Modernised operating methods and a new register of adverse reactions – Agile public agencies do exist

It’s not often that a systems project sparks joy in an expert organisation. However, that is exactly what happened at Fimea, when the reform of the register of adverse reactions turned out successful and even exceeded expectations. At Fimea, previous development projects have been a source of stress.

“People have described the new system as ‘wonderful’. The user experience is top-notch. Now, we have a user-friendly and reliable system that is easy to work with. It also reduces the possibility for mistakes, which is vitally important for developing pharmaceutical safety,” says the Product Owner of the Adverse Reaction Register Kari Salmela, who also works with human medicines.

Fimea’s old data centre-based system from 1998, had reached the end of its life. With the Hava modernisation, we also implemented a high-quality cloud management system with the so-called Platform Engineering approach, making use of the Solita CloudBlox service concept. Implementing the service in a cloud environment enables agile development, even after the project stage is over.

“We have published new features in Hava every week since it was implemented,” says Solita Project Manager Tiina Orpana about the further development stage.

More resources for experts to focus on core tasks

Fimea had a significant need to facilitate and enhance the authorities’ work by replacing rigid and ineffective operating methods with modern solutions. Additionally, international standards and data content have changed, and Hava, the register of adverse reactions, had to meet the requirements of the new R3 standard.

The pandemic created a tidal wave of adverse reaction reports. Fimea, a public authority that monitors medicines, medical devices and biobanks, as well as develops the pharmaceutical industry, has a duty to process every report. The Hava modernisation aimed at transitioning to a digital era in which operating methods are redefined, productivity is improved and the quality of work is boosted by digitalising manual processes, among other things. This frees up a significant amount of time for the experts to focus on their core tasks.

After the changes, submitting adverse reaction reports, the handling process and forwarding to the European database is done in one digital service, which makes the experts’ processing work easier and more efficient.

On the animal medicine side, citizens couldn’t submit electronic reports on animal medicine adverse reactions. This new digital service will guide users to provide the correct information and to avoid mistakes. Many of the data were restructured for the new service, which in part enhances further processing and data transfer.

“The old service didn’t direct users to create high-quality data for Fimea,” says Salmela from Fimea. 

Experts demonstrate Hava for international colleagues

Fimea Head of IT Mirke Turunen says that the system has become a natural part of the substance experts’ working culture over the course of the project.

“It has been my pride and joy to see how the experts have adopted the system as a natural part of their daily work and how they demonstrate it to our international colleagues, even when they have no background in this particular field. The technology side is no longer a separate black box, but an important part of their work,” says Turunen.

What was special about tour partnership and software modernisation was the mutual understanding and finding the common ground between the software developers and pharmaceutical professionals. This was an unusually natural meeting of industry and technology skills.

According to Turunen, the project has gotten a lot of international interest: “Our international colleagues have been surprised by how we’ve gotten our experts and IT people on the same page to this extent.” 

Humans at the core of change

The system modernisation has significantly improved job satisfaction. Fimea people have become more interested in joining new development projects, as they feel that the results will have a significant effect. Fimea Veterinary Officer Jonna Kumpulainen praises the interpersonal chemistry during the project.

“How two teams from very different environments understood each other from the start is fantastic and special. The cooperation between Solita and Fimea was immediate and seamless, with a motivational and encouraging atmosphere. Solita certainly has incredibly skilled people,” says Fimea’s Kumpulainen.

Agile public agencies do exist

The modernisation of the register of adverse reactions was the first truly agile cloud software project for Fimea. According to Turunen, there was a significant will at Fimea to try out a new kind of procurement and implementation model, as old, traditional methods hadn’t produced the desired results. Public projects are very rarely implemented with agile methods.

At the outset, it was ensured that the project team would have a shared understanding of the project’s goals, methods and the reasons why projects like this should make use of the agile approach. Targets and KPIs were set for the project and the team’s operations and they were reviewed and monitored on a regular basis.

Through a focus on what creates the most value and tight joint planning ensured that the project was always working on the right things. Bold experimentation and early user testing made it possible to change focus quickly and to learn during the project.

“Fimea’s commitment to the change and their attitude to fully engage with the agile approach were very impressive to us,” says Aleksi Kallan.

The FimeaWay operating model was built hand-in-hand with the Hava project

The Solita–Fimea partnership also resulted in the first version of the FimeaWay operating model, which will serve as a basis for future development projects. FimeaWay is a creative operating method that always evolves and systematically creates good practices for future development projects. The cornerstones of FimeaWay are a focus on quick value creation (Value), promotion of good cooperation (Us) and Fimea’s designed operating methods that consider the people and the organisation undergoing a change (Agility and change). The concrete result was the FimeaWay Playbook, which will be used, among other things, to compile experiences and good practices from development projects that can be applied elsewhere.

FimeaWay has been widely shared at Fimea, and it has a significant effect on the organisation’s culture and operating models: transparency and cooperation have increased and people work less in their own silos. Fimea now has a clear, common method for getting started on work for future development projects.

“This cooperation is characterised by the word, ease. It was carried out in agile pieces, and there was nothing that needed to be fixed, when all the ideas and definitions were already done. This agile project was such a success that it resulted in a side product, FimeaWay. It is great to take part in a project that is so successful that it is used to create a playbook. We are very pleased,” says Fimea’s Kumpulainen.

Towards better pharmaceutical safety

Fimea analyses and submits all the information it receives from reports on adverse reactions to the European Medicines Agency, through which the information finds its way to the marketing permit holder and the World Health Organisation. These changes are significant for society, as they result in higher-quality information on medical control and monitoring. Reports on adverse reactions are analysed and frequently recurring, serious adverse reactions are always studied in detail.