Outcomes Research and Biotechnology Products: A European View
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Drug lnformnrion lournol, Vol.34,pp. 185-192,Z o o 0 Printed in the USA. All rights reserved.
Copyright 0 Z o o 0 Drug Information Association Inc.
OUTCOMES RESEARCH AND BIOTECHNOLOGY PRODUCTS: A EUROPEAN VIEW T.WALLEY,MD, FRCP Professor of Clinical Pharmacology, Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, United Kingdom
In Europe, there is a single licensing authority, the European Medicines Evaluation Agency,for biopharmaceuticals. Licensing alone, howevel; does not guarantee acceptance in the market. Health care providers increasingly seek evidence of the real world benefits and cost-effectiveness of health care interventions and technologies, including new biopharmaceutical products. This evidence is produced by outcomes research. Most European countries are rapidly developing formal mechanisms to evaluate medicines, particularly new medicines, in this way. Unlike licensing, such evaluations will be conducted at a national rather than a European level because of the differences in the nature of the national health services. Products which do not prove their unique clinical or economic value in this process are unlikely to succeed commercially. Key Words: Outcomes research; Biopharmaceuticals; Europe
INTRODUCTION BIOTECHNOLOGY PRODUCTS HOLD promise of exciting new treatments for many areas of disease currently poorly treated (1). Thus far a relatively limited range of biotechnology products have come to the market. Some of these have achieved very wide applicability, such as erythropoietin and GCSF. Others have been aimed at very small numbers of patients, such as alpha-glucerosidase. In general these products are very expensive, either in terms of cost to the individual patient or in aggregate.
Presented at the DIA Workshop: “Biotechnology: Product Development for the New Millennium,” February 1-2, 1999, Dana Point, California. Reprint address: T. Walley, Professor of Clinical Pharmacology, Department of Pharmacology and Therapeutics, University of Liverpool, Infirmary, 70 Pembroke Place, Liverpool, L693GF. United Kingdom.
In recent years a further complexity has been added to the problems of drug development. Health care systems throughout the world are increasingly constrained by a lack of resources and in this situation it must be asked to what extent the new biotechnology products and indeed, any new technology, offer value for money. The days when health services would rush to embrace any new technology simply because it was seen as a scientific advance have now gone, and the marketplace has become increasingly difficult. The key question asked by health services is what benefit does the new drug or technology bring, and at what cost (2)? This question is partly answered by outcomes research which will be described in more detail. There are also key differences between outcomes research as practiced in the United States and as it might be practiced in relation to the European market which need to be considered (3).
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