Communicable Diseases Prevention and Control Act

Passed 12 February 2003

(RT1 I 2003, 26, 160),

entered into force 1 November 2003,

amended by the following Act:

08.04.2004 entered into force 01.05.2004 - RT I 2004, 27, 177.

 

Chapter 1

General Provisions

 

§ 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 (RT I 2001, 58, 354; 2002, 53, 336; 61, 375; 2003, 20, 117; 78, 527) 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.

 

Chapter 2

Provision of Medical Care to Persons Suffering from Communicable Disease

 

§ 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. Emergency care may be provided to a patient without the consent of his or her legal representative 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 without his or her consent if the person is dangerous to others and has refused treatment or violated the treatment regime.

(2)        The decision to apply involuntary treatment shall be made by a physician on the basis of a medical examination of the person, initial analysis or radiography findings.

(3)        The procedure for deciding on the application of involuntary treatment shall be established by a regulation of the Minister of Social Affairs. The decision shall set out the reasons for applying involuntary treatment with a reference to the relevant provision of law.

(4)        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 forty-eight 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 decision specified in subsection (2) of this section, a health care provider may, where necessary, use the assistance of the police to transfer a person suffering from a communicable disease to hospital and to ensure the temporary protection of his or her property, 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.

 

§ 5. Conditions and procedure for application of involuntary treatment

(1)        On the basis of the decision of a physician, a person may be subjected to involuntary treatment within forty-eight hours as of his or her hospitalisation.

(2)        Involuntary treatment may continue for a period longer than forty-eight hours only with the permission of an administrative court granted on the basis of a written application by the medical director of the corresponding hospital to which the opinion of a medical specialist has been appended. An administrative court judge shall review an application submitted for the grant of permission immediately and shall decide to grant or to refuse to grant permission without a court hearing.

(3)        Involuntary treatment applied on the basis of permission granted by an administrative court judge may continue for up to fourteen calendar days as of the date on which the court receives the corresponding application, although in the event of a case of tuberculosis, involuntary treatment on the basis of such permission may continue for up to 182 calendar days.

(4)        If an administrative court judge refuses to grant permission to apply involuntary treatment or revokes permission to apply involuntary treatment, the person concerned may leave the hospital immediately or continue treatment on a voluntary basis.

(5)        An administrative court judge may revoke permission to apply involuntary treatment on the basis of an application submitted by the person undergoing the treatment or his or her representative, after hearing the explanation of the medical director of the hospital.

(6)        The grant of permission to apply involuntary treatment and the revocation of such permission shall be decided pursuant to the provisions of the Code of Administrative Court Procedure (RT I 1999, 31, 425; 33, correction notice; 40, correction notice; 96, 846; 2000, 51, 321; 2001, 53, 313; 58, 355; 2002, 29, 174; 50, 313; 53, 336; 62, 376; 2003, 13, 67; 23, 140) concerning the grant of permission to take administrative measures.

(7)        If it becomes evident during the involuntary treatment of a person suffering from a communicable disease that the person no longer poses a threat to others, the physician concerned shall terminate the treatment by a written decision and the person may leave the hospital immediately or continue treatment on a voluntary basis. If the person has been treated with the permission of an administrative court judge, the medical director of the hospital shall inform the court in writing of the termination of the treatment.

(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 family physicians and of specialists treating communicable diseases

(1)        A family physician or a specialist treating communicable diseases 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)         arrange for medical examinations for persons who have been in contact with a person suffering from a communicable disease and, where necessary, prescribe treatment to such persons;

5)         in the case of a communicable disease subject to registration, inform the local agency of the Health Protection Inspectorate 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 physician 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.

(2)        In addition to the duties specified in subsection (1) of this section, a family physician is required:

1)         in order to prevent the spread of communicable diseases, to organise the immunisation of children on the basis of an immunisation schedule and to register immunisations, make entries in immunisation passports and forward immunisation data to the local agency of the Health Protection Inspectorate;

2)         to register any adverse effects of immunisation and to communicate information to this effect to the State Agency of Medicines.

 

Chapter 3

Prevention of Spread of Communicable Diseases

 

§ 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)        All children, persons who are at risk due to the particular nature of their work and persons in need of corresponding emergency care shall be immunised.

(2)        Physicians organising immunisation shall register the immunisations carried out, submit reports to this effect and communicate information concerning any adverse effects of immunisation pursuant to the procedure provided in subsection 6 (2) of this Act.

(3)        The procedure for the acquisition, distribution, storage and transport of vaccines and immunoglobulins, and the procedure for the functioning of the cold chain shall be established by a regulation of the Minister of Social Affairs.

(4)        Additional immunisation of members of the Defence Forces 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 of Social Affairs.

 

§ 9. Immunisation in event of epidemic

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

(2)        The procedure for immunisation and medical examinations carried out in the event of an epidemic shall be established by a regulation of the Minister of the Social Affairs.

 

§ 10. Immunisation of children

(1)        Children shall be immunised against communicable diseases on the basis of the immunisation schedule.

(2)        The communicable diseases against which children are to be immunised, the age groups to be immunised and the terms for carrying out immunisation shall be set out in the immunisation schedule.

(3)        The immunisation schedule shall be established by a regulation of the Minister of Social Affairs.

 

§ 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.

(2)        The procedure for monitoring the immunity background shall be established by a regulation of the Minister of Social Affairs.

 

§ 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 of Social Affairs.

 

§ 13. Medical examination of employees

Employers are required to demand that the following employees undergo a screening examination for communicable diseases before commencing employment and to send such employees for regular re-examination during their period of employment:

1)         persons who handle foodstuffs or drinking water, and persons who maintain the equipment for handling such substances;

2)         teachers, educators and other employees who, due to their duties, are in direct contact with children and adolescents;

3)         health care professionals, welfare workers and rescue workers who are in direct contact with patients, persons under curatorship or persons requiring care;

4)         the service staff of establishments providing accommodation and service staff engaged in the provision of beauty treatments and personal services;

5)         persons who prepare, package or sell medicinal products;

6)         police officers and prison officers who, due to their duties, are in direct contact with prisoners or detained persons;

7)         school pupils, students and employees undergoing practical training or in-service training in the fields of activity listed in clauses 1)–6) of this section.

 

§ 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 each use of a blood product.

(3)        The procedure for screening donors, donated blood and blood products for infectious agents shall be established by a regulation of the Minister of Social Affairs.

 

§ 15. Ensuring safety of transplantation 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 an organ, part thereof or tissues.

(3)        The procedure for screening organ donors, organs to be transplanted, parts thereof and tissues for infectious agents shall be established by a regulation of the Minister of Social Affairs.

 

§ 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.

 

Chapter 4

Organisation of Surveillance and Control of Communicable Diseases

 

§ 17. Obligations of state in control of communicable diseases

(1)        At state level, the control of communicable diseases is organised by the Ministry of Social Affairs which, in addition to performing the duties prescribed in the Public Health Act (RT I 1995, 57, 978; 1996, 3, 56; 49, 953; 1997, 37/38, 569; 1999, 30, 415; 88, 804; 2001, 23, 128; 2002, 32, 187; 53, 336; 61, 375; 63, 387; 90, 521; 2003, 26, 156; 160), also directs 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 the Ministry of Internal Affairs 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 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 of Social Affairs.

(4)        The Ministry of Justice and the Ministry of Social Affairs 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 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 the Ministry of Internal Affairs, 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 Protection Inspectorate in control of communicable diseases

(1)        The Health Protection Inspectorate 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, 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)         perform other functions assigned to it by this Act.

(2)        In performing the functions prescribed by this Act, the Health Protection Inspectorate shall co-operate with county governments and local governments to prevent communicable diseases and to prevent and control the spread of communicable diseases.

(3)        When participating in the international control of communicable diseases, the Health Protection Inspectorate 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.

 

§ 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 Protection Inspectorate immediately of any suspicion of an extremely dangerous communicable disease.

(3)        Local agencies of the Health Protection Inspectorate are required to inform the Health Protection Inspectorate immediately of any suspicion of the epidemic spread of a 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 Protection Inspectorate immediately of any suspicion or diagnosis of an extremely dangerous communicable disease.

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

(6)        The Health Protection Inspectorate has the right to forward the testing material needed for diagnosis of communicable diseases to a relevant foreign laboratory or an international reference laboratory without adding personal data identifying the data subject.

 

§ 20. Registration of cases of communicable diseases

(1)        Cases of communicable disease shall be registered in the register of communicable diseases, and the database comprised of such information shall be used to prevent communicable diseases and determine the tendencies of their spread.

(2)        The register of communicable diseases is a state register founded by the Government of the Republic pursuant to the Databases Act (RT I 1997, 28, 423; 1998, 36/37, 552; 1999, 10, 155; 2000, 50, 317; 57, 373; 92, 597; 2001, 7, 17; 17, 77; 2002, 61, 375; 63, 387; 2003, 18, 107; 26, 158) on the proposal of the Minister of Social Affairs. The chief processor of the register of communicable diseases is the Ministry of Social Affairs.

(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.

 

§ 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 local agency of the Health Protection Inspectorate on the basis and pursuant to the procedure established by this Act.

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

(3)        Local agencies of the Health Protection Inspectorate shall inform the Health Protection Inspectorate of the occurrence of a communicable disease and the measures taken to control the disease. Any occurrence of the plague, cholera, yellow fever and viral hemorrhagic fevers shall be reported to the alarm centre of a rescue service agency.

(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 local agency of the Health Protection Inspectorate of the residence of the tested person.

(5)        The Ministry of Defence, the Ministry of Internal Affairs, the Ministry of Justice and the Ministry of the Environment shall inform the Health Protection Inspectorate 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 Ministry of Agriculture shall inform the Health Protection Inspectorate of the detection of micro-organisms which are human pathogens and of the spread of zoonoses in the various stages of the handling of food and raw material for food.

(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 Government of the Republic.

(8)        The Health Protection Inspectorate is required to inform the World Health Organisation of the diagnosis of any of the communicable diseases specified in international agreements within twenty-four hours after such diseases are diagnosed.

(9)        The Health Protection Inspectorate 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 for the control of communicable diseases shall be established by a regulation of the Minister of Social Affairs.

(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 of Social Affairs.

(5)        The Health Protection Inspectorate shall develop measures for the control of communicable diseases which have not been previously recorded in Estonia and shall inform the persons concerned of such 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 Ministry of Social Affairs.

(3)        The procedure for informing the Health Protection Inspectorate 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 Ministry of Social Affairs.

 

§ 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.

 

Chapter 5

Prevention of Epidemic Spread of Communicable Diseases

 

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

(1)        In the event of suspicion or diagnosis of an extremely dangerous communicable disease, the Minister of Social Affairs may, on the proposal of the Health Protection Inspectorate, form a state infection control committee and a county governor may, on the proposal of the local agency of the Health Protection Inspectorate, form a county infection control committee at the focus of the disease to eliminate the risk of infection and prevent the spread of the communicable disease.

(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.

 

§ 26. Prevention of spread of communicable diseases during emergency situations

Measures to prevent the spread of communicable diseases during an emergency situation shall be applied in accordance with the provisions of the Emergency Situation Act (RT I 1996, 8, 164; 1999, 57, 598; 2002, 57, 354; 61, 375; 63, 387).

 

§ 27. Establishment and termination of quarantine

(1)        Quarantine is a restriction of the movement of persons, goods and vehicles and of the provision of services which is established with the aim of preventing any extremely dangerous communicable disease from spreading outside the focus of the disease.

(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 is established by a written order of the county governor on the proposal of the Director General of the Health Protection Inspectorate.

(4)        Quarantine requirements and the procedure for compliance therewith shall be established by a regulation of the Minister of Social Affairs.

(5)        Quarantine is terminated by a written order of the county governor on the proposal of the Director General of the Health Protection Inspectorate 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.

(6)        The establishment of quarantine requirements and the termination thereof shall be made public through the media.

 

§ 28. Prevention of epidemic spread of communicable diseases

(1)        The risk arising from the epidemic spread of a communicable disease shall be determined by the Health Protection Inspectorate on the basis of epidemiological, laboratory and clinical information submitted thereto.

(2)        In order to prevent the epidemic spread of a communicable disease and on the proposal of the head of the local agency of the Health Protection Inspectorate, a county governor or a rural municipality or city mayor may:

1)         order schools and child care and social welfare institutions to be closed temporarily;

2)         demand that disinfection, eradication of insect vermin, pest extermination or cleaning be organised;

3)         demand that persons undergo medical examinations.

(3)        The head of a child care or social welfare institution may temporarily close the institution after obtaining approval therefor from the head of the local agency of the Health Protection Inspectorate.

 

§ 29. (Repealed - 08.04.2004 entered into force 01.05.2004 - RT I 2004, 27, 177)

 

Chapter 6

Handling of Infectious Material

 

§ 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 of Social Affairs.

(4)        The following may handle infectious material:

1)         specialised medical care providers who have been granted the right to handle infectious material through an activity licence for the provision of specialised medical care which sets out the handling of infectious material as one of the health care services which the holder of the licence provides;

2)         other legal and natural persons to whom an activity licence for the handling of infectious material has been issued by the Health Protection Inspectorate pursuant to the procedure provided 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 of the Social Affairs.

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

 

§ 31. Grant of right to handle infectious material to specialised medical care providers

(1)        The Health Services Organisation Act (RT I 2001, 50, 284; 2002, 57, 360; 61, 375; 62, 377; 110, 661; 2003, 26, 157; 160; 2004, 29, 192) applies, with the specifications resulting from this Act, to activity licences for the provision of specialised medical care whereby the holder thereof is granted the right to handle infectious material.

(2)        In order to obtain the right to handle infectious material, a specialised medical care provider or an applicant for an activity licence for the provision of specialised medical care shall submit the following to the Health Protection Inspectorate:

1)         documents concerning the laboratory facilities, installations and equipment and the safety measures to be applied;

2)         a list of the testing services regarding which the right to handle infectious material is applied for.

 

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

(1)        In order to obtain an activity licence for the handling of infectious material, a person specified in clause 30 (4) 2) of this Act shall submit the following information and documents to the Health Protection Inspectorate:

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 Protection Inspectorate shall set a term for the applicant to eliminate the deficiencies.

(4)        The date on which the Health Protection Inspectorate 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 Protection Inspectorate.

(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 Teadaanded2.

 

§ 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 32 (1) of this Act, or if the application contains other deficiencies which the applicant has failed to eliminate within the term specified in subsection 32 (3) 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 30 (5) this Act;

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

4)         the requirements established on the basis of subsection 30 (3) 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 health care provider 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 38 (4) 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 Protection Inspectorate.

 

§ 41. Authorisation of reference laboratories

(1)        A laboratory which has been accredited in the relevant testing area by an Estonian or foreign accreditation institution may be granted authorisation to operate as a reference laboratory.

(2)        Authorisation to operate as a reference laboratory is granted to a laboratory on the basis of a written application submitted to the Minister of Social Affairs who shall issue a directive for the grant of authorisation which prescribes the scope of the authorisation.

(3)        The procedure for applying for authorisation to operate as a reference laboratory and for determining the scope of the authorisation of the laboratory, the criteria on the basis of which such authorisation is granted, the procedure for granting authorisation to operate as a reference laboratory to a foreign laboratory which has been granted such rights and the procedure for exercising supervision over such foreign laboratories shall be established by a regulation of the Government of the Republic.

(4)        Within the scope of the authorisation granted pursuant to this Act, a reference laboratory shall provide methodological guidance to and inspect the operation of laboratories handling infectious material. A reference laboratory shall operate on the basis of government orders submitted by the Minister of the Social Affairs.

(5)        Pursuant to the Public Health Act, the Minister of Social Affairs shall organise supervision over the operation of reference laboratories through the Health Protection Inspectorate. The Health Protection Inspectorate has the right to involve both Estonian and foreign experts in the supervision.

(6)        If a reference laboratory fails to perform its duties in the manner required, the Minister of Social Affairs has the right to specify a term of up to three months for the elimination of deficiencies. If the deficiencies are not eliminated, authority shall be revoked in part or in full. During the time prescribed for the elimination of deficiencies, authority is deemed to be suspended.

 

Chapter 7

Financing of Prevention and Control of Communicable Diseases

 

§ 42. Financing of prevention and control of communicable diseases

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

1)         the acquisition of vaccines and immunoglobulins needed to comply with the immunisation schedule and for emergency immunisation, and the storage and transport of vaccines, functioning of the cold chain and studies of the immunity background of the population;

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

(2)        Additional immunisation of members of the Defence Forces 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)         regular 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.

 

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

(1)        Prevention of the epidemic spread of communicable diseases shall be financed pursuant to the Public Health Act.

(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.

 

Chapter 8

Supervision and Liability

 

§ 44. Supervision over compliance with this Act

(1)        Supervision over compliance with the requirements arising from this Act and legislation established on the basis thereof shall be exercised by the Health Protection Inspectorate, unless otherwise provided by law.

(11)      The Health Protection Inspectorate shall exercise supervision over the safety from infection pursuant to the procedure provided by the Product Safety Act.

(8.4.2004 entered into force 01.05.2004 - RT I 2004, 27, 177)

(2)        The Health Protection Inspectorate shall exercise supervision over:

1)         involuntary treatment of communicable diseases;

2)         compliance by specialised medical care providers with the requirements for the handling of infectious material.

(3)        The Administrative Procedure Act applies to precepts issued upon exercising supervision.

 

§ 45. Rights of supervisory officials

(1)        In order to exercise supervision, officials authorised to exercise supervision over compliance with this Act and legislation issued on the basis thereof have the right to:

1)         inspect objects of supervision and take samples without charge;

2)         obtain documents for examination from natural persons and representatives of legal persons;

3)         obtain written or oral information from natural persons and representatives of legal persons;

4)         issue precepts for the elimination of detected violations and verify compliance with such precepts;

5)         take other measures prescribed by Acts and legislation issued on the basis thereof in order to ensure compliance with this Act.

(2)        Upon failure to comply with a precept specified in subsection (1) of this section, an official authorised to exercise supervision may impose a penalty payment or arrange for the obligation to be performed through the application of substitutive enforcement pursuant to the procedure provided for in the Substitutive Enforcement and Penalty Payment Act (RT I 2001, 50, 283; 94, 580). The upper limit for a penalty payment is 10 000 kroons.

 

§ 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.

(8.4.2004 entered into force 01.05.2004 - RT I 2004, 27, 177)

(2)        The same act, if committed by a legal person, is punishable by a fine of up to 50 000 kroons.

 

§ 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 10 000 kroons.

 

§ 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 20 000 kroons.

 

§ 49. Proceedings

(1)        The provisions of the General Part of the Penal Code (RT I 2001, 61, 364; 2002, 86, 504; 82, 480; 105, 612; 2003, 4, 22; 83, 557; 90, 601; 2004, 7, 40) and of the Code of Misdemeanour Procedure (RT I 2002, 50, 313; 110, 654; 2003, 26, 156; 83, 557; 88, 590; 593) apply to the misdemeanours provided in §§ 46–48 of this Act.

(2)        Extra-judicial proceedings concerning the misdemeanours provided in §§ 46–48 of this Act shall be conducted by:

1)         the Health Care Board;

2)         the Health Protection Inspectorate.

 

Chapter 9

Implementing Provisions

 

§ 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. Amendment of Public Health Act

Clause 8 (2) 2) and subsection 16 (2) of the Public Health Act (RT I 1995, 57, 978; 1996, 3, 56; 49, 953; 1997, 37/38, 569; 1999, 30, 415; 88, 804; 2001, 23, 128; 2002, 32, 187; 53, 336; 61, 375; 63, 387; 90, 521; 2003, 26, 156; 160) are repealed.

 

§ 52. Amendment of State Fees Act

Section 183 of the State Fees Act (RT I 1997, 80, 1344; 2001, 55, 331; 53, 310; 56, 332; 64, 367; 65, 377; 85, 512; 88, 531; 91, 543; 93, 565; 2002, 1, 1; 18, 97; 23, 131; 24, 135; 27, 151 and 153; 30, 178; 35, 214; 44, 281; 47, 297; 51, 316; 57, 358; 58, 361; 61, 375; 62, 377; 90, 519; 102, 599; 105, 610; 2003, 4, 20; 13, 68; 15, 84; 85; 20, 118; 21, 128; 23, 146; 25, 153; 154; 26, 156; 160; 51, 352; 66, 449; 68, 461; 71, 471; 78, 527; 79, 530; 81, 545; 88, 589; 591; 2004, 2, 7; 6, 31; 9, 52; 53; 14, 91; 92; 18, 131; 132; 20, 141; 24, 165; 25, 170) is amended by adding subsection (321) worded as follows:

“(321)    A state fee of 500 kroons shall be paid for the issue of an activity licence for the handling of infectious material.”

 

§ 53. Amendment of Health Services Organisation Act

Subsection 48 (1) of the Health Services Organisation Act (RT I 2001, 50, 284; 2002, 57, 360; 61, 375; 62, 377; 110, 661; 2003, 26, 157; 160) is amended by adding clause 8) worded as follows:

“8)       a person providing specialised medical care who holds the right to handle infectious material fails to comply with the requirements for handling infectious material established by the Communicable Diseases Prevention and Control Act (RT I 2003, 26, 160).”

 

§ 54. Entry into force of Act

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

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

2)         subsection 9 (2) 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 21 (9) of this Act which enters into force as of Estonia's accession to the European Union.

 

1 RT = Riigi Teataja = State Gazette

2 Ametlikud Teadaanded = Official Notices