91998E0694

WRITTEN QUESTION P-0694/98 by Riccardo Nencini (PSE) to the Commission (2 March 1998)

Subject: Protection of patients

Council Directive 93/42/EEC ((OJ L 169, 12.7.1993, p.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?

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.