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The Medicines Transparency Alliance:
Accounting and Accountability in the Drug
A      ti    dA       t bilit i th D
             Supply Chain

              Saul Walker, DFID
          Global Health Supply Chain Summit
             Zaragossa, 6 November 2008
Pharmaceutical Markets in Developing
Ph        ti l M k t i D      li
Countries
 Low expenditures (ARVs an exception)
 Inequitable financing (high out of pocket)
                             out-of-pocket)
 Complex state/non-state, private/public mix
 Weak infrastructure and HR
 Weak regulatory environment
 Very high information asymmetries
     Provider/patient, supplier/purchaser
 –

 Weak LMIS and limited utilisation data
 Strong external players - complex international environment
 Portable, high value goods – potential for inefficiency,
 diversion and corruption
 di    i      d       ti
Medicines Supply: A Complex Network
M di i    S   l     C   l Nt      k
                      Government
                        (MOH)
                                           Professional
     Consumer
                                           Organizations
    Organizations
                    lobbying
                               standards
                        Drug Industry
                                                  standards,
information                                       education
                      price    coverage

                       3rd Party
                               y
                        Payers
                       payments
     Consumers                               Providers
                        treatment
                                                    Source: WHO
Public Drug Supply Chain: Kenya
                                                                                                Constructed and produced by Steve Kinzett, JSI/Kenya - please communicate
      Commodity Logistics System in Kenya (as of July 2006)                                         any inaccuracies to skinzett@cb.jsikenya.com or telephone 2727210
                                                                                                                        skinzett@cb jsikenya com


  Commodity
    Type                                                                                                                             Blood                              Anti-                      Labor-
                             Contra-       Condoms
                                                                                                                                                                                       MOH
                                                                                           Vaccines
  (colour coded)                                                                                                                     Safety
                                                          STI             Essential                                                                                     Retro                       atory
                           ceptives and      for STI/
                                                                                                            TB/Leprosy                                  Malaria                       Equip-
                                                                                                                                   Reagents
                                                                                              and
                                RH          HIV/AIDS                       Drugs                                                                                        Virals                     supp-
                                                         Drugs                                                                     (inc. HIV                                           ment
                                                                                           Vitamin A
                            equipment      prevention                                                                                                                  (ARVs)                        lies
                                                                                                                                     tests)

  Organization Key
      Government
      World Bank Loan
      Bilateral Donor
      Multilateral Donor
      NGO/Private
      JSI/DELIVER
                           U               U                                                                                       D
                                                 D                                 J   C                             K      S                                                      Global
                                                                                                                                                                                   Gl b l
   Source of                                                                                                                       A
                                                                                           G
                           S    K          N             W                     B                                G
                                                                                                                                                                  US
                                      E          F                                 I   I                             N      I               GOK, WB/                              Fund for
                                                                                                                                   N
                                                                                           A
    funds for              A    f          F             H                     T                 UNICEF         D                                                                                  MSF
                                                                  GOK                                                              I
                                                                                           V
                                      U          I                                 C   D                             C      D                 IDA                                 AIDS, TB
                                                                                                                                                                  Gov
  commodities              I    W          P             O                     C                                F                  D
                                                                                           I
                                                 D                                 A   A                             V      A                                                    and Malaria
                           D               A                                                                                       A



                           U               U                                                                                              GTZ                 C       J
                                                                   K                                                                                                               PSCMC
  Procurement                         E
                                                                         Government
                                                Crown
                           S    K          N                 W                                                                                                                     (Crown
                                      U
                                                                   E                        Japanese
                                                                                                                                                              D       S
  Agent/Body                                                                                                          MEDS             (procurement
                                      R
                                                                                                       UNICEF
                                                                                             Private
                           A    f          F                 H            of K
                                                                           f Kenya
                                                Agents
                                                A   t                                                                                                                                              MSF
                                                                                                                                                                                                    S
                                                                                                                                                                                   Agents,
                                                                   M
                                      O                                                     Company                                    implementation
                                                                                                                                                              C       I
                           I    W          P                 O                                                                                                                     GTZ, JSI
                                      P                                                                                                     unit)
                                                                   S
                                      A
                                                                                                                                                                                 and KEMSA)
                           D               A                       A




                               KEMSA
  Point of first                                                                                          KEPI Cold
                               Regional           KEMSA Central Warehouse                                                                                      MEDS                   NPHLS store
  warehousing                                                                                               Store
                                Depots


   Organization                                                                                                                                                                   Provincial and
                             NLTP                                                          JSI/DELIVER/KEMSA Logistics                             KEPI
                                          KEMSA and KEMSA Regional Depots                                                                                         MEDS
   responsible                                                                                                                                                                       District      Private
                                                                                           Management Unit (contraceptives,
                              (TB/                                                                                                               (vaccines                           Hospital
  for delivery to                                                                                                                                                                                   Drug
                                                (essential drugs, malaria drugs,                                                                                  (to Mission
                            Leprosy                                                         condoms, STI kits, HIV test kits, TB                     and                                           Source
                                                                                                                                                                                   Laboratory
  district levels                                  consumable supplies)                                                                                            facilities)
                             drugs                                                              drugs, RH equipment etc)                         vitamin A)                           Staff


   Organization
                                Mainly District level staff: DPHO, DPHN, DTLP, DASCO, DPHO, etc or staff from the Health Centres,
  responsible for
  delivery to sub-                                     Dispensaries come up and collect from the District level
   district levels



                                                                                                                                                              Source: Steve Kinnset, PSI Kenya
Regulatory Framework
                                                                Taxes and                                                 Licensing of
                                                                import duties                                             suppliers
                                               Parallel                                                                                          Drug registration
                                               imports                                                                                           policies
                                                                                                 Information
                             Compulsory                                                                                                                           Price controls
                                                                       Forecasting                                                 EDLs
                             licensing                                                                                                                            Profit controls
                                                                                                                                   Formularies                    Margin limits


            Domestic Patent                                                                                                                                                        Restrictions on
                                                                                               SUPPLY CHAIN
                                          Price &                                                                                                    Clinical
            Legislation (TRIPS                                                                                                                                                     marketing &
                                                                                    (manufacturers     wholesalers retailers)
                                          availability                                                                                               guidelines
            compliant)                                                                                                                                                             advertising
                                                                          • Production efficiency (cost of production)
                                          monitoring
                                                                          • Volume efficiency/economies of scale
    Patent                                                                                                                                                                                     Volume
                                                                          • Market structure and competition (# of suppliers;
    protection                                                                                                                                                                                 controls
                                                                            brand vs. generic) among manufacturers,
                                                                            wholesalers, and retailers
                          Publicized                                                                                                                                 Utilisation
                                                                          • Distribution efficiency
International                                                                                                                                                                                        Middle-man
                          price/quality                                                                                                                              data
                                                                          • Mark-ups
trade policies                                                                                                                                                                                       policies
                          information
(e.g. TRIPS)

                                                                PRICES, AVAILABILITY, AND QUALITY OF ESSENTIAL MEDICINES

                                                                                                  DEMAND
                                                                      Patient-driven                 Provider               Provider-driven
                                                                 Disease patterns                recommendations       Knowledge
 Procurement                                                                                                                                                                                Co-payment
                                                                 Socioeconomic status                                  Incentives
 practices                                                                                                                                                                                  policy
                                                                 Education                                             Brand preferences
 - Drug selection
      g
                                                                                                    Patient
                                                                                                    P ti t
                                                                 Self-medication                                       Influence of marketing
 - Procurement
                                                                                                  expectations
                                                                 Brand preferences
   basis
                                                                 Influence of marketing

                                            Cold Chain                                                                                                   HR
                 Drugs selected for                                                                                                                                        Prescription
                 reimbursement                                                                                                                                             controls/incentives
                 (
                 (+ve/-ve lists)
                               )

                                                                                                                                    Warehouses
                                                              Transport

                                                                                          Infrastructure and Services
                                          Pricing policies -                                                                                     Generic
                                          Referencing, negotiation                                                                               substitution
                                          etc

                                                                                                 Purchasing
                                                                           (public procurement; government and private insurance)


                                                                                                                                                   Adapted from Cherly Cashin, 2008 (forthcoming)
DFID Policy Framework for MeTA
 Commitment to make progress towards the MDGs, including MDG
 8 Target 17
 “To provide access to affordable essential medicines in developing countries in co-operation
 with pharmaceutical companies”

 White Paper 3 Eliminating World Poverty: Making Governance
 Work for the Poor
     Places support for good governance at the centre of what DFID does
 –
     Focuses on increasing state capability, responsiveness and accountability
 –
     Commitment to apply experience of Extractive Industries Transparency
 –
     Initiative to other sectors
The MeTA “model”
            model
Goal: increased access to medicines (esp. for the poor)
Purpose: Test if multi-stakeholder approach increases
transparency, governance, efficiency and accountability, and
encourages responsible business practices.
Objectives: establish multi-stakeholder process in seven
   j                                       p
countries and internationally; encourage progressive
disclosure of data on price, quality, availability and promotion
                      p    ,q      y,            y     p
of medicines; use the evidence to improve policies and
p
practice; share the learning; (design a sustainable approach)
        ;                  g; (    g                    pp     )
  MeTA   13/11/2008                                           7
MeTA’s Focus

 MeTA’s focus will be on strengthening developing
 country capacity to collect, analyse, disseminate and
 use data on medicine quality availability, pricing and
                        quality, availability
 promotion.
 This will help improve transparency and accountability
 around the way medicines are selected, regulated,
 procured, distributed, supplied and then sold to and
 used by patients.
Transparency?
 Improving information access, scrutiny and use
     Transparency = not only disclosure of the price, quality,
 –
     availability and promotion of medicines
     Verifiable d t
     V ifi bl data
 –
     how to use the information to identify barriers, to reduce
 –
     asymmetries and to agree on solutions
     Accounting and Accountability
 –
Accountability?
 A multi-stakeholder approach
     Country L
     C   t Level
               l
 –
        Bring together players that impact pharmaceutical market
        Scrutinise verifiable data: focus on outputs/outcomes
        Build opportunities for agreement and action


     Global alliance
 –
        DFID, WHO, World Bank
        International P i t S t and Ci il S i t
        It     ti   l Private Sector d Civil Society
        International Advisory Group: influence constituencies, share
        learning and incentivise progress (peer scrutiny)
What Brings People to the Table?
                                                                              Country Governments
Donor Governments
                                                                              Support from international community
Good governance agenda
                                                                              Improved procurement and supply
Tackle corruption
                                                                              Better public health outcomes
Increase access to medicines
                                                                              Commitment to tackle corruption
                                                                              C
Support responsible business
                                                                              Commitment to financial probity and
Fiduciary duty on aid expenditure.
                                                                              good governance




                                                                              Civil Society
                                                                              Increased information
International Institutions
                                                                              Place at the table
Good governance agenda
                                                                              Supportive environment for advocacy
Partnership with private sector
                                                                              Financial and other support
Improve health outcomes
                                                                              Improved dialogue with public and
Fiduciary duty on aid expenditure
                                                                              private sectors




                     Pharmaceutical companies
                                                          Wholesales, distributors, retailers
                     Accurate information on pricing
                                                          New support for building capacity
                     Proactive role
                                                          Improved market operation
                     Better procurement and forecasting
                                                          Tackle corruption & wasteful
                     Achieve public health objectives
                                                          practices
                     Reduce pressure for inappropriate
                     behaviour
MeTA Process
         Country Secretariat, M-S Group, Int’l and Local Partners



                                                                                       Changes in:
                      Information
New validated                                                                          • Regulatory
                                                                                                                 Changes in drug
                      made public
                         d     bli
data on drugs                                                                            environment
                                                    Analysis and                                                 prices,
generated -                                                                            • Incentive
                      Scrutiny by                   options for                                                  availability,
focus on                                                                                 structures
                      multi-                        change                                                       quality and or
outputs and                                                                            • Business/prof’l
                      stakeholder                                                                                promotion
outcomes                                                                                 practice
                      group
                                                                                       • Accountability


                                                                           Improved
                                     Improved mgmt info
                                                                           processes




MeTA Toolkit          MeTA website and              Lesson sharing                     MeTA partners at
                                                                                       int’l and country level
Baseline assessment   publications                  Technical Assistance
MeTA phase 1: March 2008- Oct 2010
 MeTA Global launches:
     15 M L d
        May London, 21 M WHO A
                       May   Assembly
                                  bl
 –

 Activities in all 7 pilot countries
     MeTA Secretariat, WHO World Bank can provide TA
          Secretariat WHO,
 –

 4 meetings of the MeTA International Advisory Group
 Global feed back meeting Feb 2010
        feed-back
 External evaluation of pilot phase
 Phase 2? DFID commitment to MeTA= 10 years
Achievements at country level




MeTA dashboard                    Peru            Ghana         Zambia             Uganda                  Jordan            Kyrgyzstan          Philippines
Exchange of letters

Multi‐stakeholder engagement   Govt+CSO+Priv    Govt+CSO+Priv    Priv + CSO                              Govt+CSO+Priv          Gov+CSO           Govt+CSO+Priv
Pre‐MeTA organisation          Grupo Impulsor    Group of 7                                                                     CSO, Secr
MeTA Forum
MeTA Forum                      13 14 Nov 08
                                13‐14 Nov 08                    12 May 2008
                                                                12 May 2008                                                                          dec 07
                                                                                                                                                     dec‐07
MeTA Council                                      10‐sep‐08                                                 regularly                                monthly
                                                                                                                             Two coordinators 
MeTA Secretariat                    CIES           GNDP                                                High Health Council      appointed          WHO, Univ.

Workplan developed             being drafted    6m / GBP50k                   zero draft by MOH only     being drafted        being drafted       being reviewed
National launch                 13‐14 Nov 08                                                               14‐jan‐09         week 15 Dec 08          dec‐07
Workplan being implemented                                                                                                                       non‐MeTA funded
Progressive disclosure

  14                                                              MeTA                                                                            13/11/2008
Contact MeTA, DFID
 Wilbert Bannenberg, Technical Director
 wilbert@metasecretariat.org
 wilbert@metasecretariat org
 Mob +31-6-20873123, Skype wilbertb1

 MeTA Secretariat, info@metasecretariat.org
 www.MedicinesTransparency.org
     M di i    T

 Saul Walker, DFID,
 S l W lk DFID s-walker@dfid.gov.uk
                       lk @dfid   k
 Mob +44 (7748) 920 597

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Accountability In The Medicines Supply Chain

  • 1. The Medicines Transparency Alliance: Accounting and Accountability in the Drug A ti dA t bilit i th D Supply Chain Saul Walker, DFID Global Health Supply Chain Summit Zaragossa, 6 November 2008
  • 2. Pharmaceutical Markets in Developing Ph ti l M k t i D li Countries Low expenditures (ARVs an exception) Inequitable financing (high out of pocket) out-of-pocket) Complex state/non-state, private/public mix Weak infrastructure and HR Weak regulatory environment Very high information asymmetries Provider/patient, supplier/purchaser – Weak LMIS and limited utilisation data Strong external players - complex international environment Portable, high value goods – potential for inefficiency, diversion and corruption di i d ti
  • 3. Medicines Supply: A Complex Network M di i S l C l Nt k Government (MOH) Professional Consumer Organizations Organizations lobbying standards Drug Industry standards, information education price coverage 3rd Party y Payers payments Consumers Providers treatment Source: WHO
  • 4. Public Drug Supply Chain: Kenya Constructed and produced by Steve Kinzett, JSI/Kenya - please communicate Commodity Logistics System in Kenya (as of July 2006) any inaccuracies to skinzett@cb.jsikenya.com or telephone 2727210 skinzett@cb jsikenya com Commodity Type Blood Anti- Labor- Contra- Condoms MOH Vaccines (colour coded) Safety STI Essential Retro atory ceptives and for STI/ TB/Leprosy Malaria Equip- Reagents and RH HIV/AIDS Drugs Virals supp- Drugs (inc. HIV ment Vitamin A equipment prevention (ARVs) lies tests) Organization Key Government World Bank Loan Bilateral Donor Multilateral Donor NGO/Private JSI/DELIVER U U D D J C K S Global Gl b l Source of A G S K N W B G US E F I I N I GOK, WB/ Fund for N A funds for A f F H T UNICEF D MSF GOK I V U I C D C D IDA AIDS, TB Gov commodities I W P O C F D I D A A V A and Malaria D A A U U GTZ C J K PSCMC Procurement E Government Crown S K N W (Crown U E Japanese D S Agent/Body MEDS (procurement R UNICEF Private A f F H of K f Kenya Agents A t MSF S Agents, M O Company implementation C I I W P O GTZ, JSI P unit) S A and KEMSA) D A A KEMSA Point of first KEPI Cold Regional KEMSA Central Warehouse MEDS NPHLS store warehousing Store Depots Organization Provincial and NLTP JSI/DELIVER/KEMSA Logistics KEPI KEMSA and KEMSA Regional Depots MEDS responsible District Private Management Unit (contraceptives, (TB/ (vaccines Hospital for delivery to Drug (essential drugs, malaria drugs, (to Mission Leprosy condoms, STI kits, HIV test kits, TB and Source Laboratory district levels consumable supplies) facilities) drugs drugs, RH equipment etc) vitamin A) Staff Organization Mainly District level staff: DPHO, DPHN, DTLP, DASCO, DPHO, etc or staff from the Health Centres, responsible for delivery to sub- Dispensaries come up and collect from the District level district levels Source: Steve Kinnset, PSI Kenya
  • 5. Regulatory Framework Taxes and Licensing of import duties suppliers Parallel Drug registration imports policies Information Compulsory Price controls Forecasting EDLs licensing Profit controls Formularies Margin limits Domestic Patent Restrictions on SUPPLY CHAIN Price & Clinical Legislation (TRIPS marketing & (manufacturers wholesalers retailers) availability guidelines compliant) advertising • Production efficiency (cost of production) monitoring • Volume efficiency/economies of scale Patent Volume • Market structure and competition (# of suppliers; protection controls brand vs. generic) among manufacturers, wholesalers, and retailers Publicized Utilisation • Distribution efficiency International Middle-man price/quality data • Mark-ups trade policies policies information (e.g. TRIPS) PRICES, AVAILABILITY, AND QUALITY OF ESSENTIAL MEDICINES DEMAND Patient-driven Provider Provider-driven Disease patterns recommendations Knowledge Procurement Co-payment Socioeconomic status Incentives practices policy Education Brand preferences - Drug selection g Patient P ti t Self-medication Influence of marketing - Procurement expectations Brand preferences basis Influence of marketing Cold Chain HR Drugs selected for Prescription reimbursement controls/incentives ( (+ve/-ve lists) ) Warehouses Transport Infrastructure and Services Pricing policies - Generic Referencing, negotiation substitution etc Purchasing (public procurement; government and private insurance) Adapted from Cherly Cashin, 2008 (forthcoming)
  • 6. DFID Policy Framework for MeTA Commitment to make progress towards the MDGs, including MDG 8 Target 17 “To provide access to affordable essential medicines in developing countries in co-operation with pharmaceutical companies” White Paper 3 Eliminating World Poverty: Making Governance Work for the Poor Places support for good governance at the centre of what DFID does – Focuses on increasing state capability, responsiveness and accountability – Commitment to apply experience of Extractive Industries Transparency – Initiative to other sectors
  • 7. The MeTA “model” model Goal: increased access to medicines (esp. for the poor) Purpose: Test if multi-stakeholder approach increases transparency, governance, efficiency and accountability, and encourages responsible business practices. Objectives: establish multi-stakeholder process in seven j p countries and internationally; encourage progressive disclosure of data on price, quality, availability and promotion p ,q y, y p of medicines; use the evidence to improve policies and p practice; share the learning; (design a sustainable approach) ; g; ( g pp ) MeTA 13/11/2008 7
  • 8. MeTA’s Focus MeTA’s focus will be on strengthening developing country capacity to collect, analyse, disseminate and use data on medicine quality availability, pricing and quality, availability promotion. This will help improve transparency and accountability around the way medicines are selected, regulated, procured, distributed, supplied and then sold to and used by patients.
  • 9. Transparency? Improving information access, scrutiny and use Transparency = not only disclosure of the price, quality, – availability and promotion of medicines Verifiable d t V ifi bl data – how to use the information to identify barriers, to reduce – asymmetries and to agree on solutions Accounting and Accountability –
  • 10. Accountability? A multi-stakeholder approach Country L C t Level l – Bring together players that impact pharmaceutical market Scrutinise verifiable data: focus on outputs/outcomes Build opportunities for agreement and action Global alliance – DFID, WHO, World Bank International P i t S t and Ci il S i t It ti l Private Sector d Civil Society International Advisory Group: influence constituencies, share learning and incentivise progress (peer scrutiny)
  • 11. What Brings People to the Table? Country Governments Donor Governments Support from international community Good governance agenda Improved procurement and supply Tackle corruption Better public health outcomes Increase access to medicines Commitment to tackle corruption C Support responsible business Commitment to financial probity and Fiduciary duty on aid expenditure. good governance Civil Society Increased information International Institutions Place at the table Good governance agenda Supportive environment for advocacy Partnership with private sector Financial and other support Improve health outcomes Improved dialogue with public and Fiduciary duty on aid expenditure private sectors Pharmaceutical companies Wholesales, distributors, retailers Accurate information on pricing New support for building capacity Proactive role Improved market operation Better procurement and forecasting Tackle corruption & wasteful Achieve public health objectives practices Reduce pressure for inappropriate behaviour
  • 12. MeTA Process Country Secretariat, M-S Group, Int’l and Local Partners Changes in: Information New validated • Regulatory Changes in drug made public d bli data on drugs environment Analysis and prices, generated - • Incentive Scrutiny by options for availability, focus on structures multi- change quality and or outputs and • Business/prof’l stakeholder promotion outcomes practice group • Accountability Improved Improved mgmt info processes MeTA Toolkit MeTA website and Lesson sharing MeTA partners at int’l and country level Baseline assessment publications Technical Assistance
  • 13. MeTA phase 1: March 2008- Oct 2010 MeTA Global launches: 15 M L d May London, 21 M WHO A May Assembly bl – Activities in all 7 pilot countries MeTA Secretariat, WHO World Bank can provide TA Secretariat WHO, – 4 meetings of the MeTA International Advisory Group Global feed back meeting Feb 2010 feed-back External evaluation of pilot phase Phase 2? DFID commitment to MeTA= 10 years
  • 14. Achievements at country level MeTA dashboard Peru Ghana Zambia Uganda Jordan Kyrgyzstan Philippines Exchange of letters Multi‐stakeholder engagement Govt+CSO+Priv Govt+CSO+Priv Priv + CSO Govt+CSO+Priv Gov+CSO Govt+CSO+Priv Pre‐MeTA organisation Grupo Impulsor Group of 7 CSO, Secr MeTA Forum MeTA Forum 13 14 Nov 08 13‐14 Nov 08 12 May 2008 12 May 2008 dec 07 dec‐07 MeTA Council 10‐sep‐08 regularly monthly Two coordinators  MeTA Secretariat CIES GNDP High Health Council appointed WHO, Univ. Workplan developed being drafted 6m / GBP50k zero draft by MOH only being drafted being drafted being reviewed National launch 13‐14 Nov 08 14‐jan‐09 week 15 Dec 08 dec‐07 Workplan being implemented non‐MeTA funded Progressive disclosure 14 MeTA 13/11/2008
  • 15. Contact MeTA, DFID Wilbert Bannenberg, Technical Director wilbert@metasecretariat.org wilbert@metasecretariat org Mob +31-6-20873123, Skype wilbertb1 MeTA Secretariat, info@metasecretariat.org www.MedicinesTransparency.org M di i T Saul Walker, DFID, S l W lk DFID s-walker@dfid.gov.uk lk @dfid k Mob +44 (7748) 920 597