CND Intersessional Meeting – 10 October: Operational recommendations on Ensuring the availability of and access to controlled substances exclusively for medical and scientific purposes, while preventing their diversion

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Rose Kiwanuka (Palliative Care Association of Uganda) delivers statement during thematic discussion on access to controlled medicines.

Gilberto Gerra, UNODC: There is a clear imbalance in terms of access to essential medicines. The UNGASS outcome document contemplates measures to facilitate this. Ethical mandate to reduce burden of pain. Countries have produced a myriad of supplementary regulations that restrict access and go beyond international obligations: burdensome registration of patients, specific permissions for doctors, stigma, etc. Necessary to revise legislation, administrative law, etc. But also to end the fear and ignorance that creates supplementary barriers to the prescription of opiates. UNODC engaged in multiple projects in different countries to work on these goals.

Stefano Berterame, INCB: In 2015, INCB issued a report where we took stock of the situation in the last 10 years. Poor availability of opiates for pain control in developing countries. Epidemic of untreated pain but also of mental health disorders that needs to be addressed. The report also addressed recommendations to improve access and limit administrative and legislative obstacles (…)

WHO: Controlled medicines are needed to alleviate pain and suffering, to support end of life care, to help people overcome drug dependence, and to save lives. However, access remains inadequate around the world. Several World Health Assembly resolutions reflect the importance of this issue, and give WHO a strong mandate to tackle access issues while also preventing diversion. The barriers include a lack of knowledge around efficient and safe supply, restrictions on supply and dispensing, and inefficient systems. WHO have recently developed guidelines for pain management in children, and soon will have new guidelines on cancer pain management in adults. We provide support and training to countries, and work closely with UNODC and INCB. [They then listed a series of WHO activities in countries around the world]. Moving forwards, our work in countries will focus on better forecasting, better supply chain management, etc. This will lead to balanced approaches to ensure availability and reduce misuse. We are committed to cooperation to fulfil the UNGASS recommendations on controlled medicines, and are keen to collaborate on the development of mechanisms to improve access.

Colombia: We thank UNODC and WHO for their information. The first recommendation of the UNGASS document suggests regulations and mechanisms to ensure access to controlled medicines. Important to consider regulatory measures to ensure access for scientific and medical purposes. The recent law 1787 establishes a regulatory framework to enable safe and informed access to cannabis and derivatives for lawful purposes. The State regulates the cultivation, production, acquisition, import, export, storage, transport, marketing, distribution, use and possession of cannabis plant seeds and derivatives purely for medical purposes. To avoid diversion, licenses under the aegis of the Ministry of Health and of Justice, and follow up measures to ensure compliance with the conditions of the law. The change is anchored in scientific and technical evidence for this form of regulation. The chemical features of the cannabis used in main Colombian cities will be also taken into account to develop adequate policies.

Slovakia, on behalf of the European Union: Ensuring appropriate access to and use of controlled substances for medical treatment while minimising their misuse is a difficult balancing act for society to achieve. Yet it is also an essential task in order to reduce pain and suffering across the globe. The need to have access to essential drugs is also prominent in the Universal Declaration of Human Rights and embedded in several legal instruments in the context of the World Health Assembly.  The rational use of opioids, mainly in the area of pain treatment, is indeed essential to health.  Given the possible negative effects of misuse, or trafficking an adequate balance between provision and control is required. However, the availability and access to these substances is not achieved in many countries: recent data show that up to 75 percent of the world population has no access to proper pain medication.  This situation induces unnecessary pain and suffering worldwide and is unacceptable. The UNGASS outcome document rightfully stresses several operational recommendations to tackle the range of existing barriers.  Reviewing legislation, strengthening national control systems and stimulating capacity building and training for health professionals are some of the measures that have shown to be effective.

The availability for opioid medication for the control of pain varies across Europe. A European study called Access to Opioid Medications in Europe (ATOME) undertook applied research to assess the barriers for access to opioid medicines for moderate to severe pain and for the treatment of opioid dependence in twelve Member States. The project developed tailor made recommendations to address these barriers and contributed to the revision of the WHO policy guidelines on controlled substances.

Technical guidance to tackle existing barriers is of utmost importance, especially for low and middle income countries.  In this regard the EU welcomes the support of WHO, UNODC and INCB.  It stresses the relevance of the WHO guidance report on ensuring balance in national policies on controlled substances, the INCB 2015/2016 reference report on ‘Availability of Internationally Controlled Drugs: Ensuring Adequate Access for Medical and Scientific Purposes. Indispensable, adequately available and not unduly restricted’, and the WHO/UNODC/UICC joint program on increasing access to controlled medicines for medical purposes. It also highlights the important role and knowledge of civil society in this area. The EU would like to encourage all states to further implement the operational recommendations as agreed in the UNGASS outcome document in order to fulfill one of the core commitments agreed upon on the international level.

Belgium: We are committed to improving the availability and access of scientific and medical purposes. Our Minister of Health pilot project on increasing access for medical purposes in the Democratic Republic of Congo exemplifies our work on this. Australia became the first international donor for this programme. Rapid assessment of policies, implementation and regulations. Strategic approach for palliative care. Monitoring and evaluating the programme. Ministry of Foreign Affairs will pursue the expansion of this programme. We aim to prioritise least developed countries. We invite other donors to join in the future. Also need to work with other bodies such as the INCB. Thanks UNODC/WHO/UICC work in addressing these shortcomings.

Mexico: It is fundamental to follow up on the operational recommendations concerning improving availability and access to controlled substances for medical and scientific purposes. The obstacles that impede adequate access leave significant individuals dying in pain. Grateful to UNODC, WHO and INCB for their efforts. To meet this challenge, the Federal Commission for the Protection of Health Risks has devised substantial changes, including the electronic prescription of opioids for palliative care and greater liberties to health professionals to prescribe. We request UNODC and other specialised agencies to foster more exchange on certain controlled substances. Ex. Stronger international dialogue on the findings of the WHO’s report on non-medical cannabis use.

Guatemala: Worked towards capacity building of professionals in the health sector on controlled substances. Acutely aware of the need for these medicines. Working to overcome red tape and bureaucratic hurdles. Also important to consider the availability of these substances in rural areas. Working group between public, private sector and Big Pharma to exchange information, lead on external evaluation programmes and country reports. In terms of the annual review, we are well up to date, even if it’s a challenge given the regularity of reviews.

China: Thanks UNODC and WHO for presentations. Supports Outcome Document on the guarantee of availability of access to controlled substances. China maintains that the international community should pay attention to the lack of access to essential medicines in some countries, as well as the abuse, overdose and deviation of controlled medicines. Countries according to their circumstances should seek balance. Regulate in accordance with law and legitimate use of substances in medical institutions for pain. China guarantees, for medical and research purposes, the accessibility to controlled medicines for the alleviation of pain and suffering. The Chinese regulation provides for this. Qualified medical professionals provide substances in cases of reasonable need. In case of non-availability of opiates, there’s the possibility of raising a request with doctors; who will timely provide the substances if the request is deemed reasonable. The Chinese law provides that, for life saving cases, the need for narcotic drugs should be treated as a priority.  For medical purposes, individuals with a prescription and an ID card can carry a single prescription. When medical professionals carry such drugs across the Chinese border, customs should provide permits. We are not against the use of alternative medicines for the purpose of detoxification. Chinese law provides for the use of methadone and other nationally-identified narcotic and psychotropic substances for the purposes of detoxification. We need to prevent abuse, overdose and diversion of controlled substances. The Chinese law provides that medical professionals use special prescriptions. The maximum amount should be in line with regulation of health authorities. The prescriber and verifier should carefully check prescription and sign their name and keep them in record. Those who are in non-conformity are refused drugs. Medical institutions should record these prescriptions in a separate register to strengthen management. Records are kept for three years for narcotics, 2 years for psychotropic substances at least… In accordance with INCB UNODC specifications.

United Kingdom: Particularly important point and welcome addition to standalone section in outcome document. Need to strive to widen access. Unacceptable imbalance of access. UK is the biggest funder of health commodities through organisations like Global Fund, UNICEF, UNFPA, etc. Working on this with the Gates Foundation, the World Bank and others. Evidence of the panellists on the work they are doing together. We support joint comprehensive action from all organisations, including INCB, UNDP, WHO, UNODC among others.

Russia: We are implementation legislation and a normative framework to ensure timely and quality prescription of controlled medications to increase access to analgesics. Robust efforts which have improved circulation of narcotic and psychotropic substances. The new federal legislation involves: ensuring accessibility to analgesics for patients who need them, increasing timeline of prescription validity to 15 days for narcotic prescriptions, enabling pharmacies and medical establishments in rural areas to issue narcotics. Russian government has issued an edict simplifying storage accounting and transport of these substances. We plan to continue working and improving this, including the legislative basi. For instance, with an electronic system of prescription, increasing schedule list of available narcotics, taking measures to licence activities involving circulation of narcotics and precursors. Authorising people to work with these substances with regulations on storage and additional requirements on release of these substances.

Rose Kiwanuka, Palliative Care Association of Uganda: Nothing gives me more satisfaction as a nurse than providing pain relief to a patient. I was the first nurse to provide oral morphine. Ours is the first country in the world allowing for nurses to undergo special training for this. Over 40 organisational and 60 individual members come together under our platform to promote importance of oral morphine to relieve pain. We work with diverse organisations to avail palliative care. Still challenges around training, human resources and accessibility. The 2015 Narcotics Act is unclear on palliative care. We have established good relationships with law enforcement and drug control authorities. Over 26 countries were represented at the African Palliative Care association conference in Kampala. Ministers and representatives from Malawi, Libya, Sudan, South Africa, Uganda, etc. The consensus statement reaffirms commitment to: assess palliative care needs to ensure adequate supply, adequate funding and human resources for palliative care initiatives, review and revise national and local legislation for controlled medicines. Developing national access moral morphine. We’d like to continue working to integrate palliative care to the SDG 2030 agenda.

Switzerland: Ensuring the availability of medicines remains a continued challenge. Concrete example:  The city of Basel is the home to two major pharmaceutic companies in the world. One would expect all preparations to be available in Basel. But the hospital pharmacy reported 172 pharmaceutical preparation disruptions. In most cases out of stock for 3 weeks, of those cases most had no alternative presentations. This is just 2% of all drugs, but still it means a group of patients is suffering, so the Parliament asked for measures from the government. A report was commissioned and identified economic and regulatory factors that contributed to supply disruptions. The report found administrative burdens associated with strict regulations often lead Pharma companies to discontinue niche products. Globalisation of supply chain and lean management of stockpiles also contributes. Cost-saving concerns lead to the reduction of stockpiles, relying on just-in-time delivery, increasing risk of disruption. Early warning mechanism needed. Need to enhance stockpiles along the supply chain. Now license holders have to provide information on potential disruptions in supply chain.

Australia: Encouraged by historic steps taken on this issue at UNGASS. Consistent with recognition international treaties of the importance of the medical use of narcotic drugs. Barriers not only legal and administrative, also social. Need to think how programmes at the local level can achieve change through engagement with civil society and practitioners. Pilot programmes in Timor Leste and Ghana show it’s possible to overcome barriers. Australia has pledged further support. Model laws practical guide to compare and identify unduly burdensome requirements. Welcomes the recent launch of the INCB Learning project.

Turkey: Turkey is fully committed to the Conventions and believes in sustaining balance between availability and efforts to avoid diversion. Importance of the cooperation of pharmaceutical companies. Importation of morphine by pharmaceutical companies was not at required level when assessed. Ministry of Health will manufacture all essential medicines in Turkey now, increasing availability. Use of OST has increased too. Pills with buprenorphine and naloxone are preferred. Training programme on adequate access. Project to establish electronic prescription system. Turkey highlights the importance of the international import/export system.

United States: Primary purpose of treaty conventions. Supports INCB work to ensure availability and avoiding diversion. Balance achieved with adequate legislative measures. Congratulates INCB Learning project. Expertise of INCB and UNODC on the accessibility and availability of essential medicines is important. Technical assistance through WHO/UNODC joint health programme on access. In depth analysis on access to controlled drugs.

Netherlands: Associates itself with the statement delivered by Slovakia (on behalf of the EU). Far from achieving the level suggested by commitment to access. Need to improve availability and affordability. Many reasons for the lack of access, including legal barriers. The Netherlands’ solution to avoid possible conflict was to create two separate laws to ensure different basis for different uses: unlawful and lawful.

Norway: Intolerable lack of access to essential medicines. Affordability is central to this work. Access is a key area. Close cooperation WHO UNODC. Strong and coordinated commitment with health authorities and law enforcement. Congratulates decision to provide for a dedicated chapter to address this key issue.

Tania Pastrana, International Association for Hospice and Palliative Care (IAHPC): Education and increasing access is a multi-year process that needs to be supported with budgets. Important to overcome opiophobia. Some countries have incorporated the teaching of rational prescription of opioid to undergraduate curricula, a welcome measure. In Argentina, opioids like methadone and morphine are of free distribution and the country manufactures the necessary amounts. The role of expert consultation determining needs is paramount. Also important to highlight advocacy within the framework of SDGs.

Chair: Tomorrow, the morning session will address issues related to supply reduction and related measures; effective law enforcement; responses to drug-related crime; and countering money laundering and promoting judicial cooperation. The afternoon session will focus on Human rights, youth, children, women and communities. We call your attention to the post-UNGASSs website, where delegations can post documentation and provide further information on the issues at hand. Also, the UK will be holding side event on NPS on 27th October (Room C4, at 9AM).

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