1. UNICEF’s Procurement of Essential Medicines Jan Komrska Essential Medicines and Nutrition Unit UNICEF Supply Division Meeting of WHO Prequalification Programme with European manufacturers and EU marketing authorisation holders Copenhagen, November 2009

2. Meeting of WHO PQP with European manufacturers and EU marketing authorisation holders, Copenhagen, November 2009 2 |2 | What is the role of Supply Division? Oversee UNICEF’s global procurement and logistics operation. Procure supplies on behalf of UNICEF and Procurement Services partners Ensure that high quality, good value supplies reach children and their families quickly. Maintain the highest ethical standards for procurement. Provide technical support to UNICEF offices and Procurement Services partners globally. Share procurement know-how with development partners. Innovate to find ever-better supply solutions for children.

3. Meeting of WHO PQP with European manufacturers and EU marketing authorisation holders, Copenhagen, November 2009 3 |3 | Why do we buy pharmaceutcals? 2008: 8.8 million 2007: 9.2 million 1990: 12.7 million Sierra LeoneSierra Leone – 270 AngolaAngola – 260 AfghanistanAfghanistan – 257 NigerNiger – 253 LiberiaLiberia – 235 Guinea-Bissau Guinea-Bissau – 234 MaliMali – 217 ChadChad – 209 Equatorial GuineaEquatorial Guinea – 206 DR CongoDR Congo – 205 Acute respiratory infections Diarrhoea Measles Malaria Malnutrition Under 5 Mortality

4. Meeting of WHO PQP with European manufacturers and EU marketing authorisation holders, Copenhagen, November 2009 4 |4 | UNICEF Strategic Products ORS, new formula, 1L sachet Zinc 20mg tablets Albendazole tablets 400mg Mebendazole 100mg tabs & 500mg tabts Amoxicillin 250mg caps Amoxicillin pwd. for oral sus. 125mg/5ml, 100ml bottle Sulfameth.+ trimeth. 100mg+20mg tabs & 800mg+160mg tabs Sulfameth.+ trimeth. pwd for o.susp. 200mg+40mg/5ml, 100ml Ferrous fum + folic acid 60mg+0.4mg tabs Ferrous salt, equivalent to 60mg iron tabs Folic acid 5mg tabs Micronutrient tablets Multiple micronutrient powder, sachet/PAC-30 Retinol (Vit.A) 100,000 IU & 200,000 IU soft gelatin caps

5. UNICEF Logistics Network and Hubs Setup

6. Meeting of WHO PQP with European manufacturers and EU marketing authorisation holders, Copenhagen, November 2009 6 |6 | Principles of public procurement: –Fairness –Transparency –Equal treatment –Best value for money Registration of the product: –Law on medicinal product for human use How do we procure?

7. Meeting of WHO PQP with European manufacturers and EU marketing authorisation holders, Copenhagen, November 2009 7 |7 | All purchases shall be carried out by means of competitive tenders UNICEF financial rules and regulations The following products may only be procured through Supply Division. Exceptions may be granted on a case-by-case basis but these must be authorised by Supply Division. (h) pharmaceuticals; (i) therapeutic food; (j) supplementary food; Book G: Supply Manual, Chapter: 7 Guiding principles

8. Requisition Choice of solicitation method Receipt of offers Adjudication ARD CRC Submission Issuing Purchase Orderd PO Value Defining commercial requirements Drafting List of Potential Suppliers Confirmation/ Production of Specifications < 100,000 USD >100,000 USD Commercial evaluation of offers Floating of bid PROCUREMENT WORKFLOW Technical evaluation of offers Compliance with manufacturing standards Compliance with product specification

9. Meeting of WHO PQP with European manufacturers and EU marketing authorisation holders, Copenhagen, November 2009 9 |9 | Overview of procurement

10. Meeting of WHO PQP with European manufacturers and EU marketing authorisation holders, Copenhagen, November 2009 10 | Top 10 pharmaceuticals in 2009 N*Item description USD value 1ZDV+3TC+NVP 300+150+200mg tabs/PAC-6019,152,780.59 2d4T+3TC+NVP 30+150+200mg tabs/PAC-6016,250,419.86 3Arteme.+Lumefan,20+120mg tab,6x4/PAC-72014,669,778.48 4Efavirenz 600mg tabs/PAC-3013,660,074.00 5ZDV + 3TC 300+150mg tabs/PAC-605,650,232.22 6Mebendazole 500mg tabs/PAC-1003,290,224.33 7New form. Oral reh.salts,1Ls/CAR-10x1002,902,373.07 8Tenofovir 300mg tabs/PAC-302,523,703.33 9Albendazole 400mg tabs/PAC-100 2,442,581.27 10Micronutrient,film-coated tabs/PAC-1000 2,056,892.67

11. Meeting of WHO PQP with European manufacturers and EU marketing authorisation holders, Copenhagen, November 2009 11 | Top 10 pharmaceuticals in 2008 N*Item description USD value 1 d4T+3TC+NVP 30+150+200mg tabs/PAC-60 16,066,672.46 2 Efavirenz 600mg tabs/PAC-30 12,693,687.08 3 Arteme.+Lumefan,20+120mg tab,6x4/PAC-720 8,920,045.80 4 ZDV+3TC+NVP 300+150+200mg tabs/PAC-60 5,823,908.70 5 d4T+3TC+NVP 30+150+200mg tabs/PAC-60 5,081,852.55 6 ZDV + 3TC 300+150mg tabs/PAC-60 4,817,080.40 7 Zinc 20mg tablets/PAC-100 3,390,646.18 8 Iodized oil 200mg caps/PAC-1500 3,228,658.47 9 Sulfameth.+trimeth.400+80mg tabs/PAC-500 3,087,592.82 10 Arteme.+Lumefan,20+120mg tab,6x2/PAC-360 2,822,615.23

12. Meeting of WHO PQP with European manufacturers and EU marketing authorisation holders, Copenhagen, November 2009 12 | Top 10 Vendors in 2009 N*Vendor USD value 1Hetero Drugs Ltd. 28,969,451.55 2Novartis Pharma AG 22,021,986.12 3Cipla Ltd. 13,070,254.58 4Ranbaxy Laboratories Ltd. 9,233,604.70 5MATRIX LABORATORIES LTD 9,202,269.41 6Aurobindo Pharma Limited 9,098,614.00 7Remedica Ltd. 7,624,767.18 8Micro Labs Ltd. 5,376,448.29 9KBI Kunststoffbeutel Prod. GmbH & C 3,964,128.24 10Medreich plc 3,718,432.64 98 vendors

13. Meeting of WHO PQP with European manufacturers and EU marketing authorisation holders, Copenhagen, November 2009 13 | Origin of product (2009)