The Danish Medicine Council adopts a confidentiality policy
At its meeting on 29 March 2017, the Danish Medicine Council approved a confidentiality policy stipulating the guidelines for the processing of confidential information by the Medicine Council.
The key focus is the principle of transparency. This means that the Medicine Council in general will create transparency in relation to the basis of the Council's assessments of new medicinal products and therapeutic areas, and that this information will be published on the Council's website right away to the widest possible extent.
For new medicinal products, the Council will publish the final application, the protocol, the categorization of the clinical added value, possible responses to hearing requests, as well as the final report. For therapeutic areas, the Council will publish the protocol, the joint regional treatment guidelines, as well as the medicinal product recommendation.
However, the Council stresses that trade secrets will be kept confidential. In this connection, the Medicine Council invites the companies themselves to clearly specify which parts are confidential when they submit information to the Council.
The Council will assess the confidentiality based on the specific stage of the procedure. In relation to new medicinal products, the Medicine Council will keep information about these products confidential until the 150th day of the EMA authorization procedure (the 56th day in respect of new indications), which is the earliest possible day for a dialogue meeting. The confidentiality policy also states that information about the application and the procedure will not be published on the Medicine Council's website until after the dialogue meeting, and when the companies have submitted a preliminary application to the Medicine Council after EMA's positive opinion. However, the preliminary application itself will not be published.
In relation to cases concerning several medicinal products within the same therapeutic area, the starting point is that these drug are already known, and therefore the Medicine Council believes that the need for confidentiality is not the same.
Further, the Medicine Council's confidentiality policy states that in special cases, the Council may enter into confidentiality agreements. For instance, such agreements are made in connection with Amgros' Horizon scanning providing an overview of new drugs, indications, and dispensing forms up to three years before the Danish marketing authorization is granted.
At the meeting on 29 March 2017, in addition to the confidentiality policy, the Danish Medicine Council also approved the Council's rules of procedure; describing its administrative procedures and assignment of tasks as well as the Council's policy on impartiality for its members and others. We will describe the latter in another Life Science Update.
Read the confidentiality policy of the Medicine Council here