Side event: Procurement, Pricing, and Access to Controlled Medicines During COVID-19

Organized by the International Association for Hospice and Palliative Care with the support of Australia, Belgium, and Dejusticia, Harm Reduction International, the Office of the High Commissioner for Human Rights, and the World Health Organization

Participants:

Ambassador Ghislain D’Hoop, Ambassador of Belgium to the UN organizations Vienna

Dr. Zukiswa Zingela, INCB

Dr. Tlaleng Mofokeng, UN Special Rapporteur on the Right to Health

Lic. José Luis Reyes,El Salvador Competent Authority

Dr. Eddie Mwebesa CEO, Hospice Africa Uganda

Ms. Naomi Burke- Shyne Executive Director, Harm Reduction International

Dr. Christophe Rerat Programme Manager Essential Medicines and Health Products, WHO

Liliana de Lima – IAHPC

Welcome which is being presented at the 64 session of the CND. My name is Liliana de Lima and I am the executive director of the organization hosting the side event. I would like to welcome Ambassador D’Hoop.

Ambassador Ghislain D’Hoop:

Thank you. Good day to you all. It is a pleasure to be chairing a side event on such an important topic. It is obvious that COVID 19 has put the multilateral system in more pressure. It has revealed inequalities in societies, and significant weaknesses in global supply chains or pharmaceutical problems and inefficient procurement and administration mechanisms for essential medications regulated under the three international drug control conventions. This side event will take the request of the INCB to use this challenging time as an opportunity to strengthen cooperation, ensuring availability of control to controlled medicines during the pandemic with a special focus on treatment for pain and drug dependence. So let me without further ado introduce our first panelist doctor Zingela.

Dr. Zingela you have joined the International Narcotics Control Board in 2020 and you are a member of the standing committee on estimates, you are a South African national who heads the Department of psychiatry and behavioral Sciences at Walter Sisulu University and Nelson Mandela academic hospital at the Eastern Cape Department of Health. You have a Masters in medicine and psychiatry from the University of Pretoria and a fellow of the College of psychiatrists of South Africa and you will speak about the joint statement on access to medicines issued by the INCB the WTO and your new DC and also on how the COVID-19 pandemic has revealed weaknesses in global supply chains procurement and administration mechanisms. Dr Zingela you have the floor

Dr. Zukiswa Zingela (INCB):

Excellencies, chair, colleagues from WHO, UN Special Rapporteur on the Right to Health, competent authorities of El Salvador, Harm Reduction International and Hospice Africa Uganda, ladies and gentlemen,

Let me express my pleasure and honour at meeting you all via this online side-event. First, on behalf of the International Narcotics Board, I would like to thank the International Association for Hospice and Palliative Care for organizing this side-event.

It is a great pleasure for me to speak on behalf of the Board about the impact of COVID- 19 on the procurement, pricing and access to controlled medicines and the joint effort of INCB, WHO and UNODC in this regard.

The issue of access to controlled substances, particularly during emergency situations, is a crucial matter for the Board and is also very close to my heart as a psychiatrist with various areas of expertise, including addiction psychiatry and substance use. We here at home in South Africa, have seen our own health challenges, including the suffering experienced in different communities that can result from restricted access to essential controlled substances or unrestricted abundance, both of which may occur during emergency situations.

The world has experienced many crises over the last two decades. These include civil wars, floods, earthquakes, mass movement of refugees, to name a few. COVID-19, however, is a very different emergency. It affects all of us at the same time, and it has been a long haul which is still continuing, even as we speak.

The global supply chain of medicines has been affected since February last year, as a result of both the disruption in the manufacturing of key materials for active pharmaceutical ingredients and of the ingredients themselves in some major manufacturing countries .

Add to this the logistical challenges arising from border closures, disruption of international transport, and other social-distancing policies adopted by a number of countries and we have an emergency situation like no other.

At the same time countries saw a surge in the demand for internationally controlled drugs that are necessary for the treatment of patients with COVID-19. Substances that are especially needed in this situation include fentanyl and its analogues (alfentanil, sufentanil and remifentanil) and midazolam, which are all necessary to provide symptomatic relief, and sedation for patients with COVID-19 admitted to intensive care units.

Considering these developments, the Board has closely monitored the situation and also provided assistance to countries foreseeing or experiencing shortages of controlled medicines. This the Board has done through, for example, facilitating communication between importing and exporting countries, speedy approval of revised estimates and assessments, and organizing expert group meetings concerning the application of simplified control measures during emergency situations, among others.

Ensuring the availability of and access to controlled medicines is a prime aim of the international drug control conventions, and has always been at the heart of the Board’s work. Since the publication of our first availability report in 2010 and the subsequent reports in 2015 and 2018, the Board has expressed its concerns over low levels of consumption of controlled medicines in some parts of the world, indicating that these substances may be almost inaccessible to some populations and outlining the barriers contributing to such imbalance.

In our Annual Report for 2020, that was launched on 25 March, we also devoted a section to the impact of COVID-19 and shed light on the importance of ensuring access to and availability of controlled medicines in times of crisis.

In April 2020, the INCB joined a call made in an article in The Lancet to extend palliative care during and after the COVID-19 pandemic.

On the 14th of August 2020, the Board issued a statement, together with UNODC and WHO, on access to internationally controlled substances during the COVID-19 pandemic, highlighting the needs of both COVID-19 patients and non COVID-19 patients who require controlled substances for other medical conditions. These include the management of pain and palliative care, surgical care and anaesthesia, mental health and neurological conditions, and the treatment of drug use disorders. Already suffering from a lack of access of controlled medicines for the treatment of these conditions, the continuous impact of COVID-19, and the emergency resulting from the third wave or even fourth wave in some countries, might put these patients in an even more precarious position.

While initially focussing to address the acute needs of COVID-19 patients and reduce casualties, it was equally important not to forget the needs of the non-COVID-19 patients who were also in need of controlled medicines and might also be suffering from pain or mental and neurological conditions during these challenging times.

The COVID-19 pandemic has shown us how important it is to have a robust supply chain for controlled medicines, without which our healthcare professionals would not be able

to provide quality treatment and care. At the same time, it has also taught us that no man is an island. The joint statement issued by INCB, WHO and UNODC during COVID-19, therefore can be viewed as a small step in our collective attempt to close the gap between the haves and haves-not in their access to essential-controlled medicines, which unfortunately has been increased by the pandemic.

To close please allow me to quote a popular idiom here at home: “I am because we are”. This is the concept of “ubuntu” and means we share a universal bond as humans, that connects all humanity. With those words I am saying that we as the Board look forward to more inter-agency collaboration towards alleviating the pain and suffering of those we serve.

Thank you and I wish you all good health.

Ambassador Ghislain D’Hoop

Thank you very much doctor Ziegler for giving us some very instructive and enlightening insights in your capacity as a member of the INCB but also in your personal capacity and specially your mentioning of the concept of abuntu I think is also very appropriate. I have not yet thought about this but it is very appropriate that we should consider how being all linked through by virtual means how we can strengthen this sense of solidarity and that one there, so thank you thank you very much

It is my pleasure to introduce Dr. Mofokeng, the UN special rapporteur on the right to health. You were appointed by the United nations Human Rights Council at this session in July 2020 are the special rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health and you are a medical doctor with deep expertise in universal health access HIV gender equality advocacy and family planning. Dr. Mofokeng is commissioner at the Commission for gender equality in South Africa and a member of the board’s of safe abortion action fund the global Advisory Board for sexual health and well being an accountability international you will draw on the international guidelines on human rights and drug policy to highlight human rights framework supporting access to controlled medicines thank you very much and you have the floor

Dr. Tlaleng Mofokeng (UN Special Rapporteur on the Right to Health):

It is my pleasure to join you today to talk about human rights frameworks of the access to controlled medicine.

Millions of people worldwide require essential medicines for pain, drug dependency and other health conditions.

Exactly five years back, in April 2016, at the United Nations General Assembly  Special Session on the World Drug Problem (UNGASS 2016),all Member States of the United Nations “reiterated their strong commitment to improving access to controlled substances for medical and scientific purposes by appropriately addressing existing barriers in this regard.  including those related to legislation, regulatory systems, health-care systems, affordability, the training of health-care professionals, education, awareness-raising, estimates, assessment and reporting, benchmarks for consumption of substances under control, and international cooperation and coordination, while concurrently preventing their diversion, abuse and trafficking”, and recommended several practical measures for the implementation of this commitment.[1]

Despite recent growing global advocacy, high-level statements of intent, including the UNGASS 2016 commitments,  and movements within international bodies and individual countries to address access to and availability of controlled medicines for pain management, progress has been extremely slow and significant challenges and barriers remain in improving the accessibility and availability of controlled medicines.[2]

Data on the amount of opioids available for medical purposes shows that there is a clear alarming gap and disparity between high-income countries versus low- and middle income countries for all controlled medicine combined (i.e. opioids such as codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine and methadone). More than 90 per cent of all pharmaceutical opioids that are available for medical consumption are in high-income countries: 50 per cent in North America, around 40 per cent in Europe, mostly in Western and Central Europe, and a further 2 per cent in Oceania, mostly Australia and New Zealand. Those high-income countries comprise around 12 per cent of the global population. On the other hand, low- and middle-income countries, which are home to some 88 per cent of the global population, are estimated to consume less than 10 per cent of the global amount of opioids available for medical consumption.[3]

The obligation to provide access to essential medicines is a core minimum obligation of the right to health, which means that such access should be prioritised.[4]The need to ensure ‘access to safe, effective, quality and affordable essential medicines’ is also reflected in the Sustainable Development Goals ( See Sustainable Development Goal 3.8.)

In accordance with international human rights law, various special procedure mandate holders of the UN Human Rights Council concluded that the failure to ensure access to essential medicines such as buprenorphine and methadone to treat opioid dependence, and morphine for pain relief, threatens the fundamental rights to health and to freedom from cruel, inhuman, and degrading treatment. [5]

Palliative careis an approach that seeks to improve the quality of life of patients diagnosed with life-threatening illnesses through prevention and relief of suffering. Moderate to severe pain is a common by-product of these illnesses, including advanced malignancies, which require opioid analgesics for management. WHO lists these and other analgesics, as essential medicines. (SR Report, 2009). The UN Independent Expert on the enjoyment of all human rights by older persons has recommended governments make palliative care more widely available, “especially for those in the terminal phase of chronic illness, so as to spare them avoidable pain and allow them to die with dignity.”[6]

UN treaty bodies, in particular the Committee on Economic, Social and Cultural Rights,  have recommended that States address barriers and increase access to medication-assisted treatment.[7]

There are several challenges and barriers to access to controlled medicinesfor pain management, all of which are complex, multi-tiered and interrelated.Compliance with procedural requirements associated with stocking, supplying and prescribingscheduled medications can be burdensome for health-care institutions and workers, creating a barrier to supply of these medications.   In particular,  the legislative and regulatory limitations on who can prescribe controlled substances  perpetuates a barrier to access, particularly in low and middle-income countries without decentralized health-care services and/or where the number of physicians or doctors is limited.

Other barriers may include trade systems, education, justice, foreign affairs, workforce and development, national supply management systems and health systems.

Dear Colleagues,

The International Guidelines on Human Rights and Drug Policy[8], which was adopted in 2019; provides some concrete guidance to overcome barriers related to access to controlled medicine. The International Guidelines recognises that the access to controlled medicines without discrimination is a key element of the right to health. This includes for use as opioid substitution therapy, for pain management, in palliative care, as anaesthesia during medical procedures, and for the treatment and management of various health conditions.

In accordance with their right to health obligations, the Guidelines recommended that States should:

  1. Take legal and administrative steps to ensure the adequate availability, accessibility, and affordability of controlled medicines, with a particular focus on those medicines included in the World Health Organization Model List of Essential Medicines. [Economic affordabilityis a central component of the right-to-health requirement of accessibility. Controlled medicines need not be made available for free; rather, at an affordable cost- SR Health, 2009]
  2. Amend laws, policies, and regulations that unnecessarily restrict the availability of and access to controlled medicines.

iii.      Follow the procedures established in the international drug control conventions when scheduling a substance that has medical uses, and balance the substance’s public health risks with the effects of scheduling on restricting the availability, accessibility, and affordability of medications containing the substance.

  1. Include access to controlled essential medicines for drug dependence treatment, treatment of pain, and palliative care in national health plans and policies and on national essential medicines lists
  2. Ensure the special provision of controlled medicines for children, including appropriate paediatric formulations of such medicines.
  3. Introduce health service provider training on drug dependence treatment, palliative care and pain management, and other medical conditions that require the use of controlled drugs for medical purposes, and integrate training regarding stigma, discrimination, and respect for patients’ rights (including the equal rights of patients who use drugs) into ongoing health workforce education and training.

vii.    Raise public awareness about the right to have access to controlled drugs for medical purposes, including for the treatment of drug dependence and pain relief, and about the availability of such treatment.

viii.    Consider reviewing the 1961 and 1971 drug control conventions’ schedules of substances under international control in light of recent scientific evidence, and prioritise exploring the medical benefits of controlled substances in accordance with the World Health Organization’s scheduling recommendations.

In the conclusion, let me emphasize that in the current COVID-19 context, States should adopt the necessary measures to ensure that the international supply chains of these substances are not disrupted.

I fully concurred with the recommendation of the International Narcotic Control Board, WHO and UNODC that States should ensure the maintenance of sufficient buffer stocks of controlled substances to guarantee availability throughout the duration of the COVID-19 pandemic.

States should use simplified control procedures for the export, transportation, storage and provision of medicines containing controlled substances, in order to ensure people can maintain consistent access to these medicines, and avoid symptoms of withdrawal.  As the pandemic increasingly affects countries with under-resourced health infrastructure and services, it is an ethical imperative to ensure that all people in all countries of the world are able to access essential medicines. This includes those medicines that are under international control.

In this context, I also urge all States to take practical initiatives at the national level s to implement measures that are listed in the International Guidelines. Thus to fulfill their obligations under international human rights law, in particular the right to health.

Ambassador Ghislain D’Hoop:

Thank you very much. Now I would like to present Jose Luis Reyes, who is representative of the El Salvador competetitive authority. He is the focal point of the INCB, representing the division of drugs of his country in international forums. Mr. Reyes will speak about access to controlled medicines in El Salvador during the COVID19 pandemic.

Liliana de Lima:

We will post the video that the government of El Salvador was able to kindly send us.

Dr. José Luis Reyes (El Salvador):

Good afternoon. It is a pleasure to share with you. I am going to share a little the experience of El Salvador in terms of the regulation of controlled medicine, specifically the work that is carried out as a Control Unit. In the narcotics unit that the regulatory entity in El Salvador through the National Directorate of Medicines. The DNM is a relatively new entity, it really emerged in April 2012 and has the legal basis in the drug law, which is a law that was formulated in February 2012. This entity has the responsibility for exercising controls for the import, manufacture, a commercialization, prescription and abuse of drugs classified as narcotic drugs, such as psychotropic drugs or chemical precursors, there is something important to mention. In El Salvador has seen the need to control them, in that sense a number of products have been regulated, some products such as the anesthetics have been included there, especially inhaled anesthetics or products that have some particular substances such as tramadol or products like Tapentadol that are opiate derivatives.

Regarding the availability of medicines, it is very important that we consider that in El Salvador since 2014 we began a process of technification that allowed us to act in a way during the emergency that helped to maintain the availability of medicines for all the patients. Since 2014 we have an online prescription model that has two very important staged, in the slide you can see that we have the wat the prescription is presented for doctors who are given access to an online platform to prescribe the drug in any of the categories that we have just mentioned and the patient with that online prescription does not need to have a print prescription, since the doctor is a certified professional. The prescription goes to the pharmacies, the pharmacies have another portal, which is the one that you can se on the screen, in which there is also a restricted access for each pharmacy to be able to dispense the medicine and we have tied the commercialization and the prescription.

I mean, with that we make it easier for patients to access medicines. We have been doing this exercise since 2014 when we started with pharmacies and as of 2017 we have doctors that prescribe. That allowed us to enter the emergency process of March 17, we who were receiving all applications in person, physically at the institution, we opened a different possibility and from March 17, 2020 in full swing of the emergency due to COVID19 we saw ourselves in the world situation of having the population be restricted to their houses of residence to do home-work. In that sense, we changed the physical reception of documents of import, commercialization, dispersion procedures and we provided users that through an email they could send us scanning the authorization requests which were processed in the National Directorate of Medicines, the users were authorized and in this way we ensured the availability of medicines for each of the establishments required to have medicines.

Obviously this emergency taught us in this process that the work orderly and foreseeing situations that lead us to have difficulties could force us to do practical actions, at that time it was the easiest thing that we found the authorization via electronic and in that way even doing the home work that we did for a good period we achieved that we really did not there would be a shortage of controlled medicines.

The home office work was vital for us and from March to December 2020 we had a lot of work done, as an institution we wend through the difficulties of even having employees that were affected by the COVID19 disease, however, none was left unattended request, we attend the entire quantity of medicines. We in Central America, El Salvador, have a fairly large strength in the prescription part in the commercialization part, even in the manufacturing part because we have34 authorized laboratories for the manufacture of medicines. Therefore, also we are exporters of controlled medicines and we have supplied the region during this difficult stage of the emergency and with which we have ensured access and availability of controlled medicines or all patients who have required it.

In this sense, El Salvador has not presented and we can say with certainty that despite the difficulties of the emergency, El Salvador has not presented a shortage of any of the drugs necessary for palliative care of patients and that due to a health condition it requires it. We can feel satisfied that the orderly work, the work using the communication techniques that are enables at this time and having prescription and dispensing platforms online has facilitated the process that we could develop with greater sense during the emergency. To say in summary, we could say that before complicating the situation, I facilitate the access and availability of medicines, therefore we feel quite satisfied as an institutions with the results obtained.

I know that the time we have is short, I have tried in a few minutes to cover the information that was required and I leave my contacts on the screen to support you in any doubt or any query that you can send us in order to answer any doubt or query that you may arise. Thank you for your attention and I hope I have covered the required information.

Ambassador Ghislain D’Hoop (Belgium):

It is now my pleasure to introduce Dr. Eddie Mwebesa of the Hospice Africa – Uganda, international programs director and fellow of the East Central. You will speak about the impact of the pandemic on access to controlled medicines, pain relief and access to palliative care in Uganda. Welcome.

Dr. Eddie Mwebesa (Hospice Africa Uganda):

Thank you very much for inviting me to speak at this side event to share with you the impact of COVID-19 on access to pain relief and palliative care in Uganda. Just to introduce Hospice Africa Uganda is a nonprofit NGO established in 1993, the vision we have is for political clear reaching all who need it in Africa and this particular organization has interdisciplinary teams at three sites in three different districts of this country. The biggest program for this country is with this organization and we’re proud that we bring patients controlled pain relief into patients homes and that we’re able to bring hope and peace at a special time of their lives. We have cared for about 34,000 patients most of them having cancer and HIV/AIDS. Regarding Uganda, just to put everything in context, we have a population of 45 million people and a quarter of the population is living below the poverty line of $1.00 a day so we really have a poor population where low income country low resource country. A lot of people never actually see a health worker and we estimated that the upwards of 250,000 patients needing palliative care many of them have horiffic tumors and very serious illnesses and they actually require opioids to control their pain, and liquid morphine is the main is a main staple in the management or moderate to severe pain in our setting. From 2011 Hospice Africa Uganda entered a private public partnership with the government to make morphine for the whole country and we have done this each year and we’re proud that we have expanded access to pain relief for patients who need it we have been assist severally and we have been assist as one of the best integrated services in Africa. COVID-19 brought a new way of doing everything it is nothing like we had never seen before so when the World Youth organization declared the pandemic declared covid as a pandemic I mean it was really something serious within the month of March we moved away from hearing that there was I needed this that was another African countries and we received our first case on the 21st of March 2020. The government had already started looking down the country and the lockdowns actually were quite to the detriment of the people who are most at need among the several restrictions that were brought into the quarantine at the cost of waivers quarantined buckling up to $840 for people who were diagnosed with COVID. Also, transport was severely restricted initially it was only public transport that was suspended and private vehicles were allowed to move if they had gone on public transport and private transport was looked down so patients and even health care workers second having severe difficulty moving to their workplaces and seeing patients by the end of the month there was a curfew and she was a nighttime curfew that was enforced by the police and by the army. Interestingly we did not see any serious covid cases with complications until July when we recorded our first deaths and it’s interesting that we have continued to have not as many deaths as we had initially thought would have. So what the pandemic actually did is that it brought a whole range of challenges to pain relief and palliative care. I mentioned some of them here in this table we suspended outreach clinics and daycare services because of social distancing and the risk that aggregating people would have if there was infection amongst any of them. The bans on public and private transport meant patients could not reach us even after the lockdown has not really completely resolved a transport fares are still so prohibitively expensive. We’re not seeing as many patients as we used to before COVID. To bring some kind of order to how has move to the roads the government required that with the regulation be given through stickers but for us in Uganda the process was very bureaucratic, there was some corruption also in how speakers were distributed at the end of the day organizations like ours which are HOSPICES could not get the stickers were given just one sticker for all the vehicles but we had you know our fleet so we’re seriously ampad by the need for stickers. Cufrew was meant that we had to leave work early we could move into offices time. Interestingly traffic jams were worse than before, the lockdowns and it all just compounded the situation that we were operating in there are some more spindles look at this treatment centers and these became out of bounds to patients and so the few hospitals that were available were difficult to reach. We are required to have personal protective equipment and as soon as that became evident for this country. We surveyed several countries where alumni of our courses are located and we found that they were suffering the very same challenges that we had here we took note of one particular facility in Ethiopia which experience and appeared lockdown stockout and patients were left in in pain because they just pulled access essential medicines and there was a purpose in field death and dying among the respondents that we interviewed mainly they were fearing that they would pass on the virus to their families and so some of them were very hesitant to take part in care of patients and that further compounded the problem of access to political care there was one particular facility in Ghana that reported that they started using telemedicine care and we too he had to specifically Uganda resorted to using a lot of the telephone and finding creative ways around how we could reach the patient. So what we did was a series of interventions we had to use our brains and go round handles that we encountered the team said it working in shifts because we’re concerned that in case any of us became infected with covid then there would be a total shutdown of operations of the organization because of the transfer difficulty we asked that members of the team were near living near the Hospice to walk to work. se did a lot of shift working, we sent out appeals for personal protective equipment. Masks were hard to come by and we resorted to making our own masks we employed local seamstresses and started making masks out of cloth, using zoom, WhatsApp groups and making phone calls to patients and using whatever means we could to reach them. We continued pursuing car stickers but being this kind you know this country being the way it is, some of us who needed to see patients become rebellious put into our cars with our ideas and clinical courts and would somehow convince the police that we’re going to see patients. We somehow did sometimes but one of the things that happened is because both the borders were being allowed to ferry food from guardians two markets and to homes. We would agree drop off centers, drop off points and patient would send their relatives saying so would send the medicine send them instructions they would send letters and communications about how they were doing and someone who were able to will get by that way. So today we see that 135M active cases in this country upwards of 40,000 cases you know that our neighbors have had different approaches to the pandemic Tanzania for example did not formally acknowledge that there was a COVID 19 pandemic. I just can’t explain how comes the deaths are not as high as we expect them to be. Lockdown initially started last in the middle of March, and there is now beginning to ease the restrictions to travel schoolchildren are beginning to go back to school and as an organization we are resuming the service provision to ensure that we can get medicines to the patients who actually need them so access to pain relief and palliative care is actually improving and we are now working with a new normal and with the hope that we can continue to reach patients who are suffering with listening here and a caring hand I was hoping that the fortunes will be completely different and that we’ll be seeing many more patients before the end of the year. So, thank you for having me and Contacts I’m happy to take questions if any thank you very much ambassador and colleagues

AmbassadorGhislain D’Hoop:

Thank you very much Dr my best effort is extremely interesting overview of how your country and you yourself have dealt with this considerable challenge that is the COVID pandemic. Thank you for sharing these very interesting views if there are any questions we will see whether we have some time at the end or they can also be put to the chat function there are one or two

It is my pleasure now to introduce Naomi Burke shine who is the executive director of harm Reduction International and with more than 15 years of experience at the intersection of law, harm reduction, HIV and human rights. You are an advocate for evidence-based responses to drug use and the rights of people who use drugs you are a member of the strategic advisory group on HIV and drug use and a member of the World Health Organization guidelines group on ensuring balance in national policies on controlled substances. She will speak about global trends in access to drug dependence medicine during 2020 and you have the floor thank you

Ms. Naomi Burke Shyne (Harm Reduction International):

Thank you so much ambassador, colleagues, I’m honored to be part of this panel today to hear from everybody. I’m going to structure my presentation around three pillars where we started how it’s going and what’s. There’s 11.3 million people around the world who inject drugs and we know 179 countries report some injecting drug use and your time reduction international’s global mapping indicates to just 84 countries around the world make opiate agonist therapy treatment for drug dependence available. Methadone is the most commonly prescribed substance where oh 80 is available followed by buprenorphine and naloxone. Heroin assisted treatment or diamorphine is the least commonly available medicine for drug dependence and is generally reserved for people with pretty pretty complex needs for whom other medicines have failed. It’s available in six countries in Western Europe and in Canada so the number of countries providing opioid agonist therapy for drug dependence is being pretty stagnant.

For years every year we see no substantive progress but perhaps a little a little bit of uptake and a little bit of cessation of services for example between 2018 2020 number of countries in which OD was available decrease by two with Burkina Faso opening its first OAT (opioid agonist therspy) clinic in a hospital and Costa Rica Bahrain and Kuwait ceasing their OAT services. this slide shows our global mapping an important thing to remember is that drug use is present in most prison settings approximately 1/3 of people worldwide are estimated to have used drugs once at least once while incarcerated which is why we work towards a future where people are not incarcerated for minor drug offenses we monitor the availability of medicines, drug dependence in prison. in 2020 there were 59 countries providing OAT in at least one prison which is an increase since 2018. I think we look at like how we started I think the important thing to remember is when it comes to drug dependence and medicine for drug dependence, stigma discrimination and criminalization force literally millions of people to conceal their drug use, meaning they’re not accessing the health services they so desperately need and this is a pretty remarkable state of affairs because it is cost-effective, decades of evidence to support It and it is it broadly kind of improves the health of both the individual and the community. In accessing controlled medicines for drug dependence, we share a lot of barriers that colleagues in palliative care emergency medicine psychiatric medicine have shared already today including the administrative burden, import storage, strict limitations on prescribing, in addition to the specific burden, the clients receiving drug dependence treatment experience because they are criminalized. We particularly observed before the pandemic a really heavy burden associated with the daily observed dose. Somebody is receiving treatment for drug dependence by a controlled medicine such as methadone or buprenorphine with methadone they need to attend the clinic daily for supervised treatment. So, second pillar, how it’s going. People who smok or inject drugs have been recognized as particularly vulnerable to COVID-19 infection compared with the general population around the world. We saw first of all massive disruptions to it programming particularly in lower middle income countries these were heightened by lockdown restrictions meaning people couldn’t leave their house to pick up their daily dose and by close borders which caused issues with the importation of medicines the closure of international borders caused disruptions to the supply of OAT medicines in Eastern Europe and Central Asia with the most well-known case being that amount bold over and our partners in Asia and sub saharan Africa reported that it was the movement restrictions which represented the biggest barrier for their clients meaning people have reduced access to service hours services were open for shorter periods of time there were fewer public transport options so a little bit similar to what my colleagues were saying it’s just hard for people to move around to even begin to think about picking up the medicine they needed. What’s interesting and unique in the context of controlled medicines is that disruptions to the medical markets during COVID-19 also impacted the illicit markets, meaning if a person couldn’t pick up their methadone from their health facility and they turned to St based supplies to avoid withdrawal symptoms then they also grapple with the additional complexities of a new source or new supplier possibly purchasing a substance with more toxic contaminants or more potency than what they’re accustomed to, because the illicit market was also working around border closures and covid restrictions after the disruption weasel innovation. Really exciting and most profound we did a tracking and rapid traffic tracking last year to see how people in countries were responding to covid. We found that 84 of the countries worldwide where 80 is available 47 of them expanded take-home capacities for providing longer take-home doses, 23 countries made distribution more accessible with home-delivery of OAT dosing at community pharmacies or distributing OAT and outreach settingsm so moving the medicine to the client and these new measures were also introduced to compensate for decreased availability of in-person services. In the Middle East and North Africa, they have turned to online consultations to replace face to face meetings. Morocco is a great example of the government putting in place policy to allow for delivery of 82 clients. In Luxembourg, Spain and Portugal OAT medical medications together within naloxone, an overdose reversal, medicine were made available in lower threshold settings so again there were service providers taking the medicines out to clients. And across Europe we saw service providers working to shorten the initiation time or the waiting lists in order to get people onto the medicines they had a safe supply of the substances they needed. The best case example in my mind is the response set up to the jewel impact of poverty and lockdown in Hamburg in Germany where a temporary OAT service was set up where anyone could initiate oat and access oat medication without any costs regardless of their health insurance status. So what next? it’s been a year of unprecedented disruption we’re hopeful that the new energy for global cooperation and access to medicines will also allow us to strengthen access to control medicines and we welcome the INCB WHO, UNODC joint statement on this in a particularly its inclusion medicines for drug dependence. I have two closing points firstly to remember that COVD shown a light on the vital role of nurses allied health care workers pharmacist and peer and community leaders in disseminating information to keep vulnerable populations safe as well as ensuring they couldn’t support access to control medicines to make sure that those patients still got their medicines during those times second point COVID adaptations in OAT initiation prescribing delivery or take home doses has improved access to OAT with no evidence of diversion. The community of people who use drugs has called for a greater focus on client or patient needs, and tailor treatment for decades. COVID-19 has catalyzed changes which should be studied assessed and preserved lessons from the past year create important evidence in support of the permanent acceptance and adoption of health interventions which place human dignity agency and the lived experience of people who use drugs at the center of the response and as such we call on the UN and governments to draw on this new evidence base and the emergence from covid phase and post pandemic era, thank you

Ambassador Ghislain D’Hoop

Oh thank you so much before very cogent and the extremely interesting presentation and thank you for making your points to such a such conviction. Colleagues, we are coming to the end it is my pleasure to ask the Turkish ambassador to make closing remarks. Christopher R is a doctor in pharmaceutical Sciences it was a technical advisor for the Pan American Health Organization for 70 years and Latin American countries in Caribbean islands and you hold professional positions in Bolivia, Barbados and Brazil. You have research and published on the effect of Coca leaves and its alkaloids on the center nervous system and that extensive expertise and work with The WHO to strengthen supply chains makes you course an ideal expert to make closing remarks of this very very interesting panel.

Dr. Christophe Rerat (WHO):

Thank you Mr ambassador and first of all I want to to thank the organizers for giving the opportunity to contribute and deliver some some insight as closing remarks on supply chain mainly I would focus my discourse on supply changing during pandemic. As you said the COVID19 pandemic have clearly showed to the world an remind us the necessity to urgently respond to the needs to diagnose and to treat the disease while maintaining functioning palliative services to attend patient suffering from other chronic diseases and health emergencies and we could see that no health care system in the world is efficient enough or resilient enough to provide an adequate and timely response to the challenges caused by COVID. Most advanced countries could see evident limitation in terms of service delivery, while the less prepared countries have seen the collapse of their health system. Many countries used the number of patients in ICU as a critical indicator. The increase of patients in English specialized hospital units put the health care providers and politics under high pressure in many countries and showing an appropriate supply of medical and build biomedical products including oxygen delivery devices providers protection devices as well as a supply of critical medicines, including obviously controlled medicines were of most importance. COVID-19 situation evolves rapidly, creating considerable challenges and causing disruption to supply chain operations. The absence of manpower, the local or national lockdowns in many countries custom clearance delays, export restrictions, lack of land transportations actually for cargo and restrictions on air ocean and flights have generated tremendous difficulties and put at risk the availability of medical products and affordability including control medicines. This is why, the INCB show in the late-2020 joint statement to alter the international community of the risks of disruption in the supply of control medicines during COVID, and for suggesting appropriate measures to mitigate these risks and protect people’s lives. It was to mention as well that the international organizations and I care, the international civil Association organization aviation also cares to ensure a statement reminding all stakeholders of the importance of following regulations and guidance particularly relevant standards contained within the international pet regulation HR 25 and this to maintain flight transportation and to mitigate local or national lockdown impacts. So the the organization has took many actions and measures during that time. I would just mention two of them because of time obviously. The organization insisted on the importance to rely on robust selection mechanisms for medical products and recalled that the mobile list of essential medicines includes operates or analgesics formulations commonly used for the control of pain respiratory distress and as has been said, it does align to the model list released electronically last year and that obviously is publicly available from our website. So I strongly right all the participant or strongly disseminate this information in your networks. I would like to mention as well the work that has been done by their regional officials, from the region of the Americas. In 2020, an essential and essential medicine list for management of patients admitted to intensive care units with suspected cases of COVID was created, and now we can have this list and protocols in the guidelines released, and that includes the operation antibiotics among other. Another critical point was it is related to the supply chain information systems. It’s evidence that manager of supply chain depend on timely and accurate data to make informed and effective decisions about supporting operations like forecasting demand and resupplying facilities, help facilities, so that informs strategic decisions to make supply chain design processes and workforce more efficient and cost effective. Improving systems systems is something that is still critically important.

The panelists showed that the inabilities of countries to access controlled medicines and their dependence. There are very few countries that concentrate the global production of API active pharmaceutical ingredients, intermediates and finished pharmaceutical products. We all know these basically two countries and the political debates in the Western Europe and the North America to push the national industry again. So it’s a question of national sovereignty to ensure access to medical goods that will become certainly in the new strategic and political priority. I refer to the relocation of Pharmaceutical industry and the development of qualified workforce. Finally I would finish there it’s important to stress that the supply chain is a continuum of operations from the production of API enrollment material as I mentioned until the delivery of services at a point of care, so any disruption at some points of the chain have add impact on the availability of the product for the user or from patients, so it’s therefore a comprehensive approach that is needed to ensure a full functionality of the supply chain and as we’re talking about medical goods ,medicines controlled medicines, the collaborative work with regulatory systems national regulatory agencies is a critical necessity to ensure the quality of products circulating in the market. I will stop here for the consideration of time but would be happy to follow discussions with the audience, thank you Mr ambassador.

Ambassador Ghislain D’Hoop:

Thank you very much doctor for these very interesting closing remarks you have mentioned the continuum from producer to patient. It is one of the challenges, far from the only challenges as we have seen during our very interesting talk and listening to the panelists. I mentioned in starting that another huge challenge is in equalities of course in society the weaknesses and the global supply chains as you mentioned but also inefficient mechanism for procurement. I think what it’s also been shown very clearly by the practitioners on in the field is how difficult it is to translate all these challenges into daily delivery of care to the patients and we’re talking of course about palliative care but a lot of you have gone beyond that and have basically addressed the challenges of the care itself giving the restrictions that this pandemic puts on availability of a number of products and even sometimes of people and I think it is this exchange between practitioners in the field on one hand, between experts and who work international organizations like you, and between us also representing government. This is unique and this is what makes decide events unique this therefore also a pleasure and an honor for me to be able to be associated with all this work.


[1]The Outcome Document of UNGASS 2016, Chapter 2; available at https://www.unodc.org/documents/postungass2016/outcome/V1603301-E.pdf

[2]World Drug Report, 2020, Booklet 6; available at https://wdr.unodc.org/uploads/wdr2020/documents/WDR20_BOOKLET_6.pdf

 

[3]World Drug Report 2020; See also Report of the  Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, A/HRC/65/255 (2010)

[4]Committee on Economic, Social and Cultural Rights,General Comment No. 14: The Right to Health, UN Doc. E/C.12/2000/4 (2000), para. 43(d).

[5]Report of the Special Rapporteur on torture and other cruel, inhuman or degrading treatment or punishment, Juan Mendéz, UN Doc. A/HRC/22/53 (2013), para. 56; Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, Anand Grover, Submission to the Committee against Torture regarding drug control laws (October 19, 2012), para. 22; Report of the Special Rapporteur on torture and other cruel, inhuman or degrading treatment or punishment, Manfred Nowak, UN Doc. A/HRC/10/44 (2009), para. 72; Manfred Nowak, Special Rapporteur on the prevention of torture and cruel, inhuman, or degrading treatment or punishment and Anand Grover, Special Rapporteur on right of everyone to the highest attainable standard of physical and mental health, Letter to Chairperson of the Commission on Narcotic Drugs, UN Doc. G/SO 214 (52-21) (2008), p. 4.

[6]Report of the Independent Expert on the enjoyment of all human rights by older persons on her mission to Costa Rica,UN Doc. A/HRC/33/44/Add.1(2016), para. 106; Report of the Independent Expert on the enjoyment of all human rights by older persons on her mission to Montenegro,UN Doc. A/HRC/39/50/Add.2 (2018), para. 113.

[7]See, e.g., Committee on Economic, Social and Cultural Rights, Concluding Observations: Belarus, UN Doc. E/C.12/BLR/CO/4-6 (2013), para. 25; Human Rights Committee, Concluding Observations: Georgia, UN Doc. CCPR/C/GEO/CO/4 (2014), para. 15(c); Committee on Economic, Social and Cultural Rights, Concluding Observations: Lithuania, UN Doc. E/C.12/LTU/CO/2 (2014), para. 21; Committee on Economic, Social and Cultural Rights, Concluding Observations: Russian Federation, UN Doc. E/C.12/RUS/CO/6 (2017), para. 51(c); Committee on the Elimination of Discrimination against Women, Concluding Observations: Russian Federation, UN Doc. CEDAW/C/RUS/CO/8 (2015), para. 36; Committee on Economic, Social and Cultural Rights, Concluding Observations: Ukraine, UN Doc. E/C.12/UKR/CO/6 (2014), para. 24(c); Committee on Economic, Social and Cultural Rights, Concluding Observations: Uzbekistan, UN Doc. E/C.12/UZB/CO/2 (2014), para. 24.

[8]Available at: https://www.humanrights-drugpolicy.org/

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