STM workshop on SoTe data legislation

ESiOR had the privilege to participate in the excellent working group meeting “Management, steering and surveillance by knowledge” organised by the Finnish Ministry of Social Affairs and Health in Helsinki on February 16, 2016. The meeting sought to gather opinions and to gain understanding on the various aspects and challenges that should be taken into account in the social welfare and healthcare reform in order to have SoTe (social affairs and health) data available for research and management.

The key message expressed by ESiOR CEO Erkki Soini in the meeting was short and concise: comprehensive, anonymous social and health care data should be made available for research purposes through reasonable, and preferably centralised, regulatory approval process to ensure fast and timely research that can be utilised to support decision making. A practical solution for this aim would be a bottom-up-approach in which locally gathered data forms the foundation for a filtered data cube that can be accessed and governed by one governmental institution. Erkki Soini also emphasized the importance of thorough understanding of health economics and know-how of associated methods if the goal is to produce information on health and societal outcomes, effectiveness and cost-effectiveness and to manage and steer social and health care services by performance in the global economy.

The key messages and insights expressed in the presentations of meeting participants and the following panel discussion were the following challenges and their practical solutions:

  • Boost the Finnish economy! Finland needs service research, contract research industry and partnerships to support evidence based decision making and leadership. Finland needs to ensure international visibility and promote competitiveness of its service research institutions and contract research organisations to create job opportunities.
  • Concepts – it is of utmost importance to have a common understanding of concepts when terms such as cost-effectiveness, real-life outcomes, real world data or efficacy/effectiveness become part of legislation. Understanding and know-how of health economics is essential when considering the cost-effectiveness objectives.
  • International competitiveness – Finland should make fair use of its registries and not give competitive advantage to other countries (e.g. Sweden). It is our understanding that Finnish registries are among the most comprehensive and our digitalisation rate among the highest in the world. Thus, it is all up to us to make things work! The SoTe data should be made accessible for research and management purposes.
  • The Finnish Health Insurance Act should make room for patient access schemes / risk-sharing schemes / evidence development schemes of (expensive) drugs. Such schemes for reimbursed drugs are possible in many countries and they provide benefits to society through “guaranteed value for investment”.
  • Problems associated with non-interventional studies and the interpretation of current legislation.
  • Registry studies, challenges in regulatory approval processes (e.g. time requirement) and what should be considered from the patient perspective.
  • Partial optimization: registry ownerships, governance, usage, and maintenance need to be agreed on.
  • Thorough understanding related to the quality, comprehensiveness, measurement and potential biases (setting, selection, Berkson) of registries is needed.
  • Practical problems associated with knowledge management and evidence-based management.

Discussion was lively and various stakeholders were well represented in the workshop. We remain optimistic in Finland: in the future we may have one stop shop for obtaining fast and timely social and health care data!

Contact: Erkki Soini