The collaboration was initiated in 2017 by the Finnish Medical Agency (Fimea), the Norwegian Medical Agency (NoMA) and the Swedish Dental and Pharmaceutical Agency (TLV).The collaboration aims at increased efficiency, resource sharing and quality in joint assessments of pharmaceuticals. In addition, the collaboration brings value to our organisations by enhancing knowledge sharing and joint competence development.
"We are very pleased that the Danish Medicines Council in Denmark has joined FINOSE. We have quite similar processes and guidelines for health technology assessment. I am confident that the collaboration will strengthen our Nordic cooperation and contribute to faster access to medicines for all Nordic patients"
says Audun Hågå, Director General of the Norwegian Medicines Agency.
All companies will benefit
To realise the potential of FINOSE for both companies and HTA-bodies, companies need to opt for a unified Nordic assessment of their products via the FINOSE process. We hope the membership of the Danish Medicines Council makes it even more attractive for companies to choose the FINOSE-process, enabling resource savings and avoiding duplication for both the companies and the HTA-organisations.
Agneta Karlsson, Director General of the Swedish Dental Pharmaceutical Agency, stated at the signing:
“Joint assessments are open to all companies and will benefit them through the joint process that should decrease the regulatory burden and speed up market access”
Strenghtens the Nordic collaboration
From the Danish Medicines Council, the motivation for joining the collaboration was expressed by one of their chairmen Steen Werner Hansen:
“A strong Nordic collaboration is becoming increasingly important to us, as we must assess and reassess more and more products and find smarter ways of working. With high-quality joint Nordic assessments, patients, clinicians and pharmaceutical companies have a real chance of benefiting from the collaboration. Being part of FINOSE also allows us to strengthen collaboration with Nordic colleagues on common challenges. These times call for collaboration also in a broader EU perspective, and we are happy to take another important step by joining FINOSE today.”
Renewed for another three years
In the coming years, joint HTA across countries will be strengthened by the European collaboration under the EU HTA regulation (2021/2282). FINOSE offers a possibility both for industry and the Nordic HTA agencies to adapt to joint HTA in Europe and to be well prepared to meet the requirements of the HTA regulation when it is implemented in 2025. The members of FINOSE expect the collaboration to continue beyond 2025 with a focus on products not covered by the European collaboration and joint assessments of health economic models.
The terms of the cooperation are clarified in the Memorandum of Understanding, originally signed by the Director General in September 2017 and renewed in June 2020.
Yesterday, the Memorandum of Understanding was renewed again, when it was signed by Agneta Karlsson, Director General of TLV, Steen Werner Hansen, Director of DMC and Audun Hågå, Director General of NoMA. The agreement has also been signed by Director General Eija Pelkonen and Director Piia Vuorela of Fimea and by Director Jørgen Schøler Kristensen of DMC. The renewed Memorandum of Understanding will be published shortly.