Currently in the drafting phase, the legislative amendment focuses on the utilisation of the country’s social welfare and health records in a data secure manner. In a few years' time, this will allow for knowledge-based management which is necessary due to the ageing of the population and the scarcer financial resources, in particular.
The demand for register-based research is growing not only in Finland but also globally. At best, this will generate novel forms of work and competence. More extensive use of the records benefits the patient when, for example, the effectiveness and safety of medicines can be studied on Finnish patients.
The legislative amendment offers new possibilities for the research operations of the pharmaceutical companies. While the current Act only permits the utilisation of the registers for scientific purposes, the information would also be more easily available for commercial purposes in the future. It is fair to say that Finland has now also understood the research-related investment potential which is further enhanced by the population databases that are exceptionally comprehensive even in the global scale.
Smoother authorisation procedures
As the amendment is enacted, the intention is to create a smooth system whereby companies apply for research authorisations and the necessary research materials from one single authority. The contacts with the authorities and the access to the materials are expected to become smoother.
The development of a new digital user environment is also underway. It will ensure that the materials are handled in a data secure manner, also making the delivery of the authorisations and materials more transparent. These features will contribute to the predictability of the operating environment from the companies' perspective.
Processes and MOs must be in place
Companies and other relevant stakeholders have been heard during the legislative preparations. The new Act aims at striking a balance between the wider use of the registered data and the data security needs. The legislative preparation process seeks to identify the potential risks associated with the wider use of the data at the earliest possible stage.
From the companies’ point of view, the mere legislative amendment is not sufficient. The processes of the authorities and the MOs of the organisations must also comply with the requirements of the new Act. The legislative proposal is currently out for opinions, and the intention is to have the new Act in force as of January 2018.