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Launching pharmaceuticals in the Nordics: Opportunities and challenges

The Nordics are a well-known powerhouse of pharmaceutical innovation and production. But what opportunities do the region’s own pharma markets offer industry players, and what do marketing authorisation holders need to know when bringing new medicines to these countries?

The Nordic countries have it all. From beautiful landscapes lit by the northern lights to world-class living standards and generous welfare systems, it’s no wonder that Denmark, Sweden, Norway, Finland and Iceland boast some of the happiest and healthiest populations in the world.

Related factors have long made the Nordics a lucrative market for distributing medicines. Healthcare systems are not only robust and comprehensive in these countries, but also funded through taxation, providing universal coverage for citizens. Demographic profiles are rapidly ageing, partly due to public healthcare access, as well as a range of lifestyle factors.

An ageing population

Finland has one of the fastest-ageing populations in Europe, with those aged 65 or over now making up more than 23% of people. This age group represents 21% in Denmark, 20% in Sweden, 19% in Norway and 15% in Iceland. Average life expectancy at birth is high, at 83.2 years in Norway, 83 in Iceland, 82.4 in Sweden and 81.5 in Denmark.

This trend is accompanied by a rise in lifestyle-related diseases such as diabetes and obesity, which are both driving the growth of the pharmaceutical markets here, particularly cardiovascular.

Pharmaceutical expenditure is thus on an upward trajectory. In 2022, year-on-year spending grew the fastest in Denmark and Norway, at 5% and 4.9%, respectively. In addition, the share of healthcare spending sourced from the public sector exceeded 80% in Denmark, Iceland, Norway and Sweden.

There is a strong and growing market for pharmaceutical products in the Nordics, and numerous opportunities and challenges across the market-access journey. Here, we provide a summary of everything you need to know.

Decentralised healthcare

One of the key challenges of launching medicines in the Nordic region is the decentralisation of healthcare in Sweden, Denmark and Finland, meaning that health systems are managed and run by local authorities rather than a national entity. When evaluating new medicines, local authorities make the final pricing and reimbursement decisions, based on recommendations from the national authority, such as the Danish Medicines Council in Denmark, or the Dental and Pharmaceutical Benefits Agency (TLV) in Sweden.

While there are benefits to decentralisation, it can act as an obstacle to a more equitable healthcare system. By nature, it also leads to fragmentation, making drug launches in these countries more complex to navigate. Norway is moving away from this approach, however, and is currently classed as semi-decentralised.

Health technology assessments

When it comes to health technology assessments (HTAs), governments in the Nordics have been a key driving force behind the pan-European trend for greater cross-border collaboration. 

In 2017, three HTA agencies from the region – the Finnish Medicines Agency, Norwegian Medicines Agency and the Swedish TLV – established the landmark FINOSE network for joint assessments. Denmark’s Danish Medicines Council joined this year, further strengthening the Nordic collaboration.

FINOSE claims to provide pharmaceutical companies with an attractive, more efficient pathway to market by reducing the complexity of HTA submissions. Its key goal is to support timely and equal access to new medical technologies.

Pricing mechanisms

Further cross-border collaborations are in play when it comes to pricing and reimbursement negotiations.

The Nordic Pharmaceutical Forum (NPF) initiative was established in 2015, with the aim of solving common medicine access challenges across Denmark, Iceland, Sweden, Finland and Norway. By conducting joint price negotiations with all these countries, pharma companies can increase their penetration in these smaller markets, although unit costs may be lower due to the stronger negotiating power of the united countries.

The NPF initiative is still in its pilot phase and operates on a voluntary basis. When approached separately, there remain a range of differences – and similarities – between each country’s approach to market access. Overall, the comprehensive healthcare systems in the Nordics provide favourable market access conditions for marketing authorisation holders. However, the region has a strong focus on containing and lowering healthcare costs, which may limit the revenue of pharmaceutical companies.

The Norwegian Government is one of Europe’s strongest proponents of generic and biosimilar substitution as a means of lowering healthcare costs. Sweden has also developed several pricing mechanisms to this end.

Finland mostly relies on competition, as well as a combination of generic substitution and reference pricing to drive down medicine prices. Iceland, meanwhile, uses a reference pricing system whereby its pharmaceutical prices are based on those set by the other Nordic countries.

Denmark takes a different approach again. The country’s free price policy, whereby the Danish Medicines Agency plays no part in a pharmaceutical company’s price decisions, offers the most favourable market access conditions for industry players. The country is regarded as a strong market for early launches in Europe and it may also offer opportunities for an accelerated drug registration process.

According to GlobalData, the registration of a pharmaceutical product under Denmark’s national procedure takes an average of 128 days – significantly less than the US and EU averages of 322 and 366 days, respectively.

The key to successful launch

Launching pharmaceuticals in the Nordics may have its challenges, yet this is a corner of Europe that cannot be overlooked, as these countries have a combined population of 27.8 million people and demand for medicines is growing. There are opportunities for efficient pathways to market across this region, as the average time to receive decisions on both pricing and reimbursement in the Nordic countries are on the lower end of the scale. Timelines are particularly low in Denmark and Norway, but Sweden, Iceland and Finland are also in Europe’s top 15 for short drug registration timelines.

As with any European drug launch, it’s essential to study reimbursement schemes in each country and devise a market access strategy as early in the drug development process as possible, as this gives manufacturers an opportunity to engage with the market’s main stakeholders at the national, regional, and/or local level.

Furthermore, companies looking to strengthen their presence in this region can do so with the help of a seasoned expert such as Abacus Medicine Pharma Services (AMPS), an industry service provider on a mission to improve medicine access around the world.

AMPS provides services across the commercial journey, from market access and commercial strategy to medical affairs, supply chains and compliance. With its headquarters in Copenhagen and a particularly strong distribution infrastructure across Northern Europe, AMPS could be your answer to a successful drug launch in the Nordics.