Ministry of Social Affairs and Health, Finland N.B. Unofficial translation. Legally valid only in Finnish and Swedish

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Ministry of Social Affairs and Health, Finland N.B. Unofficial translation. Legally valid only in Finnish and Swedish Act on Specialized Medical Care (1062/1989) Chapter 1. General provisions Section 1 (1328/2010) This Act lays down provisions on the organization of specialized medical care and related operations. Provisions on the content of specialized medical care services and operations are laid down in the Health Care Act (1326/2010). Section 2 was repealed by Act No. 1328/2010. Section 3 1. Each municipality shall see to it that persons domiciled in that municipality as referred to in the Municipality of Residence Act (201/1994) receive the necessary specialized medical care as referred to in the Health Care Act. In order to organize specialized medical care in accordance with this obligation, each municipality must belong to a hospital district joint municipal board. (1328/2010) 2. In urgent cases, municipalities have the same obligation regarding the specialized medical care of persons who have no domicile in Finland. (908/1992) 3. References hereinafter to 'domicile' or 'municipality where the person is domiciled' mean the municipality required to provide the person concerned with specialized medical care under paragraph 1 or 2. References to 'municipal residents' mean persons that the municipality is required to provide with specialized medical care under paragraph 1 or 2 above. Section 4 (1328/2010) The Act on Planning and Government Grants for Social Welfare and Health Care (733/1992) and the Act on Central Government Transfers to Local Government for Basic Public Services (1704/2009) apply to any municipal activities organized under this Act, unless otherwise provided by law. Section 5 (1548/2009) 1. The Ministry of Social Affairs and Health is responsible for general planning, guidance and supervision concerning specialized medical care. 2. The Regional State Administrative Agencies are responsible for planning, guidance and supervision concerning specialized medical care within their area of operation.

3. The National Supervisory Authority for Welfare and Health operating under the Ministry of Social Affairs and Health guides the operations of the Regional State Administrative Agencies in order to harmonise their principles of operation, procedures and decision practices in the guidance and supervision of specialized medical care. Furthermore, the Supervisory Authority guides and supervises specialized medical care in particular when it is question of: 1) issues that are important as a matter of principle and of great consequence; 2) issues regarding the area of operation of several Regional State Administrative Agencies or the whole of the country; 3) issues related to the supervision of a health care professional being dealt with by the Supervisory Authority; and 4) issues that the Regional State Administrative Agency concerned is disqualified to deal with. 4. Further provisions on the division of duties between the National Supervisory Authority for Welfare and Health and the Regional State Administrative Agencies can be laid down by Government decree. 5. The National Institute for Health and Welfare is the expert agency in the field of specialized medical care. Provisions on the National Institute are laid down in the Act on the National Institute for Health and Welfare (668/2008). Section 6 1. This Act applies to the Province of Åland only in so far as matters referred to in section 11, paragraph 2, subparagraph 15, of the Act on the Autonomy of Åland (670/1951) are concerned. 2. However, the joint municipal board for the Varsinais-Suomi Hospital District may agree on the organization of specialized medical care under this Act with the body running the central hospital in the Province of Åland. 2 Chapter 2. Hospital districts and catchment areas Section 7 1. For specialized medical care purposes, Finland is divided into hospital districts as follows: Helsinki and Uusimaa Hospital District Varsinais-Suomi Hospital District Satakunta Hospital District Kanta-Häme Hospital District Pirkanmaa Hospital District Päijät-Häme Hospital District Kymenlaakso Hospital District Etelä-Karjala Hospital District Etelä-Savo Hospital District Itä-Savo Hospital District Pohjois-Karjala Hospital District Pohjois-Savo Hospital District Keski-Suomi Hospital District

3 Etelä-Pohjanmaa Hospital District Vaasa Hospital District Keski-Pohjanmaa Hospital District Pohjois-Pohjanmaa Hospital District Kainuu Hospital District Länsi-Pohja Hospital District Lappi Hospital District. (241/1999) 2. The area of a hospital district comprises municipalities that belong to the joint municipal board for the hospital district in question. 3. A hospital district can be divided into hospital areas as prescribed in the basic agreement for the hospital district joint municipal board. (241/1999) Section 8 was repealed by Act No. 1127/1998. Section 9 Paragraph 1 was repealed by Act No. 1328/2010. 2. Besides the division into hospital districts, Finland is also divided into specific catchment areas for the provision of specialized level medical care. 3. Each catchment area includes a hospital district in which there is a university providing training for physicians. Further provisions on what are the special catchment areas and which hospital districts belong to which special catchment area are laid down by Government decree. (279/2002) Chapter 3. (1328/2010) Chapter 3 was repealed by Act No. 1328/2010. Chapter 4. Hospitals and units within hospital districts Section 12 (652/2000) For specialized medical care purposes, hospital district joint municipal boards shall have hospitals and, as necessary, separate medical care and other units. The joint municipal board for a hospital district decides on establishing hospitals and other units and on closing down them. The joint municipal board may decide that a unit consists of several hospitals or of a separate unit or parts thereof, provided that those constitute together the entity responsible for care provision as referred to in section 32.

Section 13 (1328/2010) 1. If appropriate in view of the permanent organization of specialized medical care, hospital district joint municipal boards may agree to establish and maintain a hospital or part of one, or a separate unit, jointly. The hospital or part of one, or separate unit, shall be administered by the joint municipal board in whose area it is located. 2. If the establishment of a joint hospital, part of one, or a separate unit that must be considered necessary for specialized medical care purposes is not agreed on, the Government may order this to be established and issue necessary orders on the terms and conditions of cooperation, taking the interests of the joint municipal boards concerned into account on a fair and equal basis. A member municipality in a joint municipal board may also submit a proposal concerning cooperation to the Government. 4 Section 14 was repealed by Act No. 1328/2010. Section 15 In addition to the hospitals and separate units of hospital district joint municipal boards, there may be State hospitals for the Defence Forces, prison administration and other special purposes. Paragraph 2 was repealed by Act No. 1328/2010. Chapter 5. Hospital district administration Section 16 1. The municipal councils of member municipalities shall elect members to the federal councils of hospital district joint municipal boards as follows: Municipal population in the last census Number of members 2,000 or less 1 2,001-8,000 2 8,001-25,000 3 25,001-100,000 4 100,001-400,000 5 400,001 or more 6 (1328/2010) 2. A personal deputy shall be elected for each member. Section 17 The aggregate voting rights of the members elected to a federal council by a municipality are determined on the basis of the municipal population registered in the last census, with every incipient 1000 residents conferring one vote. However, the aggregate voting rights shall not exceed one-fifth of the total unrestricted number of votes of the members elected by all the member municipalities. The aggregate voting rights of the members elected by a municipality are divided evenly between the members present at a time.

5 Section 18 Paragraphs 1 and 2 were repealed by Act No. 748/1992. 3. Any hospital district which includes municipalities with different languages and bilingual municipalities shall have a committee assigned to develop and coordinate specialized medical care provision and training of health care personnel in the minority language. Persons representing the minority-language municipalities and the minoritylanguage group in the bilingual municipalities shall be elected as committee members. Section 81, paragraph 4, and section 82 of the Local Government Act (365/1995) do not apply to committee members. (1328/2010) Paragraphs 4 and 5 were repealed by Act No. 748/1992. Sections 19 and 20 were repealed by Act No. 748/1992. Section 21 1. Hospital districts comprising municipalities with different languages and bilingual municipalities shall have a partial responsibility area to develop and integrate specialized medical care provision and training of health care personnel in the minority language, for which the committee representing the minority language is responsible. The minoritylanguage partial responsibility area covers the bilingual municipalities and the municipalities using the minority language within the hospital district. 2. Federal councils may assign hospitals and other units to partial responsibility areas. In such cases, the board of management of the hospital or unit shall be elected in accordance with section 18, paragraph 3. 3. Boards of management operating in the minority-language partial responsibility area other than those referred to in paragraph 2 shall have minority-language divisions to deal with matters concerning the organization of specialized medical care and training of health care personnel in the minority language. It may be laid down in the regulations that such divisions shall also include auxiliary members and personal deputies for them separately elected for the purpose by the federal council. The division members shall represent the minority-language group within the hospital district. (1328/2010) Sections 22 and 23 were repealed by Act No. 748/1992. Chapter 6. University hospitals Section 24 (241/1999) A university hospital shall exist in each of the hospital districts where the universities of Helsinki, Turku, Oulu, Tampere and Kuopio are located.

Section 25 1. A university providing training for physicians in a hospital district is entitled to appoint two members both to the federal council of the hospital district joint municipal board and to the federal board, and one personal deputy for each of them. 2. The voting rights of the university representatives on the federal council shall be 10% of the aggregate voting rights of the federal council members elected by the municipalities. The federal council members appointed by the university shall have no vote when the federal board is elected. Sections 26 and 27 were repealed by Act No 748/1992. 6 Section 28 1. Professors at a university medical training unit in a university hospital may, after giving the hospital district joint municipal board their consent, at one and the same time hold a secondary office or position as chief physician at the university hospital. Other teachers at the university may, after giving the hospital district joint municipal board their consent, at one and the same time act as physicians at the university hospital or occupy other secondary offices or positions there in accordance with further orders issued by the hospital district joint municipal board. (1328/2010) 2. If a professor is not available to carry out the functions of chief physician, or if the hospital district joint municipal board considers that special cause exists, the joint municipal board may, instead of a professor, appoint an associate professor at the university or an officeholder at the hospital with at least the qualification of docent (postdoctorate fellow) as chief physician for a period not exceeding five years at a time. (1328/2010) 3. There may also be chief physicians appointed by the hospital district joint municipal board at a university hospital who are not officeholders at the university. (1328/2010) 4. The term 'medical training unit' also refers to dental training units. Section 29 1. The hospital district joint municipal board and the university will separately agree on the engagement of professors and other teachers at the university medical training unit as physicians and other officials at the university hospital. Likewise, the engagement of professors and teachers at other institutes of higher education as hospital officials will also be agreed on separately. 2. If the hospital district joint municipal board and the university cannot reach agreement on a matter referred to in paragraph 1, the Government will resolve the matter. 3. The provisions of paragraph 1 concerning other university teachers apply as appropriate to the engagement of professors and other teachers at other institutes of higher education as holders of secondary offices at a hospital.

7 Chapter 7. Provision of medical care Section 30 (1328/2010) 1. The hospitals and units of a hospital district joint municipal board shall primarily be used to provide residents of member municipalities within the joint municipal board with medical care, unless otherwise required on the basis of arrangements made under sections 13 and 15 (1) of this Act and agreements made under sections 34, 43 and 44 of the Health Care Act. 2. Notwithstanding paragraph 1, anyone who needs urgent medical treatment shall always be provided with medical care. Sections 30a 31a were repealed by Act No. 1328/2010. Section 32 (652/2000) Medical care given in a hospital and other unit and other places on their responsibility shall be directed and supervised by the chief physician concerned or some other physician in the hospital district joint municipal board assigned with this function in the regulations. Sections 33 36 were repealed by Act No. 1328/2010. Chapter 8 (1328/2010) Chapter 9 was repealed by Act No. 1328/2010. Chapter 9. Compensation Sections 42 43a were repealed by Act No. 1328/2010. Section 43b (294/2006) Compensation for the services referred to in section 15 shall be determined on the basis of an agreement. If no agreement has been concluded regarding the compensation, the Defence Forces shall compensate the hospital district for the expenses incurred in providing the service. Furthermore, the Defence Forces shall compensate the hospital district for the expenses of providing the urgent medical care referred to in section 30, paragraph 2, although there would not exist a separate agreement on such treatment. Sections 44 44a were repealed by Act No. 1328/2010.

8 Chapter 10. Organization of teaching and research Sections 45 49 were repealed by Act No. 1328/2010. Section 50 was repealed by Act No. 1003/1996. Chapter 11 (1256/2005) Guidance and supervision Section 51 (1256/2005) 1. The National Supervisory Authority for Welfare and Health and the relevant Regional State Administrative Agency can inspect the operations of the hospital district joint municipal board referred to in this Act or the Health Care Act and the units and facilities used for organising the operations when there are justified grounds for carrying out the inspection. The Supervisory Authority can also on justified grounds order the Regional State Administrative Agency to carry out the inspection. The inspection can be carried out without prior notice. (1328/2010) 2. The inspector shall be given access to all facilities of the establishment. Notwithstanding confidentiality provisions all the documents requested by the inspector that are necessary for performing the inspection must be presented to the inspector. Furthermore, the inspector shall, notwithstanding confidentiality provisions, obtain free copies of the documents necessary for performing the inspection as requested by him or her. The inspector may also take photographs during the inspection. The inspector can be assisted in the inspection by experts, as needed. 3. The police shall, as necessary, give executive assistance to the National Supervisory Authority for Welfare and Health and the Regional State Administrative Agency for performing the inspection. (1548/2009) 4. A record shall be drawn up of the inspection. 5. Provisions on issues that shall be taken into account in particular in an inspection and on the detailed content of the inspection procedure, as well as on the record to be drawn up of the inspection and how and how long it shall be retained may be issued by Government decree, as necessary. Section 52 (1548/2009) 1. If defects endangering patient safety or other drawbacks are observed in the organization or provision of specialized medical care or if an operation is otherwise contrary to this Act or the Health Care Act, the National Supervisory Authority for Welfare and Health or the relevant Regional State Administrative Agency can issue orders to remedy the defects or to eliminate the drawbacks. When issuing the orders they shall determine the period of time within which the necessary measures must be undertaken. If patient safety so requires, the operation can be ordered to be sustained immediately or the use of the unit, a part thereof or a device can be forbidden immediately. (1328/2010)

2. The National Supervisory Authority for Welfare and Health or the Regional State Administrative Agency can oblige the hospital district joint municipal board to comply with the orders referred to in paragraph 1 under penalty of a fine or with the threat that the operation will be suspended or the use of a unit, a part thereof or a device will be forbidden. 3. The decision of the National Supervisory Authority for Welfare and Health or the Regional State Administrative Agency to sustain an operation or to forbid the use of a unit, a part thereof or a device shall be complied with notwithstanding appeal unless the appellate authority otherwise orders. 4. The provisions of this section do not apply to the operations referred to in the Medicines Act (395/1987); the supervision under that Act is the responsibility of the Finnish Medicines Agency. If the National Supervisory Authority for Welfare and Health or the Regional State Administrative Agency have in the course of their supervision observed defects or other drawbacks regarding pharmaceutical services, those must be reported to the Finnish Medicines Agency. Section 53 (1548/2009) 1. If it is observed in the context of the guidance and supervision of specialized medical care that a hospital district joint municipal board has, when organizing or carrying out its operations under this Act or the Health Care Act, acted erroneously or failed to fulfil its responsibilities, the National Supervisory Authority for Welfare and Health or the relevant Regional State Administrative Agency can issue the joint municipal board or the office-holder responsible for the erroneous action an admonition in order to prevent that such action is repeated in the future. (1328/2010) 2. If the matter does not give cause to an admonition or other measures, the National Supervisory Authority for Welfare and Health or the Regional State Administrative Agency can draw the attention of the supervised party to appropriate arranging of the operations and observing good administrative praxis. 3. An admonition issued or the drawing of attention by the National Supervisory Authority for Welfare and Health or the Regional State Administrative Agency referred to in this section may not be appealed. Section 53a (1256/2005) The supervisory authority referred to in section 5 does not examine complaints regarding specialized medical care that concern a matter that took place more than five years ago, unless there are particular grounds for examining the complaint. 9 Chapter 12 (1328/2010) Chapter 12 was repealed by Act No. 1328/2010.

10 Chapter 13. Miscellaneous provisions Section 56 was repealed by Act No. 748/1992. Section 56a was repealed by Act No. 1328/2010. Section 57 was repealed by Act No. 1328/2010. Section 58 (1328/2010) Hospital district joint municipal boards are required to provide competent State and municipal authorities with any information and reports on their operations under this Act and the Health Care Act that are considered necessary for the appropriate performance of their functions. Section 58a (908/1992) Derogations from the provisions of this Act are possible under international agreements binding on Finland. Section 59 was repealed by Act No. 1328/2010. Section 60 Provisions on the implementation of this Act will be issued separately. Entry into force of amended Acts: 1714/2009: This Act enters into force on 1 January 2010. 1328/2010: This Act enters into force on 1 May 2011. Sections 47 and 47a repealed by this Act are however applied to compensation for university-level health scientific research until 31 December 2011. Measures necessary for the implementation of this Act may be undertaken before the Act s entry into force.