Thematic session 3: The availability of internationally controlled substances for medical and scientific purposes, including for the relief of pain and palliative care, remains low to non-existent in many parts of the world

Secretariat: COVID19 guidelines

Chair: And now I would like to welcome the participants of the panel.

Background note by secretariat

(…)

UNODC: Thank you Mr. Chair. Ladies and gentlemen, good morning. This is a real pleasure for me to be here today and to present you briefly the main facts and figures that that illustrate the challenges that we face today in relation to the availability of international controlled internationally controlled masons. The availability of pharmaceutical opioids has increased dramatically in the last decades, especially between 1998 and 2008. And in the last five years you will see, we see a slight decline, but this is mostly driven by development of […]. If we look more specifically into availability by sub region, we see that availability is very high in Western Central Europe and Australia, New Zealand. So, in terms of trends, we can see here some positive trends, with a decline, where the availability of opioids of choice has been high in North America, increased availability of opioid analgesics with some of the low consumption sub-regions. Here we should be very cautious because the level of availability is still very low. So, one challenge is clearly to increase access to controlled pain medications. Another challenge is that of striking the balance between the pharmaceutical access and control. The ease of access lead to an increase in the nonmedical use. This evolved into a rise in death. Once restrictive measures have been put in place […] recent data that we have today during the covid 19 pandemic show that related deaths have continued to increase again and so the opioid crisis continues. But one of the main questions today is regarding North America with the market of fentanyl, and particularly some of its analogues that are very cheap and potent and bring very high profits to premiums… So will such substances be spreading outside of the region to other markets in other regions. My last slide is about the different systems and prompts of for actions, and influence that can act as enablers to ensure availability of controlled medicines. So in relation to four dimensions: legal and regulatory system, Supply Management System, healthcare providers and relation to the patient, the family and the community, regarding the culture, the attitudes and the conditions that affect access and availability to controlled medicines. As a conclusion, we really need more granular data about what is being used how it’s being used by whom. The number of people suffering from acute and chronic pain needs to be assessed and whether their needs are being met, where they may be over met with the amount of opportunities that are available in order to assess the extent of the gap. The importance of prescription management in the context of the opioid crisis, and how it is crucial to have a system in place that may prevent over prescription is seriously important.

[…] All right. I would like to, to express gratitude and appreciation to our partners. All too often the last slide of a presentation acknowledges important contributors, and they take this opportunity to beat the bells, so to speak, and I want to ensure I have time to say thank you. […] We work with the WHO, the essential medicine section, with cancer experts and the UNODC, all of which become critical areas during the global pandemic. We have strong working relationship with INCB and have worked with IAEA, we’ve partnered with data collection efforts at the national level, limited to the same issues with palliative care. Our civil society partners remain the International Association for hospice and palliative care and the Walter centre in Indiana University. Of course there are countless other partners such as UNDP and the African Union that help us to do our work around the world. We need research to inform practice and practice to inform research. There are many documents that I’ve shared many times with this group but I want it from INCB as well as WHO. But as we work with the country level leaders and decision makers are asking for concrete actions that they can take to create a better balance and ensure adequate access to quality essential controlled medicines – the technical document was developed with representatives from the partners I referenced previously, and takes into account a wide variety of actions that can be taken at the foundation level and reading, and then at a more advanced approach. The joint global programme is focused on providing hands on technical assistance at the national and local levels. We’ve worked with Ghana DRC, Nigeria, and Nigeria on the African continent, Panama and Mexico. And at the regional level, we have supported meetings in Central Asia, Latin America and assisted countries in the Southeast Asia region. I would like to especially thank Australia and Belgium for their steadfast support for this important work, providing leadership vision sponsoring resolutions and ensuring the programme continues with funding. Our focus is on three key areas that are intertwined and overlapping the legislative and policy aspects of health and regulatory systems, building capacity of health care workers in the workforce in general, looking at supporting efficient management of the supply chain to prevent diversion into assist with preventing non-medical use. It should be noted that the countries that we go into are already at significantly lower levels of availability, as clearly showed on the slide. I want to draw your attention to this and please do get the presentation and look at that. We work with key stakeholders to help them see that the intersection between a quality healthcare system that best meets the needs of patients overlaps with a strong regulatory system that protects both patients and healthcare providers, the point of intersection is the rational use of medicines. It is essential that we ensure adequate availability and access to essential controlled medicines keeping in mind that rational use includes the right drug, the right dosage, the right duration, the right patient in the right cost to be successful. Thank you for your attention and I’m available for questions if anyone has them

Mexico: … we’re addressing the issue of not only accessibility and availability but palliative care. We only mentioned palliative, there’s a lack of actions from our site in the three political documents to address that domain. We note with concern that the lack of access for political actions to guarantee that our needs are being addressed. Thank you.

UNODC: I do want to also commend you Mexico has done a significant amount of work with their electronic prescriptions and the work around trying to increase access and look at the supply chain being closed and preventing diversion so congratulations on that. Thank you for raising the issue of palliative care – in five minutes time I could not go into all of the areas in which we overlap with palliative care but I do believe in my heart that our partners will cover some information related to palliative care. I will say that it is a double edged sword, and that is that when we go in countries to have all of their supply chain for controlled medicines be only controlled by palliative care is also a concern, so we need to look at palliative care as one component of a larger system, and use those care experts to help inform the larger healthcare system so that’s the approach we’re taking at the national level.

India: There is a gap in the data (…)

UNODC: I can speak in general terms, my expertise in areas of work is actually the body of prevention and treatment that was presented earlier. I can tell you that the challenge of access to services remains this remains similar, we’ve talked about the challenge to access to services when we’re talking about treatment services. And along those same lines, it’s the same challenge that we have in terms of access to the pharmaceuticals, that people might need.

UNODC: I would say you could assume that the availability of buprenorphine and methadon has increased over the last two decades, but there are many parts of the world still where it is not available at all. Now, In terms of coverage of opioids treatment – in the Sustainable Development Goals there is the target for the strengthening of prevention and treatment of substance use disorders. And we have developed an indicator on the coverage of drug treatment. This can be applied to opioid use disorders, of course, and we’re starting to collect data from member states. Little by little we have produced this show for the first time there is a box in the report that shows the results of this entire collection of data for 40 countries. This is work in progress.

Chair: Now onto the panel.

Dr Musa, Nigeria on behalf of the African group: Well, already 1960 convention was intended to ensure access to open bases for pain management and palliative care. Data showed that there is a real disparity especially in low- and middle-income countries. That is a matter of concern. Nigeria is committed to the mission of CND for scientific and medical purpose. And of course we also have knowledge of pain management, and the opioid phobia among clinicians and practitioners.

To ensure balance in our national policies, we developed the national Master Plan, which is an integrated approach to a wide range of issues that are elevated and touch on each of the seven thematic areas of the UNGASS outcome document. The goal is to ensure sustained availability and accessibility to control medicines for medical or scientific purposes while preventing diversion. The next step will be actually to develop the qualification guidelines and the submission guidelines. Facilities in  Nigeria, and the region, recently showed that the medicines are actually available. So we display our health care system which is a very delicate issue. Don’t be afraid to revise the curriculum of medical schools to rational use of medicines with increased knowledge attitude and practice. At the moment, what we do in Nigeria is developing local capacity to produce conformance. Available accessible and affordable and all programmes and policies are aimed at creating a change behavior.

India: […]

WHO: […] you’ll notice UNODC has recently issued a joint statement, to allow countries to be informed on the risk of disruption in the supply of control medicine during COVID-19 before taking appropriate measures to mitigate those risks and protect people’s lives. Addressing the world drug problem demands that we all work together to tackle current challenges and that we do it by positioning public health and human rights at the center of the international drug policy dialogue.

[Western Europe and others group]: Yes, thank you. I continue my, my speech. As a doctor, the single convention on narcotic drug from 1961 and conventional psychotropic substances of 97 to one medically is comparable to the main concern of the patient and for the health and welfare of humankind. In addition, was the recognition of the medical use of narcotic drugs and psychotropic substances. The goal has always been to have access to narcotic drugs and psychotropic substances for medical and scientific purposes is still far from being universally met. people undergoing surgery without anesthesia, without that pain medication, people are still suffering. The imbalances in availability and access is particularly problematic in low- and middle-income countries. Some countries are battling with significant prevalence level of opioid dependence which is a bit related to the availability of psychotropic substances […] an oversupply of such substances, relative to medical needs.

Chair: Morning session adjourned.

[…] tools within the module will answer questions such as, why is access to controlled medicines important? And what are the barriers to adequate use, how to put in place policies on the prescription of opioids for effective pain management? What tools are available to prevent shortages in the context of the pharmaceutical supply chain – touching on legislation, regulation, governance and monitoring? How to collect and analyze data on availability and affordability and to report on the movement of internationally controlled medicines? The module also contains resources on how to ensure balance in national policies on controlled substances. And finally, resources on recommended interventions to promote rational use. Once again, this information is available on the UN toolkit on synthetic drugs website, along with other specialized modules, which can be accessed at synthetic tracks that you notice. e.org. Thank you very much, Mr. Chair. And thank you very much distinguished delegates.

Prof. David Nutt: Drug Science would argue that there are significant problems in current drug regulatory policies. But today, I want to focus on particularly in relation to the limitation of research in alternative treatments to the opioids. We’ve been very impressed by the attempts made to broaden access of opioid analgesics for pain and for palliative care that are being described today. We believe that cannabis and psychedelics offer alternatives that are probably safer and work in a different way. They have utility in chronic syndromes and there was considerable amount of research being done into these the efficacy of these treatments such as LSD and psilocybin to serotonergic psychedelics, up till the 1971 convention when they were banned, and you can see the dramatic fall off of research since that point. So as the same for cannabis, just recreational use, but they certainly impeded research. This is unfortunate because some of the work done up to 1971 showed enormous potential and disorders that are very disabling. So, here is a recent meta-analysis of the six trials of LSD, one or two treatments in alcoholism, showing an effect size greater than that we have for any current therapy for alcoholism. And yet, there’s never been a single trial subsequently, because the UN regulations even though they don’t de facto bound research, in practice, they do. There have been some resurrection at that considerable challenges in psychedelic research that is relevant to today’s discussion. So, there were two studies in end of life anxiety and depression relevant to palliative care in America. They’ve been two small studies in addiction and then a plan studies in pain syndromes, neuropathic pain and cluster headaches, and also opioid addiction. These are small studies that are very expensive to do because the current regulations do severely limit access to the medicine and also increased the costs by an order of 10-fold in complying with the current regulations. So Drug Science would offer this possible solution: we think it would be important to consider revising the UN conventions to expressly facilitate research into scheduled drugs, particularly cannabis and psychedelics where there is growing evidence of efficacy for pain, addiction and other disorders. And we should also revise or remove the current limitations on production distribution amounts, which are currently making research with certainly with psychedelic psilocybin quite difficult. And we think this would be a major advance that could benefit many millions of people who currently either do not have access to opioid painkillers or who are not benefiting appropriately or who becoming dependent on them. Thank you very much.

NGO: So we all know, drug addiction and injecting behaviour is common phenomena in our region, especially in South Asia pharmaceutical drugs have been used. Due to the injecting behaviour, HIV infection and other blood borne diseases show up high among the key population. Our laws still say drug use is crime. So due to the fact people cannot come and people cannot go for health surveys. And they they’ve been criminalized and even isolated themselves, and they keep on doing compulsive behaviors. So, it’s a very difficult situation. So medically assisted drugs oral substitution therapy programme is a best practice. I’ve been working in this field for the last 30 years and I work on record rotation for more than 12 years. I used to be against harm reduction but in our country in 2002, there was a result by the government of Nepal, there was a 68% HIV, and it was eye opening. So strategically, we have to to provide service for the users we need to save. First, medically assisted programme is one of the best practices in our country. Because people can come people can use and slowly they can lead their productive life, they can think about their family, they can choose their children, they can think about their work because they don’t have to the black market day to day. So, for policymakers need to understand: if we stop the illegal drug market, that’s this is a practice we have seen and have observed in our programme people slowly being productive life and they are looking for an opportunity to lead a healthy life and also it can promote drug free life in the future. So, this can be the one of the best model in our region that I have to say thank you.

Palliative Care Association of Uganda: Currently in the Palliative Care Association of Uganda, we are engaged in multi stakeholder dialogues with the Ministry of Health, the Ministry of Internal Affairs, and the anti-narcotics department of the police force to ensure that in Uganda can continue to prescribe morphine for their patients as per the 2004 statutes without being criminally charged under the 2016 narcotic drugs and psychotropic substances Control Act, which criminalizes people who use drugs. The act of 2016, did not necessarily repeal the 2004 statute, which allowed specially trained nurses and clinical officers to prescribe morphine, but left equal status of palliative care nurses who prescribed morphine. This is engaging the Minister of Health, who established a committee to study the act before drafting regulations to ensure that the regulations that come to gain the implementation of this act are cognizant of the fact that there was an instrument passed in 2004 that allowed specially trained nurses to prescribe certain opioids including even morphine. We also engaged in ensuring that advocacy for the combination of a trend analysis and officers are recruited, retained, and eliminated as so in the public health care system. We are therefore engaged in roundtable dialogues with the ministries concerned to ensure that law enforcement officers who are charged with implementing the new law equipped and empowered with training and skill and knowledge about the need for access to controlled medicine for pain relief among patients, as long as this is prescribed by qualified medical professionals and health workers, as established. We continue building the capacity of health workers, including pharmacists, who are in charge of stores, ordering and restocking levels for these medicines at health facilities, that they do not fall into drugstore counts and that patients in need of these services continue to receive to ensure that root cause and challenges in gaps within the medicine supply chain are filled.

European Union: Thank you, Mr. Chairman. And good afternoon, everyone. I have the honor to speak on behalf of the European Union and its member states and the following countries align themselves with this statement: the Republic of North Macedonia, Montenegro, Serbia, Albania, Bosnia Herzegovina, Ukraine, Iceland, Norway, the Republic of Moldova, and Georgia. In the 2016 UNGASS outcome document, the international community highlighted the need to enhance national efforts and international cooperation at all levels to address the low availability substances by promoting measures to ensure their availability, accessibility and affordability for medical and scientific purposes. In this context, it should also be mentioned that controlled substances, such as opioids, are the mainstay for the symptomatic treatment of breathlessness, which is particularly important in the ongoing COVID19 pandemics. At the beginning of the preamble to the 1961 single convention on narcotic drugs, the community of states clearly stated the need to ensure access to internationally controlled substances for medical care and scientific research with a patient at the center of our efforts, we need to recognize that some internationally controlled substances are indispensable in relieving pain and suffering. And we are convinced that in this field, we can do better. The European Union and its member states are very grateful that the INCB and the WHO have repeatedly placed the appropriate use of international control substances at the center of the discussion. In almost 60 years since the adoption of the single convention, these efforts have led to an increase in the use of internationally controlled substances for medical purposes. The international efforts of recent years are showing results in several regions. This is highlighted in the annual report of the INCB and yet, in many parts of the world, internationally controlled substances for medical purposes, are still not available, accessible or affordable for various reasons, as we have all recognized in the 2016 outcome document. This is particularly regrettable, as the improved knowledge and opportunities for the treatment of chronic diseases and cancer have increased the need for controlled substances in pain management and palliative care. Mr. Chair, the high number of drug related deaths resulting from inappropriate medical therapies with opioids in some parts of the world is tragic and severe. Therefore, it is important that the medical use of opioids is in the hands of appropriately trained physicians and medical personnel and it’s based on an appropriate risk benefit analysis in each individual case of treatment. This stimulates the European Union and its member states to constantly review the regulations and guidelines on access to opioids for therapeutic purposes. In order to prevent abuse and to avoid diversion for illicit purposes, it is all the more important to maintain an appropriate balance between the prevention of suffering through adequate care and the prevention of abuse. In setting these two goals, people’s health is at the focus of our efforts. For that reason, it should be essential for all states to improve the necessary conditions for the rational medical use of internationally controlled substances. The treatment of pain and severe suffering, as well as palliative care are essential needs. The provisions of the single convention are designed in such a way that these needs can be met in every respect from an international regulatory perspective. From a medical care perspective, it is particularly difficult to accept the people continue to suffer because of no or inadequate availability, or the lack of affordability of internationally controlled substances for medical purposes, in reliable pharmaceutical quality. It has been 10 years now, since the members of CND set guidelines – we’ve seen the resolution 53/4, to enable us to achieve adequate availability of internationally controlled licit drugs for medical and scientific purposes, while preventing their diversion and abuse. It’s here the European Union and its member states once again underlined the importance of this topic. We’ve seen the resolution 63/3, highlighting the promotion of awareness raising education and training as part of a comprehensive approach to ensure access to and the availability of internationally controlled substances for medical and scientific purposes, and improving their rational use. Building on the progress made so far, the international community should continue to focus on more action to improve the adequate availability and affordability of such substances for medical purposes in reliable pharmaceutical quality, without prejudice to monitoring and control measures. The European Union and its member states are willing to make their contribution to this in line with our joint commitments.

Belgium: Belgium aligns itself with the statement of the EU and its member states. Today, the international community has once again stressed that the availability of and access to internationally controlled substances for medical and scientific purposes, including for the relief of pain and suffering, remains problematic. Although there is progress, the lack of it is worrisome, especially in the light of the current public health emergency. Yet, the barriers for accessing controlled medications are known. And this is also an issue where all member states agree more needs to be done. One of the barriers is the lack of knowledge and information among healthcare professionals. The resolution entitled promoting awareness raising education and training as part of a comprehensive approach to ensuring access to and the availability of internationally controlled substances for medical and scientific purposes and improving their rational use affirms the commitment of the international community to address this issue and clarifies once more the roles and responsibilities of each party involved. The resolution received broad support, and we hope this will materialize further in the involvement of member states, especially of those that have improved the access and availability of controlled substances. Over the years, we can all learn from those improvements. Often barriers to access and availability are more easily addressed and expected. In that perspective, we can learn from good practices and experience as we are doing today. Belgium has repeatedly financially supported its partners so they can continue to provide multidisciplinary technical support to member states in this regard. As we speak, the African Palliative Care Association is working hard to organize trainings for physicians, nurses and pharmacists in four provinces into the Democratic Republic of Congo. Bearing in mind the important principle principle of a balanced approach, vigilancy is needed in order to maintain the balance between preventing non-medical use and assuring medical use. We welcome synergies and the use of all the available resources from relevant partners, including international organizations and civil society, and including from the joint global programme on access to controlled drugs for medical purposes, while preventing diversion and abuse. And let me take this opportunity to call all member states to join Australia and Belgium to support this programme. Finally, we’d like to express our gratitude towards you and Swiss delegation for organizing this event that was held today on ensuring availability of controlled substances during emergency situation. It is very pertinent in time of COVID-19. Thank you very much.

Chair: I would like to express my appreciation to all of you, those who came in person and those participating online. I believe we had an excellent meeting. During the last few days, I was very pleased to have from Fiji to the other side of the continent, everybody on board, this was exceptional also for me. The meeting is adjourned. Thank you