New Division At Danish Medicines Agency To Put Greater Focus On Benefit-Risk Issues

The Danish Medicines Agency, which was re-established as an independent entity earlier this year, will soon undergo a structural reorganization so that it is better suited to carry out its task of ensuring the availability of effective, safe and accessible medicines.

Among other things, the changes will result in: the creation of a new division for medical evaluation and biostatistics that will put greater focus on the benefit-risk profile of medicines before and after initial authorization; the establishment of a new cross-functional committee for medicinal products that will take high-level crucial decisions affecting public health; and the appointment of a number of new team leaders for some of agency's larger units.

The new organizational structure, which will come into effect on January 2017, has been devised by the agency's director general Thomas Senderovitz, who believes the changes will help modernize the agency and help achieve its ambitious goal of being recognized as a leading medicines regulator in the EU.

Senderovitz told the Pink Sheet that when he took charge of the agency in April, he felt that it "needed some fine tuning" to improve its functioning. Senderovitz has an industry background – he was a member of the management team of the global contract research organization Parexel in Berlin before joining the Danish agency – and he found the DMA "very siloed, very departmental" and decided to "modernize the agency so that it focused more on science."

Thomas Senderovitz, Director General of the Danish Medicines Agency

Regarding the new division for medical evaluation and biostatistics, Senderovitz explained that it will consist of 13 internal and 20 external medical assessors. The aim is "to create the critical mass in the area needed to make evaluations of authorizations and adverse reactions as well as overall evaluations of benefit/risk analyses for the benefit of the entire Agency," the DMA said in a statement.

Senderovitz clarified that the new division will not replace the agency's drug approvals department, which will continue to exist. The new division will be more science focused and in the long term will also look at big data. The DMA will soon advertise to recruit a director for the new division.

New Committee For Medicinal Products

The restructuring process also involves establishing cross-functional committees "to ensure transparent decision-making processes for our cross-cutting tasks," he said. This includes plans to establish a new committee for medicinal products, which would take high-level decisions, such as whether the agency should make a referral to the European Medicines Agency to evaluate the safety of a medicinal product.

The committee will not be involved in the day-to-day functioning of the agency or in micro-management, "but [will] only [issue] big decisions affecting public health at national or international level," Senderovitz explained. In addition, every agency member serving in on various positions at the EMA or other EU institutions will report back to this committee.

Senderovitz believes the changes will promote both better departmental management and a cross sharing culture "so that the right people are present at the right place."

The DMA was re-established as a standalone entity earlier this year, following its 2012 merger with the National Board of Health to form the Danish Health and Medicines Authority. While the Danish government had expected the merger to yield greater regulatory synergies between the medical product and health care services programs in addition to cutting costs, this was never realized and instead the merger started negatively affecting drug evaluation timelines. (Also see "Danish Pharma Hopes Stand-alone Medicines Agency Will Speed Up Drug Reviews" - Pink Sheet, 17 Aug, 2015.)

From the editors of Scrip Regulatory Affairs.