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International Federation of
Anthroposophical Medical Associations IVAA
LEGAL OPINION
ON DIRECTIVES 92/73/EEC and 92/74/EEC
AND ANTHROPOSOPHIC MEDICINE
M.J.Sijmons: March 1998
The "IVAA-International Federation of Anthroposophical
Medical Associations" (IVAA) commissioned the law firm Nysingh Advocaten to examine
the legal position of anthroposophic medicine following the implementation of
the Council Directive 92/73/ EEC of 22 September 1992, widening the scope of
Directives 65/65/EEC and 75/319/EEC on the approximation of provisions
stipulated by law, regulation or administrative action relating to the medicinal
products and laying down additional provisions on homeopathic medicinal products
[1] (and analogously, Directive 92/74/EEC).
The IVAA is a
federation, of which the objective is to
represent anthroposophic medical associations at international level and to
offer support in establishing legal guarantees for anthroposophically extended
medicine. The assignment for this legal opinion focuses in particular on the
consequences of the Directives in current practice, which, as the IVAA expects,
will reduce the availability of anthroposophic medicinal products. The IVAA
perceives this as discriminatory against anthroposophic medicine. The evaluation
of the Directive 92/73/EEC (as well as
92/74/EEC), as ordained in Article 10,
paragraph 3, gives the opportunity to re-examine the Directives in the light of
fundamental principles of Community law and to draw the political consequences,
when they, in the present form, fail to meet the standards of legislation. This
legal opinion sets out to conduct this examination against the background of the
general principles of European administrative law.
The following introduction gives a brief description of
anthroposophic medicine (with regard to homeopathy), as far as this is relevant
to this legal opinion, and the structure of the following sections.
As stated in the IVAA constitution, the professional
associations of anthroposophic doctors prefer the term "anthroposophically
extended medicine" to "anthroposophic medicine"[3].
Anthroposophic medicine does not reject conventional medicine, but regards
itself as an extension of medicine from anthroposophic points of view. It
therefore regards itself as a complementary form of medicine. The anthroposophic
professional associations demand that anthroposophic doctors are fully qualified
in conventional medicine. Anthroposophic nurses have their own regulatory bodies.
The essence of the anthroposophic approach is that it
consistently applies the threefoldness of the human being in body, soul and
spirit. Anthroposophy sees man functioning at three different, but interacting
levels, each with its own laws and principles. A detailed insight into these
laws and principles forms the basis of anthroposophic medicine. The body is
regarded as intimately related with nature. The experiencing soul (awareness) is
distinguished from the bodily functions as such. The free activity of thought
and will point at the spiritual level, whereby each person has an individual
biography.
From the anthroposophical viewpoint, disease is not only a
biological defect, it is also an expression of an imbalance of the individual's
biological, psychological and spiritual levels. Anthroposophic medicinal
products utilise the intimate relationships between nature and man, working with
the correspondences between natural processes and substances and human processes.
Due to its view of man and nature, anthroposophic medicine differs from
homeopathy, which is based mainly on the simile principle on an experimental
basis.
Concerning the manufacturing procedures, however, homeopathy
and anthroposophic medicine are very much alike. As is the case in homeopathy,
often dilutions are used (homeopathy and anthroposophy both have non-diluted
products). In anthroposophic manufacturing the pharmaceutical process typically
is as important as the substances used. The ways of preparation of the mother
tincture are as important as the dilution method. Furthermore, preparation and
levels of dilution have specific indications in the system of anthroposophic
medicine. Potencies below D4 are common. Indeed this applies for the majority of
the medicinal products.
To a certain extent pharmaceutical techniques for preparation
have been described in the German and British homeopathic pharmacopoeias. An
encompassing anthroposophic pharmacopoeia is under development. A bibliography (consisting
mainly of monographs) is available for anthroposophic medicines.
Anthroposophic medicine likewise meets the problem of the
proof of efficacy by conventional methods. As in homeopathy, anthroposophic
medicinal products are basically not intended to have an allopathic effect. The
development of anthroposophic medicinal products is not embedded in the
statistical experimental method. The medicinal products are used as a tool in an
individually tailored, integral therapy, with the result that double-blind,
randomised clinical trials are less suitable to demonstrate the efficacy of
anthroposophic medicinal products [4].
Anthroposophic medicinal products include products for oral
and external use as well as ampoules for injections (and other parenteralia).
Magistral and officinal preparation of anthroposophic methods of preparation are
rare (for a number of reasons), with the result that one is dependent on
industrial production and pharmaceutical specialities covered by Directives
65/65/EEC, 73/318/EEC, 75/319/EEC, 92/73/EEC and 92/74/EEC.
Owing to the fact that anthroposophic medicine is younger and
more closely related to conventional medicine, it has not yet become as
wide-spread as homeopathy. It is estimated that anthroposophic medicinal
products are prescribed by 30,000 doctors in twelve Member States (Austria,
Belgium, Denmark, Germany, Eire, Finland, France, Italy, the Netherlands, Spain,
Sweden and the United Kingdom). A few thousand doctors systematically practice
anthroposophic medicine and are members of the professional associations.
Anthroposophic medicine has a number of its own hospitals in Germany, Italy,
Austria, United Kingdom, the Netherlands and Sweden.
It is estimated that six million patients are treated by
doctors working according to the principles of anthroposophic medicine in the
Federal Republic of Germany alone. Although this number is relatively lower (to
very much lower) in other countries (e.g. southern Europe), on the whole the
utilisation of anthroposophic medicine is relevant to European legislation.
The use of anthroposophic medicinal products is even more
widespread. Anthroposophic medicinal products are covered by national insurances
in several Member States. The market share of anthroposophic medicinal products
is estimated at about 20% of the market for homeopathic (and anthroposophic)
medicinal products in the European Community. With an estimated utilisation of
these products by some 20% of all the citizens of Member States, this means that
approximately 4% of patients use specifically anthroposophic medicinal products
to a greater or lesser extent [5]. In terms of turnover, homeopathy and
anthroposophy amount to about 1 % of the volume of the European pharmaceutical
industry. Anthroposophic medicinal products therefore amount to some 0.2% [6] .
Summary:
Anthroposophic medicine:
- regards itself as a complementary form of medicine;
- is practised by fully qualified medical doctors with the
appropriate university degrees, organised in professional associations;
- is characterised by a consistent and detailed application
of the threefoldness of body, soul and spirit;
- uses medicinal products that are diluted (potentised), as
are homeopathic products and, similarly, are without allopathic effect;
- uses predominantly dilutions below D4;
- uses products of all routine dispensing (classical pharmaceutic) forms;
- is widespread and has hospitals in six Member States;
- has a marketshare of some 20 % of the market of homeopathic (and
anthroposophic) products.
The further structure of this legal opinion is as follows.
First the legal framework and the creation of Directives 92/73/EEC and 92/74/EEC
will be described, focusing on the position of anthroposophic medicine (Section
2).
The formal standards against which the legislation and
regulations in the European context can be tested are described in the next
section (Section 3). The general principles of legislation and administration,
that are embedded in the EC Treaty or that have been unambiguously accepted as
standards by the Court of Justice of the European Community, will be discussed.
Section 4 deals with the development of patient's rights at
European level and the consequences concerning non-conventional medicines in
general and anthroposophic medicine in particular.
In Section 5 the framework developed in this way will be
applied to the Directives in their current form. It will then become apparent
that in some parts the Directives do not take the position of anthroposophic
medicine sufficiently into account. As a result, the Directives do not comply
with the legal norms set for legislation by the EC. The shortcomings can,
however, be resolved by fairly simple adjustments of the Directives.
The legal opinion concludes with a summary of the
recommendations (Section 6).
On the basis of Article 100A EC Treaty, the Community is
aiming to harmonise national legislations concerning the registration of
medicinal products. The first directive to be introduced in this area was that
of 26 January 1965 (65/65/EEC). An authorization granted in accordance with this
Directive is required to market a medicinal product. In the preamble to this
Directive it appears that, although the protection of public health is the main
objective, this objective should be achieved by measures that do not hinder the
development of the pharmaceutical industry or the trade in medicinal products in
the common market. Article 5 stipulates that authorization will be refused if
the speciality submitted is harmful in normal usage or if the therapeutic effect
is lacking or has not been sufficiently demonstrated.
Directive 65/65/EEC is supplemented by Directive 75/318/EEC in
which, among other things, it is considered, that the terms 'harmful' and 'therapeutic
effect' mentioned in Article 5 of Directive 65/65/EEC, can only be examined in a
mutual context and only have a relative meaning (preamble). The application for
authorization would have to demonstrate that when the importance of the
therapeutic effect is weighed against the possible risks, the therapeutic effect
is of overriding importance. If this is not the case, the application must be
rejected.
Harmonisation, as the next step towards free trade in
pharmaceutical specialities, is continued with Directive 75/319/EEC. Article 39
of this Directive introduced a transitional period of fifteen years (expiring
1990). After that time, all pharmaceutical specialities that already had been
introduced on the market on the basis of previous authorizations, are covered by
the Directive in question.
The expiry of the fifteen-year period mentioned prompted the
Commission to make a provision for homeopathic medicinal products, that would
otherwise be confronted by the registration condition of demonstrable
therapeutic effect. As there is no allopathic explanation of the therapeutic
effect of homeopathic medicinal products, this category of medicinal products
could in practice be threatened by a ban.
Directive 92/73/EEC provides a simplified registration
procedure for homeopathic medicinal products (parallel to Directive 92/74/EEC
for homeopathic veterinary medicinal products). In its considerations, the
Council acknowledges "the restricted applicability of conventional
statistical methods for clinical trials" for these products. Furthermore,
in the considerations the Council accounts for the fact that homeopathic
medicine is officially recognized in a number of Member States and tolerated in
others. Homeopathic medicinal products are prescribed and used on a large scale
in all Member States. On the one hand, the Directive must offer the patients the
opportunity to buy these non-allopathic medicinal products, as the products of
their choice, while on the other hand, differences in legislation that can
hamper the trade in homeopathic medicinal products in the Community and lead to
discrimination and distortion of competition, must be cancelled.
Within the context of this study, the following steps in the
realisation of Directives 92/73/EEC and 92/74/EEC are of importance.
The Commission took the initiative for this Directive on the
basis of Article 100A EC. Consequently, a co-operation procedure was followed as
is now (since 1992) described in Article 189C EC. Anthroposophic medicinal
products were not yet mentioned in the Commission's first proposal of 23 March
1990 [7].
The Economic and Social Committee of the EC issued its advice
concerning the first draft on 19 September 1990 [8]. The Committee too is not
yet aware of the share of anthroposophic medicinal products in 'homeopathic
medicinal products'. It should be noted that the Committee did point out (under
3.6) the inconsistent situation that, with a view to approval of the therapeutic
effect of homeopathic medicinal products, allopathic criteria were being applied
by allopathic doctors. The therapeutic effect, the committee concluded, must be
evaluated according to the rules of homeopathic medicine, which, after all, are
decisive in its use. In this regard, the Committee noted (under 3.7), that free
trade in homeopathic medicinal products could fail if the problems concerning
the recognition of homeopathic practioners is not solved.
In respect of Article 7, paragraph 1, the Committee regards it
as essential that, in addition to oral or external use, rectal use is also
permitted. Concerning Article 7, paragraph 1, third indent, the Committee
expressed its surprise about the lack of scientific accuracy in determining the
minimum degree of dilution. Toxicity threshold values vary greatly owing to the
many different active principles used. The Committee proposed that toxicological
evidence is submitted demonstrating the innocuity of the medicinal product,
instead of demanding a minimum degree of dilution.
The European Parliament (EP) proposed some fifteen amendments
[9]. The EP wished to express that the freedom of choice of therapy is
guaranteed, despite the strongly diverging status of alternative medicine (Amendment
no. 2) in the various Member States. In Amendment 3, anthroposophy is referred
to as an independent discipline alongside allopathy and homeopathy. With a new,
fourth consideration, Amendment 5 introduced anthroposophic medicine as a
discipline that plays an important role in complementary medicine in some Member
States. This amendment intends to safeguard the interests of patients who opt
for this type of medicine. Amendment no. 8 proposes a supplement to Article 1 in
which anthroposophic medicinal products described in an official pharmacopoeia
are given equal status as homeopathic medicinal products. Amendments no. 10
[10], 12 and 13, include a reference to the anthroposophic bibliography
alongside the homeopathic, and with regard to proof of the therapeutic effect of
products that are not covered by the simplified procedure, a reference is made
to the basic principles and unique nature of anthroposophic medicine alongside
that of homeopathic medicine.
Thanks to the amendments of the EP, the position of
anthroposophic medicine appeared to be properly safeguarded.
The references to anthroposophic medicine are included in the
Commission's amended proposal of 5 August 1991 [11]. This is no longer the case
in the Council's joint position, which led to more specific amendments by the EP
to secure the position of anthroposophic medicinal products (no. 8 and 9) [12].
Finally, in its decision to adopt the Directive dated 22
September 1992, the Council has limited the reference to anthroposophic
medicinal products to the consideration that insofar as these are described in
an official pharmacopoeia and are prepared by a homeopathic method, they can be
treated in the same way as homeopathic medicinal products as regards
registration and marketing authorization. Anthroposophic medicinal products are
brought under the scope of the Directive, though without clearly expressing the
independence of anthroposophic medicine in relation to homeopathy. The
application of the Directive to anthroposophic products has become a matter of
interpretation in many details. This has consequences, which will be discussed
in the following sections. In view of the historical development of the
Directives, one may assume that in principle an equivalent position for
anthroposophic medicinal products was envisaged nevertheless.
According to Article 10, paragraph 1 of the Directive, the
Member States harmonise their legislation by 31 December 1993 at the latest,
inform the Commission, which in turn reports to the EP and the Council by 31
December 1995. This report is now available as the 'Homeopathic medicinal
products' Report dated 14 July 1997 [13]. This Report is based on a study
carried out by Arbaret & Associé s
international. The assignment, specified in tender no. III/95/64, covers a 'description
of the market of homeopathic medicinal products at national and European level'.
The Commission's Report hardly contains any such data. In any case, the market
position of anthroposophic medicinal products is not (individually) referred to.
It is therefore uncertain whether it has been given appropriate attention.
The Commission reported that most Member States have notified
implementation of both Directives. Only a few were late in the implementation.
The Commission noted a certain degree of disparity in the application of
Directives and contradictions in the interpretation thereof. The Commission
lists the following problems:
- the provision in Article 6, paragraph 1 of Directive
92/73/EEC 'each Member State shall take due account of registrations and
authorization previously granted by another Member State', is interpreted in
different ways. A more precise definition of the specific conditions for
mutual recognition is required;
- the dilution threshold of D4 (1/10,000) has in practice met
criticism. 'A high percentage of single and complex homeopathic medicinal
products would have to be withdrawn or have to be changed'. Article 7,
paragraph 1 was also criticised for restricting the simplified registration
procedure to products for oral and external use;
- there are practical objections to the exclusion of fantasy
names pursuant to Article 7, paragraph 2. The compulsory clause "without
approved therapeutic indication" is also controversial;
- at the manufacturers' request, the Commission is
considering making Article 9, paragraph 2 binding and to demand that 'the
specific rules for tests and clinical trials in Member States should provide
for the involvement of appropriate experts in homeopathic and anthroposophic
medicine'.
The independent position of anthroposophic medicine as
compared to homeopathy is only expressed in the last consideration, while
remaining implicit in the other considerations. As far as mutual recognition,
the D4 threshold, the expansion of pharmaceutical forms, fantasy names and the
warning on the packaging are concerned, the anthroposophic practitioners and
manufacturers of anthroposophic medicinal products share the criticism expressed
by the homeopathic sector regarding Directives 92/73/EEC and 92/74/EEC. In
addition, the IVAA and the national professional bodies of anthroposophic
doctors have expressed, among others, the following objections [14]:
- owing to the restriction in Article 7, whereby only
medicinal products for oral or external use of D4 potentiation or higher may
be authorized according to the simplified procedure, many characteristic and
indispensable medicinal products used in anthroposophic medicine must be
withdrawn from the market in those Member States that adopt these conditions
(all Member States except Austria and Germany);
- the prescribed designation 'homeopathic medicinal products'
(Article 7, paragraph 2), excludes the use of the current terms 'anthroposophic
medicinal product' or homeopathic medicinal product for anthroposophic
therapy', which may cause confusion about the identity of the product;
- the documents referred to in Article 8 concern homeopathic
stocks, while it must be possible to refer to bibliography establishing the
anthroposophic nature (instead of homeopathic nature) of stocks and methods
of preparation.
According to the IVAA, these issues show that homeopathy and
anthroposophic medicine are not receiving the envisaged equal treatment. This
will be examined in the following sections.
European legislation (directives and regulations) are subject
to principles of proper regulation [15]. Although the EC Treaty has no coded
system of general principles of law, a number of fundamental rights and general
principles of law have been laid down in the EC Treaty and the Treaty on
European Union (Maastricht 1992). As follows from Articles 164, 173 and 215(2)
EC the legislation of the EC should be in accordance with the written law as
well as unwritten, general principles. The European Court of Justice (ECJ) had
already accepted the applicability of fundamental rights and general principles
of law. After all, it would be unacceptable that while all Member States
recognize the adherence to fundamental rights and general principles of law, the
Community would be able to withdraw from them [16].
Of these principles, the following are relevant to our
examination:
- the duty to give reasons
- the principle of equality
- the principle of proportionality.
Article 190 EC stipulates that directives shall state the
reasons on which they are based [17]. The reasons for
legal measures must be apparent from the considerations expressed
in the preamble, among others to allow the Court to exercise its supervision in
determining the legality of the acts of the European institutions [18]. See ECJ,
case 69/89, [19911 ECR 2069 for the relationship with the principle of equality.
This principle, which in its function of retributive and
distributive justice, is one of the classic principles of law in European cultur[19],
is undoubtedly fundamental to European law. It has been incorporated in a
special manner in a number of the provisions of the EC Treaty: Articles 6, 36,
40, 48, 60, 67, 79, 119 and 132 EC. The Court of Justice has repeatedly ruled
that the discrimination prohibitions are 'merely specific enunciations of the
general principle of equality [20]. In case 265/78 [21] the Court of Justice
literally subjected regulations to tests against 'the general principle of
equality which requires that comparable situations may not be treated
differently unless difference of treatment is objectively justified’ [22].
Article 3B EC introduced by the Treaty on European Union (Maastricht
1992), stipulates that the Community's actions may not extend further than is
necessary to realise the objectives of the Treaty. Thus, the principle of
proportionality has been affirmed in the Treaty. In the Court of Justice's
decisions, this principle had already developed into a 'criterion of lawfulness
for every Community rule', particularly since 1970 [23] . Long before
codification, the former President of the ECJ, Hans Kutscher, stated that this
principle already had the status of a treaty rule and prevailed over derived
Community law [24] . Aspects of proportionality are:
- suitability
- necessity
- proportionality in the strict sense [25]
The guidelines of the Edinburgh European Council of December
1992 on article 3B EC contain some more elaborated rules for the application of
the principle of proportionality [26], of which the following elements can be
mentioned:
- any burden falling upon economic operators should be
minimized and be proportional to the objective to be achieved (par. ii);
- consideration should be given to setting minimum standards
(par. iv).
The issue in hand will be examined according to these
principles. The interests under discussion will have to be detailed further to
be able to test proportionality. Most important is the test of this principle in
stricto sensu, that has been used by the ECJ mostly in cases where the contested
measures encroach on rights granted by the Treaty, on fundamental human rights
or on other accepted general principles of law [27] . These interests are
founded in the doctor's professional freedom and the patient's freedom of choice
of therapy. These interests can be affected by measures that restrict this
freedom. Furthermore, the manufacturers' interest in free trade and undistorted
competition are also involved. The latter will hardly require further
explanation within the framework of European law. As far as the freedom of
choice of therapies is concerned, the extent to which (partly within the
framework of proportionality) the Community must respect the interests under
discussion, will be outlined in the following section.
OF
PATIENTS IN THE EUROPEAN COMMUNITY
Patients' rights are part of the European legal order. Already
in the resolution of 20 January 1984, the EP considered that the best medical
treatment is a patient's fundamental right and found it necessary to draw up a
European charter of patients' rights. The Commission never made a proposal to
this effect, even though the Articles 129 and 129A EC, introduced by the Treaty
on European Union meanwhile offer an explicit basis for such a charter.
However, the lack of such a charter does not mean that
patients' rights are not safeguarded within the Community. Recently, a study
into patients' rights in Europe was carried out. This study was commissioned by
the World Health Organisation, Regional Office for Europe [28] . The researchers
mention a number of developments that should lead to a European Declaration of
Patients' Rights. An overall approach is still lacking: "it is precisely
this need that the European Parliament expressed in 1984 in its resolution
calling for the drawing up of a European Charter of Patients' Rights. The WHO
Regional Office for Europe, which has long been concerned about the problem,
responded to this call" [29] . The WHO researchers have noted that
developments in legislation in the various Member States progress slowly.
Patients' rights are recognized in the Member States, particularly as embedded
in the European Convention for the Protection of Human Rights and Fundamental
Freedoms (1950:ECHR). The patient's freedom of choice of therapy is encompassed
in the principle of informed consent, according to which medical treatment can
only be justified by a primarily given free informed consent of the patient. The
WHO researchers' findings on this:
"The principle of consent to medical treatment is
generally acknowledged in the countries that participated in the study. The
requirement for consent to diagnosis, treatment and other medical acts (e.g.
medical examinations) is primarily based on the right to personal (physical)
integrity. This right applies on the national level because of its inclusion in
the national constitution or because the country adheres to international
conventions. Moreover, the right to integrity often forms the basis of
provisions in penal, civil and administrative law" [30].
The European Court for Human Rights decided that paragraph 8
of the European Convention (ECHR) dealing with respect for private life also
encompasses "the physical and moral integrity of the person"[31]. As
has been said, the fundamental rights of the European Convention of 1950 are
part of the legal order of the European Community in accordance with legal
precedence laid down by the Court of Justice [32], and currently due to the
Articles F and K of the Treaty on European Union. One can also refer to the
recent Resolution A4-0223/96 of the EP on respecting human rights in the EU,
dated 17 September 1996. The interpretation of Article 8 of the ECHR entails a
fundamental right to freedom of therapy, due to the principle of the patient's
free informed consent.
As a result, the WHO found sufficient basis for a common
European declaration. One may regard this declaration as offering an
acknowledged interpretation of the fundamental patient's right to physical and
moral integrity in medical situations. In March 1994, thirty-six Member States
of the WHO in western and eastern Europe, issued a 'declaration on the promotion
of patients' rights in Europe by adopting a document entitled 'Principles of the
rights of patients in Europe: a common framework’ [33]. Paragraph 3 stipulates
the requirement of 'informed consent as a prerequisite for any medical
intervention' (paragraph 3. l.). Informing patients is not restricted to
therapies that fall within the competencies of a specific doctor, as Article 2.2
stipulates:
"Patients have the right to be fully informed about their
health status ... about alternatives to the proposed procedures, including the
effect of non-treatment" [34]
Complementary to this, patients have the right to freedom of
choice of a doctor or health-care provider (paragraph 5.6.). Now that the right
to respect for cultural values and philosophical convictions must be guaranteed
in health care (paragraph 1.5.), the right to freedom of choice of for instance
doctors offering anthroposophic therapy, is encompassed by these fundamental
rights.
The Declaration of the WHO can be considered as an explication
of the rights laid down in Article 8 of the ECHR. By signing the Declaration the
Member States committed themselves to this standard of patients' rights.
On 19 November 1996, the Council of Europe, with the Community
again as cosignatory, adopted the 'Convention for the Protection of Human Rights
and Dignity of the Human Being with regard to the application of biology and
medicine: Convention on Human Rights and Biomedicine [35] . By consigning
this convention, the Community currently has a catalogue of patients'
fundamental rights. It accepted to "take in its internal law the necessary
measures to give effect to the provisions of the Convention" (Article 1).
It can hardly be imagined, that this development of the fundamental rights
embedded in the Convention (ECHR) does not bind the institutions of the
Community (in spite of matters of competence according to the EC-Treaty [36]).
Like the WHOdeclaration, the new convention also acquires legal status as an
elaboration of the fundamental rights of the ECHR [37].
Once more the freedom of therapy is guaranteed in this
convention by the general principle of free and informed consent for each
medical intervention (Article 5). The basis is the 'respect for integrity and
other rights and fundamental freedoms with regard to the application of biology
and medicine' laid down in Article 1. The legal protection of the patient in
this convention can hardly be understood to be different in scope than intended
by the WHO declaration [38].
The European Parliament adopted this resolution on 29 May
1997. Its purport is to call on the commission to carry out a thorough study
into non-conventional systems of medicine (concerning safety, efficacy, area of
application, etc.) and to launch a process of recognising non-conventional
medicine.
It is stipulated within the context of the considerations that
it is important to ensure that patients have the broadest possible choice of
therapy. This will be balanced by a guarantee for a maximum level of safety,
most accurate information and protection against unqualified individuals.
This freedom of choice has two direct consequences for
European legislation. In the first place, it affects the free movement of
persons and freedom of establishment. These freedoms are undermined by the
heterogeneous prevailing situation with regard to the status and recognition of
non-conventional medical disciplines within the European Union (Consideration
G). Part Ill, Articles 52-66 EC prohibit such restrictions. Article 57 EC in
particular could offer the basis for harmonised Community legislation in order
to guarantee these freedoms.
Further, 'if therapists are to have the opportunity to
exercise their profession properly', it is essential that European pharmacopoeia
should include the full range of pharmaceutical products used in
non-conventional medicine (Consideration M), therefore, including anthroposophic
medicinal products. This prerequisite necessitates the reviewing of the
Directive 92/73/EEC. The medicinal products of non-conventional medicine must be
available with safeguard for safety and quality to both doctors and consumers to
ensure freedom of choice of therapy.
The importance of Directive 92/73/EEC and 92/74/EEC was
expressed as follows in the Parliamentary debate on 28 May 1997 by EU
Commissioner Padraig Flynn:
"The main problem for non-conventional medicinal products
is the proof of efficacy. A special approach was taken with Directives 92/73 and
92/74 for certain homeopathic medicinal products, where a product was allowed to
be marketed without fulfilling the requirement of efficacy. The Commission is
prepared to examine the potential that this offers for giving effect to the
views expressed in the resolution" [39].
The review of the Directives can therefore only be aimed at
guaranteeing safety and quality with the least possible restrictions on the
manufacture of and trade in these medicinal products. Efficacy will have to be
examined by means of methodologies appropriate for non-conventional medicinal
products (see Consideration
On 29 October 1996, the Commission for legal affairs and civil
rights issued a recommendation concerning the draft resolution [40]. Its main
conclusions were that the main objective of each communitarian regulation in
this area must be to guarantee patients' freedom of choice of therapy (for which
Article 57 EC offers a basis). One may note a shift of emphasis compared to the
preambles of Directives 92173/EEC and 74/EEC that still stipulate the protection
of public health as the most important objective.
On the basis of the above, the status of anthroposophic
medicinal products can be described as follows.
As is demonstrated by the considerations of Directive
92/73/EEC, guaranteeing freedom of therapy is one the most important reasons of
the Directive. The 1997 resolution confirms this basis and relates it to doctors'
professional freedom or their right to freedom of establishment. The Directive
is an instrument that must ensure that freedom of choice of therapy is achieved
through minimal restrictions with sufficient consumer protection, in any case
for therapies of non-conventional systems of medicine, that offer sufficient
guarantees of safety, quality and efficacy, evaluated in accordance with its own
points of view, and guarantees of qualified application by its own professional
association. That this is the case in anthroposophic medicine, is expressed by
the recognition in the preamble of Directive 92/73/EEC. In the Lannoye Report
(A4-0075/97) of 6 March 1997, which forms the basis for the resolution of 1997,
anthroposophic medicine is called 'a fullblown system of medicine" [41].
Thus, the availability of anthroposophic medicinal products
thereby becomes a fundamental right that deserves constitutional protection.
When reviewing the Directives against the principles of
equality and proportionality, given the stated reasons (duty to state reasons),
it will have to the examined:
- to what extent unimpeded manufacturing for marketing, and
thereby availability for consumers, remains guaranteed (freedom of choice of
therapy);
- whether anthroposophic doctors' right to freedom of
establishment is not impeded if due to the registration procedure
anthroposophic medicinal products are not sufficiently available in certain
Member States. Restrictions are only justifiable if public health is
endangered (see Article 56 EC);
- whether the trade in homeopathic medicinal products is not
impeded in contravention of Article 30 EC as a result of the differences in
national legislation tolerated by the Directives [42]. Distortion of
competition between the manufacturers of homeopathic and anthroposophic
medicinal products must be prevented [43]
Restrictions for anthroposophic medicinal products ensuing
from the registration procedure can be justified exclusively by considerations
of safety and quality, and the efficacy of the products must be evaluated by
means of a methodology adapted to anthroposophic medicine (preamble, second and
tenth considerations). Any further restriction in the conditions for
registration is in contravention of Part III of the EC Treaty [44], the
Convention on Human Rights and Biomedicine of 1996 [45], human and patients'
rights (European Convention on Human Rights 1950 and the WHO Declaration 1994)
[46], the stated reasons in the preamble of Directives 92/73 and 74 [47] and the
Resolution of 1997 [48].
In the paragraphs below, the articles without a reference
number refer to Directive 92/73/EEC.
A "homeopathic medicinal product" is defined in this
article. Refer to Article 1 of Directive 65/65/EEC for a definition of a
"medicinal product".
The fourth consideration of Directive 92/73/EEC states that
anthroposophic medicinal products described in an official pharmacopoeia and
prepared by a homeopathic method are to be treated, as regards registration and
marketing authorization, in the same way as homeopathic medicinal products. They
should indeed be treated in the same way, as they, just like homeopathic
medicinal products, are not intended to have an allopathic effect, and share
general principles of manufacturing with homeopathy (f.i. dilutions).
No interests of safety and quality prevent the simplified
registration of anthroposophic medicinal products, when they have their own
manufacturing procedure described in the pharmacopoeias, or if they are derived
from products, substances or compositions, that do not happen to have an, in the
narrow sense, homeopathic correlation. These specifically anthroposophic
medicinal products are not less safe or lower in quality than homeopathic
products in the narrow sense of the word. Although anthroposophic and
homeopathic medicinal products are in a similar position compared to allopathic
medicinal products, they differ in respects not relevant to safety, quality and
efficacy (which is all that registration concerns). In contravention of the
principle of equality, the anthroposophic manufacturing procedure is not taken
into account in the definition in Article 1.
The independence of anthroposophic medicinal products was
expressed in the fifth amendment by the EP (see paragraph 2.4 above). As an
extension, a change of Article 1, paragraph 2 was also proposed in Amendment 8 (which
was adopted by the Commission), stating that an anthroposophic medicinal product
described in an official pharmacopoeia should be treated equal to homeopathic
medicinal product [49].
In the foreseeable future a comprehensive description will be
available in a pharmacopoeia. When the European Pharmacopoeia will include the
non conventional medicinal products, as is demanded in the EP Resolution on the
status of non conventional medicine, we may expect the anthroposophic
pharmacopoeia to be incorporated.
The fourth consideration and Article 1, paragraph 1, translate
the equal treatment of homeopathy and anthroposophy only by treating
anthroposophic medicinal products in the same way as homeopathic medicinal
products inasfar as these are prepared according to homeopathic manufacturing
procedures and from homeopathic stocks. Anthroposophic medicinal products are
taking into account by this regulation only in as far as they can be said to be
homeopathic medicinal products in the strict sense according to the definition
of Article 1. The formulation of the fourth consideration overlooks the
independent position of anthroposophic medicinal products and is wrongfully
discriminating (in contravention of the principle of equality), unless
interpreted aiming at an acceptance of anthroposophic medicinal products within
the framework of the Directive. The former restriction clearly cannot be
justified by the stated reasons of safety and/or quality of the medicinal
products. At least such stated reasons are not expressed in the published
documents . Therefore, if taken literally, the Directive in its present form
does not comply with the general principles of European law.
This unequal treatment not only affects the interests of
doctors and patients, but also those of the manufacturers of anthroposophic
medicinal products and their competitive position with regard to, amongst others,
homeopathic manufacturers. This interest recognized in the preamble to the
Directive, occurs automatically in all cases of unequal treatment and will no
longer be referred to separately in the following paragraphs.
A simple solution of the above mentioned problem is to prevent
a too strict interpretation concerning anthroposophic products by formulating an
equivalence of terms in such a way that where the term 'homeopathic' is used in
the Directive, it may also be read as 'anthroposophic'. This solution was
adopted by the European Parliament (see paragraph 2.4).
A: Threshold
Article 7, paragraph 1 only permits simplified registration if
the medicinal product does not contain more than one part per 10,000 of the
mother tincture.
In its report on the Directives, the Commission remarked that
manufacturers, doctors and consumers agree that, as a result of this, too many
homeopathic products will have to be changed or withdrawn from the market. After
all, the Directive assumes that (homeopathic) products below the D4 threshold do
not qualify for ordinary registration as their efficacy cannot be demonstrated
in a conventional sense, or that proof is not yet broadly accepted by
conventional medicine. Registration below the D4 threshold is not expected in
the foreseeable future. Therefore, it is requested that this criterion is
amended.
This problem plays a significant role in anthroposophic
medicinal products as most anthroposophic medicinal products are below the D4
threshold. Now that most of the anthroposophic medicinal products no longer
qualify for simplified registration, they depend on the special regulation of
Article 9, paragraph 2 in the Member States in question. However, the Commission
reports that most Member States have not taken clear action. Only Germany is
reported to have clearly defined these rules, because of its own homeopathic
tradition. As far as the other countries are concerned, it is certainly still
unclear whether the methodology as developed and recognized [50] in Germany, for
example, is applied. This is not the case in the majority of Member States. In
these Member States, the availability of anthroposophic medicinal products and
thus, patients' freedom of choice of therapy and doctor is at stake.
Anthroposophic doctors' freedom of establishment is under threat if practising
anthroposophic medicine is no longer possible owing to the lack of sufficient
anthroposophic medicinal products. Consideration M of the Resolution on the
status of non-conventional medicine recognizes this problem. There should be
valid reasons for limiting the possibility of simplified registration to a
certain category of anthroposophic medicine.
Now, maintaining the D4 threshold hardly serves any purpose.
Already in the design phase, the Economic and Social Committee pointed to the
lack of scientific accuracy in determining the minimum degree of dilution [51].
The degree of dilution says little about the harmfulness and toxicity of the
potentised substance. There are extremely toxic potentised substances above the
D4 threshold and highly innocuous and harmless ones below that. Toxicity and
harmfulness can also be assessed simply at the hand of toxicological tables in
most cases. Anthroposophic medicinal products below the D4 threshold are safe
and harmless products. This has been confirmed by decades of practical
experience with these substances. This fact cannot simply be ignored.
In Germany, where the anthroposophic medical tradition is
well-known, the D4 threshold has been replaced by the requirement of "absence
of harmful effects" [52]. Given the variation of toxological substances (toxical
effects in high dilutions) and the harmless nature of the substances used at low
dilutions in anthroposophic products, the threshold does not contribute to
safety. The threshold as such can only be useful for a limited number of toxic
substances, that can easily be identified. A general threshold excludes far too
many products, that do not differ from high dilutions in safety and quality.
The first requirement of Article 7, paragraph I is that the
degree of dilution safeguards the harmlessness of the product. This harmlessness
can be demonstrated by toxicological evidence. The inclusion of a minimum degree
of dilution is than indeed superfluous.
Furthermore, Article 7, paragraph 1 includes the stipulation
that the products may not contain more than 1/100th of the smallest dose used in
allopathy with regard to active principles. If necessary, this will suffice for
the purposes of the Directive. The minimum degree of dilution D4 does not add to
safety and quality.
Therefore, the criterion of necessity as a requirement of
proportionality has not been fulfilled [53].
Given the interests at stake, maintaining the current D4
threshold also violates the criterion of proportionality in the strict sense.
This consumer protection, as such achievable by other means, in the current
format infringes disproportionately on the interests secured by fundamental
rights. It is these very rights, that should be served by simplified
registration of anthroposophic medicinal products. The D4 threshold cannot be
regarded to be a 'minimum standard' as required by the Edinburgh guidelines. It
furthermore fails to meet these guidelines, because more than a minimal burden
is imposed on the manufactures of anthroposophic products in relation to the
objective of the Directive.
Now that the D4 threshold will have a considerably greater
impact on anthroposophic than on homeopathic medicinal products, while
homeopathy (as shown in the Commission Report [54]) has found means with which
to adapt its medicinal products to levels higher than the D4 threshold,
anthroposophic medicinal products are not treated in the same way as homeopathic
medicinal products. Manufacturers of anthroposophic medicinal products in
particular will loose their competitive edge in all cases where anthroposophic
medicinal products can be replaced by homeopathic products. A level playing
field in the area of non-allopathic medicinal products then no longer exists. As
far as substitution is likely to occur, the principle of equality among
manufacturers is also violated. Also for this reason it can be concluded, that
an unequal burden is imposed on the anthroposophic manufactures.
B: Administration
Another aspect in Article 7, paragraph 1 that is running into
objections in practice, is the requirement that the medicinal product is
intended for oral or external use. The Commission mentions some opinions that
the registration should be applicable to other pharmaceutical forms (see
Paragraph 2.5. for this), as was considered by the Economic and Social Committee
in 1990 commenting on Article 7, paragraph 1 [55].
Possible additional risks involved in, for instance,
subcutaneous injections of the medicinal products do not concern the safety and
quality of the product itself (the composition), but only the route of
administration, the mode of application. It is only the safety concerning the
composition of the medicinal product that is examined for registration.
The safety and quality of the pharmaceutical forms are
guaranteed by the pharmacopoeia and the obligation of the manufacturer to work
in accordance with the GPM-rules. Furthermore, article 7, paragraph 1 stipulates
that the Member States can determine the classification for the dispensing of
the medicinal product at the time of registration. The route of administration,
in as far as this may entail an additional risk, is subject to national
regulation (in accordance with the principle of subsidiarity). It is no longer
necessary (as a requirement for proportionality) to discriminate on method of
administration in the registration.
Registration of allopathic products in non-oral forms does not
entail compliance to additional conditions. Since there are no special risks
involved in the administration of anthroposophic parenteral medicinal products
compared to parenteral allopathic medicinal products, the proof of efficacy for
parenteralia is a disproportionate demand. Safety and efficacy of these products
should in principal not be evaluated in a different way than oral products. If
the efficacy in the same way causes a problem for parenteral medicinal products
as for oral products, simplified registration must also be open to these
products. The raison d' être of the Directive is, that the normal requirements
for proof of efficacy, would mean a ban on homeopathic products. To demand
conventional proof of efficacy for oral or- external use comes down to a ban on
anthroposophic ampoules and other parenteral medicinal products in practice
[56]. This not sufficiently supported by the stated reasons and preamble of the
Directive.
Therefore, the requirements concerning mode of administration
are wrongfully made. This restriction, therefore, also violates the principle of
proportionality.
Article 7, paragraph 2 prescribes that the label of simplified
registered products must mention the words "homeopathic medicinal product".
For the reasons set out in Paragraph 5.2., the exclusive description "homeopathic"
instead of offering the choice of mentioning "anthroposophic", is
discriminating (in contravention of the requirement of equality and
proportionality). It is certainly confusing for patients who opt for the
anthroposophic system of medicine instead of, for instance, homeopathy, that
they are given an anthroposophic medicinal product with the description "homeopathic
medicinal product". It creates the impression that anthroposophic medicine
is a branch of homeopathy. The possible confusion, and the harm that can be
caused to anthroposophic therapy as an independent form of medicine, is
unnecessary (therefore already disproportionate) and simple to resolve [57]
Article 7.2 further stipulates that the label must mention
"homeopathic medicinal product without approved therapeutic indications".
Pursuant to Article 7, paragraph 1, the label already does not mention a
specific therapeutic indication. The mention on the grounds of Article 7,
paragraph 2 must be justified independently. A clear justification (stated
reason) cannot to be found in the documents mentioned in section 2. The EP
proposed to amend paragraph 2 by deleting this unjustified clause [58]. The
mention only confirms the fact that no indication is mentioned and therefore
unnecessary (disproportionate).
The addition "without approved therapeutic indications"
appears to be in contravention of the freedom of choice of therapy to which the
Directive subscribes. Anthroposophic medicine and homeopathy are accepted as
non-conventional systems of medicine, which also means that non-conventional
indications for the use of their medicinal products are accepted (though not 'approved').
Although the indications may be based on other principles (e.g. on the patient's
health status as a whole), the medicines do not lack any therapeutic indication
(aimed effect) altogether [59]. This would in its ultimate consequences, indeed,
mean that the products are no longer medicinal. (From the consumer point of view),
the clause on the label seems to say "medicinal product without medicinal
effect" (in short: "non-medicinal medicine").
That a therapeutic effect and therefore some indication is
implied by the term "medicinal product", follows from Article 1 of the
Directive 65/65/EEC. It is the demonstrability of the therapeutic properties of
homeopathic products that have led to simplified registration, not the lack of
therapeutic effects as such (on which a homeopathic indication rests). According
to the Directive, these do not lend themselves to conventional evaluation (the
Community makes no comment on efficacy). The mention on the label is
disproportionate in the strict sense.
This point can be illustrated by referring to the European
definition of medicinal product. Concerning this definition (Article 1
65/65/EEC), the Court decided that products that are not sufficiently
efficacious (though presented as such) are included in the definition. Therefore,
the term 'medicinal product' is in itself no guarantee, that the legitimate
bearer has approved therapeutic effects.
However, this broad definition is intended as a safeguard
against products that are used instead of efficacious products [60]. This "inclusive
definition" by the Court aims to exclude inferior products from
registration and marketing. In contrast, the Directive aims at bringing
homeopathic and anthroposophic medicinal products within the reach of
registration and their use as medicinal products. So the clause on the label
appears to be contradictory and cannot be held consistent with the use of the
term 'medicinal product' in the mention.
The suggestion of denying homeopathic and anthroposophic
medicine any "approved" therapeutic indication in Article 7, paragraph
2 can, furthermore, not be harmonized with the Resolution on the status of
non-conventional medicine of 1997.
Finally, the warning clause in the current edition is not a
useful tool for the envisaged objective (safety). On the contrary, it could
create the impression that non-conventional indications are not relevant for
their use. This is counterproductive for controlled and specific use of
medication.
The warning is not suitable in the current edition (requirement
of proportionality). Now that the warning in the current edition could be
interpreted as being aimed against nonallopathic medicine as such, it goes
further than necessary and is disproportionate in the strict sense.
The Commission's proposal to amend the mention to "homeopathic
medicinal product without medical claim" does not really solve this problem.
A consequence of recognising the freedom of choice of therapy and the adoption
of the resolution should be that the clause on the label either lapses or is
amended to read "Homeopathically (anthroposophically) manufactured
medicinal product registered without indications".
For simplified registration, Article 8 requires the submission
of documents on how the homeopathic stocks are obtained and controlled and a
bibliography in which the homeopathic nature is justified.
With reference to the reasons given in Paragraph 5.2., it must
be possible to read "anthroposophic" for "homeopathic" here
as well.
Equal treatment is particularly relevant to the bibliography
with which the "homeopathic" nature of the stocks and procedures is
substantiated. The homeopathic nature of specifically anthroposophic medicinal
products cannot always be proven by a bibliography, whereas their anthroposophic
nature can be demonstrated very well with a bibliography (some seven hundred
monographs of anthroposophical medicinal products exist already in Germany today),
at least this would be an appropriate requirement.
A restriction to the specifically homeopathic bibliography is
not proportionate and consequently also discriminating without justification. To
prevent a restrictive interpretation of the Directive, reference to the "anthroposophic
nature" must be allowed in the text of the Directive.
The European Parliament, and subsequently the Commission, did
take the anthroposophic documents and bibliography into account in the design
phase of the Directive [61]. In principle, the amendment in question could be
adopted.
In Article 9, paragraph 2 too anthroposophic medicine should
be treated in the same way as homeopathic medicine. In its amendment
recommendations, the Commission implemented this equal treatment by demanding
the involvement of appropriate experts in homeopathic and anthroposophic
medicine [62] . The Commission's suggestion for Article 9, paragraph 2, which
does justice to the freedom of therapy and unique nature of anthroposophic
medicine, should be adopted in order to prevent unequal treatment in the
application of the Directive.
This Directive does not need to be discussed separately. The
comments concerning Directive 92/73/EEC are applicable mutatis mutandis to
Directive 92/74/EEC.
In order to do justice to the position of anthroposophic
medicinal products and to resolve the respective legislative shortcomings of
Directives 92/73/EEC and 92/74/EEC (contravention of the principles of equality
and proportionality), the following amendments are proposed:
- Into Article 1 a third paragraph is inserted, reading: "in
the application of this Directive anthroposophic medicinal products are to be
treated in the same way as homeopathic medicinal products".
- A new fourth paragraph is added to Article 1:"Where
this or other articles refer to 'homeopathic', it must also be taken to
refer to 'anthroposophic"'.
- The clause "they are administered orally or externally"
is deleted in Article 7, paragraph 1.
- In Article 7, paragraph 1, the clause "in particular, the
medicinal product may not contain more than one part per 10,000 of the mother
tincture" is deleted and the article is amended editorially.
- In Article 7, paragraph 2, the following clause is deleted: "-"homeopathic medicinal product without approved
therapeutic indications";" Or should read: " - " homeopathically manufactured medicinal product
registered without indications". As a consequence of the becond reconnnendation the mention
"anthroposophically manufactured medicinal product registered without
indications" should also be allowed.
- In Articles 7, paragraph 2 (labelling) and Article 8 (documents/bibliography)
in particular - in as far as this is still necessary in view of proposed
amendment 2 (above) - the words 'homeopathic' are replaced each time by 'homeopathic
or anthroposophic' (or in as far as is applicable by 'homeopathic/anthroposophic').
- The adoption of the Commission's amendment suggestion
concerning Article 9, paragraph 2 as mentioned in its Report "Homeopathic
Medicinal Products" dated 14 July 1997.
- Official Journal L297, page 8, 1992/10-13
- The facts concerning anthroposophic medicine in
this legal opinion were supplied by the IVAA.
- See also the reference work of this movement "Grundlegendes
fiir eine Erweiterung der Heilkunst nach geisteswissenschaftlichen
Erkenntnissen" (1925), translated as "Extending Practical Medicine",
London 1996, by Dr Rudolf Steiner and Dr Ita Wegman.
- See the extensive study by Dr Helmut Kiene, Komplementdr
Medizin - Schulmedizin, Schattauer Verlag GmbH, Stuttgart 1994
- See the Commission Report COM (97) 362, page 1
- See the presentation of Dr Robert Kempenich (IVAA)
to the European Parliament on 14 June 1995 (Procomed report) for more detailed
information on anthroposophic medicine and footnote 3.
- Official Journal EC no. C108 dated 1 May 1990, page 10.
- Official Journal EC no. C332 dated 13 December 1990, page
29.
- Official Journal EC no. C183 dated 15 July 1991, page 318.
- Number 28 in the Official Journal.
- Official Journal EC no. C244 dated 19 September 1991, page
8.
- Official Journal EC no. C241 dated 21 September 1992, page
93.
- COM (97) 362.
- Communicated to Arbaret & Associé
s International
- For this section, see the literature: J. Schwarze, European
administrative law, Office for official publications of the European
Communities, Sweet & Maxwell, 1992; P.G.J. Kapteyn, P. VerLoren van
Themaat, et al, Inleiding tot het recht van de Europese Gemeenschappen na
Maastricht, Kluwer, 1995 (Introduction to the law of the European
Communities, eng. ed. L. Gromley, 1989); N. Emiliou, The Principle of
Proportionality in European Law, Kluwer 1996; N.E. Bracke, Voorwaarden voor
goede EG-wetgeving, Thesis University of Amsterdam, SDU 1996.
- ECJ, case 294/83 Les Verts I [19861 ECR 1339 and Case 44/79
Hauer [1979] ECR 3746. ECR = Reports of cases before the ECJ.
- See Schwarze, pages 1400-1416.
- ECJ, case 24/62 Germany vs EC [19631 ECR 135; Case 122/78
Buitoni [1979] ECR 677; Case 77/81 Zuckerfabrik Franken [19821 ECR 681; Case
250/84, Eridania [19861 ECR 117.
- Plato, 558c (Politeia) and 757b (Nomoi) and Aristotle,
Ethica Nicomacheia, V.5-8. Ulpianus, Digests 1.1.10.
- Cases 117/76 and 16/77 Ruckdeschel [19771 ECR 1753; Cases
124/76 and 20177 Moulin SA [19771 ECR 1753 and 1812; Case 125/77 Royal
ScholtenHonig N.V. [19781 ECR 1991; Case 59/83 SA Biovilac [19841 ECR 4057;
Case 201 & 202/85 Klench [19861 ECR 3477.
- Ferwerda [19801 ECR 617.
- See Schwarze, pages 633-636 and 638-640.
- See Advocate-General Capotorti in Cases 83 and 94/76 and
40/77 Bayerse HNL [19781 ECR 1209, at page 1230, Schwarze, page 719 and
further: ECJ, case 8/55 Fé dé
char [1954-1956] ECR 292; Case 11/70 Intemationale Handelsgesellschaft
[1970] ECR 1125; Case 114/76 Bela Mühle [1977] ECR 1211; Case 66/82
Framancais [183] ECR 395; Case 331/88 Fedesa [1990] ECR I-4023; Case 44/79
Hauer [1979] ECR 3727; Schwarze, pages 863-864, and Emiliou, chapters 4 and
5, pages 115-192.
- Schwarze, pages 677-866, esp. pages 716-718; see also the
monography on proportionality by Emiliou.
- Schwarze, pages 854-860; Emiliou, pages 191-194.
- Annex 1 to Part A of the "Conclusions of the
Presidency", European Council in Edinburgh, 11-12 December 1992, pages
4 et seq.; Emiliou, pages 140-142.
- Emiliou, pages 192-193.
- H.J.J. Leenen, J.K.M. Gevers and G. Pinet, The
Rights of Patients in Europe, a comparative study, WHO/Kluwer Law and
Taxation Publishers 1993.
- Leenen et al, page ix.
- Leenen et al, page 28.
- ECHR 26 March 1985, X and Y vs the Netherlands, Series A
vol. 91.
- Case 29/69 Stauder [1969] ECR 419; Case 4/73 Nold II [1974]
ECR 491; Case 44/79 Hauer [19791 ECR 3727; Case 227/88 Hoechst [1989] 2859
with an explicit reference to the European Convention; Case 36/75 Rutili
[19751 ECR 1219.
- Tijdschrift voor Gezondheidsrecht 1994, pages 275-278.
- (loc.cit. page 279).
- Tijdschrift voor Gezondheidsrecht 1997, pages 96-102.
- Advice 2/94 of the ECJ of 28 March 1996.
- See the Explanatory Report, Doc CM (96) 175 reviseted 2,
page 5; H.D.C, Roscam Abbing, Health Law and the European Union, Eur.
Journal of Health Law 1994, pages 123-126, and Human rights and medicine. A
Council of Europe Convention, Eur. Journal of Health Law 1996, pages
201-205, esp. 201.
- See paragraph 4.2.
- Protocol, page 63.
- DOC-NE\RR\322\322066.
- See Lannoye report, Chapter 5, second paragraph
- See preamble of Directives 92173 and 74, first
consideration.
- Preamble loc.cit.; also compare ECJ, case 103 and 145/77,
Royal ScholtenHonig [19781 ECR 2037.
- See paragraph 4.4. above.
- See paragraph 4.3. above.
- See paragraph 4.2. above.
- See paragraph 2. 1. above.
- See paragraph 4.4.
- See paragraphs 2.4. and 2.5. above.
- See the Lannoye Report on German legislation (see paragraph
4.5. above).
- See paragraph 5.3. above.
- Supra footnote 12, Commission Report, page 5.
- See paragraph 5.1.
- Commission Report, loc.cit.
- See paragraph 2.3.
- See the recommendation at the end of paragraph 2. 1.
- See paragraph 5.2.
- Official Journal no C 241, dated 21 September 1992, page
94, amendement no.
- This is confirmed by some sevenhundred monographs that have
been accepted by the 'Kommision C' in Gennany in the context of the
statutory registration of medicinal products. These include therapeutic
indications for anthroposophic medicinal products.
- Case 227/82 Van Bennekom [1983] ECR 3883; Case C-112/89
Upjohn [1991] ECR I: 1703.
- See paragraph 2.4. above.
- See paragraph 2.5. above
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Anthroposophic
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