WRITTEN QUESTION E-0813/96 by Nel van Dijk (V) to the Commission (3 April 1996)

Subject: New European Union regulation concerning marketing authorization for medicinal drugs

On 14 February 1996, the Commission issued a marketing authorization valid for the entire European Union for the medicinal product Fareston (toremifene). On the same day, the European Medicines Evaluation Agency published the Summary of Product Characteristics, as part of the European Public Assessment report (CPMP/730/95), in which it was stated that the therapeutic indication is 'first line treatment of hormone-dependent metastatic breast cancer in postmenopausal patients. Fareston is not recommended for patients with oestrogen-receptor-negative tumours'.

The B-user package leaflet which contains the patient information about the drug lists as indication: 'treatment of a certain type of breast tumour in women who have had their menopause'. This information is incorrect since breast tumour may refer to both benign and malignant tumours, whilst the use of Fareston (toremifene) should be restricted to the treatment of malignant breast cancer and not of benign tumours.

1. Is it correct that the decision not to use the word cancer in the text of the user package leaflet is a result of a dispute between members of the CPMP concerning the suitability of using the word 'cancer' in user package leaflets?

2. Is the Commission of the opinion that the indication 'treatment of a certain type of breast tumour in women who have had their menopause' for a product which may only be used for the treatment of breast cancer is in accordance with Council Directive 92/27/EEC ((OJ L 113, 30.4.1992, p. 8. )) of 31 March 1992 on the labelling of medicinal products for human use and on package leaflet, particularly Article 7 which requires that 'the package leaflet shall be drawn up in accordance with the summary of the product characteristics'?

Joint answer to Written Questions E-0813/96 and E-0814/96 given by Mr Bangemann on behalf of the Commission (7 May 1996)

In the Annex to the Commission's Decision of 14 February 1996 authorizing the medicinal product Fareston (Toremifene) to be placed on the market throughout the European Union, it is true that the user package leaflet for the drug does not mention the word 'cancer', although this term appears in the summary of the product characteristics which is also annexed to the Decision. The opinion of the Committee for proprietary medicinal products, which suggests not using the term 'cancer' in user package leaflets for this drug, has been unanimously adopted.

The Commission considers that this procedure is entirely in accordance with Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets ((OJ L 113, 30.4.1992. )). Indeed, Article 7(2) of this Directive provides that 'the competent authorities may decide that certain therapeutic indications shall not be mentioned in the package leaflet, where the dissemination of such information might have serious disadvantages for the patient'. Preparatory studies on Directive 92/27/EEC indicate that the thinking behind this particular legislative provision applies precisely to a case such as this. Article 9(3)(c) of Council Regulation (EEC) No 2309/93 of 22 July 1993 ((OJ L 214, 24.8.1993. )) laying down Community procedures for the authorization to place the medicinal products on the market, provides in particular that in the event of an opinion in favour of granting the relevant authorization to place the medicinal product concerned on the market, the Committee for proprietary medicinal products shall annex to its opinion 'the draft text of the labelling and package leaflet proposed by the applicant, presented in accordance with Directive 92/27/EEC, without prejudice to the provisions in Article 7 (2) of that Directive'.

The Commission considers that it is essential to mention the therapeutic indication of a medicinal product in the package leaflet, both for consumer information and so that such products are not misused, which is why Directive 92/27/EEC makes this compulsory. Thus it is only in exceptional circumstances such as those described in Article 7(2) of the Directive that this obligation may be waived, and only if it is in the patients' interest.

In the Commission's view, Directive 92/27/EEC ensures that patients are provided with comprehensive information. However, in the near future it intends to take certain steps to make package leaflets more legible and comprehensible for patients.