WRITTEN QUESTION E-1784/96 by Nel van Dijk (V) to the Commission (3 July 1996)

Subject: Harmful effects of the pharmaceutical Premarin

The pharmaceutical Premarin, used to replace oestrogens in women during the menopause, is manufacture by the multinational Wyeth-Ayerst from the urine of pregnant mares. The horses are kept continuously pregnant in order to produce as much as possible. In order to concentrate the oestrogens in the urine the horses are kept for long periods without water by many owners. The accommodation provided for the animals is also unsatisfactory in many cases. The urine is discharged after the production process into special urine reservoirs. Research by Dr Bill Paton, professor at the University of Brandon ((PMU Pollution, by Dr Bill Paton, in the quarterly 'The Protector', spring 1996. )), shows that the high ammonia (NH3) content of the waste is very damaging to the environment. Subsequent to the answers to questions by Stephen Hughes and Anita Pollack on this subject, I have the following additional questions:

1. Can the Commission confirm that the pharmaceutical Premarin is sold in the European Union?

2. Can the Commission state how big a share Premarin commands of the market in pharmaceuticals to counteract unwanted effects of the menopause?

3. Is the Commission familiar with the method of production and its impact on the horses concerned and on the environment?

4. Does the Commission not consider that consumers have the right to know that the manufacture of the product causes severe distress to animals and pollutes the environment?

5. What action will the Commission take to inform the consumer of these aspects?

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.