Fimea’s final accounts and annual report for 2021 have been published

The Finnish Medicines Agency Fimea’s final accounts and annual report for 2021 have been published. Articles on the highlights of the year as well as statistics and graphs are also available online at vuosikertomus.fimea.fi/web/vuosikertomus-englanti/home.

“2021 was a busy year, but with the help of the staff's professional skills and efficiency, we achieved the goals set for our operations,” says Eija Pelkonen, Director General. “Close cooperation and good interactions with our stakeholders also helped us succeed.”

Fimea's financial situation remained stable in 2021. Fimea is a net budgeted agency that is funded mainly by the customer fees of pharmaceutical operators. In 2021, marketing authorisations for medicinal products, licence and audit fees for pharmaceutical operators and quality control fees under the separate statute account for approximately 82% of the agency's total funding. The remaining 18% is funded by the state budget, and it includes the general steering of pharmacovigilance by the authorities, the operation of the pharmacopoeia and the assessment of pharmacotherapies process.

COVID-19 tasks continued

The COVID-19 crisis was still a part of the everyday work at Fimea in 2021. The development of COVID-19 vaccines and medicines progressed, and Fimea participated in the evaluation and comments in cooperation with the European pharmacovigilance network. Marketing authorisations were granted to coronavirus vaccines and the number of adverse reaction records, as well as the related surveys, increased considerably. Towards the end of the year, especially the monitoring of COVID-19 antigen home tests kept us busy.

As in 2020, the situation picture and adequacy forecasts of the availability of medicines were maintained and reported at regular intervals to the Ministry of Social Affairs and Health and, in terms of the availability status, also more extensively to stakeholders.

In 2021, active participation in supporting the EU’s pharmaceutical strategy also became important. Fimea participated in numerous EU’s legislative projects, such as the preparation of the implementation of the Medical Devices Regulation, the Veterinary Medicinal Products Regulation and the Clinical Trials Regulation. Due to the changing legislation, we invested extensively in the guidance and advice of actors and stakeholders, for example by organising webinars and events.

In 2021, Fimea committed extensively to implementing the roadmap for reform of pharmaceutical matters by actively participating in the work related to its implementation. The aim of the reform is to improve the cost-effectiveness of pharmaceutical services, ensure medication safety and advisory services related to medications, as well as the fluency, availability and accessibility of services.

Implementation of the new strategy started

In 2021, Fimea published a new strategy focusing on development, the cornerstones of which are service-oriented expertise, a streamlined and enabling operating culture and national and international effectiveness. The aim is to ensure that Fimea can fulfil its tasks and the expectations of the society and its stakeholders in the changing operating environment of the 2020s in the best way possible.

The reform in the organisational structure, supporting the implementation of the strategy, entered into force on 1 March 2022. In the new organisational structure, Fimea's operations are divided into four areas of responsibility, under which the operating entities are grouped: Marketing authorisations, Safety and effectiveness, Supervision and availability and Joint services. In addition, Development and Information Services and Communications Services operate directly under the director general.

Final accounts and annual report 2021 (in finnish, pdf)

Fimea’s Year 2021 (website)