UPDATE: No votes for the Danish Medicines Agency or the Danish Health Authority
When the new Medicine Committee will start operating in 2017 there will be no voting rights for the Danish Medicines Agency (DMA) or the Danish Health Authority (DHA) when it comes to the decision-making on prioritizing medicines. Further, there will be no complaints board or appeal option.
The Medicine Committee is created by Danish Regions to secure quick and aligned use of new medicines across hospitals and regions in Denmark. To avoid any doubt about the Committee’s independence in their daily work, neither the DMA nor the DHA will participate directly in the decision-making on prioritizing medicines, but will instead function as observers.
As observers, the DMA and the DHA will still be able to coordinate the Medicine Committee’s work with their own tasks as government agencies.
The Medicine Committee’s conclusions - however significant the may be - are merely guiding for the regions – not binding. Therefore, the Committee will have neither a complaint’s board nor an appeal option. Hence, if pharmaceutical companies are dissatisfied with the guidance on prioritization of medicines or parts of this decision process, the company is referred to seek legal action against this at the Danish courts of law.
Contact DELACOUR’s team of life science specialists, if you have any questions to the coming new Danish Medicine Committee.