WRITTEN QUESTION E-2908/00 by Giuseppe Nisticò (PPE-DE) and Francesco Fiori (PPE-DE) to the Commission. e-commerce and medicinal products.
Date: 2000-09-14
Institutions: European Parliament, Provisional data
Subjects: Internet, consumer protection, electronic commerce, marketing, marketing restriction, medicinal product, public awareness campaign, public health

C 163 E/20

Official Journal of the European Communities

EN

6.6.2001

The Cypriot authorities have informed the Commission of interim decisions taken in March 2000 intended
to provide for sustainable management of the Akamas peninsula. These include continuing the dialogue
with all parties in order to reach, if possible, a consensus decision and taking a number of concrete steps
to clean up and improve the condition of the area. The dialogue with the parties concerned would be
guided by a number of objectives, including the acquisition of private properties enclaved within the state
forest, prevention of tourist development in the (cid:145)Lara Toxeftra(cid:146) area (an important sea turtle habitat), while
allowing mild and rational development outside the state forest with respect for the environment. Final
decisions would be taken by the Cypriot authorities after the dialogue is completed, taking account of the
relevant Community acquis, and international and national obligations.

(1) OJ C 89 E, 20.3.2001, p. 85.
(2) OJ L 206, 22.7.1992.

(2001/C 163 E/019)

WRITTEN QUESTION E-2908/00

by Giuseppe Nistic(cid:242) (PPE-DE) and Francesco Fiori (PPE-DE) to the Commission

(14 September 2000)

Subject: e-commerce and medicinal products

The Commission(cid:146)s attention is drawn to an extremely delicate subject which the authors have already had
the opportunity of discussing directly, albeit informally, with Commissioner Byrne: the sale of medicinal
products via the Internet.

This type of commerce is covered by the following European legislation:

(cid:129) Directive 97/7/EC (1) on the sale of goods by means of distance contracts: Article 14 of this directive
offers Member States the option of prohibiting the sale of medicinal products by means of such
contracts;

(cid:129) Directive 97/36/EC (2) on teleshopping, Article 14 of which prohibits teleshopping for medicinal

products;

(cid:129) Directive 92/28/EEC (3) on the advertising of medicinal products.

This directive prohibits the advertising of medicinal products which are available only on medical
prescription.

(cid:129) Medicinal products are not mere consumer products, but substances which affect the health of
European citizens, having the power to save lives or improve their quality, but also to produce toxic
side-effects which may sometimes even be fatal.

(cid:129) The public is concerned about the various types of medicinal products that can be purchased
electronically,
in that no guarantee or certainty is provided with regard to the correct dosage or
absence of contaminants; moreover, it is highly unlikely that potentially dangerous interactions with
other medicines taken simultaneously by the patient are taken into account.

(cid:129) The EU has developed its own system for the marketing of medicinal products (cid:129) including the

establishment of the EMEA (cid:129) to guarantee their safety, quality and efficacy.

(cid:129) The global nature of the Internet eliminates national and/or European borders, enabling people to buy
not only over-the-counter medicines, powerful and potentially dangerous psychotropics, cardiovascu-
lar medicines and hormones, etc. but also medicinal products which have not been approved in the
EU, bypassing the safeguards provided by both national and centralised EMEA authorisations.

(cid:129) Given the above, and that in over 100 countries there are no laws to regulate the marketing of

medicinal products, with obvious consequences on the safety, quality and efficacy of such products,

6.6.2001

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Official Journal of the European Communities

C 163 E/21

what measures does the Commission intend to take to tackle the problem of the electronic sale of
medicinal products? This is particularly important with a view to protecting the health of European
citizens and safeguarding the system of marketing authorisations, which guarantees that in Europe only
medicines which meet certain criteria of safety, quality and efficacy may be marketed.

(1) OJ L 144, 4.6.1997, p. 19.
(2) OJ L 202, 30.7.1997, p. 60.
(3) OJ L 113, 30.4.1992, p. 13.

Answer given by Mr Liikanen on behalf of the Commission

(23 November 2000)

The Commission is aware of a possible threat to the health of European citizens resulting from the sale of
medicinal products over the internet by companies established outside Europe.

Within Europe, a high level of protection is achieved by a number of specific Community directives and
national practices governing the authorisation, the advertising and the distribution and sale of pharmaceu-
ticals. The recently adopted Directive 2000/31/EC of the Parliament and of the Council of 8 June 2000 on
in the internal
certain legal aspects of information society services,
market (Directive on electronic commerce) (1) provides for transparency requirements and efficient control
in the Member State where the online service provider is established, and administrative co-operation
among Member States.

in particular electronic commerce,

the internet

the global nature of

increases the possibility of

However,
the advertising and sale of
pharmaceuticals to European consumers by operators from third countries bypassing the protection
provided by these Community directives. A considerable amount of work has been taken forward at the
international level (cid:129) led in particular by the World Health Organisation with the participation of the
Commission and the american Food and drugs administration (FDA) (cid:129) to ensure that patients are aware of
the risks in using unregulated internet sites. In addition, the Commission has launched work with the
Member States(cid:146) authorities to address this problem. In this context, the Commission recommends inter alia
the promotion of codes of conduct and the possible use of awareness campaigns for consumers.

therefore, whilst

In summary,
there is no restriction in Community legislation which prevents the
establishment of electronic pharmacies, such developments in Europe must (cid:129) if they are permitted by
Member States (cid:129) meet the terms of European legislation in this area. These provisions require that patients
have access to approved information only; that prescription-only medicines are delivered to patients who
can provide a prescription that reflects a meaningful contact with a qualified medical professional; and that
a qualified pharmacist is responsible for oversight of the dispensing process (when and as foreseen by
national
legislation). Such provisions would be the minimum requirements to which an electronic
pharmacy operating in the Community would be subject.

(1) OJ L 178, 17.7.2000.

(2001/C 163 E/020)

WRITTEN QUESTION E-2936/00

by Brian Simpson (PSE) to the Council

(20 September 2000)

Subject: Cyprus

Can the Council indicate what action it intends to take against Turkey in order to secure the lifting of the
illegal embargo by that country against any merchant ships that have visited ports in Cyprus, and can it
explain to Parliament why no action has been taken hitherto?