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9. 10.

98 EN Official Journal of the European Communities C 310/117

Answer given by Mrs Bonino on behalf of the Commission

(1 April 1998)

The Commission’s initiatives in the field of defending consumer interests and protecting consumer health are
based on the 1996-1998 Action Plan ‘Priorities for consumer policy’ (1).

The Commission helps fund the activities of consumer associations in the Community. For example, the three
Italian associations mentioned by the Honourable Member have participated in an information campaign
designed to help consumers make the most of the single market. The campaign was mounted in parallel and in
coordination with the Citizens First − Citoyens d’Europe campaign, notably its second phase, one of whose
themes was ‘Purchasing goods and services in the European market’. This campaign, specifically devoted to
unfair terms in consumer contracts, was mounted in five Member States (Greece, Spain, Ireland, Italy, Portugal).
The partners were the national consumer organisations that had requested to be involved in the campaign and
helped organise it. A contract was signed with each organisation in the amount of ECU 5 750.

In the context of the Euroguichets (consumer information and advice centres) network, the Commission also
funds the organisations or associations that operate these centres (financing up to 50% of their outgoings).
Following an evaluation in 1997 and a radical review currently in progress, this network now consists of ten
centres in seven Member States.

Each year the Commission publishes in the Official Journal (2) a ‘Call for submission of projects designed to
promote and protect consumer interests’. Projects are selected on the basis of their compatibility with the
Commission’s priority themes and the criteria published in the Official Journal.

The Commission has endorsed a proposal for a Parliament and Council Decision establishing a general
framework for Community activities in favour of consumers (3). This is a project with a legal basis which covers,
over a period of five years, a large part of the Commission’s actions to defend consumers’ interests and protect
their health.

Asummary list of the subsidies granted to Italian beneficiaries in 1996 and 1997 is being forwarded directly to the
Honourable Member and to the Secretariat-General of the Parliament.

(1) COM(95) 519 final.

(2) OJ C 277, 12.9.1997.
(3) COM(97) 684 final.

(98/C 310/156) WRITTEN QUESTION P-0694/98

by Riccardo Nencini (PSE) to the Commission
(2 March 1998)

Subject: Protection of patients

Council Directive 93/42/EEC (1), transposed into Italian law by Decree Law 46/1997, was intended to protect the
legitimate interests of patients by ensuring the quality of the service provided and codifying dental prostheses as
custom-made medical devices for which the dental technician and the dentist who fits them are directly
responsible. However it appears that Italian dentists, contrary to the provisions of the directive, are refusing to
provide dental technicians with the particulars of patients for whom they are asked to make prostheses, although
Annex VIII of the said directive stipulates that the manufacturer must draw up a statement of conformity which
includes the patient’s personal details, thus enabling every single medical device to be identified. Furthermore,
dentists, when issuing bills, do not explicitly mention the cost of the dental prosthesis or the name of the
manufacturer. Does the Commission intend to take action to compel European medical practitioners to comply
with the provisions in question?

(1) OJ L 169, 12.7.1993, p.1.

C 310/118 EN Official Journal of the European Communities 9. 10. 98

Answer given by Mr Bangemann on behalf of the Commission

(31 March 1998)

The question by the Honourable Member refers to the obligations incumbent on manufacturers of custom-made
devices under the provisions of Directive 93/42/EEC concerning medical devices.

Under Annex VIII of the Directive, the manufacturer of custom-made devices is required to draw up a statement
indicating that the custom-made device is intended for exclusive use by a particular patient, together with the
name of the patient. Furthermore, under the provisions of the Directive, all the parties involved, including the
doctor who issues the prescription, are bound to observe confidentiality.

The purpose of imposing these obligations on the manufacturers of custom-made devices is to enable the devices
in question to be traced back from the user to the manufacturer. It is not essential, to this end, that the
manufacturer should have the patient’s full name. As a necessary and adequate prerequisite, however, the doctor
who issues the prescription should provide the manufacturer with the information needed to identify the patient
(for instance, by means of a code), thereby enabling the patient’s name to be found in the doctor’s data base.

The Commission considers that this interpretation is justified since it takes account, on the one hand, of the health
protection needs of patients and, on the other, of the latter’s right to privacy.

Given the practical implications as far as the implementation of the Directive is concerned, the Commission
intends to examine this matter in consultation with the Member States.

(98/C 310/157) WRITTEN QUESTION E-0723/98

by Amedeo Amadeo (NI), Cristiana Muscardini (NI), Gastone Parigi (NI)
and Salvatore Tatarella (NI) to the Commission
(18 March 1998)

Subject: Petition signed by 5 000 Italian dairy farmers on application of the system of milk quotas

In a petition submitted by representatives of 5 000 Italian dairy farmers on the application of the milk quota
system in Italy and in Europe the signatories claim that the common organization of the market in the dairy sector
has created a temporary milk production quota system which is contrary to the objectives of the common
agricultural policy and the other objectives laid down in the Treaty for EU producers and consumers of milk. The
current situation allegedly infringes Articles 39, 40, 118, 123, 129, 130u, 130v, 155 and 130r of the Treaty.

They also feel that the Commission has not fulfilled the obligations aimed at guaranteeing the Italian
Government’s compliance with the provisions of the Treaty and their application.

Can the Commission say:

1. why, 13 years after the introduction of the milk quota system, it cannot yet supply precise figures concerning
Italian milk production;
2. why, since the increase in Italian quotas in 1992, the Commission has not brought proceedings against Italy
for its incorrect transposition of the European directive;
3. which Member States, with regard to powdered milk, opposed the introduction of a system allowing their
inclusion in the figures for ‘liquid’ milk?

Answer given by Mr Fischler on behalf of the Commission

(16 April 1998)

1. The Commission has official figures available to it which are notified annually by the relevant Member
State under the provisions in Community legislation (Article 8 of Commission Regulation (EEC) No 536/93 of
9 March 1993 laying down detailed rules on the application of the additional levy on milk and milk products (1)).
These figures are subjected to controls and checks in connection with the annual clearance of accounts. For
1995/96 and 1996/97, the Italian authorities told the Commission that the production data supplied were subject