Law of Georgia on Public Health

LAW OF GEORGIA

ON PUBLIC HEALTH

Chapter I - General Provisions

Article 1 - Purpose of the Law

The purpose of this Law is to promote public health and healthy lifestyle practices, ensure environmental health, promote family reproductive health, and prevent the spread of communicable and non-communicable diseases.

Article 2 - Scope of the Law

1. This Law shall apply to all natural and legal persons on the territory of Georgia.

2. This Law shall not apply to individual treatment and rehabilitation of natural persons, unless directly proceeding from this Law.

Article 3 - Definition of terms

The terms used in this Law have the following meanings:

a) public health – a set of measures aimed at improving public health, disease prevention and disease control;

b) the Ministry – the Ministry of Labour, Health, and Social Affairs of Georgia;

c) a Public Health Office – a public health office of the Ministry;

d) a health care provider – a natural or legal person providing health care, who holds a state certificate for independent medical practice or a licence to engage in a specific medical practice;

e) epidemic – growing prevalence of a disease, compared to the expected (background) rate on a specific territory or in a specific population group over a particular period of time;

f) an epidemic outbreak – a sharp increase in the incidence of a communicable disease in a limited number of the population over a short period of time;

g) pandemic – an extremely wide spreading of a communicable disease (throughout several countries, continents, or worldwide), affecting a significant part of the population;

h) epidemic focus – a location of a source of an infection and its adjacent territory within which a healthy person may, under given conditions, be infected with a pathogen;

i) extremely dangerous infections – diseases caused by highly pathogenic biological agents that pose an extreme risk to human and/or animal health;

i¹) extremely dangerous pathogens (EDPs) – highly infectious biological agents and toxins causing those extremely dangerous infections that can severely affect public health and security;

j) epidemiological surveillance – a perpetual system of collecting, analysing and disseminating public health information;

k) isolation – keeping a diseased or an infected person separately from others for the period of communicability of the disease by placing him/her in such a place and/or in such conditions that would restrict or prevent direct or indirect transmission of the disease from him/her to another person;

l) quarantine measures – a set of measures applied to a person who is not diseased but has been exposed to a communicable disease case during the period of communicability;

m) preventive therapy – medical intervention (vaccination, treatment with specific medicines) to prevent spread of communicable diseases in the population at risk;

n) preventive shot – injection of a vaccine in humans (vaccination) for the purpose of developing specific immunity against communicable diseases;

o) the National Immunisation Schedule – a list of infectious diseases requiring a preventive shot, and age criteria, time-frames and procedures of immunisation;

p) a nosocomial infection – an infection acquired at health care facilities;

q) a zoonotic disease – a disease transmittable between animals and humans;

r) a pathogenic biological agent – a micro-organism, a biological toxin, as well as any object or material containing them;

s) International Health Regulations (IHR) – a resolution adopted by the 58^th World Health Assembly of the World Health Organization, which is an international legal instrument for the prevention of the spread of diseases;

t) biosafety – a system of organisational, biomedical, engineering and technological measures and mechanisms intended to prevent personnel, population and environment exposure to pathogenic biological agents;

u) turnover of chemical substances – import, export and transit of chemical substances;

v) sanitary norms – mandatory technical regulations determined by the Ministry for ensuring public health;

w) hygiene norms – mandatory norms determined by the Ministry for a specific group;

x) fortified food products – food products enriched with microelements and vitamins intended for the prevention of diseases caused by vitamin and microelement deficiency;

y) a specific group – for the purposes of this Law, persons with limited or no capability of making independent decision (minors, persons with disabilities, the elderly, inpatients), and those, whose freedom of action has been restricted by the state.

z) the National Public Health Care Recommendations (Guidelines) – evidence-based national recommendations approved by the Ministry for planning and management of the measurements for the prevention and investigation, epidemiological surveillance and epidemiological control of infectious and non-infectious diseases; and the measurements that contribute to human health and ensure safe environment for the health.

Law of Georgia No 3417 of 1 April 2015 – website, 14.4.2015

Article 4 - Basic principles of the Law

Basic principles of this Law shall be:

a) to ensure necessary measures to prevent risks related to public health;

b) to ensure explicit delineation of the competences of state authorities in the field of public health and their close informative coordination in planning and implementation of health care measures;

c) to ensure explicit delineation of powers of state authorities and of local self-government bodies in the field of public health;

d) to protect public health by adherence to human rights and fundamental freedoms, as provided for by the international agreements and treaties of Georgia and the legislation of Georgia.

Chapter II - Rights and Obligations of the Population and Legal Persons in the Field of Public Health

Article 5 - Rights and obligations of the population and legal persons in the field of public health

1. Every person on the territory of Georgia shall be obliged to:

a) restrain from carrying out activities posing the risk of spreading communicable or noncommunicable diseases, and other risks related to public health;

b) undergo all medical procedures, as required by appropriate authorities, necessary to prevent health risks for other persons, in case of danger of emergence and spread of communicable diseases;

c) terminate an activity, if it poses a public health risk;

d) observe sanitary and epidemiological norms;

e) notify a Public Health Office of all emergency situations caused by violating sanitary norms in production and technological processes;

f) undergo vaccination, in the absence of medical contraindications, in the case of a risk of a possible outbreak or spread of a communicable disease or a threat of an epidemic;

g) undergo immunisation, if his/her occupation is related to a high risk of exposure to communicable diseases.

2. Every person on the territory of Georgia shall have the right to:

a) be protected from communicable diseases at health care facilities;

b) refuse to undergo immunisation procedures, if there is no risk of epidemic or pandemic; a person, whose occupation is related to a high risk of exposure to communicable diseases shall not have the right to refuse to undergo immunisation procedures;

c) live in a healthy environment;

d) be timely provided with comprehensive information on the essence and necessity of a preventive shot, expected clinical outcomes, the risks associated with the preventive shot, and possible consequences of refusing to receive the preventive shot.

3. All the enterprises shall be obliged to:

a) observe the applicable public health legislation of Georgia;

b) notify a Public Health Office of all emergency situations caused by violating sanitary norms in production and technological processes.

4. Non-compliance with this article shall be punishable under the legislation of Georgia.

Chapter III - Prevention of Communicable Diseases

Article 6 - Obligations of the State in the prevention of communicable diseases

The state shall ensure:

a) organisation and surveillance of preventive shots determined by the National Immunisation Schedule;

b) organisation and surveillance of supply, storage and transportation of preparations necessary for preventive shots determined by the National Immunisation Schedule;

c) organisation of immunisation and effective detection of communicable diseases, in the case of epidemiological indications.

Article 7 - Obligations of the Ministry in the prevention of communicable diseases

1. The Ministry shall ensure:

a) epidemiological surveillance of communicable diseases;

b) prevention of the spread of communicable diseases, including immunisation ;

c) surveillance of immunisation determined by the National Immunisation Schedule and/or by epidemiological indications;

d) production of national statistics on vaccination performed according to the National Immunisation Schedule;

e) production of statistics on prevalence of communicable diseases, including extremely dangerous infections;

f) laboratory confirmation of epidemic outbreaks and epidemics;

g) treatment of infected persons in order to prevent the spread of communicable diseases;

h) accessibily to immunisation determined by the National Immunisation Schedule for persons staying on the territory of Georgia.

2. In order to organise the immunisation process, the Ministry shall:

a) determine times and procedures of immunisation and the forms of medical documents and immunisation cards;

b) decide on the commencement of immunisation to prevent diseases determined by epidemiological indications;

c) ensure maximum coverage of persons residing in Georgia by vaccination determined by the National Immunisation Schedule;

d) control supplying health care providers with high quality, effective and safe preparations necessary for immunisation of the population;

e) determine the procedure for storage and transportation of preparations necessary for immunisation;

f) supervise the storage and transportation of preparations necessary for immunisation.

3. The Ministry shall determine the rules for epidemiological surveillance, prevention and control of nosocomial infections.

4. The following shall be determined by a legal act of the Minister of Labour, Health and Social Affairs of Georgia:

a) the National Immunisation Schedule

b) a list of occupations requiring mandatory immunisation

c) a list of occupations associated with the high risk of exposure to and spread of communicable diseases, and a list of appropriate preventive measures

d) a list of institutions, where a natural person may be employed only after immunisation.

5. The Ministry shall inform persons engaged in activities determined by paragraph (4)(c) of this article on the recommended vaccination.

6. The procedure for immunisation within the Armed Forces, within other military formations and at penitentiary institutions shall be determined by the Minister of Labour, Health and Social Affairs of Georgia, unless otherwise determined by the legislation of Georgia.

7. The Ministry shall disseminate information on preventive measures to be taken, including immunisation procedures.

8. The Ministry shall determine the sanitary norms applicable to penitentiary institutions

Law of Georgia No 2729 of 9 March 2010 - LHG I, No 12, 24.3.2010, Art. 65

Law of Georgia No 3548 of 1 May 2015 – website, 18.5.2015

Article 8 - Obligations of health care providers in prevention of communicable diseases

1. Appropriate health care providers shall be obliged to provide persons residing in Georgia with comprehensive information on the essence and necessity of a preventive shot, expected clinical outcomes, the risks associated with the preventive shot and possible consequences of refusing to receive the preventive shot. In the case of minors or persons with limited competence, the health care providers shall communicate this information to their legal representatives.

2. If a person refuses to receive a preventive shot, a health care provider shall prepare an appropriate document according to a form determined by the Ministry.

3. A health care provider shall be obliged to submit information on performed immunisations to a Public Health Office according to the procedure established by the Ministry.

4. A health care provider shall be obliged to submit a report on statistical data to an appropriate competent authority, according to the procedure established by the Ministry.

5. A health care provider shall be obliged to ensure prevention and control of nosocomial infections.

Law of Georgia No 3365 of 20 March 2015 – website, 31.3.2015

Article 9 - Prevention of communicable diseases while travelling outside the borders of Georgia

1. Tour service providers shall be obliged to inform tourists about:

a) the risks of contracting an infection associated with visiting a particular country;

b) the need for immunisation and other preventive measures.

2. Immunisation and other preventive measures during travelling shall be financed by the tourist.

3. Immunisation and other preventive measures during business trips shall be financed by the employer.

Chapter IV - Detection of Communicable Diseases, Isolation and Quarantine of a Person

Article 10 - Requirements for possible cases and detection of communicable diseases

1. A Public Health Office may require a natural person to undergo medical examination in the case of a reasonable doubt that he/she is a communicable disease carrier, and thus puts the public health at risk. The above must be carried out with full respect for human rights and fundamental freedoms.

2. A health care provider shall be obliged to notify an appropriate Public Health Office of each detected case of a communicable disease, according to the procedure established by the Ministry.

3. If a natural person is confirmed to be a communicable disease carrier, a Public Health Office and a health care provider shall have the right to require that he/she:

a) undergo an appropriate medical examination and/or treatment and/or seek an appropriate consultation;

b) indicate the persons who had been or are in close contact with him/her during the period of the disease communicability.

Article 11 - Isolation and quarantine of a person

1. In emergency situations, a decision to isolate and/or quarantine a natural person shall be executed by an Emergency Management Department within the Ministry of Internal Affairs of Georgia.

2. A natural person shall have the right to appeal the decision taken concerning him/her, as provided for by the legislation of Georgia.

3. A Public Health Office shall make a decision to isolate and/or quarantine a person, in compliance with the principles of the European Convention for the Protection of Human Rights and Fundamental Freedoms.

4. The state shall provide medical services to a person in isolation and/or in quarantine.

5. If a minor or a person with limited competence is isolated and/or placed in quarantine, his/her legal representative must be notified in writing. A written notice shall contain legal grounds for, and expected duration of the isolation and/or the quarantine.

Law of Georgia No 3365 of 20 March 2015 – website, 31.3.2015

Article 12 - Rights and obligations of the Governmental State Emergency Response Commission during epidemic and pandemic extremely dangerous for public health

1. An epidemic and pandemic extremely dangerous for public health shall fall into the category of emergency situations, and shall be managed under the coordination of the Prime Minster of Georgia on the basis of the recommendations and proposals of the State Security and Crisis Management Council, according to the Law of Georgia on Public Security.

2. The Government of Georgia shall approve the statute of the State Emergency Response Commission.

3. The State Emergency Response Commission shall have the following rights and obligations during an epidemic or pandemic, extremely dangerous to public health:

a) coordinating management of situations caused by an epidemic and pandemic extremely dangerous to public health;

b) making decisions in coordination with appropriate state authorities regarding the change of borders of an epidemic focus;

c) requiring any natural person within an epidemic focus to undergo medical examination;

d) ensuring quarantine measures of a natural person in an epidemic focus, through appropriate services;

e) ensuring, if necessary, the evacuation of a person staying in an epidemic focus;

f) controlling entry into and exit from an epidemic focus of natural persons during epidemics;

g) controlling entry of a vehicle into and exit from an epidemic focus;

h) inspecting baggage, goods and postal parcels of any type;

i) mobilisation of material resources and vehicles to carry out appropriate anti-epidemic measures;

j) informing the public of an epidemic through the mass media;

k) organising hospitalisation and isolation of the diseased;

l) ensuring quarantine measures of persons having been in contact with the diseased;

m) controlling food production, supply and transportation;

n) ensuring supply of high quality drinking water to the population and organising works for decontamination of polluted water;

o) informing the population of measures to be taken;

p) ensuring, in cooperation with local self-government bodies, functioning of check points at every traffic route exiting from emergency areas.

Law of Georgia No 2469 of 29 May 2014- website, 12.6.2014

Article 13 - Control of zoonotic diseases

1. To protect the population from zoonotic diseases, the procedure for reporting disease cases shall be determined on the basis of the National Integrated Epidemiological Surveillance System (the ‘Surveillance System’) for infectious diseases, including diseases caused by the EDPs.

2. If a case if a zoonotic disease is detected, the Ministry and the Ministry of Agriculture of Georgia shall jointly take epidemic outbreak response measures.

3. The Ministry shall develop the national rabies prevention programme and determine the anti-rabies preventive treatment policy.

4. The Ministry of Agriculture of Georgia shall be responsible for the supply, storage and transportation of animal rabies vaccines and for maintaining a unified animal vaccination data bank.

Law of Georgia No 1920 of 3 November 2009 - LHG I, No 35, 19.11.2009, Art. 230

Law of Georgia No 3417 of 1 April 2015 – website, 14.4.2015

Article 14 - Control of food-borne diseases

1. To monitor food-borne diseases, the procedures for coordination of reporting disease cases and implementing the measurements for the elimination of disease outbreaks shall be determined on the basis of the Surveillance System for infectious diseases, including diseases caused by the EDPs.

2. To ensure planning and implementation of comprehensive food borne disease prevention measures, the Ministry of Agriculture of Georgia shall, in accordance with the established procedure, regularly submit to the Ministry information on results and data of the state supervision of food safety and quality.

Law of Georgia No 1920 of 3 November 2009 - LHG I, No 35, 19.11.2009, Art. 230

Law of Georgia No 3417 of 1 April 2015 – website, 14.4.2015

Article 15 - Prevention and control of specific infections

1. The Ministry shall develop and implement a unified national prevention and control strategy for the following specific infections:

a) tuberculosis

b) HIV/AIDS.

2. The Ministry shall, by special legislation, determine the norms regarding blood donation and transfusion control, safety and quality of blood and its components, their production, storage and use, and protection of the health and rights of donors.

Chapter V – Ensuring Biosafety

Article 16 – Ensuring biosafety

1. The Ministry shall implement a unified state policy in order to ensure biosafety of the population. The Ministry shall carry out comprehensive organisational, medical, biological, engineering and technological measures in order to ensure public health and to protect the environment and the personnel who are exposed to pathogenic biological agents.

2. The Ministry shall compile the list of extremely dangerous pathogens (EDPs), and shall ensure its revision as necessary.

3. Possessing the types of pathogenic biological agents and in amounts that cannot be justified by their use for diagnostic, research or other peaceful purposes shall be prohibited.

4. Upon recommendation of the Ministry, the Government of Georgia shall approve the procedures and standards for the possession, use, transfer, transportation and destruction of the EDPs, and their investigation and monitoring methods.

5. The Ministry shall develop the sanitary and hygiene procedures and standards for laboratories working with extremely dangerous pathogenic biological agents, and the qualification requirements for personnel, and the principles for the health supervision of the personnel, and shall submit them to the Government of Georgia for approval.

Law of Georgia No 3417 of 1 April 2015 – website, 14.4.2015

Article 17 - Restrictions on possession, use, transfer, transportation and destruction of extremely dangerous pathogens

1. Only the legal entities that hold a licence according to the Law of Georgia on Licences and Permits for conducting operations involving extremely dangerous pathogens shall have the right to work with extremely dangerous pathogens.

2. The Government of Georgia shall compile the list of natural persons who are prohibited from possessing, using, transferring, transporting and destroying extremely dangerous pathogens, due to their criminal records or having been accused of terrorism.

3. Upon recommendation of the Ministry, the Government of Georgia shall determine additional technical and safety requirements that constitute additional conditions for issuing a licence for conducting operations involving extremely dangerous pathogens.

4. The national repository for extremely dangerous pathogens shall be established by an order of the Minister of Labour, Health and Social Affairs of Georgia.

5. Upon recommendation of the Ministry, the Government of Georgia shall approve the procedures for transfer and transportation of extremely dangerous pathogens. The procedures shall be binding for any person involved in the transfer and/or transportation of extremely dangerous pathogens.

6. Extremely dangerous pathogens may be transferred only to appropriately authorised facilities. The appropriately authorised facilities shall be notified of every expected transport of extremely dangerous pathogens in advance. The extremely dangerous pathogens must be transported according to the established procedure.

Law of Georgia No 3619 of 24 September 2010 - LHG I, No 51, 29.9.2010, Art. 332

Law of Georgia No 3417 of 1 April 2015 – website, 14.4.2015

Article 18 - Destruction of extremely dangerous pathogens

1. Extremely dangerous pathogens shall be destroyed according to procedure approved by the Government of Georgia.

2. The appropriate qualified personnel shall keep records of the species and number of the destroyed extremely dangerous pathogens.

3. In case of identifying extremely dangerous pathogens, an appropriate laboratory shall immediately notify the legal entity, where the national repository of extremely dangerous pathogens is located, and shall transport these pathogens to the national repository, or destroy them according to the statutory procedure.

Law of Georgia No 3417 of 1 April 2015 – website, 14.4.2015

Article 19 - Import and export of extremely dangerous pathogens

1. The Government of Georgia shall adopt the regulations for import and export of extremely dangerous pathogens. These regulations shall ensure the use of extremely dangerous pathogens only for peaceful purposes.

2. Extremely dangerous pathogens shall only be imported and exported by appropriately authorised persons according to the statutory procedure.

Law of Georgia No 3417 of 1 April 2015 – website, 14.4.2015

Article 20 - Functions of an appropriate office of the Ministry in the field of biosafety

If required, an appropriate office of the Ministry shall carry out extremely dangerous pathogens emergency situations preparedness and response measures.

Article 21 - The National Integrated Epidemiological Surveillance System for infectious diseases

1. The Government of Georgia shall ensure the creation of the National Integrated Epidemiological Surveillance System (the ‘Surveillance System’) for infectious diseases, including diseases caused by the EDPs.

2. The operation procedure for the Surveillance System for infectious diseases, including diseases caused by the EDPs shall be approved by the Government of Georgia.

3. The National Integrated Epidemiological Surveillance System for infectious diseases shall be based on the unified laboratory system for the detection, epidemiological surveillance and response of extremely dangerous pathogens. The unified laboratory system shall include a network of laboratories with various biosafety levels.

4. The biosafety laboratories shall meet appropriate international standards.

Law of Georgia No 3417 of 1 April 2015 – website, 14.4.2015

Chapter VI - Ensuring Healthy Environment

Article 22 - Ensuring healthy environment

1. To ensure a healthy environment, the Ministry shall determine Environmental Quality Standards (atmospheric air, water, soil, noise, vibration, electromagnetic radiation) that include norms for maximum permissible concentration and exposure limits.

2. The appropriate competent body shall monitor observance of the Environmental Quality Standards by natural and legal persons.

3. Liability of persons violating the Environmental Quality Standards shall be determined by the legislation of Georgia.

4. Extraction, receipt, manufacturing, production, circulated, use and burial of radioactive substances and other sources of ionising radiation without special authority shall be prohibited.

5. Natural and legal persons shall be obliged to terminate the use of radioactive substances and other sources of ionising radiation that violate radiation safety standards and pose a risk to human health.

6. The Ministry shall develop and approve safety standards for working with radioactive substances and other sources of ionising radiation, including norms for treatment and diagnostic procedures with medical radiology methods.

7. The Environmental Quality Standards at the places of residence or permanent stay of people shall not be detrimental to their health and shall not exceed maximum permissible limits determined by the Ministry.

8. A person whose activity caused the violation of the Environmental Quality Standards determined by the Ministry at the places of residence or permanent stay of people shall be punishable as provided for by the legislation of Georgia.

9. Nuclear and radiation safety shall be regulated by special legislation.

Article 23 - Ensuring safe water for public health

1. According to recommendations of the World Health Organisation, the Ministry shall determine quality standards and technical regulations for water safe for human health.

2. The Ministry of Agriculture of Georgia shall control the compliance of drinking water safety parameters and quality with the requirements established by the legislation, and carry out external, random laboratory control of drinking water.

3. The Ministry of Environment and Natural Resources Protection of Georgia shall:

a) develop and implement a unified state policy in the field of water resources state management by means of sustainable development and basin based principles of water resources management;

b) protect water facilities from the negative impact that may be detrimental to public health, worsen water supply conditions and result in changes in water quality;

c) plan and carry out measures for restricting, suspending or prohibiting water consumption in emergency cases.

4. Internal quality control and external laboratory audit of water shall be performed by independent accredited laboratories.

Law of Georgia No 492 of 25 March 2013 - website, 5.4.2013

Chapter VII - Chemical Safety, Safety of Technological Processes and Products

Article 24 - Chemical safety

1. The Ministry shall determine a classification of chemical substances, determine the rules for their attribution to toxicity and hazard classes, requirements for their packaging, marking and labelling, as well as a form of information leaflet on safe treatment of chemical substances and the size of data on the leaflet.

2. Chemical substances shall be produced, circulated, supplied, sold, stored, used and disposed of in compliance with established safety regulations and shall be subject to state supervision.

3. Under the legislation of Georgia, hazardous chemical substances shall fall under the category of materials with limited circulation, whose list shall be approved by the Government of Georgia.

4. The issue of chemical safety shall be regulated by special legislation.

Article 25 - Safety of technological processes at a workplace

State monitoring of safety of technological processes at a workplace, in the cases and within the framework determined by the legislation of Georgia, shall be performed by a Legal Entity under Public Law (LEPL) – the Technical and Construction Supervision Agency.

Law of Georgia No 2793 of 23 March 2010 - LHG I, No 20, 19.4.2010, Art. 108

Law of Georgia No 4469 of 22 March 2011 - website, 1.4.2011

Law of Georgia No 6165 of 8 May 2012 - website, 25.5.2012

Article 26 - Safety of products

1. Products produced on or imported into the territory of Georgia shall comply with safety regulations, to ensure human health safety.

2. If sanitary norms are violated, a person shall be obliged to suspend production, import, export, supply, transportation, sale and use of products, until the violation is eliminated.

Chapter VIII - Healthy Lifestyles, Maternal, Child and Adolescent Health Policy

Article 27 – Food safety policy

1. The Ministry shall determine food safety regulations and healthy food principles.

2. Based on an appropriate normative act, the Ministry shall determine a list of institutions that must observe diet nutritional values and nutrition standards.

3. The Ministry shall develop and approve sanitary and hygiene norms and norms of human basic needs, which must be observed by special institutions.

4. The Ministry shall determine safety standards for child nutrition (including infant nutrition), fortified food and special food products (dietary, diabetic).

5. The Ministry shall define the policy to combat disorders caused by nutritional deficiency or abundance.

Article 28 - Maternal, child and adolescent health

The Ministry shall:

a) determine a maternal, child and adolescent health policy;

b) determine a reproductive health policy;

c) ensure the development of a child friendly environment, in cooperation with other competent ministries of Georgia and international organisations.

Article 29 - Tobacco use control

1. The Ministry shall implement a tobacco use reduction and cessation policy.

2. Issues of tobacco use control shall be regulated by special legislation.

Article 30 – Anti-drug, toxic substance and alcohol abuse policy

The Ministry shall define an anti-drug, toxic substance and alcohol abuse policy.

Chapter IX - Competencies of State Authorities and Local Self-government Bodies in the Field of Public Health

Article 31 – Competencies of the Ministry in the field of public health

1. The Ministry shall have the following powers in the field of public health:

a) defining public health policy;

b) monitoring in the field of public health;

c) developing state programmes within the framework of this Law;

d) defining the policy in the field of noncommunicable diseases and ensuring its monitoring;

e) defining biosafety policy;

f) defining child and adolescent health policy;

g) defining healthy lifestyle practices policy;

h) approving the National Public Health Care Recommendations (Guidelines).

2. The Ministry shall determine:

a) a list of communicable diseases, the possible carriers of which must undergo an appropriate medical examination in the case of epidemiological indications;

b) appropriate medical examination norms;

c) measures and methods of prevention, management and elimination of spread of communicable diseases, including extremely dangerous infections.

3. The Ministry shall have the following powers in the field of public health:

a) defining, by a normative act, the procedure of carrying out medical preventive activities;

b) establishing Environmental Quality Standards;

c) determining a list of chemical substances, which shall not be used in the production of household, perfumery and cosmetic products, synthetic materials and raw materials;

d) determining, in coordination with the Ministry of Agriculture of Georgia, safety standards and procedures for labelling special food products (dietary, diabetic, fortified), as well as child nutrition products (including infant nutrition products);

e) developing procedures and standards for the possession, use, transfer, transportation and destruction of extremely dangerous pathogens, and their investigation and monitoring methods, and submitting the procedures and standards to the Government of Georgia for approval;

f) determining safety at work standards;

g) determining a list occupational diseases and their prevention standards.

4. The Ministry shall supervise and monitor sanitary and anti-epidemic measures undertaken by health care providers.

5. The Ministry shall implement monitoring in the field of biosafety.

Law of Georgia No 3417 of 1 April 2015 – website, 14.4.2015

Article 32 - Competencies of the Government of Georgia in the field of public health

The Government of Georgia shall:

a) ensure the operation of the National Integrated Epidemiological Surveillance System for infectious diseases, including the unified laboratory system for the detection, epidemiological surveillance and response of extremely dangerous pathogens;

b) approve the procedures and standards for the possession, use, transfer, transportation and destruction of extremely dangerous pathogens, and their investigation and monitoring methods;

c) compile the list of natural persons who are prohibited from possessing, using, transferring, transporting and destroying extremely dangerous pathogens due to their criminal records, or having been accused of terrorism;

c¹) approve the operation procedure for the National Integrated Surveillance System for infectious diseases, including diseases caused by the EDPs;

d) approve a technology scheme for sanitary and quarantine control at the State Border and customs control zones of Georgia.

Law of Georgia No 3619 of 24 September 2010 - LHG I, No 51, 29.9.2010, Art. 332

Law of Georgia No 3806 of 12 November 2010 - LHG I, No 66, 3.12.2010, Art. 414

Law of Georgia 5966 of 27 March 2012 - website, 12.4.2012

Law of Georgia No 3417 of 1 April 2015 – website, 14.4.2015

Article 33 – Competencies of the Ministry of Agriculture of Georgia in the field of public health

The Ministry of Agriculture of Georgia shall have the following powers in the field of public health:

a) developing and implementing a food safety policy;

b) controlling compliance with food safety requirements;

c) determining norms for burial of animals and birds killed by extremely dangerous infections, and keeping appropriate records;

d) registering pesticides and agrochemicals;

e) implementing state supervision of transportation, sale, and storage conditions of pesticides;

f) organising animal vaccination in the case of threat of epizooty;

g) controlling the compliance of drinking water safety parameters and quality with the requirements established by the legislation, and carrying out external, random laboratory control of drinking water;

h) coordinating with the Ministry, the Ministry of Environment and Natural Resources Protection of Georgia and the Ministry of Internal Affairs of Georgia, during emergency response activities.

Law of Georgia No 492 of 25 March 2013 - website, 5.4.2013

Article 34 - Competencies of the Ministry of Environment and Natural Resources Protection of Georgia in the field of public health

The Ministry of Environment and Natural Resources Protection of Georgia shall have the following powers in the field of public health:

a) organising soil pollution monitoring;

b) developing and implementing a unified state policy in the field of water resources state management by means of sustainable development and basin based principles of water resource management;

c) protecting water facilities from negative impact that may be detrimental to public health, worsen water supply conditions and result in changes in water quality;

d) planning and carrying out measures for restricting, suspending or prohibiting water consumption in emergency cases;

e) organising monitoring of the quality of atmospheric air at populated areas;

f) organising monitoring of noise, vibration, and non-ionising radiation;

g) organising monitoring background radiation;

h) ensuring dosimetry monitoring at facilities using ionising radiation;

i) licensing activities related to nuclear power and radiation;

j) coordinating with the Ministry, the Ministry of Agriculture of Georgia and the Ministry of Internal Affairs of Georgia, during chemical emergency response activities.

Law of Georgia No 492 of 25 March 2013 - website, 5.4.2013

Article 35 - Competencies of other Ministries in the field of public health

1. The Ministry and the Ministry of Education and Science of Georgia shall jointly determine sanitary and hygiene norms for educational, childcare and combined educational and childcare institutions.

2. The Ministry of Defence and the Ministry of Internal Affairs of Georgia shall have the following authority:

a) supervision of compliance with sanitary and hygiene norms within the Armed Forces of Georgia, the military services of the Ministry of Internal Affairs of Georgia and the State Security Service of Georgia;

b) undertaking preventive measures within the Armed Forces of Georgia, the military services of the Ministry of Internal Affairs of Georgia and the State Security Service of Georgia.

3. The Ministry shall, jointly with the Ministries of Defence and Internal Affairs of Georgia and the State Security Service of Georgia, determine sanitary and hygiene norms for the Armed Forces of Georgia, the military services of the Ministry of Internal Affairs of Georgia and the State Security Service of Georgia.

4. The Ministry of Corrections and Legal Assistance of Georgia shall have the following authority over penitentiary institutions:

a) monitoring compliance with sanitary and hygiene norms at penitentiary institutions;

b) undertaking preventive health measures at penitentiary institutions.

5. The Ministry and the Ministry of Corrections and Legal Assistance of Georgia shall jointly determine sanitary and hygiene norms applicable to penitentiary institutions.

6. The Ministries of Defence, Corrections, and Internal Affairs of Georgia, and the State Security Service of Georgia shall be obliged to immediately notify the Public Health Office on any case that may pose a threat to the public health and safety.

7. The Ministries of Corrections and Internal Affairs of Georgia, and the State Security Service of Georgia shall duly submit medical statistics data to the Ministry.

8. The Ministries of Defence, Corrections and Internal Affairs of Georgia, and the State Security Service of Georgia shall cooperate with the Ministry, the Ministries of Agriculture, and Environment and Natural Resources Protection of Georgia during chemical emergency response activities.

Law of Georgia No 2729 of 9 March 2010 - LHG I, No 12, 24.3.2010, Art. 65

Law of Georgia No 492 of 25 March 2013 - website, 5.4.2013

Law of Georgia No 1794 of 13 December 2013 - website, 28.12.2013

Law of Georgia No 3548 of 1 May 2015 – website, 18.5.2015

Law of Georgia No 3943 of 8 July 2015 – website, 15.7.2015

Article 36 - Powers of local self-government bodies in the field of public health

Under this Law, the following powers in the field of public health shall be delegated to local self-government bodies:

a) undertaking preventive measures against the spread of communicable diseases in animals that pose a threat to public health, including animal anti-rabies immunisation;

b) supervising compliance with sanitary and hygiene norms at educational, childcare and combined educational and childcare institutions;

c) organising deratization, disinsection and disinfection measures aimed at prevention of the spread of diseases on the territory of the municipality;

d) facilitating the implementation of preventive measures at educational, childcare and combined educational and childcare institutions on the territory of the municipality;

e) supervising compliance with sanitary norms at public institutions located on the territory of the municipality;

f) ensuring the delivery, storage and distribution among health care providers of the materials supplied by the Ministry of immunisation under the National Immunisation Schedule;

g) ensuring preventive and epidemiological control measures in the case of epidemic threat;

h) facilitating primary epidemiological research on the territory of the municipality.

Article 37 - Competencies of the autonomous republics in the field of public health

Competencies of the autonomous republics in the field of public health shall be determined by this Law and the laws of the autonomous republics.

Article 38 - Organisation of public health

The Ministry shall define a public health policy that shall be implemented by an appropriate Public Health Office of the Ministry.

Article 39 - Labour/human resources in the field of public health

1. The Ministry shall determine a list of professions and their respective authority in the field of public health.

2. Public health and epidemiology specialists shall be trained at the highest educational level according to appropriate programmes, and shall hold a Bachelor's or a higher academic degree in Public Health.

3. Persons who have taken professional training courses in the field of public health and epidemiology shall be public health workers.

Chapter X - Financing Public Health Activities

Article 40 - Sources of financing of public health activities

The following may be the sources of financing of public health activities:

a) funds allocated from the State Budget of Georgia or the budgets of the autonomous republics of Georgia

b) other sources permitted by the legislation of Georgia.

Article 41 - Budgetary financing

1. The Law of Georgia on State Budget annually determines activities financed by the state in the field of public health, based on this Law.

2. The Law on Budget of an autonomous republic determines activities financed by the autonomous republic in the field of public health based on this Law.

Chapter XI - Compensation for Damages and Responsibilities in the Field of Public Health

Article 42 - Compensation for damages in the field of public health

1. Natural and legal persons shall be obliged to compensate for damages incurred because of violation of this Law.

2. In the case of development of post/side effects or complications of vaccination, conducted under the National Immunisation Schedule, the state shall provide free medical services and rehabilitation to the population, as provided for by the law, except when post/side effects are caused by the fault of medical personnel or medical establishments.

3. If a person becomes incapable as a result of vaccination conducted under the National Immunisation Schedule, he/she shall have the right to receive compensation, as provided in law.

Article 43 - Responsibilities in the field of public health

1. Within the authorities determined by the legislation of Georgia in the field of public health, all state authorities, and natural and legal persons shall be obliged to comply with the requirements of this Law and to ensure public health safety by their activities.

2. Every person on the territory of Georgia shall be obliged to comply with the requirements of the applicable legislation of Georgia in the field of public health and respect the decisions of the Public Health Office during the exercise of their powers granted by law.

3. The state shall be responsible for managing and financing measures for prevention and control of communicable diseases and epidemics, and immunisation under the National Immunisation Schedule.

Chapter XII - Transitional and Final Provisions

Article 44 - Normative acts annulled in connection with entry into force of this Law

The following shall be null and void:

a) the Sanitary Code of Georgia of 8 May 2003 (the Legislative Herald of Georgia, No 14, 3.6.2003, Art. 91) – from 1 October 2007;

b) Order No 234/N of 6 October 2003 of the Minister of Labour, Health and Social Affairs of Georgia on Approval of Sanitation Areas and Sanitary Classification of Enterprises, Buildings and Other Facilities – upon entry into force of this Law.

Article 45 - Normative acts to be adopted in connection with entry into force of this Law

1. The Government of Georgia shall, within one month after entry into force of this Law, adopt the following normative acts:

a) a Statute of the State Emergency Response Commission;

b) (Deleted – 1.4.2015, No 3417);

c) (Deleted – 1.4.2015, No 3417);

d) (Deleted – 1.4.2015, No 3417);

e) (Deleted – 1.4.2015, No 3417);

1¹. The Government of Georgia shall adopt the procedures for the import and export of extremely dangerous pathogens.

2. (Deleted – 25.3.2013, No 492).

3. The Government of Georgia shall, before 1 July 2015, ensure the approval of the operation procedure for the National Integrated Surveillance System for infectious diseases, including diseases caused by the EDPs.

Law of Georgia No 492 of 25 March 2013 - website, 5.4.2013

Law of Georgia No 3417 of 1 April 2015 – website, 14.4.2015

Article 45¹ – Legal regulation during transition period in relation to persons declared legally incompetent by court before 1 April 2015

1. If a person was declared legally incompetent by court before 1 April 2015 and his/her individual examination has not been conducted, the health care provider must communicate the information provided for in Article 8(1) of this Law to his/her custodian.

2. If a person, who was declared legally incompetent by court before 1 April 2015 and whose individual examination has not been conducted, was isolated and/or placed in quarantine, his/her custodian must be notified in writing. A written notice must contain legal grounds for, and expected duration of the isolation and/or the quarantine.

Law of Georgia No 3365 of 20 March 2015 – website, 31.3.2015

Article 46 - Entry into force of the Law

This Law shall enter into force upon promulgation.

President of Georgia                                                                                                                                            M. Saakashvili

Tbilisi,

27 June 2007

No 5069 – ES