Press and Information Division
PRESS RELEASE No 113/03
11 December 2003
Judgment of the Court of Justice in Case C-322/01
Deutscher Apothekerverband eV v DocMorris NV and Jacques Waterval
A NATIONAL PROHIBITION ON THE SALE OF MEDICINAL PRODUCTS BY MAIL ORDER IS
CONTRARY TO COMMUNITY LAW WHERE IT APPLIES TO NON-PRESCRIPTION MEDICINES WHICH HAVE BEEN
AUTHORISED FOR SALE ON THE GERMAN MARKET.
Such a prohibition is compatible with Community law if it applies to medicinal
products which have not been authorised in a Member State.
Deutscher Apothekerverband eV is an association whose aims include protecting and promoting the
economic and social interests of pharmacists. Its members are the federations and associations
of pharmacists in the Länder, which represent more than 19,000 pharmacists.
0800 DocMorris NV is a Netherlands pharmacy established in Landgraaf (Netherlands). Mr Waterval is
a pharmacist and one of the legal representatives of DocMorris.
Since 8 June 2000 DocMorris and Mr Waterval have been offering for sale,
at the Internet address www.0800DocMorris.com, prescription and non-prescription medicines for human use, in
languages including German, for end consumers in Germany. The medicines in question have
been authorised either in Germany or in the Netherlands.
Consumers are able, for example, to consult a group of experts at the
Internet pharmacy on health issues. They may also contact DocMorris and Mr Waterval
directly on a free telephone number or by letter.
For each of the various medicines, there is a description of the package
contents and the price is stated in euros. Alongside the notice stating any
prescription requirement applicable to a particular product, there is a box for placing
orders. Further information about the product itself may be obtained by clicking on
the product icon.
DocMorris and Mr Waterval consider a given medicinal product to be available only
on prescription where the product is regarded as a prescription-only product in the
Netherlands or in the State in which the consumer is resident. Prescription medicines
are supplied only on production of the original prescription.
Actual delivery can take place in a number of ways. The consumer may
collect the order in person from DocMorriss pharmacy in Landgraaf, a town near
the border between the Netherlands and Germany. Alternatively, he may, at no additional
cost, use a courier service recommended by DocMorris.
The Apothekerverband has challenged before the Landgericht Frankfurt am Main (Germany) the internet
sale of medicines and their delivery by international mail order. In its view,
the provisions of the Arzneimittelgesetz (German law on medicinal products, the AMG) and
the Heilmittelwerbegesetz (German law on the advertising of medicinal products, the HWG) do
not permit a business of that kind to be carried on. And the
prohibitions thus imposed do not infringe the provisions of the EC Treaty on
the free movement of goods.
First, the Court sets out its view on the provisions of the AMG
prohibiting imports of medicinal products by mail order by pharmacies authorised in other
Member States in response to individual orders placed over the internet. It finds,
first, in relation to medicinal products which have not been authorised in Germany,
that the general prohibition laid down by the AMG corresponds to a prohibition
at Community level: under the directive on the approximation of provisions laid down
by law, regulation or administrative action relating to medicinal products (replaced by the
Community Code), medicinal products must, if they are to be placed on the
market of a Member State, have been authorised either by the competent authority
of that Member State or under the Community rules. Consequently, the Court need
not consider whether the prohibitions infringe the provisions of the EC Treaty on
the free movement of goods.
Next, as regards medicinal products which have been authorised for sale on the
German market, the Court points out that a national prohibition on the sale
of medicinal products by mail order is a restriction on the free movement
of goods.
Referring to its case-law, the Court states that a rule which is likely
to have a restrictive effect on the importation of pharmaceutical products is compatible
with the Treaty only to the extent that it is necessary for the
effective protection of the health and life of humans. In the case of
non-prescription medicines, the prohibition is not justified, since it is possible that adequate
advice and information may be provided. Internet buying may even have certain advantages,
such as giving consumers time to think about any questions they may wish
to ask the pharmacist from home.
In so far as the prohibition concerns medicines available only on prescription, the
Court takes the view that allowing such medicines to be supplied on receipt
of a prescription and without any other control could increase the risk of
prescriptions being abused or incorrectly used. Furthermore, the fact that the labelling of
a medicinal product may be in a different language can have more harmful
consequences in the case of prescription medicines. Consequently, a national prohibition on mail
order sales of medicinal products available only on prescription can be justified.
Second, the Court examines the provisions of the HWG prohibiting advertising of mail
order sales of medicinal products. The Court finds that where a prohibition of
that kind applies to medicinal products which require authorisation but have not been
authorised, or to medicinal products available only on prescription, the prohibition is in
keeping with the prohibition in the Community directive (replaced by the Community Code)
concerning the advertising of medicinal products.
By contrast, the Community Code precludes an advertising ban in respect of medicinal
products which are authorised and available without prescription.
The full text of the judgments can be found on the internet (www.curia.eu.int ) In principle they will be available from midday CET on the day of delivery. For further information please contact Christopher Fretwell Tel: (00 352) 4303 3355; Fax: (00 352) 4303 2731. Pictures of the reading of the judgment are available from EBS Europe by Satellite the TV service of the European Commission, DG Press and Communication, L - 2920 Luxembourg, Tel: (00352) 4301 35177, Fax: (00352) 4301 35249, or B-1049 Brussels, Tel: (0032) 2 29 64106, Fax: (0032) 2 29 65956 |