Becoming part of Europe’s best in class
The foundation of the Data Analytics Center was established, our European position was strengthened, yet not all objectives were achieved. This is the conclusion in the Danish Medicines Agency’s annual report for 2019.
The Danish Medicines Agency’s annual report 2019 has just been published and shows, among other things, that core tasks have been strengthened, that the foundation of a new Data Analytics Center has been laid and that resources have been allocated to the work with medical devices. But the annual report also shows that not all objectives were achieved.
Resource injection and strengthened international collaboration
In 2019, the Danish Medicines Agency laid the foundation of a new Data Analytics Center – a centre which, through the use of raw data, real-world data and advanced data analytics methods, is to promote health through increased availability of innovative medicines. Likewise, the Data Analytics Center is to enable a better continuous monitoring of medicines and medical devices. In 2019, the foundation of the Data Analytics Center was laid with the recruitment of the centre’s first employees, and the development of the centre will continue in the coming years.
2019 was also a year when we gradually built up capacity in the field of medical devices, the intention being to ensure a continuously closer monitoring of medical devices and ultimately enhance patient safety.
On the international scene, the Danish Medicines Agency secured Denmark a fourth place, tied with Sweden, among the countries being allocated most rapporteurships in the EU. In other words, the European Medicines Agency (EMA) appointed Denmark as responsible for the assessment and authorisation of new medicines, which helps position the Danish Medicines Agency among Europe’s best in class. The Danish Medicines Agency was awarded a total of 25 European rapporteurships. In addition, the Danish Medicines Agency contributed actively to the European work of ensuring a responsible use of antimicrobial veterinary medicines with the aim of reducing the risk of resistance development and the resultant consequences for public health and animal welfare.
In the second half of 2019, the Danish Medicines Agency, jointly with other participants, invested a lot of energy into establishing and maintaining an overview of the supply situation and the criticality for thousands of medicines since many experienced varying degrees of supply failure, and the media kept their eyes fixed on the supply of medicines. These efforts are to support the supply of medicines on the Danish and European markets, and the Danish Medicines Agency will therefore continue to give top priority to the supply of medicine this year.
Our efforts to ensure the supply of medicines drew on many of our resources in 2019 and meant that other tasks were not fully achieved.
Not all objectives were achieved
With a few exceptions, the Danish Medicines Agency observed all assessment times, and we completed inspections of pharmaceutical companies according to internationally recognised standards.
Despite the many deliveries in 2019, the Danish Medicines Agency’s overall target achievement was lower than in 2018 (87.7 per cent in 2018 and 75 per cent in 2019). The lower target achievement is partly due to the fact that the objectives for signal analyses in the pharmacovigilance area were not fully achieved and that the recruitment of a managerial head for the Data Analytics Center was postponed to 2020 because of the general election.