1. WHO Global Price Reporting Mechanism, the importance of data registration for the regulation of antiretrovirals (ARV) and PSM issues related to access to treatment
Boniface Dongmo Nguimfack & Vincent Habiyambere
HIV/Technology and Commodities
World Health Organization
October 2012

2. AMDS Strategic Information & Clearing house
Objectives
Collect, consolidate, analyse and disseminate strategic information regarding affordability, accessibility, and availability of HIV, TB and Malaria medicines and diagnostics: data on price, API and registration
In-house Products related to strategic information (next slide)

3. AMDS Clearing House: AMDS Information PlatformPQ
(EMP)
Regula-tory status
Fore-casting portal
(surveys, back-ground, papers)
Treat-ment
guide-lines
repo-sitory
Global Price Repor-ting Mecha-nism
API
Opioïd
Sub-stitution Therapy data-base
Capacity building
tools:
PSM
Toolbox
HTM
Corpo-
rate
Pricing
Policies
(MSF)
HTM
HTM H HT H H H H

4. Drug Regulatory Database http://apps. who
WHY
Limited access to information on ARV marketing authorizations by countries
Inform stakeholders and WHO management team in making strategic decision and advocacy
Inform state and non state procurement officers, donation programmes, countries using the GFATM grant on options (A and B) on which drug is registered and where
How
Collect regulatory information and make it available in the public domain
Contributors: all R&D and generic ARV producers and AMDS partners (SCMS, UNICEF, MissionPharma)

7. The Global Price Reporting Mechanism [GPRM] and Improvements currently being implemented 7

8. Our Objective Promote access to life saving medicines and technologies
Work with all concerned parties to remove or minimize obstacles to old and new commodities adoption and sustainable implementation
Provide countries with reliable data to make their owned decision (informed)

9. GPRM Sources (2002-2012): Current situation Source Active
Duplicate rate
Automatic Generation %
GPRM Records
CHAI
Yes
Low
1.07%
548
GDF No
6.19%
3,177 GF
High
26.19%
13,445
IDA
11.70%
6,004
JSI -
0.36%
186 MP
8.94%
4,591
MSH
183
PEPFAR
21.27%
10,921
UNICEF
13.71%
7,038
UNITAID
Med
9.53%
4,890
WHO
0.24%
123
WHO/CPS
0.45%
230
total
100%
51,336 9

11. Treatment Cost per Year Number of Treatment Years of Formulation
IN Name
Strength
Generic
Lamivudine (3TC) + Nevirapine (NVP) + Zidovudine (ZDV)
30 mg + 50 mg + 60 mg
generic
150 mg mg mg
Current View
Region
Income Level
HDI Group
Manufacturer
East Asia and Pacific
Low income
Low
Matrix Laboratories Ltd.
Latin America and the Caribbean
Lower-middle income
Medium
South Asia
Upper-middle income
n/a
Sub-Saharan Africa
Current Selections
IN Name Lamivudine (3TC) + Nevirapine (NVP) + Zidovudine (ZDV)
Strength mg + 50 mg + 60 mg
Manufacturer Matrix Laboratories Ltd.
Generic generic
Treatment Cost per Year
Number of Treatment Years of Formulation
Data for is provisional
Data
2008
2009
2010
2011
2012
Median treatment cost per yea
105.36
109.37
104.13
101.48
103.42
Number of treatment years of
4,382
11,550
34,784
113,487
7,636
Number of transcations 12 18 52 57 4

12. Treatment Cost per Year Number of Treatment Years of Formulation
IN Name
Strength
Generic
Efavirenz (EFV) + Lamivudine (3TC) + Tenofovir (TDF)
600 mg mg mg
generic
Current View
Country
Manufacturer
Benin
Matrix Laboratories Ltd.
Bolivia
Democratic Republic of the Congo
More...
Current Selections
IN Name Efavirenz (EFV) + Lamivudine (3TC) + Tenofovir (TDF)
Strength mg mg mg
Manufacturer Matrix Laboratories Ltd.
Generic generic
Treatment Cost per Year
Number of Treatment Years of Formulation
Data for is provisional
Data
2010
2011
2012
Median treatment cost per yea
197.63
172.40
164.86
Number of treatment years of
14,342
152,340
17,957
Number of transcations 7 44 4

13. Treatment Cost per Year Number of Treatment Years of Formulation
IN Name
Strength
Generic
Lamivudine (3TC) + Nevirapine (NVP) + Zidovudine (ZDV)
150 mg mg mg
generic
30 mg + 50 mg + 60 mg
Current View
Region
Income Level
HDI Group
Manufacturer
East Asia and Pacific
High income
Low
Apotex Inc.
Latin America and the Caribbean
Low income
Medium
Aspen Pharmacare Ltd.
South Asia
Lower-middle income
n/a
Aurobindo Pharma Ltd.
Sub-Saharan Africa
Upper-middle income
More...
Current Selections
IN Name Lamivudine (3TC) + Nevirapine (NVP) + Zidovudine (ZDV)
Strength mg mg mg
Manufacturer Apotex Inc.; Aspen Pharmacare Ltd.; Aurobindo Pharma Ltd.; Cipla Ltd.; Hetero Drugs Ltd.; Matrix Laboratories Ltd.; Micro Labs
Generic generic
Treatment Cost per Year
Number of Treatment Years of Formulation
Data for is provisional
Data
2004
2005
2006
2007
2008
2009
2010
2011
2012
Median treatment cost per yea
231.05
259.51
221.45
190.85
148.78
136.79
130.83
128.26
129.24
Number of treatment years of
470
570
7,601
74,834
207,259
490,876
1,104,634
536,493
72,990
Number of transcations 4 4 4 42
118
123
251
131 16

14. Treatment Cost per Year Number of Treatment Years of Formulation
IN Name
Strength
Generic
Lopinavir (LPV) + Ritonavir (RTV)
200 mg + 50 mg
originator
100 mg + 25 mg
generic
Current View
133.3 mg mg
80 mg + 20 mg/ml
Region
Income Level
HDI Group
Manufacturer
East Asia and Pacific
High income
High
Abbott Laboratories Ltd.
Europe and Central Asia
Low income
Low
Aurobindo Pharma Ltd.
Latin America and the Caribbean
Lower-middle income
Medium
Cipla Ltd.
More...
Upper-middle income
n/a
More...
Current Selections
IN Name Lopinavir (LPV) + Ritonavir (RTV)
Strength mg + 50 mg
Manufacturer Abbott Laboratories Ltd.; Aurobindo Pharma Ltd.; Cipla Ltd.; Matrix Laboratories Ltd.; Not Provided
Generic originator; generic
Treatment Cost per Year
Number of Treatment Years of Formulation
Data for is provisional
Data
2005
2006
2007
2008
2009
2010
2011
2012
Median treatment cost per yea
1,492.25
460.11
500.05
500.05
495.73
442.01
403.49
371.82
Number of treatment years of
224
1,897
59,424
88,871
105,780
176,595
133,714
24,936
Number of transcations 2 11
213
376
325
463
244 19

15. Multi-partner approach
Nairobi, 5-7 September 2011
CHAI
Global Fund
STB/GDF
ESTHER
Grant Management Service (GMS),
MSH/SPS
SCMS
PEPFAR
i+solutions
JSI/DELIVER
UNDP
UNICEF
UNITAID
WHO. (HQ, RO, CO)
Bangkok, February 2012
Medicine Patent Pool-MPP
MSH/SIAPS
MSH/GMS Project
PEPFAR/SCMS-Vietnam
UNAIDS
WHO (HQ, RO, CO)
128 participants (25 countries: AFRO & EMRO)
96 participants (20 countries: SEARO & WPRO)

16. Leading PSM Challenges (Bangkok)
Inventory management – Afghanistan, Bangladesh, Bhutan, Cambodia, China, India, Indonesia, Iran, Mongolia, Myanmar, Pakistan, Sri Lanka, Timor Leste, Vietnam
Funding - Afghanistan, Bangladesh, Bhutan, Cambodia, China, India, Indonesia, Iran, Mongolia, Myanmar, Nepal, Pakistan, PNG, Sri Lanka, Thailand
Lead time - Afghanistan, Bangladesh, Bhutan, Cambodia, China, India, Indonesia, Iran, Lao PDR, Myanmar, PNG, Philippines, Thailand
Management and M&E - Afghanistan, Bangladesh, Bhutan, India, Iran, Lao PDR, Mongolia, Nepal, Pakistan, PNG, Sri Lanka, Viet Nam
Quantification - Afghanistan, Bangladesh, Bhutan, Cambodia, China, India, Indonesia, Iran, Lao PDR, Myanmar, PNG
Procurement - Lao PDR, Mongolia, Nepal, Pakistan, PNG, Sri Lanka, Thailand, Timor Leste, Viet Nam
Use – Cambodia, China, Indonesia, Mongolia, Pakistan, Sri Lanka
Distribution – Cambodia, China, Indonesia, Myanmar
Overstock – Nepal, Philippines
Stock-out – Nepal, Philippines

17. Leading PSM Challenges (Nairobi)
Management/M&E – Benin, Burundi, Cameroun, CAR, Congo, DRC, Gambia, Kenya, Malawi, Mali, Mozambique, Niger, Nigeria, North Sudan, Sierra Leone, Somalia, South Sudan, Swaziland, Togo, Zambia
Quantification - Benin, Burundi, Cameroun, CAR, Congo, DRC, G.-Bissau, Gambia, Malawi, Mali, Mozambique, Niger, Sierra Leone, South Sudan, Togo, Zambia
Inventory management/LMIS – Cameroun, CAR, Comoros, DRC, G.-Bissau, Malawi, Mali, Mozambique, Niger, North Sudan, Somalia, South Sudan, Swaziland, Togo, Zambia
Distribution – Cameroun, Chad, Comoros, DRC, Gambia, Mali, Mozambique, Niger, Sierra Leone, Somalia, South Sudan, Togo, Zambia
Price and procurement – Benin, Burundi, Comoros, Congo, DRC, G.-Bissau, Gambia, Mali, Niger, Nigeria, Sierra Leone, Swaziland, Togo
Funding – Burundi, Cameroun, CAR, Gambia, Malawi, Mozambique, North Sudan, Sierra Leone, South Sudan, Swaziland, Zambia
Lead time – Cameroun, Chad, Comoros, Congo, DRC, Mali, Mozambique, North Sudan, Somalia, Togo
Storage – Benin, Cameroun, CAR, DRC, G.-Bissau, Mali, Niger, South Sudan, Togo, Zambia
Use – Burundi, Cameroun, DRC, Mali, Niger, Somalia, South Sudan, Togo, Zambia
Human resources – DRC, Mali, North Sudan, South Sudan, Togo, Zambia
Quality assurance – Benin, Cameroun, DRC, Mali, Niger, Swaziland, Togo
Stock-out – Burundi, CAR, Nigeria
Overstock – Nigeria, North Sudan

18. Needs for Technical Assistance
Inventory Management/LMIS – Afghanistan, Burundi, Cameroun, Chad, DRC, Malawi, Mali, Niger, Nigeria, Sierra Leone, Thailand, The Gambia
Quantification – Burundi, Cameroun, CAR, Comoros, DRC, Malawi, Mali, Sierra Leone, The Gambia
Storage – Kenya, Malawi, Mali, Niger, Nigeria, Sierra Leone, The Gambia
Monitor & Evaluation – Burundi, Cameroun, Mali, Sierra Leone
Quality Assurance – Comoros, Mali, Nigeria, Somalia
Distribution – DRC, Malawi, Niger, The Gambia
Price and procurement – Kenya, Sierra Leone, The Gambia
Human Resources – Chad, Mali, Guinea-Bissau
Selection & Rational Use – Burundi, Malawi

19. URL for the different databases
Global Price Reporting Mechanism (GPRM):
The Drug Regulatory Status Database:
PSM Toolbox website:
SOURCES AND PRICES OF ACTIVE PHARMACEUTICAL INGREDIENTS
Controlled Medicines:
Forecasting antiretroviral demand:
Prequalification Project :

20. Contacts Boniface Dongmo Nguimfack: dongmonguimfackb@who.int
Global Price Reporting Mechanism (GPRM)
The Drug Regulatory Status Database
SOURCES AND PRICES OF ACTIVE PHARMACEUTICAL INGREDIENTS
Controlled Medicines
Summary report from the Global Price Reporting Mechanism
Vincent Habiyambere:
PSM Toolbox
PSCM system strengthening
ARV use survey
Global ARV demand forecasts
Early warning indicators to prevent stock-out and overstock