MSF Drugs Procurement

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General principles

MSF has set up its own procurement centres, which are in charge of the purchase, storage and shipment of drugs, vaccines, specialized food items, laboratory reagents and equipments, medical material and equipments and all the goods necessary for MSF to carry out its missions

As 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 organization is to select its sources of pharmaceuticals and supply them to its teams wherever they operate and wherever MSF is authorized to do so.

In some countries indeed, National Drug Authorities do not allow humanitarian organizations to import drugs.

In such contexts, drugs are purchased on the domestic market and the responsibility to assure the quality of pharmaceuticals is incumbent on local authorities.

MSF is not a regulatory agency

Nevertheless when drugs are supplied by the MSF Procurement Centres, MSF considers that it is the moral responsibility of the organization to make sure that the drugs are safe and effective.

The MSF pharmacists have developed a "Drugs Qualification Scheme" which is a classical two-step procedure that was approved by the Executive Committee:

  • The assessment of the manufacturing site for WHO GMP compliance
  • The assessment of the product dossier

This Qualification Scheme was developed in the specific context of a NGO with human resources, infrastructures and an operating system that enable it to keep control over the whole supply chain, from the procurement to the dispensation of drugs. Download the pdf.

The scope of the MSF Qualification Scheme is limited to the drugs that are to be purchased by MSF Procurement Centres and supplied by them to MSF medical programmes.  

MSF qualifications are only valid for the working context of the organization and are granted for a limited period of time.

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 Procurement Centres supplier.

Those who want to do so are invited to download the MSF Manufacturer Information File (MIF):

Download the MIF document: MSF_Manufacturer_information_file_May2007.doc

Completed MIF should be sent by electronic mail or by post together with the requested annexes to
    
MSF International Pharmaceutical Coordination8, rue Saint Sabin        
75011 Paris            
France
              
MSF is working with a limited number of essential medicines:

Download MSF list of medicines: MSF_List_of_Medicines_2013.pdf

The expressions of interest for products that are not included in the list will not be considered

Qualification of the pharmaceuticals

The MSF qualification of pharmaceutical products is site specific.

  • The assessment of the manufacturing site for compliance with WHO GMP is the necessary first step of the evaluation. MSF usually appoints independent experts to conduct GMP audits.?However, the intention is not to duplicate the work of stringent regulatory authorities or the WHO pre qualification team.?The outcome of recent  WHO PQ, PIC/S or ICH members inspections (conducted in the last 24 months) can be taken into consideration for the evaluation of the manufacturing site.
  • Only products that are manufactured in WHO GMP compliant facilities will be evaluated. Any product that is pre qualified by the WHO 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 organization will be fully evaluated by the MSF pharmacists. The evaluation is carried out against WHO norms and standards. Details of the evaluation are given in the MSF Qualification Scheme.

Outcome of the evaluation

A MSF qualified product can be:

  • A product that has been pre qualified by the WHO
  • A product registered in a highly regulated country
  • A product that successfully passed the MSF evaluation and that meets the WHO norms and standards.

The qualification of a product is formalized by the signature of a “Product Specification Sheet” (PSS) that summarizes the characteristics of the product as approved by MSF pharmacists.

The MSF qualification is an ongoing procedure.

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.

Commercial negotiations and purchase

Only the manufacturers whose products have been qualified by MSF pharmacists will be invited to participate to commercial negotiations.