Study on the legal aspects of substitution treatment for opioid dependent drug users : an insight into nine European countries

Karolien Meuwissen (a)

Research Centre Forensic Mental Health Care (Prof. Dr. Joris Casselman), Catholic University Leuven, Belgium

Keywords

Illicit drugs – substitution treatment – legislation – Europe

Abstract

The latest decades, substitution treatment for opioid dependent drug users has gained more attention, among practitioners as well as among policymakers. This type of treatment is generally positioned in the ‘harm reduction’-approach. A recent study, financed by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) about the practices on substitution treatment in the European Union (EU), was published in 2000, touching only marginally the legal aspects of this topic [1]. Because little is known about the regulation of substitution treatment in the EU-countries, the EMCDDA commissioned a research project in addition to the forementioned study. It was granted to the Catholic University of Leuven (KULeuven), Belgium, the main purpose being to focus specifically on laws and other regulations with regard to substitution treatment and their implication(s) on practices in several EU countries. The following is an outline of this research project and the general conclusions mentioned in the final report.

Introduction

Nowadays, substitution treatment programmes for drug users are offered in all European countries, mainly based on the widespread scientific consensus as far as the benefits of these programmes are concerned in improving health, psychological and social well-being of drug (ab)users. The earlier reference to the EMCDDA-study on the current practices in this domain, pointed out the highly complex nature of the issue in the EU-Member States: practical approaches reveal large differences throughout Europe. The question rises to what extent national drug policy, legislation and regulations are responsible for these differences.

The purpose of this article is a description of the research project,centered around the question: if and how much treatment services are in practice shaped by legal constraints and what initiatives could be identified in order to improve the functioning of these services from a legal viewpoint.

More specific, the study aimed at analysing the way in which national laws and directives surrounding substitution treatment are being interpreted and/or enforced in order to show their impact on the status, design, organisation and acceptance of the substitution treatment facilities. In order to detect the impact of social and/or political attitudes towards the interaction between legal framework and common praxis, also the main opinions and possible problem-solving strategies of relevant key persons were investigated.

The study was conducted from mid 2001 until mid 2002.

Methodology

The methodology of the study consisted of two important strategies: data collection by national experts on the one hand and analysis of available data by the research staff on the other hand.

In order to study and analyse the legal basis of substitution treatment in different European countries, the first important task of the study consisted of establishing a group of experts in the domain of drug research. These experts from different European Member States and/or other European countries, have been the contact persons for the research staff throughout the study and have considerably contributed by collecting the required information on a national level. The aim was to find experts in as many European countries as possible. Nevertheless, due to the limited financial resources, the researchers were not able to include all EU-Member States in the project.

The following experts participated in the project: for Austria mr. Stefan EBENSPERGER and ms. Verena MURSCHETZ, for Belgium mr. Sven TODTS, for Finland mr. Yrjö NUORVALA and mr. Jouni TOURUNEN, for France ms. Anne COPPEL, for Greece ms. Calliope SPINELLIS and ms. Paraskevi ZAGOURA, for Ireland mr. Barry CULLEN and ms. Síle O'CONNOR, for Italy ms. Francesca MARCHI, for Norway ms. Astrid SKRETTING and for Spain ms. Marta TORRENS.

It is important to emphasize that all findings and conclusions of the study as presented in this paper are based only oninformation concerning the nine European countries participating in the project [2].

All national experts involved in the study were asked to write a report concerning the legal situation of substitution treatment in their country, following a list of topics. This list was the basic framework (developed by the research team of the KULeuven) in order to classify, compare and analyse the country-specific information.

The topic list (and consequently each country report) is built upon three main aspects of substitution treatment. The first part consists of a description of national, regional and local laws, as well as regulations and political and professional guidelines concerning substitution treatment. The second part concerns the application and interpretation of these laws and rules in practice, emphasizing also public and political attitudes towards substitution treatment (centres). Finally national experts were asked to give their opinion about the substitution treatment policy in their respective countries and to stress possibilities to improve the legal and/or practical situation concerning substitution treatment.

The findings and conclusions of the study are presented here according to the same structure of the topic list. Nevertheless it does not present the information country by country, but provides a general synthesis of all issues, highlighting common standards and main contrasts. Country-specific information will only be given by means of examples [3].

Apart from the analysis of the legal situation of substitution treatment in the participating European countries, the research staff also studied the impact of international legislation on the design of national legal systems, particularly referring to the guiding principles imposed by the UN Conventions on drugs.

1. Legal basis for substitution treatment at international level [4]

The most significant legal basis for substitution treatment at the international level can be found in the United Nations Conventions on drugs of 1961 (Single Convention on Narcotic Drugs) [5], 1971 (Convention on Psychotropic Substances) [6] and 1988 (Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances) [7]. However, these conventions do not explicitly regulate nor forbid the distribution of narcotics in view of demand reduction or drug-related harm. Instead, the objectives of the 1961 and 1971 UN Drugs Conventions should be only regarded as the finishing touch of an international control system to monitor the production of certain narcotic and psychotropic substances, by stating that any use, possession, production, etc. of scheduled substances is prohibited, except when exclusively intended for medical and scientific purposes (art. 4c. Convention 1961; art. 5.2 Convention 1971). However none of the Conventions clarify the concept of ‘medical and scientific purposes’.

Narcotic drugs and psychotropic substances are listed in schedules, according to their therapeutic value, risk of abuse and health dangers. Art. 2 of the 1961 Convention introduces control measures based on these schedules. Drugs listed in Schedule I (containing among others: methadone, heroin, cocaine, cannabis) ‘are subject to all measures of control applicable to drugs under this Convention’. Controls for substances listed in Schedules II and III are less strict according to the therapeutic properties of these substances (among others: codeine, propiram and preparations based on opium, morphine, codeine, etc.). The drugs listed in Schedule IV are considered to be the most dangerous, having only limited medical and therapeutic value. These substances (such as heroin and cannabis) are subject to the strictest control measures.

To regulate the trade in and distribution of narcotics used for medical purposes, the Single Convention introduces a control system based on authorisations and licences, including the need for medical prescriptions to supply or dispense controlled drugs to individuals. Thus, according to art. 30, if a country deems the prescription of a controlled drug to be ‘necessary’, even of Schedule I substances such as methadone, the only requirement consists of applying strict rules such as written official forms, registration and other control measures. Moreover, for drugs in Schedule IV (heroin, cannabis), art. 2.5.a states that ‘a Party shall adopt any special measures of control which in its opinion are necessary having regard to the particularly dangerous properties of a drug so included’. The medical use of heroin and its controlled supply to addicts is thus not specifically forbidden by the Convention, but it remains a controversial issue amongst European countries.

Concerning therapeutic treatment, the 1961 Convention calls on its signatory States to take all practicable measures for the treatment of drug abusers in order to reduce the abuse of drugs (see art. 38). However, the Convention does not specify what those measures imply, leaving this to the individual signatory States to define. The Second Resolution of the UN Conference for the Adoption of the 1961 Single Convention (annexed to the latter) advises ‘treatment in a hospital institution having a drug free atmosphere’, but this resolution does not seem to exclude recourse to other ‘practicable measures’. Since the 1961 Convention also clearly permits the authorised provision and use of drugs, including methadone, for medical and scientific purposes, substitution treatment is seen by most policy makers and practitioners as a legitimate type of treatment that responds to the objective of art. 38 to reduce the abuse of drugs.

As a conclusion, the UN Conventions do not explicitly forbid the controlled use of drugs for medical purposes. However, the question whether or not substitution treatment - and even more the controlled prescription of heroin - is legitimite according to international legislation, remains a problem of interpretation. This is probably due to the fact that these conventions are somewhat 'out of date' because they date back to a time when substitution treatment was not yet considered as a form of treatment [8].

2. Legal basis for substitution treatment in the European countries

2.1. Historical background

The introduction of substitution treatment practices in the European countries dates back to the 60s and 70s, although these practices were very small-scaled until the mid 80s. The advent of the HIV-epidemic formed an important impetus for the expansion of substitution treatment programmes across Europe. Although the relationship between HIV-infection, injecting drug use and the practice of substitution treatment is a complex one, sufficient sound data exist to support the case that substitution treatment is an effective component of HIV-prevention.

In countries such as Norway, where the prevalence of HIV-infection has always been rather low, it was also the deficiency of drug-free treatment that encouraged the adoption of substitution treatment practices.

Historically, the organisation and nature of drug services in each country, are predominantly defined by cultural background and legislative framework of each country [9].

Particularly in the European countries (in contrast to the United States for example), the idea that the negative effects of drug use are to a large extent attributable to the illegality of drugs (i.c. the strictly prohibitive drug policy), has become widespread. As a result, substitution treatment rapidly gained acceptance by policy makers as well as by the general public. Over the last 5 years, many Member States have reported an expansion in drug substitution treatment programmes and this trend is still rising. Currently, it is estimated that around 300 000 drug users were enrolled in substitution treatment programmes throughout Europe in 2000 [10].

Because legislation on an international level does not explicitly regulate substitution treatment (cfr. supra), the legal framework surrounding its implementation remains largely a competence of national governments. This situation is also stimulated by the general political evolution in which health policy becomes more and more regulated by local authorities. There is a large variation in the availability and the nature of substitution treatment both within and between countries. Moreover, the contrast between legal provisions and the daily practice of substitution treatment, is often striking.

It is a given fact that practices often precede laws and regulations. As certain practices became more prevalent and accepted (but without legal support), field workers pressured governments and politicians to create a proper legal framework. Even in the 90s in countries such as France and Belgium, general practitioners (GPs) were still prosecuted for prescribing methadone and other substitutes. More in general, the lack of a secure legal foundation is not very encouraging for counsellors who are willing to provide drug users with substitution medication. In the past, substitution treatment was implicitly or explicitly forbidden by law in some countries (e.g. France, Greece). Nowadays, the ban on medical substitution treatment has to a large extent vanished in Europe.

Contrary to the practice of substitution treatment in the 60s and 70s, the development of legislation with regard to substitution treatment is often a recent matter (90s). The exception is Spain, where the first laws in this domain date from 1983. We find the other extreme in Belgium where a specific legal framework was still lacking in 2002, although guidelines existed by means of documents based on such a large consensus, that they were almost regarded as law (‘Consensus Conference’) [11]. Table 1 shows the year of adoption of legislation related to substitution treatment in the countries that participated in this study.

2.2. National, regional and local laws, regulations and political and professional orientations and guidelines, including regulations to medical practice and prescription and provision rules

Regulation through laws and guidelines exists all across Europe but the content differs strongly between countries.

Over time, regulation of substitution treatment has been subject to change. Originally, laws and regulations were restrictive and contained general, sometimes vague rules. Later on, complementary regulation, changes and adjustments of existing legislation became less restrictive but also gradually more detailed.

2.2.1. Actors allowed to prescribe, provide and control prescription

Prescribing

In some countries participating in this study, the prescription of substitution medication is only allowed by physicians in a specialised/licensed centre; in other countries, also physicians in the public health system and private physicians are involved in the prescription. In some cases substitution treatment always has to be initiated in a specialised centre.

- No private physicians on their own: Finland (only assigned physician in nominated unit or hospital), France (methadone: specialised centre), Greece (special public units with a license), Norway (social services authorised for medicine assisted rehabilitation or GP in close cooperation with an authorised centre)

- Private physicians and others: Austria (practitioners who are listed by the state and drug out-patient department of state hospitals), Belgium (all physicians, in functional relationship with specialised treatment centre), France (for buprenorphine, every GP, but with secured prescription form), Ireland (every GP who followed training course, a registered patient is linked to one GP), Italy (public drug treatment centres and GP’s, in agreement with a centre), Spain (doctors in licensed prescribing centres and all licensed private doctors)

- Inititation of treatment always in a specialised centre: Finland (afterwards: continuation of treatment in specialised medical care, health centres, drug service, outpatient care and prison), France (for methadone, when stabilised: possible referral to GP)

Providing / dispensing

In some cases the dispensing of substitution medication can take place only in treatment centres; in other countries involved in this study, also community pharmacists distribute methadone and/or other substitution substances.

- Only in treatment centres: Finland and Greece (dispensing in the same social services as prescription, see above), France (methadone only in a specialised centre, strict reglementation as opposed to buprenorphine (Subutex)), Italy (GPs collaborate with drug treatment centres for dispensing)

- Community pharmacies and others: Austria (any pharmacy, but also doctors listed by the state and drug out-patient ward of state hospitals), Belgium (all pharmacies as well as specialised treatment settings), France (buprenorphine: any pharmacy), Ireland (every community pharmacy, but a registrered patient is linked to one pharmacist), Norway (when client is stabilised, dispensing can take place in a pharmacy), Spain (pharmacists in licensed prescribing centres and all licensed private pharmacists)

Controlling

Control on prescription and dispensing of substitutes is achieved mainly by means of central registration (countries that legally demand registration: Austria, Finland, France for methadone, Ireland, Spain) and/or through special prescription forms for doctors (France, Ireland).

Registration can also be used for evaluation purposes.

2.2.2. Purposes, modalities of execution, entry criteria, choice of the substances prescribed (including opiates such as heroin)

It is an overall trend in the studied countries that (legal) modalities, entry criteria and range of substances have been softened over the (past) years.

Purposes

Substitution treatment never serves a single purpose. All participating countries in this study put forward different goals at various levels with regard to substitution treatment. As far as (public) health is concerned, aims are to reduce the risk of HIV and hepatitis infection and other health risks among injecting drug users, to insert drug users in a therapeutic process, to facilitate medical follow-up of certain pathologies, to enlarge the variety of effective treatment programmes, to stabilize drug use, etc. Purposes of a social nature can be: development of social and professional skills, in particular return to employment, reintegration in society as ‘normal’ citizen. Finally, different countries mention also the decrease of criminal activity as an explicit purpose.

Remarkably, general tendencies in countries can be distinguished according to the overall goal: in some instances, a drug-free life remains the ultimate goal (e.g. Norway and Italy). Whereas in others, the basic therapeutic framework is the reduction of negative consequences of drug abuse or 'harm reduction' (e.g. Austria, Belgium, Ireland, Spain). Some approaches of countries can be positioned in between (Finland: modality of detox aims at abstinence; modality of maintenance aims at harm reduction) or express ambiguous goals (France: ultimate goal is drug-free life but in practice GPs can do 'as they please' and maintenance programmes based on the objective of drug related harm do exist).

In general we can observe an evolution which parallels the one in legislation: from abstinence to reduction of drug related harm as primary aim (e.g. Norway: purpose was abstinence and resocialisation in 1994, in 2000 guidelines add ‘reducing harmful effects of drug use’ to that purpose).

Modalities

Not all countries employ different modalities of substitution treatment. In some countries, a distinction is made based on the duration of treatment (e.g. short term/detox, middle-long term, long term/maintenance). In general however, no consensus exists with regard to the definition of goals, modalities and duration within or between countries.

In table 2, we just highlight a few countries for illustrative purposes.

In Ireland and Spain the law stipulates no limits as to duration of treatment.

National reports seem to show that overall, methadone is rather used for longer term programmes and buprenorphine for short term treatment.

Admission/inclusion criteria

Most common admission criteria are: minimum age, indication or proof of opiate dependence and unsuccessful previous detox attempts, but no consensus exists between countries with regard to the implementation of these criteria.

In some countries, more criteria are added or special criteria for special cases have been formulated, such as softened criteria for pregnant women and people with serious health problems.

In all countries considered in this study, admission criteria have been weakened over the years.

In many countries, substitution treatment always has to be accompanied by psychosocial treatment (Austria, Finland, Greece, Italy, Norway) and sometimes urine testing (France, Greece, Italy, Norway). See table 3.

Substances

In most countries participating in the study, methadone is the substitution product ‘par excellence’. Table 4 shows that the exceptions to this rule are France, where buprenorphine (Subutex) is far more common, due to the fact that few legal obligations surround its use, as opposed to methadone, and Finland, where methadone and buprenorfine are used more or less equally.

Throughout the years, countries have added other substitution products to the list, such as buprenorphine and LAAM (Levo-Alpha-Acetylmethadol). However, LAAM – which was used rather infrequently – has now been suspended on the recommendation of the European Agency for the Evaluation of Medicinal Products (EMEA), following life-threatening cardiac disorders among subjects in LAAM therapy [12].

So far no countries, among the nine analysed in this study, have engaged in some form of medically controlled distribution of heroin, except for Spain, where 2 clinical trials are being set up (in Andalucía and Catalonia). In countries not involved in the study however, the medical prescription of heroin to chronic opiate users is under trial: in the Netherlands since 1997 and in Germany more recently. Heroin has been prescribed on a small-scale, selective basis in the UK for some decades.

2.3. Rules for the provision of substitution treatment in special settings or situations (hospitals, pharmacies, treatment centres, prisons, pregnancy)

Rules for the provision of substitution treatment in special settings or situations are rare in the studied countries. As described above, some countries only provide substitution treatment in specialised or licensed treatment centres or hospitals. In those countries, general hospitals and community pharmacies are not involved in substitution treatment (e.g. Greece) or are only authorised to continue treatment initiated in a specialised centre (e.g. Finland, Norway).

In other countries where pharmacies, hospitals and drug services are equally involved, two evolutions can be observed:

§ Increase of the number of services dealing with some form of substitution treatment (more services obtain a license or more services are willing to cooperate, e.g. Ireland, Spain).

§ Psychiatric institutions still remain underrepresented in the treatment of drug use in general and consequently, in the practice of substitution treatment in particular. This while the role of psychiatric institutions in drug treatment becomes more relevant in view of the problem of ‘dual diagnosis’ among drug users (furthermore, the few psychiatric institutions involved only provide treatment in view of abstinence).

Belgium has developed low-threshold ambulatory centres, who organise their own methadone distribution, in combination with psychosocial support.

There seems to be an evolution towards more substitution programmes in prisons[13], but this evolution is not very clear, because of different problems (reluctance of medical practitioners in prisons to cooperate in substitution treatment, lack of staff for dispensing, etc.).

There are several countries of those studied where the possibility of substitution treatment in prisons exists (Austria, Belgium, Finland, France, Ireland, Norway, Spain). But in these instances, it concerns mainly the continuation of an already started programme (so no initiation of treatment in prison) and in general aimed at short-term abstinence from methadone (decreasing dosages for short periods of time). An exception is the situation in Spain where it is possible to start new methadone programmes in prison, which are not necessarily abstinence oriented.

Pregnancy (and serious health risks like HIV- or hepatitis-infection) is often an indication for priority or for the application of less stringent rules, whether such conditions(s) is (are) explicitly regulated or not. Some countries dispose of special programmes for pregnant women and drug using mothers with children (Belgium, France, Ireland), but there is still much work to be done in this field.

2.4. Potential infractions and sanctions applied

The most prevalent potential infraction is the persistent use of heroin or other illegal drugs, while enrolled in some kind of substitution programme. In Austria, Finland, France, Italy and Norway this will or can lead to suspension of the treatment (depending on the politics of the specific centre). In Ireland, continued use of additional drugs possibly leads to the reduction of daily methadone dosage or withdrawal of take-home privileges. In Belgium and Spain, the use of heroin during treatment with methadone is not a sufficient motivation to end the programme.

Other infractions can be: drug trafficking (also of the substitution product) inside or outside the walls of the treatment service, refusing to cooperate in the programme, refusing urinalysis or tampering with urine samples and violent behaviour (mostly inside the centre). Sanction for these kind of infractions generally means discharge from the programme. In Spain, people who are excluded from one service can present themselves to another centre. In Ireland, excluded patients are detoxified from methadone during 5-7 days, prior to the discontinuation of treatment. In Austria the sanction depends on the criminal charges.

3. Application of substitution treatment regulations

3.1. Daily practices

We already mentioned that practices often precede laws and regulations. Daily practice can deviate considerably from what is stipulated in official documents. Consequently, as the legislation in European countries varies greatly; daily practices differ even more. Although it is not easy to detect general tendencies surpassing the national level, we have tried to draw a general overview.

Practices have expanded

Apart from legislation, practices of substitution treatment have increased (more or less rapidly) in all countries studied, with more actors to prescribe and an increased number of patients enrolled in substitution treatment.

The lack or limitation of a legal framework does not imply that the practice does not exist

At the time this project was conducted, in Belgium a formal legal basis for substitution treatment was not yet established. Nevertheless it has been a relatively widespread practice for several years, by private physicians as well as by public treatment centres.

In France, the prescription and distribution of methadone is very strictly regulated, contrary to buprenorphine, for which few regulations exist. In practice, more than 75% of the substitution patients are treated with buprenorphine by GPs and less than 5% of the patients is treated in a treatment centre.

Sometimes the legal framework is not translated into daily practice

In many countries of those studied, LAAM is a legal substitution product but it is hardly used anywhere, except for Portugal. Nowadays it is even retracted from the market (cfr. supra).

In Finland, the law foresees three modalities with regard to substitution programmes (detox, substitution and maintenance) though maintenance is not practiced except in one treatment unit and in a few special cases. In practice substitution treatment is still not fully accepted as an appropriate treatment method by policy makers as well as by practitioners.

In Italy, it is the other way around. Four modalities exist in theory (short-term detox, long-term detox, short-term maintenance, long-term maintenance) but common practice is long-term treatment (several years).

As in other countries, substitution treatment is legally permitted in Norway, but waiting periods for entry in a substitution programme can be lengthy (up to 1-2 years) because the number of available slots does not meet the needs.

The practices within one country can be manifold

Besides differences between countries, even within one country daily practices can vary between actors, centres or communities.

In France, many GPs and pharmacists are involved in substitution treatment on a voluntary basis and organised in dynamic networks. However, hardly any specialised treatment centre participates in these networks, although such centres practice substitution treatment as well. French treatment centres can be divided into ‘old-school centres’ (they work isolated, mainly methadone in low doses, no maintenance) and ‘new-school centres’ (basic approach is harm reduction, methadone maintenance is possible, larger number of patients, more orientation of patients to GPs when stabilized).

In Italy, different treatment centres (“Serts”) stick to different approaches. Some centres regard substitution treatment as the first step in treatment, therefore these centres emphasize psychosocial interventions. For other centres the primary aim of substitution is to become abstinent. Finally, treatment centres exist along a harm reduction approach, where methadone is provided in high doses and for long periods of time, where the use of heroin is tolerated and the primary aim for users is to normalise their social life.

In Spain, views on substitution treatment (more or less in favour of substitution treatment) and practices vary considerably between Autonomous Communities.

3.2. Problems or difficulties of judicial nature in prescribing or providing substitution substances because of the legal framework

Judicial problems depend of course on the legal framework in one country. As we already mentioned, these legal provisions differ among the studied countries. Consequently, judicial problems or difficulties will have a different nature. Nevertheless we have again tried to formulate a few general characteristics.

Lack of legal basis

In the countries studied where the formal legal basis for substitution treatment is insufficient (e.g. Belgium), there is need for a proper legal framework. Although practices can take place without a proper and/or specific legal basis, the resulting legal uncertainty causes much reluctance among doctors and social services to take part in substitution treatment.

Lack of involvement of the private sector

In countries where only public treatment services are authorised to practice substitution treatment (e.g. Finland, Ireland), it is important that also the private sector (GPs and pharmacists) should be allowed to participate. Differentiation is necessary between GPs and pharmacies within the public health service and private physicians and/or pharmacies. One reason could be the long waiting lists for patients in these countries. Even in countries where GPs are involved in substitution treatment, more and better training for GPs is needed (e.g. Austria). In general more actors should be involved.

Too many restrictions with respect to admission criteria and/or controls

Inclusion criteria (such as minimum age, minimum period of dependence, minimum number of previous detox attempts), exclusion criteria (such as using heroin and other drugs during treatment) and conditions such as urinalysis are often very stringent (e.g. Austria, Finland). When it is prohibited for patients to use heroin or other drugs during treatment, users who are not able to quit their drug use are excluded. It often happens that those are the people who need this kind of treatment the most, being the most marginalized.

A minimum of government control on prescriptions is desirable, but sometimes these controls result in interference in the treatment itself (e.g. Austria).

Limited range of substitution products

In some countries the prescription and providing of other medication or substances than methadone should be encouraged, as well as the possibility to dispense higher doses.

3.3. Social, political and public attitude (including police force on the one hand and users on the other hand) towards treatment, treatment provision and distribution centres

One can observe a cultural change across Europe towards a broader acceptance of substitution treatment, although this is often accompanied by heated debate. Substitution treatment is broadly endorsed by governments as well as by the general public. In most countries studied also professional actors such as law enforcement organs (police force and justice system) and the medical profession, have become more and more supportive in this matter.

However, opposition remains. A general consensus rarely exists. Sometimes, negative attitudes are caused by the fact that decision makers and/or the general public expect drug users to become abstinent as soon as possible. Indeed, from the abstinence perspective, methadone maintenance is not very successful. In Austria, the new government has expressed disapproval of substitution treatment, whereas the social and public attitude is rather positive. In Finland, public attitude is ambiguous; prejudices towards drug (mis)users are still very common. In Ireland, public opinion is ambiguous as well: people are only positive towards substitution treatment in view of abstinence and some community resistance towards new dispensing centres exists (cfr. the so-called ‘NIMBY-Not In My BackYard-syndrome’). In Norway, many GPs and pharmacists are opposed to having drug users as ‘customers’ and do not wish to participate in substitution treatment. In Italy, during the studied period the government announced a major shift in policy regarding treatment for drug addiction. 'Harm reduction' strategies would be abandoned and methadone treatment would only be offered as detoxification schedule and only within a high threshold drug free programme. Scientific researchers as well as field workers have massively expressed their disapproval of this policy.

Drug users who receive substitution treatment are mostly positive about the fact that this form of treatment becomes more common, but their main concerns relate to the limitations; the fact that in some countries or localities there are few centres and practitioners who provide substitution treatment and the limited availability of different substances. They find it important that this treatment is complemented with psychosocial support. Other remarks by drug users: opening hours are too limited for those who work, on-site drinking of methadone in a community pharmacy is embarrassing and sometimes waiting lists are too long.

4. Suggestions of national experts about the local substitution treatment policy

The national experts of the countries participating in this study, formulate the following suggestions and recommendations to inspire future policy considerations. Although there is no general consensus between all involved experts on every one of these suggestions, they have been expressed by the majority of the experts.

Substitution treatment should be extended

Practices as well as evaluative research show that substitution treatment programmes are successful in reducing harmful consequences of opiate addiction. Furthermore, in a lot of European countries existing substitution treatment programmes are not enough to respond to the demands of opiate addicts. Therefore substitution treatment has to be extended, as well as low threshold services and harm reduction initiatives in general.

Substitution treatment should have a proper legal foundation

A proper legal foundation for substitution treatment should exist and should be balanced, with clear rules allowing at the same time enough freedom for practitioners to differentiate, since contexts differ according to users, local situations, etc.

Substitution treatment regulation should be less restrictive

Admission criteria and regulation in general should be less strict. Strict admission criteria (high threshold) lead to long waiting lists.

Modalities should be specified more clearly and in particular the practice of maintenance treatment as a final objective in substitution treatment, remains to be more accepted for those clients who fail to detox in short term substitution programmes.

The range of possible substitution products should be extended, to enlarge the possibility of tailored treatment. Special attention should be given – especially by means of research - to the possibility of controlled prescription of heroin for some subgroups of drug users (e.g. for most problematic and marginalized patients who are not able to stay in substitution maintenance programmes).

A wider range of modalities and substances should make it possible for physicians to decide on a case-to-case basis which treatment and which substance is appropriate for an individual client.

More actors should be involved in substitution treatment

It should be possible to implement substitution treatment in a wider range of health centres, drug services, (psychiatric) hospitals and especially in prisons. Next to specialised centres, also general practitioners and community pharmacists should be (more) involved in substitution treatment to make this kind of treatment more accessible (see also: the long waiting lists in specialised treatment centres).

Substitution treatment should be accompanied by psychosocial care

Medical substitution treatment should always be complemented by adequate psychosocial support, which remains too seldomly the case in the present situation.

More scientific research

There’s a need for more scientific research and evaluation of substitution programmes.

More training and education

There’s a need for more training and education of doctors and field workers in general, regarding to substitution treatment.

Conclusion

The main conclusion about the legal aspects of substitution treatment in Europe is the fact that in all countries a legal basis for this kind of treatment for opioid dependent drug users exists, but often these regulations differ considerably between countries and even between different regions in one country. Uniformisation of basic rules is desirable, leaving at the same time enough freedom for practitioners to differentiate according to specific local situations.

An other important finding is that sometimes the legal framework is not fully translated in daily practice. Legislation should always as much as possible take into account the practical possibilities to comply with theoretical rules.

Finally the researchers regret the fact that ‘only’ nine countries could participate in this study. Future research should best include all European Countries, so a more complete picture can be drawn about this topic.

References

1 EMCDDA, Reviewing current practice in drug-substitution treatment in the European Union, Insight N° 3, Luxembourg, Office for Official Publications of the European Communities, 2000.

2 As a consequence the following countries are not involved in the study: Denmark, Germany, Luxembourg, The Netherlands, Portugal, Sweden, United Kingdom.

3 For the report as a whole, representing also the different contributions of all national experts per country, see: http://

4 With many thanks to Jacques FRANQUET, member of the International Narcotics Control Board, for the documentation.

See also: 'Reviewing legal aspects of substitution treatment at international level', EMCDDA, .

5 UN Single Convention on Narcotics Drugs, New York, 1961, as amended by the protocol of 25 March 1972.

6 UN Convention on Psychotropic Substances, Vienna, 1971.

7 UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, Vienna, 1988.

8 Chatterjee S.K., ‘The limitations of the international Drug Conventions’, in: Albrecht H.-J., Van Kalmthout A. (eds.), Drug Policies in Western Europe, Freiburg, 1989, 7-19.

9 Farrell M., Neeleman J., Gossop M., Griffiths P., Buning E., Finch E., Strang J., A Review of the Legislation, Regulation and Delivery of Methadone in 12 Member States in the European Union,Brussels, The European Commission, 1996.

10 EMCDDA, Reviewing current practice in drug-substitution treatment in the European Union, Insight N° 3, Luxembourg, Office for Official Publications of the European Communities, 2000, p.14.

11 Recently a basic Belgian law is developed concerning substitution treatment, but the practical applications through a Royal Decision still lacks.See “Wet van 22 augustus 2002 strekkende tot de wettelijke erkenning van behandeling met vervangingsmiddelen en tot wijziging van de wet van 24 februari 1921 betreffende het verhandelen van de giftstoffen, slaapmiddelen en verdovende middelen, ontsmettingsstoffen en antiseptica, B.S. 1 oktober 2002”.

12 EMCDDA, Drugs in focus, Key role of substitution in drug treatment, Luxembourg, Office for Official Publications of the European Communities, 2002.

13 See more in 'An Overview Study: Assistance to Drug Users in European Union Prisons', a study by the EMCDDA, published by the European Network for Drug and HIV/AIDS Services in Prison (ENDHASP).

See also .

Tables

Table 1 – Year of development of legal provisions related to substitution treatment, per country

Austria	1998 : Federal Narcotics Act
Belgium	(1994 : Consensus Conference) + 2002 : Law on legal recognition of substitution treatment
Finland	1997 : Orders of the Ministry of Social Affairs and Health 1997:28
France	1994 : Circular Lettre ‘relative au cadre d’utilisation de la méthadone’
Greece	1993 : Law 2161/1993 on the Suppression of the Propagation of Narcotic Drugs
Ireland	1998 : Misuse of Drugs (Supervision of Prescriptions and Supply of Methadone) Regulations
Italy	1990 : Law 309/1990 ‘in materia di disciplina degli stupefacenti e sostanze psicotrope’
Norway	1997 : Bill + Guidelines of Ministry of Health and Social Affairs I-25 1998
Spain	1983 : Ministerial Order about Regulation of Methadone Maintenance Treatment for Opioid Dependent Subjects

Source: country reports of the national experts involved in the study.

Table 2 – Illustration of possible modalities of substitution treatment

	short term	middle-long term	long term
Belgium	3 weeks – 3 months	2 years – 5 years	without explicit duration
Finland	max. 1 month	> 1month, when previous detox wasn’t successful	> 1 month, when special need: prevention of disease, improving quality of life, preparation for detox
Italy	detox short term: max. 1 month detox long term: > 1 month = reducing dosage (aim is to introduce in other programme)		maintenance short term: max. 6 months maintenance long term: > 6 months = stable dosage (aim remains final abstinence)

Source: country reports of the national experts involved in the study.

Table 3 – Admission criteria for substitution treatment, per country

	opiate dependence	minimum age	failed detox	other criteria	priority criteria
Austria	min. 1 year	20 years	x	consent of patient (to medical surveillance, to psychosocial treatment, to withstand from drug abuse)	HIV, pregnancy: no minimum duration of H-addiction
Belgium	min. 1 year	18 years	x (also spontaneously)	no counter-indications	-
Finland	opioid addiction criteria of ICD-10 classification of diseases	-	x	treatment plan	-
France (Remark: Some centres stick to criteria of 1994)	1994: min. 5 years 1995: serious opioid dependence	-	1994: different previous detox attempts 1995: -
Greece	somatic & psychosocial dpendence	25 years	serious unsuccessful previous treatment in other programme	- contract - no serious psychopathology - prohibition to use other narcotic substances	HIV, pregnancy, serious somatic or psychosocial disorder in general, high risk to die or commit offence
Ireland	-	16 years (relaxed)	-	-	pregnancy
Italy	x (methadone maintenance long term: long term addiction of opiates)	-	- (except for methadone maintenance long term: different unsuccessful previous interventions)	-	-
Norway	long career	25 years (relaxed)	reasonable amount of drug-free treatment	holistic treatment plan	serious or life-threatening illness
Spain	x	-	- (relaxed)	no medical counterindication	pregnancy, AIDS, severe physical illness

Source: country reports of the national experts involved in the study.

Table 4 – Substances for substitution treatment, per country

	methadone	buprenorphine	other substances	heroin
Austria	x (max. 0.1 gram per day)	x (mostly for pregnant women)	- morphine (Substitol): max. 2 gram per day - codeine (Kapatol)	-
Belgium	x	x		-
Finland	x	x	LAAM (not for detox) (never used)	-
France	x (specialised centres)	x (GPs)	Morphine sulfate (for patients who cannot fullfil strict conditions of specialised centres, like prostitutes or people with professional life)	- (proposition for experiment, but not yet decided)
Greece	x	x (for not heavy or chronic users) (not yet dispensed because lack of Ministerial Decision)	- LAAM (not used) - Naltrexone (after methadone treatment, to abstain from methadone)	-
Ireland	x (only 1 mg/ml) (syrup)	- (on it’s way)	- Naltrexone (occasionally, no guidelines) - Lofexidine (occasionally, no guidelines)	-
Italy	x (syrup)	x (not used)	-	-
Norway	x	x
Spain	x	x (not usual)	- LAAM - 14 other substances (not usual)	2 heroin trials

Source: country reports of the national experts involved in the study.