Session 5: Lack of Availability of Internationally Controlled Substances for Medical and Scientific Purposes

Evidence Snapshot on Access to controlled substances for medical and scientific purposes: Ms. Chloe Carpentier, Chief, Research and Knowledge Production Section, UNODC: … if we look at how much the global population has access to pain management and palliative care, we see 86% is living in countries with limited access. It would take 230 years for the availability in low availability countries to reach half of the rat eof countries with high availability. Methadone and buprenorphine – in the last 5 years there has been a stagnation and slow decrease in the increase in availability. Whats important is to strike the right balance between access and preventing that these opioids get spilled over to a nonmedical market. There are policies in place that can be designed to ensure this  – regulatory approaches.

CND Chair: We will begin. Mr Tettey you have the floor.

Intro & Expert moderator: Mr. Justice Tettey, Chief, Drugs, Laboratory and Scientific Services Branch, UNODC: .. justice and human rights. In fact, it lies at the very heart of our commitments. Some say these substances are not harmful because they are controlled. They are controlled, because they can be harmful. You, member states, committed to ensure these substances are available and accessible to those who need it. over the past years – ungass 2016 and subsequent efforts by UNODC, WHO and INCB. We need to change the narrative that substances are dangerous or harmful because they are controlled. Strong advocacy and partnerships w civil society, academia, govs and intl orgs to raise awareness has led to a better understanding. Despite these efforts, the global challenge remains. For managing pain, treating mental health disorders and treating .. conditions, 86% of the world population do not have adequate access and live with treatable pain. Children, women, the elderly, in conflict settings and those living in prison settings are particularly affected. This is not what we have promised. These medicines must be affordable without compromise on quality, safety and efficacy. At the same time, addressing these inequities requires a delicate balance. There is overprescribing when availability is high – access should never mean excess as the overdose crisis underscores. National drug testing, laboratory need standards and support with law enforcement and clinical responses. You made the decision to control 90 substances in the last few years. At the same time, research institutes require access for clinical trials. UNODC announced collaboration on access – providing support on legislation, reference standards. The tools and mandates are crystal clear.

Moderator: from your expariance as regulatory officers, what has worked?

Mr. Brian Sekayombya, Principal Regulatory Officer, Medicines National Drug Authority, Uganda (in person): we have 6 sections in the legislative framework, we define where these medicines should be, who should prescribe them, who should receive them. We define what happens if these medicines cant be accounted for. We look at everyone who had the substance in their custody. This may seem like a lot of control, but has allowed the country to have local production. We have policies there that supports local production. Morphine is produced in country, imported has higher fees. Essential medicines list – if you have controlled medicines on this list, as an officer I would give priority to the essential medicines. I move fast in having them registered and ensuring they are available at all times. Locally, the public is procuring these medicines, they will look at what is manufactured at home. They are going to give ongoing support to oversee quality and efficacy. Building a tracker system which can give a visual on what is in country, what has been imported, who has received it.

Moderator: It does not end with the conventions, you need to implement it in national laws. Exploiting the idea of essential medicines and bringing that into local production is an idea others should consider. Moving on. To the next panellist.

Ms. Ebtesam Ahmed, International Association for Hospice and Palliative Care: Will give two examples. Uganda has made significant progress in oral morphine. CSO in collaboration with government health and police became the first country to train healthcare workers in oral morphine. Local manufacture solutions address gaps in palliative care and pain management. Health professionals from other countries come to Uganda to receive training and implement in their countries. Securing a safe and available supply to produce morphine remains a challenge. Another example is Kerala, India, community-led innovation to provide home-based palliative care working hand in hand with healthcare professionals. Over 70% people in Kerala have access now.

Moderator: The message is simple, access is possible. Questions is what are you doing about it? Regarding children, particularly in low and middle income countries. In 2023, the commission had a resolution looking at this very issue. What are the key measures you recommend?

Ms. Belén Tarrafeta, Pharmaceutical Policies Advisor and Researcher, Institute of Tropical Medicines, Belgium:  Children are not small adults. They have specific needs. We have to take this into account when thinking about their health. Good development requires play – health systems need to be aligned. We can only think about addressing children’s problems if we think about how to put them at the center. Costa Rica has put the patient at the center. Some of the issues with children are not specific for them. But they are very often underdiagnosed. Identifying TB, for example, should be easy, but the gap is 75% for children. When it comes to pain, it becomes subjective on how we interpret children’s pain. If the gap for adults is big, for children much larger. We have all been children. How can this part of society be so vulnerable? Clinical trials are more complex for children. Paediatric formulations need to be tested, everything is more complicated. Very often it is a population that cannot afford medication. If we take children with their own individual rights, then we can address this group.

Moderator: During the last CND, WHO announced the publication of guidelines on balanced national policies for access and safe use. Can you share an overview of the guidelines?

Dr. Deus Mubangizi, Director, Health Products Policy and Standards Department, WHO (in person): I was in Uganda 20 years ago for the guidelines in Uganda so it is a privilege to look at it now from the international point of view. The words are telling – balanced national policies, underlined balance. As our Chair said, because they are controlled, does not make them bad. Control makes them safe. We can use safely. … We not only need to ensure availability but we need to make sure they are affordable. Especially in children, where you have mental health and substance use and other serious problems. It is the first time we have a comprehensive guideline for this topic. Access to controlled medicines is complex. It has many players that get engaged – health agencies, law enforcement, many others and international, regional, national regulatory systems. Always issues of coordination. The guidelines took a comprehensive system level approach. 7 key domains: policy, pricing and financing, medicine selection, procurement and supply chain, regulation, prescribing and dispensing, and education for both health professionals and the public. On education, we see medicines that are not accessible because health professionals don’t know much or they fear the substances. WHO made a number of guidelines already that are reinforced here. Selection of medicines should be based on scientific evidence. Those designing detection methods need access to research evidence. Where evidence doesn’t exist, it should be generation. We should be proactive to inform policies and measures that are implemented. You cannot deny access to generational evidence and have well informed policies when they won’t be underpinned by science and evidence. Use the best available epidemiological data to forecast demand instead of past estimates not adapted to current needs, resulting in shortages. If we use historical consumption data alone, that will lead to lack of availability. Digital tools and other simple technology that can prevent stockouts and diversion to nonmedical use. Excited to hear the example from Uganda. The second area is regulation and control of medicines. Safe packaging to prevent accidental use by children. This always causes fears, therefore access controls are put in. Laws that hinder access to individuals with clinical medical need should be review and revised. Patients should have adequate legal protections for possession of these medications with clinical medical need. Third, prescribing must be based on clinical guidelines. .. These recommendations highlight the need for balance and scientific evidence. Also noted several research gap, where WHO is collaborating to encourage further research.

Moderator: Panellists have been fantastic. If you are doung better than Uganda, please tell the world what are you doing. Handing over.

CND Chair: Open floor.

Oman: I raised my hand because she looked at me. We have good regulations, there is some sort of diversion but it is under control.

European Union: I have a statement. Albania, Bosnia and Herzegovina, Georgia, Iceland, Montenegro, north m, Norway, Moldova, Ukraine. Great importance of ensuring access and availability. We underline the need to implement resolution 67/2 tabled by Belgium on behalf of the EU and ivory coast last year to ensure availability to children. … community-led organizations can all contribute to raising awareness and contribute to scientific evidence as well as non-stigmatizing attitudes towards use, including from children. Opioid use disorders, people suffering should have easy access. .. there is uneven coverage among EU member states and some beyond the levels recommended by WHO. Legal financial barriers and stigma related obstacles. Needle and syringe program expansion, polysubstance use. Providing access to OA such as naloxone can prevent deaths. The provision of care during humanitarian emergencies during armed conflict such as the Russian aggression against Ukraine is a grave concern. In line with EU drug strategy, we remain commitment to raising awareness and capacity building.

Colombia: Fear and stigma about using these medicines. We heard from WHO this is a recommendation. Are there good examples to overcome fear and stigma? As mentioned by UNODC, there is a clear gap, this is a development issue. How can we close this gap that will apparently take us 230 years?

United Kingdom: Thank you for forcing me to take the floor with your stare. I don’t have a question, but the UK places great importance on ensuring medicines needed are available. We work with council on misuse of drugs, and independent panel. We have separate regulations to ensure the most dangerous drugs are not diverted.

Greece: Greece has taken steps to streamline regulatory procedures and ensure alignment. We believe the solution lies in striking a balance. International cooperation should focus on providing technical assistance to countries that lack the infrastructure to produce medications. This is a matter of human dignity.

Belgium: Digital tools are very important to know what is happening. Its extremely crucial to strike that balance to have those tools and monitor closely. But we are talking about medical privacy of people. And we are struggling with it. We shared we use our tools. But we struggle of when do we protect the privacy and when do we expand. So the question to the panel is how we go about privacy?

WHO: Thank you Colombia for that question. Also to be on record, Belgium and the EU are supporting the finalisation of the guidelines. How do we overcome fear and stigma. Information is power. People have a fear of the unknown. If you share information starting with the health professionals to say these are medicines that are needed to treat critical situations or managing pain, and they are safe. That empowers, otherwise people have stigma – even a  small dose will cause addiction and you will be on the street. A small round of information can go a long way. Related is having clear policies. When you leave policy gaps, you leave room for mysteries and conspiracy theories to evolve in society. But if you have clear policies, that will reduce the stigma and the fear.

Brian: It was not very common in severe pain management that the professor would recommend an opioid when I was in medical school. Now the training is changing, the latest clinical guidelines for managing pain uses the WHO guide on analgesics and if needed, the controlled medicines are there. If you follow guidelines, you will use controlled medicines, even if you fear them. Second is having these medicines readily available. If you find a medical worker following the guidelines, they will be using these medicines. National drug law explains how you should account for Class A medicines. Accountability mechanisms, documentation, but for this Class it is specific, including who is picking and how the medication.

Moderator: in pharmacy school learning about opioids I remember walking away with one memory – the dangerous drugs book. I see opioids I see the dangerous drugs book. I don’t see joy I don’t see people who need them.

Belén: Local manufacturing can work in Uganda but won’t necessarily work for other countries. Access to palliative care in children – doctors are not insensible for pain. In contexts where children are really suffering, you say if a child cries it is a good sign, it means the child is alive. … we need further research because barriers are very specific to countries, cultural behaviours. If we don’t get better data, we will not able to make it.

IAPC: Fear around opioids in general is a significant barrier – also among patients and their families. Oftentimes comes from misinformation and stigma. We have to focus on education, targeted education talking about the goals of palliative care, not just opioids. The distinctions between pain in palliative care and chronic pain management. At the same time, we need to educate healthcare professionals about addiction. I work side by side with physicians to talk about opioid pharmacologies. Families have a strong feeling about medications like morphine, fears and stigma. Need to explain the role and purpose of opioids in palliative care. Assure patients this is not shortening their lives, on the contrary. Policy and regulatory support – fears are worsened by poorly understood legal frameworks. Policies that separate palliative care from other opioid access.

Moderator: Any further questions? National statements can wait. Wrapping up then. The data is very clear. 86% of people who need medicines do not have access to it. We heard it gets even more critical with some populations: children, people on OAT, in conflict situations in humanitarian settings. Treatment of epilepsy, anxiety, sedation before surgery use these medications. Yet, what we promised in the Conventions, we are not meeting those obligations. The tools are there, WHO gave an example. The final point I’d leave you with: access is possible. It is happening in countries. They got around stigma. They put in place legislation. They educated. Take this, and the final message is – we made progress, but we can and should do better.

CND Vice-Chair: Thank you to the panel. Now opening the floor to those who would like to give an update on the Pledge4Action Initiative or make a new pledge.

Belgium: Tomorrow, UNODC and African Union Commission with support of Belgium will organize a regional consultation on access and availability in Africa. Provide a platform to share practices and innovative approaches and region-specific considerations. Proud to support young doctors network. Confident these young medical professionals can spread awareness in their countries. Study funded by Belgian development cooperation examined children’s access. Despite progress in integration into universal health coverage, access remains extremely limited especially for children. Common interventions could improve access. Results of the study will be available at the end of the year.

South Africa: Colombo plan program capacitated 79 officers on the universal prevention curriculum. Capacitates 329 professionals in treatment. UTC program is now implemented in all treatment centers. Implemented prevention and early intervention on violence, gender-based violence, with a special focus on institutions of higher learning, because we know young people start experimenting with drugs in higher education. … national training of trainers commenced in September 2024. .. Reviewing quality of treatment services. …

Thailand: prioritizing treatment access for individuals with psychiatric conditions. 153 center covering 32000 drug users with symptoms of psychosis nationwide. Integrating psychosocial care into justice system. Court system reduced recidivism below 1.5%. internationally, Thailand participates in the Scale UP initiative to increase access to treatment and care. At CND68, with Norway we tabled a resolution. To translate it into action, Thailand hosted 2025 international conference to address this issue. This is important to address mental health impacts of drug use, particularly jabba and meth cause psychosis. We call for more research and international collaboration. Lastly, Thailand ensures commitment to evidence-based policies and sustainable solutions for health and dignity.

CND Chair: Moving to interactive discussion. Russian Federation has the floor online. Are you online Mrs? maybe we wait. Colombia you have the floor.

Colombia: More than 87% lacks access is one of the most pressing challenges for Colombia. Access is possible. But it has to overcome significant barriers. As shown by UNODC, there is a clear access gap between developed and developing countries, hence we need to address this issue from a development perspective. Drug control policies should ensure they not impede access to medications and harm reduction measures like methadone and naloxone. Colombia prioritizes availability and reducing access costs. Equitable access for medical purposes should not be a privilege. This is a human rights matter. This is a gap that will take 200 years to close as described this morning.

Zimbabwe: In Zimbabwe, he regulatory framework includes 2 statues: dangerous drugs act covering manufacture, import, export, prescribing and record keeping. … Also embedded opioid analgesics into national clinical practice guidelines and standard treatment guidelines, including naloxone. Reform was introduced to DDA to authorize palliative care trained nurses in certain settings to prescribe and administer morphine. This measure has expanded access, particularly in rural facilities. Issuing import permits, licensing channels, and a national palliative care strategy was adopted. Civil society organizations have partnered with government to strengthen governance and safe opioid use. Made significant progress in availability. These efforts demonstrate commitment to patient-centered care while upholding drug control obligations.

Australia: … Southeast Asia and the Pacific Islands. Supporting the joint global program and its implementation particularly in Fiji. Domestically, PBS ensures medications to patients regardless of their financial circumstances. Opioid dependence treatment medicines are subsidized under PBS. Medicines for HIV and Hepatitis C are also supplied under the system. License and permit scheme facilitates import and export, including for medical purposes. Commends the UNODC on the Young Doctors Network. Vital role in equipping medical professional with the right information.

China: ……

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Ghana: … support the UNODC Young Doctors Network. .. we call for enhancing collaboration on technology transfer in line with WHO guidelines. Gahan remains concerned about nonmedical use of tramadol especially among the youth in West Africa.

Thailand: ….

Belgium: Would like to share experience with digital tools. National digital prescribing system … brought progress but challenges remain. Reporting is not always real time, leaving manual entry often. Promising predictive AI is not yet developed enough…. Belgium supports the Young Doctor Network African Chapter and the development of WHO guidelines on balanced policies. 3-year project on affordable health products in Africa. Belgium remains committed to patient-centered approaches. Strengthen prevention and protect public health globally.

France: Recall we are a signatory to the 1961, 1971, and 1988 Conventions. … National chemical precursor mission is controlling the licit trade in chemical precursor drugs. It issues national normative authorization, for example raw materials. It participates in the drafting on international, European and national texts. Submits to the INCB. Quarterly and annual statistical reports on …..

Japan: worked closely with the UNODC and international aprtners to promote balanced science based response. Essential to protect domestic societies, but our collective responsibility to uphold a more stable international community. Ensuring equitable access to substances like fentanyl is not an option, but a moral obligation to humanity, including in LMIC. In Japan, fentanyl and other narcotics are strictly regulated by a licensing system. Fentanyl is prescribed primarily for cancer-related pain. These approaches are shaped by societal concern over opioid dependence. Japan conduct public awareness campaigns and training on the medical use of fentanyl. No country is immune to the fentanyl crisis. No country should take isolationist approaches. International cooperation is the only viable path forward.

Malaysia: the adherence to the conventions should be accompanied by each governments sovereignty … We condemn the unprovoked attack on the Global Sumud Flotilla. This is a lawful mission carrying humanitarian aid. The attack is a fragnant violation from Israel of international law, maritime law. Palestinians face genocide, starvation, and health systems. The international community needs to take immediate action. …

South Africa: Thank you for the opportunity to contribute. …. For millions across Africa, the cost of controlled medicines means the difference between care and unimaginable pain. Yesterday afternoon talked about falsified medicines. It is becoming a major concern for the continent. The south African regulator authority established medicines act responsible for prescription rules that ensures access while preventing diversion. Pharmacy act regulates training, regulation and operation of pharmacies. The use of essential medicine list and standard guidelines. … Look forward to discussion at regional meeting tomorrow.

Ukraine: …. Congratulations to Armenia who will be the next chair. Even in the most difficult situation of war, committed to drug control. For the last three years… this has .. rapidly growing psychological burden among population. Despite these challenges, Ukraine remains resilient and committed. We provide services, including harm reduction and treatment to protect our people… in August 2025, adopted a new national drug strategy. In the contaxt of war, we need to strengthen access to medical care, psychological support and care. Underlines access to essential medicines, pain relief in conflict situations and for those demobilized. Our approach brings together health, social services, civil society, community-based providers. Urgent need of prevention and harm reduction programs on NPS and stimulant drug use. In line with Eu drug strategy and national drug strategy, we see the balance across the three core pillars: supply, demand, and harm reduction. It is essential.

Peru: Pleased to see a member of the regional group chairing the session today. Peru made important efforts in treatment and health services, especially expansion of access to controlled substances. First is the budgetary program for prevention and rehabilitation on drug use, with emphasis on family. This program strengthens care for people with addictions, integrating them in the national health system. Recently implemented a regulatory framework for use of cannabis. Also integrated supply system for pharmaceutical … . Need to expand coverage and availability of therapeutic care.

Portugal: we hold regular meetings with manufacturers. Use electronic prescription system that help manage supply more efficiently. Stakeholders responsibilities are clearly defined. Transparency is reinforced through publication of these information. Export permits are only granted when national market is fully guarded. Special permits are issued for authorized and non-authorized products.

INCB: regional disparities affect access to essential medications. Per capita daily doses have increased in regions with historically low consumption – eastern and southeastern Europe, East, Southeast and West Asia. Consumption of opioid analgesics…. The consumption of many psychotropic – clonazepam and fenabarbital remains low. These substances play vital roles in treating conditions like anxiety and sleep disorders. Telemedicine has improved access. Ensuring access during humanitarian emergencies is essential. INCB urges member states to utilize the provisions for this. Conducted training for competent authorities in the horn of Africa and francophone Africa. E-learning modules and capacity building activities. INCB invites all member states to actively engage with the program.

Russia: chief specialist in palliative care has technical issues, we will deliver from room. The limited access to opoid at the end of last decade was recognized by government. Analysis was conducted to identify causes. Issues like overly complicated legislation, low competency among doctors, reluctance to engage on this complex issue, and fear of leaking to illicit circulation. Legal barriers … Government hotline that accepts complaints about prescribing 24/7, issues resolved within one business day. Noninvasive medications such as oral solutions are now produced in the country. Allocates additional funding to regional authorities for purchase of narcotic medications. Educational online moduls are available. Ongoing educational initiatives – monthly trainings and forums on palliative care and pain relief. As the main medical university, szechin has been operating a palliative care center for five years. Training doctors from post-Soviet countries. My delegation will use the right to reply with regard to several statement made during the intersessional, which we will use in the afternoon session.

Young Doctors Network: UNODC YDN was established in 2023. Over the past two years, instrumental in advancing the agenda. Notable achievements: in march 2024, the YDN advocated for enhanced collaboration between regulators and health professionals. At the 68th session, YDN encouraged MS to promote research identifying barriers. In June 2025, the YDN organized an advocacy webinar series. To strengthen regional advocacy efforts, UNODC has established the young doctors Africa regional chapter.

International Federation of Medical Students Association: The International Federation of Medical Students’ Associations represents 1.5 million medical students worldwide in over 120 countries, and firmly believes that every human has the right to access controlled medicines for pain relief and palliative care. We believe the current market is profit-focused and must prioritise the positive health outcomes of accessible medicine. We support the inclusion of medicine accessibility in the development of Universal Health Coverage (UHC). Access to essential medicines, including internationally controlled substances, is a human right and a cornerstone of public health. Yet, 83% of the world’s population lives in regions with little or no access to opioid analgesics, while just 21 high-income countries consume nearly 90% of all controlled opioids. Millions of patients, especially in low and middle-income countries, live and die in unnecessary pain because morphine and other controlled medicines remain out of reach. This inequity is not due to a lack of knowledge but due to overly restrictive regulations, weak supply chains, stigma, stigma and market barriers. IFMSA works to address these barriers through advocacy, education, and capacity-building, including our work as part of the UNODC Young Doctors Network. We urge governments to ensure that national regulations strike a balance between protecting against diversion and not blocking legitimate access for medical and scientific purposes. We urge Member States to utilise the TRIPS flexibilities to promote affordable generic production, strengthen pharmacovigilance, and invest in training health professionals on the rational and safe use of controlled medicines. We also call for global cooperation between governments, WHO, UNODC, and civil society to address supply chain gaps, promote transparency in medicine pricing, and mobilise resources so that no patient suffers because of political or economic barriers. Ensuring access to controlled medicines is not just a technical issue; it is a moral imperative. As young doctors and future healthcare professionals, we stand ready to work with you to make access to medicines a reality for all.

Students for Sensible Drug Policy:  I am a graduate student studying how psychedelics affect the brain’s ability to adapt to chronic stress.  In recent years, controlled substances like psychedelics have shown tremendous promise in the treatment of psychiatric, neurologic, and pain-related conditions. However, access to these substances for researchers, like me, remains difficult. In the U.S., if a researcher wants to study a Schedule I controlled substance, they must undergo an arduous registration process which often takes longer than a year, delaying critical research and medical breakthroughs. Laboratories must undergo expensive modifications and researchers must submit detailed experimental protocols and rigorous justification for the use of controlled substances—both of which are often challenged by federal agencies.  This laborious process prevents exciting scientific hypotheses from being tested, resulting in “research harm” or the chilling effect on scientific or medical research caused by onerous regulations.  A scientist may have an idea that, say, a psychedelic could serve as a treatment in a model of a disease state in an animal. They may wish to test this in an experiment. But if this researcher has to wait over a year to get approval through a labor- and time-intensive process, they may (and often do) decide to simply pursue other avenues of research.  Given the status of the global mental healthcare crisis, all avenues of potential treatments must be allowed to be pursued and exciting ideas must be tested. Now, more than ever, the status quo is simply unacceptable. But potential solutions remain in sight. In the U.S., the HALT Fentanyl Act was recently passed, providing potential reasons for hope for myself and fellow basic researchers. While SSDP remains opposed to class-wide scheduling of substances and the War on Drugs, there are positive provisions in this bill for researchers, namely a streamlined process for researchers to study drugs in the most restrictive classifications—Schedule 1—at the federal level. It simplifies application requirements, imposes a 45-day limit on application wait-time, and eliminates the need for separate registrations for researchers at the same institution.  While much is still unclear about the HALT Fentanyl Act, if implemented properly, this legal framework may serve as a model for other member nations to follow. HALT Fentanyl is not perfect legislation; it could go farther in easing access for researchers. But it is a positive first step.  Scientists are partners in global health; research registrations should be made as simple as possible so the risks and benefits of controlled substances can be carefully studied and described. We encourage our fellow member nations to implement legislation similar to HALT Fentanyl’s research provisions to promote access to scheduled substances for researchers.

NGO: …..