The EPSO Peer Evaluation of the Danish Health and Medicines Authority Experience in practice Anne-Marie Vangsted (director) 22.11.2018

Key areas for improvement Clear Communication lines (internal and external). Prioritisation and risk assessment based on clear division of tasks between ‘obligation to act’ and ‘opportunity to act’ in relation to a sound interpretation of the legislation agreed between the Ministry and DHMA and communicated with the wider public. Feedback mechanisms. Management of expectations. Co-ordination and quality management. Independent Organisational Context of the Supervisory arm of DHMA. 22.11.2018

Focus area 1: Reorganisation of DHMA's supervisory organisation Immediately after publication of the action plan merge the two divisions in Copenhagen: ”Supervision & Patient Safety” and ”DHMA Public Health Medical Officers East” into one division ”Public Health Medical Officers East & Supervision” with one management team. Launch a process towards a clear division of tasks between the relevant supervisory functions and other divisions of DHMA to ensure independence, focus on the core tasks and efficient resource utilisation. Implement the organisational change when the legislative and strategic requirements are in place. 22.11.2018

Focus area 2: Strengthening of DHMA's quality work and quality organization Draw up a quality programme for the entire Authority determining the specific requirements and framework for quality objectives, internal audit etc. Implement one common IT system supporting the quality work in all divisions. 22.11.2018

Focus area 3: Plan for training of DHMA's staff in the supervisory organisation Formulate a recruitment and training strategy for the supervisory function. Introduce a permanent training course for the supervisory function. Arrange annual training events in selected areas. Launch introduction programmes for all new employees. Review the job appraisal concept and make sure that it takes into account the supervisory functions. 22.11.2018

Focus area 4: Communication about the supervisory organisation's work and results Develop our communication about the supervisory function to define the purpose of various types of communication, the selection of target groups for the communication and the choice of communication channels for the publication of knowledge and results in the supervisory area. Use communication to actively promote learning and compliance with rules in the health sector. Use communication to increase awareness of our tasks and role in the supervisory area. Update our website, dhma.dk, to ensure easy access to information about methods and results in the supervisory area, including information on the implementation of sanctions. 22.11.2018

Focus area 5: Involvement of external administrative expertise with a view to quality assurance Involve external administrative expertise by way of the legal adviser to the Danish government to ensure quality assurance of our handling of supervisory cases. 22.11.2018

Focus area 6: Analysis of and strategy for the supervisory function In cooperation with relevant parties, including the Ministry of Health, prepare an analysis describing how our current supervisory approach can be changed into proactive supervision based on systematic risk assessments so that resources are deployed where patient safety is most at risk. Make a clear delimitation of the supervisory organisation's core tasks. Based on the identified core tasks and in the context of the above analysis, develop a strategy for the supervisory function to define a vision, mission and specific targets for the supervisory function's work. Develop and select a method for systematic risk-based screening and selection of organisations, healthcare professionals and treatment areas. Further develop the project "Generic methods, contributing to greater efficiency in the conduct of supervision" which was launched in 2014 to ensure that the supervisory function uses consistent methods and procedures based on best practice for supervision. 22.11.2018

Focus area 7: Analysis of present legislation about supervision Enter into dialogue with the Ministry of Health on an analysis of the relevant parts of existing legislation to assess the legal framework required for risk-based supervision. Develop plans for conducting supervision in the period from the action plan is put in place until any law amendments enter into force. 22.11.2018

Focus area 8: Clarification of interfaces to other authorities and players Provide an analysis of the organisational interfaces between the various players in the supervisory organisation with the purpose of creating a clearer division of roles and responsibilities and thus prioritisation. Provide an analysis of the data-related interfaces between the various players of relevance to the supervisory organisation with the purpose of promoting efficient use of resources and robust systems. 22.11.2018

Focus area 9: Risk-based supervision based on a proactive use of health data Carry out an analysis project to define the methodological and IT requirements for systematic use of health data in the risk-based supervision. 22.11.2018