Supervision of health services and pharmaceuticals

Supervision of health services is carried out by the Danish Patient Safety Authority with the assistance of the Danish Patient Safety Authority Supervision and Guidance offices West/East. These institutions are independent, politically and administratively, of the regional and municipal health authorities. Supervision of health care personnel and their professional activities is also carried out by the Danish Patient Safety Authority. Decisions may be appealed in accordance with the applicable administrative procedures and may ultimately be brought before the courts. 

The Chief Medical Officer is responsible for supervision of health services. On behalf of the Danish Health Authority, the Chief Medical Officer supervises the healthcare activities carried out in the Faroe Islands by authorised healthcare professionals (doctors, nurses, physiotherapists, etc.).

Also the Chief Medical Officer is the consultant to the Faroese and Danish authorities regarding health matters.

The Chief Medical Officer’s Office is an institution under the Danish Ministry of Health and is professionally affiliated with the Danish Patient Safety Authority (Styrelsen for Patientsikkerhed).

The Office of the Chief Medical Officer is an independent institution under the Government of Greenland and is responsible for supervision of health services in Greenland. The chief medical officer advises and assists the Government of Greenland and other authorities in questions of health.

Supervision of health services is organized in a less formal way than in the other Nordic countries. Supervisory tasks are spread out in the whole health services system. A nationwide body for the protection of patients’ rights has been established. This body may assess whether the services provided by a municipality meet the required standards. If the body finds that the services are inadequate, and that the municipality is responsible for this, it can make recommendations about how the deficiencies may be dealt with and give a time limit for when improvements shall be made.

With supervision and guidance Finnish Supervisory Authority (LVV) ensures the adequacy of services different healthcare professionals and medical facilities provide. Supervision of healthcare is divided into four parts:

• ex-post monitoring of individual cases (meaning, for example, handling patient complaints after serious treatment injuries),
• plan-based supervision (supervision following national– or municipal healthcare supervision plans or internal supervision of medical facilities), 
• guidance and advisement of healthcare professionals and medical facilities, and
• issue of requested statements consisting in official documents to other authorities and courts of justice (including medical statements on causality of injuries for use of insurance officers).

Authorized health professionals

LVV grants, upon application, the right to practice as a licenced or authorised professional and authorises the use of the occupational title of healthcare professional. Valvira supervises and guides healthcare professionals and medical facilities both in private and public sector.

Link: Finnish Supervisory Authority (LVV) https://lvv.fi/en/frontpage 

Pharmaceuticals

Finnish Medicines Agency (Fimea) maintains and improves the health of the population by supervising and developing the pharmaceutical sector and promotes rational use of medicines in order to support the health of the population.

Before a medicine is granted marketing authorisation, its safety is studied by the pharmaceutical company involved and assessed by the authorities. Once the authorisation has been granted, the safety of the medicine is continually reassessed on the basis of studies and adverse reaction reports. If necessary, on the basis of new data, changes may be made to the summary of product characteristics or the package information leaflet, or the use of the medicine may be restricted.

Information on adverse reactions observed in Finland is collected into Fimea register of adverse reactions. Persons authorised to prescribe or dispense medication are asked to report all suspected adverse reactions, particularly all serious and/or unexpected reactions as well as all adverse reactions to new medicines.

Fimea submits information on all received adverse reaction reports to the European Medicines Agency (EMA), which conveys the information to the marketing authorization holder of the suspected drug and to the adverse reactions register of the World Health Organization (WHO).

Similarly, Fimea is in charge of biological medicinal products, biosimilars and advanced therapy medicinal products.

Link: Finnish Medicines Agency (Fimea): https://www.fimea.fi/web/en/frontpage 

The supervisory authority responsible for different areas of health care in Åland depends on the Act on the Autonomy of Åland. As a general rule, in areas falling within the legislative authority of the State, the State is also responsible for supervision. In these cases Åland is therefore covered by the national supervisory system. This is particularly relevant with regard to the supervision of health care professionals, the pharmaceutical sector and medicinal products. Exceptions may, however, be provided for in the Act on the Autonomy of Åland or in a Consentaneous Decree, whereby responsibility for supervision can be transferred to Åland or vice versa.

For decades the Government of Åland has been responsible for supervision in several areas falling within the legislative authority of the State. Pursuant to a Consentaneous Decree the Government of Åland has exercised the supervisory functions, in accordance with national law, previously carried out by the Regional State Administrative Agencies in Finland. In recent years, these supervisory responsibilities have formed part of the duties of the Chief Medical Officer.

Responsibility for the supervision of the remainder of the health care sector rests with Ålands miljö- och hälsoskyddsmyndighet (ÅMHM). 

In Iceland, the Directorate of Health is responsible for the professional supervision of health institutions and health care personnel and handles complaints from health care users. It also monitors the use of prescription medicines.

The Icelandic Medicines Agency is responsible for the regulation and supervision of medicinal products. It also provides guidance to pharmacies, pharmaceutical companies, health care professionals, and the public. 

Overall supervision and monitoring of health services is provided by the Norwegian Board of Health Supervision (Statens Helsetilsyn). County Medical Officers (administered by Statsforvalterne) supervise and treat complaints in the counties. They provide work certification/licenses for health-care personnel.  An alert system ensures that hospitals inform the board of serious adverse events. Local audits are performed by the county governors.

• National evidence-based guidelines, patient pathways, and bundles of care exist for several conditions, including stroke and cancer. Patient pathways are also being developed for mental health and addiction treatment.
• Clinical registries, which are initiated by individuals, hospitals, or educational institutions, provide information for assessing the effects of treatments. They are used for quality assurance, research, and improvement activities. 
• The national, statutory registries cover the entire population and do not require patient consent (some are based on anonymous data). These registries and other health-related databases are the responsibility of the eHealth Directorate.
• The Directorate of Health (Helsedirektoratet) oversees a national program tracking health care quality indicators. 
• The Norwegian Medicines Agency (Statens Legemiddelverk, NOMA) is in charge of granting or withdrawing marketing authorizations. All pharmaceutical companies must apply the agency for marketing authorization in order to sell their products on the Norwegian market. They determine which medications to reimburse for outpatients. NOMA’s drug-pricing scheme encourages the use of generic drugs and uses cost-effectiveness as a reimbursement criterion for drugs.  Pharmacies are private companies. The state regulates the number and physical location of the pharmacies.  

The Norwegian Labour Inspection Authority (Arbeidstilsynet) is a governmental agency under the Ministry of Labour and Social Affairs, focused on occupational safety and health. There are several local inspection offices throughout the country, to guide and supervise individual enterprises in local communities. Several different agencies monitor working environment activities in Norwegian workplaces depending on whether they are on shore, offshore or in aviation. These agencies are located under various ministries. 

In 2016, the government published a strategy for an “age-friendly society.” The goal is active, healthy aging through participation in and contribution to society. The government is also rolling out several other strategies through 2022, including a youth mental health and well-being program, an antibiotic-resistance initiative, and a mental health program aimed at adults.

The National Health Data Program, launched in 2018, aims to make health data available for government agencies, researchers, managers, health professionals, and residents.

In 2017, municipalities and GPs were invited to participate in a primary care pilot project, which promotes the use of interdisciplinary teams as a primary tool for change. GPs are now responsible for the teams, under the leadership of each municipality. The project began in spring 2018 and will run until April 2021. The pilot includes testing of two new payment models: a fee-based model, similar to the existing funding model for GPs, and an operating grant based on the number and demographic characteristics of a GP’s patients. GPs also receive pay-for-performance bonuses and out-of-pocket payments.

In 2018, the government also introduced activity-based funding for specialized mental health services in combination with block grant financing.

In addition, a commission has been appointed to give advice on a new financing model for specialist care. The commission will consider the RHAs responsibilities for providing specialist care for the population, conducting research, and educating health personnel. The commission’s findings were published late 2019.

The government has started a process to decriminalize drug use as well as possession of minor quantities of drugs. The aim is to transfer the societal responsibility for handling minor drug offenses from the jurisdictional sector to the health care sector.

The Patient Safety Act (Patientsäkerhetslagen) specifies the main responsibilities of authorized health service providers and licensed health care personnel regarding patient safety. This Act covers safety requirements by health care providers, such as preventive measures and reporting of serious risks and adverse events. The Act also regulates the responsibilities of licensed health care personnel. 

The Health and Social Care Inspectorate (Inspektionen för vård och omsorg, IVO) is a government agency responsible for supervision of health care, social services and activities under the Act concerning Support and Service for Persons with Certain Functional Impairments (LSS). The Inspectorate's work includes supervision and issuing permits for service providers. IVO carries out inspections, based on risk analysis or complaints such as from local Patient Advisory Committees, and provides guidance and feedback to service providers. 

IVO also investigates any deficiencies in health care professionals and licensed pharmacy professionals – pharmacists and dispensers. Deficiencies that could threaten patient safety may lead to corrective measures, or in the case of serious or recurring deficiencies, suspended license to practice as a health professional. The Medical Responsibility Board (HSAN) decides on authorisation matters concerning licensed health care professionals. 

The Swedish Medical Products Agency (Läkemedelsverket) is responsible for regulation and surveillance of the development, manufacturing and sale of pharmaceuticals and other medicinal products. Suspected adverse reactions, events and incidents with medical products or medical devices should be reported to the agency, by health care professionals or patients. The Medical Products Act (Läkemedelslagen) regulates the responsibilities of health care professionals in the case of incorrect prescription of medical drugs.

More information on the main regulations: https://patientsakerhet.socialstyrelsen.se/lagar-och-foreskrifter/centrala-lagar/ 

Patient Safety Act (Patientsäkerhetslagen) https://www.riksdagen.se/sv/dokument-lagar/dokument/svensk-forfattningssamling/patientsakerhetslag-2010659_sfs-2010-659 

Medical Products Act (Läkemedelslagen) https://www.riksdagen.se/sv/dokument-lagar/dokument/svensk-forfattningssamling/lakemedelslag-2015315_sfs-2015-315 

Health and Social Care Inspectorate (IVO) https://www.ivo.se/

Medical Products Agency (Läkemedelsverket) https://www.lakemedelsverket.se/en