Professor Julia Downing and Dr. Afarin Rahimi co-chaired the Guidelines Development Group for the WHO guideline on controlled medicines, launched at a side event to the World Health Assembly on May 23, 2025. This is condensed from a detailed article being published simultaneously by the International Children's Palliative Care Network.
Introduction to the WHO Guideline on Controlled Medicines
The rapid communication for the "WHO guideline on balanced national controlled medicines policies to ensure medical access and safety" was launched in May with wide support, including that of the International Association of Hospice and Palliative Care, Worldwide Hospice and Palliative Care Alliance, International Children’s Palliative Care Network, Union for International Cancer Control, International Association for the Study of Pain, Global Commission on Drug Policy, and WHO member states Belgium and Switzerland.
We hope that this guideline will help reduce inequities and enable medicines to get the people who need them, in the place that they need them, wherever they live. The guideline is based on national policies and implementation strategies that have been effective in improving access to controlled medicines while ensuring rational, legitimate use.
The full guideline, to be launched later this year, will contain definitions of the key terms used (such as nonmedical use, clinical need, etc.), identify research gaps, and more. [In 2020, a WHO guideline on the management of chronic pain in children was published.] A detailed article describing the research questions and method, as well as the process for selecting the experts involved, is available on the International Children's Palliative Care Network website.
Policy—not clinical—guidance
A Scientifically Rigorous Process
The Guideline Development Group followed the WHO gold standard methodology for the development of recommendations and good practice statements—the GRADE system. This was underpinned by systematic reviews.
The purpose of the guideline is to assist WHO Member States and their partners in developing and implementing national policies on controlled medicines to ensure their accessibility, availability, and affordability for medical and scientific uses. It is also to minimize the risk of harm arising from nonmedical use. It is important to note that the document contains policy—not clinical—guidance. There is nothing here on how to prescribe the controlled medicines listed, which include opioids, benzodiazepines, barbiturates, dissociative anesthetics, cannabinoids, hallucinogens, and amphetamine-type stimulants.
The guideline addresses policies for groups affected by conditions in which the use of controlled medicines is deemed to be medically appropriate, according to evidence-based clinical practice guidelines.
The recommendations are intended to cover all types of controlled medicines with authorized medical or scientific purposes. Throughout the document, it stresses that their use must be based upon clinical need: Is it the right medication for an individual’s type of epilepsy? Is it the right medication for an individual's type of pain? Have we carried out a good assessment? Are we able to ascertain if these are the right medicines for that particular need?
Guiding principles
Throughout the development of the guideline, two principles were key: ensure access, and avoid harm. Read our other guiding principles.
- All people have the right to enjoyment of the highest attainable standard of health, a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.
- Controlled medicines are crucial for managing many health conditions and treating illness. Access to essential controlled medicines is a component of the rights to both health and life.
- National policies pertaining to controlled medicines should be balanced to enable safe and appropriate use, ensuring access for medical and scientific need (that is uninterrupted, sustainable and continuous) while avoiding harmful consequences for individuals and societies.
- All national policies should be tailored to the needs and requirements of the social context and resources of the population, while recognizing individuals’ right to the highest attainable standard of health.
- Member States and healthcare providers should ensure that patients, their families, and their caregivers know their rights to self-determination, non-discrimination, accessible, and appropriate health services and confidentiality.
- Governments should invite patients, advocacy groups, health professionals, academia, professional societies, civil society, and other affected groups to participate in formulation of health policy.
Research gaps were a challenge
In many areas of policy there is no published evidence, and in other areas, the evidence is focused very much on high-income countries. In the full document to be released later, we will identify reasons that gaps in research might exist. Cost-related issues are also discussed, along with how we ensure access and safety for all, in particular within humanitarian crises and for vulnerable populations.
Now, the guideline needs to be used
It's crucially important that these guidelines do not just sit on the shelf and gather dust, never to be read. They need to be used.
At its launch, Dr. Deusdedit Mubangizi, from the WHO Department of Health Policies and Standards, said: “Together, we must all work to ensure the effective implementation of the recommendations in these guidelines so that safe, affordable medicines are available to all."
We need to make sure that people around the world who need controlled medicines for clinical need should be able to access them—wherever they live and whatever their condition. We hope that this guideline will be useful, that it will be used, and that it will help us in ensuring access and maintaining safety.
Editor's note: The upcoming July issue of IAHPC's Literature Search by Barry Ashpole focuses on palliative care policies and practice.
Read more of this week's issue of Pallinews
Palliative Care in Chile
Even high-income countries have gaps in care. A report by Dr. Alejandra Palma.
Guidance for Policymakers
An introduction to the WHO guideline on controlled medicines, by Professor Julia Downing, who co-chaired its development.
A Trans-Atlantic First
The 2025 International Seminar on Public Health Palliative Care Research, a report by Dr. Luc Deliens.