Directive 2004/18/EC: implications for public medicine procurement in Europe Authors: Zegaoui Y., Sogokon P., Morrison S.
- GfK UK Limited, 25 Canada Square, Canary Wharf, E14 5LQ, London
OBJECTIVES: Directive 2004/18/EC provides a framework to any “public contract concluded in one of the EU Member State on behalf of the State, regional or local authorities […]”. This applies to medicines purchased by public hospitals. The research aim is to identify and compare the impact of the directive on procurement in European countries.
METHODS: The Directive 2004/18/EC, national European guidelines on public procurement were reviewed in addition to secondary research to identify any differences in the application of the directive. Procurement models and current level of implementation of the directive were then compared based on past vs future processes to assess any direct impact on the medicines purchase. The research findings were used to develop a typology of the various procurement models as well as to establish any modification in payers’ behaviour regarding medicines purchase.
RESULTS: Although the EU directive applies to all European members, differences have been highlighted in countries based on a private vs public national insurance system. Fourteen years after its ratification, countries with less interest in the directive still do not use it, e.g. Italy where a more value-based contract model is used at the national level by AIFA. In countries where fully applied, e.g. Belgium, a shift between direct contracts with manufacturers towards a more transparent and clear tender process is happening. Countries governed by a more private health model, e.g. Netherlands and Germany are less impacted by the introduction of the Directive.
CONCLUSIONS: Three different models of applications were identified across European countries. Each model impacts the procurement of medicines by influencing payers behaviour, influencing the flexibility for Managed Entry Agreements and modifying the procurement processes.
