What Does the Over-the-Counter Industry in Europe Need?
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0092-8615/98 Copyright 0 1998 Dnrg Information Association Inc.
Drug
WHAT DOES THE OVER-THE-COUNTER INDUSTRY IN EUROPE NEED? HUBERTUSCRANZ,PHD Director, European Proprietary Medicines Manufacturers Association. Brussels, Belgium
This paper provides an overview of the European Proprietary Medicines Manufacturers Association and its role in the growing trend toward responsible selfmedication. Seumedication has received widespread political support in Europe. The three areas which will have a major impact on determining the parameters of nonprescription medicines: classification of medicines, communication, and marketing authorization, are discussed. Expected changes in this market are covered. Key Words: Over-the-counter; Europe; Self-medication
THE EUROPEAN PROPRIETARY Medicines Manufacturers Association, more commonly known as the Association Europtenne des SpCcialitCs Pharmaceutiques Grand Public (AESGP), was founded in 1964 in Paris and over the years has developed into an umbrella organization of the European manufacturers of nonprescription medicines. It brings together 24 national associations representing this area and five years ago also established an associate member status for the major international companies active in this sector. The ofices were moved from Paris to Brussels in 1989 and in 1996 a satellite office at Canary Wharf in London was opened, near the premises of the European Medicines Evaluation Agency (EMEA). The big difference between today and the time when this association was founded more than 30 years ago is that self-medication is no longer discussed under the general question “yes or no.” Today, society is moving toward
Presented at the DIA 9th Annual Euromeeting, May 26-28, 1997, in Dusseldorf, Germany. Reprint address: Hubertus Cranz, PhD, Director, European Proprietary Medicines Manufacturers Association, 7, Avenue de Tervren, B-1040, Brussels, Belgium.
establishing an active promotion of responsible self-medication. The promotion of the over-the-counter (OTC) concept means people are doing more than accepting it in a passive manner. As everyone knows, this trend is particularly influenced by the growing willingness of the people around Europe to take more responsibility for their own health and by the ongoing problems in financing the social security systems. This financial pressure is likely to become even more severe when Member States around Europe continue to reduce their public expenditure in order to be in line with the Maastricht criteria for entering into a European Monetary Union. This move is reflected in important statements adopted by the most important political bodies of the European Union (EU) during the course of 1996-1997. Of particular importance were the resolutions of the European Parliament and the Council of Ministers in relation to an industrial policy for the pharmaceutical sector. The European Parliament stated on April 16, 1996: “Considers that responsible self-medication should be further promoted, which will foster the growing desire of the European
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