MSF Quality Assurance linked to procurement of Medical Products
As a medical organisation, MSF regularly dispenses and uses medical products. These include medicines, medical devices and specialised medical food for patients in the programmes we run all over the world. We attach the utmost importance to the quality of these medical products.
We strongly believe that any patient, wherever they live, has the right to be treated with effective and safe medical product. We also believe that it is our legal and moral responsibility to guarantee the quality of the medical products we use and distribute.
Like many other humanitarian organisations, MSF is aware that the quality of medical products is not always properly guaranteed on the global market. To this end, we have set up our own centres for international supply, which are in charge of the purchase, storage and shipment of products for us to carry out our medical and humanitarian mission. These centres are authorised by their respective Competent Authorities as Humanitarian Wholesaler/Distributors: MSF Logistique in France, MSF Supply in Belgium, and Amsterdam Procurement Unit in The Netherlands. Their objective is twofold:
- Operational: to procure and supply medical and non-medical products to MSF projects in a timely manner, consolidating MSF volumes.
- Qualitative: to ensure the compliance of the products with our technical requirements following international standards and to monitor their quality.
Quality Assurance system
The Quality Assurance Coordination is set-up within MSF’s International Office, to ensure its independence from supply centers and operational centers.
The main role of the International Office QA (IO QA) coordination is to develop and maintain a Quality Assurance System to:
- ensure the level of quality of medical products complying with relevant international standards of quality, safety and efficacy throughout the entire supply chain, from the manufacturer to the patient;
- provide technical support and expert advice globally within the organization and supply chain;
- monitor the implementation of the quality policy throughout MSF, and make sure it is available and understood by all relevant staff.
MSF procurement policy
MSF medical procurement policy’s main principle is that, by default, we procure internationally through our supply centres the medical products approved through MSF qualification processes.
We comply with all applicable national regulation concerning importation processes as defined by the National Competent Authority and in accordance with the countries’ Memorandum of Understanding (MoU) and, where existing, the MSF Host Country Agreement (HCA).
In some countries, however, MSF is not authorised to import medical products. In that case, the legal responsibility to assure the quality of the medical products rests with the National Medicines Regulatory Authorities. Within that frame, we apply a specific local procurement validation procedure.
MSF does not accept in-kind donations of medical products or health technology. Under exceptional circumstances, and on a case-by-case basis, MSF may consider accepting such donations according to the criteria and conditions set forth in MSF’s Policy for In-Kind Donations of Medical Products and Health Technology.
Adverse drug reactions and drug quality issues are closely monitored in MSF projects.
These situations are timely investigated, usually in collaboration with the drug manufacturer(s), in accordance with MSF pharmacovigilance guidelines and national regulations, where applicable, to determine the root cause of the issues and the appropriate corrective and preventive actions.
Management of Quality Complaints and Non-Conformities
We follow a procedure for the Management of Quality Complaints and Non-Conformities, and to handle any recall of medical products through the whole supply chain.
MSF requires our suppliers to have a traceability system in place and a procedure for monitoring quality complaints and to trigger recalls.
MSF Medical product storage guideline
MSF has developed internal guidelines for good storage and distribution practices based on WHO Good storage and distribution practices for medical products, 2020. There is also regular training provided internally.