92003E2351

WRITTEN QUESTION P-2351/03

by Rosemarie Müller (PSE) to the Commission

(11 July 2003)

Subject: Seal of approval for Internet pharmacies

Sooner or later, Internet pharmacies will become established in the European Union. In this connection, fears are being expressed that mail-order pharmacies will not offer the same guarantees as high-street pharmacies and will, therefore, pose a serious threat to public health.

Accordingly, uniform framework conditions need to be established for Internet trade in pharmaceutical products in order to guarantee health and consumer safety for patients in Europe. One possible solution might be the introduction of a seal of approval for Internet pharmacies which would be valid throughout Europe. The introduction of a seal of approval along the lines of the VIPPS (Verified Internet Pharmacy Practice Sites) Programme in the USA would enable patients to distinguish between high-quality mail-order pharmacies and somewhat dubious mail-order firms.

Internet pharmacies would apply voluntarily for the seal of approval and would be awarded it only if they were able to prove that they satisfied strict quality standards laid down for Europe as a whole with regard to product philosophy and processes.

At least the following standards must be taken into account: Quality control of the pharmaceutical products, qualified pharmaceutical advice, a complete range of products, 24/7 service, despatch and delivery security, multiple deliveries.

A certification programme of this nature would make it easier for European citizens of either sex to select a safe and reliable Internet pharmacy.

Against the background of high-quality health and consumer protection in Europe, does the Commission think that this proposal might be implemented?

Answer given by Mr Liikanen on behalf of the Commission

(9 September 2003)

The existing Community law does not stipulate the activity of internet pharmacies in detail.

First, Internet pharmacies is not defined in an unambiguous manner. Therefore, the examination of the activities in light of existing Community law would depend on the exact services performed by such Internet pharmacies. To the extent such pharmacies provide an information society services such activities could be covered by the provisions of the eCommerce Directive (2000/31/EC) see e.g. recital 18 and 21.

Secondly, It is up to Member States to allow or to prohibit the electronic selling of medicinal products and, if permitted, to ensure compliance with all necessary safeguards of public health. However, to the extent the activities of the Internet pharmacies are information society services the Member States shall abstain from authorisation requirements which are specifically and exclusively targeted at information society services cf. Article 4. Furthermore, the Member States would have to apply the procedure in Article 3 vis-à-vis services providers established in another Member State.

The concept of quality seals may contribute to ensure compliance with all necessary safeguards of public health. Its application requires first that quality standards are established and second that such standards are applied with regard to individual pharmacies.

The experience with quality seals in other areas like medical devices shows that one of the key challenges is to determine independent acknowledged institutions, which are capable of examining and certifying the quality of internet based services.

In the context of internet pharmacies, such function could fall upon governmental or semi-governmental institutions of the Member States that control pharmacies periodically on site as well as the scientific qualification of the personnel by checking their certificates of education. Sealing of quality could be a solution, which however needs to be developed and applied in close co-operation of Member States, European institutions and other stakeholders like health care professionals. The conditions of awarding such quality seal should be based on coherent standards throughout the Community to guarantee a high level of health protection in all Member States and to improve the Single Market of medicinal products.