Sweden unveils new cross-sector partnership to attract more clinical trials – Euractiv

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 the country’s competitiveness, the Swedish government announced on 27 June that it was tasking the Swedish Medical Products Agency (Läkemedelsverket) with investigating the possibility of establishing a national cross-sector partnership.

Sweden follows in the footsteps of Australia, Denmark and Norway, which have already established various forms of cooperation aimed at strengthening the life sciences sector.

“We are very happy about this assignment as we play a key role in the Swedish and European work to improve the capacity to conduct clinical trials,” Gunilla Andrew-Nielsen, head of the Clinical Trials and Special Authorisations Department at the agency, told Euractiv.

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

Decline in clinical trials

During Sweden’s golden years, from 2005 to 2013, the number of drug research applications ranged from 440 to 303 per year. There followed a decade of slow and general decline, with a few exceptional individual years. This period ended with a record low of 216 applications in 2023, according to Läkemedelsverket.

The Agency is currently collecting statistics on the number of clinical trials conducted in Sweden.

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

Sweden’s Christian Democratic 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 to strengthen Sweden’s global competitiveness.

A partnership similar to the Danish model, Trial Nation, was first proposed in Sweden by a government researcher in March 2023 under the name SweTrial and focuses exclusively on industry-led clinical trials.

Wider reach

According to Läkemedelsverket, in addition to research on other medical therapies, medical-technical products and in vitro studies, clinical trials conducted by academic scientists should also be included.

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

Many stakeholders have been waiting for government action in this area.

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

He also hopes that the government’s proposal to finance cooperation will prove effective, as the Swedish health service is overloaded and understaffed.

“We really hope that SweTrail can be a milestone that makes clinical drug trials more feasible,” she said.

Industry Reservations

The industry welcomes the new initiative, but has some reservations.

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

Furthermore, he believes that its outcome will depend on how the partnership is structured, provided that “key stakeholders, such as the pharmaceutical industry, are invited.”

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

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

Lack of funds

In addition, Swedish clinics sometimes reject offers to conduct clinical trials due to lack of staff and resources. “That is unfortunately not uncommon,” he said.

In an interview with Euractiv, Jonas Ålebring, Medical Director of Pfizer Sweden, stressed the importance of clinical trials:

“If we do not invest in clinical research, we will not have the knowledge to develop new and innovative medicines and therapies that will advance healthcare. Clinical research is extremely important, and such a proposed partnership initiative will probably also increase Sweden’s competitiveness as well as its GDP.”

Ålebring emphasizes that the need to shorten the waiting time for ethical approval and patient recruitment is particularly relevant in the context of future Swedish cooperation.

Unlike other research companies, Pfizer has increased the number of drug trials in Sweden from 20 in 2023 to 34 in 2024.

Pfizer says this is due to overall growth and the acquisition of Biohaven and Seagen.

The ongoing health crisis

According to Frida Lundmark, an expert from LIF, the Swedish Pharmaceutical Industry Association, the health crisis is also a factor influencing this state of affairs.

“There are too few opportunities in the healthcare sector to implement research, and Sweden does not provide what is needed to attract such research,” she told Euractiv.

As she explained, clinical trials need to become a more integrated part of patient care.

“The unfortunate thing is that these activities contradict each other when it would be better to combine them,” Lundmark said.

She therefore welcomed the government initiative as a “first step” towards partnership in Sweden.

Trial Nation

The Danish Trial Nation was founded in 2018 and is a national cross-sectoral collaboration between industry, the five Danish regions, the Ministry of Industry and the Ministry of Health, including the umbrella patient organisation, the Danish Medical Societies.

This initiative creates a single national point of contact where stakeholders can sponsor, participate in and conduct clinical trials.

The association aims to create “the 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.

(Author: Monica Kleja, editing: Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab)

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