Ambassador Vermuelen (Belgium): introduced the topic and the history of Belgium’s involvement including last year’s initiative, which was at the heart of Belgium’s Presidency of CND.
Speakers: Dilkushi Poovendran (WHO), Ghislain D’Hoop, Carolyn Patterson (Assistant Secy Govt of Australia, Health and Aged Care)
Jagit Pavadia, President, INCB: Thank you to the govt of Belgium and congratulations to Ambassador D’Hoop as chair of 65th CND. I am honored to participate in this initiative. Half a century ago, the international community made a commitment to the health and welfare of humankind. While some progress has been made, imbalance in availability remains globally. This contradicts the aims of the Single Convention and numerous human rights instruments that contain the right to health and medical care. The INCB is committed to improving availability. We collect info on impediments published in annual report supplements, the latest one in 2022. The report confirms inequities and need for decisive action particularly in the lower and middle-income countries (LMICs). There is limited access to affordable morphine. One reason is that the majority is converted into other drugs and not used for palliative care. Problem is that many countries do not submit good estimates. We have the same problem with psychotropics. Sourcing and structural problems at the root. Civil society organizations confirm the relevance of training. Rural and remote areas are a problem. There have been several positive developments. Of the countries that reported, 60% had changed legislation, 45% changed regulations improving availability of medicines for cancer and palliative care. Increasing number of healthcare professionals allowed to prescribe. Some have introduced electronic methods. Some introduced low-cost community home based palliative care services. Improving availability requires a multi-pronged approach. Only a few countries follow morbidity based estimate methods, which are more precise. Countries need to strengthen digital networks for data collection for determination of estimates for population requirements. Some need to change legislation while maintaining adequate control. Procurement alone will not improve the situation. There is a need to train health workforces about proper prescription and administration. Governments need to work relentlessly to ensure that goal is included in national policy. They need a master plan at the national level to determine time bound action. NGOs have crucial role to highlight gaps in system. Conversations with policymakers are needed. INCB remains committed to improving access.
Justice Tettey, UNODC: Worldwide, millions of people, mostly living in LMICs, suffer from severe and untreated pain due to unavailable and inadequate access to controlled medicines. 1 million of those are HIV/AIDS patients with end stage conditions. When you look at the three international drug control conventions, all embody that commitment to make adequate provision to ensure, rather than unduly restricting, the availability of controlled substances considered essential for medical and scientific purposes. All major policy documents from UNGASS on and Resolution 63/3 from CND promote awareness raising, education, and training, as part of a comprehensive approach to ensure access to and availability of controlled medicines. Last year, the Chair of CND, Ambassador D’Hoop, through the Secretariat of the Governing Bodies, issued a Joint Call to Action which was followed by events in Geneva, New York and Vienna to raise awareness and call on member states to increase their efforts to ensure availability of controlled medicines while preventing diversion and abuse.
As part of global efforts to scale up implementation of international drug policy commitments on improving access to controlled substances for medical and scientific purposes, UNODC have been advocating for eliminating barriers through at least three pilot programs in four countries, focusing on the assessment of national legislation and policies, training of policy makers and health workers, mapping gaps in the supply chain, to ensure access to controlled medicines. In the framework of a joint program with UICC and WHO, UNODC has mobilized efforts in Ghana, DRC, Fiji, Panama, Antigua, Nigeria, and Timor L’Este.
Urgent action is needed to ensure access to internationally controlled medicines, not just for management of pain but also for the treatment of drug use disorders, mental health and neurological conditions. Ensuring access to people affected by emergencies and humanitarian crisis is crucial to prevent people from being left behind. When you look at places like Ukraine and other war torn areas we see that controlled medicines must be available and accessible to those in need. This is a basic principle and our responsibility to implement the treaties. We have to build on last year’s action and take immediate action to improve the current situation. Time is of the essence. We cannot afford to delay but rather must “act now”. It is a cruel necessity to alleviate the suffering of those who are neglected and often forgotten. UNODC is relaunching the initiative. We have appointed Elizabeth Saenz to work on it full time. We urge all member states to join in the initiative.
Dilkushi Poovendran, WHO: WHO was founded in 1948 as the specialized health agency of the UN on the conviction that health is a human right to be enjoyed by all people, not a privilege for the few. As part of our commitment to achieving universal health coverage, WHO works to ensure that all medicines, including those that are subject to control through the international drug control treaties are available to alleviate the pain and suffering associated with a range of medical conditions including for cancer and palliative care.
Therefore WHO fully supports continuation of efforts made through the 65th CND to strengthen safe, equitable, and affordable access to controlled medicines particularly in low and middle income countries where there is an even greater struggle to ensure patients have access to life-saving medicines. WHO has been long concerned about the stark global inequities in accessing medicines, and recognize that the international control status of medicines that have psychoactive properties exacerbates some of those already existing challenges surrounding medicines access.
WHO has seen considerable progress in bringing increased awareness to the need for safe, balanced access to controlled medicines in the past few years through coordinated efforts at international, regional, and national levels. Therefore, dialogue such as the one that we are having today are important in sustaining the momentum.
Many controlled medicines are listed on the WHO List of Essential Medicines, a list of medicines that WHO considers to be key to the delivery of essential health services. Opioid medicines such as morphine are still inaccessible or unaffordable to the vast majority of patients in the world who need them for palliative care, cancer care, or pain management. Many countries have low availability of opioids that are needed for scientifically proven treatments such as opioid agonist therapy for the management of substance use disorders.
While much attention has been given to controlled medicines disparity in relation to opioids given the problems of lack of access in many countries and overuse in others, many other controlled medicines are also needed for the treatment of other health conditions. This includes medicines for the management of epilepsy and other related conditions and neurological disorders, for the management of mental health conditions, for the provision of anaesthesia, surgery and so on.
When there is low availability and accessibility to controlled medicines for recognized therapeutic purposes, the clinical need for these medicines persists, leading individuals to seek them out in illicit, unregulated, and often unsafe markets instead of under the supervision of healthcare professionals. On the other hand, when controlled medicines are available in quantities that exceed what is clinically necessary, they may be diverted for non-medical use while still not being available for those who need them medically.
Collectively, we must work in coordination to promote policies that are balanced in their objectives of enabling access to controlled medicines while also preventing or minimizing their non-medical use. To do this, we may wish to reflect on several key questions and challenges:
- Where should controlled medicines be made available?
Medicines with narcotic and psychotropic properties are needed to alleviate pain and suffering caused by a range of medical conditions. Controlled medicines should be available in all healthcare settings in which they have proven uses, and those healthcare services must be sustainably financed. Urgent action should be taken to consider settings like humanitarian and emergency situations in which supply chains may be severely disrupted, leading to shortages of essential controlled medicines. In this regard WHO, INCB, and UNODC have issued a joint call to governments to facilitate access to controlled medicines in emergency settings, including during pandemics and climate-related disasters.
2. What controlled medicines should be available?
Countries should prioritize the availability of medicines that have been proven to be both safe, effective, and affordable to patients, and this determination should be based on objective, scientific information. Equally, controlled medicines dispensed in those settings must be priced in a way that is affordable to national governments, healthcare facilities, and ultimately patients themselves. Controlled medicines are needed for all populations, including elderly populations, children, and babies. Special formulations of medicines are often needed for these populations. In this regard, support of scientific research into treatments for conditions in which controlled medicines may be needed is critical. National governments must then properly quantify the amount of controlled medicines that are needed to effectively treat clinical populations, and to have mechanisms in place to procure and safely store those medicines.
3. How should controlled medicines made available?
At clinical level, the ways in which clinicians prescribe, dispense, and administer controlled medicines influence both access and safety issues. Clinical guidelines at national level should exist to support clinicians in the safe and effective use of controlled medicines.
4. And finally, who should make them available?
Education, knowledge, and attitudes towards controlled medicines are critical to reduce attitudinal barriers to the safe prescribing of medicines in settings amongst the health workforce. Training of healthcare professionals in these services is needed to sustain these areas.
Conclusions: Madame Chair, health leadership to address these global inequities in access to controlled medicines is needed now more than ever. This year, WHO will be publishing a guidance document for national policymakers to ensured balanced, safe access to controlled medicines and will be publishing a study on morphine availability, and will update its Essential Medicines List. WHO also stands ready to directly support countries in initiatives to ensure safe, balanced access to controlled medicines. Together, we must work to reduce the preventable suffering of millions of patients around the world and stand by them to ensure that no one is left behind.
Video presentation by the Democratic Republic of Congo (DRC) on an experiential learning project.
Dr Emmanuel Luyirika, ED, African Palliative Care Association: We have gone through a training exercise and supported a team from the DRC to go to Uganda to see how they are procured for patient use. Kakese Lumanisha Innocent is deputy medical director of national cancer center. He was leading a joint delegation from MoH. The exchange concerned with palliative care knowledge and use of oral morphine. Received by MoH in Uganda during CoVID. Strong impression remained after field visit. We learned from supply chain discussions that integrate all medical supplies, distribution as well as use in care facilities. We also went to the National Cancer Institute where we saw the implementation of the whole strategy. We saw the integration of palliative care and use of morphine at bedside of patients. Today on our return we have the responsibility of integrating this experience in our country. In addition, we are leaving with the duty to go and initiate the local repackaging of morphine as soon as possible in our country. Dr Jacki Ndono Kingolo coordinates hospital platform bringing together several hospitals in Congo. Had to captialise on many positive elements. We learned three essential things: the value of public private partnerships. We saw how civil society collaborates with government for wellbeing of population. Uganda is integrating PC in a holistic way in hospitals we visited. We saw the patient centered care and team spirit between providers: docs, pharmacists, and nurses working together. Final element is use of morphine. Will give detailed feedback in our country. We will get closer to institutions of the MoH so we can plan how to work together in the effective integration of PC but above all the sensitization of docs and nurses about use of morphine.
Practical approaches to improving access and use of morphine We have developed Draft Clinical Guidelines as a reference tool for use of controlled medicines in clinical practice in Africa. We provide online training and mentorship on a platform provided free by ECHO. We believe other countries can do the same. We are building national level learning and best practices through exchange. We are supporting frameworks for nurse prescription of controlled medicines. Policy, guidelines, mentorship, link to morphine reconstitution and supply chain for controlled medicines.
Anselme Kananga and Mubeneshayi Kananga DRC: presentation slides show 25 teams of Pallia Famillli. Congolese Pharmaceutical Regulatory Authority is setting up a device to strengthen availability of opiates in collaboration with associations campaigning for palliative care. A day of high awareness will be organized in May. Last year we did a survey on opioid use in hospitals. Pallia is setting up a statistical database on opiates in health institutions. Will be reference tool that will first be tested in 5 hospitals this year.
We are strengthening the education of health workers and the population. The best strategy is education. There are three parts. Awareness, training, and transmissions, which is supported in practice. Mentorship is key. Our mobile team is supported by the government. We have five mobile units including pediatrics. We are training student nurses, snf partnering with the Belgian palliative care association who come to teach.
Ambassador D’Hoop, Belgium: I am no longer the ambassador but I came to Vienna to help with some side events of UICC and Walther Institute to support the availability launch from last year. This is a proverb from my country: “If you say A, you also are meant to say B.” That is what is driving me. I am close to retirement but I have decided to say “B”. To give body to this global joint call to action. As it was so potently brought forward is to join forces to raise awareness and maybe start with raising awareness to those who are not already convinced, sadly don’t care and once they would know would care and could help us fight pain. Pain is intolerable. I use the word “pain,” because “access and availability” too technical. Sometimes we have to to use one-syllable language. We need to convince people, the general public, and our governments, influencers, private sponsors, that this is a cause worth fighting for. What I am trying to do, why I am so grateful, is to allow me to appeal to you that we should all structure our commitment better and more strongly than we have done. We have all said A, We need to get out of this box and take action. When we know how much already is done to bring palliative care and cancer medication and those substances used to alleviate mental health still it is not enough. So please I know you are convinced but I would love you to take a few more steps forward and join us in whatever campaign we are starting up. I am stating my private commitment to combat this really intolerable situation where more than 75 % of the world have no access to these substances. This action which we should continue is entirely focused on controlled substances in a controlled medical environment. Not an advocate for anything else. A cause worth fighting for. Thank you for your attention and support which we hope will be massive.
Katherine Pettus, IAHPC: what is the role of the global pharmaceutical industry in this?
Nicole of SSDP international: People dependent on opioids could get substitution therapy on methadone. Effective in enhancing life quality. Pure heroin is provided in Switzerland as part of a treatment programme. Do you think it is possible to treat heroin addiction with heroin?
Amb D’Hoop: Pharmaceutical industry is increasingly subject to principle of corporate social responsibility. It should be possible to focus on pharma. I suggest that we request they bring this on board as their social responsibility.
Carolyn Paterson, Australian Government: The breadth of information covered and experience shared this afternoon shows our responsibility and the importance of mitigating the devastating consequences this can cause. Australia applauds the vison and initiative of Ambassador D’Hoop on this complex and multifaceted issue. Progress will be made by including all relevant stakeholders including affected communities. Australia cannot overstate importance of continuing this initiative. Member states must continue to work on providing access and availability aligning with commitments to SDGs. Access is also a crucial facet to uphold sustainable development more broadly, given inherent dignity at heart of development issues. Encompasses pain management, surgical care, palliative care, drug use mental health conditions, yet we all remain concerned that millions remain deprived due to lack of access to and timely provision of affordable, safe and effectively controlled meds. Women are disproportionately affected by lack of access. WHO reports gender disparities in access to controlled substances. Women have less access to health services and less control of decisions regarding their own bodies. Australia encourages global community to contribute to the Joint Program, particularly in the wake of crisis. Public health and human rights based approaches will drive innovative responses. Australia is focused on reducing unacceptable disparities. We re proud to continue supporting the Joint Program working in Timor L’Este, Indonesia, Fiji. This shows what multilateral agencies, governments, CSO drive change at local, regional, global, levels. We are looking for collaborating partners who can overcome the barriers to ensure medicines are available to all in need. Move towards stage B. Thirty participants joining online. In union lies strength.