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II. Obligations arising from human rights standards

1.3 Access to controlled substances as medicines

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, States should:

i. 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.

ii. 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.

iv. 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.

v. Ensure the special provision of controlled medicines for children, including appropriate paediatric formulations of such medicines.

vi. 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.

Commentary:

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.[203] The need to ensure ‘access to safe, effective, quality and affordable essential medicines’ is also reflected in the Sustainable Development Goals.[204] Yet several substances on the World Health Organization’s Model List of Essential Medicines are also subject to control under the international drug conventions. These include morphine, methadone, and buprenorphine to treat pain and opioid dependence.[205] The World Health Organization has recognised that strong opioids, such as morphine, are ‘absolutely necessary’ for the relief of moderate to severe pain and that providing methadone or buprenorphine to treat opioid dependence is essential to meet minimum standards of health provision.[206]

The Special Rapporteurs on torture and on the right to health have concluded that 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. They have urged States to scale up opioid access as a matter of priority.[207] Further, as recommended by the Special Rapporteur on torture, ‘[g]iven that lack of access to pain treatment and opioid analgesics for patients in need might amount to cruel, inhuman and degrading treatment, all measures should be taken to ensure full access and to overcome current regulatory, educational and attitudinal obstacles to ensure full access to palliative care’.[208] UN treaty bodies have likewise recommended that States address barriers and increase access to medication-assisted treatment.[209]

The Special Rapporteur has also raised concern about oncologists’ routine practice of providing written reports to police about patients receiving opioid medication, in violation of the rights to privacy and confidentiality, and has recommended that excessive police interference with opioid prescription be ended.[210] The UN Independent Expert on the enjoyment of all human rights by older persons has recommended that 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’.[211]

The Special Rapporteur on the right to health, the International Narcotics Control Board, the World Health Organization, and the UN Office on Drugs and Crime have highlighted the importance of safeguarding the availability and accessibility of controlled medicines for the treatment of drug dependence and palliative care, including for older persons in the context of the COVID-19 pandemic.[212] The Special Rapporteur on the right to health has recommended that States adopt necessary measures to ensure that the international supply chain of these substances is not interrupted and use simplified procedures for the export, transportation, storage, and provision of medicines containing controlled substances to ensure consistent access to them and to help people who use drugs avoid withdrawal symptoms.[213] The International Narcotics Control Board, the World Health Organization, and the UN Office on Drugs and Crime have made clear that in the context of acute emergencies, it is permissible for States to take such measures. They have recommended that States ease COVID-19-related transport restrictions for controlled medicines and consider local production solutions when feasible.[214]

People who use drugs are vulnerable to HIV, tuberculosis, and hepatitis infection, as well as overdose. Ongoing access to medicines, including those that may be subject to international or national control, to treat these conditions is essential to their health. The Special Rapporteur on the right to health has thus recommended, in the context of the COVID-19 pandemic, that States consider adopting measures to ensure the adequate production or import of access to medicines to treat HIV, tuberculosis, and hepatitis, as well as overdose; these medicines include antiretroviral treatment for people living with HIV/AIDS, anti-tuberculosis drugs (including second-line treatment), antiviral and interferon drugs for hepatitis, and naloxone.[215]

In recognition of the lack of access to controlled medicines, the UN General Assembly Special Session 2016 Outcome Document dedicates an entire chapter to the issue, providing detailed recommendations to ‘appropriately [address] existing barriers in this regard’, such as ‘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’.[216]

Relationship to the UN drug control conventions

The human rights obligation to provide access to controlled medicines adds to and strengthens related provisions of the drug control treaties, as the International Narcotics Control Board and the Commission on Narcotic Drugs have recognised.[217] The 1961 Single Convention on Narcotic Drugs explicitly states that ‘the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering’ and that ‘adequate provision must be made to ensure the availability of narcotic drugs for such purposes’.[218] This imposes the obligation on States ‘to ensure adequate availability of narcotic drugs, including opiates, for medical and scientific purposes’.[219] Working to ensure such access while preventing diversion and harms to health is a core aspect of the mandates of the International Narcotics Control Board, the World Health Organization, and the UN Office on Drugs and Crime.

The World Health Organization is the body charged under the 1961 and 1971 drug conventions with the scientific and medical review of proposals for scheduling narcotic drugs and psychotropic substances under international control. Under the 1961 Single Convention on Narcotic Drugs, the Commission on Narcotic Drugs can either accept a World Health Organization proposal regarding changes in the control of substances or take no decision at all.[220] Under the 1971 Convention on Psychotropic Substances, the Commission must take into account the Organization’s recommendations, which are ‘determinative’ with respect to medical and scientific matters, while bearing in mind other economic, social, legal, administrative, and other factors it considers relevant.[221] In the context of these two conventions, the Commission thus has the discretion to accept, reject, or amend the Organization’s recommendations, but it may not place a substance under international control without such a recommendation, as the legal criteria for doing so under the conventions would not have been met.[222] In making its determination on scheduling matters, the Commission should take into account State obligations under the right to health and, at a minimum, prioritise exploring the medical benefits of substances under consideration that could warrant a change in their control status.

  • 203. ^

    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).

  • 204. ^

    Sustainable Development Goal 3.8.

  • 205. ^

    World Health Organization, WHO Model List of Essential Medicines, 20th ed. (2017).

  • 206. ^

    World Health Organization, Achieving Balance in National Opioids Control Policy (2000), p. 1; World Health Organization, Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence (2009), pp. xiv, 7, 11; World Health Organization, Integrating Palliative Care and Symptom Relief into Primary Health Care: A WHO Guide for Planners, Implementers and Managers (2018).

  • 207. ^

    Report of the Special Rapporteur on Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, Juan Méndez, 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, https://www.ohchr.org/sites/default/files/Documents/Issues/Health/drugPolicyLaw.pdf, 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.

  • 208. ^

    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. 74(e).

  • 209. ^

    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.

  • 210. ^

    Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health on His Visit to Armenia, UN Doc. A/HRC/38/36/Add.2 (2018), paras. 105, 111(h).

  • 211. ^

    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.

  • 212. ^

    United Nations, ‘Statement by the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health on the Protection of People Who Use Drugs during the COVID-19 Pandemic’, 16 April 2020, https://www.ohchr.org/EN/NewsEvents/Pages/DisplayNews.aspx?NewsID=25797; International Narcotics Control Board, World Health Organization, and United Nations Office on Drugs and Crime, ‘Statement on Access to Internationally Controlled Medicines during the COVID-19 Pandemic’, 14 August 2020, https://www.incb.org/incb/en/news/news_2020/incb--who-and-unodc-statement-on-access-to-internationally-controlled-medicines-during-covid-19-pandemic.html.

  • 213. ^

    United Nations, ‘Statement by the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health on the Protection of People Who Use Drugs during the COVID-19 Pandemic’, 16 April 2020, https://www.ohchr.org/EN/NewsEvents/Pages/DisplayNews.aspx?NewsID=25797.

  • 214. ^

    International Narcotics Control Board, World Health Organization, and United Nations Office on Drugs and Crime, Statement on Access to Internationally Controlled Medicines during the COVID-19 Pandemic’, 14 August 2020, https://www.incb.org/incb/en/news/news_2020/incb--who-and-unodc-statement-on-access-to-internationally-controlled-medicines-during-covid-19-pandemic.html.

  • 215. ^

    United Nations, ‘Statement by the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health on the Protection of People Who Use Drugs during the COVID-19 Pandemic’, 16 April 2020, https://www.ohchr.org/EN/NewsEvents/Pages/DisplayNews.aspx?NewsID=25797.

  • 216. ^

    UN General Assembly, Resolution S-30/1: Our Joint Commitment to Effectively Addressing and Countering the World Drug Problem, UN Doc. A/RES/S-30/1 (2016), ch. 2.

  • 217. ^

    Commission on Narcotic Drugs, Resolution 61/7: Addressing the Specific Needs of Vulnerable Members of Society in Response to the World Drug Problem (2018); International Narcotics Control Board, Availability of Internationally Controlled Drugs: Ensuring Adequate Access for Medical and Scientific Purposes (2015), paras. 8–23.

  • 218. ^

    Single Convention on Narcotic Drugs (as amended by the 1972 Protocol), 520 UNTS 7515 (1961), preamble.

  • 219. ^

    International Narcotics Control Board, Availability of Opiates for Medical Needs (1996).

  • 220. ^

    Single Convention on Narcotic Drugs (as amended by the 1972 Protocol), 520 UNTS 7515 (1961), art. 3.

  • 221. ^

    Convention on Psychotropic Substances, 1019 UNTS 14956 (1971), art. 2.

  • 222. ^

    Commentary on the Convention on Psychotropic Substances, 1971 (1976), p. 71, para. 22.

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