The company is instructed to make identical submissions to Fimea, NoMA and TLV containing the information and data that are intended to be shared among the agencies. These identical sets of information, sent by the company to Fimea, NoMA and TLV with the intention to serve as a basis for the joint report, are called the common submission.
The basis of working with confidential data in the FINOSE collaboration is a waiver given by the company. The waiver allows the participating agencies to discuss on the common submission covered by the waiver and to produce a joint report based on confidential data.
At a national level, the joint assessment report produced by FINOSE will be used for making recommendations for the used of the assessed intervention. Therefore, information about the assessments needs to be shared with the decision makers, and representatives of the Finnish university hospitals participating in price negotiations , LIS in Norway and the NT-council in Sweden.
The company may also have data that is intended to be used only locally in one of the agencies and not to be shared among the agencies, e.g. data related to local pricing. In this case, the company should not include this data in the common submission but submit local data separately, in a submission to the agency in question, clearly indicating that this data is not intended for sharing among the agencies.
The agencies will provide the company with a draft assessment report if as unpublished material submitted by the company was utilised in its preparation. The company has two weeks to react and make annotations in the draft of any previously unpublished information the company considers to be confidential or declare that the draft does not contain any confidential information. In the published version of the assessment report, confidential information will be concealed. The company’s view on confidentiality is taken into consideration. Nevertheless, it should be noted that Fimea, NoMA and TLV work under national legislation on public access to information and secrecy, which determines access to information submitted to the agencies.
To avoid delays in the process, the clinical experts recruited for the assessment may receive the draft report prior to the checking of the confidential material.