CND intersessional meeting, 26 september 2018: Access to controlled substances for medical and scientific purposes

Chair: Good Morning. Let’s start right away with the presentations and take advantage of the opportunity to conduct interactive sessions.

PANEL: Dr. Gilberto Gerra, Chief of Drug Prevention and Health Branch, UNODC: Access to controlled drugs for medical purposes while preventing misuse and diversion. For long time this aspect was not paid attention so now is the time for us to realize that one of the prime aims of the conventions is to have access to medicines. I want to remind you, the control system is alive, last CND we made decisions to schedule new substances, so on the proposal of MS, WHO makes evaluations and we report to the Commission and consider control. In many MS access to controlled medication is almost non-existent, it was a special issue in the 2010 report. UNGASS in 2016 two pages are devoted to this issue. The purpose is to move drugs from the streets to pharmacies, for legitimate use. The problem is that they are not available to professionals, but they are on the streets and are dangerous. We have to find a balance between control and availability. We have an impressive case with ketamine – China proposed to put it under control, but I want you to observe my slides and understand that in many countries it is used for medical purposes and we have to recognise their importance in medic. Pain relief is a human right. The disparity is enormous: 17% of population account for the 90% use of morphine while there is a huge population in need.
A large rate of overdoses is not unintentional, they are suicide cases. This should be very alarming, and we have to start thinking about it more than a demand reduction program. In the World Drug Report, you can see the pro capita consumption do not respond to availability.
Additional restrictive measures, we found a grey area: there are MS that add restrictions that are not directly related to reduction of problems, but they are creating problems, for example restriction for doctors’ prescriptions and pharmacies. We work with other health related UN agencies to improve this issue. To reduce barriers, we need trainings, culture changes – we have to create a new generation of professionals, law makers, etc, we have to dismantle prejudices.
Referring to the outbreak in the US: To avoid diversion and abuse, we have to align national rules to conventions, systematic monitoring, and case by case managing. Providing drugs together with interpersonal relationships, you have to mediate your relationship with your patient and drugs. We have to have full respect for individuals, their attitude, personal view, religion, etc. not just have doctors as conveyor belts for drugs. This is what compassion looks like in the brain.

Chair: Questions first, then we respond.

Egypt: I’m a fan of painkillers myself. I think what we have to take a good look at is not just availability but the quality. To be honest, in my country some of the painkillers that we seize from overseas have lethal ingredients and not fit for human consumption. Control effects availability as you said, don’t we have a variety of options when it comes to international control? Don’t the schedules allow us to have proper control?

Iran: One person that really understand this is me because I’ve been dealing with pain for 30 years every day. Maybe we have availability but in many countries,  there is a problem about logistics and finances and culture – what can we do about that? What can we do for countries that really need it, especially in Africa? As the report shows 80% of people don’t have due access, but in other countries there is an epidemic. What can we do?

Belgium: I saw passion pragmatism evidence combined in the presentation! We are informed in reports of the worrying use of opioids. As you showed today, the causes are multi-factorial. Do you see a decrease of motivation of policy makers and health professionals as a consequence, if so what can the international community do to counter the situation?

China: You mentioned China in the presentation: our initiative of pushing for the ketamine scheduling. We sent many medical personnel to Africa and helped build hospitals. According to our knowledge it is not the only drug that Africans can access so your claim that it is the only available painkiller doesn’t uphold. In hospitals built by China in our medical teams sent there, it is not he mainly used drug. To my knowledge, ketamine is mainly used for infants and for animals. We know it is used for animals in many European countries. Why don’t we give Africa the same medicines? Why do we let African countries use animal drugs? We believe Africa has the same right to access the same drugs, so we appeal effective and practical measures to be adapted to increase support for developing countries, in particular we appeal to those countries who use human rights as a main pillar for their foreign policies. Guarantee for scientific purposes: we noticed conventions guarantee these but at the same time we believe that these are cornerstones for our fight against drugs, therefore the focus of the conventions is reducing harms, so from this perspective we believe preventive measures are much more important for our discussion. Guarantee for medical access is a provision and is in the mandate of WHO so we hope the next step for cooperation of international organisations is finding a solution.

USA: Many rural regions have access but don’t have trained personnel and proper facilities. How can we increase the access there?

Tanzania: low availability in Sub-Saharan countries. What is UNODC’s strategy to help us train professionals, raise awareness and affordability?

Dr. Gilberto Gerra, UNODC: To Egypt, indeed the quality of medication available is problematic. Criminal organizations outside the system produce the substances in illegitimate frameworks. We have evidence about adulterants – some are unimaginable! It’s a correct indication of Egypt of the schedules. But why should schedule 1 be a problem for medical access? I think we should consider grey areas.
To Iran, […]
To Belgium, we should realise the problem is not only availability, there is a number of elements.
To China, on ketamine, there is a reason it is used, it is a dissociative anaesthetic. it doesn’t reduce the functions of the central nervous system as many other substances done. I am sure you have great strategies, but we have to think of countries where China is not present. Why should be there a problem if we put ketamine under control? We have to understand the real impediments in access to controlled medication.
To the USA, it is a re-emerging problem. There is a lack of capacity and also for evaluating the needs of people in need of pain management and engagement of health professionals.

Slovakia: People who become addicted suffer from various problems. Shouldn’t we deal with double diagnoses? People who use prescription medicines often also suffer from mental health issues.

Morocco: The unequal use is not connected to the lack of materials. The obstacles influencing availability can be regulation, behaviour, logistical and cultural factors as well as the environment. In some African countries it is worsened by poverty and conflicts. We lack a real assessment of the problem. Are the specific programs by the UN organizations to assess the situation and provide technical assistance?

Dr. Gilberto Gerra, UNODC: Slovakia mentioned an interesting point, we indeed should be screening for mental health disorders. For example eating disorders can shift to addictive behaviours. If they have true pain, we can’t deny access but we have to have proper assessment. If we have time, we will show pilot projects for providing technical support.

PANEL: INCB: Dr. Gerra mentioned the conventions and there are 3 fundamental concepts: controlled substances are indispensable, they should be adequately provided and unduly restriction should be avoided.
WHO recommended countries to compile a list of essential medicines. Psychotropic substances are not often mentioned, but they have importance – diazepam, lorazepam, midazolam, phenobarbital is used for anxiety disorders. 88% of morphine is used as cough syrups, only 10% is used for direct consumption – 92% of that is used by the 17% of the World.
The opioid situation is presented in a map: 50% more consumption in the US than the need, similar to Canada and availability drops drastically when we look at Asia or Africa. Diazepam shows similar instability. In terms of daily doses, huge increase in fentanyl, morphine is relatively stable – it is affordable and available, but many countries find it difficult to have because it is not profitable for pharmaceutical companies to circulate.
Most recorded impediments to access: lack of training, fear of addiction, limited resources in procuring, cultural/social attitudes. Based on this we made some recommendations and I believe it was duly considered during UNGASS.
Solutions: e-prescriptions, review of domestic legislation, simplify processes, maintain control mechanisms, regular assessments, expedite the process of issuing import/export authorisation. Administrations have to work together with the private sector and work on building capacity and develop due training.  We launched GLOY04 in 2014 and the WHO issued three new guides on palliative care recently. Measuring progress: questionnaire to governments on the UNGASS outcome implementation to which 130 responded and results will be published in the INCB Annual Report in early 2019.

Russia: Ministry of Industry and Trade – We joined the conventions on drug control to ensure the availability for medical and scientific purposes. In order to coordinate actions, there is an order from the government to increase the medical accessibility. As part of this, with leading manufacturers, we have 29 medicines that are listed and licensed for legal use from the schedules -some are prepared by companies locally and some are imported. We considered cultivating opium poppy to meet the needs of the country without clashing with the conventions. How does home produced raw poppy effect….? Russia is continuing ensuring necessary legislation to avoid ending up in illegitimate use.

Chair: please refrain from national statements at this point in the meeting. I encourage questions.

Afghanistan: The presentation mentioned that 80% of the world’s population doesn’t have access to proper pain medication. At the same time countries are not allowed to use seizures for medical purposes. How do we deal with this paradox?

Argentina: I’d like to hear both panellists opinion on the matter of undue restrictions. Argentina has been working on monitoring and providing training but there is on barrier that is more difficult to overcome: social perceptions and cultural attitudes both among the medical community and patients’ family. What campaigns, actions are most effective in your opinion?

China: Availability of controlled substances is still alarming in many countries. What are the standards and criteria when we make such judgements? We should not use data from developed countries to make global judgements. Iran has talked about his personal experience and he said his medicine he used to use is no longer working for him. In developed countries, the doses are very different than in developing countries. How can we take on board all these different factors?

INCB: Congrats to Russia on their measures to ensure availability for those in need while maintaining the control system. For Afghanistan regarding seized illegally produced material, you have an obligation to destroy that not to give an incentive for further production.
To Argentina, the availability and the infrastructure is not sufficient indeed, I will let other panelists respond to this in more detail. Regarding the bias, one of the characteristic of the US opiate epidemic, it was restricted to white working class males, but more recently, there is an increase in use by women and African American communities. Many of the doctors (he has evidence) were not describing opioids to African Americans because they expected them to be more at risk for developing addiction.
To China, it is difficult to precisely estimate that. We have been using data based on the WHO’s world-wide collaborative work and global estimates relying on disease experts. Certainly there is room to improve but it is a good proxy for now, otherwise we would be operating in the dark.

Belgium: Cooperation with industry – we understand it can depend on affordability, but can you elaborate on this a bit further?

Iran: I would like to highlight two problematic points in the presentation. You mentioned 80% of the World’s population is left behind, on the other hand stocks are enough to cover demand. It’s important to know how this gap can be closed and how INCB and CND could contribute to the solution. We would like the presentations to be shared via email.

Secretary & Chair: We made a special sub-website for capitals to access information.

USA: INCB collects a lot of info on manufacturing, what do they do with this information, especially tracking drugs manufacture to country? When you find a substance is unduly restricted, what does the INCB do?

India: Addiction is related to prescription drugs, now the unavailability in Africa indicates some bias […] How do you resolve the balance between unavailability and lack of an addiction problem?

INCB:  Regarding industry cooperation, there are many steps that can be taken, eg. promoting social responsibility, conditioning the importer, aiding regional hubs. In the case of morphine, there is no patent, it is easily produced and the board is encouraging the pharmaceutical industry to make generics available, so it is up to MS with large manufacturers to encourage progress.
What is perceived to be sufficient, in response to India, I think countries need to assess the needs a lot more effectively, this is what we found on our country visits. This requires efforts from the countries. On the difference between pain medication and vulnerability to dependence and train doctors should be able to screen this.
To the USA, yes we have a lot of data as is the obligation of countries to share these, but if destination countries don’t report, we have a discrepancy and we follow up to try to verify, most cases are due to clerical errors. We notify authorities anyway. We encourage countries to review legislations. Regarding manufacturers, we don’t have direct relationships, it is up to member states – some have built good relationships.

PANEL: John Cleary: I am here today to highlight the joint global program, a wonderful join international cancer control, UNODC, WHO. est in 2013. First, we worked in Ghana with a number of resources UICC, UNODC, INCB. With the support of Australian government, we participated in a number of meetings to ensure access to opioids. We improved the supply chain and training schemes. Third area we work in is Congo with Palia Familia, we provide training materials and help implement campaigns, talk to the media, etc. Our materials have been translated to French. We believe there is a need for strong civil society involvement and we appreciate the contribution of UN agencies. We need to ensure balance between access and preventing diversion.

PANEL: Alberto Miguel Guzman, Mexico: The two main issues today: ensuring access and preventing abuse. The unit I am responsible for, regulates the production of substances while preventing diversion. In 2013 WHO, INCB and Human Rights Watch informed us 54% less of the world-wide morphine was available which gave rise to a warning within our national office. There wasn’t so much as a shortage of morphine, but it just didn’t reach the patients in need. In order to respond, we launched a campaign for pain control and palliative care. We brought together various national, federal institutions, industries, representatives of the judiciary. We aimed to coordinate and ensure proper implementation of care. In 2014 the general health council published mandatory action to be upheld by health actors. Among others, we implemented e-prescriptions. In 2015 we set up a platform to deal with the e-prescription that streamlined the process for accessing medicine. Important to note is that this platform ensure total traceability. We also carry out statistical studies based on the data gathered on the online platform to improve policy making.  We also participate in intergovernmental programs, we carry out visits to public and private hospitals to ensure responsible prescriptions. We have a set of guidelines for pharmacies as well, informing them of consequences to not complying. This year, we are planning to set up a complementary platform that comprise pain control medication and to ensure oversight. When we carry out monitoring visits, it is a good opportunity engage with personnel. We plan to put an end to the paper based system and issue an online booklet with relevant information.

USA: Does Mexico collect information on the prescribing patterns of providers and what do you do with this information?

Brazil: I am also curious what the USA asked. Is there any data on the distribution throughout territories? In the morning we were talking about access, now once a doctor uses a system, based on your experience, it is easy for the patient to access the medicine?

Mexico: The system identifies the most frequently prescribed. What do we do with the data? Within our scope, we try to regulate medicines most effectively. The system applies to all narcotic medications. We discuss with the private sector. As to what Dr. Gerra said concerning prescription requirements. Here, narcotics are subject to limitations to treatment that take 30 days. The implication is that if a patient has a more complicated illness, their prescription is problematic to be subscribed once.
We see differences between poorer states and more developed states when it comes to methadone. Many drug dependents receive replacement treatment in Tijuana. This doesn’t come under palliative issues. In terms of ease of access, it depends on the patient’s location, so less populated areas have larger difficulties, but we have efforts under way to facilitate access for remote communities.

Ecuador: It’s important to understand what incentives are given to doctors. Who covers the costs of the platform?

Russia: We also planned to implement a similar service soon, so one technical issue: is this platform on a federal level or does each state have their own platform? Is the e-prescription is duplicated in paper form to be given to the patient?

Mexico: On incentives, it is mandatory for all hospital units to have an area for palliative care and sufficient trained doctors to prescribe these medications. We are working with the medical community to promote the platform and generally improve the manner of prescription. A former university dean has been spearheading an initiative to ensure in 2019 the specific issue of palliative care to become part of the curriculum.
We cover the costs, the day to day costs are really low as it is not a complicated system to run.
Concerning controlling substances, it is undertaken by the national, federal agency.
The platform makes sure the data of the doctor is restricted and papers are retained in the pharmacies until the monitoring visits.

PANEL: Medecins Sans Frontiers, Switzerland: The first time I was confronted with pain management as a new graduate. I was the newest resident and saw many injuries and cancers. By the end of the day, our professor locked the cupboard with all the pain medication and we had to call him when we needed. It was in the days before mobile phones so by the morning, we had patients in horrible pain and we could visibly see the medication but couldn’t help them. Since then, I worked for several organizations in about 30 countries, currently for Medicines Sans Frontiers. Palliative care is a daily reality. The cases we manage range greatly from humanitarian crises (in reality, this is where you need most pain medications)
The step between hospital to patients is the problematic one. In large hospitals, many sophisticated ways exist, but outside that in low resource areas and most in need, they severely need help. But we have dealt with chronic infectious diseases, daily injuries, cancers as well. The problem with consistent, dignified palliative care is multifaceted – unavailability, regulatory hurdles especially in time sensitive cases. Palliative care in not acute situation, especially in underdeveloped areas, we receive late presentations so often that often all we can do is alleviate pain. There are many diseases that are treatable but with lack of medicine, expert, infrastructure, we can’t treat them.
Just to add to the Ketamine debate, it has been used successfully for appropriate anesthesia for surgery when we don’t have the proper equipment on site. Most often in giving birth in low resource areas needs ketamine. The ability to get trained personnel is one thing, the other is willingness to use. Opiates are so stigmatized, people hesitate to use them as medicines. Malnutrition and malaria in Indonesia were leading causes for death when we worked there. Practitioners there said patients are not in enough pain, so there is a fear of overestimation when they evaluate pain as moderate. The situation fortunately is much more acknowledged now. There has to be a larger degree of flexibility both by providers and receiving countries. Humanitarian crises impose complications to regulatory systems and we have to be flexible about it. We have little access to opiates because regulatory restriction so we use tramadol a lot more, but there are more effective substances. The situation in humanitarian settings is very different and for effective management and control of misuse, some revaluation is needed. The Lancet Commission’s “access abyss” is a relevant concept. Access issues are due to lack of research and development or prices, but with morphine, it is not really complicated, so the situation is puzzling.

Egypt: We agree with most of what was said. We believe there is importance to have better availability in humanitarian conditions, but regarding tramadol – when countries speak about scheduling tramadol, there are plenty of different tables to sort it, it does not necessary mean restricting it. African countries face a lot of humanitarian situations. INCB reports on increased abuse of tramadol in our region and university studies report similar. Last CND, the African group highlighted the INCB report and urged the international community to take steps to address this problem through considering scheduling tramadol while ensuring medical access. I think countries in humanitarian conditions can speak for themselves. MY country is a producer of tramadol, so we believe it is important that this to be supervised.

Slovakia: Concerning tramadol, we have to weigh risks and gains, if we put the limit too low or too high on regulations, how much suffering can it cause… It is now unregulated, any medical doctor can describe it, but most patients really need it who use it. In developed countries, the use of opioids for people who suffer from opioid addiction, so there is a fear from doctors to prescribe.

Belgium: We are struck by the distance you mentioned between the hospitals and patients. What measures do you recommend to tackle this?

Chair: Have humanitarian personnel been assaulted by criminals to gain access to the substances? OR has it created black markets in the regions?

Switzerland: Egypt, we acknowledge there are cases of abuse, we don’t say it shouldn’t be regulated. We say that despite the provisions in the treaties, once substances get scheduled, they tend to become less available and we fear the same fate for tramadol. Then we would have very little tools in our hands to treat pain. To Slovakia, we have very little experience in addressing the outcomes of addiction, the target is not treating withdrawal, but it is an issue that people with high dependency suffer from other illnesses and we are working on a solution.
Tackling the distance was one of my main points. It is absolutely important so secure medicine in hospitals, but the main issue was the lack of confidence – we have been told to reserve this as a last result. I don’t believe that. Pain should not reach intolerable levels to be alleviated. Many practitioners fear causing overdoses, so we have Nalaxone and etc. coming together, but it is an uncomfortable topic. So, we should highlight the needs of patients and aim to change the culture that makes stigma possible.
The criminal threat is real, many cases we are in places with problematic areas so we are in constant danger because of all our equipment – we have money, we have tools, so securing our staff and equipment is an important element to our work. There hasn’t been a targeting specifically for opioids.

USA: The scope of the control laid out in the conventions – how can we support countries to ensure access while preventing diversion?

Switzerland: I have little qualification to talk about the legal frameworks. The further you go from capitals, the further you go into humanitarian settings, the further from where laws are written, the less is available – personnel, medicine, infrastructure, everything. There is a distinction in what is theoretically available and what reality is in a given country. We have experienced this that we provided service, but 5 kilometers outside of our reach, mortality rate doubled.

Chair:  morning session adjourned.

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AFTERNOON SESSION

PANEL: Dr.Lukas Radbuch, Lancet Commission: Thank you Chair, esteemed delegates, ladies and gentlemen. I am a palliative care physician and anesthesiologist, and a member of the Lancet Commission on Palliative Care and Pain Relief. I have worked in, and trained physicians in Uganda, the Gambia and India. I am here today to tell you about the severe health related suffering experience by more than 61 million people in the world’s countries, as a result of lack of access to internationally controlled essential medicines, and how it can be relieved. Severe health related suffering results when illness or trauma is not relieved by medical interventions, and when it compromises physical, social or emotional functioning. This kind of preventable suffering creates enormous economic and developmental burdens to individuals, communities, and government. More than 83 percent of people experiencing severe health related suffering live in low and middle-income countries with unbalanced drug control systems that make opioids such as oral morphine unavailable, inaccessible, unaffordable [1]. In countries with balanced systems, on the other hand, access to these medicines ensures their appropriate use in palliative care, surgery, and primary care, and prevents diversion and misuse. The good news is that the Lancet Commission has developed an essential package of palliative care that all countries can make available to treat health related pain and suffering in their countries. At the center of the essential package is immediate release, oral and injectable morphine, a medicine that has been on the WHO Model List for many decades. The essential package includes other medicines and medical devices for symptom relief, and human resources from physicians to community health workers and volunteers. It is not expensive. Per capita cost estimates for three countries run from between 27 US$ in Vietnam and 122 US$ in Mexico for the medicines in the essential package, and between 119 US$ and 796 US$ per capita for the whole package. This represents less than 1% of current health expenditures in Vietnam and Mexico, and only 3.4% of the Ruanda health budget. The Lancet Commission Report provides clear recommendations for governmental and nongovernmental stakeholders, covering stewardship, building public awareness, monitoring and evaluation, universal health coverage, training and capacity building. Most importantly for CND, it supports the recommendations of Chapter Two of the UNGASS Outcome Document, which directs UN member states to improve access to internationally controlled essential medicines. AND, It supports Target 3.8 of the 2030 Agenda for Sustainable Development, which calls for Universal Health Coverage (UHC) and access to essential services and medicines. Member states can implement it with guidance from WHO, INCB, UNODC, and civil society organisations such as IAHPC. We do not expect you to implement it on your own, but can rely on our national and regional palliative care organisations to support you as you operationalize your commitment to move forward to relieve severe health related suffering in your countries, implement the UNGASS Outcome Document, and achieve the Sustainable Development Goals.

Slovenia: Last time in many countries using for palliative care a combination of opioids and cannabinoids, can you tell us something about that?

USA: Access is critical and CSO participation that brought this issue to the front so thank you for your work. Can you please elaborate on healthcare providers’ role?

Tanzania: Low accessibility and availability in low-income countries – social acceptance is one of many issues, but we also see issues in attitude and a lack of knowledge. In Tanzania pharmacies were responsible for dispensing methadone, but there was a growth in drug use disorders, so when I was in Mozambique who are about to launch the methadone program, they saw the regulatory environment, it was an issue. So, I was thinking, the model used in Uganda, a little more flexibility is needed while observing diversion.

China: What is the picture of an ideal atmosphere where we can have a balance? Do you think we need to delete the word narcotic when it comes to medicines?

CSO (?): Cannabis are highlighted an emerging hope, but I have to say it has been used for thousands of years – we in Germany a bit disappointed in the effect as an analgesic. It is more like codeine… it doesn’t give sufficient pain relief. About the public awareness question, it is a good point. Most physicians are only willing to subscribe it if the patients is dying. Information material from cancer societies with good patient access work best in raising awareness for the general population. Changing attitudes take time, but it’s a worthwhile project and the best way to start is changing training for health care professionals. For Tanzania, I like the suggestion of nurses being able to prescribe opiates, then it means they have received a good, rigid training and that they are supervised while they set up their programs. I believe that is the only way to reach rural areas where it could be that people never in their life see a doctor. For the question about atmosphere, I hope the Lancet report will be available in every country and there are ways to provide the essential package in any given scenario. That is my ideal vision, but we might be a long way from that.

Slovakia: It is important that you mentioned you expanded the indications. We use ketamine in palliative care, but it should be standard procedure in specific conditions. For the other colleagues, who are not professionals, there are conditions where opioids are the best response (for example breathlessness), but we need more standards and evidence to fall back on. Is there a work of WHO or other UN agencies?

CSO (?): Breathlessness is technically off-label use, but yes, thank you for mentioning this horrible condition. Unfortunately, the only guideline by the WHO is the pain guideline that id on the way and we hope it will be out by the end of the year, based on evidence. Production of such papers is very expensive, so I encourage funding for WHO.

PANEL: Sri Lanka: When we consider these drugs, we abide by the conventions and made regulations accordingly. When it comes to dangerous drugs, we closely work with the Ministry of Health it has a medical supplies division and collect data on hospitals and issue permits on amounts to import to the National Narcotic Bureau. We ensure that these drugs are used for scientific and medical purposes, we are in a good position to monitor and regulate. We have other chemicals on the market and monitor them closely. We also monitor transportation, storage and distribution… we are doing a great job for comprehensive monitoring to avoid diversion. We further aim to improve legislation to look at end-users so in the future we can do a better job.

Chair: Ensuring availability lets finish this discourse.

Norway: We depend on these controlled substances to alleviate pain, we use them for significant purposes. More concretely, cancer is on the rise so the need for pain alleviation is on the rise. UNGASS is a good step but we would like to see better working when it comes to accessibility. We believe focus should be on reviewing the regulatory frameworks and regulate substances in a way that cater to medical needs and make sure that access is not restricted to cities. Our experience says it is possible without addiction epidemic. In addition, we have global funds to fight, we have been supporting these for long time, but when it comes to controlled substances there are fears and prejudices that need to be overcome.

Austria on behalf of the European union: Madam Chair,The European Union and its Member States wish to thank you for organising this intersessional meeting in which we can continue the preparations for the Ministerial segment of the 62nd CND with a special focus on the availability of and access to controlled substances for medical and scientific purposes as well as share our experience in that field. The EU and its Member States appreciate fully the importance of the access to and availability of controlled substances such as opioid medications in the treatment of pain and opioid dependence, whilst also acknowledging the potential for the diversion and misuse of these medications. The global lack of access to and availability of controlled substances for pain management, palliative care but also the treatment of mental health and neurological disorders, such as anxiety and epilepsy is indeed a global health concern, and leads to avoidable and unacceptable suffering in many parts of the world. At the same time, the growing misuse of some psychoactive medicines in certain parts of the world is highly problematic. However, the opioid epidemic in certain parts of the world cannot disengage us from ensuring adequate access to and availability of controlled substances globally as enshrined in the UN drug conventions and confirmed in the UNGASS outcome document. We are of the opinion that it is the enforcement of the provisions in the existing framework of the international drug control conventions that provide adequate guarantees to prevent the misuse of psychoactive medicines. We also note, however, that the inadequate interpretation of the international drug control systems in place may inadvertently limit the availability of and access to the medicines. The EU and its Member States advocate the need to remedy the situation as for example in some of the actions outlined in the EU Drug Action Plan for 2017 to 2020 that tackle both aspects, namely availability and access and diversion, in a balanced manner. Thus, seeking to increase the availability of and access to these medicines, medical practitioners and other health care professionals receive special training on the use and regulation of such controlled medicines as part of their continuous professional development. One example of an EU action as regards this particular topic is the EU project CODEMISUSED, developed by a partnership of researchers and pharmacy industry experts. The results of the project will increase understanding of customer sales, purchasing habits and patterns of use, misuse and dependence, as well as will allow strengthening tracking systems, pharmacy dispensing practice and prescription procedures, along with treatment protocols, public health and drug information campaigns. This in turn, may provide an example of a best practice approach on how one is to better provide availability of and accessibility to these controlled medicines without inadvertently aiding and abetting their diversion.
We believe that the methodology and results of the EU-funded project on access to opioid medication in Europe, called ‘ATOME’, such as the use of the WHO document on “Ensuring balance in national policies on controlled substances: guidance for availability and accessibility of controlled medicines”, could provide examples for interested UN member states, by developing tailor-made solutions for improved access to opioid medicines. Several EU Member States finance concrete projects on the ground in Africa in the framework of the UNODC – WHO – UICC Joint Global Program on “Access to Controlled Drugs for Medical Purposes While Preventing Diversion and Abuse” or the INCB Learning Project. In Nigeria, the EU-funded project “Response to Drugs and Related Organised Crime in Nigeria” has taken a comprehensive approach to drug control issues that includes a special focus on increasing access to controlled medicines within a context of a strong regulatory system that protects patients and healthcare workers from harm. The EU highlights that the reference documents of this project have first been elaborated with national competent authorities.
Madam Chair, The EU and its Member States support the efforts of the WHO, UNODC and INCB in providing technical guidance and assistance in tackling existing barriers and guaranteeing the availability of and accessibility to controlled substances for medical and scientific purposes for those in need. We are glad that the topic of access to controlled medicines constitutes one of the six areas of the Memorandum of Understanding that was concluded between the Executive Director of UNODC and the Director General of WHO in 2016. In the same vein, we welcome a regular exchange of views and the enhancement of coordination efforts on this issue among these competent organisations. We also underline the importance of working with civil society and scientific community, as well as the private sector in this area given their role, expertise and networks. Thank you.

Australia: We have taken active role in promoting accessibility to controlled substances, we are greatly concerned that so many citizens in areas don’t have the possibility to proper pain alleviation. We must work together that the treaties are not interpreted in a way that impedes access to medicines. In 2016 we reiterated our intention to improve training, supply, quality, etc. Many social and cultural indicators also need to be seriously addressed. We developed a framework that demonstrated that it is possible to increase access while monitoring diversion. We support the work of UN agencies and respect their guidelines. We welcome the INCB’s learning project. There has been tremendous contribution in terms of research from UN agencies, CSOs and expert. We support their work and hope another MS join us.

USA: We believe no person should suffer unnecessarily. Balancing the opioid crises and adequate access to medication is our main focus now. W declared a nationwide public health emergency. Last week, the administration released an updated action plan and we would like to gather more data to better understand the situation. For better pain management, we are committed to take new steps and work on overdose reversing drugs’ accessibility to be increased. We believe a comprehensive, all-hands-on-deck evidence-based approach will reach our shared goals. Safe access to opioids is a priority and non-opioids based pain relief.

Ecuador: The WDR issued a number of alerts including the non-medical consumption of opioids. We keep opiates in therapeutical environment and push for medicines that are safe and affordable. Tramadol for example is important to keep being analysed. We are implementing a national control register system that is planned on the national, annual level and attaches risk levels to substances and ensures medical access.

Belgium: We align ourselves to the EU’s statement. We value this special focus on availability for scientific use. The data on medical access is alarming. UNGASS outcome document brought an important legacy – a comprehensive and integrated health care system that featured trained personnel. We funded a project 2016-2018 in Congo to build a well-performing, quality health care workforce. Key leaders and decision makers participated in the pilot. In Belgium we invest in providing evidence based info and dissemination for such through various ways, including e-learning. Pallia Familia – 30 professionals have been trained, not only diagnostics prescription guide but also methodologies to implement pain care I their own contexts. A ‘week without pain’ campaign was launched to raise the awareness combined with focus group sessions of various stakeholders. The rich discussions allowed for open dialogue and allowed a new layer of professionals into using pain relief efficiently. Capacity building among authorities is also crucial; together with France we provided funding to INCB to develop the e-learning program. We stress the importance of including patients and their families in the work as it is always about the patient. We call upont he international community to scale up efforts to secure availability of essential medicines. We organize a side event tomorrow in New York.

China: Great importance to the access to controlled and non-controlled drugs. We support states to seek balance between controlled and non-controlled drugs. To apply the solution to the national situation, we have detailed regulations to regulate illicit drugs while ensuring access to medicines. It is expected in China that professionals have to respond to the needs of patients including sedatives, narcotics. China has conducted research on the needs for controlled substances and actively adopted the annual assessment systems. We strictly control the exportation of drugs – to effectively carry out the international trade in narcotics and psychotropic substances, these activities are run through licenses. Apart from this, there is steady growth in the consumption of morphine – 200 kilos per year rose to 1200 in 2016. We noted some countries lack the provision of basic medicines, we call on the international community to give increased attention to the issue and give them assistance so no country is left behind. We also noticed there is an issue some places medication is being diverted and it’s a serious issue and call the attention of the international community to that.

UNODC: How UNODC assists MS in implementing the UNGASS outcome document. We do a lot in the context of drugs for medical purposes and raise advocacy on the global level, particularly including CSOs. I want to underline Belgium’s statement and call your attention to the side event in New York tomorrow. We are here to summarize the science and provide it for your disposal. We provided technical guides at last CND and we keep doing this as a joint global program. Together with the EU, we developed a program in Nigeria for data collection, pain management guidelines and staff training. In Congo, we provide on-the-field trainings with UICC and Pallia Familia. Panama had a different kind of focus, on research and data collection to identify main challenges and a study will be launched in October. There are other plans in the pipeline we are excited to work on.

CIAAG civil society intervention: Lauren Deluca: Thank you for the floor, Chair, honored delegates, ladies and gentlemen. I would also like to thank the Vienna NGO Committee on Drugs and the International Association for Hospice and Palliative Care for their encouragement and support for my statement on behalf of patients who need internationally controlled essential medicines for the relief of pain. My name is Lauren Deluca and I am the Founding President of Chronic Illness Advocacy & Awareness Group, a national non-profit working in the United States to raise awareness of the crisis of untreated pain in our country. Our organization was formed as a result of my personal healthcare struggles in 2017 when I suffered from a pancreatic attack and was denied access to appropriate care. I have, quite literally, been fighting for my life since May of 2017 and I am only standing here today due to the extreme measures I took to get myself and fellow patients the help we need to manage our pain and severe symptoms. For nearly a year I was bounced doctor to doctor and turned away. One doctor told me he had taken all their patients off opioids rather than risk losing his license for anyone. Legitimate pain patients such as myself have been slandered by care teams when we attempt to advocate for pain control as our right. Several pain management clinics have told us they no longer take new patients as the US Drug Enforcement Agency has advised them they would be shut down and their licenses withdrawn if they prescribed to any new patients. I recently had a feeding tube put in as I can now, can no longer eat solid foods due to the damage I incurred; all stemming from a denial of care based on wholly on physicians’ fear of law-enforcement and the legislative changes taking place to address the overdose crisis. Let me be clear. These measures are not addressing the current opioid overdose crisis. The tragedy of people using illicit opioids and dying from overdoses, should not impact pain or palliative care patients such as myself. Our lives matter as much as theirs, yet we are being punished by bureaucrats, regulators, and law enforcement agencies with no medical training. Sadly, what I went through, and many others are going through in the US is becoming the “new normal” for patients suffering with chronic illness, disease and incurable conditions. Law enforcement targeting of physicians and patients increased, and there is no relief in sight, either for families suffering from the opioid epidemic, or for patients and physicians. This is why I paid my own way to come from the US to speak to you today.If the current direction continues,all individuals will be cut off from rational access to essential opioids except for patients suffering from end-stage cancer. And even some cancer patients are coming under scrutiny, as regulators question whether their cancer is “painful enough” to warrant an opioid prescription, rather than Tylenol. Chronic Illness Advocacy & Awareness Group is working with Elected Officials and the patient community to help restore balance between protecting the public health from drug abuse and the safe, essential access to opioid analgesics for the chronically ill, older persons, and persons with disabilities. CIAAG is proposing a practical solution: we have recommended a Palliative Care Model to properly enable those with known painful conditions and illnesses to receive the appropriate care they need using a coordinated care team approach. Individuals would receive treatment for the various symptoms of their illness or condition, including appropriate pain relief, to promote quality of life for the patient and their family. In addition, we have devised a tracking method via the ICB-10 codes to categorize the data by the illnesses type rather than number of opioid doses. This tracking mechanism will permit law enforcement to ensure proper controls are in place to alleviate diversion of controlled substances, while maintaining the ability to develop data on “best practices” for opioid prescribing. While we recognize the importance of having controls on scheduled medications, we must not lose sight of the fact that opioids are life-sustaining, essential medications. The United States approach to combatting the overdose crisis is fatally aggravating it, as reflected in the record breaking number of deaths in 2017 and 2018 despite prescribing being at a 25 year low. Failure to protect patients’ rights to access essential medications and healthcare, will result in the loss of innocent lives through suicide, and inflate an already deadly to a human rights crisis. And, we as a nation and a community, deserve better. The INCB and CND have been helping the world become aware of the crisis of access to controlled medicines in more than 75% of the world. The US opioid crisis must not be allowed to derail the progress made during the UNGASS, at the Human Rights Council, and at the World Health Organisation. I thank you.

Chair: Thank you, this bring us back to the centre of the issue which are human beings.

Dr. Rumana Dowla, Bangladesh Palliative And Supportive Care Foundation: Speaking points here.

Mark Mwesiga, Palliative Care Association of Uganda, Uganda:

PANEL: João Batista Garcia (Federación Latinoamericana de Asociaciones para el Estudio del Dolor (FEDELAT), Brazil: I am a specialist in pain and work in the medical university. I am the president of the Latin American Federation on Pain, we have an opioid crises in Latin America. restricted access and availablilty. the reality of brasil. a country big as a continent. many people still die in pain. rural areas.

INCB: We reaffirm the purpose of CND in continuing the advocacy in the name of progression.

Dr. Gerra: It is important to look at the reality of people experiencing pain. Try to find time before CND 62 to talk about availability. Controlled drugs are medication and should be considered as such.

IAHPC: I hope the contributions from patients and providers side have provided useful insight.

Chair: great day, let’s return to the request of tomorrow to continue the discussion.

Pakistan: In preparation to HLMS, it is time to make good contributions. It is our position for post 2019 directions that there is no need to produce a new policy document. We have ambitious goals and we have to enhance efforts for implementations. Some of the key challenges are increased drug use on the domestic level and increased trafficking. We carried out drug awareness campaigns in cooperation with civil society, sports competitions, contests, music and other recreation. We use social media and relevant narcotic agency maintains other online platforms. Say no to drugs campaign is widely disseminated via mainstream media and we have a youth ambassador program to engage young people to educate each other. We run many rehabilitation centers that thousands benefitted from guidance and reintegration programs. In 2018 CND we developed a compressive guideline that we operate along with all relevant national stakeholders. Capacity building and training professionals remains our priority. We look forward to enhance cooperation among UN agencies and member states. It is important for our delegation that all presentations adhere to the maps that agreed by the UN security agencies.

Norway: We use a knowledge based policies to help treatment and integration. We did not legalize the possession but we think decriminalization does not impede harm reduction efforts. We think substance use is essentially a health challenge that contributed to various social issues. We need a shift in our understanding of the World Drug Problem and the way we address it. The committee is free to view other countries’ experiences and should take a look at Portugal example separately. We think the ban of drugs is an important signal to the dangers of them and it is important for the police to be able to break up drug scenes, nevertheless we will not chase people for being addicted. Certain changes will enable police to channel their resources to the prevention of dangerous crime. Recognizing that many people who live with addiction, we established a heroin substitution treatment to experiment whether we can improve the lives of those who need help. We will prevent what we can and repair what we have to – clearly prevention is the first choice in many ways. We are delighted to have been able to support UNODC and WHO publications. Let me briefly reflect on yesterday and todays discussion, we see a 31% increase of PUD and HIV at 11.8% remains stable. Norway is ready to discuss how we can improve our work.

Austria: Developing drug policies based on evidence supported by evaluation systems is at the heart of EU’s priorities in tackling the problem. We brought together around 200 scientists to exchange best practices – EPIC and EMCDDA are prevention-based projects that are streamlined to understand the problem and feed evidence into decision making. EU and MS address substance use disorders as a public health issue and we are motivated to develop cost effective interventions. We appreciate the work of UNODC and that of the updated standards. We have to tackle societal problems imposed by drugs but also marginalisation. As a comprehensive system 6 member states provide targeted harm reduction needle exchange and 10 MS offer take home naloxone programs. Declining hepatitis prevalence was reported as a result. We encourage other countries to monitor and stay alert on trends. We insist on the value of formalised cooperation among UN and EU agencies.

China: We implemented firmly the three conventions and the 2009 declaration. We always adhere to people-centric and scientific approach, so the situation has approved in China. The number of drug users in the country has dropped 46.1% percent for young people. We design new programs for prevention that are widely posted across the country, we have a daily average visits of a few million. The government funded 180 anti-aids publicity programs last year. In drug treatment we promote community projects, maintenance and rehabilitation, inviting users to voluntarily quit. We have good indicators for the success of community rehabilitation programs. We respect the human and legal rights of PUD but we believe under certain circumstances it is a form of corruption of society, drug users act on the cost of the many. We made comprehensive provisions and support UNODC to update international standards to better guide MS to implement preventive education programs and with a deeper understanding, we hope countries will have support in diversifying their policies.

USA: We support a comprehensive and balanced approach that balanced cooperation among various sectors. We experience a crisis on an unlimited scale, but it is not unique to our country (Easter Europe, Asia and African regions). This worldwide phenomena is largely due to traffickers stepping up their ways and we have to efficiently respond. Many who die are accidentally exposed to a fatal dose, drug use prevention must remain a critical element of the global plan to combat the world drug problem. We need comprehensive world-wide data collection mechanisms, we don’t have a full grasp of what is on the market to adequately respond.

As a continuous donor to UNODC, we push for increased communication among vital UN entities. It is clear that we need a balanced and comprehensive approach to tackle the world drug problem.

Secretary: We have a time pressure, so I propose to take three more speakers and we will continue the debate tomorrow afternoon. I would like to seek guidance from the floor how to proceed.

Chair:  OK

El Salvador: Regarding demand reduction, in particular in prevention, we carried our 3 national study re the use of psychoactive substances. Based on the agreements made in 2009 and 2016, we launched a set of measures that are implemented by a set of institutions, including the health ministry – education centres for children, family programs, etc. We also address alcohol within communities of students and we put in place risk prevention programmes at the workplace. We coordinate efforts across sectors to create greater awareness for the effected population. By focused actions, our national anti-drug strategy includes forging healthy school environments by training teachers and developing monitoring mechanisms. We work with various municipalities to decentralize our drug policies, furthermore with the support of international organizations. We are working on capacity building and training for health professionals to address people with problematic drug use patterns. We work with UNODC to build centres.

Netherlands: Placing importance on public health and human rights based approach leads to positive results. New HIV infections in our country dropped to practically zero. Our challenge is the increase of recreational drugs, especially ecstasy. We try to identify different user groups based on motivation to use, we research profiled of PUD. We have different programs to reach young people in nightlife settings. ‘Celebrate Safe’ was initiated by event organizers – we disseminate practical information for staying safe, drugs, alcohol, sex, and hearing.

Czech Republic: We are fully aligned with the statement delivered by Austria. There is the need to minimize the negative consequences of drug use on the individual their environment, the public and budget. Evidence leads us to less repressive policies, we search for optimal solutions based on excessive data together with NGOs. We ensure that people who suffer are encouraged to come forward in time without being stigmatized. We attribute a significant positive effect to the people-centered approach towards infections and saw decriminalization to have good results. We hope for evidence-based policies that respect human rights on the international level.

Chair: We will continue tomorrow with the countries who have their plates raised.

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