WRITTEN QUESTION No. 1785/96 by Nel van DIJK to the Commission. Unnecessary use of the pharmaceutical Premarin
Date: 1996-07-03
Institutions: European Parliament, VAN DIJK
Subjects: consumer information, environmental protection, equidae, hormone, labelling, medicinal product, pharmaceutical legislation, product quality, product safety, protection of animals













EUR-Lex - 91996E1785 - EN






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91996E1785

WRITTEN QUESTION No. 1785/96 by Nel van DIJK to the Commission. Unnecessary use of the pharmaceutical Premarin  


Official Journal C 011 , 13/01/1997 P. 0020 





WRITTEN QUESTION E-1785/96 by Nel van Dijk (V) to the Commission (3 July 1996)Subject: Unnecessary use of the pharmaceutical PremarinThe pharmaceutical Premarin is used to replace oestrogens in women during the menopause. Its manufacturing process causes severe distress to animals and is environmentally polluting. Premarin is nevertheless the most commonly prescribed pharmaceutical for counteracting unwanted side-effects of the menopause. Worldwide, 44 301 000 units of Premarin were sold last year. The prescription guidelines for this pharmaceutical are non-restrictive. The excessive use of Premarin is unacceptable, firstly because superfluous use of any pharmaceutical is undesirable from a health point of view, and secondly because the production of Premarin is particularly damaging to nature and the environment.1. Can the Commission confirm that the prescribing of Premarin is not confined to restrictive indications?2. What action will the Commission take to counteract the excessive use of pharmaceuticals in general and of Premarin in particular?Joint answer to Written Questions E-1784/96 and E-1785/96 given by Mr Bangemann on behalf of the Commission (6 September 1996)Premarin is a pharmaceutical product which contains natural conjugated oestrogen and is authorised in many Member States as an oestrogen replacement therapy for menopausal and post menopausal women.The Commission has no information on the market share of Premarin.The Commission does not have any information to indicate that there are farms within the Community where urine is collected from pregnant mares to produce hormones.The method of production of Premarin is set out in the application dossier which is submitted to the authorities of the Member States when an application for marketing authorisation is requested and is reviewed in order to ensure that medicinal products meet the criteria of quality, safety and efficacy. The farming methods used are not included in the dossier for marketing authorisation for human use medicinal products.The labelling provisions for pharmaceuticals have been designed to provide information to patients so as to ensure the correct use of the product rather than to give any reference to the manufacturing process by which the product was obtained. These provisions have been drawn up in consultation with consumer groups, health care professional groups and experts from the Member States.The indications for which Premarin may be prescribed are set out at the time a marketing authorisation is granted. These have been determined by each Member State, since this product has been authorised nationally. The rational use of medicinal products, including the supervision of the prescription of medicines and their use within the approved indications, is ensured by the Member States especially through the pharmacovigilance procedures.