OBJECTIVES: Health care decision-making processes, including public reimbursement of pharmaceuticals, fall under the responsibility of individual European states, with each country developing its own pharmacoeconomic evaluation recommendations. Each guideline addresses HRQL and utility assessment issues but vary in content and approach. The objective of this study was to provide an understanding of these differences. METHODS: MEDLINE and government agency searches were performed to identify pharmacoeconomic guidelines published in Europe. Recommendations on HRQL and utility evaluation were extracted and compared across guidelines. RESULTS: Guidelines on conducting health economic evaluation studies were found in 14 European countries. Ten were directly or closely related to the reimbursement authorities, while 4 had academic origin. Four different recommendations were proposed for evaluating HRQL outcomes: 1) Disease-specific and generic instruments should be used together (France, The Netherlands, Poland, Portugal); 2) Either specific and/or generic instruments should be used depending on the objectives of the health economic study (Belgium, Hungary); 3) Only generic HRQL measures should be used only (Denmark, Spain); and 4) Three types of HRQL instruments should be used simultaneously in health economic evaluations: generic, disease-specific and utility-based HRQL instruments (Italy). Four countries did not recommend preferred methods for HRQL evaluation in their guidelines (Germany, Finland, Norway, UK). With respect to utility assessment, there appeared to be some consensus across guidelines: the EQ-5D and the HUI are acceptable instruments for estimating utilities indirectly, while the time-trade-off and the standard gamble methods are the most accepted methods for the direct measurement of utilities. CONCLUSIONS: Although there appears to be agreement on the preferred choice of utility-based instruments, recommendations for psychometrically-based HRQL evaluation vary substantially across guidelines published in various European countries.