Side event: Taking action to increase access to controlled drugs for medical purposes while preventing diversion and misuse

Organized by the Governments of Australia, Ecuador and Belgium, the United Nations Office on Drugs and Crime, Drugs and Health Branch, the International Narcotics Control Board and the International Association for Hospice and Palliative Care.

Permanent representative, Australia: People are at the centre of our efforts. The Conventions were established to uphold the welfare and wellbeing of humankind. Access to controlled medicines and pain relief is essential. Australia is deeply concerned about the global disparity for controlled substances for the relief of pain. The Ministerial Declaration commits to access and availability of substances controlled, for scientific and medical purposes. We must work together to ensure the Treaties are not interpreted in ways that hinder access. Create systems of control, reduce suffering and diversion. Domestic conditions restricting access: lack of resources, etc. UNGASS suggests avenues for redress. Barriers are also social and cultural.

Verónica Espinoza Serrano, Minister of Health, Ecuador: When we think of an opioid crisis, we think of the overdose crisis in North America. But in Ecuador, we see it in a different way. We have a strong problem regarding access and availability of opioids. One of the worst crises in the last years. The crisis is not just about use but also lack of access. This is actually what most countries experience. North America seems to be over-using prescription opioids. Whereas the rest of the world is severely under-served. Access is incredibly unequal. While this is the reality for most of the world, the problems of Canada and the United States, which matter and are very important, dominate discussions in the media and international forums. In Ecuador, over the last 6-7 years, we have seen the lowest consumption in the region. It is not about lack of need, but lack of availability and access. Many reasons: registrations of morphine (14 medicines, but most pharmaceutical companies are not marketing the products). Consumption amounts – The number of units for the treatment of pain (of the only presentation of oral morphine) in 2016 and 2018 was 0. For parenteral morphine, it’s still very low too. Doctors and health professionals do not know how to use morphine. In their years of practicing, they have not learnt to use it because availability was poor. Doctors are afraid. They couldn’t be trained because the drugs weren’t’ available. Vicious cycle. Tramadol use has increased significantly. It’s the only alternative left. We have a legal framework that should foster access. One of the few constitutions that enshrines access to medicines as part of the right to health and creates an obligation on the state to provide them. In 2015, three new drugs that were not internationally controlled (e.g. buprenorphine) were included as options because it made prescription easier. The National Drug Policy in 2017 focuses on this issue and commits to tackle. In 2018, the government declared morphine a drug of public interest. First time after antiretrovirals because of the lack of availability. Big challenge: limited access and availability, no quality of life. Why? Legal and regulatory framework (controlled substances legislation imposes disproportionate limits…and pharmaceuticals are not particularly interested because morphine is not very profitable). Similar cases? Buprenorphine, naloxone, methadone, codeine, medical cannabis. We need to work to do better. If we look at the problem of drugs from a perspective of human rights, we can start advancing to a more balanced approach.

Lukas Radbruch, IAHPC: I work mostly in the Global North, where options are available. It’s impressive and disheartening to see something so normal lack in other places. In many countries, people have to travel hours to get to dispensaries where they can obtain pain management. The Lancet Commission published a report in 2018 about this matter. The report contains 5 key messages: Alleviation of the burden of health-related suffering is a global health and equity imperative; universal access to an affordable essential package of palliative care can alleviate much of the burden; LMICS can improve the welfare of poor people ad modest cost by publicly financing the essential package; (…). Serious health related suffering means that some health conditions that are life threatening/limiting are associated to “days” of health related suffering. We found that 25.5 million deaths would have been preceded by serious suffering. 35.5 million people not dying would also experience SHS. 61.1 million people worldwide suffered. 80% in LMICS. In terms of resources, morphine is key. We looked about importations and distribution of morphine. We also considered the opioid crisis in the US, particularly because of the fear that the overdose crisis might act as a deterrent for LMICs. Fear IS one of the key barriers to availably/access. The essential package includes medicines, medical equipment and human resources. A lockbox is included in the equipment list (keeping in mind with the mandate to avoid diversion). Closing the global pain divide, at current prices, would be USD600 million. But challenges of human resources too. Per head cost, 20-70 cents… Universal Health Coverage cannot only focus on prevention, promotion, treatment and rehabilitation but also palliative care. The Lancet Commission will continue to work on this issue. Specific to pain relief, we ask to adopt DOME/SHS as an overtime country performance measure; use W European benchmark, develop pain specific performance measure (collect data on how much morphine goes specifically to pain relief vs. OAT, for instance); improve country data reporting; collaborate with WHO, WB and the IFIs, incorporate pain relief and palliative care into UHC; establish WHO/INCB joint task force for balanced access to opioid medications. In Uganda, despite being a LMIC, work with nurse professionals and associations to ensure distribution.

Viroj Sumyai, INCB: The pain divide is made clearer by the work of the Lancet Commission, and data by the INCB. It is an important study that the international community should use to try to better address the problem at hand. The Conventions specify controlled medications should be indispensable, adequately provided and not unduly restrictive. This is not the case in reality. INCB has brought this matter to the attention of the international community in a supplement of its 2015 report. The UNGASS Outcome Document reaffirms the importance of access and availability of controlled substances for medical and scientific purposes. In terms of progress, the INCB has invited countries to discuss actions taken to address these barriers. 130 governments responded. Civil society was also invited to contribute. There isn’t a lack of raw materials for opiate production. 10% of the morphine available is used for pain management. The majority is used to manufacture codeine, used almost exclusively for cough medicine. Often, our discussions are about pain relief; but mental health conditions (e.g. anxiety) are very underserved. While 80% of people with epilepsy live in LMICS, their consumption remains largely unknown… INCB asked countries to provide feedback on the implementation of Chapter 2 of the Outcome Document. The analysis has been included in the 2018 Annual report. IN most countries, medical specialists can prescribe opioids; only a few allow nurses. The lack of doctors in highly centralised health systems means access is very hindered. Most countries limit the validity of prescriptions to one week or less, creating further barriers. Some countries are taking steps to improve accessibility; by for instance improving health insurance systems and affordability. We suggest to increase and strengthen availability of training for healthcare professionals, ensure prescriptions are appropriate to the needs of patients whilst ensuring monitoring and dispensing arrangements are adequate; enable a broader range of healthcare professionals to prescribe controlled substances; offer low-cost palliative care; include palliative care in the national curricula of medical and nursing schools;  mitigate sanctions in unintentional prescribing errors; bolster production; enforce regulations of the pharmaceutical industry to deal with promotional campaigns (consider banning promotional material advertising to the general public); ensure the pharmaceutical industry produces and makes available controlled substances that are affordable; ensure health concerns are prioritised when issuing licenses related to essential medicines; periodically review estimates and assessment of needs to ensure adequate capacity to prescribe and dispense rationally; expand coverage of health services and ensure substances in the WHO model list of essential medicines are included in national list of essential medicines; establish tools for processing import/export authorisations.

Sylvia Trent-Adams, Principal Deputy Assistant Secretary for Health: Limited access to controlled medicines is a critical global health prices. No one should suffer from untreated pain or be denied medication when needed. The opioid crisis is devastating our nation, however. We have implemented strong measures to ensure access whilst preventing diversion. In terms of public health, drug overdose deaths are now the leading cause of injury deaths. The majority relate to opioids. Addressing this is a top priority for Trump administration. Nationwide public health emergency. 5 point strategy: 1. Access: Better Prevention, Treatment, and Recovery Services; 2. Data: Better Data on the Epidemic; 3. Pain: Better Pain Management; 4. Overdoses: Better Targeting of Overdose-Reversing Drugs; 5. Research: Better Research on Pain and Addiction. US taking steps to decrease diversion and better prescription practices. Actively engaged in discussions on how we treat pain. Ex. CDC has worked in developing guidelines, improving pain management. CDC released guidelines on prescribing opioids for chronic pain for primary care providers. Intended to improve communication providers and patients to improve safety and effectiveness. Reduce risk of long-term opioid therapy, including for opioid use disorders. Educational tools to implement the guidelines. Funding for scientific support to equip centres with databases. Take-back days. Scientific research on pain and addiction.

Miwa Kato, UNODC: As UNODC, we appreciate the heightened and priority attention to the opioid crisis related to overdose deaths, a societal, economic and political issue. UNDOC wants to support responses. But it is important to consider that, in a world of “no one left behind”, it is our responsibility to highlight the other side of the opioid crisis; the disparity of access. In terms of technical assistance and UNODC’s experience, one area is supporting building capacity of health workers using controlled drugs for pain management. In Ghana, Nigeria and Timor Leste we have concluded activities in this sense. There’s a whole generation of practitioners that are not trained and acquainted; so we’re happy to support. In Nigeria, we took it one step forward to create a curriculum for medical schools to reflect that in the future generation of practitioners. Another area of importance, working with government and university in Panama, an assessment to determine actual access to controlled medicines based on experiences of affected populations (patients, doctors and pharmacists); used by the government as the basis to address challenges in the drug supply change and find workable solutions. In Nigeria, with additional support from the EU, a series of new policies developed on this are; which could be a global model. As you hear, why in 3 countries? This assistance is asked by most countries. But this area is critically underfunded. How do we take it beyond those convinced about the importance of this area? How do we increase funding to replicate experiences in other countries, in a localised manner? Going beyond, we need to think together of ways to overcome this.

Gilles Forte, WHO: (…)

Tania Pastrana, ALCP: (…)

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