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'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'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.

1. In what way has the European Commission taken notice of the measures set out in the aforementioned study?

2. Has it taken specific steps for the drafting of EU legislation and international legislation on this 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 authorisation, 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, in particular electronic commerce, in the Internal Market (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.

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.

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 pharmaceuticals to European consumers by operators from third countries. A considerable amount of work has been taken forward at the international level led in particular by the World Health Organization with the participation of the Commission and the American Food and Drug Administration (FDA) 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.