- Tous > Medicine Information and Evidence for Policy > Medicines Policy
- Tous > Medicine Access and Rational Use > Controlled Medicines
- Tous > Quality and Safety: Medicines > Regulatory Support
- Mots-clés > Access to Opioid Medications in Europe (ATOME)
- Mots-clés > controlled medications
- Mots-clés > controlled substances
- Mots-clés > legal framework
- Mots-clés > legislation
- Mots-clés > morphine - pain control
- Mots-clés > opioids
- Mots-clés > pain treatment
- Mots-clés > palliative care
- Mots-clés > regulation
(2014; 156 pages)
This report presents the outcomes of the Access To Opioid Medication in Europe (ATOME) project funded under the European Union’s 7th Framework Programme. The project investigated why opioid medicines for moderate to severe pain and for the treatment of opioid dependence are not used adequately in twelve European countries, and developed tailor-made solutions for improved access to opioid medicines in these countries. The intended readership of this report is regulatory and law enforcement authorities, policy makers, opinion leaders, and healthcare professionals.
Opioid medicines are the mainstay of medical treatment of severe pain and breathlessness, and the treatment of opioid dependence. They are effective and cheap medicines to relieve unbearable suffering from physical symptoms in severe progressive illness, and to prevent unnecessary harm and deterioration of health in people suffering from opioid dependence.
For these reasons, WHO defines opioid medications as essential medicines.
Due to their potentially harmful effects, opioids are defined as controlled substances and are controlled under the Single Convention on Narcotic drugs. The purpose of this treaty is to prevent the misuse of controlled substances while guaranteeing their availability for scientific and medical use. This implies a dual obligation for governments – that is, to implement regulations and policies that help to prevent potential harm resulting from opioids while ensuring that they are adequately available, accessible and affordable for those in need of them (the ‘principle of balance’). However, in many countries the emphasis is on control and restriction, hereby unduly interfering with availability of opioid medicines.
In the twelve European countries addressed by this project, strict regulations and inappropriate policies were found to have negative impact on adequate access to opioid medicines. Major barriers were found to exist in these countries in the field of legislation; national policies; knowledge and societal attitudes; and economic aspects, including affordability. Recommendations were developed for each country to address barriers to adequate opioid availability on different levels.
It is recommended that governments implement the WHO policy guidelines Ensuring Balance in National Policies on Controlled Substances, Guidance for Availability and Accessibility for Controlled Medicines including the self-assessment checklist in order to analyse the situation in their country and initiate action towards improvement.