COVID-19 continued to generate work

© GettyImages/Marian Vejcik

Vaccine ampoule and syringe.

The COVID-19 crisis continued to be visible in Fimea's everyday life, and tasks related to the COVID-19 pandemic continued to generate work in 2021.

In 2021, the first COVID-19 vaccines were made available to Finns over 12 years of age. The adverse effects of vaccines have always been the subject of general interest, and when almost the entire population was given the opportunity to take the COVID-19 vaccine, interest in the adverse effects caused by the COVID-19 vaccines grew considerably. This was reflected in the activity of reporting adverse reactions and the number of surveys. The need for information on adverse effects of vaccines was high for health care professionals, consumers and the media alike. Information on adverse reactions was actively distributed by providing information to the media, providing situation reviews to health care professionals and the Parliament's Social Affairs and Health Committee, by participating in citizen webinars, and publishing information and summaries on Fimea's website on a regular basis, and responding to citizens’ questions.

The development of COVID-19 medicines progressed at a tremendous pace in 2021, and Fimea participated in their evaluation and commenting. All COVID-19 medicinal products were processed through a common European centralised marketing authorisation procedure, most often in the so-called rolling review procedure, and their management in the EU has been a huge effort for the entire network of EU pharmaceutical authorities, including Fimea. The evaluation work has been carried out under pressure of time in each agency, and the working groups and committees have met several times in additional meetings to discuss COVID products. Since the medicines generate extensive interest and many contacts, communication to individual citizens and media representatives has become a significant part of the job description of several experts. 

In 2021, the availability of medicines clearly improved compared to 2020 and normalised to 2019 levels. 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 .

The COVID-19 pandemic did not cause demand peaks in medicines such as 2020 in Finland, but individual problem groups could still be observed in medicines due to the pandemic. For example, wide-ranging production problems were identified with immunoglobulins, as plasma used as raw material could not be collected sufficiently to meet demand due to the COVID-19 pandemic. In January 2021, the Ministry of Social Affairs and Health decided, on Fimea's proposal, to exempt intravenous immunoglobulin products from compulsory storage of medicines in order to ensure their availability for healthcare use. Challenges related to plasma availability have already been identified before the COVID-19 crisis, and in accordance with the EU recommendations, a study on improving plasma availability and self-sufficiency was also launched in Finland in co-operation with Fimea, the Finnish Red Cross Blood Service and the Ministry of Social Affairs and Health.

Due to the pandemic, a longer-term shortage of availability of anti-inflammatory tocilizumab medicinal products also began in the second half of 2021, which will continue in 2022. Tocilizumab products are used globally for the most severe symptoms of COVID-19, unlike the indications indicated in the marketing authorisation. In late 2021, the European Commission approved the use of COVID-19 on the basis of the company's application.

The EU Health Union actions launched as a result of the COVID-19 pandemic, such as strengthening the role of the European Medicines Agency in crisis preparedness and management, impose significant monitoring and reporting obligations on national pharmaceutical authorities. These actions have been developed and launched in co-operation with the pharmaceutical agencies of other countries and the European Medicines Agency during 2021.

National co-operation with other actors in the field has also continued, and the exchange of information has been intensified and further improved in supervisory interfaces. Co-operation with the National Institute for Health and Welfare and the Social Insurance Institution of Finland (Kela) has continued especially in COVID-19 crisis tasks, and we are also involved in updating the pandemic plan co-ordinated by the Ministry of Social Affairs and Health. We were also actively involved in the inter-agency and joint working groups of the Ministry of Social Affairs and Health that had already been established as a result of the crisis.

The intensified market surveillance of surgical masks, which began in 2020, continued in 2021. In January 2021, a comprehensive testing of the marketed face masks was commissioned for consumers, which showed the products to be, excluding small individual observations, suitable and compliant. As a new significant device group at the end of the year, the monitoring of the antigenicity tests in COVID-19 generated a great deal of work. The number of home tests in the market increased tenfold rapidly and required action, especially with regard to the advice and guidance of distributors.

Due to the COVID-19 tasks, it has been necessary to prioritise other tasks at Fimea in order to ensure the operation of the activities related to the pandemic and statutory activities. In particular, employees have been added to the processing of adverse reaction reports for vaccines, the investigation of adverse signals and the provision of information on them through internal transfers and external recruitment. E-services have also been continuously developed during the pandemic, which has streamlined operations and also enabled extensive remote work.