Study in support of the evaluation and impact assessment of the EU general pharmaceuticals legislation: Analytical Report

Abstract

The Analytical report focuses on reporting on secondary quantitative data analysis that was carried out as part of the the study in support of the Evaluation and Impact Assessment of the EU general pharmaceuticals legislation. It relies on existing proprietary and public databases and was used to populate pre-defined high-level indicators to assess relevant aspects of the 2004 revision of the general pharmaceutical legislation. The empirical analyses revolve around various macroeconomic, environmental, social and technological indicators that may have been affected by the legislation. These quantitative indicators have been grouped in seven categories to address the policy elements in scope for the study with specific indicators selected to inform the main evaluation criteria of effectiveness, efficiency, coherence, relevance and EU added value of the legislation. These indicators provide trend analysis and comparison of pre- and post-legislative periods with respect to the implementation of the 2004 revision of the general pharmaceutical legislation. Reference data from other jurisdictions was also used to assess the impact of the EU legislation.