WRITTEN QUESTION P-2351/03 by Rosemarie Müller (PSE) to the Commission. Seal of approval for Internet pharmacies.
Date: 2003-07-11
Institutions: European Parliament, Provisional data
Subjects: European standard, consumer protection, electronic commerce, marketing standard, pharmaceutical legislation, pharmacy, public health, quality label

C 51 E/242

Official Journal of the European Union

EN

26.2.2004

(2004/C 51 E/263)

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.

26.2.2004

EN

Official Journal of the European Union

C 51 E/243

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.

(2004/C 51 E/264)

WRITTEN QUESTION E-2358/03

by Maurizio Turco (NI), Marco Pannella (NI),
Marco Cappato (NI), Benedetto Della Vedova (NI), Gianfranco Dell’Alba (NI)
and Olivier Dupuis (NI) to the Commission

(17 July 2003)

Subject: Violation of religious freedom in China (cid:1) further arrests of priests of the ‘clandestine’ Catholic

Church

International press sources report that five priests belonging to the ‘clandestine’ Chinese Catholic Church
were arrested on Thursday 3 July at Baoding, in the northern republic of Hebei, about 100 kilometres
south of Beijing. According to reports by the Cardinal Kung Foundation, a Catholic human rights
organisation based in Connecticut, the priests Kang Fuliang, Chen Ghuozen, Pang Guangzhao, Joseph Yin
and Wang Lijun, all of them between 25 and 31 years old, were arrested whilst on their way to visit
another member of the clandestine church, Lu Genjun, who had recently been released after three years’
forced labour. Furthermore, Father Lu Xiaozhou, another member of the Roman Catholic church was also
arrested last June.

Can the Commission say whether it has any further information about these serious incidents? What kind
of diplomatic pressure will it bring to bear to put a stop to this violent campaign against Catholic clerics,
who are ‘guilty’ only of recognising the authority of the Pope?

Does it intend to convey to the government in Beijing its firm condemnation of these acts of intimidation
and, more generally, the systematic restrictions of religious freedom imposed on Chinese citizens, together
with a forceful request to respect Article 18 of the Universal Declaration of Human Rights which
recognises every individual’s ‘freedom, either alone or in community with others and in public or private,
to manifest his religion or belief in teaching, practice, worship and observance’?

Answer given by Mr Patten on behalf of the Commission

(12 August 2003)

The Commission takes note of the events reported by the Honourable Members.

Freedom of religious belief is one of the topics discussed in the EU-China bilateral dialogue on human
rights.

The European Union will make the Chinese authorities aware of its concerns about the situation of the five
Chinese Catholic priests arrested on 3 July in Baoding through this dialogue, as it has often done in similar
cases in the past.