Nakkushaiguste ennetamise ja tõrje seadus (NETS)

§ 1. Scope of application of Act

(1) This Act regulates the way in which the control of communicable diseases is organised and the procedure for the provision of health care services to infected persons (hereinafter provision of medical care), and sets out the obligations of the state, local governments, legal persons and natural persons in the prevention and control of communicable diseases.

(2) This Act applies to all natural persons in the territory of the Republic of Estonia and to legal persons located in the territory of the Republic of Estonia unless otherwise provided by an international agreement or international convention.

(3) The provisions of the Administrative Procedure Act apply to administrative proceedings prescribed in this Act, taking account of the specifications provided for in this Act.

§ 2. Definitions

In this Act, the following definitions are used:

1) “infectious agent” means a prion, virus, bacterium, microscopic fungus, protozoan, helminth or arthropod, and their components and toxins capable of causing communicable diseases;

2) “communicable disease” means a disease, or carrier state with no signs of disease, which is caused by the entry of an infectious agent into the human body which is transmitted or with regard to which there is reason to believe that it may be transmitted directly or indirectly person-to-person or animal-to-person;

3) “extremely dangerous communicable disease” means a disease with a high level of infectiousness which spreads rapidly and extensively or which is serious or life-threatening. For the purposes of this Act, the plague, cholera, yellow fever, viral hemorrhagic fevers and tuberculosis are extremely dangerous communicable diseases;

4) “person suffering from a communicable disease” means a person who has been diagnosed as having a communicable disease using methods accepted by medical science;

5) “ person suspected of being infected” means a person who has been exposed to similar conditions as a person suffering from a communicable disease or who may have been infected by a person suffering from a communicable disease but who has not developed any symptoms of disease by the time he or she undergoes a medical examination;

6) “control of communicable diseases” means the application of health protection measures which enable the early detection and consequent testing and treatment of persons suffering from communicable diseases and of persons suspected of being infected in order to ascertain the causes and mode of their infection, prevent the spread of the communicable disease and prevent healthy persons from being infected;

7) “epidemic” means an outbreak of a communicable disease which calls for infection control measures to be applied extensively;

8) “surveillance” means systematic collection, analysis, interpretation and dissemination of health data, including epidemiological studies of communicable diseases and risk factors for contracting communicable diseases for the purpose of prevention of the spread and control of communicable diseases;

9) “disease outbreak” means the occurrence of cases of communicable disease connected with the same source of infection or spread factor in excess of what would normally be expected within a certain period.

10) “retention sample of donor blood” – sample of donor blood taken from a dose of blood.

(2) A dangerous novel communicable disease for the purposes of this Act is a communicable disease:

1) that has the features of an extremely dangerous communicable disease provided for in clause 3 of subsection 1 of this section;

2) that has no effective treatment or for which no effective treatment is available or the spread of which may exceed the hospital treatment capacity.

§ 3. Consent for provision of medical care

(1) Medical care shall be provided to a person suffering from a communicable disease or to a person suspected of being infected with his or her consent.

(2) Medical care shall be provided to a person with restricted active legal capacity with the consent of his or her legal representative based on his or her will in so far as the person is able to express such will. Emergency care may be provided to a patient without the consent of his or her legal representative or without the person’s will if failure to do so might endanger the life of the patient or cause significant damage to his or her health. Third parties shall not prohibit or prevent the provision of emergency care.

§ 4. Involuntary treatment of persons suffering from communicable disease

(1) In order to prevent the spread of extremely dangerous communicable diseases, a person suffering from such disease may be hospitalised regardless of his or her will if the person is dangerous to others and has refused treatment or violated the treatment regime.

(2) Involuntary treatment shall be applied only on the basis of a court ruling.

(3) Involuntary treatment may also be applied without a court ruling if it is inevitable for the protection of the person or the public and if a court ruling cannot be received as quickly as necessary. A decision to apply involuntary treatment without the court’s permission shall be made by a physician upon the arrival of a person in the hospital or if after carrying out a medical examination of a person who is under treatment in the hospital the need to admit the person for involuntary treatment becomes evident. The date of documenting a decision is deemed to be the commencement of involuntary in-patient treatment.

(4) On the basis of the decision specified in subsection 3 of this section, involuntary treatment may be applied within forty-eight hours after the commencement of involuntary in-patient treatment. The physician shall immediately inform the person suffering from a communicable disease of the decision to apply treatment to him or her and shall inform the person close to or the legal representative of the person within twelve hours as of the decision being taken.

(5) A person suffering from a communicable disease or a person authorised by him or her shall arrange for his or her property to be protected.

(6) On the basis of a court ruling specified in subsection 2 of this section or a decision specified in subsection 3, a health care provider may, where necessary, use the assistance of the police to transfer a person suffering from a communicable disease to hospital, in which case the health care provider shall provide the police officers with appropriate protective equipment in conformity with the communicable disease control requirements provided in § 22 of this Act and instruct them in the proper use of such equipment.

(7) A health care provider shall, at the first opportunity, notify the police of a person suffering from an extremely dangerous communicable disease, who is dangerous to others, who has refused treatment or violated the treatment regime and whose location is unknown, by forwarding a copy of the court judgment pursuant to subsection 2 or the decision pursuant to subsection 3 of this section to the police.

(8) The police shall promptly notify the health care provider having submitted the decision to apply involuntary treatment if the location of the person specified in subsection 7 of this section has been ascertained.

(9) A health care provider shall notify the local authority of a person suffering from an extremely dangerous communicable disease, who is dangerous to others, who has refused treatment or violated the treatment regime if it is necessary for placing the person in a closed institution.

§ 5. Conditions and procedure for application of involuntary treatment

(1) The application, extension and termination of involuntary treatment shall be decided by court pursuant to the procedure prescribed for the proceeding for placement of the person in a closed institution provided for in the Code of Civil Procedure unless otherwise provided by this Act.

(2) An application for the implementation of preliminary legal protection for involuntary treatment and for placing a person in a hospital as well as an application for extending the term of preliminary legal protection may also be filed by the person’s attending physician to the court of the site of a hospital pursuant to the procedure provided for in the Code of Civil Procedure.

(7) After the circumstances specified in subsection 1 of § 4 of this Act have ceased to exist, the person’s attending physician shall submit an application to the court for termination of involuntary treatment of a person suffering from a communicable disease.

(8) A person suffering from a communicable disease who is hospitalised for involuntary treatment shall be placed in an isolated ward which meets the requirements for safety from infection. A person suffering from a communicable disease may leave the ward only under the conditions established in the relevant hospital instructions and only if measures to ensure safety from infection have been applied. Communication may be restricted for the person in so far as this is necessary to prevent the infection from spreading.

§ 6. Duties of health care professionals upon prevention and control of communicable diseases

(1) A health care professional for the purposes of subsection 1 of § 3 of the Health Services Organisation Act shall:

1) comply with the requirements set out in this Act for the prevention and control of communicable diseases;

2) administer medical examinations to persons suffering from a communicable disease and to persons suspected of being infected, forward testing material to a laboratory for analysis if necessary, and prescribe treatment to the persons;

3) determine the time when a person suffering from a communicable disease became infected, ascertain the source and mode of the infection and the factors of transmission of the infection, and identify the persons who have been in contact with the person suffering from the communicable disease;

4) notify the persons who have been in contact with a person suffering from a communicable disease of the need for medical examinations;

5) in the case of a communicable disease subject to registration, inform the Health Board of a suspicion of any suspected cases of the communicable disease, of diagnosis of the disease, of the circumstances under which the person suffering from the disease became infected and of the laboratory test findings pursuant to the procedure provided in § 21 of this Act;

6) inform a person suffering from a communicable disease, or his or her legal representative, of the communicable nature of the disease, the route of transmission of the disease, the consequences of the disease remaining untreated and the restrictions to be applied with regard to the person pursuant to law, and instruct the patient in how to prevent the infection spreading. The health care professional shall make an entry in the person’s medical file concerning the information communicated to him or her;

7) in the case of a sexually transmitted disease, issue a notice to the person suffering from the communicable disease which indicates the name of the disease and the need to inform persons who have been in sexual contact with the patient of the occurrence of the disease and of the necessity to undergo medical examination.

§ 7. Principles of prevention of spread of communicable diseases

In order to prevent the spread of communicable diseases, the immunisation of persons shall be organised, medical examinations shall be carried out and other measures to ensure safety from infection shall be applied.

§ 8. Organising immunisation

(1) The Ministry of Social Affairs coordinates the renewal of the immunisation schedule, immunisation pursuant to the procedure of emergency care, and the immunisation necessary for the prevention of an epidemic spread of communicable diseases.

(1¹) Family physicians shall:

1) organise immunisation on the basis of the immunisation schedule;

2) ensure that the persons entered in his or her list have access to immunisation or refer them to another health care provider for immunisation, if necessary.

(1²) The functions of a family physician specified in clause 1 of subsection 1¹ of this Act shall be performed by a family nurse, school health care provider or midwife if he or she complies with the requirements provided for in the regulation established under subsection 5 of this section.

(2) Health care professionals organising immunisations shall:

1) ascertain the temporary and permanent contraindications of the immunisation;

2) maintain records of the immunisations carried out according to the requirements provided for in subsection 3 of § 4² and § 59² of the Health Services Organisation Act and in the regulation established under subsection 5 of this section;

3) submit the immunisation reports according to the requirements provided for in the regulation established under subsection 5 of this section;

4) register the adverse events of immunisations and notify the State Agency of Medicines thereof on the basis and pursuant to the procedure provided for in the Medicinal Products Act.

(2¹) If a nurse or midwife organises the immunisation specified in subsection 2 of this section, he or she shall involve a physician to confirm any permanent contraindications or to diagnose any adverse events of immunisation.

(4) Additional immunisation of servicemen sent on missions abroad shall be organised by the Ministry of Defence as necessary.

(5) The requirements for organising immunisation shall be established by a regulation of the minister in charge of the policy sector.

(5¹) The Estonian Health Insurance Fund organises the distribution, preservation and transportation of the procured immunological preparations and the functioning of the cold chain. The principles of distribution of immunological preparations are approved with the Health Board.

(6) In order to preserve the quality, safety and efficiency of immunological preparations, the functioning of the cold chain must be ensured in all stages of handling. Ensuring the requirements of the cold chain of immunological preparations upon the preservation and transportation thereof shall be effected on the basis and pursuant to the procedure provided for in § 34 of the Medicinal Products Act.

§ 9. Immunisation in case of epidemic

(1) If it is necessary in order to prevent the epidemic spread of a communicable disease, immunisation may be organised for persons at risk.

(2) In case of an epidemic, the minister in charge of the policy sector shall have the right to establish the appropriate code of conduct for the immunisation of persons at risk.

§ 10. Immunisation schedule

(2) The immunisation schedule sets out the communicable diseases immunised against, the age groups or risk groups to be immunised and the terms of immunisation.

(3) The immunisation schedule shall be established by a regulation of the minister in charge of the policy sector.

§ 11. Monitoring of immunity background

(1) The immunity background is the proportion of persons in the population who are immune to a specific disease. The immunity background is monitored by way of health examinations.

§ 12. Screening of pregnant women for communicable diseases and carrier states

(1) Pregnant women shall be screened for syphilis, hepatitis B and HIV in order to prevent the transmission of communicable diseases to the embryo or foetus or to the new-born child.

(2) The procedure for screening and treating pregnant women shall be established by a regulation of the minister in charge of the policy sector.

§ 14. Ensuring safety of blood donation from infection

(1) In order to protect donors and recipients, the Blood Centre and health care providers shall apply measures to ensure safety from infection.

(2) The Blood Centre or the health care provider shall prepare a document recording the preparation and use of blood products, in compliance with the requirements provided for in the Blood Act (RT I 2005, 13, 63) and in the legislation established on the basis thereof.

(3) The procedure for screening donated blood and blood components for infectious agents shall be established by a regulation of the minister in charge of the policy sector.

(4) A retention sample of donor blood shall be preserved for five years according to the procedure provided for in subsection 3 of this section. The documents on laboratory testing procedures and the testing results received in the course thereof shall be preserved for 15 years.

§ 15. Ensuring safety of procurement, handling and transplantation of cells, tissues and organs from infection

(1) In order to protect recipients and live donors, health care providers shall apply measures to ensure safety from infection.

(2) A health care provider shall prepare a document recording the use of cells, tissues and organs.

(3) The conditions of and procedure for screening donors for infectious agents shall be established by a regulation of the minister in charge of the policy sector.

§ 16. Avoiding infection while travelling abroad

Undertakings which provide tourism services shall inform their customers about to travel to a foreign country of:

1) the risks of becoming infected with a communicable disease in the country to be visited;

2) the feasibility of immunisation or of using medicinal products;

3) the possibility of obtaining medical advice before the trip and medical assistance during the trip and of the need for a medical examination following the trip.

§ 17. Obligations of state upon surveillance and control of communicable diseases

(1) At state level, the surveillance and control of communicable diseases is organised by the Ministry of Social Affairs who directs the activities to control communicable diseases.

(2) Ministries shall act pursuant to this Act and legislation established on the basis thereof in applying measures for the prevention of communicable diseases and of the spread of such diseases and in organising medical care in the agencies in their area of government.

(3) The Ministry of Justice and Digital Affairs and the Ministry of the Interior shall organise provision of the following in penal institutions and in police detention houses and detention cells respectively:

1) working conditions which are as safe from infection as possible for prison officers, health care professionals and persons who are in direct contact with detained persons, persons in custody and prisoners;

2) conditions of detention which are as safe from infection as possible for detained persons, persons in custody and prisoners;

3) mandatory medical examinations, for epidemiological reasons, of prisoners who, due to the particular nature of their activities, may transmit communicable diseases through contact with food, water or other vectors and fomites;

4) in order to prevent the spread of tuberculosis, mandatory radiographic examinations of lungs of detained persons, persons in custody and prisoners and of prison officers, guards and health care professionals in direct contact with them. The procedure for administering radiographic examinations shall be established by a regulation of the minister in charge of the policy sector.

(4) The Ministry of Justice and Digital Affairs and the Ministry of the Interior shall ensure conditions which are as safe from infection as possible during the transport of detained persons, persons in custody and prisoners.

(5) The Ministry of Justice and Digital Affairs shall authorise health protection officials to exercise supervision over the application of measures to control communicable diseases in penal institutions.

(6) The Ministry of Justice and Digital Affairs and the Ministry of the Interior, together with the Ministry of Social Affairs, shall arrange for persons suffering from tuberculosis to be sent for treatment pursuant to the procedure provided for in this Act after such persons are released from a penal institution, police detention house or detention cell.

§ 18. Duties of Health Board upon prevention, surveillance and control of communicable diseases

(1) The competent authority in the area of prevention, surveillance and control of communicable diseases shall be the Health Board which shall:

1) conduct epidemiological investigations with the aim of ascertaining the circumstances under which persons suffering from a disease became infected and of determining the circumstances of the spread of the communicable disease, contact the persons suffering from a communicable disease and persons who have been in close contact therewith, and, in the event of clusters of disease, shall provide instructions for the application of disease control measures;

2) inform the population through the media of the occurrence of a communicable disease and the measures taken to control the outbreak of the disease;

3) make a proposal on the procurement and distribution of immunological preparations to the Estonian Health Insurance Fund if the risk of an epidemic spread of a communicable disease arises;

4) collect, analyse and publish data concerning immunisations;

5) organise the surveillance of communicable diseases, including the sentinel surveillance, according to the relevant legislation of the European Union and recommendations of the World Health Organisation.

(2) The competent authority in the area of epidemiological risk analysis and risk assessment of communicable diseases shall be the Health Board who shall determine and assess:

1) tendencies of spread of communicable diseases;

2) immunisation coverage.

(3) The authorised authority upon participation in the international control of communicable diseases shall be the Health Board who shall handle the early warning and response system of the European Centre for Disease Prevention and Control in Estonia.

(4) The Health Board shall be the liaison body authorised by the World Health Organisation and European Commission concerning biological agents in connection with the application of international health regulations.

(5) The Health Board shall participate as the competent authority in the disease-specific epidemiological activities of the World Health Organisation and the European Centre for Disease Prevention and Control, including in the international disease control programmes by performing the role of the national reference laboratory in the relevant testing areas of communicable diseases.

(6) In performing the functions prescribed by this Act, the Health Board shall co-operate with local authorities for the prevention, surveillance of communicable diseases and to prevent and control the spread of communicable diseases.

(7) When participating in the international control of communicable diseases, the Health Board is required to inform other states of the occurrence of a communicable disease and the measures taken to control the outbreak of the disease. The requirements and procedure for international co-operation in the control of communicable diseases and the provision of information related thereto shall be established by the Government of the Republic.

(8) The Health Board shall provide health services pursuant to the provisions governing the provision of specialised medical care set out in the Health Services Organisation Act. Upon the provision of specialised medical care, the form requirement of a legal person provided for in subsection 1 of § 21 of the Health Services Organisation Act shall not be applied to the Health Board.

§ 19. Suspicion of communicable disease and diagnosis of disease

(1) Suspicion of a communicable disease is raised if a person exhibits clinical symptoms characteristic of the communicable disease or if a person has been in direct or indirect contact with an infected person or animal. Suspicion of a communicable disease may be confirmed by laboratory test findings.

(2) Physicians are required to inform the local agency of the Health Board immediately of any suspicion of an extremely dangerous communicable disease.

(4) Microbiology, virology and parasitology laboratories engaged in detecting human pathogens, and research laboratories engaged in scientific research in those fields are required to inform the Health Board immediately of any suspicion or diagnosis of an extremely dangerous communicable disease.

(5) The information specified in subsections 2 and 4 of this section shall be communicated together with the personal data of a data subject.

(51) Microbiology, virology and parasitology laboratories engaged in detecting human pathogens are required to forward testing material for additional testing to a reference laboratory engaged in the relevant testing area. Upon the collection, preservation and transportation of testing material, the laboratory shall adhere to the instructions prepared by the reference laboratory.

(6) The Health Board has the right to forward the testing material needed for diagnosis of communicable diseases in a pseudonymised format to a relevant foreign laboratory or an international reference laboratory with the aim of ensuring the prevention and control of communicable diseases.

§ 20. Registration of cases of communicable diseases and Estonian Communicable Diseases Register

(1) Cases of communicable diseases shall be registered in the Estonian Communicable Diseases Register (hereinafter the register), which is maintained in order to register the cases of communicable diseases, to determine the tendencies of their spread, prevent communicable diseases, organise the control and health services, develop the health policy, analyse the communicable diseases morbidity, spread and mortality, to evaluate the diagnostics and treatment, organise statistics and scientific research, including epidemiological research.

(2) The register shall be founded and the statutes thereof shall be established by a regulation of the minister in charge of the policy sector, setting out:

1) the processor of the database if a processor has been determined and the functions of processors;

2) the specific composition of data collected in the database and the procedure of entry thereof in the database;

3) the procedure of access to and issue of data;

4) the list of persons submitting data and the data received therefrom;

5) other organisational issues.

(3) Information regarding suspicion of a communicable disease, diagnosis of such a disease, the factors affecting the risk of becoming infected, and the prevention of infection shall be registered at the place where the person seeks medical help.

(4) The following data shall be processed in the register:

1) general data of the person suffering from a communicable disease depending on the notice – first name and surname, personal identification code, date of birth and sex;

2) other data on the person suffering from a communicable disease – education, position, place of work or educational institution, contact details, including the place of residence, place of birth, nationality and socio-economic condition;

3) health data of the person suffering from a communicable disease – diagnosis, becoming infected, immunisation, testing material, testing method and result, pathogenic agent and sensitivity thereof, causes of testing, circumstances of becoming infected and the assumed way of spreading, hospitalisation and treatment;

4) source of infection upon the spread of HIV from a mother to a child or of a person infected by sexual means, belonging to a risk group, delivery method, prophylactic treatment during pregnancy and after birth, upon parenteral infection also the mode of infection;

5) AIDS indicator diseases;

6) date and cause of death of a person suffering from a communicable disease;

7) data on the health care provider;

8) registration data of a notice.

(5) The data entered in the register shall be preserved without a term. The logs and source data shall be preserved according to the provisions of the statutes of the register.

(6) The controller of the register is the Health Board.

§ 20¹. Research ethics committee

The research ethics committee, an independent body consisting of scientists and experts of various fields, specified in § 26 of the Organisation of Research and Development and Innovation Act, shall assess whether the issue of personal data from the register specified in § 20 of this Act for the purposes of research or statistics is ethical and justified.

§ 21. Communication of information

(1) Health care providers shall communicate information concerning any suspicion of a communicable disease, diagnosis of such a diseases, the factors affecting the risk of becoming infected, and the prevention of infection to the Health Board on the basis and pursuant to the procedure established by this Act.

(2) Health care providers shall immediately inform the Health Board of any suspicion of the rapid spread of food poisoning or disease, or the rapid spread of disease.

(3) The Health Board shall notify the Alarm Centre of any occurrence of plague, cholera, yellow fever and viral hemorrhagic fevers.

(4) Laboratories engaged in microbiological, virological, parasitological and serological testing shall communicate laboratory test findings to the physician who submitted the tested material. The findings of laboratory tests conducted in order to determine the presence of an infection subject to registration shall be sent to the Health Board of the residence of the tested person.

(5) The Ministry of Defence, the Ministry of the Interior and the Ministry of Justice and Digital Affairs shall inform the Health Board of the occurrence of communicable diseases in the agencies in their area of government and of the risk factors related to the diseases pursuant to the procedure provided for in this Act.

(6) The agencies in the area of government of the Ministry of Rural Affairs and the agencies governed thereby shall inform the Health Board of the detection of zoonotic agents in food and in the various stages of the handling of food, and zoonoses diagnosed on animals.

(6¹) Data on suspicion or diagnosis of a communicable disease shall be communicated together with the personal data of a data subject, if necessary. The list of communicable diseases which require the communication of data together with the personal data of a data subject shall be established by a regulation of the minister in charge of the policy sector.

(7) The procedure for submission of the data prescribed in subsections 1, 4, 5 and 6 of this section and the composition thereof shall be established by a regulation of the minister in charge of the policy sector.

(8) The Health Board is required to inform the World Health Organisation of the hazards or the identification of cross-border health hazards specified in international agreements within twenty-four hours after the identification of a hazard or an event that endangers public health.

(9) The Health Board is required to inform the agency for the epidemiological surveillance and control of communicable diseases in the European Union of the diagnosis of any of the communicable diseases included in the list prepared by the European Commission.

§ 22. Requirements for control of communicable diseases

(1) The requirements for the control of communicable diseases shall set out the instructions for the control of communicable diseases and for prevention of the epidemic spread thereof.

(2) The requirements for the control of communicable diseases are mandatory for health care professionals, health protection officials, persons present in infected areas and other persons involved in the control of communicable diseases as a result of their duties.

(3) The requirements and measures for the control of communicable diseases shall be established by a regulation of the minister in charge of the policy sector.

(4) The procedure for treating patients suffering from drug-resistant tuberculosis who violate the treatment requirements shall be established by a regulation of the minister in charge of the policy sector.

(5) The requirements and measures for the control of communicable diseases which have not been previously recorded in Estonia and of dangerous novel communicable diseases, that have not been established based on subsection 3 of this section, shall be developed by the Health Board based on the competence and authority thereof, and shall inform the persons concerned of such requirements and measures.

§ 23. Surveillance, prevention and control of nosocomial infections

(1) A nosocomial infection is an infection which a patient did not have before being admitted to or visiting a hospital or any other enterprise providing health care services and which is not a residual effect of the patient’s stay there but is a condition which the patient developed during his or her stay there or as a result of treatment received there and the symptoms of which develop during the patient’s stay or after leaving.

(2) The measures for surveillance, prevention and control of nosocomial infections to be applied by health care providers and the procedure for communicating the corresponding information shall be established by a regulation of the minister in charge of the policy sector.

(3) The procedure for informing the Health Board of the findings of laboratory surveillance of nosocomial infections and test findings concerning the drug resistance of microbes, as carried out by microbiology and virology laboratories, shall be established by a regulation of the minister in charge of the policy sector.

§ 24. Obligations of employers in control of communicable diseases

An employer is required to:

1) create working conditions which are as safe from infection as possible for employees working in areas where there is a risk of becoming infected with a communicable disease;

2) ensure that the requirements established for safety from infection are met at the workplace;

3) ensure that employees in areas specified in clause 1 of this section are immunised and, if necessary, provided with preventive treatment;

4) permit employees to undergo medical examinations for the detection of communicable diseases or carrier states and to receive emergency immunisations during working hours;

5) prevent the spread of infectious agents upon the handling of raw materials and finished products;

6) ensure that infectious waste is rendered harmless.

§ 25. Requirements for prevention of spread of extremely dangerous communicable diseases

(2) The procedure and conditions for the prevention of extremely dangerous communicable diseases on the Estonian state border shall be established by a regulation of the Government of the Republic.

§ 27. Establishment and termination of quarantine

(1) For the purposes of preventing any extremely dangerous communicable disease from spreading outside the focus of the disease, quarantine means the imposed:

1) prohibition on stay for the purposes of the Law Enforcement Act;

2) restriction on the movement of persons, goods and vehicles on a certain territory or departure therefrom, or

3) restriction on the provision of services.

(2) For the purposes of this Act, the focus of a disease is a delimited territory containing persons suffering from a communicable disease and persons suspected of being infected and where intensified surveillance over the residents is exercised by the health protection authorities.

(3) Quarantine shall be established by the Health Board with an administrative act. If the establishment of quarantine is accompanied with a significant effect on the society or economy, the quarantine shall be established by an order of the Government of the Republic. The term of quarantine shall be determined in an administrative act. The term of quarantine determined in an administrative act may be extended until the objective established in subsection 5 of this section has been achieved.

(3¹) Upon the establishment of quarantine specified in subsection 3 of this section, persons concerned shall be involved immediately according to the provisions of § 40 of the Administrative Procedure Act.

(4) Quarantine requirements and the procedure for compliance therewith shall be established by a regulation of the minister in charge of the policy sector.

(5) Quarantine shall be terminated by the administrative authority who established the quarantine after the spread of the communicable disease has been prevented, the requirements for the control of the communicable disease have been fulfilled and the focus of the disease has been rendered harmless. If quarantine has been established in the same focus of disease by the Health Board and the Government of the Republic, the rights and obligations arising from the administrative act of the Health Board shall be deemed to be terminated as of entry into force of the administrative act of the Government of the Republic concerning the part in which these rights and obligations are different or contradictory.

(6) Information on the establishment and termination of quarantine may be published in media, provided that the number of addressees of the administrative act is more than 50.

(7) An administrative act on the establishment and termination of quarantine shall enter into force upon the communication thereof to the direct addressee or publishing thereof in media, unless the administrative act itself provides for another term.

§ 30. Handling of infectious material

(1) Material is infectious if it contains bacteria, viruses, microscopic fungi, infected cell cultures, human internal parasites or other bioactive agents causing communicable diseases.

(2) For the purposes of this Act, the handling of infectious material is the taking of samples from material specified in subsection 1 of this section, the transport, processing, testing and storage of such material and the rendering of such material harmless.

(3) Upon the handling of infectious material, it shall be ensured that the infection is prevented from spreading. The procedure for handling infectious material shall be established by a regulation of the minister in charge of the policy sector.

(4) Infectious material may be handled by health care providers and other legal and natural persons to whom the Health Board has issued an activity licence for the handling of infectious material pursuant to the procedure provided for in §§ 32–36 of this Act.

(5) The requirements for the laboratory facilities, installations and equipment of persons handling infectious material and the safety measures to be applied shall be established by a regulation of the minister in charge of the policy sector.

(6) A laboratory worker responsible for the testing of infectious material must have the qualifications of a physician or biologist.

§ 32. Application for activity licence for handling of infectious material from Health Board

(1) In order to obtain an activity licence for the handling of infectious material, a person specified in subsection 4 of § 30 of this Act shall submit the following information and documents to the Health Board:

1) an application which sets out the name of the applicant and the location and address of the place of business;

2) copies of the memorandum of association or foundation resolution and of the articles of association or partnership agreement of the legal person being founded;

3) in the case of a sole proprietor, the name, personal identification code, residence and business name of the undertaking;

4) a list of the testing services regarding which the activity licence is applied for;

5) copies of the professional certificates of employees to be engaged in the testing of infectious material;

6) information on the laboratory facilities, installations and equipment;

7) information on the safety measures to be applied;

8) the telecommunications numbers of the applicant.

(2) Before submitting an application, an applicant for an activity licence shall pay the state fee.

(3) If an applicant for an activity licence fails to submit any information or documents specified in subsection 1 of this section or if the application contains other deficiencies, the Health Board shall set a term for the applicant to eliminate the deficiencies.

(4) The date on which the Health Board receives all the information and documents prepared in accordance with the requirements specified in subsection 1 of this section is deemed to be the date of submission of an application.

§ 33. Decision on issue of activity licence

The issuer of activity licences shall check the documents and information submitted by an applicant and shall make a decision to issue or to refuse to issue an activity licence not later than within one month as of submission of the documents and information specified in § 32 of this Act.

§ 34. Issue of activity licence

(1) Activity licences are issued by the Health Board.

(2) An activity licence shall be issued within ten working days as of the corresponding decision being made.

(3) A decision to issue an activity licence shall be published in the official publication Ametlikud Teadaanded.

§ 35. Information and conditions set out in activity licence

An activity licence shall set out:

1) the name, place of business and address of the holder of the activity licence and, in the case of a sole proprietor, also his or her personal identification code, residence and business name;

2) the number and date of issue of the activity licence;

3) a list of testing services.

§ 36. Refusal to issue activity licence

(1) An activity licence shall not be issued if the applicant for the activity licence:

1) has not submitted all the documents and information specified in subsection 1 of § 32 of this Act, or if the application contains other deficiencies which the applicant has failed to eliminate within the term specified in subsection 3 of § 32 of this Act;

2) does not comply with the requirements established for handlers of infectious material;

3) submits false information;

4) is bankrupt.

(2) The issuer of activity licences shall notify an applicant for an activity licence of its refusal to issue the activity licence in writing within ten working days as of the decision to refuse to issue the licence being made. The notice shall set out the reasons for the refusal to issue the activity licence together with a reference to the corresponding provisions of law.

§ 37. Validity of activity licence

Activity licences shall be valid for five years as of the issue thereof.

§ 38. Revocation of activity licence

(1) The issuer of an activity licence shall revoke the activity licence if:

1) so requested by the holder of the activity licence;

2) the facilities, installations or equipment of the laboratory or the safety measures to be applied do not conform to the requirements established on the basis of subsection 5 of § 30 this Act;

3) the qualifications of employees responsible for the testing of infectious material do not conform to the requirements provided for in subsection 6 of § 30 of this Act;

4) the requirements established on the basis of subsection 3 of § 30 of this Act are not complied with upon the handling of infectious material;

5) the testing specified in the activity licence has not commenced within a period of one year as of the issue of the licence;

6) the holder of the activity licence engages in testing which is not listed in the activity licence issued thereto.

(2) A decision to revoke an activity licence shall set out:

1) the name, place of business and address of the holder of the activity licence and, in the case of a sole proprietor, his or her name, personal identification code, residence and business name;

2) the number and date of issue of the activity licence;

3) the circumstances which caused the activity licence to be revoked and a reference to the provision of law pursuant to which the activity licence is revoked;

4) the date on which the decision was made;

5) the name, official title and signature of the person who made the decision.

(3) The holder of an activity licence shall be notified of a decision to revoke the activity licence within five working days as of the decision being made. The decision to revoke the activity licence shall be published in the official publication Ametlikud Teadaanded.

§ 39. Partial revocation of activity licence

(1) If the bases for revocation of an activity licence exist only with regard to some of the tests, the activity licence may be partially revoked by restricting the list of tests set out in the licence.

(2) Upon partial revocation of an activity licence, the corresponding decision shall, in addition to the information specified in subsection 4 of § 38 of this Act, set out the tests with regard to which the decision to revoke the activity licence applies.

(3) The holder of an activity licence shall be notified of a decision to partially revoke the activity licence within five working days as of the decision being made. A decision to partially revoke an activity licence shall be published in the official publication Ametlikud Teadaanded.

§ 40. Application for new activity licence

(1) The holder of an activity licence shall apply for a new activity licence if:

1) the licence expires;

2) the holder of the licence wishes to amend the list of testing services set out in the licence.

(2) A new activity licence shall be issued pursuant to the procedure provided for in §§ 32–36 of this Act.

(3) In order to apply for a new activity licence, an applicant shall submit that information and those documents specified in § 32 of this Act which does not or do not contain information already known to the Health Board.

§ 41. Reference laboratory

(1) For the purposes of this Act, a reference laboratory is a laboratory which provides reference service in the testing areas specified in this section by using the high sensitivity and specificity diagnostics method.

(2) A laboratory which has been accredited in the relevant testing area by an Estonian or foreign internationally recognised accreditation institution may operate as a reference laboratory.

(3) The testing areas of a reference laboratory are:

1) HI-viruses;

2) influenza and other respiratory viruses;

3) other viruses;

4) causative agents of tuberculosis and mycobacteriosis;

5) causative agents of sexually transmitted communicable diseases;

6) causative agents of invasive bacterial communicable diseases;

7) causative agents of other bacterial communicable diseases;

8) antimicrobial resistance.

(4) The functions of a reference laboratory upon the provision of reference service in its testing area are to:

1) organise and coordinate the quality management of laboratory diagnostics;

2) counsel other laboratories concerning the method of laboratory diagnostics;

3) prepare and update the instructions for the collection, preservation and transportation of laboratory testing material;

4) confirm laboratory diagnoses, if necessary;

5) identify the pathogenic agents forwarded for testing, and the collection and preservation thereof;

6) collect and analyse laboratory surveillance data;

7) forward the test results to the register of communicable diseases according to subsections 6¹ and 7 of § 21 of this Act;

8) cooperate with the international reference laboratories and institutions of the relevant testing areas.

(5) The provision of reference service in the testing areas specified in this section shall be organised by the Health Board. For the provision of reference service, the director general of the Health Board may enter into a contact for five years with a laboratory corresponding to the requirements of this Act.

§ 42. Financing of prevention, surveillance and control of communicable diseases

(1) The following shall be financed from the state budget through the Ministry of Social Affairs:

2) the fulfilment of government orders placed with reference laboratories.

(1¹) Antiretroviral medications and tuberculosis medications as well as the medications of side effects associated with tuberculosis medications shall be financed from the Estonian Health Insurance Fund budget.

(1²) The acquisition, storage, transport and functioning of the cold chain of vaccines and immunoglobulins needed to comply with the immunisation schedule and for emergency immunisation, and studies of the immunity background of the population shall be financed from the Estonian Health Insurance Fund budget.

(2) Additional immunisation of servicemen sent on missions abroad shall be financed from the state budget through the Ministry of Defence.

(3) Immunisations which are not included in the immunisation schedule and which are administered at the request of the patient or at the recommendation of the physician shall not be financed from the state budget.

(4) An employer shall finance:

1) immunisation and preventive treatment to protect the health of employees who are at risk of becoming infected due to the particular nature of their work;

2) additional medical examinations of employees in areas where the particular nature of the work may contribute to the transmission of communicable diseases.

(5) Employers are not required to finance the screening of employees for communicable diseases before the employees commence work in an area where the particular nature of the work may contribute to the transmission of communicable diseases.

(6) The prevention and control of communicable diseases may be financed from rural municipality or county government budgets.

(7) The prevention and control of communicable diseases may be financed from the health insurance budget.

§ 43. Financing of prevention of epidemic spread of communicable diseases

(1) Prevention of the epidemic spread of communicable diseases shall be financed from the state budget according to the order of the Government of the Republic.

(2) Expenditure shall not be compensated for pursuant to the procedure provided in subsection 1 of this section if:

1) when making of the expenditure, the legal person or natural person violated the requirements established by this Act or legislation issued on the basis thereof or the precept of a health protection official;

2) such expenditure was made before any suspicion of the epidemic spread of a communicable disease arose.

§ 44. State and administrative supervision

(1) State and administrative supervision over compliance with the requirements arising from this Act and legislation established on the basis thereof shall be exercised by the Health Board.

(2) Supervision over compliance with the requirements arising from clauses 1 and 2 of subsection 1 of § 13 of this Act shall be exercised by the Agriculture and Food Board. Supervision over the handlers of drinking water shall be exercised by the Agriculture and Food Board to the extent provided for in the Food Act.

§ 45. Special state supervision measures and specifications for application of coercive measure

(1) For the execution of state supervision provided for in this Act, the law enforcement agency may apply the special state supervision measures provided for in §§ 30, 31, 32, 44, 49, 50 and 51 of the Law Enforcement Act on the basis of and pursuant to the procedure provided for in the Law Enforcement Act.

(2) The law enforcement agency may, pursuant to the procedure provided for in § 46 of the Law Enforcement Act, if it is inevitably necessary, apprehend a person suffering from a communicable disease in order to take the person to his or her place of residence or lodging if he or she is a threat to the life or health of him- or herself or others and has not or does not comply with the requirements established in this Act and on the basis thereof and if other supervisory measures are not effective.

(3) The coercive measure imposed to ensure the compliance with the requirements, measures and restrictions provided for in the administrative act issued by the Government of the Republic or the Health Board shall be applied by the Health Board.

§ 46. Violation of requirements for control of communicable diseases

(1) Violation of the requirements for the control of communicable diseases or for the handling of infectious material is punishable by a fine of up to 200 fine units.

(2) The same act, if committed by a legal person, is punishable by a fine of up to 32 000 euros.

§ 46¹. Violation of quarantine requirements

(1) Violation of the quarantine requirements is punishable by a fine of up to 200 fine units.

(2) The same act, if committed by a legal person, is punishable by a fine of up to 32 000 euros.

§ 46². Violation of requirements for prevention of epidemic spread of communicable diseases

(1) Violation of the requirements established under § 28 of this Act is punishable by a fine of up to 100 fine units.

(2) The same act, if committed by a legal person, is punishable by a fine of up to 13 000 euros.

§ 47. Delay in submission of information

(1) Failure to communicate information related to communicable diseases in time is punishable by a fine of up to 50 fine units.

(2) The same act, if committed by a legal person, is punishable by a fine of up to 6400 euros.

§ 48. Non-compliance with terms for immunisations

(1) Failure to conduct, in time, the immunisations prescribed to prevent the epidemic spread of a communicable disease is punishable by a fine of up to 100 fine units.

(2) The same act, if committed by a legal person, is punishable by a fine of up to 13 000 euros.

§ 49. Proceedings

(2) The body conducting extra-judicial proceedings concerning the misdemeanours provided in §§ 46–48 of this Act shall be the Health Board.

(3) The body conducting extra-judicial proceedings concerning the misdemeanours provided in §§ (46¹) and (46²) shall also be the Police and Border Guard Board if it has been involved in the performance of functions of the Health Board pursuant to the procedure provided for in § 45² of this Act.

§ 50. Right to handle infectious material

(1) Specialised medical care providers and other persons providing laboratory services who are engaged in the handling of infectious material are required to apply for the right to handle infectious material within two years as of the entry into force of this Act.

(2) A specialised medical care provider or other person providing laboratory services loses the right to handle infectious material if the person has not submitted an application to obtain the right to handle infectious material within the term specified in subsection 1 of this section or if the authority which grants the right to handle infectious material refuses to grant that right.

§ 51

–

§ 53

[Omitted from this text.]

§ 54. Entry into force of Act

This Act enters into force on 1 November 2003, except for:

1) subsections 1 and 2 of § 20 of this Act which enter into force on 1 July 2004;

2) subsection 2 of § 9 of this Act which enters into force on 1 November 2004;

3) section 11 of this Act which enters into force on 1 May 2005;

4) subsection 9 of § 21 of this Act which enters into force as of Estonia’s accession to the European Union.