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TBS, Geneva, November 2015 1 | PROGRESS AND FUTURE AGENDA FOR ACCESS TO QUALITY MEDICINES Access and quality of medicines through efforts of the UNCoLSC
TBS, Geneva, November 2015 1 |
PROGRESS AND FUTURE AGENDA
PROGRESS AND FUTURE AGENDA FOR ACCESS TO QUALITY MEDICINES
Access and quality of medicines
through efforts of the UNCoLSC
TBS, Geneva, November 2015 2 |
Outline
Global Markets, Policy, and Regulation (GRAMPS)
– Prequalification, Collaborative Procedure
– Market dynamics: studies on procurement, quality,
status of RH commodities
– Collaboration Resources: Specifications, procurement
tools and workshops
– PmRN outputs
– Support to Interagency Supply Group
TBS, Geneva, November 2015 3 |
WHO Prequalified RMNCAH commodities (as of 20th October 2015)
Year Number of RMNCAH products
reaching PQ status
2009 – 2012 11
2012 - 2015 +18
Total 29
TBS, Geneva, November 2015 4 |
WHO-PQT collaborative registration process: Participating countries
Africa Euro/Asia
• Botswana
• Burkina Faso
• Burundi
• Cameroon
• DR Congo
• Ethiopia
• Ghana
• Ivory Coast
• Kenya
• Madagascar
• Malawi
• Mozambique
• Namibia
• Nigeria
• Senegal
• Sierra Leone
• Tanzania
• Uganda
• Zambia
• Zanzibar
• Zimbabwe
Armenia
Georgia
Kyrgyzstan
Ukraine
Since June 2012: participation by 25 NMRAs from 24 countries
TBS, Geneva, November 2015 5 |
Collaborative procedure uptake,
RMNCH and others
Condition Number Percentage HIV 38 44%
Tuberculosis 16 18%
RH (oral contraceptives) 15 17%
Malaria 17 20%
Filariasis 1 1
Total 87 100
TBS, Geneva, November 2015 6 |
Key No manufacturer 1 or 2 manufacturers Atleast 3 manufacturers
Information for market shaping
COUNTRIES Levonorgestrel 75mg implant
Levonorgestrel 0.75mg tablet
Oxytocin inj 10 IU
MgSo4 500mg inj Dexamethasone
inj. 4mg/ml
Ceftriaxone 250mg, 500mg or
1g in a vial
Gentamicin 40mg/ml
Amoxicillin 250 or 500mg
dispersible tablets
Zinc sulfate 10mg or 20mg
dispersible tablets
Burkina Faso 1 1 1 1 1 1 1 1
Comoros1
DRC 1 1 1 2 6 2 2
Ethiopia 2 3 1 1 5 14 7
Ghana 1 3 3 1 23 1 2
Guinea 1 1 1 1 1 1
Kenya 3 8 2 4 8 47 16 7 1
Kyrgyzstan 2 2 4 32 9 8
Madagascar 2 2 2 4 15 5 1 1
Malawi 1 1 1 1 2 1 1 2 1
Nepal 3 5 2 1 10 21 9 1 3
Nigeria 3 3 9 4 5 30 9 4
Senegal 3 2 12 2
Sierra Leone2 1 1 2 1 1 1 1 1
Somalia3 2 1 1 2 2 1
Tajikistan Had 5IU 4 34 7 4
Tanzania 1 2 2 1 4 25 5
Uganda 2 1 5 3 5 22 6 1 5
Uzbekistan 1 1 1 6 53 5 1
Viet Nam 5 2 4 54 19 1 1
Zambia 1 1 1 1 1 1 1 1 1
Zimbabwe 1 2 6 1 9 7 1 1
TBS, Geneva, November 2015 7 |
Model procurement workshops
Promote Commodity Security
– Collaboration on quantification information
– Promote common procurement specification
– Encourage sharing of e-LMIS data beyond national medical
stores
Quality assurance
– Identify means to increase post marketing surveillance and
pharmacovigilance for "high risk" products
– Strengthening good distribution practice
TBS, Geneva, November 2015 8 |
Outputs: Strategy per participating country
TBS, Geneva, November 2015 9 |
Information for market shaping
12
17 15
14 12
13
8
0
5
10
15
20
Almost all commodities were included on
the EML in majority of countries except:
female condoms, Ulipristal, mifepristone,
Chlorhexidine 4%,
All commodities on the EML were reported
to be included in the national procurement
contracts for the past 12 months
Almost all UNCoLSCs were supplied free
of charge in all countries
No
. o
f c
ou
ntr
ies
TBS, Geneva, November 2015 10 |
India, 395, 35%
China, 175, 16% Local manufacturers,
120,11%
Others, 421, 38%
Number , percentage of registered manufacturers per
commodity in 22 EWEC countries by origin (n=1111)
Findings for future strategies
TBS, Geneva, November 2015 11 |
Findings for future strategies
Commodity Number of manufacturers per commodity registered in 21 EWEC countries
REPRODUCTIVE HEALTH
Levonorgestrel 75mg Implant 8
Etonogestrel 68mg implant 4
Levonorgestrel 1.5mg tab 16
Levonorgestrel 0.75mg tab 25
MATERNAL HEALTH
Oxytocin inj. 10 IU 36
Misoprostol 200υg tab 21
Magnesium sulfate 500mg inj 16
NEW BORN HEALTH
Gentamicin Inj 40mg/ml 103
Ampicillin Injection 108
Ceftriaxone Inj 282
Dexamethasone inj. 4mg/ml 59
CHILD HEALTH
Amoxicillin dispersible tab 36
Zinc sulfate dispersible tab 20
TBS, Geneva, November 2015 12 |
Findings for future strategies Recommendations of PmRN
(Pediatric medicines Regulators Network)
To support harmonization and
stabilize markets:
– Develop and promote model
expressions of interest
– Facilitate regional collaboration on
selection and common technical
specifications
