On the specific areas highlighted in the Commission sponsored study which can be summarised as follows:

1. Data sources and safety issue detection

• Need to harmonize the different sources of safety information between member states (Individual Case Safety Reports, PSURs, registries, consumption data, safety studies).
• Develop & implement common set of statistical tools to be used by member states.
• Optimize national data bases.
• Make sure that Marketing Authorization Holders fulfill their role of first-line signal detection for both centrally and nationally authorized products.
• Make sure that safety reporting is easy, accessible to all stakeholders, not cumbersome or time consuming (public electronic terminals? – internet?).
• Facilitate involvement of healthcare professionals (doctors, nurses, pharmacists) and patients.
• Clarify type of safety issues to be reported (need to include known side effects?).
• Distinguish between safety & pharmacovigilance questions.

2. The legal framework and new legal tools

• Prioritize mandatory phase IV studies for innovative medicines.
• Implement no blame system on AE reporting.
• Regulate internet pharmacies.
• Harmonize legal framework and its implementation between Member States.

3. Decision making in pharmacovigilance

• Involve patient representatives in PSUR/CHMP decisions.
• Involve patients/representatives in reevaluation of risk/benefit ratio in approved medicines.
• Make adequate use of external expertise.
• Harmonize & streamline process within Community.
• Identify and remove disparities between Member States.
• Improve coordination with international partners.

4. Impact of communications and actions

• Harmonize & streamline mechanisms to inform doctors, pharmacists, patients and the general public in Member States.
• Improve impact on prescription behaviour.
• Consult patients/patient groups in decision making prior to communications and actions.
• Assess outcomes of regulatory actions.

5. Facilitation and monitoring of compliance with pharmacovigilance requirements

• Collaboration between Member States should be improved by implementation of multinational phase IV cohort studies (large number of patients needed to capture rare AE).
• Measure industry compliance.
• Establishment of confidentiality between patient organisations and pharmaceuticals to balance the need for timely information and commercial and legal concerns when sharing such information in advance of public announcements.