DG Entreprise therefore proposes two main actions:
better implementation of the current system or
changing the legal framework for pharmacovigilance in the EU.
Better implementing the current system
According to DG Enterprise improving the implementation of the current framework will include:
Working with the Commission’s Directorate General for Research on funding of studies into the safety of medicines as well as studies into the methodologies used to conduct pharmacovigilance.
Working with the Member States to resolve implementation issues, including administrative practices that complicate reporting rules for industry.
Working with the EMEA to strengthen its coordinating role including supporting full compliance and maximum utilisation of the EU pharmacovigilance database ‘Eudravigilance’.
Changing the legal framework
Proposals for change to the legal framework will focus on:
Strengthening the rules on transparency relating to pharmacovigilance data, assessment and decision-making and involve stakeholders (e.g. patient and healthcare professional groups) in the processes including reporting (including patient reporting).
Establishing clear standards for the conduct of pharmacovigilance by both the industry and regulators.
Rationalising and simplifying the reporting of suspected adverse drug reactions (ADRs), both expedited and periodic reporting, making best use of current information technology (including Eudravigilance) and matching the reporting requirements with the level of knowledge about the safety of a specific product.
Making clear the respective roles and responsibilities and minimising duplicated efforts, while maintaining the current split of competencies between the Member States and the EMEA.
Stimulating innovation by establishing a clear legal requirement to conduct post-authorisation safety studies, including those in risk management systems.
Rationalising EU decision-making on drug safety issues to deliver fast, robust decisions that are equally and fully implemented for all relevant products and across all markets.
Official documents:
A detailed analysis of the public consultation
Individual consultation responses
Details of the Commission strategy
