WHO unveils new guideline to improve global access to controlled medicines
The World Health Organization (WHO) has released a rapid communication outlining its comprehensive new guideline on balanced national policies for controlled medicines. The guideline’s recommendations were officially presented during a high-level side event at the Seventy-eighth World Health Assembly on Friday 23 May 2025. It is designed to support countries in ensuring safe, equitable and affordable access to essential controlled medicines which are critical for treating acute and chronic pain, mental health conditions, substance use disorders and other serious health issues.
“The suffering caused by lack of safe, affordable access to controlled medicines is both preventable and unacceptable,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, in her opening remarks. “This guideline is a critical step toward achieving universal health coverage. It enables governments to strike the right balance between access and safety, ensuring that no patient is left behind. This guideline is not just about regulation; it’s about restoring dignity to care.”
Controlled medicines, such as many opioids, benzodiazepines, barbiturates, amphetamines and dissociative anaesthetics, are drugs that have authorized use for medical or scientific purposes. They should be prescribed under careful regulation and medical supervision as they have properties that can increase health risks if used for non-medical purposes and they can be associated with drug use disorders and drug dependence, unless rational use is ensured. But they also have essential life-improving properties, reducing suffering and improving health and well-being when used appropriately for treating specific medical conditions.
However, access remains uneven globally, with many patients in low- and middle-income countries (LMICs) unable to obtain necessary treatments, due to many factors including overly restrictive medicines control policies and lack of training and education for healthcare professionals.
Despite increasing medical need, the majority of the world’s population lives in countries with limited or no access to controlled medicines, even when they are proven to be safe and effective for treatment. In 2021, over 80% of the world’s morphine was distributed to high-income countries, which leaves out 5.5 million terminal cancer patients and millions of others suffering from acute illness and end-of-life suffering in LMICs. Studies show that 75% of people living with epilepsy in LMICs do not receive treatment.
The updated WHO guideline offers a clear roadmap for Member States to develop and implement balanced national policies that support the medical and scientific use of controlled medicines while protecting individuals and communities from the risks associated with non-medical use.
The document provides new evidence-based recommendations and best practice statements. Key highlights include:
- ensuring accurate and timely quantification of controlled medicines based on current consumption and projected needs;
- banning misleading and unethical marketing practices;
- strengthening procurement and supply chain systems using appropriate tools and technologies to enhance traceability, reduce stockouts and waste and ensure equitable distribution;
- enabling local production where feasible;
- facilitating continuous access to opioid agonist treatment in all clinically needed settings; and
- promoting robust training for health-care professionals and public education campaigns for safe, informed use.
The critical role of clinical guidelines being developed without commercial influence and stronger regulations against misleading and unethical marketing practice are also emphasized. Crucially, the WHO guideline encourages countries to adopt patient-centred approaches, uphold non-discrimination, and engage communities in the development of policies related to controlled medicines.
These measures aim to ensure that controlled medicines are available, affordable, and used safely for legitimate medical and scientific purposes, so that no patient needlessly suffers or dies due to a lack of essential medicines, WHO said.
The rapid communication announced at the event will be followed by the full document of the “WHO guideline on balanced national controlled medicines policies to ensure medical access and safety” to be released online in June 2025. The new guideline aligns with WHO’s broader roadmap for access to medicines and health products.
From policy to practice: a call to bridge the access divide
H.E. Ambassador Christophe Payot, Permanent Representative of Belgium to the United Nations in Geneva, opened the session with a strong call for international collaboration to close the persistent access gap for controlled medicines. Belgium’s leadership and co-sponsorship of the event highlighted its commitment to global health equity and the responsible availability of controlled medicines.
The event, moderated by Deusdedit Mubangizi, WHO’s Health Products, Policy and Standards Director, featured compelling keynote addresses by Dr Julia Downing and Dr Afarin Rahimi-Movaghar, Co-Chairs of the WHO Guideline Group. Dr Downing underscored the urgent need to operationalize the newly launched WHO guideline to address longstanding barriers to access to controlled medicines, particularly in palliative care and among vulnerable populations. Dr Rahimi-Movaghar emphasized the necessity of integrating scientific evidence with human rights-based approaches to ensure that national policies are both effective and equitable.
A diverse panel of civil society and professional experts reinforced the urgency of addressing global disparities in access. Speakers from the fields of drug dependence treatment, palliative care, pain management, and cancer control shared firsthand experiences of the consequences of inadequate access, particularly in LMICs. In her closing remarks, H.E. Ruth Dreifuss, former President of Switzerland and founding member of the Global Commission on Drug Policy, called for political will and sustained commitment to implementing balanced policies that safeguard both access and safety, stressing that failing to do so constitutes a preventable public health and human rights failure
