Management review 2021

© GettyImages/exdez

As was the case in in 2020, in 2021 Fimea's activities largely focused on managing the coronavirus epidemic. The development of COVID-19 vaccines and medicines progressed at a tremendous pace, and Fimea participated in their evaluation and comments in cooperation with the European Medicines Control Network. Both citizens and the media showed great interest, and communication became a significant part of the job description of several experts, for example in the form of sharing information produced in the evaluation of joint European Covid 19 vaccines and medicines.

The COVID-19 vaccines became available to Finns over 12 years of age at the beginning of the year, and interest in the adverse effects caused by the COVID-19 vaccines increased. This was seen as a significant increase in reporting adverse reactions and in the number of enquiries. The need for information on adverse effects of vaccines was high for health care professionals, consumers and the media alike. Fimea shared information openly, for example, with a regularly updated compilation report on its website and press releases on new adverse effects.

Nationally, pharmaceutical service as a whole will be reformed in a long-term process in accordance with the roadmap included in the Ministry of Social Affairs and Health report (2019:5). The aim 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. In 2021, Fimea invested in and been committed to the implementation of the roadmap for pharmaceutical reform, for example by actively participating in division and sub-division work related to implementation. In 2021, Fimea also carried out a Ministry of Social Affairs and Health-commissioned study included in the reform on development needs that was based on the current status of the medicines data repository’s operating requirements and medicinal product information.

During autumn 2021, we made a list of all the development needs for information management in Fimea's different areas of responsibility and prepared a step-by-step development path until 2026.  With the development of information management, we will improve the efficiency of data utilisation, streamline daily operating processes and introduce modern systems and reporting tools.

In cooperation with the Ministry of Social Affairs and Health, Fimea prepared the funding for the provision on minimum staffing in accordance with the Act on Care Services for Older People, partly by reducing the costs of pharmacotherapy. The discussion has included amendments to the Medicines Rate Regulation, which determines the retail price of medicines, and measures aimed at promoting the use of biosimilars.

In 2021, active participation in the implementation and planning of the EU pharmaceutical strategy was emphasised. The work includes numerous EU legislative projects in which Fimea is actively involved and in which it has also invested extensively in the consultation, guidance and advice of actors and stakeholders.

The medical devices sector was significantly amended by the end of the transition period of the new EU Medical Devices Regulation and the full application of the MDR as of 26 May 2021. The main objective of the MD Regulation is to improve patient safety of medical devices in the European Union. For example, Fimea organised a webinar for over 700 people and renewed and updated the website for medical devices. In 2021, Fimea also introduced the new Cere register for the supervision of medical devices.

The EU Veterinary Medicinal Products Regulation entered into force in January 2019 and its application begins on 28 January 2022. The Veterinary Medicinal Products Regulation will significantly harmonise existing legislation at the EU level, and it will bring about changes to such things as marketing authorisation for veterinary medicinal products and the pharmacovigilance of veterinary medicinal products. Fimea has prepared the update and implementation of the Regulation together with the Ministry of Social Affairs and Health. Some of the Regulation’s important objectives include the promotion of the availability of veterinary medicinal products and the combating of antimicrobial resistance.

In the scope of our monitoring of clinical trials, we prepared for the long-awaited application of the EU Clinical Trials Regulation, the full application of which began on 31 January 2022. The new procedure was piloted at the national level in cooperation with Ethics Committee, TUKIJA, and stakeholders were provided guidance by answering an abundance of relevant questions, compiling information on the website and organising separate virtual information days.

As part of the implementation of biobank enforcement activities at Fimea, the first biobank inspection cycle started the previous year was continued, and in 2020-21, Fimea inspected all the biobanks operating in Finland. In 2021, Fimea also organised the first national biobank day on 2 December 2021.

The Regulation of the European Parliament and of the Council on Health Technology Assessment was adopted in December 2021 and will enter into force in early 2025. The Regulation will establish a framework for cooperation within the European Union on the assessment of pharmacotherapies and other health technologies. This Regular sets requirements in particular for developing the capacity of Fimea's evaluation activities over the next few years.

In 2021, Fimea published its new strategy and launched its implementation. All of our personnel were involved in outlining and describing the strategy's more detailed content and concrete objectives through workshops and surveys. The implementation of the strategy will also be strengthened in 2022 by means of an updated organisational structure.

2021 was another busy year, but our personnel’s stone-hard skills and efficiency we achieved the goals set for our operations. Close cooperation with our stakeholders also contributed to this. Thank you for this past year and let’s keep up the good work.