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Strategies Promoting Access to Medicines The
role of supply management
Unit of Essential Medicines, Vaccines and Health
Technologies, Nov 2004.
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Policy Development Process

• Sep 2003 Governing bodies request PAHO to
  develop policy options for countries
• March 2004 Strategic lines presented to the
  Sub-Committee of Planning and Programming
• June 2004 Working Group (WHO, UNDP, MSH, MSF,
  countries and Collaborating Centers) develops
  strategic lines
• June 2004 Executive Committee endorse policy
  options and drafts resolution
• Sep 2004 Directing Council adopts policy options
  and resolution

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A Framework for Access
Selection
POLICY
ACCESS
REGULATION
Financing
Pricing
RATIONAL USE
QUALITY
Supply Management
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Data on Pharmaceutical Expenditures (IMS)
Data on Pharmaceutical Expenditures (IMS)
1994
1994
2001
2001

• Global Expenditure
• US 364 billion
• Latin America
• 5 or US 18.2 billion

• Global Expenditure

• Global Expenditure
• US 246 billion
• Latin America
• 7 or US 18.5 billion

• Lack of access to health care for large segments
  of the population
• Increasing role of the public sector in health
  care provision
• Intensification of cost containment in the
  pharmaceutical sector

IMS DEC 2003
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Share of Household Health Expenditure by Type
Country Direct Direct Direct Direct Direct Indirect (Insurance)
Country Year Consultations Drug Hosp. Diagnostics Other Indirect (Insurance)
Argentina Bolivia Ecuador El Salvador Panama 1996-97 1997 1995 2001 1997 47 18 19 12 16 53 58 54 68 34 13 19 36 21 9 1 13 29 5 52
Source Table A.6 (III) PAHO Health Accounts and
National Health Accounts, 2003
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Strategic Lines for PAHO and Access

• WHO Medicines Strategy 2007
• Policy
• Quality and Safety
• Rational Use

• PAHO and
• Coherent Generic Medicines Policy
• Cost Containment Strategies
• Commodity Supply Systems
• Procurement Mechanisms

Access
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1. Developing Coherent Generic Policy

• Understanding differences in definition
• Reviewing legislation, regulations and policy
• Examining incentives promoting generics
  (production, registration, distribution,
  prescription, dispensing, and use)
• Assessing impact
• Providing Options

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1. Developing Coherent Generic Policy
Common Criteria Reference Product Competitor Principle Variables Variable Categories
Similar Active Ingredient Same Concentration / Dosage Same Route of Administration Same Use Nomenclature INN
Similar Active Ingredient Same Concentration / Dosage Same Route of Administration Same Use Nomenclature Branded
Similar Active Ingredient Same Concentration / Dosage Same Route of Administration Same Use Nomenclature Mix
Similar Active Ingredient Same Concentration / Dosage Same Route of Administration Same Use Interchangeability Required through BE studies
Similar Active Ingredient Same Concentration / Dosage Same Route of Administration Same Use Interchangeability Required through other studies
Similar Active Ingredient Same Concentration / Dosage Same Route of Administration Same Use Interchangeability Not required
Similar Active Ingredient Same Concentration / Dosage Same Route of Administration Same Use Marketing Exclusivity Data Protection
Similar Active Ingredient Same Concentration / Dosage Same Route of Administration Same Use Marketing Exclusivity IP
Similar Active Ingredient Same Concentration / Dosage Same Route of Administration Same Use Marketing Exclusivity Both or none
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Savings to Consumers and Governments from Buying
Generic
Brand median MPS Most sold generic median MPS
33 Generic savings
33
108
21
423
176
186
271
Source WHO-HAI Medicine Prices, 2003
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Strategies to Achieve a Mature Generics Market
National strategies for generics 1. Supportive
legislation regulation 2. Reliable quality
assurance 3. Professional, public acceptance 4.
Economic incentives
Percent of new prescriptions, U.S.A.
Source WHO Rockefeller
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Strategic Lines for PAHO and Access

• WHO Medicines Strategy 2007
• Policy
• Quality and Safety
• Rational Use

• PAHO and
• Coherent Generic Medicines Policy
• Cost Containment Strategies
• Commodity Supply Systems
• Procurement Mechanisms

Access
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2. Cost Containment Approaches

• Understanding Pricing
• Tender Options
• Negotiations
• Price Controls
• IP Regulatory Options provided for by TRIPS
• Voluntary / Compulsory Licensing
• Parallel Imports
• Data Protection
• Global, Regional and Bilateral Trade Agreements
  Monitoring Access and Pricing

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Cost Containment for ARVs in Andean Countries
Regional Price Negotiation for ARVs, REMSAA, June
2003, ORAS/PAHO
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2. IP and Access

• Meeting of the Working Group on IP (Nicaragua
  2004)
• Meeting of MOHs and Ministries of Trade and
  Commerce, Ecuador, Colombia and Peru, July 2004.
• Methodologies to assess impact of trade
  agreements
• Training materials for health professionals

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2. Monitoring TRIPS Implementation in Latin
America

• Assessment in 11 countries, recently published in
  the Bulletin of the World Health Organization1
• Methodology Analysis of IP legislation in 11
  countries focusing on tersm of patents issued
  patentable subject matter transition periods
  burden of proof of patent infringement
  exhaustion rights, compulsory licensing and
  early working.
• Results
• By 2000 all countries had reformed legislation
• 10 of 11 made use of TRIPS safeguards and
  flexibilities
• Andean countries, DOR and Panama made use of
  parallel importing
• Early working exception in two countries (DOR and
  Brazil)

• Oliveira MA, Bermudez JAZ, Chaves GC, Velasquez
  G.
• Bulletin of the World Health Organization.
  November 2004, 82 (11). Pp 815-820.

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Strategic Lines for PAHO and Access

• WHO Medicines Strategy 2007
• Policy
• Quality and Safety
• Rational Use

• PAHO and
• Coherent Generic Medicines Policy
• Cost Containment Strategies
• Commodity Supply Systems
• Procurement Mechanisms

Access
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3. Access and Supply Management

• To ensure continuous availability of essential
  medicines and public health supplies
• of quality
• coherent with the needs of the public health
  system
• focusing on priority public health programs
• maximizing resource utilization
• using efficient and dynamic administrative and
  management processes
• promoting rational use of pharmaceutical products

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An Overview of the System
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Characteristics of a Supply Management System

• Pharmaceutical Management Framework
• Product Selection
• Acquisition
• Inventory Management and Distribution
• Rational Use
• Monitoring and Evaluation

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The Pharmaceutical Supply Management Framework
A National / Regional Pharmaceutical Policy
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1. The Pharmaceutical Supply Management Framework
B Definition of the Supply System

• MOH / Drug Regulatory Authority
• MOH / Dept. Pharmacy Services
• MOH / Procurement Service
• MOH / Priority Programs
• Ministry of Finance
• Central Medical Stores
• Social Security System
• Therapeutic Committees
• Drug Selection Committees
• Tendering Committees
• Reference Hospitals
• Primary Health Care Pharmacies
• Community Pharmacies
• National QC Laboratories
• MOH / Pharmaco-surveillance

Rational Use
Acquisition
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1. The Pharmaceutical Supply Management Framework
B Definition of the Supply System

• .Definition of Responsibilities
• Identification of Coordination
• Mechanisms
• Integration of Existing Institutions
• Programs

Rational Use
Acquisition
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Operational Framework for Supply Management
COHAN, Colombia
Coordination MOH
Technology Transfer
Research
Supply System
Training
Selection Needs Estimation
Quantitative Approaches
Qualitative
Purchases
Technical Support
Marketing
Stock Managememnt
Sales
Rational Use
Source COHAN 2004
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Product Selection

• National Therapeutic and Drug Selection
  Committees based on information provided in
• Treatment Norms
• National Essential Drug List
• Cost v Therapeutic Class

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Product Selection
Financial Regulations And Admin. Procedures
Health Regulations And Drug Registration

• Requires understanding
• of the
• Public Health
• Regulatory Framework

Commercial and IP Regulations
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Product Acquisition

• Good Practices for Pharmaceutical Procurement,
  WHO 2002 presents basic principles for effective
  pharmaceutical procurement

• Selection of reliable manufacturers and suppliers
  (Prequalification)
• Lowest cost for products of quality
• Appropriate delivery times
• Transparent procurement procedures and management

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Product Acquisition
Compilation of Information
Quantity
Financial
Market Intelligence
Reference Prices
Morbidity Data Treatment Norms
Local / International Availability
Historic Use
Procedures
Funding
Patent
Original/Brand
INCOTERMS Taxes
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Inventory Management Distribution
means Information Management
By product, batch no, expiry date, budget line,
health program, location etc
Customs, Taxes, Registration, Quality Order
verification, Costing
Product, Presentation, Qt Suppliers,
Prequalification Pricing, Shipping, Delivery
Times
Institution information, Product picking,
Invoicing Accounting, Shipping Transport,
Usage Evaluation
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Rational Use Drug Supply
Systems Monitoring Rational Use Adherence to
Treatment Norms Registering Product
Use Monitoring Clinical Response Surveillance for
Adverse Reactions Resistance
Changes in Product In the Supply Chain
Product Availability Affordability
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Monitoring an Evaluation
Process Indicators Result Indicators

• Pharmaceutical Management Framework
• Product Selection
• Acquisition
• Inventory Management and Distribution
• Rational Use

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The HR Factor
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PAHO Program of Work 2004 Supply Management

• Regional Workshops in HIV/AIDS to Assess the Gaps
• Caribbean (February 2004) Central America
  (August 2004)
• Methodology
• Participation of HIV/AIDS Program Managers, HR
  Managers, Chief Pharmaceutical Officers,
  Strategic Planning Managers Country Reports
• WG1 Assessment of Minimum Requirements for
  scaling up by country, focusing on Logistics, HR
  and Planning
• WG2 Assessment of Min. Requirements,
  inter-country by area
• WG3 Definition of priorities by country and TC
  requirements

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Results of Workshop / Caribbean
Countries No. of PLWHA under ART, Feb 2004 No. of People under ART Sept. 2004 Increase in No. of PLWHA Under ART Feb Sep 2004
Bahamas 1,237 1,454 217
Barbados 280 333 53
Belize 60 146 86
Guyana 300 480 180
Jamaica 350 500 150
Dutch Antilles 87 230 143
Suriname 127 253 126
Trinidad Tobago 600 855 255
Dominican Republic 120 420 300
Others 2,200 appx 2,400 appx 200
Total 5,417 6,656
1,239
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TC Priorities for Caribbean

• Processes of quantification, prequalification and
  procurement
• IPR and Drug Regulation
• Coordination Mechanisms in Supply Management

• Training in Procurement and Supply Management
  (using WB materials)
• Direct support to countries and CARICOM on IP and
  drug regulation assessment and options
• Development of regional capacity in QC
• Establishment of Caribbean Network of Procurement
  and Supply Management Agencies (CariPRO)

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Results of Workshop / Central America
Aspecto Belice Costa Rica Guatemala El Salvador Honduras Nicaragua Panamá
Accumulated Cases Reported Since 2003 (infections AIDS) 3.133 Casos SIDA (no incluye infectados) 1.400 Casos SIDA 6.579 12.629 Informa casos estimados 1.402 6.296
Total No. of deaths since 2003 431 1.238 No informa Séptima causa de muerte No informa No informa 4.629
Total No. of patients under ARV Treatment Sep/ 2003 2 Dic/ 2003 21 Junio 2004 51 1.850 (100 del estimado). 2003 2.612 2004 3.617 2001 73 2002 326 2003 524 2004 1.515 2002 183 2003 1.535 2004 2.312 33 (10 del estimado) 2001 673 2002 1.147 2003 1.709 20041.873 (58)
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Results of Workshop / Central America
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TC Priorities for Central America

• Monitoring and Evaluation Performance Assessment
  of the Supply Chain
• Good Storage and Distribution Practices
• Coordination Mechanisms in Supply Management

• Support in performance assessment
• Good Storage and Distribution Practices
• Networking / Intercountry cooperation
• Assessments of Supply System in NIC and HON

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Strategic Lines for PAHO and Access

• WHO Medicines Strategy 2007
• Policy
• Quality and Safety
• Rational Use

• PAHO and
• Coherent Generic Medicines Policy
• Cost Containment Strategies
• Commodity Supply Systems
• Procurement Mechanisms

Access
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4. Procurement / PAHO Strategic Fund
2000
2004

• Established by the Director, with formal
  invitations to countries
• A procurement mechanism to support countries in
  supply management of prequalified TB, HIV, and
  malaria public health supplies

• 12 Countries with signed participation agreements
• gtUS 14 million in purchase orders by three
  countries
• Strategic review of Fund framework through SPP
  and PAHO Working Group

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The Review Process WHO Audit

• Procurement Funds and Linkages to Technical
  Cooperation in the Americas, March - April 2004
• To assess the efficiency of the process and the
  effectiveness of activities in the achievement of
  stated objectives.
• Methodology reviewing planning, program design
  and implementation, reliability of information,
  communication and monitoring

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Recommendations from the Audit

• The Strategic Fund should be a fundamental
  component of the PAHO strategy to promote Access
  to priority public health supplies
• Political impetus be provided through advocacy to
  Member States
• The product mix be reviewed
• Technical cooperation scope and mechanisms be
  developed specifically in demand forecasting,
  supply management and quality at the country
  level.

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Strategic Fund Work Program 2005

• Focus on PAHO/AMRO priority countries and the
  Caribbean
• Update technical framework document and product
  mix
• Review of legal framework to facilitate
  participation of GFTAM projects
• Commence training in focus countries

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And Finally.

• Weve lots to do. !!!!

And we can do it together
Thank You - Gracias
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Next Steps

• Modify TORs, prepare meeting report and
  disseminate
• Modify Indicators and disseminate. Set date for
  collection
• Establish the Sharepoint website
• Organize next meeting (April 04 with PAHO/WB
  training?)