June 2, 2011

VI. Europe

Regional Overview

There is a clear pattern in opioid consumption in Europe: Western European countries all consume at least 10 times as many opioids as is necessary to treat their terminal cancer and HIV/AIDS patients; Eastern European countries consume less but generally several times more than is necessary to treat their terminal cancer and HIV/AIDS patients.

A handful of Eastern European and Central Asian countries—Armenia, Azerbaijan, Belarus, Kazakhstan, Russia, Ukraine, and Uzbekistan—consume only enough opioids to treat less than 30 percent of their terminal cancer and HIV/AIDS patients. Two central Asian countries, Tajikistan and Turkmenistan, can treat less than 10 percent of these patients. As a result, at least 480,000 terminal cancer and HIV/AIDS patients die in Europe each year without access to adequate pain treatment.

As mentioned, Western European countries all consume at least 10 times as many opioids as is necessary to treat their terminal cancer and HIV/AIDS patients, and some Western European countries—Austria, Denmark, Germany, and Switzerland—consume more than thirty times more. These medicines are necessary to treat the many other patients that suffer pain, and this tdemonstrates that comparing actual opioid consumption to that which is necessary to treat terminal cancer and HIV/AIDS patients only gives an indicator of a country’s relative ability to meet its patients’ needs for pain relief.

In countries where most people have access to the medicines they need most of the time, consumption is much higher than that which is necessary to treat terminal cancer and HIV/AIDS patients. Countries who can treat only those patients (i.e. those that score around 100 percent in these tables, such as Chile, Costa Rica, Mexico, Syria, Lebanon, and Uzbekistan) still have a very long way to go to ensure all patients in need can access essential pain medicines.

Our survey results indicate that the marked contrast between opioid consumption in Eastern and Western Europe is not solely attributable to differences in economic development or medical infrastructure. The Eastern European countries surveyed have fewer policies to support pain treatment and palliative care, fewer opportunities for education in pain management and palliative care, more restrictive regulation on prescribing, and poorer accessibility of morphine across a range of healthcare settings.

Policy

Governments in four of the nine countries surveyed in Europe provide strong policy support for palliative care: France, Poland, Turkey, and the United Kingdom all have national palliative care policies and cancer control policies that include palliative care. The first three also have national HIV policies that reference palliative care. There has been recent progress in Georgia, where a national palliative care policy and a cancer policy that includes a palliative care development plan have been submitted to parliament for adoption, but the HIV policy makes no reference to palliative care. Other countries surveyed provide less policy support. Germany does not have a national palliative care policy nor a national cancer or HIV control policy or an essential medicines list. Romania, Russia, and Ukraine do not have national palliative care policies but do provide for palliative care in national cancer control plans.

Ukraine stands out as the only country surveyed in Europe where oral morphine is not a registered medicine. Ukraine and Georgia are the only countries surveyed that have essential medicines lists but have not included oral morphine.

Table 18: Pain Treatment and Palliative Care Policies in Europe

Education

The European countries surveyed have the most extensive availability of training in pain management of any region. In France, Poland, and the United Kingdom, training in palliative care is compulsory for all undergraduate medical students. In 2009 Germany introduced legislation that will make training in palliative care compulsory for all undergraduate medical students by 2014. In all other countries surveyed, with the exception of Russia, palliative care instruction was available in at least some undergraduate medical programs. In Russia such instruction is available only in a few such programs. Survey respondents from all countries said that training in palliative care is available in post-graduate medical education.

Table 19: Availability of Education in Pain Management in Europe

Drug Availability

Supply and Distribution

Our survey findings show a large gap between availability of morphine in Western and Eastern Europe. Availability was best in France, Germany, and the United Kingdom, with oral and injectable morphine available in most or all hospitals and pharmacies. In Poland and Turkey, the medications are available in most or all hospitals but only in some pharmacies. Survey respondents in Romania and Russia said injectable morphine was available in most hospitals but oral morphine only in some hospitals and pharmacies. Georgia and Ukraine reported the most problematic situations, with oral morphine altogether unavailable in Ukraine and only available in some tertiary hospitals, pharmacies, and hospices in Georgia. In most countries surveyed, except Germany, Poland, and France, survey respondents reported that it is harder to access morphine outside of major cities.

Table 20: Accessibility of Morphine in Different Healthcare Settings in Europe

Drug Regulations

Significant differences between regulations in Western and Eastern Europe are apparent from the survey, with Georgia, Russia, and Ukraine imposing both greater numbers of and more severe restrictive prescription requirements than other countries surveyed. Four of five European Union countries require special prescription forms but do not impose other problematic regulatory restrictions.

Turkey requires special prescription forms, as well as signatures from multiple doctors for long-term opioid prescriptions, and imposes a 200 mg daily dose limit for morphine, which is likely to be insufficient for significant numbers of patients. Georgia, Russia, and Ukraine require special prescription forms but doctors must also get special licenses to be allowed to prescribe morphine, and these counties impose low limits on the number of days a prescription can cover. Russia and Ukraine also require that multiple doctors sign prescriptions and impose limits on daily doses, with Ukraine’s limits particularly low, lower than the average daily dose for a patient with terminal cancer of HIV/AIDS.[109] Georgia and Ukraine also limit the right of prescription of opioids to doctors in certain specialties, such as oncology. In all surveyed countries except Romania and France, survey respondents reported that fear of legal sanction deters prescribing of opioids.

Table 21: Restrictive Regulation of Morphine Prescribing in Europe

Cost

In most of the European countries surveyed, healthcare workers mentioned that the cost of morphine is fully or partially-subsidized by the government, but in several countries only cancer patients qualify for subsidies or subsidies are more generous for cancer patients.

Best Practice and Reform Efforts: Romania

Romania has taken significant steps in the last few years to revise laws and regulations in order to improve access and availability of pain treatment and palliative care in the country. New legislation from November 2006 and new regulations from May 2006 corrected imbalanced laws and regulations that had severely limited doctors’ authority to prescribe opioids in Romania. The new laws and regulations establish that it is the sole responsibility of the doctor to determine the appropriate opioid dose and allow doctors to prescribe opioids to patients in severe pain regardless of the underlying disease. Prior to the reforms, doctors could only prescribe opioids to patients suffering from a limited class of diseases, such as cancer in its advanced stages. Progress has also been made in ensuring the availability of a variety of opioid formulations in Romania, many of which are produced domestically.

The new regulations also provide for the improvement of Romanian health workers’ education in palliative care.[110] The new regulations led Casa Sperantei, the first independent hospice in Romania, in Brasov, to offer courses in palliative care to health professionals, with the assistance of a grant from the Open Society Institute (OSI). Over 4,000 doctors have since completed this Ministry of Health-approved course. Although the Romanian Ministry of Health had identified palliative care as a “medical sub-specialty” in 2000, the medical profession had not received adequate training, and fear of prescribing opioids on the part of health professionals remains widespread. Increased and improved education in palliative care is a step towards addressing these barriers.

Romania’s progress demonstrates what can be achieved through the combined efforts of local professionals, international experts, and national authorities.[111] Reform efforts in Romania began with Romania’s participation in a 2002 workshop convened by OSI and WHO. Following an initial assessment and action plan for improving palliative care in Romania, Romania was selected as a pilot country by OSI and the Pain and Policy Studies Group (PPSG). In 2002, the Romanian Ministry of Health appointed a commission of specialists to provide reform recommendations. Working in collaboration with PPSG, the palliative care commission used WHO guidelines to present the Ministry of Health with a number of recommendations for the reform, many of which were incorporated into the country’s revised laws and regulations.

Despite the impressive progress that has been made, substantial challenges remain in providing palliative care in Romania. Many hospitals continue not to stock morphine because it “is not included in the drug list for emergencies in acute hospitals.” This leads to reliance on pethidine, a weaker opioid that is not appropriate for treatment of chronic pain. Accessibility issues persist as the number of pharmacies stocking morphine, particularly in rural areas, remains inadequate. Many doctors in Romania are still hesitant to prescribe opioids, indicating that further education efforts are needed.[112]

[109] 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; Germany imposes a limit of 20,000mg per prescription, but this can be exceeded if the doctor marks the prescription in a specified manner.

[110] Article 54 of the regulation.

[111] Daniela Mosoiu et al., “Romania: Changing the Regulatory Environment”, Journal of Pain and Symptom Management, vol. 33, no. 5 (2007), p. 613.

[112] Human Rights Watch interview with Associate Professor Dr. Daniela Mosoiu, Romania, February 17, 2010.