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Procurement of ACT'sInformal Workshop on Prequalification of

Antimalarial Drug ProductsGeneva, 5th May 2004

WHO/UNICEF JOINTREQUEST FOR PROPOSALS

The interim solution

Françoise Mas, Contracting and Procurement Services

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MARCH 2003•No ACT prequalified, nor likely to be in the short term•Two countries have adopted Artesunate + Amodiaquine first line treatment

Procurement of ACT'sWHO/UNICEF Interim solution

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In April 2003, tripartite meeting to discuss possible solutions and actions until a sufficient number of products are pre-qualifiedWHO/UNICEF cooperation on selection and procurement.

Procurement of ACT'sWHO/UNICEF Interim solution

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WHO/UNICEF joint tender 2003 Evaluation based on the UNICEF product

quality questionnaire (similar to WHO's)Criteria included GMP certification, registration

information (countries), API, stability reports, shelf-life and storage conditions

Quality assurance based on a review of the documentation submitted jointly by UNICEF Pharmaceutical Team and WHO (EDM and Procurement with assistance from QSM when necessary)

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UNICEF/WHO joint tender 2003

No co-packaged product could be selected after evaluation, mainly due to lack of stability data.By June, only two products (in separate blisters) satisfy the evaluation and allow to place the first orders, but at a high cost ($ 2.60 per adult treatment).By December we had a choice of three Artesunate 50mg and two for Amodiaquine 150mg base, lowering the price of adult treatment to $1.68.

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WHO/UNICEF joint tender 2004

By end of January 2004, still no change in the prequalification status for ACTs.

WHO and UNICEF decide to repeat the joint tender exercise, this time including all the current WHO recommended ACTs, as well as separate blisters and the range of invitees is also expanded.

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WHO/UNICEF joint tender 2004Offers received from nine companies on tender opening (23 February 2004)Joint evaluation begun on 9 March in Copenhagen with WHO staff (EDM and PRS) should be concluded in June.We aim to have at least two suppliers for ACTs.Once the products are selected, WHO can sign letters of agreement with suppliers in order to to include products in the WHO e-procurement catalogue.

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WHO/UNICEF joint tender 2004

Artesunate + Amodiaquine 5 offersArtesunate + Mefloquine 1 offerArtesunate + SP 1 offerSP + Amodiaquine 1 offer

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Other on Malaria Treatments

WHO/Novartis agreement for supply of Coartem to UN, NGOs and Governments

Teamwork between Procurement, Roll Back Malaria and the EDM Quality Assurance Unit for new products through the Pilot Pre-qualification Project.