The Danish Parliament has issued a new executive order which means that the Danish medicines supply contingency programme has been made permanent. The rules came into force on 1 March 2021.
The Danish Executive Order no. 305 of 27 February 2021 on the medicines supply contingency programme (bekendtgørelse om lægemiddelberedskabet) constitutes an implementation of a previous draft Bill provision which, among other things, amended the Danish Medicines Act (lægemiddelloven). This involved a material revision of the rules governing the Danish national medicines supply contingency programme. This article offers a brief review of the changes that came into force on 1 March 2021.
The reason for the new rules
The new rules were laid down in the wake of a previous executive order on the medicines supply contingency programme issued in connection with the Danish government's handling of the COVID-19 pandemic. However, these rules lapsed on 28 February 2021.
If, afterwards, no new rules on a Danish medicines supply contingency programme were to be stipulated in substitution, Denmark would not be able to maintain a necessary national medicines supply contingency programme, and this, in turn, would have a significant adverse effect on the distribution of vaccines against COVID-19 and thus result in a delay in the process of vaccinating the Danish population of similar proportions.
Furthermore, during the COVID-19 pandemic, it has been necessary to apply the temporary rules, for instance, to order companies to report on their supplies of medicines, to ration and re-allocate certain medicines and to prevent the hoarding of medicines.
Accordingly, the rules have been – and still are – required to ensure the supply of medicines to and in Denmark in order to protect and preserve the life and health of the Danish population in times of medicines shortage.
The Danish Medicines Agency's new powers
Under the new rules, the Danish Medicines Agency will be given more powers. If the medicines supply contingency programme is activated, the Medicines Agency will be authorised to order Danish pharmaceutical companies, as far as medicines, intermediates and active substances are concerned, to report about their supplies of medicines in full details, to increase supplies and to re-allocate and deploy supplies as specified by the Medicines Agency; and to ban reallocation and deployment of supplies as well as to regulate the terms of business during such deployment.
The scope of such authority will be determined based on a specific assessment that will depend on the Danish Minister of Health's full or partial activation of the rules.
Moreover, the Medicines Agency will be authorised to order pharmacies and authorised distributors of OTC medicines to ration medicines. The Medicines Agency will also be authorised to issue special temporary licences to handle medicines.
Finally, in special circumstances such as emergency situations, the Medicines Agency may regulate price increases for medicines, ordering that the rate of increase must not exceed a specified percentage. The Medicines Agency may even fix the price of, for instance, crucial medicines that are subject not only to supply shortages but also to price hikes.
The Medicines Agency's subject-matter authority
However, despite an activated contingency programme, the Medicines Agency may apply its new powers only when proportionate to protect and preserve the lives and health of humans and animals as these powers constitute special measures expected to be used for a limited and brief period only.
As an example, similar rules have had to be applied during Denmark's management of COVID-19 to ensure, among other things, that crucial medicines available were used for treatment of the patients who needed them the most.
The Minister of Health expects that the need for accumulating supplies of medicines may generally be solved in a close dialogue between pharmaceutical companies, pharmacies and Danish regions. Accordingly, the need for issuing orders to companies pursuant the Executive Order does not seem to become customary procedure.
For more details on the legal amendments, click here.