Saskia Jünger, health scientist at the University Hospital of Bonn (Germany) and member of the ATOME Project Management Team; Marjolein Vranken, pharmacist and lawyer at the Utrecht Institute for Pharmaceutical Sciences of Utrecht University (the Netherlands) and member of the ATOME team.
“Laws are often old-fashioned because they are in place for decades”, says Dr Clive Ondari, Coordinator, Medicine Access and Rational Use, Essential Medicines and Health Products at the World Health Organization, highlighting a common problem of the controlled substances legislation in many countries. Reviewing legislation as part of the Access to Opioid Medication in Europe (ATOME) project was the focus of a workshop held in Utrecht (the Netherlands) on 31 January – 1 February 2013. For one and a half days, delegates of the national ministries in the ATOME countries, legal experts and international speakers from the ATOME team and the Pain and Policy Studies Group were working hard to improve controlled substances legislation in the respective countries.
Socio-cultural labelling: opioids as an evil to mankind
Rick Lines, the director of Harm Reduction International, presented thought-provoking facts about opioid legislation. In the United Nations Single Convention on Narcotic Drugs¹ opioids are referred to as a possible source of ‘evil’ to mankind (“Recognizing that addiction to narcotic drugs constitutes a serious evil for the individual and is fraught with social and economic danger to mankind”; Preamble, p. 1). This is particularly remarkable since not even severe crimes such as torture or genocide are labelled as ‘evil’ in the international conventions. Criminalisation of opioids and language use around controlled substances were vigorously discussed, in particular in proportion to other medicines.
Stigmatising language as a potential barrier to access to opioid medicines had been identified in the legislation of all European countries that had undergone review. Terms such as ‘narcotic drugs’, ‘poison’, ‘toxic / harmful / dangerous substances’ are considered to contribute to fear and reluctance towards the medical use of opioids both in physicians and in patients. It can also be questioned whether it is useful to label a substance by one of its side effects (‘narcotic’) – “After all, opioids could just as well be referred to as ‘constipative drugs,’” says Willem Scholten, pharmacist and past team leader of the ‘Access to Controlled Medicines Programme’ of the World Health Organization.
Insight from the outside
“Penalties against possession of a drug should not be more damaging to an individual than the use of the drug itself; and where they are, they should be changed.” Jimmy Carter, 1977.
Group work was designed to encourage exchange among delegates from different countries and to have a critical view of each other’s legislation. Many commonalities were revealed – for example, heavy administrative requirements for prescribing and dispensing opioid medicines. But also controversies emerged; for example, whether limited validity of a prescription constitutes a barrier to opioid accessibility or not?
There was a sense of both boldness and cautiousness in the workshop and we noticed a momentum for change in many countries. For example, in Estonia an amendment to the Medicinal Products Act – aiming at ensuring greater availability of opioid medicines – had passed first reading the day before the workshop.
“When this amendment comes into force, all pharmacies – and not only those with a special licence – will be allowed to dispense all medicinal products containing controlled substances.” said Eda Lopato, head of the Bureau of Import, Export, Narcotic Drugs and Psychotropic Substances and leader of the ATOME country team in Estonia. Close collaboration with country teams in the European countries will ensure that recommendations for legislative changes made within the ATOME project will be validated and their applicability to the country-specific situation will be verified.
To learn more about this topic, please join us at an EAPC ATOME session on regulatory barriers in palliative care opioid treatment during the 13th EAPC World Congress in Prague (1 June 2013, 16:30 – 18:00).
1. United Nations. Single Convention on Narcotic Drugs. 1961; as amended by the 1972 Protocol.
To find out more…
- World Health Organization. Ensuring balance in national policies on controlled substances. Guidance for availability and accessibility of controlled medicines. Organization WH, editor. Geneva: World Health Organization; 2011. (http://www.who.int/medicines/areas/quality_safety/guide_nocp_sanend/en/)
- Caraceni A, Hanks G, Kaasa S, Bennett MI, Brunelli C, Cherny N, et al. Use of opioid analgesics in the treatment of cancer pain: evidence-based recommendations from the EAPC. The lancet oncology. 2012;13(2):e58-68. Epub 2012/02/04. (Free to download to EAPC members and registered users).