June 2, 2011

II. Survey Findings: Global Overview of Barriers to Pain Treatment

Our survey mapped barriers to palliative care related to health policy, education of healthcare workers, and drug availability in 40 countries. We asked healthcare workers questions about a number of common barriers in each of these areas to understand how widespread they are. The questions are based on research that Human Rights Watch previously conducted for its March 2009 report, “Please, do not make us suffer anymore…”: Access to Pain Treatment as a Human Right.[25]

The results of this survey confirm the general findings in that reportbut provide a more detailed picture of the specific barriers that exist in individual countries, as well as the prevalence of these barriers internationally. They provide a roadmap for individual countries and the international community for steps they need to take to improve palliative care availability. Our comparisons of consumption of opioid medications with mortality figures for cancer and HIV/AIDS demonstrate just how poor the availability of pain treatment is in many countries around the world.

We found enormous unmet need for pain treatment. Fourteen countries—Antigua and Barbuda, Bolivia, Cameroon, Comoros, Djibouti, Gambia, Guinea, Guinea-Bissau, Kiribati, Honduras, Swaziland, Solomon Islands, Tanzania and Tuvalu—reported no consumption of opioid pain medicines between 2006 and 2008, meaning that there are no medicines to treat moderate to severe pain available through legitimate medical channels in those countries.

In a further eight countries that do not report opioid consumption to the International Narcotics Control Board—Afghanistan, Belize, Equatorial Guinea, Fiji, Liberia, Niue, Somalia, and Timor-Leste—the situation is likely similar, as countries that participate in the international drug control regime undertake not to export opioids to these countries. Thirteen other countries—Burkina Faso, Burundi, Cambodia, Central African Republic, Chad, Cote d’Ivoire, Ethiopia, Haiti, Malawi, Mali, Niger, Nigeria, and Rwanda—do not consume enough opioids to treat even one percent of their terminal cancer and HIV/AIDS patients.

Of course, this means that in all of these countries, each year tens of thousands of patients suffer unnecessary pain. For example in Nigeria, more than 173,000 people with terminal cancer and HIV/AIDS patients need treatment for moderate to severe pain each year, but all the opioids consumed in Nigeria could treat just 274 such patients. In Ethiopia, more than 85,000 such patients need treatment, but there are drugs for less than 500. Less populous Cambodia still has more than 14,000 terminal cancer and HIV/AIDS patients suffering pain each year but drugs to treat just 91 of them. In addition to Nigeria, China, India, Indonesia, and Russia all have poor availability of opioids for pain relief and more than 100,000 patients who die from cancer or HIV/AIDS each year without access to adequate pain treatment.

The combined suffering due to lack of opioid pain medicines worldwide is staggering. Our calculations confirm that more than 3.5 million terminal cancer and HIV/AIDS patients die each year without access to adequate pain treatment. This includes at least 1.7 million terminal cancer and HIV/AIDS patients in Asia, 1.2 million in sub-Saharan Africa, 480,000 in Europe, 180,000 in the Middle East and North Africa, and 100,000 in the Americas. It must be emphasized that these are very conservative estimates, which assume that all opioids are used to treat this patient group. This is why it is lower than WHO’s estimate that each year 5.5 million terminal cancer patients and 1 million patients in the last phases of HIV/AIDS suffer without pain treatment.[26]

Our calculations focus on patients with terminal cancer and HIV/AIDS because their need is great and because mortality data is available for these causes for most countries but not for many other diseases that cause immense pain. In reality, the limited opioids that are available are used to treat patients suffering pain from other causes, so the real number of terminal cancer and HIV/AIDS patients with untreated pain must be higher, and many other patients with non-terminal cancer, HIV/AIDS, and with other diseases are also suffering untreated pain. Consequently, the unmet need of terminal cancer and HIV/AIDS patients must be considered merely an indicator of even greater unmet need for pain treatment.

Availability of Policies that Promote Palliative Care and Pain Treatment

WHO has stressed the importance of comprehensive strategies to improve access to palliative care.[27] Without such policies, it is difficult to ensure that all relevant government and nongovernment agencies act in a coordinated fashion to address all barriers that impede the development of palliative care simultaneously. Under the right to health, countries are obliged to develop health policies that address the needs of the entire population, including people facing life-threatening illnesses.[28]

In our survey, we sought information about the availability of national palliative care policies; whether palliative care was addressed in national cancer and HIV control policies or plans; and whether oral and injectable morphine were included on national essential medicines lists.

National Palliative Care Policies: Of the 40 countries surveyed, 29 did not have a national palliative care policy. Those that did are Argentina, Brazil, Indonesia, France, the Philippines, Poland, South Korea, Turkey, Uganda, the UK, and Vietnam. Although survey respondents were not directly asked about implementation, in two of these countries, Argentina and Brazil, the respondents told Human Rights Watch that the governments were not actually implementing the palliative care policies.[29] In Indonesia, survey respondents said that policies were only partially implemented.[30]

National Cancer Control Policies and Plans: National cancer control policies and plans of 24 of the 40 countries surveyed make reference to pain management or palliative care. Eight countries do not have a national cancer control policy or plan at all. In some countries, like India, the reference to palliative care is essentially rhetorical as it is not backed up by an action plan, targets, or budget allocation.[31] It is not clear in how many of the other countries surveyed that is the case.

National HIV/AIDS Control Policies and Plans: In 23 countries surveyed, national AIDS control policies did not make reference to palliative care, including three high-burden countries—Cameroon, Ethiopia, and Kenya.[32] AIDS control policies in 11 countries surveyed made reference to palliative care, including a number of high burden countries like South Africa, Tanzania, Nigeria, and Uganda. Four of the countries surveyed do not have a national AIDS control policy at all.

The fact that palliative care was mentioned in more than twice as many cancer policies may reflect the fact that palliative care has long been associated with cancer control. For example, WHO has made extensive recommendations on developing palliative care as part of cancer control programs but has said little about its importance for patients with other diseases. [33] Palliative care and pain treatment have often been neglected in national and international responses to HIV/AIDS, despite significant prevalence of pain and other symptoms in people living with HIV/AIDS. [34]

National Essential Medicines Lists: WHO considers injectable and oral morphine essential medicines for the treatment of pain that should be available to all people who need them.[35] Of the countries surveyed, only South Korea did not have injectable morphine on its essential medicines list; six had not included oral morphine: South Korea, Tanzania, Egypt, Iran, Ukraine and Georgia. Three countries–Germany, the United Kingdom (UK), and the United States (US)—do not have an essential medicines list.

Training for Healthcare Workers

One of the largest obstacles to the provision of good palliative care and pain treatment services in many countries is the lack of training for healthcare workers. Many do not have an adequate understanding of palliative care, do not know how to provide it and subscribe to various myths about morphine and other opioid analgesics. Key informants from 16 countries surveyed told us when asked whether healthcare workers feared potential legal repercussions when using opioid medications that the bigger problem was that healthcare workers in their countries were reluctant to use opioid medications because of exaggerated fears that they would cause dependence syndrome or respiratory distress in patients.[36]

To overcome these obstacles, WHO has recommended that countries provide training on palliative care to healthcare workers.[37] Under the right to health, countries are obliged to ensure that healthcare workers at least receive training in the basics of palliative care.[38] Given that almost all doctors will encounter patients in need of palliative care and pain treatment, instruction in these disciplines should be a standard part of undergraduate medical curriculum and postgraduate training in medical disciplines that routinely deal with patients who require palliative care.

In our survey, we sought information on the availability of instruction on palliative care in undergraduate and postgraduate medical studies as well as continuing medical education. We also asked key informants whether palliative care instruction in undergraduate studies was mandatory.

Undergraduate Medical Studies: Instruction in pain management (whether or not as part of instruction in palliative care) was available in all undergraduate programs in just five countries surveyed (France, Kenya, Poland, Uganda, and the United Kingdom). It was compulsory for undergraduate medical students in four of them: France, Poland, Uganda, and the United Kingdom. In Germany, compulsory instruction in palliative care in undergraduate medical studies will gradually be introduced starting in 2014. [39] In 33 of 40 countries instruction in pain management is available in some undergraduate medical programs.

Postgraduate Medical Studies: In the majority of surveyed countries—31 of 40—survey respondents reported that there are opportunities for postgraduate training in pain management (either as part of palliative care instruction or separately). In Ethiopia, Tanzania, Cameroon, Guatemala, Iran, Jordan, and China there is no postgraduate training in palliative care available at all. Many respondents, particularly in Africa and Asia, stated that healthcare workers who wanted to specialize in palliative care completed postgraduate training by correspondence or in foreign countries.

Drug Availability

Because of their potential for abuse, morphine and all other strong pain medicines are regulated under the Single Convention on Narcotic Drugs and national drug-control laws and regulations. [40] This means that their manufacture, import and export, distribution, prescription, and dispensation can only occur with government authorization, overseen by a body created by the Single Convention, the International Narcotics Control Board.

The fact that morphine and other strong analgesics are controlled medications has given rise to a host of problems related to their availability, as countries have struggled to put in place functioning supply and distribution systems; their accessibility, as many countries have enacted drug control laws that make it difficult for doctors to prescribe the medications and for patients to receive them; and their cost, as control measures and other factors have unnecessarily driven up the price of these medications, which can be produced at very low cost.

WHO has urged countries to put in place functioning supply and distribution systems and to ensure that drug control measures do not unnecessarily impede their availability and accessibility.[41] Under the UN drug conventions, countries are obliged to ensure the “adequate provision” of controlled medications while preventing their misuse or diversion.[42] Under international human rights law, countries are obliged to ensure the availability and accessibility of essential medications like morphine.[43]

In our survey, we sought information to assess the quality of countries’ supply and distribution systems for opioid analgesics, their drug regulations, and the cost of opioid analgesics.

Supply and Distribution System for Opioid Analgesics

As the import, production, and distribution of controlled medicines are under exclusive government control, they will simply not be available without government action to put in place effective supply systems. Governments need to provide annual estimates to the INCB for the amounts of morphine and other opioid medications needed. They must also approve production or import of such medications; provide licenses to health care providers and pharmacies before these can stock and dispense them; and authorize movements between producers, pharmacies, and health facilities.

In our survey, we sought to establish how widely available morphine is in different types of healthcare facilities in countries as a way of measuring the effectiveness of the supply and distribution systems governments have put in place. In particular, we asked about the availability of injectable morphine in hospitals and oral morphine in tertiary hospitals, other hospitals, pharmacies, health centers, hospices, and AIDS clinics. We also asked whether, in the experience of the key informants, morphine was harder to access outside major cities and whether health care providers were involved in developing their government’s estimates of its need for opioid medications.

Injectable Morphine: Key informants reported that injectable morphine is available in all hospitals in just 10 of the 40 countries surveyed: France, Georgia, Iran, Japan, Poland, Russia, Thailand, Turkey, the UK, and the US. In a further 12 countries, it was reported to be available in most hospitals. Key informants said that injectable morphine was available only in “some” hospitals in the remaining 18 countries.

Oral Morphine: Two countries surveyed, Ukraine and Iran, do not have oral morphine at all. In Ukraine, despite recommendations by WHO to the contrary, injectable morphine is used to treat chronic pain, while in Iran a weaker oral opioid, Tramadol, is used. Table 1 contains an overview of the data on availability of oral morphine in the various healthcare settings.

Table 1: Availability of Oral Morphine in Different Healthcare Settings in Countries Surveyed

Health facility

None

Few

Some

Most

All

Don’t know

N/A

Tertiary hospitals

3

-

19

6

12

-

-

Other hospitals

6

3

14

9

4

4

-

Pharmacies

6

5

24

3

2

-

-

Health centers

22

5

10

3

-

-

-

Hospices

5

1

8

7

13

-

6

AIDS clinics

17

1

7

3

3

5

4

The table demonstrates that oral morphine is generally most widely available in tertiary hospitals and hospices; somewhat less available in pharmacies and smaller hospitals; and least likely to be available in health centers or AIDS clinics. In other words, patients with pain often need to be referred to larger health facilities, making pain treatment less accessible and more costly for them.

Poor availability of oral morphine in smaller healthcare facilities also compounds access problems for people who live far from major cities, where larger health facilities are likely to be located. In many developing countries, distance and the cost of travel make it very difficult for people living in rural areas to reach any health facility, but their closest facility is likely to be a small clinic or health centre or perhaps a pharmacy or small hospital. As oral morphine and other opioids are less likely to be available in these settings than in larger hospitals, rural patients’ barriers to accessing pain treatments are compounded. [44]

A key component of a functioning supply and distribution system is a robust process to estimate the need for opioid medications. WHO has recommended that the government involve healthcare workers in developing such estimates.[45] In 23 of the countries surveyed, healthcare workers, who were mostly leading palliative care or pain management specialists, were not aware of any such consultations.[46] In several other countries, survey respondents reported occasional consultations that were thought to be inadequate or have no real affect on the estimates process.[47]

Unsurprisingly, industrialized countries like Germany, France, the United Kingdom, and the United States had widespread availability of oral morphine across these settings. Besides Iran and Ukraine, which have no oral morphine, other countries that stood out as having particularly poor accessibility across the various health settings were scattered throughout the regions and included Bangladesh, Cameroon, Ethiopia, Georgia, Guatemala, Morocco, and Pakistan.

Drug Regulations

The Single Convention on Narcotic Drugs lays out three minimum criteria that countries must observe when developing national regulations governing the handling of opioids. First, individuals must be authorized to dispense opioids by their professional license to practice or be specially licensed to do so. Secondly, movement of opioids may only occur between institutions or individuals so authorized under national law. Finally, a medical prescription is required before opioids may be dispensed to a patient. Governments may, under the convention, impose additional requirements if deemed necessary. [48] But WHO has observed that the right to impose additional requirements “must be continually balanced against the responsibility to ensure opioid availability for medical purposes.” [49]

Many countries have adopted regulations that go well beyond the requirements of the Single Convention, often creating complex procedures for procurement, stocking, and dispensing of controlled medications that impede their accessibility for patients with a legitimate medical need. Under the UN drug conventions and international human rights law, countries must balance their efforts to prevent the misuse of controlled substances against the obligation to make them available to patients who need them.[50] Drug control regulations that have a disproportionately negative effect on availability and accessibility of controlled medications will violate both drug conventions and human rights treaties.

In our survey, we collected information about three types of regulations that are commonly reported to limit the accessibility of controlled medicines: special licensing requirements for healthcare workers; use of special prescription forms and other special prescription requirements; and limits on the amount of morphine that can be prescribed using one prescription or the length of time that a prescription can cover. We also asked key informants whether, in their experience, doctors were reluctant to prescribe opioid medications because of worries about potential legal scrutiny.

Special Licensing Requirements: The Single Convention on Narcotic Drugs requires that people who handle opioid medications be licensed to do so. The convention does not require a special license and in many countries healthcare workers are licensed to handle such medications by virtue of their professional license. Yet many countries require a special license and some allow only certain types of doctors to prescribe opioid medications. WHO has recommended that “physicians, nurses and pharmacists should be legally empowered to prescribe, dispense and administer opioids to patients in accordance with local needs.”[51]As patients who suffer pain have a right to access essential medicines including morphine, the right to the highest attainable standard of health requires that limits on which healthcare workers can prescribe opioids be no more restrictive than is reasonably necessary to prevent their diversion to misuse.[52]

Fourteen of the forty countries surveyed require doctors to obtain a special license or registration in order to prescribe controlled medications. Survey respondents in some countries, such as the United States, said that the process for obtaining this special license is simple and almost all doctors have one.[53]Others said that obtaining the necessary license requires considerable paperwork or even invasive screening of the doctor. For example, the Philippines requires doctors applying for a license to submit urine for drug tests.[54]In Ukraine, doctors must obtain certificates from the police department and drug treatment clinic that they do not have a criminal record or are not registered as drug users. Survey respondents from Morocco and the Philippines stated that, as a result of complex licensing procedures, very few doctors have a license to prescribe opioids.[55]

Egypt, Ukraine, and Georgia limit the right to prescribe opioids to doctors practicing in certain specialties, commonly oncology, pain management, or anesthesiology. [56] In Russia, physicians who do not work in the government health care system cannot prescribe opioids. [57]

Only 2 of 40 countries, Uganda and the United Kingdom, allow nurses to prescribe controlled medicines in certain circumstances. In a third country, the United States, most but not all states allow nurses to prescribe. In South Africa, efforts to introduce nurse-prescribing are underway. [58] Nurse-prescribing is essential in resource-limited settings where doctor-patient ratios are very low and many people never see a doctor in their lifetime. [59] The INCB has commended Uganda for introducing nurse-prescribing. [60]

Special Prescription Requirements: The Single Convention does not require prescriptions for controlled medicines to be written on special prescription forms but does explicitly permit this practice. WHO has observed that special multiple-copy prescription requirements “typically reduce prescribing of covered drugs by 50 percent or more.” [61] While the use of special prescription forms and procedures is not by definition inconsistent with the right to health, they must be easily accessible for healthcare workers and not add cost to the medicines.

Our survey found that 30 of the 40 countries surveyed require special prescription forms. In two countries, Germany and Morocco, survey respondents mentioned that doctors have to apply to receive the forms; in the Philippines they have to pay for them.[62] Survey respondents in three countries, El Salvador, Turkey, and Ukraine, mentioned problems accessing enough special prescription forms.[63]

In three countries, Russia, Ukraine and—for longer prescriptions—Turkey, prescriptions for morphine must be approved by more than one doctor. In Ukraine, such prescriptions must be made by a group of three doctors, one of whom must be an oncologist, and approved by the chief doctor of the hospital.[64]

Prescription Limitations: WHO has recommended that “decisions concerning the type of drug to be used, the amount of the prescription and the duration of therapy are best made by medical professionals on the basis of the individual needs of each patient, not by regulation.” [65] Yet, many countries have regulations that unnecessarily constrict these medical decisions, in violation of patients’ right to the highest attainable standard of health. [66]

Our survey found that 25 of the 40 countries surveyed impose limits of these kinds. Some countries, including Ukraine and Turkey, limit the daily dose of morphine that can be prescribed and others, including Germany, Egypt, and Russia, limit the amount that can be prescribed in one prescription, and others, including the Philippines, set a maximum monthly dose. Other countries limit the number of days that a morphine prescription can cover. In our survey, the shortest daily limits were seven days in Cambodia, Egypt, Morocco, and Georgia, and ten days in Argentina, Russia, and Ukraine. Jordan imposes a limit of ten days for cancer patients and just three days for other patients. In China, the limit varies according to the morphine formulation, fifteen days for immediate release morphine tablets, seven days for slow release tablets, and just three days for injectable morphine. [67]

Fourteen of the countries surveyed do not impose a time limit on the number of days one prescription can cover: the United States, Germany, Turkey, the United Kingdom, Pakistan, Nigeria, Uganda, Tanzania, Nepal, India, Ethiopia, Indonesia, Kenya, and South Korea. Another 15 of the countries maintained a limit of 28 to 30 days.

Fears of Legal Sanction: Regulations that contain ambiguous standards regarding medical prescription and handling of opioids, or punish mishandling harshly, can chill legitimate prescribing. The INCB has said the “vast majority of health professionals exercise their activity within the law and should be able to do so without unnecessary fear of sanctions for unintended violations.” [68] Criminalizing unintentional mistakes in opioid prescription is not consistent with the right to health. [69] Countries must ensure that regulations are unambiguous and that complete information about them is readily available for health care providers, so that they do not unreasonably chill opioid prescribing, denying patients pain treatment.

Key informants from 34 of 40 countries said that doctors were hesitant to prescribe opioids because of fear of legal sanction for mishandling them, such as criminal sanctions or professional sanctions such as license revocation. Only key respondents from Thailand, France, Romania, Japan, Colombia, and Cameroon felt that healthcare workers have no fears of legal sanction sufficient to deter prescribing such medications.

Cost of Opioid Medications

Basic oral morphine in powder or tablet form is not protected by any patent and can be produced very cheaply. In India, basic morphine tablets are sold for as little as US$0.017 or about US$0.12 for a typical daily dose. [70] Yet, the actual cost of morphine is much higher in many countries due to a variety of factors that drive up the price, including government regulation, licensing and taxation, poor distribution systems, low demand, large overhead of local production, and price regulation by some industrialized governments. [71] In some countries, the promotion of non-generic and costly forms of opioid analgesics has resulted in pharmaceutical companies withdrawing inexpensive formulations. [72] Paradoxically, morphine is often more expensive in low- and middle-income countries than in industrialized countries. [73]

The International Association for Hospice and Palliative Care recommends that “no government should approve modified release morphine … without also guaranteeing widely available normal release oral morphine.” [74] Under the right to health, governments are obliged to ensure that both immediate release and slow release morphine tablets are available, as both are included in the WHO’s Model List of Essential Medicines. [75] They must also explore ways to ensure that morphine is available at the lowest cost and is affordable to all people who need it, including by taking steps to ensure that government regulation does not disproportionately affect cost and considering subsidies for poor patients. [76]

Few of the healthcare workers surveyed were able to provide comprehensive information about the cost of morphine in their countries, but various healthcare workers did discuss the following matters:

Availability of Expensive Formulations: Survey respondents in Bangladesh, Thailand, Ecuador, South Africa, and South Korea reported that inexpensive immediate release oral morphine was not available while more costly slow-release oral morphine tablets were.

Subsidies: Subsidies can help ensure the affordability of pain medications. Survey respondents in Colombia, Egypt, Russia, and Uganda reported that their governments provide at least one formulation of morphine free of charge to all patients. Respondents from 13 countries –France, Georgia, China, Germany, Japan, Kenya, Mexico, Poland, Romania, South Africa, South Korea, Thailand, and the United Kingdom—said governments offered at least partial subsidies in some circumstances. In some of these countries, morphine was subsidized only for patients with low incomes or for hospital inpatients but not for outpatients, an approach that is inconsistent with WHO’s recommendation that countries prioritize developing home-based palliative care. [77] In France, Georgia, Poland, and Romania, there are greater subsidies for cancer patients than other patients. This reflects the reality, discussed above, that WHO has made extensive recommendations on developing palliative care as part of cancer control programs but has said little about its importance for patients with other diseases. [78] This approach could violate governments’ obligations to uphold the right to the highest attainable standard of health and specifically to provide essential medicines without discrimination on the basis of health status. [79]

Best Practices: Addressing Barriers to Pain Treatment and Palliative Care through Comprehensive Reform

In most low and middle-income countries, an assessment of barriers to access to morphine and the development of a plan of action must be the first step in a comprehensive effort to address those barriers. To be successful, reforms must address both supply and demand for morphine simultaneously; improving supply chains to increase morphine stocks will not improve patient access unless doctors are also adequately trained in pain treatment and palliative care, and vice-versa. In undertaking these reforms, governments can draw upon the expertise of the INCB and WHO. There are several nongovernmental organizations (NGOs) that work to improve the availability of medicines in developing countries, including Supply Chain Management Systems, the IDA Foundation, and Health Action International. [80] On the whole, these NGOs have yet to turn their efforts to the availability of opioid pain medicines, but they have considerable relevant expertise that governments could draw upon.

A number of countries have begun comprehensive reform efforts aimed at improving access to pain treatment and palliative care, with support from international organizations and have had some initial success. Such efforts in Uganda, Vietnam, Jordan, Colombia, and Romania are profiled in this report.

[25] Human Rights Watch, “Please, do not make us suffer any more…”: Access to Pain Treatment as Human Right, March 2009, http://www.hrw.org/sites/default/files/reports/health0309web_1.pdf. See Appendix 2 for survey questions.

[26] “Briefing Note: Access to Controlled Medicines Program,” World Health Organisation Briefing Note, February 2009, http://www.who.int/medicines/areas/quality_safety/ACMP_BrNoteGenrl_EN_Feb09.pdf (accessed August 6, 2010).

[27]World Health Organization, Cancer Pain Relief: a Guide To Opioid Availability, (2nd ed. 1996).The need for a comprehensive palliative care policies is also stressed by academic experts: Stjernsward, J. & D. Clark, Palliative Medicine: A Global Perspective, in Derek Doyle et al., eds., Oxford Textbook of Palliative Medicine (Oxford: Oxford University Press, 3rd ed. 2003) pp. 1199-1222; DFID Health Resource Center, Review of Global Policy Architecture and Country Level Practice on HIV/AIDS and Palliative Care (2007).

[28] UN Committee on Economic, Social and Cultural Rights, “Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights,” General Comment No. 14, The Right to the Highest Attainable Standard of Health, E/C.12/2000/4 (2000), http://www.unhchr.ch/tbs/doc.nsf/(Symbol)/40d009901358b0e2c1256915.

[29]Human Rights Watch email correspondence with Dr Roberto Wenk, Argentina, October 18, 2010; Human Rights Watch email correspondence with Dr Roberto Bettega, Brazil, December 10, 2010.

[30]Human Rights Watch interviews with Indonesian doctors who requested anonymity, January 19, 2010, and November 5, 2010.

[31] Human Rights Watch, Unbearable Pain: India’s Obligation to Ensure Palliative Care, October 2009, http://www.hrw.org/en/reports/2009/10/28/unbearable-pain-0.

[32]“High-burden” is defined as adult HIV prevalence greater than 5%; data from UNAIDS, Report on the Global AIDS Epidemic, 2010, http://www.unaids.org/globalreport/ (accessed March 11, 2011).

[33] World Health Organization, Cancer Pain Relief: a Guide To Opioid Availability, (2nd ed. 1996); World Health Organization, “National Cancer Control Programs: Policies and Managerial Guidelines,” 2002, http://www.who.int/cancer/media/en/408.pdf (accessed August 6, 2010), pp. 86.

[34]K. Green, Evaluating the Delivery of HIV Palliative Care Services in Out-Patient Clinics in Viet Nam, Upgrading Document, London School of Hygiene and Tropical Medicine (2008); Kathleen M. Foley et al., “Pain Control for People with Cancer and AIDS,” in Dean T Jamison et al., Disease Control Priorities in Developing Countries (Washington: World Bank Publications, 2nd ed. 2003), pp. 981-994; Francois Larue et al., “Underestimation and Under-Treatment of Pain in HIV Disease: A Multicentre Study,” British Medical Journal, vol. 314 (1997) http://www.bmj.com/cgi/content/full/314/7073/23 (accessed August 6, 2010) p. 23; J. Schofferman & R. Brody, Pain in Far Advanced AIDS, in K. M. Foley et al., eds., Advances in Pain Research and Therapy (1990) pp. 379-386; E. J. Singer et al., “Painful Symptoms Reported by Ambulatory HIV-Infected Men in a Longitudinal Study," Pain, vol. 54 (1993) pp. 15-19; P. Selwyn & M. Forstein, “Overcoming the False Dichotomy of Curative vs. Palliative Care for Late-Stage HIV/AIDS,” Journal of the American Medical Association, vol. 290 (2003) pp. 806-814; Richard Harding et al., “Does Palliative Care Improve Outcomes for patients with HIV/AIDS: A systematic review of the evidence,” Sexually Transmitted Infections , vol. 81 (2005), pp. 5-14; Justin Amery et al., “The Beginning of Children’s Palliative Care in Africa: Evaluation of a Children’s Palliative Care Service in Africa,” Journal of Palliative Medicine, vol. 12 (2009), pp. 1015-1021.

[35] World Health Organization, “Model List of Essential Medicines - 16th List,” March 2009, http://www.who.int/selection_medicines/committees/expert/17/sixteenth_adult_list_en.pdf (accessed August 6, 2010), includes the following opioid analgesics: Codeine Tablet: 30 mg (phosphate); Morphine Injection: 10 mg (morphine hydrochloride or morphine sulfate) in 1‐ml ampoule; Oral liquid: 10 mg (morphine hydrochloride or morphine sulfate)/5 ml., Tablet: 10 mg (morphine sulfate); Tablet (prolonged release): 10 mg; 30 mg; 60 mg (morphine sulfate).

[36] Such fears were mentioned by healthcare workers from Bangladesh, Brazil, Cambodia, Cameroon, China, Colombia, the Dominican Republic, Ethiopia, Guatemala, Nepal, Philippines, South Africa, South Korea, Tanzania, Thailand, and Vietnam.

[37] World Health Organization, Cancer Pain Relief: a Guide To Opioid Availability (2nd ed. 1996).

[38]See Chapter IX for more detail on governments’ obligation to ensure that healthcare workers receive education in palliative care.

[39] Human Rights Watch interview with Professor Lucas Radbruch, Germany, February 4, 2010.

[40] Single Convention on Narcotic Drugs, United Nations, Single Convention on Narcotic Drugs (1961) http://www.incb.org/pdf/e/conv/convention_1961_en.pdf (accessed August 6, 2010).

[41] World Health Organization, Cancer Pain Relief: a Guide To Opioid Availability (2nd ed. 1996).

[42] Single Convention on Narcotic Drugs, United Nations, Single Convention on Narcotic Drugs (1961) http://www.incb.org/pdf/e/conv/convention_1961_en.pdf (accessed August 6, 2010), preamble.

[43]UN Committee on Economic, Social and Cultural Rights, “Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights,” General Comment No. 14, The Right to the Highest Attainable Standard of Health, E/C.12/2000/4 (2000), http://www.unhchr.ch/tbs/doc.nsf/(Symbol)/40d009901358b0e2c1256915 para. 43.

[44]For more discussion of this problem in one particular country, Kenya, see Human Rights Watch, Needless Pain: Government Failure to Provide Palliative Care for Children in Kenya, September 2010, http://www.hrw.org/en/reports/2010/09/09/needless-pain-0.

[45]WHO, Cancer Pain Relief: with a guide to opioid availability, 2nd ed. (Geneva: World Health Organization, 1996),

http://whqlibdoc.who.int/publications/9241544821.pdf (accessed February 20, 2011), p. 49.

[46]Argentina, Bangladesh, Cambodia, Cameroon, China, Ecuador, Egypt, El Salvador, Ethiopia, Germany, Guatemala, India, Indonesia, Iran, Kenya, Nepal, Pakistan, Philippines, South Africa, South Korea, Thailand, the United Kingdom and the United States. In Germany, South Korea, the United Kingdom and the United States, survey respondents commented that as there is good availability of opioids and complete consumption data is available to the government, such consultations are probably unnecessary.

[47]France, Jordan, Morocco, Nigeria, Ukraine, and Vietnam.

[48] United Nations, Single Convention on Narcotic Drugs (1961). http://www.incb.org/incb/convention_1961.html (accessed August 6, 2010).

[49]WHO, Cancer Pain Relief: with a guide to opioid availability, 2nd ed. (Geneva: World Health Organization, 1996),

http://whqlibdoc.who.int/publications/9241544821.pdf (accessed February 20, 2011), p. 56.

[50] Single Convention on Narcotic Drugs, United Nations, Single Convention on Narcotic Drugs (1961) http://www.incb.org/pdf/e/conv/convention_1961_en.pdf (accessed August 6, 2010), preamble;UN Committee on Economic, Social and Cultural Rights, “Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights,” General Comment No. 14, The Right to the Highest Attainable Standard of Health, E/C.12/2000/4 (2000), http://www.unhchr.ch/tbs/doc.nsf/(Symbol)/40d009901358b0e2c1256915

005090be?Opendocument (accessed January 17, 2010), para. 43; WHO, Cancer Pain Relief: with a guide to opioid availability, 2nd ed. (Geneva: World Health Organization, 1996),

http://whqlibdoc.who.int/publications/9241544821.pdf (accessed February 20, 2011), p. 56; Human Rights Watch, “Please, do not make us suffer any more…”: Access to Pain Treatment as Human Right, March 2009, http://www.hrw.org/sites/default/files/reports/health0309web_1.pdf.

[51] World Health Organization, Cancer Pain Relief: a Guide To Opioid Availability 10 (2nd ed. 1996).

[52]See Chapter VII for more detail on governments’ obligation to make pain medicines available under the right to the highest available standard of health.

[53] Human Rights Watch interview with Don Schumacher, president and CEO, National Hospice and Palliative Care Association, United States of America, February 8, 2010.

[54] Human Rights Watch interview with Dr Francis Javier, Director, Pain Management Centre, Philippines, August 26, 2009.

[55] Ibid.; Human Rights Watch interviews with Professor Mhamed Harif and Dr Maati Nejmi, Morocco, January 21, 2010.

[56] Human Rights Watch email correspondence with an Egyptian pain management specialist who requested anonymity, Egypt, October 7, 2010; Nathan I. Cherney et al., “Formulary Availability and Regulatory Barriers to Accessibility of Opioids for Cancer Pain in Europe: A Report from the ESMO/EAPC Opioid Policy Initiative,” Annals of Oncology, vol. 21, no. 3 (2010).

[57]Human Rights Watch email correspondence with a Russian doctor who requested anonymity, December 12, 2010.

[58]Human Rights Watch interview with Don Schumacher, February 8, 2010; Human Rights Watch interview with Dr. Bill Noble, Macmillan Senior Lecturer in Palliative Medicine, Sheffield University, United Kingdom, December 14, 2009; Human Rights Watch interview with Dr Liz Gwyther, CEO, Hospice Palliative Care Association of South Africa, South Africa, October 6, 2010; Human Rights Watch interview with Dr Henry Ddungu, advocacy manager, African Palliative Care Association, Uganda, August 10, 2009.

[59] J. Jagwe and A. Merriman, “Uganda: Delivering Analgesia in Rural Africa: Opioid Availability and Nurse-prescribing,” Journal of Pain and Symptom Management, vol. 33 no. 5 (2007), p. 547.

[60] International Narcotics Control Board, “Report of the International Narcotics Control Board for 2004,” E.05.XI.3, 2005, http://www.incb.org/pdf/e/ar/2004/incb_report_2004_full.pdf (accessed October 28, 2010), para. 196.

[61] World Health Organization, Cancer Pain Relief: a Guide To Opioid Availability 10 (2nd ed. 1996).

[62] Human Rights Watch interview with Dr Maati Nejmi, January 21, 2010; Human Rights Watch interviews with Professor Lucas Radbruch, Palliative Medicine, Aachen University, Germany, February 4, 2010, Professor Rolf-Detlef Treede, president of the German Pain Society, Germany, October 12, 2009, and Dr Henry Lu, immediate past president of the Pain Society of the Philippines, Philippines, September 2, 2009.

[63]Human Rights Watch interview with Professor Serdar Erdine, chairman, Department of Pain Management, Istanbul University, president of the Turkish Society of Pain Management, Turkey, November 19, 2009; Human Rights Watch Interviews with Dr Larin Lovo and Dr Carlos Eduardo Rivas, El Salvador, 2010; Human Rights Watch interview with Viktoria Tymoshevska, International Palliative Care Initiative, Ukraine, September 24, 2010; Human Rights Watch interview Nathan I. Cherney et al., “Formulary Availability and Regulatory Barriers to Accessibility of Opioids for Cancer Pain in Europe: A Report from the ESMO/EAPC Opioid Policy Initiative,” Annals of Oncology, vol. 21, no. 3 (2010), p. 620.

[64] The Ministry of Health of Ukraine: Order No. 356; Human Rights Watch interview with Victoria Tymosnevska, Ukraine, September 24, 2010.

[65] World Health Organization, Cancer Pain Relief: a Guide To Opioid Availability 10-11 (2nd ed. 1996).

[66]See Chapter VIII for more detail on governments’ obligation to make pain medicines available under the right to the highest available standard of health.

[67]Human Rights Watch interviews with doctors in China, February, October, and November, 2010.

[68] International Narcotics Control Board, Demandfor and Supply of Opiates for Medical and Scientific Needs, 15 (1989).

[69]See Chapter VII for more detail on governments’ obligation under the right to health to ensure that regulation of morphine prescribing does not unreasonably make pain medicines unavailable under the right to the highest available standard of health.

[70]Scott Burris & Corey S. Davis, A Blueprint for Reforming Access to Therapeutic Opioids: Entry Points for International Action to Remove the Policy Barriers to Care, Centers for Law and the Public's Health: A Collaborative at Johns Hopkins and Georgetown Universities, 2008, http://www.painpolicy.wisc.edu/internat/DCAM/Burris_Blueprint_for_Reform.pdf, (accessed November 2, 2010) p. 18; In low and middle-income countries a typical daily dose of morphine for patients in palliative care programs is 60 to 75 milligrams per day: Kathleen M. Foley et al., “Pain Control for People with Cancer and AIDS,” in Dean T Jamison et al., Disease Control Priorities in Developing Countries (Washington: World Bank Publications, 2nd ed. 2003), pp. 981-994. The average daily dose in industrialized countries tends to be higher. This is due, among other reasons, to longer survival of patients and the development among patients of tolerance to opioid analgesics—based on Human Rights Watch e-mail correspondence with Dr. Kathleen M. Foley, January 23, 2009.

[71] Liliana De Lima et al., “Potent Analgesics Are More Expensive for Patients in Developing Countries: A Comparative Study,” Journal of Pain and Palliative Care Pharmacotherapy, vol. 18, no. 1, (2004), p. 63.

[72] Ibid; David E. Joransen, M.R. Rajagopal and Aaron M. Gilson, “Improving Access to Opioid Analgesics for Palliative Care in India,” Journal of Pain and Symptom Management, vol. 24, no. 2 (2002), pp. 152-59.

[73] Liliana De Lima et al., “Potent Analgesics Are More Expensive for Patients in Developing Countries: A Comparative Study,” Journal of Pain and Palliative Care Pharmacotherapy, vol. 18, no. 1, (2004), p. 63.

[74] International Association for Hospice and Palliative Care, IAHPC List of Essential Medicines for Palliative Care, undated, http://www.hospicecare.com/resources/pdf-docs/iahpc-essential-meds-en.pdf (accessed November 2, 2010).

[75]UN Committee on Economic, Social and Cultural Rights, “Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights,” General Comment No. 14, The Right to the Highest Attainable Standard of Health, E/C.12/2000/4 (2000), http://www.unhchr.ch/tbs/doc.nsf/(Symbol)/40d009901358b0e2c1256915

005090be?Opendocument (accessed January 17, 2010), para. 43.

[76]See Chapter VIII for more detail on governments’ obligation to make pain medicines available under the right to the highest available standard of health.

[77] World Health Organization, “National Cancer Control Programs: Policies and Managerial Guidelines,” 2002, http://www.who.int/cancer/media/en/408.pdf (accessed August 6, 2010), pp. 85, 91.

[78] World Health Organization, Cancer Pain Relief: a Guide To Opioid Availability, (2nd ed. 1996); World Health Organization, “National Cancer Control Programs: Policies and Managerial Guidelines,” 2002, http://www.who.int/cancer/media/en/408.pdf (accessed August 6, 2010), pp. 86.

[79]UN Committee on Economic, Social and Cultural Rights, “Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights,” General Comment No. 14, The Right to the Highest Attainable Standard of Health, E/C.12/2000/4 (2000), http://www.unhchr.ch/tbs/doc.nsf/(Symbol)/40d009901358b0e2c1256915

005090be?Opendocument (accessed January 17, 2010), paras. 18-19, 43.

[80] Supply Chain Management Solutions, http://scms.pfscm.org/scms (accessed December 1, 2010); IDA Foundation, http://www.idafoundation.org/we-are.html (accessed December 1, 2010); Health Action International, http://www.haiweb.org/ (accessed December 1, 2010).