The newly adopted proposal to amend the Medicines Act aims to ensure that selected pharmaceutical companies have safety stockpiles that can meet the need for critical medicines in the event of supply difficulties in Denmark, so that patients and society will not be affected.
The new Article 75(2) of the Medicines Act entails that companies that market critical medicines in Denmark, which are used in the primary sector, must establish safety stockpiles in Denmark of the respective medicine. However, parallel importers and parallel distributors of critical medicines are exempt from this requirement for mandatory safety stockpiles.
The specific requirements for the stockpile obligation will be determined by the Danish Medicines Agency, including the definition of critical medicines, exemption possibilities, notifications, the size and calculation of the stockpile, as well as the use of the stockpile in case of supply difficulties, cf. Article 75(4) of the Medicines Act.
Furthermore, the new Article 75 b(1), of the Medicines Act sets a requirement that companies that market a critical medicine in Denmark, which is used in the primary sector, must report the stock levels of the respective medicine to the Danish Medicines Agency. The Danish Medicines Agency will establish the specific rules for this reporting obligation.
The law also gives the Danish Medicines Agency the authority to impose administrative fines of DKK 500 per week on companies that fail to comply with the reporting obligation under Article 75 b, cf. Article 105, (3) of the Medicines Act.
The bill had faced criticism from both the pharmaceutical industry and the opposition in the Danish Parliament but was ultimately passed on June 4, 2024.
The law has come into force on July 1, 2024, after which an implementation period of six months has begun, so that companies covered by the rules must have established the safety stockpiles by January 1, 2025, at the latest.
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