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Substitution Treatment - Legal basis and substances

Country What is the legal basis for ST programmes ? Are they general health laws, or specific laws for ST? Does the national legislation specify/authorise substances for ST programmes? Which?
Belgium The law of 22 August 2002 provides a legal basis for substitution treatment in Belgium. This law states in its article 2 that a medical practitioner cannot be punished for using controlled substances for treatment. Specific ST YES: A Royal Decree on the substitution treatments was adopted on 19 March 2004. Methadone and buprenorphine.
Czech Republic ST is mentioned in the Act on Prevention of Harms Caused by Tobacco, Alcohol and Other Psychoactive Substances, No. 379/2005, as a treatment modality for drug users and addicts. The guideline of the Ministry of Health No. ZD07/2001, ‘The Standard of Substitution Treatment’, is regulating conditions of ST provided in specialized substitution centres. Conditions for authorised handling of methadone and buprenorphine are regulated by the Act on Addictive Substances No. 167/1998. Drug-related harm prevention law and specific ST guidelines YES: Decree of the Ministry of Health No. ZD07/2001, ‘The Standard of Substitution Treatment’ Methadone and buprenorphine
Denmark From 1.1.2007: § 142 of the Act on Health (Sundhedsloven. Lov nr. 546 af 24. juni 2005) and § 41 of the Act on Authorisation of Health Personel and on Health Professional Practice (Lov nr. 451 af 22. maj 2006 om autorisation af sundhedspersoner og om sundhedsfaglig virksomhed). The National Board of Health Guideline of June 8, 2007 concerning the prescription of addictive substances, including ST. General health laws, with specific ST guidelines YES: National Board of Health, Guideline of June 8, 2007 concerning the prescription of addictive substances paragraph 7 Methadone and buprenorphine
Germany Section 13 of the Narcotics Act and Sections 5 and 5a of the Narcotic Drugs Prescription Ordinance. There are also guidelines developed by the Federal Medical Board (defining the state of the art and specifying the law) and guidelines introduced by the Federal Association of Physicians and Public Health Insurance Organisations (defining the admission criteria forST paid by social health insurance). Drug control law YES: Section 5 subsection 4 of the Narcotic Drugs Prescription Ordinance levomethadone, methadone, levacetylmethadol, buprenorphine and in particular exceptional cases codeine or dihydrocodeine may be prescribed.
Estonia General laws as follows:
1.Health Services Organisation Act (RT I 2001, 50, 284);
2. Mental Health Act (consolidated text July 2002) (RT I 1997, 16, 260);
3. Act on Narcotic Drugs and Psychotropic Substances and Precursors thereof (consolidated text June 2005) (RT1 I 1997, 52, 834);
4. Regulation No. 73 of the Minister of Social Affairs of 18 May 2005. Conditions and Procedure for Handling of Narcotic Drugs and Psychotropic Substances for Medical and Research Purposes, and Conditions and Procedure for Maintaining Records and Reporting in that Area and Schedules of Narcotic Drugs and Psychotropic Substances (RTL 2005, 57, 807).
General laws on provision of health care services. YES: Regulation No. 73 of the Minister of Social Affairs of 18 May 2005. Conditions and Procedure for Handling of Narcotic Drugs and Psychotropic Substances for Medical and Research Purposes (RTL 2005, 57, 807). Buprenorphine.
Other substances are specified by the Drug Treatment Guidelines issued by the National Union of Psychiatrists (not legally endorsed).
Greece 2161/1993 (general drug law), 2716/1999 (general health law), 2955/2002 (general Health law) and the specific for ST ministerial decrees ΓΕΟ 1995, 100847/2002 and 19546/2003. Drug control law, general health law, and specific ST decrees YES: Ministerial decree ΓΕΟ 1995; 100847/2002; and 19546/2003 Methadone; buprenorphine; and naltrexone (respectively)
Spain Royal Decree 75/1990 of 19 January, about regulation of opioid treatments for opioid-dependent subjects; and Royal Decree 5/1996, 15 January, that amends the previous one. Specific ST YES: Annex of Royal Decree 75/1990 of 19 January; RD 5/1996 Buprenorphine, butorphanol, codeine, dextropropoxyphen, dihidrocodeine, etilmorphine, folcodine, methadone, morphine, noscapine, opium, pentazocine, petidine, tilidine; Levo alfa acimetadol.
France General health laws on medicines (L.5111-1 CSP ‘definition of a medicinal product’): French Medicines Agency or Drug regulation agency (AFSSAPS). L.3411-1 & L.3411-5 and D.3411-1 to D.3411-9 CSP on ‘care system for drug users’ General health laws, with specific ST guidelines YES: L. 5111-1 CSP Methadone and buprenorphine high dosage. In 2007, four medicinal products are marketed.
Ireland Misuse of Drugs (Supervision of Prescription and Supply of Methadone Regulations) 1998 Specific ST YES: Schedule to the Regulations Methadone and buprenorphine
Italy Presidential Decree 309/90 (modified and integrated by Law 49/2006). Drug control law. There are guidelines which date back to 1994 in the form of a memorandum, with limited legal value. YES: Legislative Decree 219/06 regarding regulation of medication. Methadone and buprenorphine
Cyprus There is no legal framework specifically for ST, but a framework is being prepared. However, under Regulation 160/79 issued under the Narcotic and Psychotropic Substances Law of 1977, (reg.6), a doctor is allowed to prescribe certain substances which are mentioned in the appendix to the Regulation, and which include substances used for ST programmes, e.g. methadone. Drug control law NO: Some substances listed under Regulation 160/79, but not specifically for ST. Not applicable.
Lithuania Order No 702 of Ministry of Health of the Republic of Lithuania as of December 22, 1997, on Approval of Substitution Treatment Procedure for Patients Suffering from Opiate Addiction (Žin., 1998, 13-326). Order No 204 of the Minister of Health of the Republic of Lithuania as of May 3, 2002 on Approval of Standards for Treatment and Rehabilitation of Addictive diseases (Žin., 1998, No 13-327). Specific ST YES: Order No 702 of Ministry of Health of the Republic of Lithuania as of December 22, 1997 Methadone
Luxembourg Art 8(2) of the law of 27 April 2001, modifying the basic drug law of 19 February 1973 concerning the sale of medicinal substances and the fight against addiction. Modalities of the substitution treatment programme, for instance admission criteria and psychosocial follow up of drug addicts are detailed in the grand ducal decree of 30 January 2002. Drug control law YES: Article 13 of the grand-ducal decree of 30 January 2002 Methadone, buprenorphine. Morphine salt in extraordinary cases.
Hungary The National Drug Strategy adopted by the Parliament decree No. 96/2000. The Methodological Guideline of the Professional College of Psychiatry on Methadone Treatment gives more detailed instruction to professionals (it was published in the Official Health Journal in 2002). [The answers come from this Guideline. Developing of the new Methadone treatment protocol started in November 2005.] Drug control Strategy, and ST guidelines NO: Methodological Guideline of the Professional College of Psychiatry on Methadone Treatment Methadone
Netherlands Opium Act and Opium Act decree. Drug control law YES: Annex Ministerial decree (Opium Act Decree) Methadone, Buprenorfine
Austria § 8 Suchtmittelgesetz (SMG) [= Narcotic Substances Act]: embodies substitution treatment explicitly in the law. Drug control law YES: Article V.4. Decree “Oral Substitution Treatment of Addicts” (“Substitution Decree”) Methadone. In special cases (intolerance, strong side effects etc.) other substitutes may be used such as morphine, codeine or buprenorphine. Pregnant women are usually given buprenorphine.
Poland The Regulation of the Minister of Health and Social Security of 6th September 1999 on substitute treatment that was adopted in accordance with the Act of 24th April 1999 on Counteracting Drug Addiction. It was further amended by the Regulation of 13 May 2004 amending the Regulation on substitute treatment. Specific ST YES: § 3 of the Regulation of the Minister of Health of 6 September 1999 (with the amendments of 16 May 2001) Methadone and methadone salts. Others in special cases.
Portugal Decree-Law Nº 183/2001, of 21st June; a specific law for harm reduction policies. General Framework of Prevention and Harm Reduction Policies YES: Decree-Law 183/2001, Art 42a) Methadone
Slovenia Prevention of the Use of Illicit Drugs and Dealing with Consumers of Illicit Drugs Act (1999) Prevention and treatment law YES:Prevention of the Use of Illicit Drugs and Dealing with Consumers of Illicit Drugs Act (1999), Art.8 Methadone: Health Council has also approved buprenorphine and slow-release morphine
Slovakia “Professional Guideline on standards for diagnostics and therapy in drug addiction area” in Ministry of Health gazette (2003 , unit 12-15, No. 45); “Methodical Instruction on providing methadone maintaining therapy for opiate addicted patients with persistent development of desease” in Ministry of Health gazette (2004, unit 21-27, No. 31) – “Instruction”; “ Ministry of Health Measure on reimbursement of medicines on basis of health insurance” (2003, M/5649/2003). Specific ST YES: Instruction of Ministry of Health Methadone. Buprenorphine is subject to general medication legal norms (as well as health insurance reimbursement norms) with no ST programme legal framework.
Sweden Substitution treatment is permitted under general health laws, but in order to use medical substitution substances classified as narcotic drugs/ psychotropic substances the treatment must be given in a treatment centre and in compliance with the National Board of Health and Welfare´s Code of Statutes SOSFS 2004:8 General health laws, with specific ST guidelines YES: The National Board of Health and Welfare`s Code of Statutes SOSFS 2004:8
and the Medical Products Agency´s Code of Statutes LVFS 1997:12
Methadone and buprenorphine.
United Kingdom The legisation governing prescribing is the Medicines Act 1968. The primary legislation for governing controlled drugs in the UK is the Misuse of Drugs Act 1971. Section 7.3(a) of that act allows for prescription and administering of controlled drugs by medical practitioners and section 10.2(g)-(i) allows for the development of regulations on the control and monitoring of prescriptions of controlled drugs. The enabling legislation for substitution treatment is the Misuse of Drugs Regulations 2001. Drug control law. No No, there is no legislation to restrict prescribing but the MDR 2001 means that cocaine, diamorphine and dipipanone can only be prescribed for the treatment of addiction if the medical practitioner is licensed by the Home Office.
Norway ST programmes have the legal base in several different acts: Act no 81 of 13 December 1991 (Social Services Act) chapter 6; Act no. 66 of 19 November 1982 relating to Municipal Health Services art. 2-2; Act no. 63 of 2 July 1999 on Patients’ Rights to Health Care art. 2-1 (right to necessary health care) and art. 2-5 (right to individually adjusted treatment plan); Act no 61 of 2 July 1999 on Specialist Health Care Service art. 2-1 and art. 3-12 (both social services and doctors can refer to ST treatment) ; Regulation 24 April 1998 no. 455 on the requisition and distribution of pharmaceuticals by a pharmacy art 2-1 (3) c and d; the justification for special ST centers, approved by the government. This is probably the most important rule in this setting; it’s the justification for prescribing the drugs used in ST, providing the treatment is a part of a treatment program approved by the government. The goals, obligations, organisation, cooperation and entrance and discharge criteria are regulated by several government circulars I-35/2000, I-33/2001 and I-5/2003. General health laws, with specific ST guidelines NO: It is up to the professional judgement, in co-operation with the patient Mainly methadone and buprenorphine are actually used. A few trial projects using Natrexone implants are ongoing.

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Page last updated: Wednesday, 21 November 2007