Procurement And Market Access


How do countries procure TB diagnostics? How autonomous is their decision making? How much is it influenced/guided by WHO and/or donors?


  1. Who are the major buyers in developing countries (e.g. Ministries of Health (MoH), laboratories, National TB Programs (NTPs), international donors)? What is the reimbursement environment for diagnostics?
  2. What are the most important MOH concerns, and how does the MOH procure, direct procurement, and make decisions on vendors (e.g. tenders)?
  3. How important are ‘consumers’ in the various developing markets?
  4. What are the market access challenges and options for addressing them? Specifically, is procurement linked to regulatory approval? Will each country require an independent study of a TB diagnostic, or is a single study sufficient?
  5. What are the logistics and distribution challenges? How fragmented is the distribution pathway? What will be necessary to set up a distribution and supply chain? Who pays for distribution, the manufacturer or the purchaser? Are these issues separate for public and private sector purchasing and distribution, or is there a single national or centralized process in countries?
  6. Are there regulations such as taxes/import duties in country that affect business models?
  7. What will be required by developers/suppliers to provide sales and after-sales support, as well as service and maintenance in a reliable manner?
  8. Will countries use a mix of different products using the same technology (i.e. different NAAT tests from different manufacturers)?



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