Sweden unveils new cross-sector partnership to attract more clinical trials [Advocacy Lab Content]

The Swedish government will explore a national stakeholder partnership to increase the number of clinical trials in Sweden. The move comes after a decade of slow decline in trial applications, which reached a record low in 2023.

To encourage more clinical trials in Sweden and improve Swedish competitiveness, the Swedish government announced on 27 June that it is giving the Swedish Medical Products Agency (Läkemedelsverket) a mandate to investigate the establishment of a national cross-sector partnership.

Sweden is following in the footsteps of Australia, Denmark, and Norway, which have already established various forms of cooperation to strengthen the life science sector.

“We very much welcome this task, as we have a central role in the Swedish and European work to improve the capacity for clinical trials,” Gunilla Andrew-Nielsen, Head of the Department of Clinical Trials and Special Permissions at the agency, told Euractiv.

It will now consider how a Swedish partnership would be implemented and funded in close cooperation with stakeholders from the pharmaceutical industry, the healthcare sector and patient associations. The department will deliver its report within a year.

Decline of clinical trials

During Sweden’s golden years, between 2005-2013, the number of applications for drug trials fluctuated between 440 and 303 per year. A decade of slow and general decline followed, with some exceptional single years. The period ended with a record-low number of 216 applications in 2023, according to Läkemedelsverket.

The agency is currently compiling statistics on the number of clinical trials that are being conducted in Sweden.

“But we already know that the trend has been decreasing for ten years now, not only in Sweden but also in Europe for multiple reasons,” Gunilla Andrew-Nielsen said.

Sweden’s Christian Democrat health minister Acko Ankarberg Johansson said in a press release that the initiative aims to contribute to the faster development of new medicines and treatments and strengthen Sweden’s global competitiveness.

A partnership similar to the Danish model, Trial Nation, was first proposed in Sweden by a governmental investigator in March 2023 under the name SweTrial, focusing only on industry-led clinical trials.

Broader reach

According to Läkemedelsverket, clinical trials conducted by academic researchers also needed to be included, alongside trials for other medical therapies, med-tech products and in-vitro studies.

“I assume that the government would like to have an ‘inclusive partnership’ since that is incredibly important for success,” Andrew-Nielsen commented.

Many stakeholders have been waiting for the government to act in this area.

“For a long time, it seemed nothing had happened after the SweTrial proposal. Now, we will see how this new proposal turns out. From a patient perspective, we want every patient who needs it to be offered clinical trials and innovative medicines,” Margareta Haag, the chair of the Swedish Network against Cancer, an umbrella patient organisation, told Euractiv.

Her hope is also that the government’s financial proposal for the collaboration would be effective since Swedish healthcare is under strain and understaffed.

“But we really hope SweTrail could be a stepping stone so that drug trials can be more feasible,” she said.

Industry reservations

The industry welcomes the new initiative but with some reservations.

Tobias Bäckström, the Nordic head of Novartis, told Euractiv: “It would be great and important to invest in such a partnership model, provided that there are enough financial resources.”

In addition, he believes that its outcome would depend on how the partnership is organised, provided that “the most important stakeholders, such as the pharma industry, are invited.”

Novartis is among the companies that have reduced its number of clinical trials in Sweden in recent years.

“The reason is that our business group has implemented a new model for how we allocate our clinical trials to generate the best benefit for patients, make the trials as fast and secure as possible, and also cheaper. Then some countries have a priority,” Tobias Bäckström said.

Lack of resources

Additionally, Swedish clinics sometimes turn down offers to conduct clinical trials, due to a lack of personnel and resources. “That is unfortunately not uncommon,” he said.

Also speaking with Euractiv, Jonas Ålebring, the Medical Director of Pfizer Sweden, underlined the importance of clinical research:

“If we don’t invest in clinical research, we won’t have the knowledge to develop new and innovative drugs and therapies to advance the healthcare. Clinical trials are immensely important, and such a proposed partnership initiative will probably also increase Sweden’s competitiveness powder as well as its GDP.”

Ålebring highlights the need to speed up the time to ethical approval and patient recruitment as particularly important for a forthcoming Swedish collaboration to deal with.

In contrast to other research companies, Pfizer has increased its drug trials in Sweden from 20 in 2023 to 34 in 2024.

Pfizer says this is due to an overall increase and the company’s acquisition of Biohaven and Seagen.

Ongoing health crisis

The health crisis is also a factor, according to Frida Lundmark, an expert at the LIF, the Swedish Association of the Pharmaceutical Industry.

“There is too little implementation capacity in the health sector to conduct trials, and Sweden is not delivering what is needed to attract trials,” she told Euractiv.

As she explained, clinical research needs to be a more integrated part of patient care.

“What is unfortunate is that these activities are set against each other when it would be better to link them,” Lundmark said.

Therefore, she welcomed the government’s initiative as “a first step” towards a partnership in Sweden.

Trial Nation

Denmark’s Trial Nation was established in 2018 and is a national cross-sector collaboration between the industry, the five Danish regions, the Ministry of Industry and the Ministry of Health, including the umbrella patient organisation, the Danish Medical Societies.

Through this initiative, a single national entry point for stakeholders to sponsor, participate in and conduct clinical trials has been created.

It aims to be a “leading public-private ecosystem for clinical trials in Europe,” based on an infrastructure consisting of eleven medical therapy centres, networks and associations – as the Phase IV Association – and a medical technology centre.

[By Monica Kleja, Edited by Vasiliki Angouridi, Brian Maguire| Euractiv’s Advocacy Lab]

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