7.2 Administration and governance
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The most important actors in the establishment, governance and operationalization of the health care system in the country are the Parliament, the Government, the Ministry of Health, the Ministry of Finance, the Health Insurance Fund, the Institute of Public Health, the State Sanitary and Health Inspectorate and the Agency for Medicines and Medical Devices. The two central institutions in the health care system are the Ministry of Health and the Health Insurance Fund. The Ministry of Health is responsible for health policymaking, organization of the health care system and the enforcement of health legislation, although all policies go through a process of consultation and agreement with the relevant ministries and agencies within regulated legal procedures. The HIF is responsible for purchasing services from both public and private providers on behalf of users. Relations between the HIF and various providers at the primary, secondary and tertiary levels are regulated through performance-based contracts negotiated and signed for a predefined period of time.
The Ministry of Health (Министерство за здравство) performs the activities related to:
- health care and health insurance of the population;
- pollution of air, water, land and animal products;
- organization and development of healthcare;
- monitoring the health status of the population;
- the protection of the population against infectious diseases, the harmful effects of gases, ionizing radiation, noise, air pollution, water and land; 3
- objects for general use;
- hygiene-epidemiological condition;
- medicines, auxiliary medicines, medical devices, medical equipment, sanitary devices and materials;
- poisons and narcotic drugs;
- supervision under his jurisdiction and
- perform other activities determined by law
The Health Insurance Fund of Republic of North Macedonia is established with the Law on Health Insurance (Закон за здравственото осигурување) for the purpose of implementing mandatory health insurance, as an institution that performs activities of public interest and public authorizations determined by the Law.
The main activity of the Institute of Public Health of the Republic’s health care is prevention through monitoring, researching and studying of health condition, the causes and spread of communicable and non-communicable diseases of social and medical importance, the impact of environmental factors and taking measures for protection and promotion of health.
The 10 regional Centers of Public Health have similar functions as the Institute of Public Health, but at the regional level, with the exception of research, education and policy advising roles. The Centre of Public Health’s role is disease prevention and health promotion, based on earmarked funding from the state budget-funded programs of the Ministry of Health.
The State Sanitary and Health Inspectorate (Државен санитарен и здравствен инспекторат) carries out inspection supervision over the implementation of health regulations in the area of health care, protection of the population against contagious diseases, health insurance, protection of patients' rights and rights in the field of mental health.
The Agency for Medicinal Products and Medical Devices (Агенција за лекови и медицински средства) of the Republic of North Macedonia was established in September 2014, on the basis of the Law on Medicines and Medical Devices (Закон за лековите и медицинските помагала), as an independent body of the state administration. The agency's authority is to issue approvals for the production and trade of medicines and medical devices; maintains Register of medicines, drug manufacturers and Register of manufacturers of medical devices in the Republic of North Macedonia; issue approvals and / or notices for clinical trials of medicinal products; makes an evaluation of the expected benefit in relation to the potential risk for the health of the subjects for the medicinal product that is subject to a clinical trial; makes the classification of products as medicines or medical devices; prepares an annual report on reported adverse drug reactions in the Republic of North Macedonia; carries out inspection supervision over medicines and medical devices; and other.
Today, the Ministry of Health assumes the main coordinating role with other government agencies in committees where intersectoral consultation and policies affecting youth are needed. In July 2013, the Committee for Health and Environment was established, led by the Prime Minister and co-chaired by the Minister of Health, in addition to development of regulations and policies through intersectoral consultations and public hearings. Inclusive participatory processes were used in the development of strategic health documents, but are still not part of regular procedures, an example being the establishment of the Committee for Advancement of the Health System in 2009. The Ministry of Health led this participatory process, which resulted in the development of the Green book in health, which serves today as a roadmap for health sector reforms (health care system management, administering health care, financing, pharmaceutical care and patients’ rights protection). The process is based on consensual agreement and acceptance among most stakeholders involved in the process, including citizens, professional associations, academia, civil society and private sector stakeholders
However, the whole of society approach that engages multiple stakeholders in public health policies across contexts is still not a regular practice, although highly recognized as an approach to provide a fair process in policy development and better results in policy implementation. Other initiatives for intersectionality are driven by international actors, such as WHO and the Global Fund to Fight Aids, Tuberculosis and Malaria discussion on the institutionalization of a National Health Account to provide the Ministry of Health with clear tracking of funds in specific health areas.