The Nordic countries are each small entities in the pharmaceutical market. However, in line with the trend of larger collaborative networks, such as the Joint Clinical Assessment (JCA) which kicked off in 2025, there are several initiatives for collaboration in the pharmaceutical area, of which some are already in place.
Common HTA process
The Nordic countries have previously joined forces with a common process for health technology assessments with the establishment of FINOSE in 2018, which enabled a common application for reimbursement in Finland, Norway and Sweden. Since then, the collaboration has been extended to include all five Nordic countries, with Denmark joining in 2023 and finally Iceland in 2024. The current pan-Nordic process is now referred to as The Joint Nordic HTA Bodies – JNHB (1).
The final negotiations and recommendations will remain national, but the overall aims of JNHB are (1):
• supporting timely and equal access to medicinal products for patients in all Nordic countries
• less divergence in HTA methodologies and evidence requirements between the Nordic HTA bodies
• sharing of resources and knowledge between the Nordic HTA bodies
• increased efficiency in generation of assessment reports
• reduced administrative burden for industry
Common Nordic packages
Over the past few , there have been recurring reports of shortages of essential medicines in the Nordic markets.
One key objective is to have common multilanguage Nordic packaging as routine for all pharmaceutical companies that operate in several Nordic countries. The advantages in terms of availability of medicines and cost-efficiency are unquestionable, but are the companies’ EU marketing authorization departments sufficiently aware of this opportunity? Thanks to the close cooperation between the Nordic medicines authorities there are detailed guidelines to facilitate packs with all five languages (2). It would be advantageous to have Nordic regulatory experts involved in the process right from the outset of writing the EN labelling texts to avoid the pitfalls that could prevent the application of a common package in the Nordics.
To improve the availability by simplifying production and distribution, a pilot project will introduce English-language common Nordic packages starting in 2025 and will explore the feasibility of such an initiative (3). The project involves all Nordic countries — Denmark, Finland, Iceland, Norway, and Sweden.
Joint effort to secure access to antibiotics
Another area where the Nordic countries are vulnerable as separate markets is in antibiotics. In recent years, the Nordics have indeed experienced difficulties to the supply of antibiotics. are 1) products not registered in one or more of the Nordic countries, 2) deregistration due to low profitability and 3) global production capacity (4).
Several possible measures have been proposed by the Public Health Agency in Sweden, which were reviewed by the Nordic Council of Ministers in April 2024 (4). All participants agreed on the importance of continuing to strengthen Nordic cooperation on antimicrobial resistance (AMR).
One priority that all participants agree on was for new reimbursement models with income guarantees to manufacturers. Another important proposed measure was the harmonization of treatment guidelines across the Nordics to expand the market for relevant antibiotics.
Cooperation for knowledge sharing and common solutions
The Nordic Pharmaceuticals Forum established in 2015 is a voluntary cooperation between the five Nordic countries, with the purpose of ensuring timely access of pharmaceuticals for patients. The scope is sharing knowledge and working towards common Nordic solutions (5).
Cooperation in the forum includes everything from joint tendering procedures and environmental criteria to joint price negotiations for new medicines and sharing knowledge about horizon scanning. According to the director of the pharmaceuticals division at Sykehusinnkjøp HF in Norway, the initiatives and experience within the collaboration means that the Nordics are on their way to becoming the most integrated region in Europe on medicines. This was further underscored with the inclusion of the forum in the European Commission’s Critical Medicines Alliance. The role of the alliance is to advise the Commission and other EU policy makers about the strategy for supplying critical medicines (6).
Take home message
The Nordics is striving to consolidate the entire pharmaceutical market process — from approval to patient access. The communicated strategies and goals from all areas of cooperation between the five countries clearly aim to streamline the processes for market access, ultimately of benefit to both manufacturers and patients.
On all relevant activities in all Nordic countries, we at PharmaLex are excited to follow the further development of collaboration.
About the authors
Annabelle Forsmark is Associate Director Market Access and Healthcare Consulting at PharmaLex. She draws on her vast experience in managing projects concerning all the Nordic markets, including reimbursement dossiers, supporting payer negotiation processes, health economic modelling, evaluation of clinical and health economic data, and strategic advice on market access.
Pirkko Talvio is Senior Director, Regulatory affairs Northern Europe at PharmaLex. She has more than 30 years of experience in regulatory affairs for medicinal products spanning EU marketing authorization and lifecycle maintenance procedures as well as local Nordic regulatory affairs, launch and GDP activities.
References
- https://jnhtabodies.org/about/
- https://www.lakemedelsverket.se/globalassets/dokument/tillstand-godkannande-och-kontroll/forsaljningstillstand/produktinformation/guideline-on-nordic-packages.pdf
- https://laegemiddelstyrelsen.dk/en/news/2024/common-nordic-packages-for-better-availability/
- https://www.folkhalsomyndigheten.se/contentassets/96b6d0eb149f474d83017ff69b12f1a4/nordic-cooperation-better-sustainable-access-antibiotics.pdf
- https://nordicpharmaceuticalforum.com/
- https://nordicpharmaceuticalforum.com/index.php/2024/04/25/nordic-pharmaceuticals-forum-joins-eu-critical-medicines-alliance/
