Study on the legal aspects
of substitution treatment for opioid dependent drug users : an insight into
nine European countries
Research Centre Forensic
Mental Health Care (Prof. Dr. Joris Casselman), Catholic University Leuven, Belgium
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 on
information 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).