The change follows a review of the central health administration in Norway and will take effect on January 1st, 2024. The English name of the directorate is the Norwegian Medical Products Agency (NOMA).
“Compared to the Norwegian Medicines Agency, the new directorate will have an expanded portfolio of responsibilities within emergency preparedness and public financing of medical products. We are taking on more tasks and are establishing closer collaboration with both existing and new stakeholders" says Director Audun Hågå.
The new directorate will also have responsibilities related to the approval of actors handling blood, cells, and tissues.
See also: Practical information about the transition
Strengthened emergency preparedness for medical products
In the autumn of 2023, the Norwegian Government presented a parliamentary report on health preparedness. NOMA assumes overall responsibility for the supply security and emergency preparedness of medical products. This includes monitoring the value chains, an enhanced role in product procurement, and management of emergency stockpiles.
"The COVID-19 pandemic demonstrated how medical products have a complex and vulnerable supply chain. Subsequently, new emergency preparedness functions have been established in Europe, creating a need for enhanced national coordination. In this context, the directorate assumes a system responsibility in Norway for preparedness and supply security of medical products, says Hågå.
This involves closer dialogue with stakeholders and strengthened international cooperation. Cooperation with the European Medicines Agency (EMA) and the Health Emergency Preparedness and Respons Authoroty (HERA) becomes particularly important.
Norway’s foremost expertise in health economics
Medicines and health technology are rapidly developing, and the industry is proactive. The increasing availability of products improves people's quality of life, but also poses a complex fiscal challange on public budgets
The new directorate will become Norway's foremost expertise in health economics, with about 70 employees specializing in this field. The directorate will be responsible for cost-benefit assessments of all medical products, including vaccines and medical devices.
“As more cost-benefit assessments are prepared, alongside increasingly complex documentation, we need to maintain a good balance between ensuring solid cost-benefit assessments and being efficient in our assessment processes. Therefore, it is necessary that we continually evaluate how this work is carried out. A large and attractive professional environment will ensure that we develop and remain at the forefron" says Hågå.
In addition to health technology assessments, the directorate will have expanded responsibility for market insight and the procurement of vaccines. A professional environment for the procurement processes of National Insurance-financed medicines and vaccines, vaccines for vaccination programs, and medicines for the emergency stockpile in Norway, will also be established. This includes examining the use of innovative public procurement to ensure access to medical products.