Copenhagen, Denmark September 2014
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1 Joint UNICEF, UNFPA & WHO meeting with manufacturers and suppliers of diagnostic products, vaccines, finished pharmaceutical products and active pharmaceutical ingredients 1
2 Priorities for Product Development and Procurement Reproductive Health Mr. Morten Sorensen, Deputy Chief, Procurement Specialist PSB, UNFPA 2
3 Reproductive and Maternal health The Commission estimated that, if more widely accessed and properly used, these commodities could save the lives of over 6 million women and children. This would catalyze and accelerate the reduction in deaths for women and children. /un-commission-on-life-saving-commodities#sthash.1lucbicm.dpuf Joint UNICEF, UNFPA & WHO MEETING with manufacturers and suppliers 3
4 Priorities for Product Development and Procurement Reproductive and Maternal health UNCoLSC (UN Commission on Life-Saving Commodities) Female condoms Implantable contraceptives Emergency contraception Oxytocin Misoprostol Magnesium Sulphate Other Long Acting Reversible contraceptives - injectable Joint UNICEF, UNFPA & WHO MEETING with manufacturers and suppliers 4
5 Reproductive and Maternal health WHO Prequalified RH medicines extracted from WHO PQT INN Formulation and strength Applicant Packaging Reference Date of PQ Etonogestrel Implants 68mg NV Organon Blister pack (polyethyleneterephtalate glycol sealed with coated paper) 1 implant (in the cannula of a disposable sterile applicator) Etonogestrel Implant (X-ray detectable) 68mg NV Organon Blister pack (PETG sealed with HDPE lidding); 1 implant (preloaded in the stainless steel needle of a ready-to-use, disposable, sterile applicator) RH020 (a) RH036 (a) 2010-Jun May-23 Levonorgestrel Coated tablets 30µg Bayer Pharma AG PVC/Alu blister 3 x 35 RH002 (a) 2009-May-26 Levonorgestrel Implants (without inserter) 2 rods each with 75mg Bayer Oy PE bag (manufactured from spunbonded PE film and a PET/PE film), 2 rods in one package RH017 (a) 2009-Sep-23 Levonorgestrel Tablets 0.75mg Gedeon Richter Plc Al/PVC blister 1 x 2 RH024 (a) 2010-Aug-20 Levonorgestrel Tablets 1.5mg Famy Care Ltd Al/PVC/PVDC blister 1 x 1 RH Oct-21 Levonorgestrel Tablets 750µg Famy Care Ltd PVC/PVdC/Alu blister 1x2 RH Jun-14 Levonorgestrel Tablets 0.75mg Cipla Ltd Al/PVC/PE/PVDC blister 1 x 2 RH Apr-08 Medroxyprogesterone acetate Suspension for injection 150mg/ml Pfizer Glass vial 1ml RH018 (a) 2010-Aug-20 Misoprostol Tablets 200µg Linepharma International Alu/alu strip 1x4, 15x4, 30x4 EMA Art 58 Misoprostol Tablets 200µg Cipla Ltd Alu/Alu blister 1 x 4, 7 x 4, 15 x 4 RH Apr-08 Norethisterone enantate Injection 200mg/ml Bayer Schering Pharma AG Glass ampoule 1ml (100 per carton) RH022 (a) 2011-Oct-05 Joint UNICEF, UNFPA & WHO MEETING with manufacturers and suppliers 5
6 Reproductive and Maternal health Injectable contraception Depo Medroxyprogesterone acetate (DMPA) One WHO PQed Norethisterone enantate One WHO PQed Innovator products - non-radioopaque, radioopaque Generic implants none WHO PQed Joint UNICEF, UNFPA & WHO MEETING with manufacturers and suppliers 6
7 Reproductive and Maternal health Implants Innovator products - non-radioopaque, radioopaque Generic implants none WHO PQed Joint UNICEF, UNFPA & WHO MEETING with manufacturers and suppliers 7
8 Reproductive and Maternal health Procurement Volumes of hormonal contraceptives DFID, IPPF, KfW, MSI, PSI, UNFPA, USAID Product Oral Contraceptive pills (cycles) 161,882, ,382, ,526,922 Emergency contraceptive pills (per treatment) 3,262,617 3,500,948 3,368,120 Injectables (vials) 63,334,037 72,406,531 76,733,437 Implants (set) 1,561,545 2,494,956 4,094,739 Sources: Joint UNICEF, UNFPA & WHO MEETING with manufacturers and suppliers 8
9 Reproductive and Maternal health Oxytocin CHALLENGES: Stability Varying storage instructions on the products - Store below 25 to 2-8 C Reality stored in normal shelves, no temperature control and often at temperatures above 25 C NEEDS: Heat stable Formulations under studies different organisations Sublingual tablet Pharmacokinetic studies Inhaled oxytocin studies are on-going Joint UNICEF, UNFPA & WHO MEETING with manufacturers and suppliers 9
10 Reproductive and Maternal health Magnesium Sulphate AND Misoprostol Mg Sulphate None is WHO Pqed Misoprostol Two WHO PQd One SRA approved PPH not included in indications off-label Some country programmes resistance to use the product as an off-label Joint UNICEF, UNFPA & WHO MEETING with manufacturers and suppliers 10
11 Reproductive and Maternal health Procurement values (USD) UNFPA Oxytocin, Mag Sulphate, Misoprostol Name of product Magnesium Sulphate 486, ,070, , Misoprostol 39, , , Oxytocin 565, , , Joint UNICEF, UNFPA & WHO MEETING with manufacturers and suppliers 11
12 UNFPA AccessRH Inventory Procurement Please visit: 12
13 AccessRH: Partners in Reproductive Health Supplies Better Planning Safe and Effective Products Easy Ordering
14 AccessRH Online Product Catalog
15 AccessRH Online Product Catalog Contraceptives Reproductive health kits Midwifery and Fistula repair kits Medical equipment items Pharmaceutical products
16 Wait time for condoms from inventory is about 15 weeks less than from production wait time reduction Production Inventory 2011 Q Q Q Q3
17 17
18 Contraceptive Distribution Latest statistics
19 Pharmaceuticals Distribution Latest statistics
20 On-going and new initiatives > Greening Health Care Procurement including pharmaceutical procurement > On-going ERP > On-going Pre-qual > On-going lab training (onsite), lab workshops, procurement capacity building etc. > Capacity building regulatory authorities 20
21 THANK YOU 21
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