WRITTEN QUESTION E-0506/03

by Salvador Garriga Polledo (PPE-DE) to the Commission

(21 February 2003)

Subject: Understanding package leaflets

In view of the recommendations heard in television commercials concerning the necessary precautions when taking the pharmaceutical products being advertised, it is surprising that in many EU Member States the package leaflets accompanying medicinal products are published only in the language of the country of consumption.

This prevents citizens of other EU countries who for whatever reason (work, tourism, etc.) are in a country other than their home country from being able to understand the explanations given by such pharmaceutical package leaflets, particularly as regards contra-indications.

Does the Commission believe that it should propose the adoption of corresponding Community legislation requiring that all pharmaceutical package leaflets be published in three languages, so as to enable citizens from the remaining EU countries who consume the products concerned to understand what is indicated in the leaflet and prevent the health risks for consumers which may arise from possible contra-indications?

Answer given by Mr Liikanen on behalf of the Commission

(22 April 2003)

The essential aim of the Community rules governing the production, distribution and use of medicinal products is to safeguard public health. The information supplied to users has to provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information.

Article 59 of Directive 2001/83/EC(1) requires that the package leaflet shall be drawn up in accordance with the summary of the product characteristics. For products authorised by the Community, there is a single product characteristics agreed at Community level that forms part of the Community decision, and the text of the package leaflet is the same throughout the Union.

In accordance with Article 63(2) of this Directive, the package leaflet must be presented at least in the official language or languages of the Member State(s) where the product is placed on the market. When more than one language is used, then all the text must be in each language, and the overall readability of the label should not be adversely affected. The content of all language versions must be identical.

At the moment, the package leaflet translation into three or more languages is only an option for the marketing authorisation holder.

The Commission supports any initiative to improve patient information on medicines. Our proposal to review Directive 2001/83/EC and Regulation 2309/93/EC(2) includes various important suggestions related to this area. In December 2002, the Commission accepted some Parliament amendments with regard to increasing the transparency in this field and to make more and better information accessible to patients. However, no amendment was included by the Parliament regarding the languages of the package leaflet.

(1) Directive 2001/83/EC of the Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use OJ L 311, 28.11.2001.

(2) Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products OJ L 214, 24.8.1993.