RMNCH Medicines in Every Woman Every Child Countries Survey results on Regulatory and Procurement Status Lisa Hedman Deus Mubangizi Robinah Najjemba World Health Organization RMNCH TRT, April 2014, New York

Objective: to clarify the regulatory and procurement status of life-saving commodities in EWEC countries

TBS Geneva, November |3 |  Modules from a commonly developed tool by partners in the RMNCH  Distributed in Excel and on-line format  Distributed to 49 EWEC National Medicines Regulatory Agencies (NMRA) and Central Medical Stores (CMS)  Collection and review of available registers from respondent NMRAs Methods

TBS Geneva, November |4 |  Full or partial responses received and analyzed from 21 countries (43%)  Most responding countries required assistance to complete the survey  Some responses included copies of all registered medicines Regulatory status

Registration status: UNCoLSC RH commodities Registrations: RH

Registration status of Maternal Health Lifesaving Commodities in 21 EWEC countries Registrations: Maternal Health

Registration status of Newborn health lifesaving Commodities in 21 EWEC Countries Registration: Newborn

Registration Status of Child Health Commodities in 21 EWEC Countries Registration: Child

TBS Geneva, November |9 | CommodityTotal registered mfg Levonorgestrel 75mg Implant 8 Levonorgestrel 1.5mg tablet 16 Levonorgestrel 0.75mg tablet 25 Registered manufacturers: RH

TBS Geneva, November | CommodityTotal registered mfg Oxytocin inj. 10IU36 Misoprostol 200mcg tablet 21 Magnesium sulfate 500mg injection 16 Registered manufacturers: Maternal Health

TBS Geneva, November | CommodityTotal registered mfg Gentamicin 40mg per ml103 Procaine penicillin 1 g vial17 Ampicillin Injection 250mg, 500mg or 1g 108 Ceftriaxone 250mg, 500mg or 1g282 Betamethasone inj. 4mg per ml9 Dexamethasone inj. 4mg per ml59 Chlorhexidine 4% gel or solution2 Registered manufacturers: Newborn

TBS Geneva, November | CommodityTotal registered mfg Amoxicillin 250 or 500mg dispersible tablets 36 Oral Rehydration Salts50 Zinc sulfate 10mg or 20mg dispersible tablets 20 Registered manufacturers: Child

TBS Geneva, November |  Full or partial responses received and analyzed from 11 EWEC countries (22%)  Responses were more limited  Questions were reviewed for fitness of purpose and several recommended for modification Procurement status

RH lifesaving commodities included in the EMLs of 11 EWEC Countries EML Status: RH

EML Status: Maternal

New born Health lifesaving commodities included in EMLs of 11 EWEC countries EML Status: Newborn

Child Health lifesaving commodities included in EMLs of 11 EWEC Countries EML Status: Child

TBS Geneva, November | EML and regulatory status did not directly correlate to procurement availability Use of large wholesalers to impact markets not likely to be useful as an access lever in the responding countries Strong presence of certain products may be related to: –Demand generation activities –International commodity funding –Other considerations Conclusions

TBS Geneva, November | Country markets can consolidate demand around correct formulations and quality products through: –Updates to NEML developed in collaboration –Coordination of procurement options (not necessarily pooled procurement) Promote quality assurance strategies that are consistent and clear –Oxytocin labels might benefit from change, but requires evidence and a consolidated approach –Incorporate quality assurance measures into supply chain Strategies to stabilize markets

TBS Geneva, November | Streamline regulation to facilitate multi-country distribution and stability: –Develop model dossiers to avoid duplication in multiple countries –Review dossiers together as regulators to benefit from sharing resources Streamline upstream from regulation and identify procurement requirements that address quality and safety, not just low price –Regulators will not be able to harmonize or streamline if procurement continues to be segmented Strategies to stabilize markets

TBS Geneva, November | THANK YOU