Fimea is strongly involved in the management of the corona epidemic

Corona vaccine ampoules on the table.
© GettyImages/solarseven

The year 2020 was completely exceptional in Fimea's operations as well due to the global corona pandemic. The year taught us a lot about the importance of preparedness and cooperation. One of the most important lessons learned was the importance of constant and regular risk assessment and preparedness for crises. The better the risk prevention and preparedness, the better the prospects for handling the crisis. In order to safeguard pharmacovigilance and the safety of patients, we also had to consider new, more agile practices, such as the rolling marketing authorisation assessment procedure and remote inspections.

At Fimea, we already initiated preparedness measures in view of the COVID-19 epidemic in early 2020. We reviewed the stock situation of medicines, considered the critical medicinal products and their availability, and mapped out the manufacturing processes of the medicines currently on our market. We also contacted pharmaceutical industry operators, such as manufacturers, importers and wholesale and retail distributors. We urged them to assess the effects of the spread of the virus on the availability and supply chains of medicinal products and to initiate the necessary preparedness and risk management measures in respect of, among other things, the stock situation.

Together with healthcare professionals, we reviewed the list of critical medicines needed in the COVID-19 treatment and anticipated the additional supply needs of medicines. The Finnish system of mandatory reserve supplies of medicines helped to manage and stabilise the situation and proved to be an important safeguard mechanism in this crisis situation as well.

A shared, up-to-date situation picture is essential in crisis management

A rapidly changing situation requires close liaisons and a clear division of responsibilities. In March, the Ministry of Social Affairs and Health set up a coordination group in its administrative branch and an operational group for the management of the COVID-19 epidemic. The monitoring and coordination of the overall picture of the whole country was centralised under the Coordination Group of the Prime Minister's Office, the Situation Centre, and the newly set up Operations Centre.

Fimea also switched to the crisis management model, and we set up a crisis group separate from normal operations that focused on the management of the corona situation. By appointing separate responsible persons to address the crisis, we wanted to ensure the continuity of Fimea’s other operations with as little disruptions as possible.

In order to understand and maintain the overall picture of pharmaceutical services, a new data collection system was quickly set up at Fimea, which enabled us to monitor the consumption of medicines and the sufficiency of medicine stocks in real time. The information was used to generate a situation picture of pharmaceutical services for the use of the government. This information was used, among other things, to assess the consumption of, and procurement need for, intensive care medicines.

Open communications increase trust

In exceptional situations, there is an immense need for communications both with regard to citizens, the media, industry operators and other administration alike. Right at the onset of the epidemic, we gathered answers to frequently asked questions on our website as well as news articles about the disease, possible medicines, and vaccine development.

We appointed the responsible persons to answer questions from the media and citizens and to provide on-call communications. We also held Twitter question hours where our experts answered questions on the medicinal treatment of a corona infection, among other things. For enquiries from the citizens, we opened a dedicated e-mail service, enhanced our media monitoring, and activated the monitoring of social media and participation in discussions.

Having already operated in multiple locations for quite some time, Fimea is perhaps more familiar with remote work and virtual meetings than many other agencies, but maintaining a shared situation picture and communication also within the organisation is important and essential for the smooth functioning of the agency.

Throughout the year under review, our entire personnel gathered every week or two in a virtual info session where we reviewed the epidemic situation, Fimea's actions to ensure the functioning of pharmaceutical services, and the impact of the situation on our own operations. Regular weekly meetings were held with supervisors to discuss the securing of operations in an exceptional situation and to share tips on the challenges involved with remote management. Our in-house intranet has its own corona website and a Q&A column. 

Vaccines are developed in international cooperation

In the autumn, the focus of our operations shifted to marketing authorisations for corona vaccines. Fimea was actively involved as a commenting Member State in the evaluation of vaccines under the auspices of the European Medicines Agency (EMA). Fimea's experts reviewed at the application materials and evaluation reports. Through written comments and committee and working group discussions, Finland's views have also been taken into account in the evaluation.

The marketing authorisation evaluation of Covid vaccines is similar to that of other medicines, but the timetable is considerably faster and more flexible. At the end of 2020, a conditional marketing authorisation was granted for the first corona vaccine, and the vaccinations were also started in Finland. The work will continue in 2021 in the marketing authorisation process of other vaccine manufacturers and in the safety monitoring of vaccines

Read more

The corona spring taught us a lot about the importance of preparedness and cooperation (in Finnish)

Crisis situations measure the effectiveness of cooperation – Q.E.D! (in Finnish)

Centralised marketing authorisation process for corona vaccines (in Finnish)

Marketing authorisation of new corona vaccines - how does the quality assessment work? (in Finnish)

New vaccines are developed for the Covid-19 disease (in Finnish)