Study on cost-benefit analysis of reference laboratories for human pathogens : executive summary

At present, there is no EU-wide system for reference laboratory networks for human pathogens that would consolidate operating standards of microbiological reference laboratories or provide resilience when significant cross-border outbreaks occur. The purpose of this study is to provide a cost-benefit analysis and analysis of regulatory options to strengthen the existing coordination of reference microbiology provision in the EU in order to support the European response coordination to outbreaks of pathogenic infectious agents. The scope for the analysis was set inter alia by identifying and characterising in detail the functions and activities of EU reference laboratory networks relevant for consideration. A set of key types of costs and benefits specific to EU reference laboratory networks was developed to guide the data collection, which was based on a set of case studies corresponding to existing reference laboratory networks or projects. The results of this study indicate that the benefits (monetary and non-monetary) of maintaining a formally-defined overarching system of EU reference laboratory networks are likely to outweigh costs, both in a Member State and in an EU perspective. The study also identified several issues that will need to be addressed in the further process of creating such a system, including the need for adequate reference laboratory infrastructure at national level; the need to provide sustainable funding, including for emergency situations; the need to consolidate the focus of the existing networks, e.g. by grouping diseases or networks with similar areas of expertise; the need to harness relevant technological improvements; and the need to choose the coordination options most suitable in specific cases.