Guiding pharmocotherapy through cooperation and in line with national objectives
In brief:
- The guidance of pharmacotherapy aims to ensure the implementation of rational pharmacotherapy throughout the country.
- The Ministry of Social Affairs and Health is responsible for guiding and developing pharmacotherapy together with the wellbeing services counties and a variety of different actors.
- Legislation and guidance influence what treatments receive public funding and what is required of various actors to ensure the implementation of pharmacotherapy.
- Responsibility for supervising pharmacotherapy lies with the Finnish Supervisory Agency, the Finnish Medicines Agency (Fimea) and the Social Insurance Institution of Finland (Kela).
The guidance of pharmacotherapy and pharmaceutical services is based on legislation, up-to-date information and cooperation between public authorities.
The aim is to ensure the implementation of effective, safe, high-quality, economical and equal pharmacotherapy, i.e. rational pharmacotherapy, and the availability of medicines across the country. Cooperation ensures that medicines are used effectively, processes for implementing pharmacotherapy are safe and equality is realised between different regions and population groups.
Which actors participate in the guidance and development of pharmacotherapy?
Responsibility for monitoring, assessing, guiding and supervising pharmacotherapy and pharmaceutical services rests with a number of different actors.
The Ministry of Social Affairs and Health has the overall responsibility for guiding and developing pharmacotherapy and pharmaceutical services in cooperation with the following actors:
- Wellbeing services counties
- Pharmaceuticals Pricing Board (HILA)
- Council for Choices in Health Care in Finland (COHERE Finland)
- Finnish Medicines Agency (Fimea)
- Finnish Supervisory Agency
- Finnish Centre for Client and Patient Safety
- Finnish Coordinating Center for Health Technology Assessment (FinCCHTA)
- Finnish Institute for Health and Welfare (THL)
- Social Insurance Institution of Finland (Kela).
The Finnish Supervisory Agency, the Finnish Medicines Agency and the Social Insurance Institution also supervise pharmacotherapy.
More information on the activities and responsibilities of various actors can be found below.
How are pharmacotherapy and pharmaceutical services regulated?
The regulation governing pharmacotherapy and pharmaceutical services comprises numerous different pieces of legislation, the most important of which are listed on the following page.
The aim of the regulation is to ensure access to affordable medicines, and the effectiveness, quality, safety and accessibility of services.
What are the grounds for guiding the prescription of medicines by legislation?
According to the Decree of the Ministry of Social Affairs and Health on the Prescription of Medicines (1088/2010), special attention must be given to the safety of medicines. Selection of a medicine must first and foremost be based on research evidence that confirms the effectiveness and safety of the medicine or, when this is not available, on a generally acceptable treatment practice.
The selection of a medicine or medicinal product must draw special attention to the price and the clinical effects achieved with the cost of the treatment. Products subject to special authorisation do not meet the requirements listed above, and the appropriateness and safety of their use are the responsibility of the treating physician.
In addition to these, the medicine reimbursement system guides the prescription of medicines in numerous ways.
Provisions on service choices in healthcare are laid down in the Health Care Act (1326/2010). According to the Act on Health Care Professionals (559/1994), a licensed physician decides on a patient’s medical examinations, diagnosis and related treatment, and a licensed dentist does the same with regard to dental care.
How is the implementation of pharmacotherapy guided?
Healthcare professionals support, by means of guidance and advice, the users of medicines in implementing rational pharmacotherapy and monitoring the effects of pharmacotherapy.
Pharmacotherapy is often implemented on behalf of medicine users in different healthcare and social welfare units, for example. The Guide to Safe Pharmacotherapy, which is intended as a recommendation, aims to support these units in ensuring the safety of the pharmacotherapy process.
Current Care Guidelines are clinical guidelines based on research evidence
The Current Care Guidelines are national clinical guidelines intended for the prevention and treatment of diseases, which are independent and based on research evidence. The Current Care editorial staff also produce Vältä viisaasti (‘Smart to avoid’) guidelines, which describe actions that should be avoided at least in the case of some patients.
Equitable access to medicines is ensured for all people with evidence-based national policies and regional guidelines.
How do various authorities guide and supervise pharmacotherapy?
The Ministry of Social Affairs and Health, service organisers and the cooperation structures they have formed are the key actors in the guidance of pharmacotherapy. Guidance influences what pharmacotherapies are used and how they are implemented.
Legislation and guidance influence the price, i.e. the type of treatments to which public funding is channelled, and what is required of various actors to ensure the implementation of pharmacotherapy. The price of medicines includes the maintenance and services of the national network of pharmacies and hospital pharmacies. Guidance as a whole comprises the sub-areas of legislative, information and resource guidance, and cooperation between various actors.
Below you can find information on the guidance and supervision of pharmacotherapy by each actor providing guidance and their area of responsibility.
Pharmaceuticals Pricing Board (HILA)
The Pharmaceutical Pricing Board, which operates under the Ministry of Social Affairs and Health, decides which medicines, clinical nutritional preparations and basic ointments for outpatients fall within the public medicine reimbursement system, 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 wholesale price confirmed by the Board is the basis for reimbursement under the health insurance scheme. A medicine granted marketing authorisation can be sold without a confirmed wholesale price, but in that case it will not be reimbursed.
Council for Choices in Health Care in Finland (COHERE Finland)
The Council for Choices in Health Care in Finland (COHERE Finland), which is attached to the Ministry of Social Affairs and Health, provides recommendations on which health technologies used in the treatment of a certain health issue should be included in the range of publicly funded healthcare services.
Fimea produces assessment reports on the therapeutic and economic effects of new hospital medicines. COHERE Finland’s recommendations on hospital medicines are based on Fimea’s medicine assessments.
Finnish Medicines Agency (Fimea)
The Finnish Medicines Agency, Fimea, acts as the licence and supervisory authority for medicinal products, medical devices and blood and tissue products intended for humans or animals and pharmaceutical actors. Additionally, Fimea’s tasks include the national coordination of the development of the pharmaceutical sector, research tasks and the assessment of pharmacotherapies (health technology assessment of hospital medicines).
Finnish Coordinating Center for Health Technology Assessment (FinCCHTA)
The Hospital District of North Ostrobothnia coordinates the national assessment of health technologies. The Finnish Coordinating Center for Health Technology Assessment (FinCCHTA) was established for this purpose. With regard to medicines, FinCCHTA’s key task is to coordinate decision-making and procurements at hospitals and map out the assessment needs of hospitals.
Finnish Centre for Client and Patient Safety
The Finnish Centre for Client and Patient Safety supports the work to strengthen client and patient safety at national level and coordinates the related development measures in the wellbeing services counties. In addition, the centre houses a development network for medication safety, which focuses on pharmacotherapy and related practices.
Finnish Institute for Health and Welfare (THL)
The Finnish Institute for Health and Welfare (THL) researches, monitors, assesses and develops as well as guides healthcare and social welfare activities and provides expert support for the implementation of policies and practices that promote health and wellbeing.
The institute promotes the practical application of pharmacotherapy in health and social services. It also coordinates the development of information management in pharmacotherapy and guides the development of information systems.
Finnish Supervisory Agency
The Finnish Supervisory Agency will guide and supervise the quality of services and the management of health risks from the beginning of 2026. The National Supervisory Authority for Welfare and Health, Valvira, will cease to operate on 1 January 2026. All the duties of Valvira, along with other areas of responsibility, will be brought under the new agency. The relevant websites will be updated in January 2026.
- New Finnish Supervisory Agency
- National Supervisory Authority for Welfare and Health (Valvira) (ceases to operate in 2026)
Social Insurance Institution of Finland (Kela)
Kela is responsible for the implementation of the medicine reimbursement system and its supervision. It also provides information, conducts research and draws up statistics, assessments and forecasts and gives proposals on how the legislation applicable to the sector needs to be developed. In addition, it supervises the economical prescription of biological medicines.
Kela produces, among other things, annual statistics on reimbursements for medicine expenses and on the practices of doctors for prescribing medicines. Additionally, Kela and Fimea produce annual statistics on the previous year’s medicine reimbursements and costs and the consumption of medicines.
Kela’s online service provides a prescription feedback option for doctors, with information on the number of prescriptions and the costs of the medicines prescribed.
Kela also sends personal letters for guidance which provide information on the adverse effects of prescribed medicines and safer treatment options.
- Reimbursements for medicine costs (Kela)
- Statistics on dispensed medicines reimbursable under the National Health Insurance scheme (Kela)
- Kela’s Info Tray
Aiming for extensive cooperation in pharmacotherapy
The aim is to develop the guidance 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 guidance of medicine use.
The objective is for up-to-date clinical guidelines, the medicine reimbursement system, the national range of healthcare services, the national goals for the guidance 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.
Legislation on pharmacotherapy to be developed
The project on medicines and the financial base of pharmacies develops pharmaceutical matters on a long-term basis beyond government terms. The project focuses, among other things, on the guidance of pharmacotherapy and pharmaceutical matters, the regulation governing pharmacies, and the assessment of medicines.
Further information
Elina Asola, Senior Specialist
Ministry of Social Affairs and Health, Department for Safety, Security and Health / TUTO, Biotechnology and Medicines Unit / BILA Telephone:0295163437 Email Address: [email protected]
Tuija Metsävainio, Ministerial Adviser
Ministry of Social Affairs and Health, Department for Safety, Security and Health / TUTO, Biotechnology and Medicines Unit / BILA Telephone:0295163449 Email Address: [email protected]
Mari Laurén-Häussler, Senior Specialist, Legal Affairs
Ministry of Social Affairs and Health, Department for Safety, Security and Health / TUTO, Biotechnology and Medicines Unit / BILA Telephone:0295163762 Email Address: [email protected]
Tuula Nousu, lakimies
Ministry of Social Affairs and Health, Department for Safety, Security and Health / TUTO, Biotechnology and Medicines Unit / BILA Telephone:0295163005 Email Address: [email protected]