LAW OF GEORGIA ON HEALTH CARE Chapter 1 General Provisions Article 1. This law regulates the relations in the field of Health Care between the state power bodies and physical and legal persons throughout the entire territory of Georgia. Article 2. Georgian legislation in the field of Health Care consists of Georgian Constitution, Georgia’s international agreements and covenants, the present law and other legislative and bylaw normative acts. Article 3. Definitions not having specific indication in the Law are interpreted as follows: 1) Patient’s Autonomy - the patient’s right to decide independently all issues related to providing him/her a medical care. 2) HIV - human immunodeficiency virus 3) Non-Managed Infections - the infectious diseases against which there are no highlyeffective specific preventive means. It is necessary to create entire system (social, household, veterinary, epidemiological, disinfection, deratization, etc) of complex measures against Emergence-spread of non-managed infections. 4) Independent Medical Activity - the conducting medical activity by the physical person, responsible for the results of this activity according to the rule stipulated by the law, who has higher medical education and state certificate for independent medical activity. 4’) Independent nursing activity - the conducting medical activity by the physical person, responsible for the results of this activity according to the rule stipulated by the law, who has relevant medical education and state certificate for nursing. 5) Donor - a person living or dead from whose body the organ, part of the organ, and/or tissue is removed with the purpose of transplantation to other person, or for treatment of other person. 6) Euthanasia – intentional termination of a life of a patient having incurable disease at the end-of-life stage at his/her request. 7) Endemic Disease - the disease spread at a certain territory, and caused by detrimental factors and/or the deficit of some factor necessary for the health factor. 8) Congenital Disease - hypothyroidism, phenylketonuria, galactosemia or adreno-genital syndrome 9) Culture Causing Infectious Disease - microorganisms cultivated in a special nutrition medium 10) Informed Consent - the consent of patient, his/her relative or legal representative on conducting medical intervention necessary for the patient after the explaining the risk to his/her health and life related to that intervention. 11) Critical Condition - the form of health disorder when a person’s life is in grave danger and without urgent treatment the death is inevitable. 12) Second Opinion - the opinion on diagnosis, prognosis, and optimal method of treatment of the disease provided by the medical specialist whom patient addresses bypassing his/her doctor in the case when patient is not sure in accuracy of the diagnosis and medical treatment, or intended medical treatment may be followed by grave results (e.g. mutilation due to operation). 13) Persistent vegetative State - “Social Death”, chronic unconsciousness characterized by the interchangeability of awakeness and sleep, absence of adequate behavior and reaction on external irritants and events, as well as the absence of perceived activity characteristic of brain activity. 14) Malpractice - unintentional diagnostic and therapeutic measures prescribed improperly for the patient’s condition by physician, which has become a direct cause of inflicted harm. 15) Implied Consent - the situation when a patient asked physician for medical care and despite the absence of written and verbal consent the physician talked to the patient examined him/her etc. From this very moment the physician becomes responsible for the patient in accordance with legislation. 16) Autopsy - post-mortem examination by the properly licensed physician in order to determine the cause of death and/or diagnosis of disease, and/or with educational and scientific purposes. 17) Patient - the person who notwithstanding the health condition enjoys medical care. 18) Patient’s Relative - the person who according to the order determined by Georgian legislation have preference to participate in taking decision associated with providing medical care to the patient, or the problems related to the patient’s death. 19) Primary Healthcare Care - First contact of a person or a family with healthcare system; accessible for each member of the society, continuing, comprehensive and coordinated, family medicine-based medical service, which covers activities for promotion of health, prevention of diseases, treatment and rehabilitation of wide-spread diseases including mother and children’s health care, family planning and providing the population with necessary medicines; 19’) Emergency Medical service – medical assistance without which death, disability or serious deterioration of health condition of a patient is inevitable; 19’’) Family Physician – physician-specialist, according to the rule stipulated in the law has right to provide primary multi-profile medical service to all persons of any sex and age. 19’’’) National Calendar of Preventive Vaccination – Age indicators, terms and rules for conducting preventive vaccination against infectious diseases stated by a normative act; 20) Resuscitation - the set of arrangements used for reanimation. 21) Recipient - the patient to whom the organs, parts of organs and tissues removed from donor are destined for transplantation. 21’) Protection of Social Health – The state is obliged to establish a system aiming at protecting, preserving and reinstating individual’s physical and psychological health by means of preventing diseases, studying ways of their spread and correspondingly, control, establishing healthy life-style, creating safe environments for human health. 22) Quarantine (Conventional) Diseases - especially dangerous infectious diseases (cholera, plague, yellow fever, contagious hemorrhagic viral fevers, smallpox). In case of revealing quarantine diseases a set of measures relevant to international convention is taken and it is possible to declare quarantine for preventing emergence and spreading of these diseases from epidemic or epizootic nidus. 23) Biomedical Research - all kinds of experiments held on human and animal whose sole purpose is deepening of knowledge in medicine. 2 24) Continuity of Medical Treatment - continuous provision of diagnostic, curative, preventive and rehabilitation measures. 25) Basic Package of Medical Service - the list of the state-funded medical service. 26) Medical (Doctoral) Secret - the information on patient’s physical, psychological condition, occupational and social activity, his/her personal or family life, received by doctor or other medical personnel during the professional work. This includes the fact of addressing a doctor and circumstances of death. 26’) Medical Activity – activity, which is related to prevention, diagnosis, treatment and rehabilitation of a disease and corresponds to professional and ethical standards recognized in the country; 27) Medical Intervention - any kinds of manipulation, procedure administered by physician or other medical personnel with diagnostic, treatment, preventive and rehabilitation purposes. 27’) Medical Personnel – Persons having medical or non-medical education providing medical activity. 27’’) Medical technology – rule for functional and technical equipment of the medical institution. 27’’’) Family Medicine – primary healthcare-oriented medical discipline, with the system of professional training, research and clinical activity independent and different from other disciplines; 27’’’’) Forensic Medical Examination – process of resolving biomedical issues arising during the court trial; 28) Vital Medicines - the medicines used for substitution therapy whose permanent taking is necessary for maintaining of health and life (for example: insulin). 28’) Description of specialty – the list of those issues and skills which are necessary to know and acquire for a physician having the right of medical activity in any of specialties; 29) Terminal Stage - pre-mortal stage of incurable disease or condition. 30) Brain Death - the irreversible disruption of the function of initial segments of spinal cord and brain in the background of maintenance of breathing and blood circulation by special means. 31) Continuing Medical Education - continuous updating and deepening of professional knowledge and skills by the specialist authorized for independent medical activity, confirmed by the proper certificate. 32) Ensuring Safe Environment for Health - supervision over keeping sanitary-hygienic and sanitary-epidemiological rules related to labour, life-style, recreation, nutrition, teaching, bringing up, radiation and chemical safety, issues related to sanitary-hygienic and sanitaryquarantine supervision at the borders of the country. 33) Health Promotion - the complex of educational, social economic environmental and professional factors directed to the maintenance and strengthening of health. 33’) Epidemiological control – system of preventive and anti-epidemic measures for managing epidemic process of communicable disease; 33’’) Quality Control External System – Unified system of stating objectivity and reliability of medical-diagnostic activity. Article 4 The principles of the state policy in the field of health care are the following: 3 a) To provide the population with universal and equal accessibility to medical care within the frames of state-funded medical programs. b) To provide the protection of human rights and freedoms in the field of health care, the recognition of patient’s dignity, honor and autonomy. c) The recognition of the independence of physician and other medical personnel within the frames stipulated by Georgian legislation. d) The correspondence of the health care system with the strategy of the country’s economic development and securing the manageability of the health care system; e) The protection from discrimination during the giving medical care the persons in detention and held in custody, as well as the persons suffered from certain diseases; f) The implementation and strengthening of internationally-recognized norms of medical ethics in the health care sphere; g) To provide the population with full information on all existing forms of medical care, and on the opportunities to enjoy them; h) To promote the cooperation with international health care organization. i) The state responsibility for the extent and quality of medical service determined by the program of compulsory medical insurance; j) Priority of primary and emergency medical care, with participation of state and private sectors, development of family medicine and institute of family physician and provision of healthcare accessibility based on it; k) The state responsibility for licensing of medical personnel, health care institutions, medical schools, as well as medical educational institutions; l) To provide the participation of the state, society, each citizen in the implementation of healthy life style, protection of work, residence and recreation environment;. m) Diversity of organizational-legal and ownership forms in the field of medical service, and their equality in rights; n) The use of administrative legal sanctions for the actions harmful to the population’ health; o) the funding of health care by the state through the program and the program for special purpose; the autonomy of management system and contractual financial-economic relations in order to provide the self-ruling of the state-funded health care institutions in accordance with the legislation; p) The state funding of biomedical and health care researches in correspondence with the existing resources, the creation of advantageous conditions with this purpose of attracting financial means from private sector; q) the participation of associations, academies, as well as other non-governmental organizations in creation of modern and effective system of health care through the consultations, scientific and professional discussions, elaboration of relevant projects, as well as funding of medical service, medicines, medical objects and production of medical technical objects, participation in the protection of patients’ rights. 4 Chapter II Citizens’ Rights in Health Care Article 5 Georgian citizens have the right to enjoy the medical care envisaged by the state programs on health care and approved by the determined rule. The medical care is accomplished by the proper legal entity of medical activity irrespective of ownership and organizational-legal form. Article 6 1) Discrimination of patient for his/her race, skin color, sex, religious convictions, political and other views, ethnic and social origination, property or title status, place of residence, disease, sexual orientation or negative personal attitude is prohibited. 2) The discrimination of patient in detention and in penitential place during medical care is inadmissible. Article 7 All citizens of Georgia have the right to receive in comprehensible form exhaustive and true information, to seek for second opinion on his/her health condition, except of the cases specified in Article 41. Article 8 1. The verbal or written informed consent is the necessary condition for participation of the patient in curative, diagnostic, rehabilitation and preventive processes. The list of medical interventions requiring written consent is determined by Georgian legislation. 2. The rights of the patient or healthy volunteer participating in scientific research are protected by Georgian legislation and internationally recognized norms regulating conduction of biomedical researches on human. 3. Verbal informed consent is the necessary condition for patient’s participation in the medical educational process. Article 9 A patient has the right to refuse to any kind of medical intervention, except of the cases stipulated by Georgian legislation and the Article 75 of this law. A patient also has the right to refuse to participation in scientific research and medical educational process. Article 10 All capable persons have the right to express in advance in a written form their will on conduction of resuscitation, life sustaining or palliative treatment at a terminal stage of the incurable disease. Article 11 The provision of medical intervention for incapable or mentally disabled patient or his/her involvement in the process of education and scientific research is admissible only with taking account his/her preliminary consent when the patient was able for making realized decision. If the latter is absent - by the consent of the patient’s relative and/or legal representative. 5 Article 12 The decision on medical intervention during the emergency and dangerous for life conditions in case of a patient with mental disability and incapacity to consent, is made only with taking into account the patient’s interests. Article 13 The medical care for the patient in penitential or detention place including the cases of hunger strike is allowed only in the case of informed consent of the patient. The medical care will be carried out in accordance with the rules stipulated by the present law. Article 14 The patient has the right to choose or change the medical personnel and/or medical institution in correspondence with the conditions of insurance agreement; the agreement should provide the possibility of choice. Chapter III Financing, Organization and Managing of Health Care System Article 15 State management of healthcare is carried out by the executive government. According to Georgian legislation, The Ministry of Health Care is responsible for pursuing the state policy in the field of health care. Article 16 The mechanisms of the state management of the health care are the following: 1) The certification of medical personnel and licensing of medical institutions; 2) The control of the quality of medical service; 3) The state sanitary supervision and hygienic regulation; 4) The control over the medicines, regulating pharmacy and pharmaceutical industry. 5) The promotion of implementation of new curative means and medical technologies 6) The judicial ensuring of the relations between patient and legal entity of medical activity. 7) The contribution to the implementation of the healthy life style; 8) The elaboration and accomplishment of medical programs; 9) The contribution to the development of medical science 10) Implementation of epidemiological control throughout the territory of the country; 11) Promotion of public health via establishing institutions and implementing state medical programmes. Article 17 The bodies of local government and self-governing bodies provide the health care for the population pursuant to the legislation in effect. Article 18 6 Professional associations, academies and other public organizations as well as state and private medical institutions participate in the state management of health care system within the frame of Georgian legislation. Article 19 The medical insurance of the population is regulated by Georgian law “On Medical Insurance.” Article 20 1. The state provides correctness, accuracy, timeliness and transparency of official statistics in healthcare pursuant to active legislation of the state and private sector. 2. A legal entity of medical activity is obliged to provide the Ministry of Health with the medical statistics pursuant to the determined rule. Article 21 A legal entity of medical activity which participates in the state program of health care according to the determined rule, the work done is reimbursed according to tariffs approved by the state and the requirements of the Law of Georgia on “State Purchase”. The extent of the work envisaged by the state program is to be in compliance with the requirements of state medical standards approved by the Ministry of Health Care. Article 22 The main form of state financing of health care is the funding through the programs and the programs for a special goal. Chapter IV On Awarding State Medical and Pharmaceutical Certificate Article 23 1) The goal of awarding the state certificate to medical and pharmaceutical personnel is to protect the health of country’s population from practice of incompetent medical and pharmaceutical personnel. 2) Through the awarding certificate the state guarantees that the specialist awarded the certificate and license is able to perform independent medical and pharmaceutical activity in accordance with the professional standards recognized in the country. Article 24 1) The Certification is the evaluation of the knowledge and practical skills of medical and pharmaceutical personnel in particular specialties of medicine and pharmacy which is carried out by the unified state certification exam. 2) The person possessing the state certificate undergoes the re-certification in accordance with the timetable determined by the regulations. 3) The certification and recertification are mandatory for obtaining and maintaining the right of independent medical and pharmaceutical activity. 7 Article 25 The article was abolished Article 26 The certification, recertification of the medical and pharmaceutical personnel is administered by the Council awarding the state certificate. Chapter V Medical Activity Article 27 Physician, nurse and other medical personnel are dedicated to care of health of individual, family and society in whole. The goal of medical activity is care of human’s health; protection and restoration of health, relief of suffer. Article 28 1) Only a specialist having a relevant medical education has the right of independent medical activity, who acquired the state certificate for independent medical activity in accordance with the legislation in force. Article 29 Citizens of Georgia, the citizens of other country who received medical education or the right of independent medical activity abroad, can conduct independent medical activity in Georgia in case of receiving the proper certificate in accordance with determined rule. The recognition of diploma of foreign medical educational institutions takes place in accordance with the rule determined by the legislation. Article 30 During the accomplishment of medical activity medical personnel should be guided by ethics values - principles of respect for person’s dignity, honor, justice, and compassion, as well as the norms of professional ethics listed below: a) To act only in correspondence with patient’s interests; b) Not to use his/her professional knowledge and experience against the principles of humanism; c) To be independent and free in professional decision-making connected with patient’s interests, not to act on self-interest; d) To take care of increasing the prestige of professional activity, to treat with respect colleagues and the persons higher in rank. Article 31 8 The list of medical specialties whose reception is confirmed by the state educational certificate is to be elaborated jointly by Georgian Ministry of Health Care and Georgian Ministry of Education. The Ministry of Education approves the list. Article 32 1. Georgian Ministry of Labour, Health Social affairs determines: a) The list of specialties for physicians and nurses received as a result of professional training; b) The list of neighbouring medical specialties; c) The list of neighbouring nursing specialties; d) The list of other medical specialties; e) The list of those specialties, which can not be acquired by a physician carrying a particular disease. 2. A physician or nurse has a right of independent medical activity only in a specialty determined by the state certificate save the cases, when the patient is in need of emergency medical care or life threatening symptoms are observed and physician or a nurse with relevant specialty is not available. Article 33 The physician who graduated from high medical university (institute) and has a proper certificate is authorized to accomplish independent medical activity. Article 34 Trade of physician is a free profession in its sense. In any circumstances it’s inadmissible that either official, or private person, despite their public state and post, to demand from physician the activity which runs counter the principles defined in the present law, and ethical norms of medical activity. Each activity impeding the accomplishment of professional duties by medical personnel leads to amenability to law. Article 35 The graduating students of state-certified higher medical institution prior to receiving diploma publicly take the oath of doctor in the state language. “Geneva Declaration of 1948, adopted by the Second General Assembly of World Medical Association” is used in the capacity of the oath text. Article 36 Physician has the right to provide patient with medical care, if the patient himself, or his/her relative, or legal representative, in case of patient’s incapacity, demand so, and allow physician to provide medical care; as well as in the case of implied consent when capable patient does not show in any form the resistance to medical care. Article 37 Physician has the right to refuse to provision medical care to patient only in the following cases: 1) When the continuity of medical care for the patient is available and there is no condition dangerous for life, or the patient needs no emergency medical care; 2) When during the giving medical care there is a real threat for physician’s life. 9 Article 38 1) Physician is obliged to provide patient with medical care and ensure its continuity if: a) There is a formal written or verbal consent b) There is a grave danger for life including suicide attempt, or a patient needs urgent medical care at a physician’s job place; 2) In all other cases duties related to the delivery of medical care, including obligation of providing its continuity, are assumed be physician on as starting medical assistance. Article 39 The obligation of physician as well as any citizen is to give within the possibilities urgent medical care while out of office. In this case the demand of payment is prohibited. Article 40 Physician is obliged to establish order of priority in providing medical care to the patients only in accordance with medical indications. Article 41 Physician is obliged to provide patient with full information on his/her health condition, save the cases when delivering information in regulated by the law of Georgia on “Medical Activity”. Article 42 Medical employee and all other employees of medical institution are obliged to keep medical (doctoral) secret except the cases when the disclosure of confidential information is necessary for public safety, protection of the rights and freedoms of others, judicial or investigatory bodies, in compliance with the determined rule. Article 43 1. Physician and other medical personnel are obliged: a) To make records in medical documentation in accordance with established rule; b) In case of giving medical care out of office to give a written description and pass the information to the destined place. 2. The Ministry of Health Care approves the rule of managing medical documentation. Article 44 It’s a duty of physician to provide with medical care the person in detention or held in custody only after the reception of informed consent from this person, except of the cases of emergency or grave danger for life when the consent is not available due to the patient’s severe condition. Physician is also obliged to refuse such kind of medical intervention which contradicts medical and ethical norms. Article 45 Medical personnel are obliged to deliver the information in accordance with established rule: a) When a contagious disease is diagnosed or suspected; b) In case of physical, chemical, thermal, or radiate damage of body; c) On homeless or unidentified corps. 10 Article 46 If in any professional sphere of health care, medical institution or organization, the reception of relevant payment is not the subject of agreement between physician and patient, the institution provides a physician with adequate salary; public organizations protecting the interests of a physician, the Ministry of Health, the Ministry of finances, the Ministry of social protection, labour and employment participate in establishment of the system of funding. Article 47 1. Proceeding from the state interests in particular medical specialties of medicine, as well as for medical personnel working in certain regions, privileges and supplement to salary can be established; President of Georgia approves the list of these professional spheres and regions. 2. Medical personnel working in high mountainous regions receives supplement to the salary depending of the altitude up to 1200 meters – 50%, more then 1200 meters 70%. 3. According to the law of Georgia on “Socio-economic and cultural development of mountainous regions”, the employees of medical institutions serving settlements of mountainous regions are given supplement of 50%. Article 48 The state provides mechanism to deepen professional knowledge of medical personnel, and correspondingly elevate their professional statute. Article 49 Physician has the right to attend and participate in professional meetings allowed by the legislation, despite the venue of meeting, either at his/her own expense, or through the state and other legal funding. The consent of the organizer is necessary. Article 50 1. Physician is responsible for medical malpractice activity in accordance with the rule established by the legislation. 2. Physician has a right to insurance in case of being sued due to medical mistakes. Article 51 Proceeding from patient’s health care interests, physician has the right to prescribe and/or assign any tested medicine and method of treatment. Article 52 Genetic Therapy is admissible only in the following cases: a) If its purpose is the prevention, diagnose and treatment of fatal diseases; b) The absence of other easier and less dangerous methods of treatment; c) There is a written informed consent of the patient, and/or patient’s relative, legal representative in case of patient’s incapacity; d) The modern level of development of science allows determining that the treatment will not cause undesirable change of the genome of descendants. Chapter VI 11 Medical Institution Article 53 1. Medical Institution is the legal entity of organizational-judicial form established by Georgian legislation, which performs medical activity in accordance with established regulation. In financial resources of medical institution the share received from medical activity makes up no less than 75%, and no less than 75% of the average annual worth of its main funds is directed to the accomplishment of the functions enlisted in “point 2” of this Article. 1’. In comparison with the previous year, 100% of income received from medical service based on internal standards and other economical activities, remain at disposal of medical institution, which according to economical classification as a rule are distributed by the head of establishment in coordination with the monitoring council; in addition, employment funds shall amount to no less than 30% of income. 2. The functions of medical institution are the following: a) Evaluation of patient’s condition; b) Prevention and/or treatment of diseases and/or rehabilitation of patients; c) Obstetrical activity; d) Pharmaceutical activity; e) State sanitary supervision and hygienic rate setting; f) Autopsy, legal and forensic medicine; g) Implementation of activities related to epidemiological control. 3. Medical and pharmaceutical institutions are obliged to protect the standards, rule and norms, regulating medical and pharmaceutical activity, demands determined by the system of quality external control. Article 54 1) Georgian Ministry of Health Care issues the license certifying medical institution’s right to conduct medical activity; 2) The sphere of activity of medical institution is determined by the list given in license. 3) Minister of Labor, Health and Social Affairs of Georgia approves the list of medical personnel with relevant education exercising the right of being employed at medical institution Article 55 1) The license of a legal entity of medical activity can be annulled if the medical institution: a) Does not satisfy the conditions given in the license issued; b) If the institution’s activity exceeds the limits of license; c) Does not provide proper bodies with the statistical medical information in accordance with established rule; d) Does not perform the activity envisaged by the license within 6 months after receiving the license; e) Does not carry out measures necessary for epidemiological control. 2) The decision on annulling the license of medical activity can be appealed to the Court. 12 Article 56 It is prohibited for Medical Institution to conduct medical activity without proper license. Article 57 1) Medical institution can be either enterprising or non-enterprising legal entity; 2) The enterprising medical institution performs its activity pursuant to Georgia’s law ‘On Entrepreneurship;” 3) The non-enterprising medical institution performs its activity pursuant to Georgia’s Civil Code. Article 58 1) A medical institution enjoys professional and financial independence in accordance with the regulation determined by Georgian legislation, 2) In the case of lodging a complaint against the medical personnel for medical malpractice, medical institution can create a foundation. The foundation is created on the basis of fees of medical personnel and other means allowed by the legislation. Article 59 1) Medical institution conducts activity pursuant to its rules and in accordance with Georgian legislation. 2) Within its income and in accordance with the legislation medical institution determines the organization of labor, and the order, form and amount of payment. 3) The payment for the work of medical personnel depends on the work-done, and its amount and conditions are defined in the following way: a) By the norm (rating) of maximal job done approved by Georgian Ministry of Health Care through the established rule; b) By labor agreement (contract) between medical institution and each employee. Article 60 1) During the providing a patient with the medical care exceeding the limits of the state medical program between medical institution and patient the contract is to be concluded under the established rule, which defines the extent of the medical care to be given and terms and amount of relevant payment. If patient is incapable, the contract is to be concluded with his/her relative or legal representative. 2) During the medical service and after its completion the parties noted in the first point of this Article are obliged to follow the terms of contract accurately. Should one of the parties refuse from the fulfillment of the contract, the other party has the right to appeal the Court. 3) if capable patient, or incapable patient’s relative and/or legal representative refuse to conclude the contract, which is confirmed in the act registered under the established rule, and at the same time, if the patient is not in critical condition, medical institution has the right to refuse to delivery of medical treatment to the patient. 4) In mountainous regions medical services is free of charge and is funded by state. State provides maintenance and development of medical institutions in the high mountainous regions. At the same time private medical services and realization of medicines is permitted in accordance with Georgian legislation. 13 Article 61 Within the possibility the state provides technical equipment and modernization of the institutions of medical information, medical statistics, medical information (computerized) resource centers and medical libraries. Article 62 In order to ensure the patient’s rights and the norms of medical ethic medical institutions create the committees for medical ethics; the basis of creation of the commission are determined by Georgian legislation. Article 63 Georgian Ministry of Health Care conducts the control over the quality of medical activity of medical institution in accordance with the established rule. Chapter VII Medicine and Pharmaceutical Activity Article 64 Providing the population with qualitative, safe and effective medicines, the activity of physical and legal persons involved in the circulation and use of medicine, the duties and rights of specialist and officials of pharmaceutical institution are regulated by the law of Georgia “On Drug and Pharmaceutical Activity,” other laws and bylaws. In high mountainous regions state is funding directly programmers for prevention and treatment of goiter and other endocrinal diseases. Chapter VIII Medical Technical Devices and Medical Technologies Article 65 1) Pursuant to the approved list of medical technical devices, which might be harmful for human organism, Georgian Ministry of Health Care carries out the registration of new, modernized, domestic and imported medical device. 2) The approval of the means for measuring, its registration, import and production is to be accomplished under the rule established by Georgian legislation. Article 66 The projecting, manufacturing, exploitation and repair of medical device are to be accomplished according to the rule established by legislation. 14 Article 67 Ministry of Health Care in cooperation with corresponding bodies of executive government elaborates quality and safety standards of medical technical devices and medical technologies, provides inculcation of these standards and controls them. Chapter IX Psychiatric Care of the population Article 68 The state contributes to medical and social care for the persons with mental disorders. Article 69 The protection of the rights and interests of the persons with mental disorders, the protection of society from dangerous for public actions of mentally disabled persons, as well as the rights and duties of employees of psychiatric service, and persons who are in direct contact with mentally disabled persons, are regulated by Georgian law “On Psychiatric Care.” Chapter X The State Sanitary Surveillance and Hygienic Rate-Setting Article 70 1) It is the duty of the state to provide the environment safe for health. Georgian Ministry of Health Care elaborates, approves sanitary-hygienic rules and norms (rates), and supervises keeping of these rules and norms. 2) Georgian Ministry of Health approves institutional sanitary-hygienic rules and norms. 3) Georgian legislation regulates the issues related to ensuring the environment safe for the population’s health and proper supervision over these issues. 4) The sanitary-hygienic norms and rules operating in Georgia must comply with international standards. Article 71 1) The right of Georgian population on radiation security is implemented by the set of arrangements which envisages: a) The fulfillment of established requirements of radiation safety by the legal and physical persons using the sources of ionizing radiation; b) The elimination of the effect of over threshold dose of ionizing radiation on human organism and radioactive pollution of environment. 15 2) The state is responsible for radiation monitoring of environment, and radiation safety of population. Article 72 To avoid the negative influence of environment and other factors on the population’s health, the fulfillment of sanitary-hygienic and sanitary-antepidemic rules and arrangements specially elaborated for this purpose, is mandatory for all physical and legal persons operating in the territory of the country notwithstanding the form of ownership, organizational-judicial, and institutional status. Chapter X Control of Diseases Article 73 1) It’s a prerogative of central and local government and self-ruling bodies to control contagious (including diseases of zooantroponoze and zoonoze nature), endemic diseases, epidemics, as well as widespread noncommunicable diseases. 2) In order to protect the population from particularly dangerous zooantroponozonic diseases and toxic infections, Georgia’s Ministry of Health Care in cooperation with corresponding state bodies elaborates proper programs and carries out coordinated arrangements. Article 74 Georgian Ministry of Health Care defines the list of communicable and especially widespread non-contagious diseases, works out large-scale programs of their epidemiological study, prevention and treatment of these diseases, and leads the implementation of these programs. Article 75 On the basis of the recommendations elaborated by the Ministry of Health Care the state heads a set of epidemiological control measures in the country: a) Compulsory immunization and quarantine measures; b) Relevant curative and preventive measures taken for the citizens with high risk of development of communicable diseases; c) The protection of different entities from contamination and disinfection of contaminated units. d) Fight against spreaders (disseminators) in anti-epidemic situation. c) The provision of arrangements necessary for providing the anti-epidemic readiness of medical personnel. Article 76 If there is a need to examine citizens in order to confirm the substantiated suspicion on the existence of especially dangerous contagious disease, it’s a duty of citizens to undergo all necessary examinations. During the examination the dignity and basic rights of citizens should be protected. 16 Article 77 The import, export, preservation, passing and/or working with the culture causing infectious disease, is admissible only by the permission of the Ministry of Health Care. Article 78 Georgian Ministry of Labour, Health and Social affairs works out and approves the national timetable for preventive vaccination and the medical program necessary for its implementation. Article 79 Georgian Ministry of Health Care defines the list of endemic diseases, the control and treatment of which in the medical institution and proper funding is the prerogative of the state. Chapter XII Socially Dangerous Diseases and Diseases Requiring Permanent Substitution Treatment Article 80 The state provides the arrangements of struggle against tuberculosis. The state manages this activity in cooperation with private and non-governmental organizations. The goal of the struggle is treatment of each patient, his/her physical, psychological and social rehabilitation, diminishing of spread and then elimination of this disease among the population. Article 81 The state takes necessary measures for prevention, diagnosis, treatment and follow-up supervision of enteral and parenteral hepatitis. Article 82 Georgian Ministry of Health Care takes measures necessary for prevention and control of sexually transmitted diseases, in accordance with modern standards, regarding epidemiological situation, and through the awareness-rising among the population by providing with relevant information. The state determines its policy towards the prostitution, and takes relevant measures pursuant to the situation in the country. Article 83 Law of Georgia “On Prevention of HIV/AIDS” regulates main principles of struggle with HIV/AIDS in Georgia, examination of citizens on presence of HIV/AIDS, treatment, preventive supervision and legal regime of persons affected with HIV/AIDS, the duties and rights of those infected with HIV/AIDS and medical personnel, the problems of their social security. 17 Article 84 Premeditated dissemination of sexually transmitted diseases is prosecuted by Georgian legislation. Article 85 Within the limits of obligations assumed the state provides the persons suffering from diseases requiring permanent substitution treatment (diabetes mellitus, diabetes insipidus, etc.) by vitally needed medicines, urgent medical assistance associated with the disease, psychological and social rehabilitation. Chapter XIII Protection of Social Health and Primary Healthcare Article 85’ State obligations related to protection of public health is reflected in relevant state and local programmes. Article 85’’ – According to the organic law on “Local governing and governing” in order to implement the activities related to public healthcare in cities and regions of Georgia are established municipal and regional public healthcare offices, whose methodological supervision is carried out by the Ministry of Labour, Health and Social Affairs. Article 85’’’ – 1. It is within the competence of Public Healthcare Office: a) To develop system for registration and notification on infectious and noninfectious diseases, to analyze the data obtained and to make prognosis; b) Epidemiological supervision and epidemiological control aiming at revealing and studying the reasons, the ways of their transmission and risk factor; c) To give relevant information to and prepare recommendation for healthcare department and population on the reasons of emergence, spreading and control of the infectious diseases; d) To plan activities related to prevention of spreading and eradication of infectious, as well as sexually transmitted diseases; e) To plan activities related to provision with the safe blood; f) To prevent non-infectious diseases (cardiovascular, oncological diseases caused by trauma, of insufficiency of iodine and other microelements, etc). g) To promote healthy life style; h) To promote surroundings safe to human health; 18 Article 86. In order to protect population’s health the state supports preventive measures against tobacco smoking and excessive consumption of alcohol, and creates the mechanisms to accomplish these measures. The restriction of smoking in the places of public meetings and sale of tobacco and alcohol to teenagers are regulated by Georgian legislation. Article 87 The state controls advertising of tobacco, spirits and producers or distributors of products causing harm to a person’s or public health and sponsoring of educational, rest and recreation activities. Article 88 The measures for curbing the use of prohibited medicines, and incorrect use of permitted medicines comprises creation of relevant legal basis, early exposure of the cases of their use and medical treatment of user, educational work, and preventive arrangements for risk groups. Chapter XIV Article 89 The prevention of diseases and health promotion represents the state priority; the state creates preconditions for participation of youth, non-governmental organizations, state bodies of health care and private structures in the introduction of healthy life style, in order to decrease the risk of diseases especially in educational, working, recreation and entertaining institutions. Article 89’ The Ministry of Labour, Health and Social affairs elaborates legal basis and organizationallegal rules necessary for the development of primary healthcare system, including family medicine Article 90 The state determines strategic directions, elaborates relevant programs for prevention of diseases and contribution to the population’s health among children and teenagers, in particular, and secures the implementation of these programs. Chapter XV Protection of Citizens’ Health during Extraordinary Situations - Disasters and Technical Catastrophes 19 Article 91 The state is responsible for protection of citizens’ health and safety during disasters and technical catastrophes. Central and local bodies of health care, medical institutions and respective professional unions participate in the elaboration and implementation of the programs of ensuring medical care for expected catastrophes. Article 92 In accordance with prescribed rule the accumulation and acquisition of material values of first priority of mobilization reserve necessary for medical care in disasters and technical catastrophes, the readiness for use and periodical updating of these values is accomplished by the Ministry of Health Care together with respective state bodies. Article 93 The state covers expenses related to medical assistance of those injured and infected during the state of emergency, epidemiologic situation. Article 94 The state covers the expenses for medical treatment of those injured as result of the state of emergency. Chapter XVI Professional Diseases Article 95 Georgian Ministry of Health Care considers and approves the list of professional diseases and the list of those professional activities, which are associated with risk of professional disease. Article 96 It’s duty of employer to provide employee with comprehensive information on the risk of development of professional disease in the enterprise and/or institution, the information on existence of harmful factors, and the measures to be taken against their influence. Chapter XVII Medical Education Article 97 In the medical specialties of physician, pharmacist, and nurse the education is conducted in the form of higher (university) and secondary professional education in relevant medical educational establishments in accordance with the state educational standards. 20 Article 98 The professional advanced training in medicine comprises training in different specialties (residency) and continuing medical education. Article 99 1) The higher medical education for obtaining the right of independent medical activity comprises the stages of study of theoretical and clinical medicine as well as the stage of general professional training (specialization), 2) After completion of the stages of studying theoretical and clinical medicine a higher medical institution issues respective certificate, whose owner is authorized: a) To attend the course of general professional training, and receive the right of independent doctoral activity after passing the state unified certification exams. b) To conduct research and teaching activity in theoretical spheres of medicine or other branches of health care which does not include independent doctoral activity. 3) after completion of studying all three stages of medical education - theoretical branches, clinical branches, and general professional training, and passing the state unified certification exams, the state certificate (diploma) of “General Practitioner” is to be issued which represents a groundwork for independent doctoral activity. 4) The number of contingent of residents, the rule for planning, accrediting and funding porgrammes is determined by a normative act of the Ministry of LAbour, Health and Social Affairs. Accreditation of residency programmes and monitoring of the quality of their implementation is performed by the Postgraduate and CME Council which is established by the Ministry of Labour, Health and Social Affairs. Article 99’ 1) After passing the state unified certification exam the professional training can be continued in the residency of different branches of medical specialty according to the programs approved by Georgian Ministry of Health Care. 2) Expert commissions, medical-educational institutions and professional unions participate in the elaboration of residency programs. 3) The advanced professional training in the residency of certain branch takes place in high medical schools, clinics of scientific-research institutes and other medical institutions authorized by the regulation established by Georgian Ministry of Health Care. The training is conducted on the basis of orders of both state, and private institutions within the limits established for these institutions. 4) Within the limits of the state order the number of the contingent to be trained through the residency, as well as rules of funding the residency are determined by Georgian legislation. 5) The selection of candidates to professional training by the residency programs is conducted through the competition in accordance with prescribed rule. Head of the program of residency in medical branches possesses priority in selection of candidates. Article 100 The programs of continuing medical education, teaching methods are determined by Georgian Ministry of Health in coordination with professional unions. Article 101 21 Medical and pharmaceutical colleges and secondary professional schools train professional personnel in accordance with the programs elaborated by Georgian Ministry of Health Care and Ministry of Education, which are to be finally approved by the Ministry of Education. Article 102 1) Georgian Ministry of Health Care and Ministry of Education elaborate, and the Ministry of Education approves the criteria, regulations and conditions of licensing and accreditation of medical educational institutions. 2) Medical educational institution is authorized to plan the educational and training process according to its own viewpoints and interests taking into account the state educational standards. Chapter XVIII Professional Responsibility of Medical Personnel and Medical Institution Article 103 The responsibility for moral and material detriment inflicted upon a patient, aggravating patient’s physical and psychological condition or patient’s death caused by action or inaction of medical personnel is determined by Georgian legislation. Article 104 A patient, his/her relative, and/or legal representative have the right to place a complaint against physician, nurse or other medical employ, and medical institution itself to the medical institution’s administration, health care managing body, and appeal to the Court or other arbitrary body. Chapter XIX Biomedical Research Article 105 During the biomedical research the rights of the person as the subject of medical biological research, as well as the principles of human attitude to treatment of laboratory animals are to be protected and followed in accordance with Georgian legislation, and international treaties and agreements. Article 106 Any kinds of biomedical research should correspond with norms of scientific researches accepted in Georgia. The ground of these norms is through and accurate conduction of laboratory tests and experiments on animals and deep knowledge of respective literature. The goals, objectives, methods and expected results and risk of research of biomedical research performed on human and animals, are to be pointed out in scientific plan. Any research is to be performed within the frames of this plan. 22 Article 107 A scientific plan of research should be considered and reviewed by a special commission independent on researcher and founder, and by a medical ethics commission. Article 108 Prior to the planned medical-biological research with human participation, a comparative study of the risk and expected positive result of the research is to be made. During the performing of biomedical research the interest and well-being of the person as a subject of research, are more important than the interests of science and society. The risk of research should be minimized. It should not exceed the expected benefit of the subject of research and/or the importance of the goals of research. Article 109 A person used as a subject of medical-biological research should be fully informed in advance on goals, methods, expected results of research, on the risk of research, and possible inconvenience related to this research. Biomedical research should not be performed without a written informed consent of the person participating in the research. It’s mandatory to inform the person as a subject of medical-biological research, on his/her right to refuse to participation in the research at any stage, despite preliminary declared consent. Article 110 Incapable person may become the subject of medical-biological research under the conditions given in the Article 108, if he/she does not express any resistance, and if the informed consent of his/her relative or legal representative is obtained. If incapable person has the ability of understanding his/her consent is also required. Article 111 During the research the rights of incapable persons, pregnant and child-nursing women are to be protected. The representative of this contingent of persons can be the subject of medicalbiological research only in the case, if expected results of research will significantly and directly benefit to this person, or it is expected that the results of research will not be directly beneficial to this person’s health, but may bring the benefit to other persons of the same category, or when the reception of such kind of scientific results is impossible by research of the other category of persons. Article 112 The persons in penitential places enjoy all the rights declared in the Article 108 and Article 109 of the present law. The participation of these persons in medical-biological researches is permitted only in case when the expected results of the research will be directly and significantly beneficial to the health of these persons. Article 113 During the conduction of biomedical research on animals, researcher is obliged to keep all existing principles of humane attitude to animals. 23 Chapter XX Removal and Use of Human Organs, Parts of Organs, Tissues Article 114 The donation of organs, parts of organs, tissues (hereinafter referred to as “organ”) by person in life-time and postmortem, with the purpose of transplantation to other persons, treatment, scientific research, and education, is a voluntary act. Article 115 All citizens of Georgia have the right to declare in a written form his/her consent or refusal to organ donation in life-time or postmortem. The statement confirming the consent is accepted only in case of capability of the author of the statement. It’s inadmissible to exert any form of influence on a person, in order to lead him/her to make a decision on donation of organ. Article 116 The use of the organ of the living donor for the treatment of other person and/or transplantation is admissible only in case if donor and recipient are genetic relatives or spouses. Article 117 1) The removal of bone marrow from minor (except of infant) living donor for transplantation to other person is admissible only in the following cases: a) Removal of bone marrow will not affect donor’s health, which independently from each other must confirm two properly licensed physicians; b) If bone marrow is destined for transplantation to the donor’s genetic relative of the first and second order, whose health condition endangers life and there is no other mean of treatment. 2. In the cases noted in points “a” and “b” of the first paragraph of this Article, the informed consent of the minor, his/her parents (parent), or legal representative (in case of homeless and orphan minor) is obligatory. The consent is to be confirmed by supervisory and trusteeship bodies. Article 118 If according to the accepted medical standards the deceased person is a relevant candidate for removal of the organ for transplantation, and at the same time he/she did not declare either consent, or refusal to donate his organ, and there is no ground for assumption that the distribution of organ contradicts his/her religious belief, ethics principles, the removal of organ out of his body is admissible only under the consent of the relative, or legal representative of deceased person. If it’s impossible to find the latter, the removal of organ from the corps is prohibited. 24 Article 119 The removal of the organ of deceased person is allowed only after confirming the fact of death by two and more physicians independent of each other, who do not participate in the transplantation process. Death is to be established by the modern medical methods and criteria, which correspond with ethic requirements and professional standards approved by Georgian health care bodies and professional unions of physicians. Article 120 The selection of the organ destined to recipient is to be conducted anonymously, and only in accordance with medical indications, without taking into consideration any other privileges. Article 121 It’s prohibited to trade with organs destined to transplantation, treatment, export them, or purchase the organs abroad in violation of Georgian legislation and/or international agreements. Medical personnel is prohibited to participate in taking and using the organ if he/she knows, or has well-grounded suspicion that taking of organ is performed under the deal to profit. Article 122 It’s prohibited to advertise the demand on organ, or to advertise organ with the aim of making gain. It’s prohibited for any person or institution to receive any payment for the participation in the activity related transplantation, except the substantiated sum destined to the medical care given. Chapter XXI Donation of Blood and Blood Components Article 123 1) Donation of blood and blood components by donor with the purpose of treatment, diagnose, and scientific research, is a voluntary act. 2) The taking of blood and blood components from donor is accomplished only after obtaining of informed consent and mandatory preliminary medical examination. Article 124 Georgian Ministry of Health Care defines the contra-indications of donorship. Article 125 1) The taking of blood and blood components is admissible only from the donors aged from 18 to 65 years. 2) The taking of blood and blood components from minors (except infants) is admissible only in the state of emergency and absence of an alternative mean of treatment. In this case the informed consent of minor, his/her parents (parent), or legal representative is required. 25 Article 126 The preparation, storage and use of blood and blood components is conducted according to the rule elaborated by Georgian Ministry of Health Care, and in compliance with internationally acknowledged requirements. Article 127 The preparation, processing and storage of blood and blood components are accomplished by properly licensed medical institution. Article 128 The issues related to donor’s health are determined by Georgian legislation. Article 129 1) It’s prohibited to take blood and blood components from the person placed in detention or held in custody. 2) It’s prohibited to trade with blood and blood components with the purpose of gain. It’s prohibited to export and purchase of blood and blood components abroad, in violation of Georgian legislation and/or international agreements. Article 130 The other issues of donation of blood and blood components are regulated by Georgian law “On Donorship of Blood and Blood Components.” Chapter XXII Safe Maternity and Protection of Child Health Article 131 1) The list of those kinds of labor activity in which pregnant and child-nursing mother can not be engaged, as well as the terms of interruption of work prior to and post labour, are determined by the Ministry of Health Care and the Ministry of Social Security, Labor and Occupation of Georgia. Article 132 1) The state contributes to safe maternity, and provides legal basis for creation of relevant condition and financing of child-care in enterprises and institutions, and promotes formation of public opinion on necessity of protection of the rights of mother and child. 2) Trough the compulsory medical insurance the state secures medical supervision of pregnant women, medical care during and after labour. In private sector the supervision of pregnant women and financial assistance to childbirth can be carried out by private medical insurance. Article 133 1) The managing medical aspects of reduction of child mortality and sick rate, giving children really possible highest level of medical care, including first of all, primary medical care, is a priority task of the health care system. 26 2) The state contributes to provide infants, newborns and children of other ages with safe and adequate food, supports natural feeding and keeps the international code on marketing of mother’s milk substitutes. Article 134 The state provides the screening of congenital and hereditary diseases in newborns according to preliminary defined priorities. Article 135 The state provides medical care to orphans and homeless children in the institutions destined for children with physical and mental disorders. Chapter XXIII Family Planning Article 136 All citizens of Georgia have the right to determine independently a number of children and time of their birth. The state ensures human rights in the field of reproduction according to the rule prescribed by Georgian legislation. Article 137 The state provides free-of-charge and voluntary medical-genetic consultation for couples going to marry, and/or wishing to have child. Article 138 The production, import, and distribution of contraceptives accomplishes in accordance with the rule established by Georgian legislation. Article 139 1) Protection of women health through the reduction of abortions is a priority task of the state. 2) The voluntary termination of pregnancy is allowed to perform only by licensed physician in a licensed medical institution in the following cases: a) If duration of pregnancy does not exceed twelve weeks; b) A preliminary interview has been conducted with pregnant women in the medical institution, and from the date of interview to surgical operation three days given for consideration, passed. During the interview a physician should give the priority to the protection of the life of fetus. The choice is a woman’s prerogative. Article 140 1) The advertisement of abortion is prohibited 2) In case of pregnancy exceeding twelve weeks the abortion is permitted only in accordance with medical and social indications. Georgian Ministry of Health Care makes the list of medical indications. Social indications are determined by Georgian legislation. 27 Article 141 The fertilization with donor’s sperm is permitted in the following cases: a) Childlessness, risk of transmission of genetic diseases on the part of husband, fertilization of a single woman, written consent of childless couple, or a single woman. In case of childbirth childless spouses or a single woman are considered as parents with respective responsibilities and rights. Donor has no right to be considered as a father of child born as a result of fertilization. b) If performed in a properly licensed medical institution by appropriately licensed physician. Article 142 1) Human cloning by use of the methods of genetic engineering is prohibited. 2) The state controls the researches in the sphere of genetic engineering by the rule established by law. Article 143 1) Extra corporal fertilization is allowed in the following cases: a) treatment of childlessness, risk of transmission of genetic diseases on the part of husband or wife, by use of gametes of spouses or donor or embryo, if there is a written consent of a couple. b) If a woman has no uterus, by the transferring and rising embryo received as a result of fertilization to the uterus of other woman (surrogate mother). A written consent of a couple is mandatory. 2) In case of birth of child the couple is considered as parents with all related responsibilities and rights. Donor or “Surrogate Mother” has no right to be considered as a mother of the child born. Article 144 With the purpose of artificial fertilization it’s admissible to use gametes of male and female, or embryo conserved by the method of freezing. The time of conservation is determined according to the wish of a couple, by prescribed rule. Article 145 The use of voluntary surgical contraception-sterilization is permitted: a) Only in licensed medical institution by licensed physician; b) If there is written demand of the patient; c) If physician delivered to the patient preliminary interview and from the date of interview to sterilization 1 month-long term for thinking over has been expired. d) If the patient meets criteria determined by Georgian legislation. Chapter XXIY Critical Condition, Death and Euthanasia Article 146 28 The patient in a critical condition and/or in terminal stage, or his relative, or legal representative have the right to receive full information on patient’s health condition, and the right to make decision on medical intervention. Article 147 The treatment of the patient in terminal state, post-mortem care is to be accomplished with respect and keeping patient’s dignity. Taking care of corpse is performed according to the wish stated by deceased person in life-time, or in accordance with the wish of patient’s relative and/or legal representative. Article 148 1) A capable and responsible patient in a terminal stage has the right to deny resuscitation, life saving or palliative treatment. 2) In case of the unconsciousness of the patient in a terminal stage, patient’s relative, or legal representative taking into account patient’s personal considerations, and in order to keep the patient’s dignity, have the right to deny resuscitation, life-saving or palliative treatment. Article 149 The patient in the state of unconsciousness undergoes relevant treatment, if the patient while capable and responsible for decision, did not refuse to resuscitation, life-saving or palliative treatment in advance. Article 150 In case of persistent vegetative state the treatment of the patient goes according to the regulations determined by insurance program. Article 151 Medical personnel, as well as any other person are prohibited to accomplish euthanasia, or participate in it. Article 152 Certifying patient’s death and issuing death certificate is to be accomplished pursuant to the rule and criteria approved by Georgian Ministry of Health Care. Medical documentation of deceased person represents doctoral secret except cases envisaged by the Article 42 of the present law. The documentation is stored for the term defined by the legislation. Article 153 Autopsy (post-mortem examination) is performed by appropriately certified physician in the licensed medical institution. Autopsy is mandatory when there is a suspicion of death caused by particularly dangerous infection. In all other cases autopsy is performed under the consent of relative and/or legal representative of deceased person, with taking into account the wish of deceased stated in lifetime, as well as religious and other motivations. Chapter XXIV – Medical Expertise Article 153’ 29 Issues of socio-medical expertise are regulated by the law of Georgia on “Socio-medical expertise”. Article 153’’ 1. Forensic medicine and forensic-psychiatric expertise are carried out at the properly licensed medical institution by physician with a relevant specialty. 2. Rules for medical activity of the personnel of center of forensic medicine and forensicpsychiatric expertise are determined by the Ministry of Labour, Health and social Affairs. Chapter XXV Transitional Provisions Article 154 1) For the medical personnel with high medical education medical and pharmaceutical activity without state certification is prohibited from 1 June 2001. Georgian Ministry of Labor, Health and Social Affairs determine the terms and timetable of certification exams for different specialties. 2) Person who applied to the State Certification Counsel before 1 June 2001, but did not pass certification exams has the right to medical and pharmaceutical activity up to 1 September 2001. 3) For the medical personnel without high medical education medical activity without state certification is prohibited from 1 January 2002. 4) 40 % of administrative charges for illegal (absence of the state permission, license, and certificate) medical, medical or pharmaceutical activity shall be transferred to the special account of the Ministry of Labour, Health and social Affairs, 60% - to state budget. 5) Within six months of enactment of this law the Ministry of Labour, Health and Social Affairs shall work out and approve following normative acts: a) Passport for medical and pharmaceutical institutions – documents reflecting staff, technical equipment and volume of work to be done; b) Rule for planning and financing residency programme; c) List of medical personnel employed in primary healthcare; d) Bylaw of family physician and other medical personnel of primary healthcare, including the list of those medical services for which they are responsible; e) Standards for family medicine institutions; f) Description of specialties for medical personnel with the specialty of family physician and other specialties of primary healthcare; g) Rule for conducting expertise for temporary incapability and issuing medical paper; h) Rule for conducting forensic medical and forensic-psychiatric expertise; i) Rule for activity of medical personnel of forensic medical examination; f) Rule for registering medical technical equipment. 6. Minister of labour, Health and Social Affairs shall approve the rule of external control of quality before 31 August, 2003. 30 Article 154’ Supplement to wages (amount by September 1, 2003) considered by paragraph 3 of the article 47 of this law is issued: a) From 1 September, 2003 – 25%; b) From 1 September, 2004 – 35%; c) From 1 September, 2005 – 50%. Chapter XXVI Final Provisions Article 155 The present law is to be enacted from the date of publication. President of Georgia Eduard Shevardnadze Tbilisi December 10, 1997 No 1139 –Is 31