Legislation, steering and supervision, cooperation
Pharmacotherapy and pharmaceutical services are strictly regulated. Regulation comprises of many different statues the most important of which are listed on the following page.
- Legislation on pharmacotherapy, pharmaceutical service and health care appliances and supplies (in Finnish)
Steering the prescription of pharmaceuticals
According to the Ministry of Social Affairs and Health Decree on the prescription of medicines (1088/2010), special attention must be given to the safety of pharmaceuticals. Selection of a pharmaceutical must first and foremost be based on research evidence that confirms the effectiveness and safety of the pharmaceutical or, when this is not available, on a generally acceptable treatment practice. In the selection of a pharmaceutical or medicinal product special attention must be drawn to the price and the clinical effects achieved with the cost of the treatment. Products sold with special permits do not meet with the aforementioned requirements and the appropriateness and safety of their use is the responsibility of the treating physician. In addition to these, the pharmaceutical reimbursement system steers the prescription of pharmaceuticals in numerous ways.
Service choices are regulated in the Health Care Act (1326/2010). According to the Act on Health Care Professionals (559/1994), a licences physician decides on a patient’s medical examinations, diagnosis and related care, and a licensed dentist does the same with regard to dental care.
- Ministry of Social Affairs and Health Decree on the Prescription of Medicines (in Finnish)
- Health Care Act (Finlex)
- Act On Health Care Professionals (Finlex)
Steering and supervision
The Ministry of Social Affairs and Health, service organisers and the cooperation structures they have formed are key actors in the steering of pharmacotherapy. Steering influences what pharmacotherapies are used. Legislation and steering influence the amount of money meaning the type of treatments to which public funding will be channelled. Steering comprises of legislation, information and resource steering and their components and of various other actors.
Pharmaceuticals Pricing Board, Hila
The Pharmaceutical Pricing Board, which operates under the Ministry of Social Affairs and Health decides on which pharmaceuticals, clinical nutrition preparations and general creams for outpatients will be in the scope of the public pharmaceutical reimbursements, in what scope and at what price. A reasonable wholesale price is the maximum price at which such a product can be sold to pharmacies. The Board-approved wholesale price is the basis for pharmaceutical reimbursements from health insurance. A pharmaceuticals granted marketing authorisation can be sold without a confirmed wholesale price, but in that case, it will not be reimbursed.
- Pharmaceuticals Pricing Board (Hila)
- Decree of the government concerning Pharmaceuticals Pricing Board 196/2009 (Finlex) (in Finnish)
Council for Choices in Health Care in Finland (COHERE Finland)
The Council for Choices in Health Care in Finland (COHERE Finland) is is subordinate to the Ministry of Social Affairs and Health and provides recommendations on which healthcare methods should be funded by the public sector.
Fimea produces assessment reports on the therapeutic and economic effects of new hospital pharmaceuticals. COHERE Finland’s recommendations on hospital pharmaceuticals are based on Fimea’s medicine assessments.
- Council for Choices in Health Care in Finland (COHERE Finland)
- Health Care Act 1326/2010 78 a § (Finlex)
- Decree of the Government concerning Council for Choices in Health Care 63/2014 (Finlex) (in Finnish)
Finnish Medicines Agency Fimea
Finnish Medicines Agency Fimea acts as the licence and supervisory authority for pharmaceutical actors and for medicines, blood and tissue preparations intended for humans or animals.
Additionally, Fimea’s tasks include the national coordination of the development of the pharmaceutical sector, research tasks and the assessment of pharmacotherapies (HTA of hospital medicines).
- Finnish Medicines Agency Fimea
- Finnish Medicines Agency Act (Finlex) (in Finnish)
- Decree of the Government on Finnish Medicines Agency 616/2009 (Finlex) (in Finnish)
Finnish Coordinating Center for Health Technology Assessment FinCCHTA
The Hospital District of Northern Ostrobothnia coordinates the national assessment of health care methods (Government decree on division of work in specialist medical care and the centralising of certain tasks). Finnish Coordinating Center for Health Technology Assessment FinCCHTA has been established for this purpose. With regard to pharmaceuticals, FinCCHTA’s key task is the coordination of decision making and procurements at hospitals and to monitor out the assessment needs of hospitals.
- Government decree on division of work in specialist medical care and the centralising of certain tasks (Finlex) (in Finnish)
- Finnish Coordinating Center for Health Technology Assessment( FinCCHTA)
Finnish Institute for Health and Welfare
Finnish Institute for Health and Welfare THL researches, follows, assesses and develops as well as steers healthcare and social welfare activities and provides professional support for the implementation of policies and practices that promote welfare and health. THL promotes the practical application of pharmacotherapy in health and social services. THL continues to support the activities of the Rohto network and Rohto workshops, which were previously supported by Rohto, the former medicines agency.
- Finnish Institute for Health and Welfare
- Act on the Finnish Institute for Health and Welfare (Finlex)
- Government Decree on the Finnish Institute for Health and Welfare (Finlex)
National Supervisory Authority for Welfare and Health Valvira
National Supervisory Authority for Welfare and Health Valvira steers and supervises the quality of services and the management of health risks. Valvira steers and supervises the practices for prescribing medicines by both health care professionals and operational units. Valvira’s task is to supervise the appliances and equipment used in health care and to promote their safe use.
- National Supervisory Authority for Welfare and Health (Valvira)
- Act on the National Supervisory Authority for Welfare and Health (Finlex) (in Finnish)
- Government Decree on the National Supervisory Authority for Welfare and Health (Finlex) (in Finnish)
Social Insurance Institution of Finland (Kela)
Kela is responsible for and supervises the implementation of the pharmaceutical reimbursements system, as well as provides communication, researches and draws up statistics, assessments and forecasts and gives proposals on how the sector’s legislation needs to be developed. Kela produces annual statistics on pharmaceutical reimbursements and on the practices of doctors for prescribing pharmaceuticals. Additionally, Kela and Fimea produce annual statistics on the previous year’s pharmaceutical reimbursements and costs and the consumption of pharmaceuticals.
Kela’s online service provide a prescription feedback option for doctors, with information on the number of prescriptions and the costs of the pharmaceuticals prescribed. Kela also sends personal letters for guidance which provide information on the adverse effects of prescribed pharmaceuticals and safer treatment options.
- Pharmaceuticals and pharmaceutical reimbursements (Kela) (in Finnish)
- Statistics on reimbursements for prescription medicines (Kela)
- The compensation for medical treatment by each municipality (in Finnish)
- Feedback on prescriptions (Kela) (in Finnish)
- Act on the Social Insurance Institution (Finlex) (in Finnish)
- Government Decree on the Social Insurance Institution (Finlex) (in Finnish)
The aim is to develop steering of pharmacotherapy and pharmaceutical services so that it is national and centralised, as well as based on up-to-date information and shared objectives. Existing registers and statistics are the basis for the monitoring and steering of pharmaceutical use. The objective is for up-to-date treatment recommendations, the Pharmaceutical Reimbursement System, the range of services provided by national healthcare, the national goals for the steering of pharmacotherapy as well as the monitoring of treatment results to form the basis for the decisions made by various organisations and healthcare professionals at different phases of the pharmacotherapy process.
The Current Care Guidelines are national recommendations for care that are independent and based on research evidence. They cover important issues related to Finnish health and the care and prevention of illnesses. Current Care also provides the Vältä viisaasti recommendations, which describe actions that should be avoided at least in the case of some patients.
The equality of all people in accessibility to pharmaceuticals is ensured with evidence-based national policies and regional instructions.
Elina Asola, Senior Specialist
Ministry of Social Affairs and Health, Department for Safety, Security and Health / TUTO, Biotechnology and Medicines Unit / BILA Telephone:0295163437