WRITTEN QUESTION E-0319/01 by Piia-Noora Kauppi (PPE-DE) to the Commission. Community legislation on the marketing of medicine through the Internet and teleshopping networks.
Date: 2001-02-13
Institutions: European Parliament, Provisional data
Subjects: EC Directive, consumer protection, distance selling, electronic commerce, medicinal product

C 261 E/88

Official Journal of the European Communities

EN

18.9.2001

(2001/C 261 E/092)

WRITTEN QUESTION E-0319/01

by Piia-Noora Kauppi (PPE-DE) to the Commission

(13 February 2001)

Subject: Community legislation on the marketing of medicine through the Internet and teleshopping

networks

A study on the marketing of medicines through the Internet and teleshopping networks, drawn up by
members of the faculty of the University of Barcelona for the STOA Panel of the European Parliament(cid:146)s
Directorate General for Research and published in the March 2000 edition of the European Heart Network
newsletter, advocates strongly the need for European rules on e-commerce in medicines.

Rules governing which medicines are available only on prescription differ greatly among the Member
States. The availability of US-pharmaceutical products and the more liberal US rules for the advertisement
of medication complicate the situation further.

According to the aforementioned study, international regulations should ultimately govern e-commerce in
medicines; but, for the time being, Community regulations are indispensable.

Interim measures are suggested in the aforementioned study,
including: changes to EU legislation on
advertisements and trade in medicines, explicitly taking into account the specific features of electronic
media and services; establishing a code of practice for e-commerce in medicines by the pharmaceutical
industry; introduction of the possibility of confiscating medicines originating in non-EU-countries if the
Union(cid:146)s legislation is stricter than legislation in those third countries; creation of a monitoring system for
activities related to the marketing of medicine on the Internet; and the promotion of health education for
Internet users.

In what way has the European Commission taken notice of the measures set out in the aforemen-

1.
tioned study?

Has it taken specific steps for the drafting of EU legislation and international legislation on this

2.
matter, which is of great importance for the health of EU citizens?

Answer given by Mr Liikanen on behalf of the Commission

(11 May 2001)

1. Within the Community a number of specific Directives have been adopted governing the authorisa-
tion,
labelling, advertising and distribution of medicines which apply equally to the sale of medical
products by electronic means as they do to their sale by more conventional means. In addition, Directive
2000/31/EC of the Parliament and of the Council of 8 June 2000 on certain legal aspects of information
society services,
(Directive on electronic
commerce) (1) provides for transparency requirements, administrative co-operation between Member States
and efficient control in the Member State where the on line service provider is located. The Directive
clearly encourages the adoption of codes of conduct for medical professions and e-pharmacies, in the same
way as these exist already within the regulatory framework.

in particular electronic commerce,

in the Internal Market

It is however worth noting that reimbursed medicines are different from almost all other goods, for
reasons related to political sensitivity, reimbursement and classification. Despite the Community legislative
framework described above, patients have differing access to medicines in different Member States within
the Community, just as without, for all of these reasons. At present, demand for internet medication in
Europe is demonstrably weak and unlikely to increase tremendously in the near future. The Commission
nevertheless feels that there may be some scope for action at Community level to ensure the free
circulation of goods whilst keeping a high level of consumer protection.

18.9.2001

EN

Official Journal of the European Communities

C 261 E/89

As a follow-up to the e-Europe initiative, the Commission established a working group during 2000 to
examine the impact of the internet on the healthcare sector. At this stage, no specific plans for additional
legislation are considered. The Commission is also working with Member States and other stakeholders to
establish ways in which possible problems with third country information, advertising and supply might
be handled.

2.
The global nature of the internet increases the potential for the advertising and sale of pharmaceu-
ticals to European consumers by operators from third countries. A considerable amount of work has been
taken forward at the international level (cid:129) led in particular by the World Health Organization with the
participation of the Commission and the American Food and Drug Administration (FDA) (cid:129) to ensure that
patients are aware of the potential problems in using internet sites established in third countries. In
addition, the Commission has launched work with the Member States to address these problems at
Community level so that the benefits of such systems can be maximized, in terms of better value for
money and a more convenient service to patients.

(1) OJ L 178, 17.7.2000.

(2001/C 261 E/093)

WRITTEN QUESTION E-0322/01

by Luigi Cesaro (PPE-DE) and Generoso Andria (PPE-DE) to the Commission

Subject: Mar(cid:237)ne pollution in the bay of Ogliastro Mar(cid:237)na

(13 February 2001)

For some years now the bay of Ogliastro Mar(cid:237)na, a beautiful place in the Cilento region of the province of
Salerno renowned for its crystal-clear waters, has been suffering from a serious environmental problem:
daily discharges of sludge which pollute the water and, worse still, prevent people from bathing in it. This
is a disastrous situation which involves serious breaches of Council Directive 76/160/EEC (1) of 8 Decem-
ber 1975 on the quality of bathing water. The lack of concern shown by environmental organisations is
highlighted by the fact that the Lega Ambiente (League for the Protection of the Environment) has awarded
the neighbouring port of Acciaroli a (cid:145)blue ribbon(cid:146) identifying its water as fully suitable for bathing.

In view of the foregoing:

1. Does the Commission intend to ask the relevant authorities to ensure that the pollution of the bay of

Ogliastro Mar(cid:237)na is stopped for good?

2. Would the Commission be prepared, if asked to do so, to fund an environmental management project
in the area concerned to restore the severely disrupted ecological balance of the bay of Ogliastro
Mar(cid:237)na?

3. What measures will the Commission take, if it discovers that Community legislation on the environ-

ment has been infringed, to ensure that it is implemented correctly?

(1) OJ L 31, 5.2.1976, p. 1.

Answer given by Mrs Wallstr(cid:246)m on behalf of the Commission

(26 April 2001)

In particular, the
The Commission(cid:146)s powers are limited to those conferred on it by the EC Treaty.
Commission is responsible for ensuring that Community law is properly applied within all Member States.
On the basis of Article 211 (ex-Article 155) of the EC Treaty, (cid:145)in order to ensure the proper functioning
and development of the common market, the Commission shall ensure that the provisions of this Treaty
and the measures taken by the institutions pursuant thereto are applied(cid:146). On the basis of Article 226 (ex-
Article 169) of the EC Treaty (cid:145)if the Commission considers that a Member State has failed to fulfil an