EMA has held a second forum regarding the implementation of new pharmacovigilance legislation, which gave stakeholders the opportunity to discuss their expectations on various aspects of the new legislation’s execution. The forum, held on June 17, 2011, was attended by a wide cross-section of participants from industry, patient, and consumer representatives, as well as those from the EMA and national authorities, and represented a clear effort to guarantee timely input from all stakeholders during the implementation process.
The first meeting, held in April 2011, attempted to obtain feedback on the EMA and member states’ technical contribution to the draft European Commission implementing measures. Primary objectives of the second meeting included providing progress updates, introducing subjects for feedback, and discussing topics particularly relevant to patients and healthcare professionals.
Andreas Pott, EMA’s acting executive director, opened the meeting and stressed the importance of the new leglislation but also the commitment EMA has to work closely with stakeholders. This was followed by sessions and panel discussions, actively seeking the views and expectations from involved parties.
Minimum requirements for quality systems to assure integrity of pharmacoviglilance systems were described, outlining the responsibilities of market authorization holders, national authorities, and EMA. Additional guidance will be available in the forthcoming “Good Vigilant Practice” (GVP) guide.
First insight was given into the current proposal for public hearings, which are presented as an opportunity to gain stakeholder feedback during drug assessment. Direct patient reporting was also a key topic; recent research in the United Kingdom has complemented existing information and indicated its value and the need to increase awareness among patients of their opportunity to report adverse reactions directly. It was noted though that direct reporting from patients should serve to complement information obtained from healthcare professionals and not replace it.
Participants were given an outline of new developments in Eudravigilence and its access policy in the context of the new legislation. Information held in the database will be made public in a phased manner with initial priority given to centrally authorized medicines.
Further meetings and interactions with stakeholders are planned for later in the year and into 2012. The agenda, slide presentations, and session videos from the second session will be made available on the EMA website in the near future.