By the Pompidou Group

Executive Summary

Context, objective, mandate

According to data from the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), out of an estimated population of 1.3 million “high risk opioid users” in the European Union, less than 650,000 people receive opioid agonist treatment. This treatment is defined as a “treatment for opioid dependence syndrome, including the long-term prescription of opioid agonist medicines (OAMs)”, principally methadone and buprenorphine.

This average figure hides wide disparities. Whilst in certain European Union countries this rate approaches 80%, in others, it is below 20%. In other parts of the world, certain countries continue to exclude, in law or in fact, such prescriptions (figure 1). Differences between countries are explained by a number of factors such as limited access to opioid agonist treatment or overall limited availability of any kind of treatment services. However, regional differences exist also within countries, notably between urban and rural areas, as well as disparities amongst populations at risk of discrimination, such as women, minors, migrants, or detained persons (Map 1). Only a limited number of European countries provide wide access to opioid agonist treatment, through primary-care physicians and dispensing pharmacies (map 2), so as to facilitate treatment outside major urban areas.

Prior authorisation schemes are a further barrier to accessing opioid agonist treatment. First implemented in the 1970s, these follow in the footsteps of the international system for the control of psychoactive substances. These schemes have in common that, in many countries, fully licenced physicians are not allowed to initiate a much-needed evidence-based therapy without first obtaining permission from the administration or from a medical government agency. An analysis of these schemes reveals that they stem from a historical, but scientifically and medically erroneous understanding, of “replacing an illicit drug by a legal drug”.

However, by their pharmacological action, opioid agonist medicines prescribed for the treatment of opioid dependence syndrome have very different effects from opioids used for hedonic purposes in a non-medical setting. Implemented according to appropriate arrangements, these medicines have positive effects on persons in treatment: they stabilise the emotional state, reduce or eliminate the subjective reinforcing effects causing dependence, and protect against opioid-induced death. They constitute therefore a central element of a treatment integrating medical, psychological and social aspects. Because of their clinical effectiveness, appropriate access to these medicines causes a highly significant reduction in mortality and comorbidities, including those related to the intravenous use of heroin (HIV, HCV infection). From this point of view, in addition to their primary function as medical treatments, these medicines are a key part of a public-health approach to risk and harm reduction. Two medicines in particular, methadone and buprenorphine, have been on the World Health Organisation (WHO) Model List of Essential Medicines since 2005.

To respect their obligations regarding access to healthcare and prevention of discrimination, countries are invited to review their regulations, aiming to rely as much as possible on the ordinary provisions regulating medicines and healthcare professions.

To assist administrative authorities in this process, the Pompidou Group`s Permanent Correspondents mandated a group of health and legal experts to identify criteria for the appropriate use of agonist medicines used in opioid dependence treatment, in line with ethical standards, international law, scientific knowledge and best medical practice

(...)