As clinical trials increasingly drift toward Asia and the US, can Denmark offer a blueprint for revitalising Europe’s competitive edge?
As Europe’s leader in clinical trials per capita, Denmark combines a deep domestic commitment to cutting-edge research with strong international confidence as a destination for investment. In 2023, the number of active trials reached 450, a nearly 10 percent increase from the previous year. High levels of citizen engagement and public willingness to participate have played a decisive role in Denmark’s success. As Vanessa Vega Saenz, Director at Invest in Denmark, notes, “Given that trial recruitment is always a key challenge, Danish openness to trial participation makes the country an ideal setting for clinical research.”
Yet, despite these achievements, Denmark faces intensifying global competition and a wider European trend of declining competitiveness in clinical research. While the total number of ongoing trials rose in 2023, the number of newly initiated studies fell from 106 to just 68. Even strong ecosystems must continue evolving to remain attractive.
“Of course, maintaining leadership in this space requires ongoing effort,” says Marianne Pilgaard, CEO of Trial Nation – a public-private partnership aimed at increasing investments in pharmaceutical and medtech clinical trials within Denmark. “Clinical trials are not static; they demand constant improvement,” she continues. “Many countries see the benefits that trials bring not only in public health but also to economic growth. Therefore, competition in this area is stiff.” In response, Denmark’s Life Science Strategy Towards 2030 has made trial competitiveness a strategic priority and set the trajectory for the future of Danish clinical research.
As part of one of six strategic initiatives under the plan, the Danish government has set a benchmark: by 2030, the country should remain among Europe’s top performers in clinical trials per capita. Alongside financial measures like a permanent 120 percent R&D tax deduction, more than USD 123 million in funding for health and life sciences research, and USD 33 million dedicated to strengthening clinical and independent research, the strategy outlines an enhanced framework. It aims to leverage Denmark’s digital infrastructure for decentralised trials, reduce barriers to health data access, and translate regulatory excellence onto a European stage while using policy agility to overcome the limitations of scale.
World-Class Data & Digital Infrastructure
At the core of Denmark’s clinical research strength lies its comprehensive health data ecosystem. The country’s person registry (CPR) system assigns each citizen a unique ID that integrates data from hospitals, disease-specific registries, and biobanks into a lifelong health record.
According to the National Danish Genome Center, 72 percent of Danes trust researchers and the healthcare system to handle data responsibly; a key enabler of clinical research. This high level of public trust underpins one of the world’s most complete and cohesive health data infrastructures.
“Denmark has long distinguished itself through the depth, quality, and cohesion of its national health data infrastructure. Anchored by a personal identification number assigned to every citizen, this centralised system enables the seamless integration of health data across all sectors,” explains Nils Falk Bjerregaard, Director General of the Danish Medicines Agency (DKMA), which oversees clinical trial authorisations and medicinal product licensing. “Combined with the country’s high degree of digitalisation, this infrastructure forms the backbone of Denmark’s leadership in data-driven healthcare and regulation.”
Denmark’s digital sophistication was also recognised by the European Commission, which named it the EU’s most advanced digital infrastructure in its 2021 Digital Economy and Society Index. This maturity supports the industry’s shift toward decentralised clinical trials (DCTs). In 2021, Denmark launched its DCT Dialogue Forum and national DCT guidelines, positioning itself at the forefront of this model. “Whether that means data collection, treatment, or communication, the goal is to make the entire process more accessible and patient centred,” says Pilgaard.
Still, challenges remain. Despite Denmark’s robust digital foundation, accessing health data is often perceived as a slow, complex process. “The country’s digital infrastructure, national registries, and access to high-quality data are incredibly advanced. The foundation is there; the next step is fully leveraging these assets,” notes Montse Jansà, General Manager and Managing Director of Merck Denmark.
One focus of the life science strategy is reducing case processing times for data access while maintaining security and transparency. “Plans are in motion to establish a single point of contact and a national analytics platform for health data,” explains Vega Saenz. “This will allow researchers and companies to access public datasets in a coordinated way, through both public and public-private frameworks.”
Although a centralised authority is still in development, the government has begun collaborating with the National Board for Digitalisation and Data for the Healthcare and Senior Citizen Area. Established in 2024, the new body is responsible for the management of digital health infrastructure and patient data use.
An Ecosystem Powered by Collaboration & Government Support
While advanced data systems are a critical advantage, Denmark’s success also rests on its supportive policy environment and culture of collaboration. “DKMA has made the enhancement of Denmark’s clinical research environment a strategic priority,” says Bjerregaard. “Central to this effort is a regulatory culture rooted in openness, dialogue, and responsiveness.”
That philosophy is embodied by Trial Nation, which since 2018 has acted as a single-entry point connecting sponsors with clinical sites and research partners. “Close coordination and public-private partnerships are a stronghold for Trial Nation and Denmark,” adds Pilgaard. “Ensuring well-functioning clinical trials is a key aspect in attracting collaborations to uncover future medical solutions.”
For global companies, this approach signals a long-term opportunity. “Having an active clinical research footprint highlights both our long-term commitment to the Danish market and our drive to accelerate access to cutting-edge therapies through rigorous scientific exploration,” says Steve Wright, General Manager and Head of Human Pharma at Boehringer Ingelheim Denmark & Norway. “We’re entering what may be the most active period in our clinical development history… This convergence of national leadership, regulatory openness, and scientific innovation marks a pivotal moment not just for Boehringer Ingelheim, but for the broader healthcare landscape we’re proud to support.”
This philosophy also underpins MSD’s presence. “Where we invest in trials, we also support training, infrastructure, and local engagement, and it is often in these same environments that new therapies can more readily reach patients,” says Søren Granhøj Pedersen, Managing Director, MSD Denmark & Iceland. “This cycle between research and implementation is something we continue to advocate for, and while there is room for improvement, it is encouraging to see it reflected in Denmark’s national life science strategy as a clear objective.”
While Denmark’s population of six million limits total trial volume, the country has embraced its size as a strength by focusing on early-phase trials where speed, quality, and expertise matter more than scale. To support this, the government established a Medical Research Ethics Committee that fast-tracks Phase I approvals within 14 days.
“Our focus on early-phase trials leverages our technical expertise whilst acknowledging our population limitations,” says Helle Harder, Head of the Science & Ethics Division at the Danish National Centre for Ethics. “Denmark possesses the scientific capabilities to contribute meaningfully to Phase I trials, establishing this as our strategic emphasis.”
Bringing Europe to the Forefront
Even with its national advantages, Denmark operates within a wider European landscape that is losing ground globally. “Europe’s global share of clinical trials has dropped from 22 percent in 2013 to just 12 percent in 2023,” warns Pedersen. “If this trend continues, the region risks weakening a sector that is not only essential for patient health but also critical to economic resilience and scientific leadership.”
To counteract this, Denmark aims to lead by example and set the bar for a more competitive ecosystem across the region, starting with their fast-track approval policy. “For multinational trials, we can guarantee 14-day processing whilst encouraging sponsors to identify other countries capable of matching this timeline,” says Harder. “This approach utilises market forces to pressure other systems toward similar performance standards, ultimately benefiting European competitiveness rather than only providing sustained Danish advantage.”
She continues, “Whilst competition between European countries may drive individual improvements and contribute to regional competitiveness, our fundamental objective involves creating an attractive European Union environment for clinical trials.”
Pilgaard agrees, going on to say, “there is an increasing awareness within the EU of the need to harmonise regulatory frameworks and reduce operational barriers, as national legislation can sometimes overlap or conflict with the broader European regulatory frameworks.” For Bjerregaard, Denmark’s position is clear: “Denmark is not merely a recipient of European Medicines Agency (EMA) decisions; we are an active participant in the scientific and regulatory processes that lead to them.”
Looking ahead, Denmark’s continued leadership will depend not only on what it achieves at home but on its ability to elevate the entire EU clinical research environment. As Harder concludes, “The Danish model can serve as an inspirational framework for other European nations, demonstrating how regulatory excellence can become a competitive advantage rather than an impediment to innovation.”
