31. 12. 90 Official Journal of the European Communities No C 332/29 
Opinion on the proposal for a Council Directive widening the scope of Directives 
65/65/EEC and 75/319/EEC on the approximation of the laws of the Member States 
on medicinal products and laying down additional provisions on homeopathic medicinal 
products (x) 
(90/C 332/07) 
On 5 April 1990 the Council decided, in accordance with Article 100A of the Treaty 
establishing the European Economic Community, to consult the Economic and Social Com­
mittee on the abovementioned proposal. 
The Section for Industry, Commerce, Crafts and Services, which was responsible for preparing 
the Committee's work on the subject, adopted its Opinion on 5 September 1990. The 
Rapporteur was Mr. Rolao Goncalves. 
At its 279th plenary session (meeting of 19 September 1990), the Economic and Social 
Committee adopted the following Opinion unanimously. 
1. Introduction 
1.1. While eschewing value judgements, either absol­
ute or relative, on the principles governing allopathic 
or homeopathic medicine, it is nevertheless the case 
that homeoapathic medicine has been used to treat 
human beings in several Member States for at least two 
centuries. Nowadays the percentage of the population 
accepting this form of medicine ranges from 18% in 
some countries to 75 % in others. 
1.2. Over the last few years, there has been excessive 
substitution of 'natural' products by 'synthetic' prod­
ucts, sometimes because there has been no alternative, 
sometimes on economic grounds not always compatible 
with ensuring the quality of life. Possibly in reaction 
to this, there has recently been increased demand for 
traditional and old-fashioned practices and products 
adapted to the modern day, such as homeopathy and 
homeopathic medicines. 
1.3. It is not easy for the man in the street to dis­
tinguish between what is 'genuine' and what is 'fake', 
between qualified practitioners and opportunists, par­
ticularly in the health sector, where the psychological 
dimension plays a significant role in a patient's suffer­
ing. The patient therefore has the right to expect that 
the State, as guardian of public welfare, should take 
responsibility for sorting things out. 
1.4. Consequently, as in other sectors, there is a need 
to take steps to guarantee consumers—in this case 
patients—the requisite safety in terms of both the actual 
treatment, and impeccable quality of the medicines 
used. Likewise, the consumer should have access to this 
form of medicine throughout the Community, in line 
with the principles of free circulation of goods. 
1.5. Various Member States have already legally 
recognized the importance of this issue, but have dealt 
with it in quite different ways: West Germany has drawn up a separate pharmacopoeia to cover it, France 
has included it in its official pharmacopoeia and has, 
furthermore, adopted special authorization procedures 
and monographs for homeopathic preparations; Britain 
has incorporated legislation on homeopathic medicines 
into the medicines act. 
2. Principles of a proposal 
2.1. While maintaining the neutrality of Community 
rules, and without interfering in an individual Member 
State's decision to accept or reject homeopathy, the 
proposal seeks to align legislation within the Com­
munity governing the free circulation of homepathic 
remedies for human use; this is to be done at the highest 
level of health, safety, environmental and consumer 
protection. 
2.2. On the basis of Article 100A of the Treaty 
establishing the European Economic Community, the 
proposal seeks to extend the scope of current legislation 
on medical products (Directives 65/65/EEC and 
75/319/EEC) to cover homeopathic products also. 
2.3. At the same time, it introduces a simplified 
registration procedure for homeopathic medicines 
which are considered safer because of their high degree 
of dilution, the way they are administered (i.e. not 
injected), and the lack of specific (therapeutic) indi­
cations. For other products, however, the existing 
arrangements for allopathic or traditional medicines 
will continue to apply. In any case, the simplified regis­
tration process will be aligned throughout the Com­
munity. 
(*) OJ No C 108, 1. 5. 1990, pp. 10-13. 2.4. For magistral preparations prescribed by home­
opathic practitioners, the same principles apply as for 
No C 332/30 Official Journal of the European Communities 31. 12. 90 
allopathic medicine equivalents; this covers a high pro­
portion of the homeopathic pharmacopoeia. 
2.5. No provisions have been made for revising the 
registers already in existence on the date the Directive 
comes into force; these registers will still apply only to 
those Member States employing them. 
3. General comments 
3.1. The Committee welcomes the proposal, subject 
to the following comments. 
3.2. The Committee fully understands the difficulties 
involved in aligning legislation on homeopathic prac­
tices in general and the different schools of homeopathy 
in particular. It does, however, feel that the goals of 
the proposed Directive would be much better served if 
steps were taken to secure convergence of views leading 
to a joint, non-restrictive agreement on homeopathic 
practices. 
3.3. The Committee likewise considers that the com­
pilation of a European homeopathic pharmacopoeia 
should be encouraged, under the auspices of the Council 
of Europe, so as to bring these remedies under the 
general rules on medicines and thus guarantee 
maximum consumer protection. Given that the hope of 
a cure is both a right and a positive aid to recovery, a 
patient should be able to feel confident about a medical 
process and the medicines used because the good quality 
and safety of both are guaranteed, particularly as 
regards possible side-effects. 
3.4. The Committee thinks that the rules on the 
distribution of homeopathic medicines in the broadest 
sense should be fully clarified, and in line with the rules 
for allopathic medicines. 
3.5. The Committee also considers that rules on 
labelling and accompanying literature should be the 
same for all medicines of whatever type, the only accept­
able exception being for medicines approved under the 
simplified registration procedure; in this case thera­
peutic indications may not be given for these medicines. 
3.6. Moreover, the Committee feels it must point 
out that inconsistencies might appear in the assessment 
(for the purposes of the general approval procedure) of 
therapeutic effects of homeopathic medicines, because 
the assessment is geared to allopathic medicine and is 
carried out by allopathic doctors. The possibility of 
testing homeopathic medicines according to the prin­
ciples underlying the practices of the homeopathic 
school should be considered; these medicines are after 
all intended for the practice of homeopathy. 3.7. The Committee believes that failure to solve 
problems relating to (a) homeopathic practices, (b) 
official recognition of homeopaths' legal right to pre­
scribe homeopathic medicines and (c) the distribution 
of these medicines, could jeopardize the intended objec­
tive of this proposal, namely the free circulation of 
homeopathic medicines. 
3.8. The Committee notes that since there is no 
provision for back-dating, the proposed Directive will 
not cover current registers for products on sale in 
member States which have approved them. It does, 
however, agree with the Commission's approach, i.e. 
that, from the date the Directive enters into force, 
free circulation of homeopathic products outside these 
member States throughout the Community will be auth­
orized only if these products are on registers which 
have been compiled on the basis of principles adopted 
in line with the present proposal. 
4. Specific comments 
4.1. Recital 
The Committee believes that the last recital would be 
clearer if the following 2 recitals were added: 
'Whereas, having regard to the specific character­
istics of these medicinal products, such as their very 
low content of active principles, it is difficult to 
apply to them the conventional methods used for 
clinical trials on allopathic medicines;' 
'Whereas it is appropriate to introduce simplified 
registration arrangements for those traditional 
homeopathic medicinal products which do not pre­
sent a risk for patients and are placed on the market 
without specific therapeutic indications.' 
4.2. Article 1 
First paragraph 
While endorsing the thrust of the definition, the Com­
mittee queries its validity in those Member States whose 
pharmacopoeia does not cover this sector; it reiterates 
the need for measures to encourage the compilation of 
the European homeopathic pharmacopoeia, as 
mentioned in point 3.2. 
In order to avoid misinterpretation, in the French ver­
sion the phrase 'd'un Etat membre' should be replaced 
by 'd'un des Etats membres'. 
Second paragraph 
The Committee holds the view that, in the interests of 
using the more precise technical term, the expression 
'by successive dilutions' should be replaced by 'by sue-
31. 12. 90 Official Journal of the European Communities No C 332/31 
cessive decimal, centesimal and millesimal dilutions', so 
as to guarantee to the consumer that the concentration 
marked on the labelling is correct. 
4.3. Article 7(1) 
First indent 
Amend to read:'—they are administered orally, rectally 
or externally;'. 
4.4. Article 7(1) 
Third indent 
The Committee is surprised at the lack of scientific 
accuracy in determining the minimum dilution limit 
(1:1 000 000), in view of the considerable variety of the 
active principles used and therefore the wide variations 
in toxicity limit values. While understanding the aim 
of the proposal here, the Committee recommends that 
this indent be replaced by the following text, or one 
equivalent in meaning: 
'—there is a sufficient degree of dilution to guaran­
tee the safety of the preparations, i.e. if the prep­
aration contains less than one part per million of 
any active principle, which, when used in medicines, 
requires a medical prescription. If the concentration 
is higher, the simplified registration procedure can 
still be used, as long as the above requirements 
are met, but the competent licensing authority can 
require appropriate written toxicological evidence 
of the medicine's safety.' 
Article 7(2) 
Except where there are therapeutic indications (home­
opathic medicines can only be authorized according to 
Done at Brussels, 19 September 1990. the simplified registration procedure if they have no 
therapeutic indications), the Committee feels that label­
ling rules for homeopathic products should be identical 
(cf. point 3.4). For this reason, ti considers it essential 
to replace the restriction 'and no other information' at 
the end of the fourth line by 'at the very least'. The 
Committee feels that consumer information should not 
be limited without good reason; on the contrary, manu­
factures should be urged to provide as much infor­
mation as possible. 
4.5. Article 8 
The expression 'batch-to-batch consistency' (fifth line) 
is rather ambiguous; it should be replaced by 'sustained 
consistency of batch-to-batch characteristics'. 
4.6. Article 9(1) 
In line with earlier comments (in particular points 3.4 
and 4.3), it is necessary to add, at the end of the 
paragraph, 'and also the provisions of Directive ... (on 
the labelling and literature accompanying homeopathic 
medicines).' 
Article 9(2) 
The thrust of this derogation is contrary to the declared 
aim of aligning tests, and is only acceptable as a tempor­
ary measure since it might otherwise create discrimi­
nation in the medium term. 
The Chairman 
of the Economic and Social Committee 
Alberto MASPRONE