Finland has a long history of being the model country of healthcare registers. They contain immense quantities of information, and the debate on their utilisation for research purposes has also been going on for quite a while. The recent article in the Finnish Medical Journal (issue of 14 November 2014) analysed the process of application for research permits from the Institute for Health and Welfare (THL) and the National Insurance Institution (Kela) as well as other register holders. The longest process took a year while the fastest was just a few days.
The article concludes that it should not take a full year to complete the permit process. Such a long wait may start to impact the research question, and at worst, the subject matter is obsolete before the permits are there. The respondents also find it problematic that the applicants cannot predict the length of the permit process.
The article in the Finnish Medical Journal was a description of the research permit procedure. The study focused on the implementation of the Current Care Guidelines in the treatment of diabetes. Before starting to dig into the question, the research group had to ask for research permits from THL, Kela, ethics committee and Statistics Finland as well as from local register holders at the healthcare units.
Could registers constitute competitive edge for Finland?
The growth potential of the pharmaceutical branch and health technology are well understood in Finland. In addition to conventional clinical pharmaceutical research, Finland has the opportunity to launch new research operations in the area of register-based research. With a more encouraging operative environment, the Finnish register research could become an attractive investment option. Predictability can be improved with more precise information on the requirements imposed and duration of the permit processes and on the time of access to the actual research materials.
The research group found that just a few measures would bring substantial remedy to the situation. If the information pool in the various registers were described in sufficient detail, vague requests for information or unrealistic research plans could be avoided. The overlapping work done by different authorities is also a problem. Finally, the group highlights the need to have a third party responsible for merging the materials and deleting any identification data.
Some of these problems may be solved when the project run in collaboration by Statistics Finland and the National Archives is finalised in 2015. The project will concentrate the permit process in one portal used by both the applicant and all parties granting permits. After the permit has been granted, the materials ordered are available at a digital desktop.
Pharma Industry Finland PIF retained EPID Research to perform the survey on the Finnish implementation of the Current Care Guidelines related to diabetes. The research group also included THL, the Finnish Medicines Agency Fimea, Aalto University, Medical Affairs Consulting Oy and Pharmaceutical Information Centre Ltd.