Management review 2022

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In 2022, Fimea continued to implement its strategy that focuses on development. At the beginning of March, the organisation structure was reformed to better support the optimisation of operations, shared use of expertise and efficient working. This promotes increased dialogue and collaboration within Fimea and with stakeholder groups. 

Fimea’s new organisation consists of three areas of responsibility: Marketing authorisations, Supervision and availability, and Safety and effectiveness. The areas of responsibility are supported by Joint services, Communications, and Development and Information Services. This new structure boosts our ability to promote the main strategic goals: service-oriented expertise, streamlined and enabling operating culture, and national and international effectiveness.

We started supervisor coaching to support the implementation of the strategy, strengthen a uniform employer role and increase the shared use of resources. We also offered media and performance training for the personnel and provided tips for tasks that require special concentration, meeting practices and improved communications and dialogue. 

In December 2022, we researched the development of Fimea's operations and compliance with our strategy from the perspective of our customers through a customer satisfaction survey. Customer satisfaction in Fimea’s operations has improved compared to the previous survey conducted in 2019. The results show that Fimea is considered to be a reliable source of drug information in Finland and have an active national role in the pharmaceutical sector. According to our customers, creating new and innovative practices leaves the most room for improvement.

2022 was a year of many legislative changes. Fimea has assumed a particularly active role in a cooperative effort to update EU medical legislation. The new EU Regulation on EMA’s extended mandate became applicable in March, and we have participated in several committees and working groups involved in its preparation and implementation. This Regulation also assigns new international data collection and reporting tasks to Fimea. 

Medical device legislation underwent a significant change as the Medical Device Regulation (MDR) and the In Vitro Diagnostic medical devices Regulation (IVDR) entered into force. In 2022, realisation of the new EU legislation became visible, and the challenges brought by the end of the transition periods for the Regulations were highlighted. Fimea has actively contributed to finding solutions to ensure patient safety. 

The new EU Clinical Trials Regulation aims to improve the attractiveness of EU for clinical research, and it became applicable in January 2022. Application of the Regulation uses the Clinical Trials Information System (CTIS), and functional problems of the system burdened Fimea’s experts during the year.

Fimea has also participated in groups preparing the implementation of the new EU Health Technology Assessment (HTA) Regulation. The purpose of the Regulation is to harmonise operations, and it is expected to be in effect in 2025. The end of 2022 saw the launch of more extensive development of the assessment procedure in cooperation with stakeholder groups. 

In addition to legislative reforms, Fimea’s representatives have contributed to the development of several EMA functions and the combat against antimicrobial resistance. 

Fimea has actively participated in international collaboration and focused on meeting the national challenges of drug and medication safety. Fimea produced a solution description for the medicinal data repository and an assessment of the cost-benefit and change impact. These supplement previous reports and create a foundation for national decision-making on the implementation of the medicinal data repository. Fimea also started an analysis of the knowledge management of rational pharmacotherapy and pharmaceutical services. The Ministry of Social Affairs and Health commissioned Fimea to produce two large reports on the content of statutory drug advice provided by outpatient pharmacies, and the retail distribution of medicines and pharmacy systems in Europe. 

In 2022, Fimea began to develop the enterprise architecture. This effort included preparation of the principles and a management model for the enterprise architecture. In addition, the reform of our IT policies paved the way for Fimea’s cloud transformation. We continued the comprehensive and long-term reform efforts of our information systems and information management to further improve the production of up-to-date, usable, relatable and user-friendly drug information for the purpose of knowledge management. 

Fimea also continued the reform of the premises. Our Kuopio office moved to the city centre by Lake Kallavesi when the complete renovation of the building in Hallituskatu 14, previously used by the Kuopio County Government, was completed at the end of 2022. A laboratory and façade renovation began in our Helsinki office. 

Fimea’s management wants to thank our committed and expert personnel and all our excellent partners for 2022!