The Benchmarking process of the European Medicines Agency Network inspires improvement through learning from others

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The European Medicines Agency Network regularly assesses the operations and practices of the agencies. In the assessment carried out in 2023, the Finnish Medicines Agency Fimea received better scores than ever before. In particular, Fimea was commended for its crisis management, information security and inspection services.

The assessments aim at consistent and high-quality regulatory operations in all medicines agencies in Europe, the current number of which is about 40. The strengths identified in the assessment will be shared with the entire network, allowing the agencies to make use of the proven practices of other agencies in order to improve their own operations. The Benchmarking Process (BEMA) is owned by the Heads of Medicine Agencies (HMA).

Fimea (and its predecessor the National Agency for Medicines) has participated in the assessments since they were first conducted in 2004. Finland was first assessed in 2006.

Assessment consists of self-assessment and interviews 

The basic idea of the assessment has remained the same, but the questionnaire form used in the assessment and the self-assessment report based on it have been revised and frame of reference improved based on the lessons learned from previous rounds. 

The assessment consists of a self-assessment report submitted in advance and interviews with assessors. The assessors give a score on a scale of 1 to 5. The self-assessment report is the most important step of the entire process, in which the organisation describes its own practices, assessing its own strengths and areas of development.

The assessors are persons from various medicines agencies who have received Benchmarking training. They have expertise in different areas of the operations of the medicines agencies. For each assessment visit, the assessors are picked separately and at least one assessor with a scientific education in the medical field is always included.

5th BEMA round in progress

The European medicines agencies have been evaluated four times and the fifth round is in progress. The assessments of a round are always distributed over several years. The ongoing assessment round is scheduled for 2023–2025 and the final reporting will be completed in 2026. As a rule, Finland’s assessment results have improved round by round, but in the assessment carried out in 2023, we clearly reached a new level.

The interviews for the fifth BEMA assessment round were held at Fimea on 28–30 November 2023. At the end of August, the self-assessment report was sent to the three assessors, with members from the Polish and Hungarian medicines agencies and the lead reviewer from the German Paul Erlich Institute. A total of twelve areas were assessed, divided into 40 sub-sections: strategy and planning, leadership and organisational culture, stakeholders, quality management, risk management, crisis management, human resources management, operational management, information management, interfaces, scientific decision-making and regulatory impact/efficiency.

Fimea received full scores in crisis management, information security and inspection services

In the assessment, Fimea received the highest score (5) for crisis management related to human and animal health, information security and inspection services.  

The assessors also considered Fimea’s decision-making process to be a strength at a mean sub-section score of 4.3. In addition, the assessors’ final summary highlighted the stakeholder and job satisfaction surveys that give us information on the level of our operations and related areas of development. The detailed risk assessment process and the medicine stock monitoring tool developed during the COVID-19 pandemic were also considered to be exemplary for the entire network of European medicines agencies. 

The assessors identified the most need for improvement in the process of continuous improvement related to the quality system, which now requires a lot of manual work to collect the development measures. We received a score of 3 there, and in the self-assessment before the assessment interviews, we had also observed it as an area of development. Other recommendations related to the development of operations concerned, among other things, the development of the entire quality system and a more detailed identification of various indicators to measure the achievement of goals. 

The final report produced by the assessors provides a reference for the areas to be developed and Fimea itself defines the areas in which we want to further improve our operations. After the final report, an action plan is submitted to the BEMA Secretariat, which coordinates the assessments and now operates in connection to the Agency for Medicinal Products and Medical Devices of Croatia. The implementation and monitoring of development measures takes place as part of normal operational planning.