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Legal frameworks of opioid substitution treatment

Opioid substitution treatment is increasing rapidly, though sporadically, across Europe. The same could be said of the systems for its legal regulation; each year, a number of National Focal Points report new laws or regulations addressing aspects of substitution treatment in their country.

In 2003 the EMCDDA published a detailed report on the Legal Aspects of Substitution Treatment in nine EU countries (see ELDD Legal Reports). Expert recommendations concluded that substitution treatment programmes should have a proper legal foundation, but remain flexible, and that their regulations should be less restrictive.

At European level, the Council Recommendation on the prevention and reduction of health-related harm associated with drug dependence of 18 June 2003 included the recommendations that Member States should:

“6. provide, in accordance with the individual needs of the drug abuser, drug-free treatment as well as appropriate substitution treatment supported by adequate psychosocial care and rehabilitation taking into account the fact that a wide variety of different treatment options should be provided for the drug-abuser;


7. establish measures to prevent diversion of substitution substances while ensuring appropriate access to treatment;”

This Topic Overview therefore aims to identify what aspects of substitution treatment are regulated by which types of national law, if at all, and to summarise the content of those laws, in the areas of substances, admission criteria, treatment modalities and sanctions.

The scope of the legal framework varies considerably between Member States, reflecting the trade-off between strength of the legal framework and flexibility. In some countries, such as Belgium, substitution treatment is covered by a specific parliamentary law, while in others, such as Cyprus, its implementation is subject to interpretation of the laws on controlled substances. The national laws normally designate those substances that can be used for substitution treatment. In most cases, only methadone and buprenorphine or only methadone can be prescribed, although in a few countries other drugs such as morphine or codeine are permitted.

Similarly, in almost all countries the admission criteria for substitution treatment programmes are laid down either in national laws or in ministerial decrees or guidelines. The most common criteria are diagnosis of addiction and minimum age, with the need for previous unsuccessful drug-free treatment also featuring. In some countries, sanctions for violating treatment rules are set out in national laws, while in others the issue is at the discretion of each individual treatment centre.

The laws usually also define who is permitted to prescribe. This is primarily doctors in treatment centres, though in some countries any doctor or certain trained or accredited doctors may prescribe. In practice, it is rare for doctors outside treatment centres to initiate substitution treatment (1). Maximum doses are rarely defined in law. To prevent duplicate prescriptions, most countries use special prescription forms; a central register is found in several countries, and a few issue special ID cards.

Authorised dispensaries are usually also specified in the legislation, mostly pharmacies or treatment centres, though some countries also allow doctors to dispense. Finally, in most countries, a system for taking doses home has been established by law, guidelines or simply tolerance, but occasionally this is specifically forbidden.

The details can be seen in the following tables:

Substitution treatment - Legal basis and substances authorised

Substitution treatment - Prescription regulations

Substitution treatment - Treatment regimes

Substitution treatment - Infractions and sanctions.



(1) See Table HSR-2 in the EMCDDA Statistical Bulletin 2008.

For further information on the number of clients in substitution treatment in the Member States, please consult Tables HSR 1, 2, 3 of the Statistical Bulletin 2008.

About the EMCDDA

The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is the reference point on drugs and drug addiction information in Europe. Inaugurated in Lisbon in 1995, it is one of the EU's decentralised agencies. Read more >>

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Page last updated: Friday, 31 October 2008