Burundi

Under article 1 of the Constitution, Burundi is an independent, sovereign, secular, democratic and unitary republic that respects its ethnic and religious diversity.

Article 55 of the Constitution establishes that every person has the right to access health care. According to Article 44, every child has the right to special measures to ensure or improve the care necessary for their well-being, health and physical security and to be protected against mistreatment, extraction or exploitation.

Article 13 of the Constitution establishes the principle of equality and proclaims that every Burundian is equal before the law, enjoys the same rights, and has the same obligations without any discrimination, particularly on grounds of race, language, religion, sex, or social origin. Discrimination based on these or other reasons is punishable by law. It is reiterated in Article 22 which states that all citizens are equal before the law, which guarantees them equal protection. No one may be subjected to discrimination, particularly on the basis of origin, race, ethnicity, sex, color, language, social status, religious, philosophical or political beliefs, physical or mental disability, or because of being a carrier of HIV/AIDS or any other incurable disease.

The law is structured around 8 titles: the first provides general principles including the scope of the law and key definitions (articles 1 to 4); the second title provides for management and regulatory bodies(articles 6 to 10) ; the third title addresses medicines (articles 11 to 70), the fourth title provides the rules to govern milk substitute (articles 71 to 101), the fifth title provides the rules to govern the profession of pharmacist and optician (articles 102 to 188), the sixth title addresses traditional medicines (articles 189 to 206) while title VII provides for penalties (articles 207 to 227). The last title provides for transitory and final provisions.

Under title 2 dedicated to regulatory and management bodies, two entities are referred to: the Regulatory authority for medicines and food ("Autorité burundaise de regulation du médicament à usage humain et des aliments" - ABREMA) covered from articles 4 to 6, and the National agency for quality insurance for medicines and food ("agence nationale d'assurance qualité des médicaments et de la sécurité sanitaire alimentaire" - ANAMSSA) covered from articles 7 to 10.

The third title on medicines covers a large array of issues including medicines' approval (articles 11 to 23), import of medicines (articles 24 to 42), medical and scientific information (articles 43 to 51), medical samples (articles 52 to 54), narcotic substances (article 55), fight against the use of drugs (articles 56 to 61), cosmetic products (articles 62 and 63), tests (articles 64 to 66), price regulation for medicines (art. 67), pharmacopoeia incl. essential medicines lists (articles 68 to 70).

The Law No 1/012 contains 328 articles that are grouped into seven titles. The First Title (Articles 1-68) covers the purpose of the law, the scope of application and definitions of concepts, and provides provisions on, inter alia, the national health system, general and specific sanitary measures such as reproductive health, family planning, vaccination, mental health, etc. Title Two (Articles 69-146) is dedicated to the fight against communicable diseases and other behaviours with social implications and contains provisions relating to International Health Regulations. Title Three (Articles 147-211) is dedicated to nutrition, regulation of breast milk substitutes, protection of consumer health, the Burundian Drugs and Food Regulatory Authority (ABREMA), and public health establishments. Title Four (Articles 212-223) contains provisions on the practice of medical and paramedical profession and human biology. Title Five (Articles 224-237) is dedicated to blood transfusion, transplantation of organs and other human tissues, autopsy and dissection of corpses, genetic manipulation, medical assisted procreation and human cloning. Title Six (Articles 238-301) addresses biomedical research. Finally, Title Seven (Articles 302-328) contains criminal, transitional and final provisions.

Article 4 of the Law outlines the guiding principles of the national health policy that prioritize Primary Health Care (Soins de Santé Primaires) and emphasizes the importance of acceptability, effectiveness, quality, and efficiency in healthcare. It also stresses results-oriented management, decentralization, good governance, coordination, sustainability, ethics, equity, inclusivity, and gender-sensitive approaches to ensure a responsive and ethical health system.

Article 60 of the Law establishes the National Health Information System within the Ministry of Public Health and the Fight against AIDS.
The National Health Information System is responsible for the collection, encoding, processing, analysis and interpretation of data, feedback and archiving within the Ministry responsible for public health.
It serves as the national reference for all activities related to health information.

The Code contains 126 articles that are grouped into four titles covering the following: Title One (Articles 1-48) contains provisions on general health protection; Title Two (Articles 49-78) is dedicated to fight against communicable diseases; Title Three (Articles 79-89) covers diseases with social impact; and Title Four (Articles 90-126) contains provisions on the exercise of medical and related professions.

Article 90 of the Code provides that the authorization to practice medicine in Burundi is granted by the Minister of Public Health. According to Article 91, the authorization to practice medicine in Burundi is granted to those with a recognized medical degree, who are Burundian nationals (unless exempted), hold a valid tropical medicine certificate or relevant foreign training, and have completed a prescribed internship.

According to Article 2 of the Decree, the health system is defined by four levels: the central level, intermediate level, peripheral level, and community level. The central level coordinates macro-systemic activities, collaborates with technical and financial partners, drives inter- and multi-sector health initiatives, and is responsible for sectoral policy formulation, strategic planning, partner coordination, resource allocation, and monitoring and evaluation. The intermediate level represents a decentralized level of the Ministry which includes 18 Provincial Health Offices whose mission is to ensure the implementation of health policy in the province through coordination and administrative, technical and logistical support to the districts. The peripheral level is made up of health districts and has the mission of planning, coordinating and supervising the implementation of health program activities in public, religious/approved and private health facilities operating within the district. The community level is made up of community relays which are: community health workers, grouped into groups of community health workers, Health Committees

In line with Article 4, the central administration services of the Ministry comprise the coordination of the Cabinet of the Ministry, the Permanent Secretariat, the Permanent Executive Secretariat of the CNLS and the General Inspectorate of Public Health and the Fight against AIDS. According to Article 5 of the Decree, the following structures are attached to the Cabinet of the Minister: National Institute of Public Health, Central Purchasing Center for Essential Medicines of Burundi (CAMEBU), the National Blood Transfusion Center (CNTS), the National Hospitals of Third Reference, the National Reproductive Health Program (PNSR), the National Reference Center for Physiotherapy and Medical Rehabilitation (CNRKR), the Burundian Regulatory Authority for Medicines for Human Use and Food (ABREMA).

The Decree regulates the attributions of the following directorates: the General Directorate of Health Services and the Fight against AIDS (Article 8), the General Directorate of Planning (Article 9), the General Directorate of Resources (Article 10), the General Directorate of Health Care Supply modern and traditional medicine, food and accreditation (Article 11), the General Directorate of Health Services and the Fight against AIDS (Article 16), the Directorate of Health Promotion, Healthcare Demand, Community and Environmental Health (Article 17), the Directorate of Laboratories Medical Biology (Article 18), the National Technical Unit for Performance-Based Financing (Article 19), the General Directorate for the Supply of Modern and Traditional Medicine Care, Food and Accreditation (Article 20) , the Directorate of Quality Assurance of Care, Hygiene and Safety in Healthcare Settings (Article 21), the Directorate of Accreditations (Article 22), the Directorate for the Promotion of Traditional Medicine, the balanced diet and natural therapeutic diet (Article 23), the General Directorate of Planning (Article 24), the Directorate of Planning and Monitoring of Health Policies (Article 25), the Directorate of the National Health System Health Information (Article 26), the General Directorate of Resources (Article 27), the Human Resources Directorate (Article 28), the Budget and Procurement Directorate (Article 29), the Health Infrastructure and Equipment Directorate (article 30) .