New executive order raises fees in the area of the Danish Medicines Agency

Higher fees become payable for medicinal products and pharmaceutical companies as a result of a new executive order entering into force on 1 May 2022. The last time the fees were adjusted was in 2017.

The higher fees introduced by the new executive order are to ensure that the agency can continue to perform its statutory tasks at a consistently high standard and speed. Both the workload and complexity of the tasks that the Danish Medicines Agency is responsible for handling have increased over recent years.

The fees are therefore adjusted to bring revenue in line with the actual costs of operating the agency’s fee-based activities. Consequently, the raised fees are going to cover a total funding need corresponding to DKK 34 million annually. The sum is going to fund, for example, new computerised systems and additional resources for the agency’s efforts related to safety monitoring and supervision in the pharmaceutical area.

“The Danish Medicines Agency incessantly strives to work smarter and more efficiently. That's why we have so far been able to keep up with the increased complexity and workload without raising any fees. But we must realise that starting now and over the coming years, we need to replace old computerised systems with new and better solutions – including IT solutions that can integrate with the systems used by the other drug regulatory authorities in Europe. We rely on these IT systems and databases to complete our statutory tasks at a standard and speed expected by society,” says Lars Bo Nielsen, director general of the Danish Medicines Agency. 

The agency has been exceptionally busy in the past two years because of activities related to the COVID-19 pandemic. Unfortunately, this has impacted the review times in other areas of our business. One of our most important focus areas is therefore now to deal effectively with the administrative work that has been piling up.

“We are right now evaluating the status on the review times of our regulatory tasks across the organisation to identify the areas where we need to take action. We are recruiting people continuously, but it obviously takes time before they know the ropes and we can catch up. But we are very aware that keeping the assessment times is very important for the companies, says Lars Bo Nielsen. 

In the coming months, the executive order on fees will be revised again to reflect the new veterinary medicinal products regulation that entered into force at end-January. It will introduce separate fees in the veterinary area. 

The website of the Danish Medicines Agency will be updated with the new fees once in force.

The executive on fees is available in Danish at Retsinformation, the official Danish online legal portal: https://www.retsinformation.dk/eli/lta/2022/531