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General information on access to controlled medicines

In its resolution 12/24 on "Access to medicine in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health," the Human Rights Council encouraged states to consider including in their national reports to the universal periodic review mechanism, information on measures taken to promote access to medicines.[i] 

Several of the drugs on the WHO's List of Essential Medicines, including morphine for pain treatment and methadone and buprenorphine for the treatment of substance dependence, are regulated by the international drug conventions.[ii]   The importation, manufacture and distribution of these medicines are under exclusive government control, as is the licensing of doctors and pharmacies to prescribe and dispense them.  Consequently, if governments do not take steps to ensure access to controlled medications, they will simply be unavailable.  Unreasonably denying access can lead to violations of the right to the highest attainable standard of health and potentially amount to cruel, inhuman or degrading treatment.[iii]

Morphine is the mainstay medication for treating moderate to severe pain and is inexpensive, safe and effective.[iv]  Oral morphine is the drug of choice for chronic pain, and can be taken in institutional settings and at home.  A typical daily dose of basic oral morphine for pain associated with cancer or end-stage HIV/AIDS could cost as little as US$0.70.[v] Several developing countries have community-based palliative care services that use oral morphine to provide pain treatment in patients' homes, at low cost.[vi]

Access to methadone or buprenorphine is vital for opioid-substitution therapy (OST), one of the most effective treatments for opioid dependence, and critical to HIV prevention and improving uptake and adherence to antiretroviral therapy among people who inject drugs.[vii] 

Access to controlled medicines in Belarus

Belarus' low consumption of morphine and other opioid medicines, reported annually to the International Narcotics Control Board, indicates that access to medicine for pain treatment is very limited.[viii]  Belarus' consumption of morphine and alternative strong opioid medicines is sufficient to provide pain treatment to less than twenty percent of its terminal cancer patients.[ix]  As these medicines are also used to provide pain treatment for non-terminal cancer patients, people living with HIV/AIDS and patients with pain from surgery, injuries and other diseases, an estimate can be made that each year, thousands of people in Belarus suffer from untreated moderate to severe pain.[x]  

It is estimated that there are nearly 50,000 people who inject drugs in Belarus.[xi]  Injection drug use is closely linked with HIV transmission; in 2008, an estimated 8330 people who injected drugs in Belarus were HIV positive.[xii]  Yet access to OST remains very limited - as of 2008, the very restrictive eligibility criteria included: having injected illicit opioids for more than two years, having made at least two unsuccessful attempts at abstinence-based treatment and being HIV positive.[xiii]  Only fifty people were receiving treatment, suggesting that the restrictive eligibility criteria unnecessarily compromised the lives and health of people who inject drugs who might have accessed OST, by limiting access to effective measures to prevent HIV and support antiretroviral uptake and adherence.[xiv]

Failure to take steps to ensure provision of essential medicines to all those in need of pain treatment and OST will result in violations of the right to the highest available standard of health and instances of cruel, inhuman or degrading treatment.

Recommendation

  • Belarus should, as a matter of urgency, remove legal and administrative obstacles to access to opioid medications for pain treatment and OST, examine other reasons for low consumption of controlled medications and develop a plan of action to improve their availability. 

Note

The submission is based on research by Human Rights Watch's Health and Human Rights Division.  It should not be interpreted as a statement that Human Rights Watch does not have other concerns about human rights violations in Belarus.


[i] UN Human Rights Council, "Access to medicine in the context of the right to everyone to the enjoyment of the highest attainable standard of physical and mental health," Resolution 12/24, A/HRC/12/L.23.

[ii] WHO, Model List of Essential Medicines, 15th List, March 2007, http://www.who.int/medicines/publications/essentialmedicines/en/index.html (accessed August 5, 2009); Single Convention on Narcotic Drugs, 1961, adopted March 30, 1961, 520 U.N.T.S. 151, entered into force December 13, 1964; Convention on Psychotropic Substances, 1971 adopted February 21, 1971, 1019 U.N.T.S. 175, entered into force August 16, 1976.

[iii] See letter from Manfred Nowak, Special Rapporteur on Torture, and Anand Grover, Special Rapporteur on the right to the highest attainable standard of health, to Her Excellency Ms Selma Ashipala-Musavyi, Chairperson of the 52nd Session of the Commission on Narcotic Drugs, December 10, 2008, https://www.hrw.org/sites/default/files/related_material/12.10.2008%20Let... Human Rights Council, Report of the Special Rapporteur on Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, Manfred Nowak, "Promotion and Protection of All Human Rights, Civil Political, Economic, Social and Cultural Rights, including the Right to Development," A/HRC/10/44, January 14, 2009, paras. 72, 74(e). 

[iv] See Human Rights Watch, "Please, Do Not Make Us Suffer Any More..." : Access to pain treatment as a human right, March, 2009, https://www.hrw.org/en/reports/2009/03/02/please-do-not-make-us-suffer-any-more, pp. 7-10.

[v] Basic oral morphine in powder or tablet form is not protected by any patent and can be produced for as little as US$0.01 per milligram. A typical daily dose in low and middle income countries ranges from 60 to 75 milligrams per day: K. M. Foley, et al., "Pain Control for People with Cancer and AIDS," in Disease Control Priorities in Developing Countries, 2nd ed., (New York: Oxford University Press, 2003), 981‐994.   

[vi] See Human Rights Watch, "Please, Do Not Make Us Suffer Any More...", pp. 38-40; Human Rights Watch, Unbearable Pain: India's Obligation to Ensure Palliative Care, October, 2009, https://www.hrw.org/en/reports/2009/10/28/unbearable-pain-0, pp.16-17.

[vii] WHO, UNAIDS, UNODC, "Substitution maintenance therapy in the management of opioid dependence and HIV/AIDS prevention: position paper," 2004, http://www.unodc.org/docs/treatment/Brochure_E.pdf (accessed October 30, 2009). 

[viii] International Narcotics Control Board, Narcotic Drugs: Estimated World Requirements for 2009 - Statistics for 2007, E/F/S.09.XI.02 (New York: United Nations, 2009), pp. 220, 251. In 2007, the most recent year for which data are available, Belarus consumed 5kg of morphine, 65.38g of fentanyl, and no other strong opioids.     

[ix] Human Rights Watch calculates that all of the morphine and fentanyl consumed in Belarus in 2007 was sufficient to provide adequate treatment to about 18% of Belarus' terminal cancer patients.  The calculation is based on the following: WHO statistics indicate that at approximately 13900 people die of cancer in Belarus each year (World Health Organization Statistical Information System (WHOSIS) http://www.who.int/whosis/en/index.html (accessed July 15, 2009)); one authoritative study estimates that 80 percent of terminal cancer patients and 50 percent of terminal HIV/AIDS patients will develop moderate to severe pain symptoms, on average for a period of about 90 days, requiring treatment with 60 to 75 milligrams of morphine per day, or an equivalent dose of another strong opioid (K. M. Foley, et al., "Pain Control for People with Cancer and AIDS," in Disease Control Priorities in Developing Countries, 2nd ed., (New York: Oxford University Press, 2003), 981‐994). 

[x] According to UNAIDS, in 2007 there were approximately 13000 people living with HIV/AIDS in Belarus and 1100 AIDS deaths: 2008 Report on the Global AIDS Epidemic (Geneva: UNAIDS, 2008), pp. 219, 222.  Thousands more people suffer injuries (WHOSIS) or have pain from non-terminal cancer or other diseases.  

[xi] C. Cook and N. Kanaef, The Global State of Harm Reduction in 2008 (London: International Harm Reduction Association, 2008), p. 34.  The International Harm Reduction Association reports that in 2008 there were an estimated 49,896 injecting drug users in Belarus.

[xii] Ibid, reporting 16.7% HIV prevalence amongst people who inject drugs.

[xiii] Eurasian Harm Reduction Network, "Opioid Substitution Therapy in Selected Countries of Eastern Europe and Central Asia," December, 2008, http://www.harm‑reduction.org/images/stories/library/ost_in_cee_ca_2008_en.pdf (accessed October 29, 2009), p. 4.

[xiv] Ibid, p. 6.