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Burkina Faso
Order on the National Vigilance Commission for Health Products (Arrêté n°2013-543)
This order from Burkina Faso’s Ministry of Health officially establishes the National Vigilance Commission for Health Products, as mandated by the 2012 decree on the national vigilance system. The document details the commission’s specific missions, including evaluating adverse effect information, assessing technical reports, and providing recommendations to the Minister of Health to prevent health incidents. It outlines the commission’s extensive multi-stakeholder composition, chaired by the Director General of Pharmacy, and defines its operational rules regarding meetings, decision-making, and confidentiality.
Use Cases
- National Vigilance Commission – Evaluate Health Product Safety: To evaluate all information on the adverse effects of health products from various sources and provide formal opinions and recommendations to the Minister of Health.
- Director General of Pharmacy (DGPML) – Lead the Commission: To act as the President of the National Vigilance Commission, convene its ordinary and extraordinary sessions, and oversee the preparation of its work by the secretariat.
- Minister of Health – Make Final Regulatory Decisions: To receive the opinions and recommendations from the commission and take appropriate action to stop, reduce, or prevent incidents related to the use of health products.
- Specialized Technical Committees – Provide Expert Reports: To conduct specialized technical analyses of vigilance data and submit their reports to the National Commission for consideration in its deliberations.
- Commission Members – Provide Multi-sectoral Expertise: To represent their respective organizations (e.g., professional orders, consumer associations, public health directorates) and contribute their expertise during the commission’s deliberations on product safety .
- Commission Secretariat – Manage Administrative Functions: To be responsible for the administrative and preparatory work for the commission’s meetings, ensuring that all necessary documents and reports are ready for discussion.
Key takeaways you'll learn
The resource’s purpose is to formally establish and define the operational framework of the National Vigilance Commission, the central deliberative body responsible for evaluating health product safety issues and advising the Minister of Health in Burkina Faso.
- Operational Arm of the National System: This order directly implements the 2012 decree by creating the National Vigilance Commission, which serves as the main body for evaluating and making recommendations on vigilance signals.
- Broad and Diverse Membership: The commission’s composition is intentionally multi-stakeholder, including representatives from various Ministry of Health directorates, professional orders (physicians, pharmacists), consumer associations, the pharmaceutical industry, and even traditional health practitioners, ensuring a wide range of perspectives .
- Defined Evaluation Mandate: The commission is explicitly charged with evaluating information on adverse effects, assessing reports from specialized technical committees, and proposing investigations or other work it deems necessary for evaluating vigilance signals
- Formalized Operating Procedures: The functioning of the commission is highly structured, with rules for meeting frequency (twice a year in ordinary session), quorum (two-thirds of members), conflict of interest declarations, and confidentiality, ensuring a formal and transparent process.
- Direct Advisory Role to the Minister: The commission’s primary output is to issue opinions and recommendations directly to the Minister of Health (via the DGPML), giving it a significant advisory role in the final decision-making process for regulatory actions.
