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Management review

Illustration.

© GettyImages/Erikona

Fimea’s year 2020 was predominated by the management of the corona crisis. In order to safeguard pharmacovigilance and patient safety, we had to consider new, more agile operating practices, but despite the new situation, we also proceeded responsibly and in line with our objectives with our basic and development tasks throughout Fimea.

In the spring, we quickly managed to organise our operations between remote and in-office work. We secured the continuity of our operations in exceptional circumstances by supporting our staff with regular info sessions and by organising technical support for remote work.

The need for information is immense in the face of a pandemic situation. We actively provided ministries and politicians with Covid 19 information and expert support for decision-making. We published news on the subject on a regular basis, compiled information packages on our website, and answered a number of questions from the media and citizens, including social media.

Marketing authorisation functions were adapted to urgent application processes. The availability of medicinal products was also safeguarded by means of flexible procedures during the pandemic. We set up a new data collection system for monitoring the information on national supplies of medicines and for forecasting their sufficiency. The remote inspection model was developed during 2020 and integrated as part of Fimea's inspection operations.

In 2020, we introduced structured and standardised provision of pharmaceutical information for the new register of marketing authorisations and medicinal products. We also upgraded the FimeaWeb medicines search and integrated shortage notifications as part of it. Additionally, we started publishing notifications as open data.

The assessment of, and guidance on, the reporting of the presence of substantial nitrosamine impurities in medicinal products on a joint-European basis according to agree-upon rules continued intensely during the year under review. We also worked on the product changes caused by the UK’s withdrawal from the EU and secured the availability of critical products.  Early this year, we launched the national implementation of the new Veterinary Medicinal Products Regulation and a pilot project for the processing of notifications of clinical trials under the new regulation in collaboration with the National Committee on Medical Research Ethics (TUKIJA).

In 2020, a national procurement process for expensive medicines primarily used in hospitals was initiated. HUS Pharmacy engages as a party to the price bargaining negotiations, while Fimea supports the price negotiations with expert assessments. Additionally, a Government’s analysis, assessment and research activities funding (VN TEAS) project to explore the activation of price competition for medicinal products and the clients’ expectations with regard to pharmacy operations in the evolving healthcare and social services system was also started.

On the order of the Ministry of Social Affairs and Health, Fimea compiled a report on national medicinal data repository as part of the implementation of the roadmap for the pharmaceutical sector. We also prepared a guide for safe pharmacotherapy in collaboration with our stakeholders. During the year under review, a report on the changes proposed for the development of the pharmaceutical tariffs, the pharmacy fee and the pharmacy tax, obstacles to the changes and potential drivers of change, was also brought to completion.

Fimea arranged a global PIC/S seminar for GMP inspectors under the theme ‘Remote inspections’. The annual PIC/S seminars are training and discussion events for inspectors of pharmaceutical plants. The seminars are also intended to promote and harmonise the activities of inspectors around the world. The seminar was arranged for the first time as a completely virtual event, and it received excellent feedback from the participants.

The supervision of medical devices, operators in the sector and device trials were transferred from Valvira to Fimea in the 1st January 2020. Additionally, guidance, supervision and registration duties related to biobanks, supervision duties related to embryo research and gene technology legislation, as well as certain the licensing and supervision duties specified in the Act on the Medical Use of Human Organs and Tissues that were under Valvira’s responsibility, was also transferred to Fimea.

During the year under review, Fimea represented Finland in the GAPP project coordinated by the EU Commission, which prepared guidelines for the competent authorities of EU Member States for the assessment and authorisation of the processing of blood, tissue and cell transplants. The guidelines that were under Fimea’s responsibility were completed on time and have been well received by operators in the sector.

At the beginning of the year, Fimea's Helsinki office moved to Tilkanmäki. Hardcopy document archives were digitalised, and the 240 m2 archive space could be abandoned. Digitalisation was promoted by upgrading the case management system (VirastoVahva) and by introducing an electronic long-term storage solution for documents.