions, including acute and chronic pain, mental health disorders, and substance use disorders. It also addresses the needs of vulnerable populations, including children and older people, who are often disproportionately affected by a lack of access to these medicines.

 * A Call for Systemic Change: The new guideline is not just about policy; it’s a call for a fundamental change in how health systems operate. It provides governments with a framework for strengthening their procurement and supply chains, ensuring equitable distribution, and educating health professionals and the public on the safe and appropriate use of controlled medicines.

The release of the new WHO guideline is a significant step toward achieving a more equitable global health system. It provides a clear path forward for countries to ensure that their citizens have access to the life-saving medicines they need while also protecting them from harm.