Chair of the Danish Medicines Council: “Criticism is inevitable”

The task is straightforward – at least on paper.

The Danish Medicines Council is responsible for ensuring that patients in Denmark have access to new medicines that are effective, safe and reasonably priced.

In short, the Council assesses new medicines and decides which should be recommended as standard treatments at Danish hospitals – and which should not.

It may sound simple, but the reality is anything but black and white.

How do you strike the right balance between giving patients access to new, effective treatments and making the best possible use of healthcare resources so that they benefit as many patients as possible?

It is a demanding exercise in priority-setting.

And it often involves difficult dilemmas and tough decisions, says Birgitte Klindt Poulsen.

Birgitte is a consultant and Head of the Department of Clinical Pharmacology at Aalborg University Hospital and has served as Chair of the Danish Medicines Council since the beginning of 2025.

The Danish Medicines Council operates according to seven politically determined principles. But even with a clear mandate and overall framework in place, deciding whether a particular medicine should be recommended as standard treatment is not always easy.

“Sometimes we face incredibly difficult dilemmas,” Birgitte says.

“Sometimes we face incredibly difficult dilemmas.”

In some cases, there is considerable uncertainty about how effective a medicine is, or limited knowledge about its side effects because very few patients have been included in the studies. In other cases, the price may be so high that it is difficult to justify recommending the medicine while also adhering to the principle of getting the greatest possible health benefit from the available resources.

And when the Danish Medicines Council says yes – or no – to a new medicine, the decision has significant consequences.

Once the Council recommends a treatment, it is usually available to patients within a matter of weeks.

“That means we need to be reasonably confident that it will benefit patients and that we are not exposing them to an unnecessary risk of serious side effects,” Birgitte says, continuing:

“It also means that resources are automatically allocated to the new treatment in the regions. And we are well aware that those resources have to come from somewhere else in the healthcare system.”

For Birgitte, it is important that the Danish Medicines Council is as transparent as possible. She believes there must be openness about how the Council reaches its decisions.

“We are very transparent about how we set priorities, and we are continually working to explain the rationale behind our decisions even more clearly,” Birgitte says, continuing:

“That is essential if people are to have confidence in the recommendations we make.”

What about rare diseases?

None of the decisions made by Birgitte and the other members of the Danish Medicines Council are easy. They always require thorough preparation, and the Council discusses each case in depth.

One area, however, presents some particularly difficult challenges: rare diseases.

The Danish Medicines Council assesses medicines for rare diseases in the same way as medicines for more common diseases, Birgitte emphasises.

But rare diseases present a number of specific challenges.

First, there are very few patients, which means that the evidence from clinical studies is often limited.

“There is often no control group, which means that we do not really know how well the new treatment works compared with the treatment patients receive today,” Birgitte says.

“Another challenge is the price. Companies generally set very high prices for these treatments,” she adds.

The Danish Medicines Council has faced criticism from several quarters over its assessment of medicines for rare diseases. The main criticism is that too few new treatment options for patients with rare diseases are recommended.

Last year, an analysis by the Danish Association of the Pharmaceutical Industry (Lif) found that 56 per cent of medicines for rare diseases failed to secure a recommendation for use in Danish hospitals.

“Criticism is inevitable when you have a priority-setting body like the Danish Medicines Council.”

“When more than half of medicines for rare diseases are rejected, that is too many medicines failing to reach patients. Particularly when we know that patients with rare diseases often lack access to effective treatment,” Louise Broe, Director of Hospital Medicines Policy at Lif, said in July 2025.

From the Chair’s perspective, it is hardly surprising that the Council attracts criticism.

“Criticism is inevitable when you have a priority-setting body like the Danish Medicines Council. There will always be criticism when priorities have to be set – and we completely understand that. We listen to the criticism,” Birgitte says.

The Danish Medicines Council is to be evaluated

One criticism frequently levelled at the Danish Medicines Council is that its economic calculations are too narrow.

The Council primarily considers the cost of the medicine itself, but it also takes into account costs such as diagnostic scans, follow-up appointments and the time patients spend travelling to and from treatment.

However, the Council does not include what are known as ‘dynamic effects’. These might include, for example, whether a treatment could enable a patient – or a family caregiver – to return to work and thereby increase labour supply.

“That is not something we have included in our assessments so far, because it is not currently part of our mandate,” Birgitte says.

That may soon change.

The Danish Medicines Council is due to be evaluated in autumn 2026, with its economic assessments and its approach to medicines for rare diseases set to come under close scrutiny.

How do you feel about the possibility that the evaluation could ultimately require you to change the way you work?

“We are very open to the evaluation,” Birgitte says, continuing:

“We will see what comes out of it. If we are given a political mandate to work within a different framework or take other factors into account, then of course we will adapt accordingly.”

Alternative agreements

Whether the autumn evaluation will fundamentally change the Danish Medicines Council’s work remains to be seen. Either way, Birgitte expects rare diseases to remain a major focus in the years ahead.

One approach the Council is already exploring for rare diseases is the use of alternative pricing agreements. In simple terms, pharmaceutical companies enter into special agreements with Amgros – which procures medicines for the Danish regions – and the Danish Medicines Council takes these agreements into account when assessing whether to recommend a medicine.

One example is an outcomes-based agreement, Birgitte explains.

“This means that the regions pay for the treatment of patients who benefit from the medicine, but not for patients for whom it does not work,” she says, continuing:

“Another model could be a volume-based discount – the more we buy, the greater the discount. Or the agreement could be that we pay a fixed amount of, say, x million kroner a year for a medicine, regardless of how much we use.”

Birgitte hopes that these alternative models will become increasingly common in the coming years, as they could help make more new medicines available to patients.

“Amgros has an entire catalogue of alternative agreements, and new models are being added all the time. They could offer a good way forward, but of course this requires companies to engage in dialogue with us.”

Working across borders

Another area that is certain to feature prominently on the Chair’s agenda in the years ahead is international collaboration.

At EU level, the Health Technology Assessment (HTA) Regulation is particularly significant. It has established a framework for joint EU-level health technology assessments, meaning that the Danish Medicines Council will increasingly work with organisations in other EU countries to assess new medicines.

“In some areas, companies are practically stepping on each other’s toes, while there are other diseases where very little development is taking place.”

From 2028, medicines for rare diseases will be included in the joint assessments. The hope is that countries will be able to make even greater use of data across borders and that access to medicines will become faster and more transparent.

“It will be very exciting because we will have the opportunity to help shape European collaboration and the way we work with data. I very much hope that we can make even better use of our health data,” Birgitte says.

The Chair also hopes to see closer collaboration between the Nordic countries on medicine assessments, data collection and price negotiations.

Birgitte also has one request for pharmaceutical companies as they plan for the future: broaden your focus.

“We are seeing a tendency for treatments to cluster around a small number of disease areas. In some areas, companies are practically stepping on each other’s toes, while there are other diseases where very little development is taking place,” she says, continuing:

“It would be good to see that effort spread more evenly.”