Law of Georgia on Health Care

Law of Georgia on Health Care
Document number	1139
Document issuer	Parliament of Georgia
Date of issuing	10/12/1997
Document type	Law of Georgia
Source and date of publishing	Parliamentary Gazette, 47-48, 31/12/1997
Registration code	470.000.000.05.001.000.304
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Law of Georgia

on Health Care

Chapter I – General Provisions

Article 1

This Law regulates the relations between state authorities and natural and legal persons in the field of health care of citizens.

Article 2

The legislation of Georgia in the field of health care comprises the Constitution of Georgia, treaties and international agreements of Georgia, this Law, and other legislative and subordinate normative acts.

Article 3

Unless a special reference has been made in the law, the concepts used shall have the following meanings:

a) patient autonomy – a patient's right to make independent decisions on all issues related to the provision of medical care to him/her;

b) HIV – human immunodeficiency virus;

c) unmanageable infections – infectious diseases against which there is no highly effective specific preventive means;

d) independent medical practice – professional activities of a person with a higher medical education who holds a state certificate confirming his/her right to engage in independent medical practice, for the results of which he/she shall be responsible under the legislation of Georgia;

d ¹) independent nursing practice – professional activities of a person with the appropriate medical education, for the results of which he/she shall be responsible under the legislation of Georgia;

d²) paramedic – a person with the appropriate higher medical education who, after having taken a specialised course, provides independent emergency medical service at a prehospital stage within the scope of the emergency medical aid, and is responsible for the consequences thereof under the procedure established by the legislation of Georgia;

e) donor – a living or deceased person from whom an organ, part of an organ, or tissue is removed to transplant into another person or to administer treatment to another person;

[e) donor – a person whose organ, tissue or cell is donated during his/her lifetime or after his/her death; (Shall become effective from 1 January 2025)]

f) euthanasia – the intentional termination of the life of a person with an incurable disease in its terminal phase at his/her request;

g) endemic disease – a disease caused by harmful factors active in a certain territory or by the deficiency of a factor that is necessary for health;

g ¹) voucher – a negotiable financial instrument in materialised and/or non-materialised form transferred by the State to a target group, which is intended to finance medical services or personal insurance;

h) congenital disease – hypothyroidism, phenylketonuria, galactosemia, or adrenogenital syndrome;

i) especially dangerous pathogens – highly contagious biological agents and toxins of especially dangerous infections which can cause serious damage to public health and safety;

j) informed consent – the consent of a patient or his/her relative or legal representative to medical intervention necessary to be performed for the patient, after intervention-related risks to the patient's health and life have been explained;

j ¹) National Clinical Practice Recommendations (Guidelines) – evidence-based recommendations for the management of a clinical condition (nosology/syndrome), developed on the basis of medicine, which shall be approved by the Minister of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia by an individual administrative-legal act;

j ²) Clinical Condition Management State Standard (Protocol) – clearly determined stages of clinical condition management and sequence of actions developed on the basis of the National Clinical Practice Recommendations (Guidelines), which shall be approved by the Minister of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia by an individual administrative-legal act;

k) critical condition – a form of deterioration of health when a person's life is in danger and, unless urgent treatment is administered, death is inevitable;

l) second opinion – an opinion on the diagnosis, prognosis, or optimum treatment method for a disease by a specialist, whom a patient consults bypassing the physician in charge, if the patient is not confident about the correctness of the diagnosis and treatment or if application of the intended treatment method entails serious consequences (e.g., a mutilating operation);

m) persistent vegetative state – ‘social death’, chronic unconsciousness characterised by an alternation of alertness and sleep and, at the same time, by the absence of conscious actions and adequate reactions to external irritants and events that are characteristic of behavioural or brain activity;

n) medical error – unintentional diagnostic and/or therapeutic measures inappropriate for the patient's condition taken by a doctor, which is a direct cause of harm;

n ¹) beneficiary of support – persons specified in Article 12(4-5) of the Civil Code of Georgia;

o) implied consent – a situation when a patient consults a doctor to receive medical care and the latter, regardless of the existence of a written or verbal agreement, interviews, examines him/her, etc.; from that moment, the doctor shall undertake responsibility towards the patient as provided for by law;

p) autopsy – autopsy performed by an appropriately certified physician to ascertain the cause of death and/or the diagnosis of a disease, or for educational or research purposes;

q) patient – a person who receives medical care, regardless of his/her health status;

r) patient's relative – a person who has a priority right to take part in the decision of issues relating to the provision of medical care to the patient or those relating to the patient's death, according to the priority sequence established by the legislation of Georgia;

s) primary health care – the first contact of an individual or a family with the health care system; continuous, comprehensive, and coordinated medical services primarily based on a system of family medicine, available for each member of society, and implying measures of health promotion, disease prevention, and widely prevalent disease treatment and rehabilitation, including maternal and child health care, family planning, palliative care, and ensuring accessibility to essential medicines;

s ¹) emergency medical care – medical care without which a patient's death, disability, or serious deterioration of health status is inevitable;

s ²) family doctor – a physician-specialist having the right to deliver primary multi-profile medical services to persons of all ages and both genders as provided for by the legislation of Georgia;

s ³) Preventive Immunisation National Schedule – the age indicators, dates, and procedures for compulsory preventive immunisation against infectious diseases, established by a normative act;

s ⁴) palliative care – service using a multidiscipline approach which, through an early detection, correct evaluation, and treatment of pain and other physical, psychosocial, or mental problems, moral support, and prevention and mitigation of suffering, improves the quality of life of patients with chronic diseases and/or life threatening diseases, and their family members;

s ⁵) palliative treatment – a medical service, which does not radically improve a patient's status, does not change a hopeless prognosis, and is aimed to temporarily relieve the patient's condition;

s⁶) hospice care – part of palliative care intended for the incurably-ill patients whose expectancy of life is limited. Hospice care shall be carried out by a specialised team of palliative care. As necessary, it shall be carried out at a hospice, as well as at home, a long-term care facility or a multidiscipline inpatient medical institution. When providing hospice care, medical interventions oriented on curing of a disease shall not be applied and only medical interventions intended for management of the disease symptoms and improvement of the quality of life shall be carried out. When providing hospice care to children, life expectancy may not be limited and interventions oriented on curing of a primary disease may be carried out at the same time;

s⁷) long-term care – a combination of services aimed at satisfying both medical and non-medical needs of a person with a chronic disease and/or with disabilities, when such a person cannot take care of himself/herself continuously;

t) resuscitation – a combination of measures used for supporting life;

u) recipient – a patient for whom transplant organs, transplant parts of organs, or transplant tissues removed from a donor are intended;

[u) recipient – a patient who receives a human organ and/or for whom a human tissue or cell is intended to be used; (Shall become effective from 1 January 2025)]

u ¹) public health – a system of state obligations aimed to protect, maintain, and restore a person's physical and mental health through disease prevention, disease prevalence study and disease control, promotion of healthy lifestyle practices and environmental health;

v) especially dangerous infections – diseases caused by highly pathogenic biological agents posing a particular risk to human and/or animal health;

w) biomedical research – any experiment conducted on human beings or animals whose only aim or one of the aims is to deepen knowledge in the field of medicine;

x) continuity of medical care – uninterrupted implementation of measures of preventive, diagnostic, therapeutic, rehabilitative, and palliative care;

y) health services basic package – a list of health services whose cost is financed by the State;

z) medical confidentiality – information about a patient's physical or mental status, his/her public or work-related activities, or family or private life that a doctor or other medical personnel obtain while carrying out their professional activities, including the fact of visiting a doctor, also the circumstances of death;

z ¹) medical activities (medical services) – activities related to disease prevention, diagnosis, and treatment; maintaining a patient's positive health status, and improving and restoring a patient's health (mental, social, medical, and physical rehabilitation); palliative care; medical care of a patient; prosthetics; medical transportation of a patient; a patient's medical education; forensic medical expert examination; forensic psychiatric expert examination; public health measures; and services accompanying medical activities conducted in medical institutions, which shall be carried out according to the established procedure;

z1) medical intervention – any manipulation or procedure performed by a physician or other medical personnel for the purposes of diagnosis, treatment, prevention, rehabilitation, and palliative care;

z1 ¹) health care personnel – a doctor, a nurse, a paramedic, a pharmacist, and other persons whose activities are related to disease prevention, diagnosis, and treatment, patient rehabilitation, palliative care, and forensic medical expert examination; also health promotion specialists and managers of medical and health care services;

z1 ²) medical techniques – the functional and technological arrangement of medical institutions;

z1 ³) family medicine – a primary health care-oriented medical discipline, based on an independent system of professional training, research and clinical practice that differs from that of other medical disciplines;

z1 ⁴) forensic medical expert examination – the process of ascertaining medical and biological issues arising during legal proceedings;

z2) essential medicines – drugs used for replacement therapy whose permanent intake is vital for maintaining life or positive health (for example, insulin);

z2 ¹) description of speciality – a list of issues and skills that a doctor holding the right to independently practice a medical speciality must know and master;

z3) terminal stage – terminal stage of an incurable disease or condition;

z4) brain death – complete and irreversible termination of the functions of the brain and upper segments of the spinal cord against the background of maintaining breathing and blood circulation using special means;

z5) continuous medical education – a component of continuous professional development that includes both self-education and participation in formal education/training programmes, also different activities that contribute to the consolidation and improvement of a doctor's professional knowledge and skills (participation in congresses and conferences, publishing research papers, teaching practice, etc.);

z5 ¹) post-graduate professional training – professional training following higher medical education based on practical medical activity and aimed at mastering a medical speciality;

z5 ²) continuous professional development – a period following higher medical education and post-graduate professional training that continues for the entire duration of the professional activity of the subject of independent medical practice and is an integral part of medical practice, the goal of which is ensuring compliance of theoretical knowledge and practical skills of a subject of independent medical practice with the achievements and techniques of contemporary medicine;

z6) ensuring environmental health – surveillance over compliance with sanitary and hygiene rules and standards of safety at workplace, in daily life, at leisure, of food, education and radiation and chemical safety, and sanitary-epidemiological rules; issues of state sanitary and hygiene and sanitary-quarantine border control;

z7) health promotion (strengthening health) – a complex of educational, social, economic, environmental, and professional factors that are directed at maintaining positive health status and strengthening health;

z7 ¹) epidemiological control – a system of preventive and anti-epidemic measures of contagious diseases epidemic process management;

z7 ²) (Deleted).

z7 ³) unidentified dead body – a dead body that has not been identified within a fixed term after being found despite measures taken according to the legislation of Georgia and whose burial shall be ensured by the State;

z7 ⁴) unattended dead body – a dead body that has been identified but it is impossible to ascertain (find) a relative or a legal representative of the deceased person, or another person entitled to receive the inheritance, and whose burial shall be provided by the State, or a dead body that has been identified, and a relative or a legal representative of the deceased person, or another person entitled to receive the inheritance is ascertained (found) but he/she refuses to bury the deceased person;

z7 ⁵) random control – an administrative action taken by a competent body of the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia according to the violation risk assessment;

z7 ⁶) (deleted – 19.2.2015, No 3094);

z7 ⁷) (deleted – 19.2.2015, No 3094);

Law of Georgia No 889 of 25 May 2001 – LHG I, No 15, 11.6.2001, Art. 50

Law of Georgia No 974 of 20 June 2001 – LHG I, No 20, 3.7.2001, Art. 73

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 2331 of 6 June 2003fLHG I, No 19, 1.7.2003, Art. 125

Law of Georgia No 2527 of 18 July 2003 – LHG I, No 22, 8.8.2003, Art. 162

Law of Georgia No 1435 of 13 May 2005 – LHG I, No 25, 2.6.2005, Art. 163

Law of Georgia No 3836 of 7 December 2006 – LHG I, No 48, 22.12.2006, Art. 317

Law of Georgia No 4719 of 8 May 2007 – LHG I, No 18, 22.5.2007, Art. 149

Law of Georgia No 4816 of 25 May 2007 – LHG I, No 19, 11.6.2007, Art. 171

Law of Georgia No 4921 of 8 June 2007 – LHG I, No 22, 19.6.2007, Art. 202

Law of Georgia No 5129 of 29 June 2007 – LHG I, No 27, 17.7.2007, Art. 262

Law of Georgia No 6000 of 21 March of 2008 – LHG I, No 9, 4.4.2008, Art. 75

Law of Georgia No 3553 of 21 July 2010 – LHG I, No 46, 4.8.2010, Art. 282

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Law of Georgia No 5665 of 28 December 2011 – website, 11.1.2012

Law of Georgia No 3094 of 19 February 2015 – website, 27.2.2015

Law of Georgia No 3367 of 20 March 2015 – website, 31.3.2015

Law of Georgia No 2156 of 18 April 2018 – website, 4.5.2018

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Law of Georgia No 3719 of 14 November 2018 – website, 3.12.2018

Law of Georgia No 4277 of 19 February 2019 – website, 25.2.2019

Law of Georgia No 2793 of 2 May 2023 – website, 19.5.2023

Law of Georgia No 3615 of 1 November 2023 – website, 22.11.2023

Article 4

The principles of state health care policy shall be:

a) universal and equal accessibility of health care for the population within the limits of the State obligations provided for by the state health care programmes;

b) protection of human rights and freedoms in the field of health care, and acknowledgement of the honour, dignity, and autonomy of the patient;

c) independence of doctors and other medical personnel within the limits determined by the legislation of Georgia;

d) compliance of the health care system with the economic development strategy of the country and ensuring the system’s manageability;

e) protection of patients placed in penitentiary institutions, and persons suffering from a disease, from discrimination during rendering medical care.

f) introduction of universally acknowledged norms of medical ethics in the field of health care;

g) providing the population with comprehensive information on all existing forms of medical care and its availability;

h) contributing to cooperation with international health care organisations;

i) the State's responsibility for the volume and quality of health care services envisaged by mandatory health care insurance programme;

j) the priority of primary health care, including the priority of emergency medical care, participation of the State and private sectors therein, development of family medicine and the institute of the family doctor and ensuring the accessibility of health care services based on it;

k) the State's responsibility for certification of doctors, licensing of medical activities, and issuing permits to medical institutions;

l) participation of the State, society, and each citizen in the promotion of healthy lifestyle practices and in the protection of living, working, and recreational environments;

m) diversity of forms of ownership and legal-organisational forms in the field of health care services and their coexistence based on equal rights;

n) application of administrative sanctions envisaged by legislation for actions harmful to the health of the population;

o) programme-based and targeted programme-based health care state financing; the autonomy of the financial, economic and contractual relations and the management system to ensure self-financing and self-governance of health care institutions of the state sector as provided for by legislation;

p) state financing of biomedical and health care research according to existing resources and creation of favourable conditions for attracting financial resources from the private sector for this;

q) participation of professional associations, also other non-governmental organisations, in the formation of a modern and effective system of health care through consultations, scientific and professional discussions, developing projects, and participating in the protection of patients' rights;

r) supporting the development of the process of medical mediation in disputes arising between a patient and an insurance company, between an insurance company and a health care provider, and between a patient and a health care provider.

r) (deleted – 19.2.2015, No 3094);

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 2716 of 9 March 2010 – LHG I, No 12, 24.3.2010, Art. 53

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Law of Georgia No 5665 of 28 December 2011 – website, 11.1.2012

Law of Georgia No 3094 of 19 February 2015 – website, 27.2.2015

Law of Georgia No 3540 of 1 May 2015 – website, 18.5.2015

Chapter II – Citizens' Rights in the Field of Health Care

Article 5

Citizens of Georgia and stateless persons with the corresponding status in Georgia shall have the right to receive medical care envisaged by state health care programmes approved under the established procedure. Medical care shall be provided by an appropriate legal entity engaged in medical practice, regardless of its form of ownership and legal form.

Law of Georgia No 6301 of 25 May 2012 – website, 12.6.2012

Article 6

1. It shall be prohibited to discriminate against a patient due to his/her race, skin colour, language, sex, religion, political and other beliefs, national, ethnic and social affiliation, origin, property status and title, place of residence, disability, disease, sexual orientation, or a personal negative attitude.

2. It shall be prohibited to discriminate against a patient placed in a penitentiary institution during rendering medical care.

Law of Georgia No 2716 of 9 March 2010 – LHG I, No 12, 24.3.2010, Art. 53

Law of Georgia No 3540 of 1 May 2015 – website, 18.5.2015

Law of Georgia No 6847 of 14 July 2020 – website, 28.7.2020

Article 7

All citizens of Georgia shall have the right to receive comprehensive and objective information, and to obtain a second opinion about their health status in a form that is understandable to them, except in cases provided for in Article 41 of this Law.

Article 8

1. A verbal or written informed consent shall be necessary for a patient's participation in the processes of therapeutic, diagnostic, rehabilitative, preventive and palliative care. The list of medical interventions that require written consent shall be determined by the legislation of Georgia.

2. The rights of ill persons and healthy volunteers taking part in a scientific research shall be protected by the legislation of Georgia and recognised international norms of conducting biomedical research on human beings.

3. A verbal informed consent shall be necessary for a patient's participation in the process of medical education.

Law of Georgia No 4719 of 8 May 2007 – LHG I, No 18, 22.5.2007, Art. 149

Article 9

A patient shall have the right to refuse to undergo any medical intervention, except for cases envisaged in the legislation of Georgia and in Article 76 of this Law. A patient shall also have the right to refuse to take part in a scientific research or in the process of medical education.

Article 10

All legally capable persons shall have the right to express their will in writing in advance on undergoing resuscitative, life-saving, or palliative treatment, and/or palliative care in case of being diagnosed to be in the terminal stage of an incurable disease.

Law of Georgia No 4719 of 8 May 2007 – LHG I, No 18, 22.5.2007, Art. 149

Article 11

Performing medical intervention on minor or those patients who are unable to make a conscious decision, or involving them in medical education and scientific research shall only be admissible taking into consideration their will expressed in the past (when they had the ability to make a conscious decision). In the absence of such will, the above activities shall be admissible with the informed consent of a relative or a legal representative of the patients.

Law of Georgia No 3367 of 20 March 2015 – website, 31.3.2015

Article 12

The decision to perform medical intervention on minor or those patients who are unable to make a conscious decision when emergency medical assistance is required for them, or during their life-threatening condition, shall only be made taking into consideration the interests of the patients.

Law of Georgia No 3367 of 20 March 2015 – website, 31.3.2015

Article 13

It shall only be admissible to render medical care to a person placed in a penitentiary institution, including during a hunger strike, based on his/her informed consent. Medical care shall be rendered according to the rules provided for in this Law.

Law of Georgia No 3540 of 1 May 2015 – website, 18.5.2015

Article 14

Patients shall have the right to choose or change medical personnel and/or a medical institution, taking into consideration the conditions of an insurance agreement. An agreement shall provide the possibility of making such a choice.

Chapter III – Management, Organisation, and Financing of the Health Care System

Article 15

The Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia (the ‘Ministry’) shall ensure pursuit of the State’s health care policy and shall develop and issue respective legal acts on issues within the scope of its authority, unless otherwise determined by the legislation of Georgia.

Law of Georgia No 6000 of 21 March of 2008 – LHG I, No 9, 4.4.2008, Art. 75

Law of Georgia No 5665 of 28 December 2011 – website, 11.1.2012

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 16

1. The mechanisms of health care state management shall be:

a) certification of doctors, licensing of medical activity, issuance of permits to medical institutions;

b) medical care quality control;

c) approval of the National Clinical Practice Recommendations (Guidelines) and the Clinical Condition Management State Standards (Protocols) by the Minister of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia;

d) quality control of therapeutic agents, regulation of pharmacy and pharmaceutical production;

e) facilitation of the introduction of new therapeutic agents and medical technologies;

f) legal support of the relations between a patient and a legal entity engaged in medical practice;

g) promotion of healthy lifestyle practices;

h) development and implementation of medical programmes;

i) contribution to the development of medical science;

j) sanitary-hygienic standardisation and epidemiological control;

k) contribution to developing public health by appropriate institutional arrangements and implementation of state medical programmes;

k¹) facilitation of the introduction of appropriate standards and methods for the provision of medical services to persons with disabilities;

l) (Deleted – 19.2.2015, No 3094).

2. In order for legal entities under public law subject to state control of the Ministry to execute their powers, an ordinance of the Government of Georgia may establish service fees and service fee rates, and determine the procedures for fee payment and fee refund, also the conditions for the exemption from fees.

3. To provide the national administration mechanisms in the fields of medical and pharmaceutical activities, the Ministry shall, through a legal entity under public law operating within its system, carry out the state control of compliance with the relevant regulatory legislation, for which reason it shall be authorised to:

a) ensure implementation of various measures facilitating compliance with the standards available in the fields of medical and pharmaceutical activities, including communication of information to the public/the persons operating in the fields of medical and pharmaceutical activities and that are subject to state control, raising of their awareness, and implementation of other active measures;

b) in accordance with the legislation applicable in the fields of medical and pharmaceutical activities, at any time of day or night, without prior notification, enter any facility subject to state control. The procedure, rule and conditions for exercising that power shall be approved by an ordinance of the Government of Georgia;

c) request inspection, inviolability, sealing and/or seizure of any material, item, substance, document, facility under supervision or any part thereof, which is necessary to carry out state control within reasonable limits. The rules for carrying out the said measures, including the periods of their implementation, shall be defined by a normative act of the Minister of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia;

d) do measurements, photographic surveys or video recordings, make entries or extracts, or request making of copies;

e) when administrative offences are committed, issue electronic penalty charge notices. The form of an electronic penalty charge notice, the procedure for filling and submitting it, and the form of a writ of execution and the procedure for issuing a writ of execution shall be approved by a normative act of the Minister of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia;

f) issue individual legal acts with regard to administrative offence cases, draw up administrative offence reports, apply measures of administrative liability and give respective instructions;

g) issue writs of execution in accordance with the Law of Georgia on Enforcement Proceedings. The form of a writ of execution and the procedure for issuing a writ of execution shall be approved by a normative act of the Minister of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia.

4. A decision of an appropriate competent agency of the Ministry made with regard to an administrative offence in question committed in the fields of medical and pharmaceutical activities shall be referred for immediate enforcement. Appealing that decision shall not suspend its enforcement.

5. In administering a state healthcare programme, mechanisms for suspending/withholding compensations shall be applied in cases, under the procedure and conditions defined by an ordinance of the Government of Georgia.

Law of Georgia No 2013 of 28 May 1999 – LHG I, No 20(27), 9.6.1999, Art. 87

Law of Georgia No 889 of 25 May 2001 – LHG I, No 15, 11.6.2001, Art. 50

Law of Georgia No 974 of 20 June 2001 – LHG I, No 20, 3.7.2001, Art. 73

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 4816 of 25 May 2007 – LHG I, No 19, 1.6.2007, Art. 171

Law of Georgia No 3553 of 21 July 2010 – LHG I, No 46, 4.8.2010, Art. 282

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Law of Georgia No 5665 of 28 December 2011 – website, 11.1.2012

Law of Georgia No 3094 of 19 February 2015 – website, 27.2.2015

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Law of Georgia No 6847 of 14 July 2020 – website, 28.7.2020

Law of Georgia No 3455 of 3 July 2023 – website, 25.7.2023

Article 16 ¹ – (Deleted)

Law of Georgia No 3094 of 19 February 2015 – website, 27.2.2015

Article 17

Powers of a municipality with respect to population health care shall be defined under the legislation of Georgia.

Law of Georgia No 4633 of 11 December 2015 – website, 23.12.2015

Article 18

Professional associations and other public organisations, also state and private medical institutions, shall take part in the health care system state management, within the limitations set by the legislation of Georgia.

Article 19

1. Health care services for a target group financed by the State shall be provided under the Law of Georgia on State Procurement or by means of a voucher.

[1. Medical services funded by the state shall be provided to a target group under the Law of Georgia on Public Procurement or by means of a voucher. (Shall become effective from 1 January 2025)]

2. Personal insurance for a target group financed by the State shall be provided by means of a voucher.

3. Health care services or personal insurance by means of a voucher, including cashing a voucher and cashing related transactions, shall not be deemed state procurement.

[3. (Deleted – 9.2.2023, No 2553). (Shall become effective from 1 January 2025)]

4. A voucher shall be personalised. Its owner may be a person or a group of persons (family, community, etc.). The rights of a minor shall be exercised under the procedure provided for by the legislation of Georgia.

5. According to the terms and conditions of the voucher, its owner shall have the right to freely choose a healthcare services provider or an insurance company.

6. Issuance of an insurance voucher to an insurance company shall be deemed to be the equivalent of an insurance contribution (premium) provided for by the Civil Code of Georgia.

7. The legislation of Georgia determines a reasonable term after the expiry of which, if an insurance company still has not been chosen, it may be chosen (identified) according to the voucher conditions.

8. A health care services provider or an insurance company that agrees to provide services under the voucher conditions may be chosen based on the expressed will of the health care services provider or the insurance company, according to the procedure provided for by the voucher conditions.

9. Owners of equal vouchers shall receive health care or insurance services on equal terms, without any discrimination.

10. A voucher that has been used shall be cashed by a respective budgetary organisation responsible for cashing vouchers by transferring money to organisations having submitted the vouchers.

11. Voucher conditions (including the procedures of declaration of intent by organisations receiving the voucher and of issuance of the voucher, the list of health care services, the price of the voucher, issues relating to the use and reimbursement of the voucher, etc.) shall be provided for by a law of Georgia and/or an ordinance of the Government of Georgia.

Law of Georgia No 5129 of 29 June 2007 – LHG I, No 27, 17.7.2007, Art. 262

Law of Georgia No 2553 of 9 February 2023 – website, 27.2.2023

Article 20

1. In the field of health care, the State shall ensure that official statistical data are correct, accurate, timely, and public, as required by legislation.

2. A legal entity engaged in medical practice shall, under the established procedure, provide health care statistical information to the Ministry.

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 21

A legal entity engaged in medical practice that takes part in a state health care programme shall be reimbursed for its work according to procedures for reimbursement and funding approved under the legislation of Georgia.

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 4816 of 25 May 2007 – LHG I, No 19, 1.6.2007, Art. 171

Article 22 – (Deleted)

Law of Georgia No 4816 of 25 May 2007 – LHG I, No 19, 1.6.2007, Art. 171

Chapter IV – Awarding of the State Certificate

Law of Georgia No 2013 of 28 May 1999 – LHG I, No 20(27), 9.6.1999, Art. 87

Law of Georgia No 6000 of 21 March 2008 – LHG I, No 9, 4.4.2008, Art. 75

Article 23

1. The intent of awarding a state certificate shall be to protect the health of the population from activities of incompetent medical personnel.

2. By awarding a certificate, the State shall guarantee that the specialist holding it has the skills enabling him/her to perform independent medical practice according to the professional standards existing in the country.

Law of Georgia No 2013 of 28 May 1999 – LHG I, No 20(27), 9.6.1999, Art. 87

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 6000 of 21 March 2008 – LHG I, No 9, 4.4.2008, Art. 75

Article 24

1. Certification shall be the assessment of professional knowledge and practical skills of medical personnel in an individual medical speciality, which shall be performed by a unified state certification examination.

2. Certification shall be mandatory in order to obtain the right to engage in independent medical practice.

Law of Georgia No 6000 of 21 March 2008 – LHG I, No 9, 4.4.2008, Art. 75

Article 25 – (Deleted)

Law of Georgia No 2013 of 28 May 1999 – LHG I, No 20(27), 9.6.1999, Art. 87

Article 26

Certification of medical personnel shall be conducted according to the Law of Georgia on Medical Activities and other legal acts and subordinate normative acts of Georgia.

Law of Georgia No 2013 of 28 May 1999 – LHG I, No 20(27), 9.6.1999, Art. 87

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 6000 of 21 March 2008 – LHG I, No 9, 4.4.2008, Art. 75

Law of Georgia No 5665 of 28 December 2011 – website, 11.1.2012

Chapter V – Medical Activities

Article 27

Health care workers shall be obliged to protect the health of individuals, families, and the society in general. Medical activities shall aim to protect, maintain, and restore the health of human beings and relieve their suffering.

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Article 28

Only individuals with corresponding medical education, having obtained a certificate confirming their right to engage in independent medical practice in the respective speciality as provided for by the legislation of Georgia, shall have the right to engage in independent medical practice.

Law of Georgia No 2013 of 28 May 1999 – LHG I, No 20(27), 9.6.1999, Art. 87

Law of Georgia No 889 of 25 May 2001 – LHG I, No 15, 11.6.2001, Art. 50

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Article 29

1. Citizens of Georgia, foreign nationals, or stateless persons who have received education or the right to engage in independent practice abroad may only conduct such practice in Georgia after their educational documents have been acknowledged and/or after they have obtained the right to engage in independent practice.

2. Educational documents of a foreign country shall be acknowledged according to the legislation of Georgia.

Law of Georgia No 2013 of 28 May 1999 – LHG I, No 20(27), 9.6.1999, Art. 87

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Article 30

1. When carrying out medical activities, health care workers shall be guided by ethical values — the principles of recognition of human honour and dignity, fairness, and compassion, also the following norms of professional ethics:

a) acting only in the patient's interests;

b) not using their professional knowledge and experience against the principles of humanism;

c) acting freely and independently when making professional decisions relating to the patient's interests, not acting with self-interest;

d) caring about enhancing the prestige of their professional activity and treating colleagues with respect.

2. Medical institutions and health care workers shall be obliged to observe the following norms of conflict of interests:

a) not acting with self-interest, or for the benefit of a third person, in their relations with patients when carrying out professional medical activities;

b) not conspiring with a medical institution and/or a pharmaceutical company to use patients for personal commercial interests and to obtain a material benefit from such action;

c) it shall be inadmissible to use forms of medical documentation with a differentiating sign of a pharmaceutical product when carrying out professional medical activities.

3. Violation of the norms of conflict of interests provided for in paragraph 2 of this article shall entail responsibility of the medical institution and/or health care workers as provided for by the legislation of Georgia.

4. All persons, regardless of their official or other privilege, shall be prohibited from demanding that the personnel employed in a medical institution act contrary to the principles defined in this Law and the norms of conflict of interests.

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Article 31

The list of medical specialities whose acquisition shall be confirmed by a state educational certificate shall be jointly compiled by the Ministry and the Ministry of Education and Science of Georgia, and shall be approved by the Ministry of Education and Science of Georgia.

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Law of Georgia No 358 of 16 March 2021 – website, 18.3.2021

Article 32

1. The Ministry shall determine:

a) the list of medical and nursing specialities acquired through post-graduate professional training;

b) the list of related medical specialities;

c) the list of related nursing specialities;

d) the list of other medical specialities;

e) the list of medical specialities, which prohibits the subjects of independent medical practice suffering from certain diseases to work;

f) the competency of a paramedic.

2. A doctor shall only have the right to be engaged in independent medical practice in the speciality indicated in the state certificate, except for cases when a patient requires emergency medical care and/or is in a life-threatening condition and it is impossible to find a doctor with the corresponding speciality.

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 6000 of 21 March 2008 – LHG I, No 9, 4.4.2008, Art. 75

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Law of Georgia No 2793 of 2 May 2023 – website, 19.5.2023

Article 33

Only graduates of higher medical education institutions, having obtained a state certificate confirming their right to engage in independent medical practice as provided for in the legislation of Georgia, shall have the right to engage in independent medical practice.

Law of Georgia No 2013 of 28 May 1999 – LHG I, No 20(27), 9.6.1999, Art. 87

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Article 34

A physician’s profession is essentially a free profession. No representative of the authorities or an individual may, under any circumstances, demand that a doctor act contrary to the principles or the ethical norms of medical activity set forth in this Law, irrespective of the official capacity and social status of the person making the demand. Any action preventing medical workers from fulfilling their professional duties shall entail responsibility envisaged by legislation.

Article 35

Graduates of higher medical education institutions with state accreditation shall take an oath publicly and in the official language, before receiving a diploma. The Declaration of Geneva of the 2^nd General Assembly of the World Medical Association of 1948 shall be used as the text of the oath.

Article 36

A physician may render medical assistance to a patient when the patient, or a relative or a legal representative of the patient, if he/she is a minor or unable to make a conscious decision, requires so or allows the physician to render medical assistance; or, in the case of implied consent, when a patient, or a relative or a legal representative of the patient, if he/she is a minor or unable to make a conscious decision, expresses no objection when rendering medical assistance.

Law of Georgia No 3367 of 20 March 2015 – website, 31.3.2015

Article 37

A physician shall have the right to refuse to provide medical care to a patient only if:

a) it is possible to ensure the continuity of medical care for the patient and the patient is not in a life-threatening condition, or the patient does not require emergency medical care;

b) the physician’s life may be exposed to a real danger during the provision of medical care.

Article 38

1. A physician shall be obliged to provide medical care for a patient and ensure its continuity if:

a) there is an officially concluded (written) or verbal agreement;

b) there is a life-threatening condition, including a condition caused by an attempted suicide, or a patient requires emergency medical care at the physician’s workplace.

2. In all other cases, the obligations relating to providing medical care, including the obligation to ensure its continuity, shall be imposed on a physician as soon as he/she starts providing medical care.

Article 39

It shall be an obligation of a physician outside of his/her workplace, also of any citizen, to provide emergency medical care, to the possible extent. At that time, it shall be inadmissible to demand any remuneration.

Article 40

A physician shall be obliged to determine the sequence of providing medical care only according to medical indications.

Article 41

A physician shall be obliged to provide a patient with full information about the patient’s health status. In exceptional cases, the issue of informing a patient shall be regulated by the Law of Georgia on Medical Activities.

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Article 42

Medical workers and all employees of a medical institution shall be obliged to observe medical (physician-patient) confidentiality, except in cases when a relative or a legal representative of a deceased person, a court, or investigatory bodies demand disclosure of confidential information, or when this is necessary to ensure public safety or to protect other people's rights and freedoms.

Article 43

1. Physicians and other health care workers shall be obliged to:

a) maintain records in medical documentation according to the established procedure;

b) make a written description of medical care provided outside of their workplace and transfer the information to the body concerned.

2. The procedure for maintaining medical documentation shall be approved by the Minister of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia (the ‘Minister’).

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 44

A physician shall be obliged to render medical care to a person placed in a penitentiary institution only after obtaining his/her informed consent, except for an urgent and life-threatening condition when it is impossible to obtain consent due to the patient's severe condition. A physician shall also be obliged to refuse to carry out an intervention that contradicts medical and ethical norms.

Law of Georgia No 3540 of 1 May 2015 – website, 18.5.2015

Article 45

Medical workers shall be obliged to transfer information, under the established procedure, to the institutions concerned:

a) when a contagious disease is diagnosed or suspected;

b) in case of physical, chemical, radiation, or thermal damage to a human body;

c) about an unattended or unidentified dead body.

Article 46

If receiving the appropriate remuneration in a health care institution is not an object of an agreement between a doctor and a patient, the institution shall provide the physician with appropriate remuneration according to the labour agreement (contract).

Article 47

According to the state interests, benefits and additions to salary may be established for medical personnel working in individual medical specialities, also for those working in certain regions. The list of the above specialities and regions shall be approved by the Government of Georgia.

Law of Georgia No 2088 of 9 June 1999 – LHG I, No 24(31), 26.6.1999, Art. 116

Law of Georgia No 691 of 13 December 2000 – LHG I, No 50, 27.12.2000, Art. 147

Law of Georgia No 1955 of 29 January 2003 – LHG I, No 5, 19.2.2003, Art. 31

Law of Georgia No 2476 of 23 December 2005 – LHG I, No 56, 28.12.2005, Art. 416

Law of Georgia No 1241 of 20 September 2013 – website, 8.10.2013

Article 48

The State shall create conditions appropriate for medical workers to deepen their professional knowledge and, accordingly, enhance their professional status.

Article 49

Health care workers shall have the right to attend and take part in professional meetings and other events permitted by the legislation of Georgia, regardless of venue and source of funding.

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Article 50

A physician shall be held responsible for erroneous medical actions as provided for by legislation.

Article 51

A physician shall have the right to prescribe and/or administer any approved medicine and any proven treatment method, proceeding from the health care interests of the patient.

Article 52

Gene therapy shall only be allowed if:

a) it aims to prevent, diagnose, and treat a fatal disease;

b) there is no other simpler and safer method of treatment;

c) a written informed consent of a patient, or of a relative or a legal representative of the patient, if he/she is a minor or unable to make a conscious decision, has been obtained;

d) the contemporary level of science development makes it possible to ascertain that the treatment will not cause an undesirable change in the genome of the person's descendants.

Law of Georgia No 3367 of 20 March 2015 – website, 31.3.2015

Chapter VI – Medical Institutions

Article 53

1. A medical institution shall be a legal person with an organisational-legal form permitted by the legislation of Georgia that carries out medical activities according to the established procedure. The share of a medical institution's financial resources obtained from medical activities shall constitute not less than 75%, whereas not less than 75% of the average annual value of the fixed assets on its balance sheet shall be allocated to fulfil the functions indicated in paragraph 2 of this article.

1 ¹. One hundred per cent of the income received from providing health care services and other economic activities performed according to internal standards, compared to the previous year, shall remain at the disposal of the medical institution. As a rule, the head of the institution, in agreement with the supervisory board, shall distribute this sum, according to the economic classifier. At the same time, the payroll fund shall constitute not less than 30% of the income.

2. The functions of a medical institution shall be as follows:

a) determination of a patient's health status;

b) prevention and/or treatment of diseases and/or rehabilitation and/or palliative care of patients;

c) obstetric activities;

d) pharmaceutical activities;

e) (deleted).

f) conduction of pathological-anatomical examination and forensic-medical expert examination of a dead body;

g) implementing epidemiological control measures.

2¹. A medical institution shall render urgent medical aid to a patient in cases provided for by Article 38(1)(b) of this Law.

3. Medical and pharmaceutical institutions shall be obliged to observe the standards, procedures, and norms laid down in the legislation regulating medical and pharmaceutical activities.

4. Medical and pharmaceutical institutions shall provide persons with disabilities with equal access to the aforementioned institutions.

Law of Georgia No 974 of 20 June 2001 – LHG I, No 20, 3.7.2001, Art. 73

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 2527 of 18 July 2003 – LHG I, No 22, 8.8.2003, Art. 162

Law of Georgia No 3836 of 7 December 2006 – LHG I, No 48, 22.12.2006, Art. 317

Law of Georgia No 4719 of 8 May 2007 – LHG I, No 18, 22.5.2007, Art. 149

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Law of Georgia No 1116 of 28 June 2017 – website, 10.7.2017

Law of Georgia No 6847 of 14 July 2020 – website, 28.7.2020

Article 54

1. The Ministry shall issue a document certifying the respective right to carry out medical activities (a licence and/or a permit).

2. (Deleted).

3. The Minister shall approve the list of medical personnel who have the right to be employed in a medical institution and have the respective education.

Law of Georgia No 889 of 25 May 2001 – LHG I, No 15, 11.6.2001, Art. 50

Law of Georgia No 3553 of 21 July 2010 – LHG I, No 46, 4.8.2010, Art. 282

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 55

The procedure for revoking a licence/permit for a respective medical activity shall be provided for by the Law of Georgia on Licences and Permits.

Law of Georgia No 974 of 20 June 2001 – LHG I, No 20, 3.7.2001, Art. 73

Law of Georgia No 3553 of 21 July 2010 – LHG I, No 46, 4.8.2010, Art. 282

Article 56

A medical institution may not perform medical activities requiring a licence and/or a permit under the legislation of Georgia without the respective licence and/or permit.

Law of Georgia No 3553 of 21 July 2010 – LHG I, No 46, 4.8.2010, Art. 282

Article 57

1. A medical institution may be an entrepreneurial or non-entrepreneurial legal person.

2. An entrepreneurial medical institution shall carry out its activities according to the Law of Georgia on Entrepreneurs.

3. A non-entrepreneurial medical institution shall carry out its activities according to the legislation of Georgia.

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Article 58

1. A medical institution shall enjoy professional and financial independence as provided for by the legislation of Georgia.

2. A medical institution may establish a fund for cases when a complaint is filed against its medical personnel for erroneous medical activity. The fund shall be established with contributions of the medical personnel and funds permitted by legislation.

Article 59

1. A medical institution shall carry out its activities according to its statute under the legislation of Georgia.

2. A medical institution shall determine the procedure of organisation of labour and the procedure, form, and amount of remuneration, within the limits of its income, as established by the legislation.

3. Medical personnel shall be paid on a piece-rate basis. The amount and terms of remuneration shall be determined by:

a) a standard of the maximum workload in individual specialities, which shall be approved by the Ministry under the established procedure;

b) a labour agreement (contract) between a medical institution and an individual worker.

4. (Deleted).

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 60

1. When providing medical services to a patient in excess of the state medical programme limits, a medical institution and the patient shall, under the established procedure, make an agreement to include conditions and amount of the medical services to be provided and of the appropriate payment.. If the patient is a minor or unable to make a conscious decision, the agreement shall be made with his/her relative or legal representative.

2. During and after the provision of medical services, the parties indicated in paragraph 1 of this article shall be obliged to accurately carry out the conditions of the agreement. If one of the parties refuses to carry out the conditions of the agreement, the other party shall have the right to apply to court.

3. If a minor patient, or a patient who is unable to make a conscious decision, or his/her relative or legal representative refuse to make an agreement, which is confirmed by an act made under the established procedure, and the patient shows no signs of critical condition, the medical institution may refuse to start treatment.

4. Health care in mountainous regions shall be provided under the procedure established by the legislation of Georgia. The State shall ensure the retention and development of medical institutions in a mountainous region. In parallel with this, rendering of private health care services and sale of medicines shall be permitted in a mountainous region under the procedure established by the legislation of Georgia.

Law of Georgia No 2088 of 9 June 1999 – LHG I, No 24(31), 26.6.1999, Art. 116

Law of Georgia No 3367 of 20 March 2015 – website, 31.3.2015

Law of Georgia No 2156 of 18 April 2018 – website, 4.5.2018

Article 61

The State shall, within the limits of available resources, ensure the technical equipment for and modernisation of the institutions dealing with health care information systems and health care statistics, health care information resource centres, and medical libraries.

Article 62

Commissions on medical ethics shall be created at medical institutions that shall ensure the protection of patient rights and the observance of norms of medical ethics; the grounds for creating the commissions shall be provided for in the legislation of Georgia.

Article 63

The Ministry shall control the quality of medical activities of all medical institutions under the procedure established by the legislation of Georgia.

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 63 ¹

1. Medical activities performed on an outpatient basis/at a day care inpatient facility involving high risk shall be regulated by the Technical Regulations of Medical Activities and shall be subject to mandatory notification to the Ministry.

2. List of medical activities to be performed on an outpatient basis/at a day care inpatient facility involving high risk (‘high-risk medical activities’) shall be determined by an ordinance of the Government of Georgia.

3. The Technical Regulations of High-Risk Medical Activities shall be adopted by an ordinance of the Government. It shall include requirements relating to medical equipment and instruments, hygienic conditions, and maintenance of medical documentation.

4. Compliance with the Technical Regulations of High-Risk Medical Activities shall be checked by random control, according to the procedure approved by an order of the Minister. Non-compliance with the Regulations shall entail responsibility as provided for by the legislation of Georgia.

4¹. When breaches are revealed in the course of checking of Compliance with the Technical Regulations for High-Risk Medical Activities, if human life and health and/or the epidemiological condition are endangered, a relevant competent agency of the Ministry may, completely or partially, suspend the high-risk medical activities until the conditions of the technical regulations are met. The relevant competent agency of the Ministry shall, within 24 hours after making the decision on suspending the high-risk medical activities, file a motion with a court for approving the suspension of the high-risk medical activities. If the motion is not filed within the said time limit, the decision on suspending the high-risk medical activities shall be deemed revoked, and the activities shall be deemed restored. The procedure for suspending and restoring the high-risk medical activities shall be defined by an ordinance of the Government of Georgia. The decision on suspending the high-risk medical activities shall be approved under the procedure established by Chapter VII²⁶ of the Administrative Procedure Code of Georgia.

4². If the breaches are eliminated after suspension of the high-risk medical activities, the relevant competent agency of the Ministry shall, on the basis of an application of a person with the right to conduct the high-risk medical activities, within 5 business days, inspect the fact of compliance with the technical regulation conditions on site, issue a respective inspection act and make the decision to revoke the decision on suspending the high-risk medical activities.

4³. If the relevant competent agency of the Ministry makes the decision to refuse to revoke the decision on suspending the high-risk medical activities, its reasoned decision must be immediately served on/sent to the interested party. The said decision shall be appealed to the court. The court shall consider the case under the procedure established by Chapter VII²⁶ of the Administrative Procedure Code of Georgia.

5. Checking compliance with the Technical Regulations of High-Risk Medical Activities by random control shall be carried out only in relation to the activities referred to in paragraph 2 of this article, that are subject to notification. At the same time, the Technical Regulations of High-Risk Medical Activities shall be made available for interested persons, as provided for by the legislation of Georgia.

6. High-risk medical activities shall be checked by random control three times a year. In this case, Article 3(2) and (2¹) of the Law of Georgia on Control of Entrepreneurial Activity shall not apply.

7. If a medical activities/health care services provider performs an activity envisaged in a licence/permit, it shall have the right to perform an activity defined in paragraph 2 of this article without notification, if the terms of its licence/permit include the requirements envisaged by the Technical Regulations of High-Risk Medical Activities and if this activity is performed at a single actual address. In this case, random control shall be carried out only according to the requirements of the Law of Georgia on Licences and Permits.

8. The mandatory notification form for providers of high-risk medical activities/health care services shall include the name of the medical activity (activities) provided for in paragraph 2 of this article and the person's identification data, address and contact information.

9. The mandatory notification form for providers of high-risk medical activities/health care services may be filed electronically.

10. The Minister of Labour, Health and Social Affairs of Georgia shall approve the mandatory notification form and procedure for providers of high-risk medical activities/health care services. This procedure shall envisage a different period for mandatory notification for active providers of high-risk medical activities/health care services.

Law of Georgia No 3553 of 21 July 2010 – LHG I, No 46, 4.8.2010, Art. 282

Law of Georgia No 1776 of 13 December 2013 – web-site, 28.12.2013

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Law of Georgia No 3455 of 3 July 2023 – website, 25.7.2023

Article 63 ²

1. Palliative care, hospice care and long-term care medical activities shall be regulated by an appropriate technical regulation (regulations) and its implementation shall be subject to compulsory notification to the Ministry.

2. The technical regulation (regulations) defined by paragraph 1 of this article shall be adopted by an ordinance of the Government of Georgia.

Law of Georgia No 4277 of 19 February 2019 – website, 25.2.2019

Chapter VII – Medicines and Pharmaceutical Activities

Article 64

The provision of high-quality, safe, and effective pharmaceutical products; the state requirements regarding the production, import, distribution, and sale of pharmaceutical products and the control over their compliance shall be regulated by the respective legislation.

Law of Georgia No 2088 of 9 June 1999 – LHG I, No 24(31), 26.6.1999, Art. 116

Law of Georgia No 6000 of 21 March 2008 – LHG I, No 9, 4.4.2008, Art. 75

Chapter VIII – Medical Technical Devices and Medical Technology

Article 65 – (Deleted)

Law of Georgia No 2013 of 28 May 1999 – LHG I, No 20(27), 9.6.1999, Art. 87

Law of Georgia No 6000 of 21 March 2008 – LHG I, No 9, 4.4.2008, Art. 75

Article 66

Design work, production, maintenance, and repair of medical technical devices shall be carried out under the procedure provided for by legislation.

Article 67

1. The Ministry shall, together with appropriate state bodies, develop and introduce the quality and safety standards of medical technical devices and medical technologies.

2. The type of the means of measurement shall be approved, entered into the register, imported, and produced according to the legislation of Georgia.

Law of Georgia No 6000 of 21 March 2008 – LHG I, No 9, 4.4.2008, Art. 75

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Chapter IX – Psychiatric Assistance

Article 68

The State shall support the provision of medical and social assistance for mentally ill persons.

Article 69

The protection of the rights and interests of mentally ill persons, the protection of the society from their socially dangerous actions, and the rights and duties of workers of psychiatric service providers and of persons having direct contact with mentally ill persons shall be regulated by the Law of Georgia on Mental Health.

Law of Georgia No 6361 of 23 June 2020 – website, 1.7.2020

Chapter X – Sanitary and Hygiene Standardisation and Epidemiological Control

Law of Georgia No 974 of 20 June 2001 – LHG I, No 20, 3.7.2001, Art. 73

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Article 70

1. Ensuring environmental health shall be the State's obligation. The Ministry shall develop and approve the sanitary and hygiene standards and epidemiological control measures.

2. The Ministry shall approve the sanitary and hygiene procedures and standards for individual agencies.

3. The issues of ensuring environmental health of the population and respective surveillance shall be regulated by the legislation of Georgia.

4. Sanitary and hygiene standards and procedures and epidemiological control requirements currently in force in Georgia shall comply with international norms.

Law of Georgia No 974 of 20 June 2001 – LHG I, No 20, 3.7.2001, Art. 73

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 71

1. The right of the population of Georgia to radiation safety shall be exercised through a complex of measures that include:

a) requirements for radiation safety by natural and legal persons using ionising radiation sources;

b) prevention of excessive doses of ionising radiation on a human organism and of environmental radioactive pollution.

2. The State shall be responsible for environmental radiation monitoring and the radiation safety of the population.

Article 72

Compliance with sanitary and hygiene and sanitary anti-epidemic procedures and measures developed and approved to prevent the adverse effects of the environmental and other factors on the health of the population shall be mandatory for any natural and legal person in the country, regardless of their organisational-legal form and departmental subordination.

Chapter XI – Disease Control

Article 73

1. Control of communicable diseases (including those of zooanthroponotic and zoonotic nature), endemic diseases, epidemics and particularly prevalent non-communicable diseases shall be exercised under the legislation of Georgia.

2. The Ministry shall, together with appropriate institutions of state authority, develop programmes and carry out coordinated measures to protect people and animals from especially dangerous zooanthroponotic diseases and toxic infections.

Law of Georgia No 4633 of 11 December 2015 – website, 23.12.2015

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 74

The Ministry shall compile the list of especially dangerous pathogens and develop measures for epidemiological study, treatment, and prevention of particularly prevalent communicable and non-communicable diseases, including endemic diseases.

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 75

The State shall, based on recommendations developed by the Ministry, manage a complex of measures of epidemiological control in the country:

a) immune prevention and quarantine measures;

b) proper treatment and preventative measures for citizens with a high risk of developing communicable diseases;

c) protecting various objects from being infected and neutralising infected objects;

d) combating carriers in an anti-epidemic situation;

e) taking measures necessary for epidemiological preparedness of medical workers.

Law of Georgia No 974 of 20 June 2001 – LHG I, No 20, 3.7.2001, Art. 73

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 76

When it is necessary to examine citizens to confirm a well-grounded suspicion concerning the existence of an especially dangerous communicable disease, citizens shall be obliged to undergo all appropriate examinations. The dignity and the basic rights of citizens shall be protected during such examinations.

Article 77

Export and import of especially dangerous pathogens shall be regulated according to the legislation of Georgia.

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Article 78

The Ministry shall develop and approve the Preventive Immunisation National Schedule and a state medical programme necessary for its implementation.

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 79

The Ministry shall compile the list of endemic diseases. It shall be the prerogative of the State to control these diseases, ensure their treatment in a medical institution, and provide adequate funding.

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Chapter XII – Social Diseases and Diseases That Require Permanent Replacement Therapy

Article 80

1. The State shall ensure the implementation of measures to fight tuberculosis. The State shall perform this activity in cooperation with legal entities under private law. The fight against tuberculosis shall aim to ensure the protection of health of natural persons and public health care, prevent the spreading of tuberculosis throughout Georgia, cure individual patients with tuberculosis, and ensure their physical, psychological, and social rehabilitation.

2. Basic legal, organisational and financial principles for arranging tuberculosis control measures in Georgia shall be established, and issues related to tuberculosis control and the rights and duties of persons with tuberculosis shall be regulated under the Law of Georgia on Tuberculosis Control.

Law of Georgia No 4633 of 11 December 2015 – website, 23.12.2015

Article 81

The State shall take measures necessary for the prevention, diagnostics, dispensary supervision, and treatment of enteric and parenteral hepatitis.

Article 82

The Ministry shall take measures necessary for the prevention and control of sexually transmitted diseases in compliance with contemporary standards, taking into consideration the epidemiological situation, through providing health education to the population and raising public awareness. The State shall determine its policy towards prostitution and take the respective measures according to the situation existing in the country.

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 83

The basic principles of measures against HIV infection/AIDS and the issues of testing natural persons for HIV infection and treatment and care of persons infected with HIV/ill with AIDS, also the rights and obligations of persons infected with HIV/ill with AIDS, and medical workers, shall be regulated by the Law of Georgia on HIV Infection/AIDS.

Law of Georgia No 2043 of 17 November 2009 – LHG I, No 37, 30.11.2009, Art. 277

Article 84

Intentional transmission of sexually transmitted diseases shall be punishable by law, under the legislation of Georgia.

Article 85

Within the limits of obligations it has undertaken, the State shall provide persons with diseases requiring permanent replacement therapy (diabetes mellitus and diabetes insipidus) with vital medications, emergency medical care relating to the disease, and physical, psychological, and social rehabilitation.

Chapter XIII – Public Health and Primary Health Care

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Article 85 ¹

The obligations defined in the field of public health shall be included in the appropriate programmes.

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 7001 of 15 July 2020 – website, 28.7.2020

Article 85 ² – (Deleted)

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Law of Georgia No 7001 of 15 July 2020 – website, 28.7.2020

Article 85 ³

The competence of the public health offices shall include:

a) establishing a system of registration and notification of infectious and non-infectious diseases, analysing the data obtained, and forecasting;

b) implementing epidemiological surveillance and control to identify and study the causes, transmission routes, and risk factors of diseases;

c) providing health care offices and the population with appropriate information and preparing recommendations on causes of emergence, prevalence, and control of infectious diseases;

d) planning measures to limit the prevalence of or to eradicate communicable diseases, including sexually transmitted diseases;

e) planning measures necessary to ensure safe blood provision;

f) preventing non-infectious diseases (cardiovascular diseases, oncological diseases, traumas, diseases caused by deficiency of iodine, other microelements and vitamins, etc.);

g) contributing to healthy lifestyle practices promotion;

h) contributing to environmental health promotion.

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Article 86

The State shall support measures for prevention of smoking of tobacco and excessive use of alcohol products and create mechanisms for their implementation, to protect the health of the population. Smoking of tobacco in public places and sale of tobacco and alcohol products to minors shall be regulated by the legislation of Georgia.

Article 87

Measures necessary to prevent misuse of permitted preparations and use of prohibited preparations shall include the creation of an appropriate legislative base, early identification of cases of use, treatment of users, raising public awareness of the issue, and implementation of prevention measures targeted at risk groups.

Chapter XIV – (Title deleted)

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Article 88

Disease prevention and health promotion shall be a state priority; the State shall create preconditions for the participation of youth and non-governmental organisations, also public and private health care organisations in the promotion of healthy lifestyle practices, especially for minimizing the risk of developing diseases in educational and work institutions, and in leisure and entertainment establishments.

Article 89

The State shall determine strategic directions, develop appropriate programmes for disease prevention and for contributing to the health care of the population, especially among children and adolescents, and shall ensure their implementation.

Article 89 ¹

The Ministry shall develop the legislative base and the procedure of organisational-legal arrangement necessary for developing the system of primary health care, including family medicine.

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Chapter XV – Protection of Citizens' Health at the Time of Emergencies – Natural and Man-made Disasters

Article 90

The State shall be responsible for the protection of citizens' health and safety at the time of natural and man-made disasters. The bodies of health care management, medical institutions, and respective professional associations shall take part in the development and implementation of disaster medical preparedness and response.

Article 91

The Ministry shall, together with appropriate state government bodies, under the established procedure, accumulate a stock of first-degree material values of mobilisation reserves necessary for natural and man-made disaster medical preparedness and response and ensure its completeness, readiness for use, and periodic replenishment.

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 92

Medical institutions shall have emergency response plans, agreed upon with the Ministry, which shall be in line with the National Response Plan.

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 93

The expenses of medical assistance to those who suffer injuries or become ill as a result of an emergency situation or an epidemic outbreak shall be borne by the State.

Law of Georgia No 974 of 20 June 2001 – LHG I, No 20, 3.7.2001, Art. 73

Chapter XVI – Occupational Diseases

Article 94

The Ministry shall review and approve the list of occupational diseases and a list of occupations that are associated with the risk of developing an occupational disease.

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 95

An employer shall be obliged to provide an employee with comprehensive information concerning the risk of developing an occupational disease, the existence of harmful factors, and the preventive measures necessary to avoid their effects in the enterprise or establishment.

Chapter XVII – Medical Education

Article 96

Teaching the speciality of physicians, pharmacists, nurses, and other medical specialities in appropriately authorised medical educational institutions shall have the form of higher education and secondary vocational education, according to state educational standards.

Article 97

1. After receiving higher medical education, the upgrading of a physician’s professional qualifications shall involve post-graduate professional education and training and continuous professional development.

2. The aim of post-graduate professional education and training shall be to master a medical speciality, while the aim of continuous professional development shall be to maintain a physician’s professional competence in his/her medical speciality, so that his/her theoretical knowledge and practical skills are up to date with contemporary medicine achievements and technologies.

Law of Georgia No 1435 of 13 May 2005 – LHG I, No 25, 2.6.2005, Art. 163

Article 98

1. Higher medical education shall be received on the basis of one-cycle studies, according to a special higher education programme.

2. A graduate of a higher medical education institution holding state accreditation shall have the right to:

a) take a course of post-graduate professional education and training, and obtain the right to engage in independent medical practice, after passing the state certification examination;

b) carry out research and teaching activities in theoretical fields of medicine or other fields of health care that do not involve independent medical practice;

c) work as a junior physician;

d) work as a paramedic after having taken an appropriate specialised course.

Law of Georgia No 1435 of 13 May 2005 – LHG I, No 25, 2.6.2005, Art. 163

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Law of Georgia No 2793 of 2 May 2023 – website, 19.5.2023

Article 99

Issues of physician post-graduate professional education and training shall be defined by the Law of Georgia on Medical Activity and other legislative acts.

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 1435 of 13 May 2005 – LHG I, No 25, 2.6.2005, Art. 163

Article 100

The components and respective forms of physician’s continuous professional development, and the criteria and procedure of assessing a physician’s participation shall be provided for by the Law of Georgia on Medical Activities and other legislative acts.

Law of Georgia No 1435 of 13 May 2005 – LHG I, No 25, 2.6.2005, Art. 163

Article 101

Medical and pharmacy colleges and secondary vocational educational institutions shall train professional personnel according to the programmes developed by the Ministry and the Ministry of Education and Science of Georgia, and approved by the Ministry of Education and Science of Georgia.

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Law of Georgia No 358 of 16 March 2021 – website, 18.3.2021

Article 102 – (Deleted)

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Chapter XVIII – Responsibility of Health Care Personnel and Medical Institutions

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Article 103

Responsibility for the deterioration of a patient's physical or mental status, a patient's death, or moral or material damage inflicted to a patient that is caused by an action or inaction of health care personnel shall be determined by the legislation of Georgia.

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Article 104

A patient or his/her relative or legal representative shall have the right to file a complaint against a physician, a nurse, other medical worker, or a medical institution with the administration of the medical institution, a health care management body, a court, or other dispute adjudicating body.

Article 104¹

Activities of a paramedic shall be subject to state supervision under the procedure and conditions determined by a relevant order of the Minister, considering the special aspects of the state supervision mechanisms and forms of responsibility defined for medical practice as provided for by the Law of Georgia on Medical Practice.

Law of Georgia No 2793 of 2 May 2023 – website, 19.5.2023

Chapter XIX – Biomedical Research

Article 105

At the time of biomedical research, the human rights of a person, as an object of biomedical research, and the principles of humane treatment of laboratory animals shall be observed, according to the legislation of Georgia and the international agreements and treaties of Georgia.

Article 106

Any and all biomedical research shall conform to the norms of scientific research accepted in Georgia based on utmost accuracy in conducting laboratory trials and experiments on animals and comprehensive knowledge of the relevant literature. The goals, objectives, methods, expected results, and research risk of a biomedical study conducted on human beings or animals shall be set forth in the research plan. Any and all research shall be conducted in the framework of this plan.

Article 107

The research plan shall be discussed and reviewed by a special commission independent of the researcher and the funding source and by a commission on medical ethics.

Article 108

Before starting a planned biomedical research involving a human being, it shall be necessary to weigh the expected benefits against the potential risks. At the time of a biomedical research, the interests and well-being of a human being, as an object of research, shall be more important than the interests of science and society. The research risk shall be reduced to minimum. It shall not exceed the expected benefit for the research object and/or the significance of the research goals.

Article 109

A person, as an object of biomedical research, shall be given comprehensive information in advance about the goals, methods, expected results, and the research risk of a study, also on the risk-related possible discomfort. Biomedical research may not be conducted without written informed consent of the person participating in it. A person, as an object of biomedical research, must be informed of his/her right to refuse to participate in the research at any stage of the research, regardless of his/her advance consent.

Article 110

A beneficiary of support may be an object of biomedical investigation under the conditions defined in Article 108 if he/she expresses no objection and when he/she receives an appropriate support. A minor may be an object of biomedical investigation under the conditions defined in Article 108 if he/she expresses no objection and when the informed consent of his/her relative or legal representatives has been obtained.

Law of Georgia No 3367 of 20 March 2015 – website, 31.3.2015

Article 111

The rights of minors and pregnant and nursing women must be protected when performing research. Any person from these categories may only be an object of biomedical investigation if it is expected that the investigation results will bring a direct and significant benefit to this person, or when it is not expected that the investigation results will bring a direct benefit to the health of this person but it will benefit other persons from the same category and if it is impossible to receive similar scientific results when investigating persons from other categories.

Law of Georgia No 3367 of 20 March 2015 – website, 31.3.2015

Article 112

Persons placed in a penitentiary institution shall enjoy all the rights provided for under Articles 108 and 109 of this Law. Participation of these persons in a biomedical research shall be admissible if it is expected that the research results will bring a direct and significant benefit to their health.

Law of Georgia No 3540 of 1 May 2015 – website, 18.5.2015

Article 112 ¹

1. It shall be permissible that educational and scientific institutions, which carry out medical, educational, and scientific programmes, also medical and expert examination institutions, use an unattended and/or unidentified dead body or its anatomical structures for study and/or scientific research purposes if the fact of a person’s death has been confirmed under the procedure established by the legislation of Georgia by an attending doctor of a medical institution, a pathologist (clinical pathologist), a forensic pathologist, or another entity of independent medical practice, and, within one month after this fact was ascertained, the dead body has been declared as an unattended dead body or unidentified dead body in accordance with this Law.

2. If a person defined in paragraph 1 of this article has not expressed in life his/her consent or refusal to the transfer of his/her body or anatomical structures of his/her body after his/her death for the purposes provided for in this article and there are no grounds for the assumption that its/their transfer is against the religious belief and ethical principles of the aforementioned person, it shall be possible to transfer it/them to educational and scientific institutions for study and/or scientific research purposes.

3. Transfer of an unattended dead body or unidentified dead body to educational and scientific institutions for study and/or scientific research purposes shall be possible one month later after the fact of death is ascertained, following the appropriate decision made by an authorised body. The transfer of the unattended dead body or unidentified dead body to educational and scientific institutions for study and/or scientific research purposes shall be finalised by a protocol to be signed by the parties transferring and accepting the unattended dead body or unidentified dead body. The aforementioned protocol and appropriate documentation shall be retained during 5 years.

4. The educational and scientific institutions shall ensure the storage of the transferred dead body within 6 months after it is transferred, and after the expiry of 6 months from the transfer of the dead body, it shall be possible that the dead body or its anatomical structures be used for study and/or scientific research purposes.

5. Responsibility for the storage/use of an unattended dead body and/or unidentified dead body by educational and scientific institutions shall be vested in the aforementioned institutions.

6. The decision on transferring an unattended dead body or unidentified dead body, with regard to which criminal investigation is in progress, to educational and scientific institutions, and to medical and expert institutions, shall be made by a prosecutor in accordance with the Criminal Procedure Code of Georgia.

7. If a relative, a legal representative, an inheritor of a deceased person, or a party to a life annuity agreement/breadwinner (if the agreement also covers payment of the expenses related to the death of the annuitant) is found but he/she refuses to bury him/her, the decision on using the dead body for study and/or scientific research purposes must be made by the relative, the legal representative, or the inheritor, which will be confirmed by an appropriate document.

8. When a dead body is identified after it is transferred to educational and/or scientific institutions, and/or if a relative, a legal representative, or an inheritor of the deceased person appears, if the aforementioned person so desires, the use of the dead body for study and/or scientific research purposes shall be terminated and the dead body shall be transferred to this person. If, after the dead body is transferred to the aforementioned person, it becomes necessary for investigation purposes that the dead body be examined, or an additional expert examination be conducted, an investigation body shall have the right to carry out appropriate measures.

9. Educational, scientific, or medical institutions shall ensure that the dead body is buried after it has been used for study and/or scientific research purposes.

10. For study and/or scientific research purposes, it shall be permissible to bring a dead body from abroad/use it with an appropriate accompanying document. The document must include information about the processing of the dead body. It may also include information about the name, surname, and age of the deceased person, the reason and the date of his/her death, and other data.

Law of Georgia No 4921 of 8 June 2007 – LHG I, No 22, 19.6.2007, Art. 202

Law of Georgia No 2156 of 18 April 2018 – website, 4.5.2018

Article 113

When conducting biomedical research on animals, a researcher shall be obliged to observe all the existing principles of humane treatment of experimental animals.

Chapter XX – Removal and Use of Human Organs, Parts of Organs, and Tissues

[Chapter XX – Transplantation of Human Organs; Use of Human Tissues and Cells (Shall become effective from 1 January 2025)

Law of Georgia No 3615 of 1 November 2023 – website, 22.11.2023

Article 114

Giving organs, parts of organs, or tissues (‘organ’) by a human being during his/her lifetime or after his/her death for the purpose of their transplantation into or treatment of another human being, research, and teaching shall be a voluntary act.

[Article 114

1. Donation of a human organ, tissue and cell shall be voluntary and gratuitous.

2. A person shall have the right to give a written informed consent or express the refusal to donate his/her organ, tissue or cell during his/her lifetime or after his/her death. A human organ, tissue or cell shall be obtained only on the basis of a written informed consent of a donor. No influence whatsoever may be exerted on a person in order for him/her to make the decision concerned.

3. A human organ may be transplanted into or a human tissue and/or cell may be used for a recipient only on the basis of a written informed consent of the recipient.

4. It shall be forbidden to receive, offer/give a monetary remuneration and/or any other benefit in return for the donation of a human organ, tissue or cell. Human organ trade, and human tissue or cell trade in violation of the requirements of the legislation of Georgia shall be forbidden.

5. The procedure and conditions for donating and obtaining a human organ, tissue and cell shall be defined by the Laws of Georgia on Human Organ Transplants and Use of Human Tissues and Cells. (Shall become effective from 1 January 2025)]

Law of Georgia No 3615 of 1 November 2023 – website, 22.11.2023

Article 115

All citizens of Georgia shall have the right to make a written statement containing consent or refusal to give an organ during their life or after their death. A statement confirming consent shall only be valid if the person making the statement is legally capable. It shall be inadmissible to exert any type of influence on a person to compel him/her to make such a decision.

[Article 115

1. The State shall ensure that the state policy for quality and safety protection in the area of human organ transplantation and use of human tissues and cells be defined and pursued, the appropriate rules for quality and safety protection be elaborated and introduced, and their compliance control.

2. An institution engaged in the area of human organ transplantation and use of human tissues and cells shall introduce the appropriate quality and safety system under the procedure established by the legislation of Georgia. (Shall become effective from 1 January 2025)]

Law of Georgia No 3615 of 1 November 2023 – website, 22.11.2023

Article 116

It shall be admissible to use an organ of a living donor for treatment of and/or transplantation into another human being only if the living donor is:

a) the recipient's genetic relative;

b) the recipient's spouse, if not less than one year has passed since registration of the marriage;

c) a child, mother, (mother-in-law) father, (father-in-law), grandchild, grandmother, grandfather, sister (sister-in-law), brother (brother-in-law), child’s spouse (daughter-in-law, son-in-law), grandchild’s spouse (grand-daughter-in-law, grand-son-in-law), sister’s spouse (brother-in-law), brother’s spouse (sister-in-law) of the recipient, if not less than two years have passed since the registration of the marriage.

Note : All potential living donors defined in sub-paragraph (c) of this article, shall have the right, if needed, to have the organ of the relative, to whom he/she has the right to be a donor, transplanted into his/her body.

Law of Georgia No 3113 of 18 June 2010 – LHG I, No 31, 5.7.2010, Art. 196

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Law of Georgia No 2152 of 21 March 2014 – web-site, 4.4.2014

[Article 116

A human organ shall be obtained and transplanted, and a human tissue or cell shall be obtained, tested, processed, preserved, stored, distributed and/or used for humans on the basis of an appropriate licence/permit. (Shall become effective from 1 January 2025)]

Law of Georgia No 3615 of 1 November 2023 – website, 22.11.2023

Article 117

1. It shall be admissible to remove the bone marrow from an underage living donor (except a child) to transplant into another human being only if:

a) the removal of the bone marrow does not affect the donor's health, which shall be confirmed independently by two appropriately certified physicians;

b) the bone marrow is intended to be transplanted into the donor's first- or second-degree genetic relative who has a life-threatening health condition and there is no other means of treatment.

2. In the cases mentioned in paragraphs 1(a) and (b) of this article, it shall be necessary to obtain the informed consent of the underage person, his/her parents (parent), and in the case of an underage person outside of parental care – his/her legal representative. This consent shall be confirmed by agencies of guardianship and trusteeship.

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

[Article 117

Other issues related to the transplantation of human organs and the use of human tissues and cells shall be defined by the Laws of Georgia on Human Organ Transplants and Use of Human Tissues and Cells. (Shall become effective from 1 January 2025)]

Law of Georgia No 3615 of 1 November 2023 – website, 22.11.2023

Article 118

If a deceased person is a suitable candidate for removal of an organ according to accepted medical standards and, at the same time, he/she has not expressed either his/her consent or refusal to give an organ when he/she was alive and there are no grounds to assume that giving an organ contradicts his/her religious beliefs or ethical principles, it shall only be admissible to remove an organ with the consent of a relative or legal representative of the deceased person. If it has been impossible to find a relative or a legal representative, it shall not be admissible to remove organs from the dead body.

[Article 118 – (Deleted) (Shall become effective from 1 January 2025)]

Law of Georgia No 3615 of 1 November 2023 – website, 22.11.2023

Article 119

It shall only be admissible to remove an organ of a deceased person after two or more physicians, none of whom takes part in the transplantation process, independently from each other, pronounce the person dead. The fact of death shall be established based on the methods and criteria of the contemporary level of medicine that are in compliance with ethical requirements and professional standards approved by physician professional associations and health care bodies of Georgia.

[Article 119 – (Deleted) (Shall become effective from 1 January 2025)]

Law of Georgia No 3615 of 1 November 2023 – website, 22.11.2023

Article 120

An organ intended to be transplanted into a recipient shall be selected based on the principle of anonymity and only according to medical indications, regardless of any other privileges.

[Article 120 – (Deleted) (Shall become effective from 1 January 2025)]

Law of Georgia No 3615 of 1 November 2023 – website, 22.11.2023

Article 121

It shall be prohibited to trade organs intended for transplantation or treatment, to purchase them abroad, or export them in violation of the legislation currently in force in Georgia and/or international agreements. Medical personnel shall be prohibited from taking part in removal and use of an organ, if they know or have a well-founded suspicion that the above organ has been obtained based on an illegal transaction.

[Article 121 – (Deleted) (Shall become effective from 1 January 2025)]

Law of Georgia No 3615 of 1 November 2023 – website, 22.11.2023

Article 122

It shall be prohibited to advertise the demand for an organ, also to advertise it with the aim of receiving or giving remuneration. Any and all persons and institutions shall be prohibited from receiving remuneration for taking part in activities related to transplantation, except for a substantiated sum determined as remuneration for provided medical assistance.

[Article 122 – (Deleted) (Shall become effective from 1 January 2025)]

Law of Georgia No 3615 of 1 November 2023 – website, 22.11.2023

Chapter XXI – Donation of Blood and Blood Components

[Chapter XXI – Donation of Human Blood and its Components (Shall become effective from 1 January 2025)]

Law of Georgia No 2388 of 15 December 2022 – website, 27.12.2022

Article 123

1. Giving blood and blood components by a donor for the purposes of treatment, diagnostics, and scientific research shall be a voluntary act.

2. Blood and blood components may only be taken from a donor after obtaining informed consent and performing any necessary preliminary medical examination.

[Article 123

1. Donation of human blood (the ‘blood’) shall be based on the principles of voluntariness, gratuitousness and anonymity.

2. An individual shall have the right to donate blood or its components of his/her own free will, without compulsion.

3. An individual must donate blood or its components without any monetary payment and/or benefit equivalent to the monetary payment. A donor of blood or its component may not receive any monetary payment and/or benefit equivalent to the monetary payment in return for the donated blood or its components, nor any monetary payment and/or benefit equivalent to the monetary payment may be offered/given to him/her.

4. Donation must be carried out anonymously, meaning that personal data (including genetic data) of the donor and the recipient (a person who has undergone blood transfusion) of blood or its components must be protected and they cannot be identified by a third person under the legislation of Georgia. (Shall become effective from 1 January 2025)]

Law of Georgia No 2388 of 15 December 2022 – website, 27.12.2022

Article 124

The Ministry shall define indications against donation of blood.

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

[Article 124

1. A person who meets the compliance criteria for a donor of blood or its components as determined by the Law of Georgia on Quality and Safety of Human Blood and its Components and by the subordinate normative acts issued on its basis, and who has undergone the procedures for the selection and assessment of compliance of a donor of blood or its components shall have the right to donate blood.

2. The rule for the selection and assessment of compliance of a donor of blood or its components, and the rights and duties of a donor of blood or its components shall be defined by the Law of Georgia on Quality and Safety of Human Blood and its Components and by the appropriate subordinate normative acts. (Shall become effective from 1 January 2025)]

Law of Georgia No 2388 of 15 December 2022 – website, 27.12.2022

Article 125

1. Blood and blood components may be taken from a donor aged between 18 and 65 years of age.

2. Blood and blood components may be taken from an underage person (except a child) only in an emergency situation and when it is impossible to provide alternative treatment. In this case, it shall be necessary to obtain informed consent from the underage person or his/her parents (parent) or legal representative.

[Article 125

Blood and its components shall be collected, tested at the central testing laboratory, processed, stored, distributed and given out on the basis of a relevant licence/permit. (Shall become effective from 1 January 2025)]

Law of Georgia No 2388 of 15 December 2022 – website, 27.12.2022

Article 126

Blood and blood components shall be prepared, kept, and used in compliance with the recognised international requirements, under the procedure developed by the Ministry.

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

[Article 126

Other issues relating to blood and its components shall be defined by the Law of Georgia on Quality and Safety of Human Blood and its Components. (Shall become effective from 1 January 2025)]

Law of Georgia No 2388 of 15 December 2022 – website, 27.12.2022

Article 127

Blood and its components shall be prepared, processed, and kept by a medical institution authorised appropriately by the Law of Georgia on Licences and Permits.

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

[Article 127 – (Deleted) (Shall become effective from 1 January 2025)]

Law of Georgia No 2388 of 15 December 2022 – website, 27.12.2022

Article 128

The issues of protection of donor health shall be defined by the legislation of Georgia.

[Article 128 – (Deleted) (Shall become effective from 1 January 2025)]

Law of Georgia No 2388 of 15 December 2022 – website, 27.12.2022

Article 129

1. It shall be prohibited to take blood and blood components from a person placed in a penitentiary institution.

2. It shall be prohibited to trade blood and its components for profit, to purchase them abroad, or to export them in violation of the legislation of Georgia and/or international agreements.

Law of Georgia No 2716 of 9 March 2010 – LHG I, No 12, 24.3.2010, Art. 53

Law of Georgia No 3540 of 1 May 2015 – website, 18.5.2015

[Article 129 – (Deleted) (Shall become effective from 1 January 2025)]

Law of Georgia No 2388 of 15 December 2022 – website, 27.12.2022

Article 130

Other issues of blood and donation of blood components shall be regulated by the Law of Georgia on Donation of Blood and Its Components.

[Article 130 – (Deleted) (Shall become effective from 1 January 2025)]

Law of Georgia No 2388 of 15 December 2022 – website, 27.12.2022

Chapter XXII – Safe Motherhood and Child Health Care

Article 131

1. The list of types of labour activities in which pregnant women and nursing mothers may not be engaged, and time limits for termination of labour activities before and after childbirth, shall be defined by the Ministry.

2. During the mentioned periods remuneration shall be paid under the established procedure.

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 132

1. The State shall contribute to safe motherhood, legal provisions for creating and funding conditions necessary for child care in enterprises and establishments, and the formation of public opinion on the necessity of protecting the rights of mothers and children.

2. Medical counselling of pregnant women and delivery and post-natal medical care shall be ensured according to the legislation of Georgia.

Law of Georgia No 5129 of 29 June 2007 – LHG I, No 27, 17.7.2007, Art. 262

Article 133

1. Management of medical aspects of decreasing child mortality and morbidity, also provision of the highest possible level of medical care, including, first of all, primary health care, for children, shall be a priority objective of the health care system.

2. The State shall contribute to providing new-born babies, infants, and children of other age groups with safe and adequate food, supporting natural breastfeeding, and observing the International Code of Marketing of Breast-milk Substitutes.

Article 134

The State shall ensure that hereditary and congenital diseases among new-born babies are identified according to priorities determined in advance.

Article 135

The State shall ensure medical care at institutions designated for orphans, children outside of parental care, and children with disabilities.

Law of Georgia No 6847 of 14 July 2020 – website, 28.7.2020

Chapter XXIII – Family Planning

Article 136

All citizens of Georgia shall have the right to independently determine the number of children they have and the time of their birth. The State shall ensure human rights in the field of reproduction as provided for by the legislation of Georgia.

Article 137

The State shall provide voluntary medical-genetic counselling free of charge to couples who plan to get married, also those who want to have children.

Article 138

Contraceptives shall be produced, imported, and distributed as provided for by the legislation of Georgia.

Article 139

1. Protection of women's health by reducing the number of abortions shall be a priority objective of the State.

2. Voluntary termination of pregnancy shall only be permitted at a medical institution holding the appropriate authorisation, and shall be performed by a certified physician if:

a) the duration of pregnancy does not exceed 12 weeks;

b) a pregnant woman has been interviewed in the medical institution and a five-day term for making a decision has passed from the interview to the surgical abortion. During the interview, the physician shall give priority to the protection of the life of the foetus. Making a decision on abortion shall be the prerogative of the woman. The procedures for pre-abortion counselling by/preliminary interview with a physician shall be determined by the order of the Minister.

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Law of Georgia No 2646 of 1 August 2014 – website, 8.8.2014

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 140

1. Advertising for abortions shall be prohibited.

2. If the term of pregnancy exceeds 12 weeks, an abortion shall be allowed only on the basis of medical and social indications, the list of which shall be determined by an order of the Minister.

Law of Georgia No 2646 of 1 August 2014 – website, 8.8.2014

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 141

Fertilisation with a donor's sperm shall be allowed:

a) due to infertility, if there is a risk of transmitting a genetic disease from the husband to the child, or for fertilisation of a single woman, if a written consent of the infertile couple or the single woman has been obtained. If a child is born, the infertile couple or the single woman shall be deemed as parents, with the responsibilities and authorities proceeding from this fact. The donor shall not have the right to be recognised as the father of the born child;

b) (Deleted).

Law of Georgia No 3553 of 21 July 2010 – LHG I, No 46, 4.8.2010, Art. 282

Article 142

1. Human cloning using genetic engineering methods shall be prohibited.

2. The State shall exercise control over the research in the field of genetic engineering as provided for by law.

Article 143

1. In vitro fertilisation shall be allowed:

a) to treat infertility, if there is a risk of transmitting a genetic disease from the wife or the husband to the child, using the gametes or embryo of the couple or a donor, if a written consent of the couple has been obtained;

b) if a woman does not have an uterus, by transferring the embryo obtained as a result of fertilisation to the uterus of another women (‘surrogate mother’) and growing it there; obtaining a written consent of the couple shall be obligatory.

2. If a child is born, the couple shall be deemed as parents, with the responsibilities and authorities proceeding from this fact; the donor or the ‘surrogate mother’ shall not have the right to be recognised as a parent of the born child.

Article 144

It shall be possible to use male and female gametes or embryos that have been conserved by freezing for the purpose of artificial fertilisation. The time of conservation shall be determined according to the couple's will, under the established procedure.

Article 145

Applying voluntary surgical contraception – sterilisation shall be permitted:

a) (Deleted).

a ¹) only at an institution holding the appropriate permit, and shall be performed by a certified physician;

b) if there is the patient's written request;

c) if the physician has conducted a preliminary interview with the patient and a one-month term for making a decision before sterilisation has passed after the interview;

d) if the patient meets the criteria defined by the legislation of Georgia.

Law of Georgia No 3553 of 21 July 2010 – LHG I, No 46, 4.8.2010, Art. 282

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Chapter XXIV – Critical Condition, Death, and Euthanasia

Article 146

A patient who is in a critical condition and/or in a terminal stage or his/her relative or legal representative shall have the right to receive full information about the patient's health status and to make a decision on medical intervention.

Article 147

Treatment and palliative care of a patient in a terminal stage and care of a deceased person shall be carried out with respect to his/her honour and dignity. A deceased person shall be taken care of according to the will of the person expressed when he/she was alive or according to the will of his/her relative or legal representative.

Law of Georgia No 4719 of 8 May 2007 – LHG I, No 18, 22.5.2007, Art. 149

Article 148

1. A legally capable patient who is in a terminal stage and is able to make a conscious decision shall have the right to refuse to receive resuscitative, life-saving, or palliative treatment and/or palliative care.

2. If a patient in a terminal stage is unconscious, his/her relative or legal representative shall have the right to refuse to provide him/her with resuscitative, life-saving, or palliative treatment and/or palliative care, in order to protect the dignity of the dying person and taking into consideration his/her (the patient's) personal views.

Law of Georgia No 4719 of 8 May 2007 – LHG I, No 18, 22.5.2007, Art. 149

Article 149

An unconscious patient shall be given appropriate treatment, unless the patient refused to receive resuscitative, life-saving, or palliative treatment and/or palliative care in advance, when he/she was able to make a conscious decision.

Law of Georgia No 4719 of 8 May 2007 – LHG I, No 18, 22.5.2007, Art. 149

Article 150

In case of persistent vegetative state, a patient shall be provided with treatment according to the procedures defined by the insurance programme.

Article 151

Medical personnel, also any and all other persons, shall be prohibited from carrying out or taking part in euthanasia.

Article 152

Pronouncement of a patient's death and issuance of a certificate on the latter shall be carried out according to the criteria and procedure approved by the Ministry. Medical documentation of a deceased person shall be medical confidentiality, except for cases provided for by Article 42 of this Law. The documentation shall be kept for a period defined by the legislation of Georgia.

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Article 153

An autopsy shall be carried out by an appropriately certified physician in a medical institution holding licence for the activity. An autopsy shall be necessary if there is suspicion that death was caused by an especially dangerous infection. In all other cases, an autopsy shall be performed taking into consideration religious or other motives, also the will of the deceased person that was expressed when he/she was alive, or with the consent of his/her relative or legal representative.

Law of Georgia No 2013 of 28 May 1999 – LHG I, No 20(27), 9.6.1999, Art. 87

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Chapter XXIV ¹ – Medical Expert Examination

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Article 153 ¹

The issues of medical social expert examination shall be regulated by the Law of Georgia on Medical Social Expert Examination.

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Article 153 ²

1. A forensic-medical examination and a forensic-psychiatric examination may only be conducted by an appropriately certified physician in a medical institution authorised by the Law of Georgia on Licences and Permits.

2. The procedure for conducting forensic examination and forensic-psychiatric examination, and the procedure of activity of the medical personnel of the Centre for Medical Examination shall be defined by the Ministry.

Law of Georgia No 1768 of 22 November 2002 – LHG I, No 31, 10.12.2002, Art. 144

Law of Georgia No 4133 of 17 December 2010 – LHG I, No 76, 29.12.2010, Art. 509

Law of Georgia No 3094 of 5 July 2018 – website, 11.7.2018

Chapter XXV – Transitional Provisions

Article 154

1. Medical personnel with a medical education shall be prohibited from engaging in independent medical and pharmacy practice without a state certificate of a specialist as of 1 June 2001. The schedule and terms of examinations by individual specialities shall be determined by the Ministry of Labour, Health and Social Affairs of Georgia.

2. Persons who apply to the Certification Council before 1 June 2001, but are not invited to take the certification examination, shall be given the right to engage in independent medical and pharmacy practice till 1 September 2001.

3. Medical personnel with non-medical education shall be prohibited from engaging in independent medical practice without a state certificate of a specialist as from 1 January 2002.

4. (Deleted).

5. The Ministry of Labour, Health and Social Affairs shall, within six months after the date that this Law takes effect, develop and approve the following normative acts:

a) a passport of medical and pharmaceutical institutions – a document reflecting the number of personnel, the volume of technical equipment, and the amount of work to be done;

b) (Deleted);

c) (Deleted);

d) (Deleted);

e) (Deleted);

f) (Deleted);

g) the procedures for conducting an expert examination on a temporary disability and for issuing a medical sick-leave certificate;

h) the procedures for conducting a forensic-medical examination and a forensic-psychiatric examination;

i) the procedure of activity of medical personnel engaged in conducting forensic-medical examination;

j) (Deleted).

6. (Deleted).

7. The Ministry of Labour, Health and Social Affairs of Georgia shall develop and approve, before 1 December 2010, the form and procedure of mandatory notification and the procedure of maintaining a registry for providers of high-risk medical activities/services to be carried out at an out-patient/in-patient day care facility.

8. The Government of Georgia shall, before 1 December 2010, ensure the adoption of the Technical Regulations of High-Risk Medical Activities.

9. The Government of Georgia shall, before 1 October 2019, ensure the adoption of the technical regulation (regulations) provided for by Article 63²(2) of this Law.

10. The Government of Georgia and the Minister of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia shall, not later than 1 August 2023, ensure adoption and issuance of the subordinate normative acts defined by Article 16 of this Law and implementation of other necessary measures.

Law of Georgia No 91 of 24 December 1999 – LHG I, No 52(59), 31.12.1999, Art. 253

Law of Georgia No 162 of 24 February 2000 – LHG I, No 8, 15.3.2000, Art. 14