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European Court of Human Rights
You are here: BAILII >> Databases >> European Court of Human Rights >> CANTONI v. FRANCE - 17862/91 [1996] ECHR 52 (15 November 1996)
URL: http://www.bailii.org/eu/cases/ECHR/1996/52.html
Cite as: ECLI:CE:ECHR:1996:1115JUD001786291, CE:ECHR:1996:1115JUD001786291, [1996] ECHR 52
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In the case of Cantoni v. France (1),
The European Court of Human Rights, sitting, pursuant to
Rule 51 of Rules of Court A (2), as a Grand Chamber composed of the
following judges:
Mr R. Ryssdal, President,
Mr R. Bernhardt,
Mr Thór Vilhjálmsson,
Mr F. Gölcüklü,
Mr L.-E. Pettiti,
Mr S.K. Martens,
Mr I. Foighel,
Mr J.M. Morenilla,
Sir John Freeland,
Mr A.B. Baka,
Mr M.A. Lopes Rocha,
Mr L. Wildhaber,
Mr G. Mifsud Bonnici,
Mr J. Makarczyk,
Mr D. Gotchev,
Mr P. Jambrek,
Mr K. Jungwiert,
Mr P. Kuris,
Mr E. Levits,
and also of Mr H. Petzold, Registrar, and Mr P.J. Mahoney, Deputy
Registrar,
Having deliberated in private on 28 March, 28 August and
22 October 1996,
Delivers the following judgment, which was adopted on the
last-mentioned date:
_______________
Notes by the Registrar
1. The case is numbered 45/1995/551/637. The first number is the
case's position on the list of cases referred to the Court in the
relevant year (second number). The last two numbers indicate the
case's position on the list of cases referred to the Court since its
creation and on the list of the corresponding originating applications
to the Commission.
2. Rules A apply to all cases referred to the Court before the entry
into force of Protocol No. 9 (P9) (1 October 1994) and thereafter only
to cases concerning States not bound by that Protocol (P9). They
correspond to the Rules that came into force on 1 January 1983, as
amended several times subsequently.
_______________
PROCEDURE
1. The case was referred to the Court by the European Commission
of Human Rights ("the Commission") on 29 May 1995, within the
three-month period laid down by Article 32 para. 1 and Article 47
(art. 32-1, art. 47) of the Convention for the Protection of
Human Rights and Fundamental Freedoms ("the Convention"). It
originated in an application (no. 17862/91) against the French Republic
lodged with the Commission under Article 25 (art. 25) by a
French national, Mr Michel Cantoni, on 26 November 1990. Mr Cantoni
was designated by the initials "M.C." in the proceedings before the
Commission, but he subsequently consented to the disclosure of his
identity.
The Commission's request referred to Articles 44 and 48
(art. 44, art. 48) and to the declaration whereby France recognised the
compulsory jurisdiction of the Court (Article 46) (art. 46). The
object of the request was to obtain a decision as to whether the facts
of the case disclosed a breach by the respondent State of its
obligations under Article 7 of the Convention (art. 7).
2. In response to the enquiry made in accordance with
Rule 33 para. 3 (d) of Rules of Court A, the applicant stated that he
wished to take part in the proceedings and designated the lawyers who
would represent him (Rule 30).
3. The Chamber to be constituted included ex officio
Mr L.-E. Pettiti, the elected judge of French nationality (Article 43
of the Convention) (art. 43), and Mr R. Bernhardt, the Vice-President
of the Court (Rule 21 para. 4 (b)). On 8 June 1995, in the presence
of the Registrar, the President of the Court, Mr R. Ryssdal, drew by
lot the names of the other seven members, namely Mr B. Walsh,
Mr I. Foighel, Mr M.A. Lopes Rocha, Mr L. Wildhaber,
Mr G. Mifsud Bonnici, Mr J. Makarczyk and Mr P. Jambrek (Article 43 in
fine of the Convention and Rule 21 para. 5) (art. 43).
4. As President of the Chamber (Rule 21 para. 6), Mr Bernhardt,
acting through the Registrar, consulted the Agent of the
French Government ("the Government"), the applicant's lawyers and the
Delegate of the Commission on the organisation of the proceedings
(Rules 37 para. 1 and 38). Pursuant to the order made in consequence,
the Registrar received the Government's memorial on 19 and
26 January 1996 and the applicant's memorial also on 26 January 1996.
5. On 21 February 1996 the Chamber decided, in view of a request
made by the Government, to relinquish jurisdiction forthwith in favour
of a Grand Chamber (Rule 51). In accordance with Rule 51 para. 2 (a)
and (b), the Grand Chamber comprised as ex officio members the
President and the Vice-President of the Court (Mr Ryssdal and
Mr Bernhardt) together with the full members and the four substitutes
of the original Chamber, the latter being Mr Thór Vilhjálmsson,
Mr F. Gölcüklü, Mr R. Macdonald and Mr J.M. Morenilla. On
24 February 1996 the names of the additional seven judges were drawn
by lot by the President, in the presence of the Registrar, namely
Mr S.K. Martens, Mr F. Bigi, Sir John Freeland, Mr A.B. Baka,
Mr D. Gotchev, Mr P. Kuris and Mr E. Levits. Thereafter
Mr K. Jungwiert replaced Mr Macdonald, who was unable to take part in
the hearing (Rules 22 para. 1 and 24 para. 1). Subsequent to the
hearing Mr Bigi died and Mr Walsh was unable to take part in the
further consideration of the case.
6. In accordance with the President's decision, the hearing took
place in public in the Human Rights Building, Strasbourg, on
26 March 1996. The Court had held a preparatory meeting beforehand.
There appeared before the Court:
(a) for the Government
Mr M. Perrin de Brichambaut, Director of
Legal Affairs, Ministry of Foreign Affairs, Agent,
Mr J. Lapouzade, administrative court judge
on secondment to the Legal Affairs Department,
Ministry of Foreign Affairs,
Ms H. Sainte-Marie, Adviser, Health Department,
Pharmaceutical Section, Ministry of Labour
and Social Affairs, Advisers;
(b) for the Commission
Mr J.-C. Soyer, Delegate;
(c) for the applicant
Ms E. Monegier du Sorbier, avocate
at the Paris Court of Appeal,
Mr Y. Capron, avocat at the Conseil d'Etat
and the Court of Cassation,
Ms I. Jamnet, avocate at the Paris Court of Appeal, Counsel.
The Court heard addresses by Mr Soyer, Ms Monegier du Sorbier
and Mr Perrin de Brichambaut, and their answers to a question put by
a judge.
AS TO THE FACTS
I. Particular circumstances of the case
7. Mr Michel Cantoni, a French national who was born in 1947, is
the manager of a supermarket owned by the Euromarché chain at
Sens (Yonne).
A. The proceedings in the Sens Criminal Court
8. In 1988 criminal proceedings were brought, at the instigation
of the Yonne Pharmacists' Association and several individual
pharmacists, against the applicant and other managers of supermarkets
in the region for unlawfully selling pharmaceutical products. He had
sold in his shop aqueous eosin at 1% strength, 70% strength modified
alcohol, 10-volume hydrogen peroxide, vitamin C (tablets of 500mg and
sachets of powder of 1000mg), inhalations made out of plant essences,
pocket inhalers, antiseptic sprays and mineral supplements.
In their defence the applicant and his fellow accused
maintained that the products in question were not medicinal products
within the meaning of Article L. 511 of the Public Health Code
(see paragraph 18 below) and were accordingly not covered by the
pharmacists' monopoly.
9. On 30 September 1988 the Sens Criminal Court found the
applicant guilty as charged, fined him 10,000 francs and ordered him
to pay damages of 1 franc to each of the civil parties. After
considering the products in question individually, it took the view
that they were medicinal products, in some cases on account of their
function and in others on account of their presentation
(see paragraph 19 below).
B. Proceedings in the Paris Court of Appeal
10. On 18 May 1989 the Paris Court of Appeal upheld the
first-instance judgment, on the following grounds:
"It is necessary to examine each of the products marketed
listed above in order to determine whether or not they are
medicinal products ...:
(1) BIO-OLIGO with trace elements
At the bottom of the cardboard packaging for the
36-capsule bottles is to be found the indication 'Yeast
enriched with minerals', 'dietary supplement'.
The back of the cardboard packaging carries the following
text:
'Introduction:
Recent research shows that the earth is losing minerals, while
our bodies' need for these 'new vitamins' of the
twentieth century is greater than before.
[C.] Laboratories produce a range of products specially
enriched with minerals to make up for these deficiencies in
our diet.'
The analysis in grammes for every 100g states:
Protein 50
Fat 6
Carbohydrate 36
Vitamin B1 30
Vitamin B6 4
Energy value 398Kcal/1667KJ
The analysis also indicates, as applicable, the levels of
copper, zinc or calcium to be the following:
On the bottle of zinc capsules, 'Zinc 3000'.
On the bottle of copper capsules, 'Copper 4'.
On the bottle of calcium capsules, 'Calcium 50'.
Furthermore, there is a precise indication of how each of
these elements is supposed to help the human body:
(a) zinc aids reproduction and sexual development; 'it helps
the body to fight infection more effectively';
(b) copper 'activates our systems of defence against infection
- helps combat inflammation'; and
(c) calcium is 'essential for strong bones - it also improves
the circulatory nervous system'.
The dosage, which depends on whether the capsules contain
zinc, copper or calcium is then given, under the heading:
'Directions for use'.
The back of the cardboard packaging carries the mention, at
the bottom, '[C.] Laboratories PARIS', after specifying that
this laboratory has 'been advised by Dr P. W.', an
oligotherapist (sic).
Therefore, these products, which contain an amalgam of various
different substances, are presented as capable of contributing
to the prevention or cure of human diseases.
They are medicinal products within the meaning of the
above-mentioned legislation.
(2) 70% STRENGTH MODIFIED ALCOHOL 120 ML is sold in
120ml bottles. The label bears the above words and, in the
bottom left-hand corner, on a blue and green background,
four small white squares in the shape of a cross, irresistibly
evoking the image of a pharmacist's sign. To the right of
this, in large white letters on the same blue and
green background, the name '[V.] Laboratories, PARIS' appears
with, in smaller letters, its address.
The product in question smells strongly of camphor.
Thus the way in which this product is presented - the bottle,
and the cross alongside the name '[V.] Laboratories' -
suggests that it is in fact the pharmaceutical product well
known by that name and which is used as an antiseptic,
particularly in surgery. Therefore, by virtue of its
presentation, this is also a medicinal product and not simply
a hygiene or beauty product.
(3) 120ml BOTTLE OF 10-VOLUME HYDROGEN PEROXIDE. This bears
the words 'do not swallow' and 'in the event of contact with
the eyes, rinse immediately'. It has the same white cross and
words '[V.] Laboratories PARIS' as the modified alcohol
mentioned above, on a pale blue and darker blue background.
For the same reasons, it evokes the medicinal product known by
that name. This is another medicinal product by virtue of its
presentation, which distinguishes it from a mere hygiene or
beauty product.
(4) 'VITAMIN (500)' is sold in cardboard packets of
24 chewable tablets, on which is printed: (a) the white cross
described above and the name '[V.] Laboratories PARIS', on a
yellow and orange background; (b) the recommended dosage,
specifying that vitamin C should not be taken at the end of
the day; and (c) the composition of each tablet, namely:
coated ascorbic acid and sodium ascorbate (with an indication
of the quantities); and the excipient, a compound of several
substances.
This is also a medicinal product, at least by virtue of its
presentation, since there is nothing to distinguish it from a
genuine pharmaceutical product which has had to meet the
required standards in terms of dosage, quality control and
production. It is of little importance whether the
medicinal product really has the effect claimed or not; on the
other hand, there are known contra-indications to the
excessive use of vitamin C."
C. Proceedings in the Court of Cassation
11. Mr Cantoni appealed to the Court of Cassation on points of law.
He complained in particular that there had been a violation of
Article 7 para. 1 of the Convention (art. 7-1) and of Articles L. 511,
L. 512 and L. 517 of the Public Health Code (see paragraph 18 below).
He contended that, especially when applied to parapharmaceutical
products, the notion of medicinal product, as defined in the provisions
on which his conviction had been based, was not sufficiently clear to
enable him to determine with accuracy what acts would incur criminal
liability.
On 29 May 1990 the Criminal Division of the Court of Cassation
dismissed the appeal in the following terms:
"... the appellate court held, referring to the wording on the
cardboard packaging and bottles containing the above-mentioned
products, that these products were presented as being capable
of contributing to the prevention and cure of human diseases
and that, therefore, they constitute medicinal products within
the meaning of Article L. 511 of the Public Health Code.
The Court of Appeal thus gave a proper legal basis for its
decision without laying itself open to the complaints put
forward ... The provisions of Article L. 511 of the
Public Health Code ... are not contrary to the principle that
only the law can define a criminal offence and prescribe a
penalty; nor are they incompatible with the instruments
referred to in the grounds of appeal ..."
II. Relevant community and domestic law
A. Community law
1. Directive 65/65 of 26 January 1965
12. According to Article 1 of the Community Directive of
26 January 1965 (Directive EEC 65/65, OJ no. L. 369 of
9 February 1965), as amended on several occasions:
"... the following shall have the meanings hereby assigned to
them ...
2. Medicinal product:
Any substance or combination of substances presented for
treating or preventing disease in human beings or animals.
Any substance or combination of substances which may be
administered to human beings or animals with a view to making
a medical diagnosis or to restoring, correcting or modifying
physiological functions in human beings or in animals is
likewise considered a medicinal product."
2. Case-law of the Court of Justice of the European Communities
13. The Court of Justice of the European Communities has received
several references for preliminary rulings concerning the
interpretation of that definition. In its Van Bennekom judgment of
30 November 1983 (case 227/82 [1983] ECR 4 3883), it held as follows
in respect of vitamin preparations:
"It is ... necessary to take the view that a product is
'presented for treating or preventing disease' within the
meaning of Directive 65/65 not only when it is expressly
'indicated' or 'recommended' as such, possibly by means of
labels, leaflets or oral representation, but also whenever any
averagely well-informed consumer gains the impression, which,
provided it is definite, may even result from implication,
that the product in question should, regard being had to its
presentation, have an effect such as is described in the
first part of the Community definition.
In particular the external form given to the product in
question - such as that of a tablet, pill or capsule - may in
this connection serve as strong evidence of the seller's or
manufacturer's intention to market that product as a
medicinal product. Such evidence cannot, however, be the sole
or conclusive evidence, since otherwise certain food products
which are traditionally presented in a similar form to
pharmaceutical products would also be covered.
... substances such as the vitamin preparations in issue,
which are not 'indicated or recommended' expressly as being
suitable for curing, treating or preventing an infection, may
nonetheless constitute substances 'presented for treating or
preventing disease' within the meaning of the
Community definition of 'medicinal products' contained in
Directive 65/65.
...
It is ... apparent from the file and from the observations
submitted to the Court, taken as a whole, that it is
impossible in the present state of scientific knowledge to
state whether the criterion of concentration alone is always
sufficient in order to be able to determine whether a
vitamin preparation constitutes a medicinal product; still
less therefore is it possible to specify the level of
concentration above which such a vitamin preparation would
fall within the Community definition of a medicinal product.
The answer to be given to the national court should therefore
be that the classification of a vitamin as a medicinal product
within the meaning of the second part of the definition in
Directive 65/65 must be carried out case by case, having
regard to the pharmacological properties of each such vitamin
to the extent to which they have been established in the
present state of scientific knowledge." (paragraphs 18-20 and
28-29)
14. The Court of Justice has confirmed this approach on several
occasions, clarifying certain points. Thus in its Delattre judgment
of 21 March 1991 (C-369/88 [1991] ECR 1487), concerning
eleven different products, including slimming products and preparations
to combat tiredness, it stated:
"... a product may be regarded as a medicinal product by
virtue of its presentation if its form and the manner in which
it is packaged render it sufficiently similar to a
medicinal product and, in particular, if on its packing and
the information provided with it reference is made to research
by pharmaceutical laboratories or to methods or substances
developed by medical practitioners or even to testimonials
from medical practitioners commending the qualities of the
product in question. A statement that a product is not a
medicinal product is persuasive evidence which the
national court may take into consideration, but it is not in
itself conclusive." (paragraph 41)
15. In the Monteil and Samanni judgment of 21 March 1991
(60/89, [1991] ECR 1 1547), concerning 2% strength eosin and
70% strength modified alcohol, the Court of Justice held:
"... the concept of 'presentation' of a product must be
broadly construed and a product is 'presented for treating or
preventing disease' within the meaning of Directive 65/65 not
only when it is expressly 'indicated' or 'recommended' as
such, possibly by means of labels, leaflets or
oral representation, but also whenever any averagely
well-informed consumer gains the impression, which, provided
it is definite, may even result from implication, that the
product in question should, having regard to its presentation,
have the properties in question.
... the external form given to the product in question may
serve as strong evidence, but is not the sole or conclusive
evidence; it must be stated that the 'form' must be taken to
mean not only the form of the product itself but also that of
its packaging, which may, for reasons of marketing policy,
tend to make it resemble a medicinal product, and account must
also be taken of the attitude of an averagely well-informed
consumer, in whom the form given to a product may inspire
particular confidence similar to that normally inspired in him
by proprietary medicinal products, having regard to the
safeguards normally associated with the manufacture and
marketing of the latter type of product.
...
... it is for the national authorities to determine, subject
to review by the courts, whether the eosin of a strength of 2%
and modified alcohol of a strength of 70% constitute medicinal
products by virtue of their function within the meaning of the
second sub-paragraph of Article 1 (2) of Directive 65/65. In
that regard, account must be taken of the adjuvants also
entering into the composition of the product, the manner in
which it is used, the extent of its distribution, its
familiarity to consumers and the risks which its use may
entail.
...
... although in principle the member States may reserve to
pharmacists the right to make retail sales of products that
fall within the Community definition of medicinal products and
although, in those circumstances, their monopoly over those
products may be presumed to constitute an appropriate way of
protecting public health, evidence to the contrary may be
produced with respect to certain products whose use would not
involve any serious danger to public health and whose
inclusion within the pharmacists' monopoly would seem
manifestly disproportionate, that is to say contrary to the
principles laid down by the Court for the interpretation of
Articles 30 and 36 of the Treaty.
If pharmacists are granted a monopoly of other products, such
as 'parapharmaceutical products', which may be of widely
varying kinds, the need for such monopoly in order to protect
public health or the health of consumers must, regardless of
how the products concerned are classified under national law,
be established in each individual case, and those two aims
must not be obtainable by measures less restrictive of
intra-Community trade.
It is for the national court to decide, having regard to those
criteria, whether the action before it is well-founded."
(paragraphs 23-24, 29 and 43-45)
16. In the Upjohn judgment of 16 April 1991
(C-112/89 [1991] 1 ECR 1703), the Court of Justice recalled that:
"It is for the national court to determine on a case-by-case
basis the classification of each product having regard to its
pharmacological properties as they may be ascertained in the
current state of scientific knowledge, to the way in which it
is used, to the extent to which it is sold and to consumers'
familiarity with it." (paragraph 23)
17. Finally in the Ter Voort judgment of 28 October 1992
(C-219/91 [1992] ECR 5485), the Court of Justice held:
"... a product recommended or indicated as having prophylactic
or therapeutic properties is a medicinal product within the
meaning of the provisions of the first subparagraph of
Article 1 (2) of Directive 65/65, even if it is generally
regarded as a foodstuff and even if in the current state of
scientific knowledge it has no known therapeutic effect.
...
The conduct, action and approaches of the manufacturer or the
seller which disclose his intention to make the product he
markets appear to be a medicinal product in the eyes of the
averagely well-informed consumer may therefore be conclusive
for the purposes of deciding whether a product should be
regarded as a medicinal product by virtue of its
presentation." (paragraphs 21 and 26)
B. National law
1. The Public Health Code
18. At the material time, the relevant provisions of the
Public Health Code were as follows:
Article L. 511
"'Medicinal product' shall mean any substance or combination
of substances presented for treating or preventing disease in
human beings or animals and also any product which may be
administered to human beings or animals with a view to making
a medical diagnosis or to restoring, correcting or modifying
their physiological functions.
In particular, the following shall be considered as
medicinal products:
products referred to in Article L. 658-1 of this Code:
which contain any substance having a therapeutic effect as
defined in paragraph 1 above; or
containing a greater dosage or concentration of
poisonous substances than that laid down in the list referred
to in Article L. 658-5 of this Code, or containing
poisonous substances which do not appear on that list;
dietary products containing chemical or biological substances
which are not themselves foodstuffs but which are added to
dietary products, either to give them special properties which
are sought after for the purposes of dietary therapy or to
make them suitable for use in medical tests.
..."
Article L. 512
"Only pharmacists may ...:
(1) prepare medicinal products for use in the treatment of
human beings;
...
(3) sell, whether wholesale or retail, or otherwise supply
the public with such products or articles;
..."
Article L. 517
"Any person who knowingly carries out acts whose performance
is restricted exclusively to pharmacists, without being
qualified to act as a pharmacist shall be sentenced to a fine
of between FRF 2,400 and FRF 12,000 and, if the offence is
repeated, to a fine of between FRF 4,800 and FRF 24,000 and to
a term of imprisonment of between six days and six months, or
to either of these penalties."
2. Case-law
19. On the basis of the above provisions the courts have classified
products as medicinal products by virtue of their function, by virtue
of their presentation or by virtue of their composition.
20. According to the information provided to the Court, the courts
sitting as tribunals of fact are divided on the question whether the
products for whose sale the applicant was convicted are
medicinal products within the meaning of Article L. 511 of the
Public Health Code.
Thus vitamin C was classified as a medicinal product by the
Courts of Appeal of Douai (9 April 1987), Poitiers (17 December 1987),
Angers (5 May 1988) and Versailles (22 January 1996 in plenary
session). However, decisions taking a contrary view were given by the
Courts of Appeal of Douai (20 February 1988, 28 October 1988 and
23 March 1989), Angers (30 January 1989), Colmar (23 March 1988),
Dijon (15 December 1988) and Paris (23 May 1995).
70% strength alcohol was designated as a medicinal product by
the Courts of Appeal of Poitiers (4 December 1986 and 28 January 1987),
Aix-en-Provence (17 November 1987) and Colmar (23 March 1988), but not
by the Courts of Appeal of Dijon (18 May 1988 - four judgments - and
15 December 1988), Limoges (18 November 1988), Paris (14 December 1988
and 21 February 1995) and Douai (23 March 1989).
Mineral supplements (oligo-éléments) have been regarded as
medicinal products by the Courts of Appeal of Poitiers
(17 December 1987) and Angers (5 May 1988), but not by those of
Colmar (23 March 1988), Dijon (18 May and 15 December 1988), Angers
(30 January 1989) and Douai (23 March 1989).
As regards 10-volume hydrogen peroxide and 1% or 2% strength
eosin, the majority of the courts sitting as tribunals of fact consider
that these products are mere hygiene products, for example, in respect
of hydrogen peroxide, the Courts of Appeal of Colmar (23 March and
18 May 1988), Douai (28 October 1988) and Paris (14 December 1988);
and, in respect of eosin, the Courts of Appeal of Dijon (18 May 1988)
and Paris (14 December 1988 and 21 February 1995).
21. To date the Court of Cassation has always either upheld
decisions classifying a parapharmaceutical-type product as a medicinal
product (judgments of 4 April 1957, 19 February 1959, 24 July 1967,
23 November 1967, 28 May 1968, 13 April 1976, 5 May 1981,
6 December 1988 - two judgments -, 29 May 1990 - see paragraph 11 above
- and 25 May 1994), or quashed decisions refusing to accord this
designation to such products (judgments of 19 December 1989 -
three judgments -, 8 March 1990, 6 March 1992 - plenary court -,
25 May 1994 - two judgments).
PROCEEDINGS BEFORE THE COMMISSION
22. Mr Cantoni lodged his application with the Commission
(application no. 17862/91) on 26 November 1990. He complained that the
statutory definition of medicinal product lacked sufficient clarity and
precision to satisfy the requirements of Article 7 para. 1 of the
Convention (art. 7-1).
23. The Commission declared the application admissible on
10 January 1994. In its report of 12 April 1995 (Article 31)
(art. 31), it expressed the opinion, by fifteen votes to nine, that
there had been a violation of that provision (art. 7-1). The full text
of the Commission's opinion and of the dissenting opinion contained in
the report is reproduced as an annex to this judgment (1)
_______________
Note by the Registrar
1. For practical reasons this annex will appear only with the printed
version of the judgment (in Reports of Judgments and Decisions 1996-V
but a copy of the Commission's report is obtainable from the registry.
_______________
FINAL SUBMISSIONS TO THE COURT
24. In their memorial to the Court, the Government "called for the
application to be dismissed".
25. At the hearing the applicant's lawyers requested the Court to
hold that Article L. 511 of the Public Health Code "[was] not
sufficiently precise to protect the rights of individuals in France".
AS TO THE LAW
ALLEGED VIOLATION OF ARTICLE 7 OF THE CONVENTION (art. 7)
26. The applicant complained of a violation of Article 7 of the
Convention (art. 7), which is worded as follows:
"1. No one shall be held guilty of any criminal offence on
account of any act or omission which did not constitute a
criminal offence under national or international law at the
time when it was committed. Nor shall a heavier penalty be
imposed than the one that was applicable at the time the
criminal offence was committed.
2. This Article (art. 7) shall not prejudice the trial and
punishment of any person for any act or omission which, at the
time when it was committed, was criminal according to the
general principles of law recognised by civilised nations."
He maintained that the definition of medicinal product
contained in Article L. 511 of the Public Health Code was very
imprecise and left a wide discretion to the courts. The
Court of Cassation's case-law in this field was marked by arbitrariness
and a lack of certainty which were themselves directly responsible for
the conflicting classifications given to parapharmaceutical products
by the lower courts. This state of affairs still persisted and
concerned all the substances in question, whether hydrogen peroxide,
70% strength alcohol or vitamin C. The case-law of the
Court of Justice of the European Communities was not particularly
helpful because it left it to the national courts to decide on a
case-by-case basis whether a substance should be classified as a
medicinal product and referred to notions that themselves lacked
precision and were not sufficiently technical.
In short, the definition found in the legislation and the
case-law failed to afford the requisite foreseeability and
accessibility. It followed that Mr Cantoni could not reasonably have
been expected to appreciate, before putting the products in question
up for sale, what constituted the material element of the offence in
respect of which he was prosecuted.
27. The Commission in substance subscribed to the applicant's view.
It observed that, although the criteria developed by the Convention
institutions with regard to other provisions could be transposed to the
field of application of Article 7 (art. 7), that provision (art. 7)
nevertheless required that they be applied more strictly.
28. Referring to the case-law of the Court, the Government argued
that a law could be formulated in relatively general terms making it
possible for its provisions to be adapted, through the process of
interpretation, to changing situations. Even the most perfectly
drafted law required a judge to clarify its limits and Article L. 511
of the Public Health Code was no exception.
The definition given in Article L. 511 was based in particular
on extensive case-law concerning the notion of medicinal product and
was no more open to criticism than any other statutory definition.
Indeed it was actually far more precise than many of the definitions
to be found in the Criminal Code. Above all, the legislature had no
alternative but to have recourse to such a definition because to date
no more satisfactory definition of medicinal product had been
established. The only other solution - the drawing up of exhaustive
lists - was not practicable because in this field there were thousands
of different products and their number varied on an almost daily basis.
A list would therefore never correspond to the reality. Indeed this
explained why in its Directive 65/65 the Council of Ministers of the
European Economic Community had adopted the French approach, a solution
for which the majority of the States of the European Union had
subsequently opted. A finding that Article L. 511 was defective would
therefore amount to making the same finding in respect of
Directive 65/65.
In addition, the definition of medicinal product had given rise
to hardly any problems in the criminal courts until the end of the
1980s. The disputes that occurred at that time had been created
artificially and deliberately by supermarket chains. They had
succeeded in disorientating some of the lower courts, but not the
Court of Cassation, which had applied the same principles for more than
a century.
29. As the Court has already held, Article 7 (art. 7) embodies,
inter alia, the principle that only the law can define a crime and
prescribe a penalty (nullum crimen, nulla poena sine lege) and the
principle that the criminal law must not be extensively construed to
an accused's detriment, for instance by analogy. From these principles
it follows that an offence must be clearly defined in the law. This
requirement is satisfied where the individual can know from the wording
of the relevant provision (art. 7) and, if need be, with the assistance
of the courts' interpretation of it, what acts and omissions will make
him criminally liable.
When speaking of "law" Article 7 (art. 7) alludes to the very
same concept as that to which the Convention refers elsewhere when
using that term, a concept which comprises statutory law as well as
case-law and implies qualitative requirements, notably those of
accessibility and foreseeability (see, as the most recent authority,
the S.W. and C.R. v. the United Kingdom judgments of 22 November 1995,
Series A nos. 335-B and 335-C, pp. 41-42, para. 35, and pp. 68-69,
para. 33, respectively). In the present case only that last aspect is
in issue.
30. The fact, pointed to by the Government, that Article L. 511 of
the Public Health Code is based almost word for word on
Community Directive 65/65 (see paragraph 12 above) does not remove it
from the ambit of Article 7 of the Convention (art. 7).
31. As the Court has already had occasion to note, it is a logical
consequence of the principle that laws must be of general application
that the wording of statutes is not always precise. One of the
standard techniques of regulation by rules is to use general
categorisations as opposed to exhaustive lists. The need to avoid
excessive rigidity and to keep pace with changing circumstances means
that many laws are inevitably couched in terms which, to a greater or
lesser extent, are vague. The interpretation and application of such
enactments depend on practice (see, among other authorities, the
Kokkinakis v. Greece judgment of 25 May 1993, Series A no. 260-A,
p. 19, para. 40).
32. Like many statutory definitions, that of "medicinal product"
contained in Article L. 511 of the Public Health Code is rather general
(see paragraph 18 above). When the legislative technique of
categorisation is used, there will often be grey areas at the fringes
of the definition. This penumbra of doubt in relation to borderline
facts does not in itself make a provision incompatible with Article 7
(art. 7), provided that it proves to be sufficiently clear in the large
majority of cases. The role of adjudication vested in the courts is
precisely to dissipate such interpretational doubts as remain, taking
into account the changes in everyday practice.
The Court must accordingly ascertain whether in the
present case the text of the statutory rule read in the light of the
accompanying interpretive case-law satisfied this test at the relevant
time.
33. In the applicant's submission, other solutions were available
to the authorities, such as recourse to exhaustive lists of medicinal
products. It is, however, not for the Court to express a view on the
appropriateness of methods chosen by the legislature of a
Contracting State; its task is confined to determining whether they are
in conformity with the Convention.
34. Nor is the Court persuaded by the argument based on the
decisions of the lower courts cited by the applicant and concerning the
type of "borderline" product for the sale of which he was convicted.
There were indeed divergencies in the decisions of the lower courts
(see paragraph 20 above). According to the Government, these may be
explained essentially by the fact that the comparisons of decisions did
not take account of prosecutions brought in respect of different
concentrations of the products in question.
The Court notes in the first place that the applicant did not
indicate whether the decisions cited classified these products as
medicinal products by virtue of their function or by virtue of their
presentation, and, in the latter case, whether the presentation was the
same on each occasion.
Even assuming that the decisions dealt with identical cases,
the questions before the lower courts were principally questions of
fact. For the first category of decisions, concerning products
regarded as medicinal by virtue of their function, it was essentially
a matter of establishing the current state of scientific knowledge.
For the second category, that is decisions relating to products
regarded as medicinal by virtue of their presentation, the courts aimed
to gauge the impression gained by the averagely well-informed consumer.
Moreover, there is, in the Court's view, one decisive
consideration. From, at the latest, 1957 onwards the
Court of Cassation has always either confirmed the decisions of the
courts below classifying a parapharmaceutical-type product as medicinal
or quashed decisions which denied that classification. It has never
upheld a decision by a lower court finding that such a product fell
outside the notion of medicinal product (see paragraph 21 above).
Thus, well before the events in the present case, the
Court of Cassation had adopted a clear position on this matter, which
with the passing of time became even more firmly established.
35. The Court recalls that the scope of the notion of
foreseeability depends to a considerable degree on the content of the
text in issue, the field it is designed to cover and the number and
status of those to whom it is addressed (see the
Groppera Radio AG and Others v. Switzerland judgment of 28 March 1990,
Series A no. 173, p. 26, para. 68). A law may still satisfy the
requirement of foreseeability even if the person concerned has to take
appropriate legal advice to assess, to a degree that is reasonable in
the circumstances, the consequences which a given action may entail
(see, among other authorities, the Tolstoy Miloslavsky
v. the United Kingdom judgment of 13 July 1995, Series A no. 316-B,
p. 71, para. 37). This is particularly true in relation to persons
carrying on a professional activity, who are used to having to proceed
with a high degree of caution when pursuing their occupation. They can
on this account be expected to take special care in assessing the risks
that such activity entails.
With the benefit of appropriate legal advice, Mr Cantoni, who
was, moreover, the manager of a supermarket, should have appreciated
at the material time that, in view of the line of case-law stemming
from the Court of Cassation and from some of the lower courts, he ran
a real risk of prosecution for unlawful sale of medicinal products.
36. There has accordingly been no breach of Article 7 (art. 7).
FOR THESE REASONS, THE COURT UNANIMOUSLY
Holds that there has been no violation of Article 7 of the
Convention (art. 7).
Done in English and in French, and delivered at a public
hearing in the Human Rights Building, Strasbourg, on 15 November 1996.
Signed: Rolv RYSSDAL
President
Signed: Herbert PETZOLD
Registrar