The GOVERNANCE of the health system with regard to COVID-19 relates to pandemic response plans and the steering of the health system to ensure its continued functioning. It includes emergency response mechanisms, as well as how information is being communicated, and the regulation of health service provision to patients affected by the virus.
The country has been readying its emergency response system through its IHR core capacity strengthening for the last two years and increasing its capacity to detect and care for patients.
Prevention and control activities for infectious diseases in North Macedonia, including those with international risk, are based on the:
o National Action Plan of the health sector for preparedness and response in emergencies, crisis and disasters (2017).
o Operational plan and guidelines Risk Management in case of pandemic influenza in the Republic of Macedonia (2013)
o Specific Standard Operation Procedures/Algorithms developed for responding to a potential Covid-19
These plans and procedures were activated upon the request of the Commission for Infectious Diseases as the technical advisory body to the Minister of Health, after the announcement of the first positive COVID-19 case in the country.
On 18 March 2020, the President of the Republic of North Macedonia declared a national emergency for COVID-19 on the whole territory of the country for 30 days, without restriction of movment. During a state of emergency, the Government can adopt decrees that have the force of law, i.e. it will be able to execute both legislative and executive powers. This facilitates the work of the Government in times of crisis and decisions for the benefit of citizens will be faster and more efficient.
A Steering Committee was formed to support the coordination and management of the national crisis, composed of Ministers of the Interior, Health, Transport and Communications, Defence, Foreign Affairs and the Head of the Assessment Group. The Committee holds meetings as needed with the Minister of Health and the Operational Crisis Committee for decision-making at the highest level.
The Ministry of Health is coordinating the response through the following expert committees:
1. Infectious diseases commission as a technical expertise to MOH
2. IHR multisectoral commission
3. Operational Crisis Committee – Task Force for COVID-19.
Responses at the regional level are supported by the 10 regional Centres for Public Health (CPH) and 21 local units of the Centres for Public Health at the municipality level, together with the National Institute of Public Health. These centres have rapid outbreak investigation teams that work in collaboration with the Institute of Public Health and local authorities.
The Agency for Medicines and Medical Devices (MALMED) is responsible for the regulation and licensing of medical devices and aids. In case of urgent need of regulation and licensing of medicines and medical devices, it can respond immediately with all its capacities:
• The existing software solutions for drug registration and drug import provide the opportunity to complete procedures in one day.
• Imports of medical devices is regulated by the Law on Medicinal Products; the import license is issued in one day.
• The quality control of all imported medicines and medical devices can be performed by the authorized laboratories at the Institute of Public Health and the Faculty of Pharmacy in Skopje in a very short time.
• Vaccines can be imported in accordance with the approval of the Agency for Medicines and Medicinal Products in cooperation with the Ministry of Health.
• All the above procedures are initiated at the request of the Ministry of Health in consultation with the above-mentioned committees.
The surveillance, communication and international reporting is coordinated by the IHR Focal Point in North Macedonia, the National Public Health Institute. The Institute is issuing a daily report on the COVID-19 situation and is sharing information with WHO/EURO; it is also reporting the newly detected cases according to IHR requirements. The National Public Health Institute is also responsible for coordination and surveillance of the testing for COVID-19.