RMNCH Medicines in Every Woman Every Child Countries

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RMNCH Medicines in Every Woman Every Child Countries Survey results on Regulatory and Procurement

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

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

Methods Ø Modules from a commonly developed tool by partners in the RMNCH Ø

Methods Ø Modules from a commonly developed tool by partners in the RMNCH Ø Distributed in Excel and on-line format Ø Distributed to 49 EWEC National Medicines Regulatory Agencies (NMRA) and Central Medical Stores (CMS) Ø Collection and review of available registers from respondent NMRAs 3 | TBS Geneva, November 2014

Regulatory status ØFull or partial responses received analyzed from 21 countries (43%) ØMost responding

Regulatory status ØFull or partial responses received analyzed from 21 countries (43%) ØMost responding countries required assistance to complete the survey ØSome responses included copies of all registered medicines 4 | TBS Geneva, November 2014

Registrations: RH Registration status: UNCo. LSC RH commodities

Registrations: RH Registration status: UNCo. LSC RH commodities

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

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

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

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

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

Registered manufacturers: RH Commodity Levonorgestrel 75 mg Implant Levonorgestrel 1. 5 mg tablet Levonorgestrel

Registered manufacturers: RH Commodity Levonorgestrel 75 mg Implant Levonorgestrel 1. 5 mg tablet Levonorgestrel 0. 75 mg tablet 9 | TBS Geneva, November 2014 Total registered mfg 8 16 25

Registered manufacturers: Maternal Health Commodity Total registered mfg Oxytocin inj. 10 IU 36 Misoprostol

Registered manufacturers: Maternal Health Commodity Total registered mfg Oxytocin inj. 10 IU 36 Misoprostol 200 mcg 21 tablet Magnesium sulfate 500 mg injection 10 | TBS Geneva, November 2014 16

Registered manufacturers: Newborn Commodity Total registered mfg Gentamicin 40 mg per ml 103 Procaine

Registered manufacturers: Newborn Commodity Total registered mfg Gentamicin 40 mg per ml 103 Procaine penicillin 1 g vial 17 Ampicillin Injection 250 mg, 500 mg 108 or 1 g Ceftriaxone 250 mg, 500 mg or 1 g 282 Betamethasone inj. 4 mg per ml 9 Dexamethasone inj. 4 mg per ml 59 Chlorhexidine 4% gel or solution 2 11 | TBS Geneva, November 2014

Registered manufacturers: Child Commodity Total registered mfg Amoxicillin 250 or 500 mg dispersible 36

Registered manufacturers: Child Commodity Total registered mfg Amoxicillin 250 or 500 mg dispersible 36 tablets Oral Rehydration Salts 50 Zinc sulfate 10 mg or 20 mg dispersible 20 tablets 12 | TBS Geneva, November 2014

Procurement status Ø Full or partial responses received analyzed from 11 EWEC countries (22%)

Procurement status Ø Full or partial responses received analyzed from 11 EWEC countries (22%) Ø Responses were more limited Ø Questions were reviewed for fitness of purpose and several recommended for modification 13 | TBS Geneva, November 2014

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

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

EML Status: Maternal

EML Status: Maternal

New born. EML Health. Status: lifesaving commodities Newbornincluded in EMLs of 11 EWEC countries

New born. EML Health. Status: lifesaving commodities Newbornincluded in EMLs of 11 EWEC countries

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

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

Conclusions l EML and regulatory status did not directly correlate to procurement availability l

Conclusions l EML and regulatory status did not directly correlate to procurement availability l Use of large wholesalers to impact markets not likely to be useful as an access lever in the responding countries l Strong presence of certain products may be related to: – Demand generation activities – International commodity funding – Other considerations 18 | TBS Geneva, November 2014

Strategies to stabilize markets l Country markets can consolidate demand around correct formulations and

Strategies to stabilize markets l 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) l 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 19 | TBS Geneva, November 2014

Strategies to stabilize markets l Streamline regulation to facilitate multi-country distribution and stability: –

Strategies to stabilize markets l 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 l 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 20 | TBS Geneva, November 2014

THANK YOU 21 | TBS Geneva, November 2014

THANK YOU 21 | TBS Geneva, November 2014

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Medicines Authority Harmonisation of Medicines Regulatory Affairs MedicinesMedicines Authority Harmonisation of Medicines Regulatory Affairs Medicines
EVERYCHILDCOUNTS EVERYSTUDENTMATTERS Every Child Every Student Every ChildEVERYCHILDCOUNTS EVERYSTUDENTMATTERS Every Child Every Student Every Child
Every Child Every Family Every School Every DayEvery Child Every Family Every School Every Day
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Every child is a child Every one inEvery child is a child Every one in
Every day in every community every child inEvery day in every community every child in
every child every school every day Whats theevery child every school every day Whats the
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every child every day every way Restorative Practicesevery child every day every way Restorative Practices
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Regulating Medicines Medicines Development Eureka 10 000 substancesRegulating Medicines Medicines Development Eureka 10 000 substances