As a medical organisation, MSF regularly dispenses medical products to patients in the programmes it runs all over the world. MSF attaches the utmost importance to the quality of the medical products that are given/dispensed to patients.
MSF strongly considers that any patient wherever he/she lives has a right to be treated with effective and safe medical products.
MSF has set up its own procurement centres, which are in charge of the purchase, storage and shipment of drugs, vaccines, specialised food items, laboratory reagents and equipments, medical material and equipments and all the goods necessary for MSF to carry out its missions
Like many other humanitarian actors, MSF is aware that the quality of drugs is not always properly guaranteed on the global market (WHO Medicines Strategy 2004-2007).
The general policy of the organisation is to select its sources of medical products and supply them to its teams wherever they operate and wherever MSF is authorised to do so.
To this end, MSF has set up its own European Supply Centres (MSF Logistique, Bordeaux in France in 1986; MSF Supply in Neder-Over-Heembeek, Belgium in 1989; and Amsterdam Procurement Unit in Amsterdam, The Netherlands in 1984). The objective is twofold:
- Operational: to supply medical and non-medical relief goods to MSF teams according to the requested delivery date
- Qualitative: to keep a strict control on the quality of supply and make sure that it is compliant with MSF's technical requirements
When drugs are supplied by the European Supply Centres, MSF considers that it is the moral responsibility of the organisation to guarantee their quality. The MSF Executive Committee has consequently asked MSF pharmacists to develop a qualification procedure in order to achieve this objective. The acceptability of pharmaceutical products intended for import by MSF in countries for its programmes, and supplied by MSF European Supply Centres, is assessed according to the "MSF Medical Product Qualification Scheme" for International Pharmaceutical Supply.
In some countries, however, MSF is not authorised to import medical products. In that case, the MSF qualification procedure cannot apply and the responsibility to assure the quality of the drugs rests with National Drug Authorities.
Qualification of pharmaceutical products
In order to avoid any duplication of work, any product that is pre-qualified by the WHO Pre-Qualification Programme (PQ) or that is registered in a highly regulated country is automatically qualified by MSF.
Products that are neither WHO pre-qualified nor registered in a highly regulated country and that present an interest for the organisation will be fully evaluated by the MSF pharmacists. The evaluation is carried out against WHO norms and standards. The evaluation includes two steps (details are given in the MSF Medical Product Qualification Scheme):
- The assessment of the manufacturing site for compliance with WHO Good Manufacturing Practices (GMP) is the necessary first step of the evaluation. Only products that are manufactured in WHO GMP compliant facilities will be evaluated. GMP inspections carried out by the WHO PQ inspectors, or inspectorates recognised by MSF are taken into consideration by MSF. For facilities which have not been previously inspected and approved by WHO PQ or a SRA inspectorate, the MSF International Pharmacist Coordinator appoints a GMP expert to perform an audit.
- The second step of the process is the evaluation of a product dossier according to standards set by WHO, and based on a standard Product Questionnaire common to the Interagency Pharmacist Group (UNICEF, ICRC, The Global Fund, WHO procurement center, UNFPA, GDF and MSF).
MSF is not a Medicines Regulatory Agency. The MSF Qualification Scheme has been exclusively designed for the organisation and the decisions taken are only valid for MSF.
The qualification of a product is formalised by the signature of a "Product Specification Sheet" (PSS) summarising the characteristics of the product as approved by MSF pharmacists. The assigned PSS number is then used as a reference for procurement.
The MSF qualification is an ongoing procedure and products approved through a product dossier are monitored at regular intervals. Monitoring activities focus on the re-evaluation of the WHO GMP compliance of the manufacturing site and the updating of the information and data given in the product questionnaire.
Expression of interest
As a principle, each and every drug manufacturer is free and welcome to express his interest to be considered as a possible MSF European Supply Centres' supplier.
Those who want to do so are invited to download the MSF Manufacturer Information File (MIF).
Completed MIF should be sent by e-mail or by post together with the requested annexes to:
Assistant to the QA coordinators
Rue de l’Arbre Bénit 46
The expressions of interest for products that are not included in the list will not be considered.
Commercial negotiations and purchase
Only the manufacturers whose products have been qualified by MSF pharmacists will be invited to participate to commercial negotiations.
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.