The European Medicines Agency’s (EMA) Management Board has adopted a new framework to govern interaction between the Agency and industry stakeholders. The framework covers interactions involving human and veterinary medicine, however there are still unanswered questions about specific products and procedures that will be resolved by internal EMA departments. The adopted framework seeks to facilitate and streamline communication, structure interactions, increase accountability and transparency, and includes a plan to monitor and report on interactions.
According to the EMA’s minutes, comments by the European Commission on the framework were supportive and emphasized the need for transparency and called for dialogue among stakeholders. By Q1 2016, the EMA’s framework hopes to identify eligible organizations and set out the criteria for stakeholders to be included in the Agency register for participation in EMA activities. Also at this time, EMA aims to develop a stakeholder information webpage and a dedicated contact point within the Agency to coordinate interaction.
On an annual basis, the EMA will monitor and report on the interaction with stakeholders which will be organized by the EMA through an ongoing process. The discussions will focus on issues of common interest in cooperation with the European Commission as well as the European Medicines Regulatory Network. By Q4 2016, the EMA aims to share its experience with NCAs and other EU Agencies.
The EMA explains the need for such a framework by noting the pharmaceutical industry remains as one of the Agency’s key stakeholders with whom communication is a major part of day-to-day operations. These communications range from contacts with companies through early innovation task forces and briefs to direct contact during regulatory procedures. Article 78 of Regulation (EC) No 726/2004 calls for the Agency, its Management Board, and Scientific Committees to develop contacts with industry stakeholders. Furthermore, the EMA has identified open communication with the pharmaceutical industry as a key goal that is increasingly changing as innovations in medicine grow across the health sector.
Now as the EMA increases in size, scope, and complexity, the Agency describes its current stakeholder management activities as “fragmented”. This has resulted in “sub-optimal” results, spurring the EMA’s interest in centralizing interactions with industry associations. The scope of this framework is intended to include organizations that support and operate in the pharmaceutical industry, including industry trade associations representing pharmaceutical companies; associations of professionals or service providers operating in or supporting the general interests of industry; organizations engaged early on in the innovation life-cycle from development; associations with multiple stakeholders including industry members; and stakeholders operating in domains related to pharmaceuticals such as medical devices or HTA.