1. Access to Medicines for HIV/AIDS, Tuberculosis and Malaria.
WHO/UNICEF Technical Briefing Seminar on
Essential Medicines Policies.
November 2008
Sophie Logez
Pharmaceutical and Health Technology Unit

2. Presentation Outline Global Fund grants: portfolio update and results
Global Fund approach to pharmaceutical and health products management
Global Fund contribution to improving access

3. Status of Global Fund Grants
Financing 577 grants in 136 countries (Nov. 08)
Status of Global Fund Grants
Financial Status
Proposals
Approved
(R1-8)
Grants signed
US$
Money disbursed
Global Fund financing (US$), November 2008
14.9 billion
10.2 billion
6.7 billion
45%
Objective of the Global Fund
“making a “sustainable and significant” contribution
to the achievement of the Millennium Development Goals”

4. Rapid scaling up of results
Global Fund Top 3 result indicators (2008)
Intervention
mid 2007
mid 2008
% increase since mid 2007
Global Fund target end 2008
HIV:
People on ARV treatment
1.1 million
1.75 m
59%
1.8m
TB:
People treated under DOTS
2.8 million
3,9 m
39%
4.5m
Malaria:
Insecticide-treated nets distributed
30 million
59 m
97%
70m

5. Pharmaceutical Health product management a key component
About 50 percent of Global Fund grants allocated to management of products
Supply chain weaknesses: a leading risk factor in bottlenecks, failures or reduced impact

6. What it can include Services Activities Products Pharmaceuticals
Health products
Health equipment
Equipment
Services
Registration
Selection
Forecasting
Procurement
Transport
Quality control
Storage
Distribution
Monitoring
Pharmacovigilance
Activities
Procurement costs
Distribution costs
Training
Technical Assistance
Capacity Building
This highlights the large scope of products, activities and services that Management of pharmaceutical and health products consist of. And the list is not exhaustive.
Definition of each category of products is included in the R8 Guidelines.
Procurement costs is seen in that case in its broad mean: transport, quality control, storage cost…etc

7. The Global Fund Approach
Pharmaceutical and Health Product Management
Principles and minimum standards, not detailed procedures
Build upon existing systems
Principal Recipients responsible for all PSM activities

8. Guide outlines what PRs need to do
Policies
Quality-assured products
Lowest possible price
National laws and international agreements
Transparent and competitive procurement
Guide outlines what PRs need to do
This is essential that applicants read the Guide on Policies before preparing the proposal- the guide exist in four langages.
Beside, Guidelines for proposal round 8 And Round 8 frequently asked questions

9. Policies and Initiatives
Quality Assurance Policy for pharmaceutical products
Revised by the Board in November 2009
MDR-TB treatment
Green Light Committee support services
Voluntary Pooled Procurement and Capacity Building Services
To be launched early 2009
Affordable Medicine Facility for malaria (AMFm)
Approved by the Board in November 2008
There are 3 policies approved by the Board to be highlighted regarding management of pharmaceutical and health products.
The QA policy
Procurement of medicines for MDR TB including funding for GLC support services
And voluntary Pooled procurement services and capacity building services, approved by the Board in April 2007, which is still being operationalized by the Secretariat. Thus, it will have no incidence on the Round 8.

10. Goals of the Global Fund procurement initiatives
Significantly increase speed of grant implementation
Reduce the burden on recipient countries by easing procurement bottlenecks in country
Develop/review policy procedures and/or requirements for countries
Coordination with Partners.

11. Health System Strengthening
Medical Products and Technologies
One of the
WHO's Six Building Blocks for Health Systems
HHS section is an optional additional section for applicants
The Global Fund's major objectives in providing funding for health systems strengthening are to: (i) improve grant performance, and (ii) increase overall impact of responses to the three diseases.
We recognize that supporting the development of equitable, efficient, sustainable, transparent and accountable health systems furthers achievement of these objectives.
One of the 'WHO's Six Building Blocks for health systems' is Medical products, vaccines and technologies
“A well-functioning health system ensures equitable access to essential medical products, vaccines and technologies of assured quality, safety, efficacy and cost-effectiveness, and their scientifically sound and
cost-effective use.”

12. HSS cross-cutting interventions What it can include
Activities
Registration
Selection
Forecasting
Procurement
Transport
Quality control
Storage
Distribution
Monitoring
Maintenance
Health Systems
NDRA
National Committee for Selection of essential medicines
STGs committees
Logistics and communication systems
National Laboratory Control
Pharmacovigilance
Managing pharmaceutical and health products include the activities as already mentioned AND it involved various national entities and organizations, part of the health systems to perform the required activities,
like
registration, monitoring pharmaceutical activities, promoting rational use and pharmacovigilance by the national drug regulatory authorities,
QC by the laboratory control, etc…
These entities might receive support and be strengthened in order to provide the services and activities they are entitled to, in an optimal way
And
In GF proposal for HHS , it can include
pharmaceutical and health products management;
Procurement systems;
Logistics, including transport and communications; and
Technology management and maintenance.

13. Improving Access Rational Selection: PRs required to
Procure only medicines on National, Institutional or WHO Model List of Essential Medicines and Treatment Guidelines
Indicate strategies in place to ensure appropriate use of procured medicines
Affordable Prices: PRs required to
Procure quality assured products at the lowest price
Conduct procurement in a transparent and competitive process
Encouraged to apply TRIPS flexibilities in a manner consistent with National & International laws

14. Improving Access/2 Sustainable financing
Increased funding made available (sustainability?)
Coordination with other donors
Reliable Health and Supply Systems
Provide funds for health systems strengthening activities
Grants funding accessible by all sectors involved in the health system: Public, Private and NGO organizations
Policy on Quality Assurance for pharmaceuticals

15. Procurement and Supply Management http://www. theglobalfund
Additional information available on the GF website for PSM and more specifically on the QA policy and its implementation.

16. Capacity building as planned
Planning
Technical support
PSM plan preparation
Team work
Technical support to prepare the proposal:
PSM experts
Laboratory experts
Regulatory authorities
IPR experts
Capacity building as planned
TA as planned
TA as planned
Proposal +
Attachment B
Proposal writing:
Define the best procurement system according to the need of the programme in terms of products, taking into account requirements, resources, weaknesses and gaps.
Coordination with other members of the proposal team
Medicine selection, Forecasting, estimation of PSM cost: transport, QC, storage, distribution
Identify the gaps, needs in the PSM chain, request for TA in specific area
Partnership: technical agencies, consultants, national authorities
Opportunity to include capacity building activities with adequate costing for various PSM activities
The PSM plan:
A detailed description of the systems and PR capacity to manage pharmaceutical and health products included in the grants.
PSM plan development: the sooner the better. In line with the proposal
Before the grant signature.
Phase 1
Phase 2
Proposal approved
Grant signature
Phase 2 review
Preparation

17. PSM Plan Approval Process
PR submits PSM Plan to Global Fund
GF & LFA assessment process
Proposal recommended for funding
Revise Plan
Implementation
of program in line with Grant
Global Fund approval & disbursement