Outcomes Research and Biotechnology Products: A European View

Abstract

In Europe, there is a single licensing authority, the European Medicines Evaluation Agency, for biopharmaceuticals. Licensing alone, however, 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 bio-pharmaceutical 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.