The European Medicines Agency (EMA) has recently undergone a year-long evaluation by Ernst & Young assessing its effectiveness and efficiency, and the results are largely positive for the agency.
The final report breaks the main findings of the evaluation into seven areas: committees organization, involvement of national competent authorities (NCAs) in the agency’s work, role of the Secretariat, procedures, communication, industry fees, telematics and future challenges.
For the most part, the report believes that the structure of the EMA is efficient and effective. However, it also adds that: “the whole system is progressively attaining its maximum capacity”, explaining that the main opinion-making committees, Committee for Medicinal Products for Human Use (CHMP) and Committee for Veterinary Medicinal Products (CVMP), have tremendous workloads. Consistency between the agency’s 35 entities/committees was also identified as a “constant challenge”.
To overcome issues relating to work overload, the report suggests that two dedicated committees could be created to deal with referrals and generics. “In addition, working parties organization should also be reviewed; some may be removed, others may be created according to their relevance with regards to the evolution of the scientific research and European medicines agency internal organization,” says the report.
Involvement of NCAs in the agency’s work
According to Ernst & Young, scope for improvement in this area mainly centres around non-fee paid activities. The European Medicines Agency compensates NCAs for their contribution to the centralized authorization system; however, NCAs can also make contributions to non-fee paid activities, but this may be difficult for NCAs facing an increasing lack of resources.
“Despite some differentiation based on their internal resources, such difficulties impact directly their level and type of involvement in agency activities,” says the report. “The whole compensation process is very complex and NCAs may have the feeling to be poorly compensated for referrals, pediatric investigation plan or orphan designation.”
In response, the report believes that the funding system should be clarified and calls for “realistic” funding for each type of assessment activity — something that will be very important as non-fee paid activities increase in the near future with the growing number of pediatric and orphan products.
Role of the Secretariat
The EMA’s Secretariat (management board) was considered to be a strong contributor to the agency’s success and only a few areas for improvement were identified, but the report did warn that the Secretariat must be careful not to “increase too much formalism and administrative burden” on dossiers.
Improvements in this area mainly concerned veterinary medicines — the procedures for which increase the administrative burdens of both companies and the agency’s Committee for Medicinal Products for Veterinary Use. In response to the issues identified, the report suggests that human and veterinary subjects be split and considered as independent fields.
Communication was one area where praise for the EMA dipped slightly as the final report concluded that the agency “generally suffers from a lack of visibility”. Although the agency does make use of the many channels available, the impact is limited and communication strategy is heavily dependent on the network of NCAs. However, the report does acknowledge that the agency has “recently put a lot of effort in order to improve its level of transparency, going beyond the legislation requirements”.
The report recommends that the agency “pursue the work engaged on a differentiated communication strategy per target group: citizen, patients, consumers, healthcare professionals, veterinarians, academics, HTA, pricing and reimbursement bodies, etc.”
Industry fees were considered to be “fair and appropriate”, although Scientific Advice was singled out as often being too expensive. The main criticism, however, was in the complexity of the agency’s fee structure, which results from consecutive regulations. “It may benefit from a simplification to lighten the administrative procedures, while keeping the fairness of fees as an important goal,” says the report.
The main problem in this area related to EudraVigilance, the data processing network and management system for reporting and evaluating suspected adverse reactions. Although the system was considered a key tool, it was also described as a “complex system” with “room for improvement”.
The report also added: “More generally, coordination between the agency and NCAs may be reinforced in all IT-related projects.”
The full report can be downloaded from the European Medicines Agency website.