Geneva, 23 May 2025 — The World Health Organization (WHO) has announced a new guideline aimed at helping countries ensure safe, fair, and affordable access to controlled medicines. These drugs, which include opioids and other substances used to treat pain, mental illness, and substance use disorders, are often hard to access—especially in low- and middle-income countries (LMICs).
The new guideline was officially introduced during a high-level side event at the Seventy-eighth World Health Assembly. It outlines steps that governments can take to balance access with safety, improving care while reducing the risk of misuse.
“The suffering caused by lack of access to controlled medicines is preventable and unacceptable,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “This guideline is a critical step toward universal health coverage. It helps countries strike the right balance between access and control, and ensures no patient is left behind.”
The Global Access Gap
Controlled medicines—such as opioids, benzodiazepines, barbiturates, and amphetamines—are used for serious medical conditions. While these drugs are strictly regulated due to the risk of misuse and dependence, they are essential for relieving pain and improving quality of life.
However, access remains highly uneven. In many LMICs, patients cannot get the medicines they need because of restrictive laws, poor health systems, and lack of training for medical staff. Although the medical need is growing, most of the world’s population lives in countries with little or no access to these medicines.
In 2021, more than 80% of the world’s morphine was used in high-income countries. This left millions—such as 5.5 million terminal cancer patients in LMICs—without adequate pain relief. In addition, around 75% of people with epilepsy in these countries go untreated.
Key Recommendations for Policy Change
The WHO guideline offers a policy framework to help countries ensure both access and safety. It includes practical steps based on new evidence and best practices:
- Accurately calculate current and future needs for controlled medicines
- Ban misleading and unethical marketing practices
- Strengthen supply chains with better tracking and distribution systems
- Support local production when possible
- Ensure access to opioid agonist treatment in all clinical settings
- Provide strong training for health workers and run public awareness campaigns
The guideline also stresses the importance of clinical standards free from commercial influence and stronger controls against unethical marketing. Countries are urged to create patient-centered policies, fight discrimination, and involve communities in decision-making.
The goal is to make controlled medicines more available and affordable while making sure they are used safely and only for legitimate medical or scientific purposes.
The full guideline, titled “WHO guideline on balanced national controlled medicines policies to ensure medical access and safety,” will be published online in June 2025. It aligns with WHO’s broader goals for expanding access to essential health products.
Global Call for Action
Belgium co-hosted the launch event, with Ambassador Christophe Payot calling for global cooperation to close the access gap. Dr. Julia Downing and Dr. Afarin Rahimi-Movaghar, who co-chaired the WHO Guideline Group, stressed the need to put the recommendations into action—especially in palliative care and for vulnerable populations. They called for policies grounded in science and human rights.
A panel of civil society leaders and health experts shared real-world stories of patients suffering due to lack of access, particularly in LMICs. They highlighted the urgent need for change.
Closing the event, former Swiss President Ruth Dreifuss urged governments to act. She warned that failing to implement balanced policies is a preventable public health and human rights failure.
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