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EDM support to countries
example of the African RegionGilles ForteWHO/EDM
Drug Action Programme
2 WHO/EDM - Regional & country collaboration
Objectives of this sessionAt the end of the session participants will understand:
the WHO global strategy for working with countries the EDM strategy for country support how EDM work with countries is co-ordinated across WHO (country offices, regional
offices, and headquarters) the types of support to countries how EDM works with other organisations to achieve common goal
3 WHO/EDM - Regional & country collaboration
Mission statement for country support
Support countries for the development, implementation and monitoring of relevant medicines policies and programmes and for building sustainable environment and capacity that will ensure that quality, safe and effective essential medicines are available, affordable to the population and are used appropriately.
4 WHO/EDM - Regional & country collaboration
Maximising Country Support5 principles guiding WHO country support in medicines:
1. Co-ordinated efforts within WHO2. Enhanced expertise in country offices.
5.
4.Evidence based planning and interventions
5. Collaboration with partners
3. Support to countries based on needs and priorities
6 WHO/EDM - Regional & country collaboration
1-Co-ordinated efforts within WHO
Headquarters: Strategy & policy making Planning & monitoring Specific technical & policy support Strategy for development & training Partnerships and collaboration
Regional Office: Oversee country operations Planning and monitoring Technical, policy and management support Human resources development & training Partnerships and collaborations
Country Offices: Assess needs and identify priorities for technical support Plan & implement WHO work Assist Co-ordination Partnerships &collaborations Feed back and report
Ministries of Health: Identify needs & priorities Plan, implement and monitor action Co-ordinate with bilateral and multilateral agencies and CSOs.
7 WHO/EDM - Regional & country collaboration
Maximising Country Support5 principles guiding WHO country support in medicines:
1. Co-ordinated efforts within WHO2. Enhanced expertise in country offices.
5.
4.Evidence based planning and interventions
5. Collaboration with partners
3. Support to countries based on needs and priorities
8 WHO/EDM - Regional & country collaboration
2-Enhanced expertise in country offices
Cameroon Chad Ethiopia Ghana Kenya Mali Nigeria Senegal Rwanda Tanzania Uganda
Medicines Advisors to:
Assist in planning, implementation and monitoring of medicines policies
Assist in coordination of partners involved in pharmaceuticals
There are 11 medicine advisors in Africa
10 WHO/EDM - Regional & country collaboration
Maximising Country Support5 principles guiding WHO country support in medicines:
1. Co-ordinated efforts within WHO2. Enhanced expertise in country offices.
5.
4.Evidence based planning and interventions
5. Collaboration with partners
3. Support to countries based on needs and priorities
11 WHO/EDM - Regional & country collaboration
3-Support to countries: based on needs & priorities
Type A.
Type B.
Country needs and priorities Needs and priorities from countries or
regionsType A: Situation analysis & monitoringassessment of pharmaceutical situation, identify priority
needs - recommendations for interventions
Type B: Specific technical support
Ad hoc or regular support Usually focused on a
subset of the following areas: policy; access; quality, safety & efficacy; and rational use
Type C: Comprehensive programme support
Time frame may cover one or more biennia
Usually involves a full-time pharmaceutical adviser in the country
Covers most or all of the following areas: policy; access; quality, safety & efficacy; and rational use
Type IC: Intercountry Ad hoc or regular
support involving two or more countries often from the same region
Usually focused on a subset of the following areas: policy; access; quality, safety & efficacy; and rational use
12 WHO/EDM - Regional & country collaboration
3-Support to countries: based on needs and priorities
Improving access to information on medicines Providing technical advise for policy, tools and guidelines Supporting capacity building and training programmes Strengthening institutions Assisting in assessments & surveys-gathering evidence Contributing to planning, management and monitoring Facilitating partnerships & collaborations
13 WHO/EDM - Regional & country collaboration
Maximising Country Support5 principles guiding WHO country support in medicines:
1. Co-ordinated efforts within WHO2. Enhanced expertise in country offices.
5.
4.Evidence based planning and interventions
5. Collaboration with partners
3. Support to countries based on needs and priorities
14 WHO/EDM - Regional & country collaboration
4-Evidence based planning and interventions
Based on assessing and monitoring the pharmaceutical situation, objectives can be established and targeted interventions planned
Interventions should be implemented in coordination with partners, including bilateral and multilateral agencies, NGOs, and other stakeholders
WHO has developed indicator-based tools to evaluate structures, processes, outcomes and several specific pharmaceutical components
15 WHO/EDM - Regional & country collaboration
Rationale for an evidence-based approach
Raise awareness about real situation (i.e. MOH, WHO)Provide “numbers for advocacy” to convince policy-makers of
changesSet priorities among possible areas for interventionAssess country medicines situation and trends over timeMeasure impact of interventions
16 WHO/EDM - Regional & country collaboration
Core indicators to monitor national pharmaceutical situations
Level I Structures &
processes
Level II Outcomes
Level IIIIndicator tools for specific components of the pharmaceutical sector such as
• Pricing• HIV/AIDS• TRIPS
•Regulatory capacity •Traditional medicine• etc.
17 WHO/EDM - Regional & country collaboration
Affordability of medicinesAffordability of Treatment of Pneumonia in 5 African Countries: Average Number of Day's Wage of Lowest
Government Salary Needed to Pay for Treatment
1.6 1.41.53.3
0.4 0.7
5.8
1.3 1.4
10.5
1.1 1.3 1.5 1.4
02468
1012
Public Health FacilityPharmacies
Adults
Private Pharmacies Public Health FacilityPharmacies
Children
Private Pharmacies
Country 1 Country 2 Country 3 Country 4 Country 5
18 WHO/EDM - Regional & country collaboration
Affordability Improve access to price
information & monitoring of drug prices
Ensure inclusion of TRIPS safeguards in intellectual property legislation
Promote use of generic medicines of assured quality
Interventions to improve affordability of medicines
2. Plan3. Implement
1. Assess and Monitor
20 WHO/EDM - Regional & country collaboration
Core indicators to monitor national pharmaceutical situations
Level I Structures &
processes
Level II Outcomes
Level IIIIndicator tools for specific components of the pharmaceutical sector such as
• Pricing• HIV/AIDS• TRIPS
•Regulatory capacity •Traditional medicine• etc.
21 WHO/EDM - Regional & country collaboration
WHO/HAI pricing project in countries
Promote analysis of medicines affordability
Make reliable, up-to-date information on medicines prices available particularly in low income countries
Improve price transparency and empower actors concerned with health and medicines policy
Compare retail drug prices both within, among countries and over time
22 WHO/EDM - Regional & country collaboration
Price components (total markup as % CIF price)
0 % 20 % 40 % 60 % 80 % 100 % 120 % 140 % 160 %
South Africa publicprocurement
Sri Lanka public
Sri Lanka private
Armenia private, observedminimum
Armenia private, observedmaximum
Kenya private, observedminimum
Kenya private, observedmaximum
Peru private, observedmaximum
customs, fees, insurance, clearance import tax importer mark-updistribution/wholesale mark-up retail mark-up VAT
23 WHO/EDM - Regional & country collaboration
Policy options to correct higher prices
Goverment to establish price regulation - from Manufacturer selling price (MSP) to margins in WHOLESALE and RETAIL and/or profesional fees
Perform (international) price comparisons and price surveys routinely Competition likely to be more effective than regulation in many settings Need to introduce degressive mark-ups to encourage the dispensing of generics Countries should cease taxing essential medicines
24 WHO/EDM - Regional & country collaboration
Brand versus generic price ratios-ciprofloxacin
0102030405060708090
100
Price ratio
Armenia Brazil Peru Sri Lanka
Originator brandGeneric
25 WHO/EDM - Regional & country collaboration
Governments to use the flexibilities of TRIPS for patentted medicines to introduce generics while patents are in force
Generic Policy on :
- substitution- prescribing- consumer education on availability and acceptability of generics
Change remuneration policy to dispensing fees and degressive margins
Policy options to reduce originator brand premiums
26 WHO/EDM - Regional & country collaboration
Meeting on the impact of globalization (Jakarta, May 2000) (9)
Briefing on TRIPS (SADC) South Africa, June 2000) (7)
Workshop on TRIPS (Harare, August 2001) (4)
Intercountry meeting on the TRIPS Agreement (Warsaw, September 2001) (22)
Country support (9)
Participants in both, South Africa and Harare meetings (11)
Meeting on TRIPS in OAPI countries (Yaoundé, May 2002) (15)
WHO policy and technical support on TRIPS to over 60 countries - health, trade and patent officials
28 WHO/EDM - Regional & country collaboration
Country pricing surveys in the African Region
Training and planning workshop, Tunis February 2004: Algeria, Chad, Cameroon, Mali, Morocco, Tunisia
Training and survey to start in Uganda 20 April and in Chad 25 April 2004
Regional training and planning workshop for Anglophone African countries in June-July 2004: Ethiopia, Tanzania, Ghana, Kenya...
29 WHO/EDM - Regional & country collaboration
Core indicators to monitor national pharmaceutical situations
Level I Structures &
processes
Level II Outcomes
Level IIIIndicator tools for specific components of the pharmaceutical sector such as
• Pricing• HIV/AIDS• TRIPS
•Regulatory capacity •Traditional medicine• etc.
30 WHO/EDM - Regional & country collaboration
Support to improve drug regulation in Africa-some examples
Review of drug regulatory situation in Ethiopia, Tanzania, Mali, Senegal, South Africa
Three year work plan developed with Ethiopia, Tanzania, Mali and Senegal
31 WHO/EDM - Regional & country collaboration
Improving information management, communication, transparency and accountability
Networking of computers of DACA and creation of website and training of web site operators
Donation of computers Provision financial assistance to cover local cost
Training of two staff in drug registration in Zimbabwe each for one month Two weeks training on GMP & drug regulation 27 people (DACA staff and industry production and quality assurance heads) Provision different publications and guidelines
Support to the Drug Administration and Control Authority (DACA) of Ethiopia-Phase 1
32 WHO/EDM - Regional & country collaboration
Support to Tanzanian Food and Drug Authority (FTDA) –Phase 1
Improving information management and communication, transparency and accountability
Purchase of new computers Networking of computers Creation of website and training of web site managers
Financial support to public and decision-makers awareness programmes- Radio /TV spots, posters and brochures
Financial support to quality surveillance Support to participation in GMP trainingPurchase of dissolution apparatus for QC lab.
33 WHO/EDM - Regional & country collaboration
Promotion of drug regulation harmonization
Technical and financial support to SADC harmonizationSupport the initiation of harmonization and technical cooperation in
pharmaceuticals in UEMOA Member States (Economic and Monitory Union of West Africa)
Sub-regional training courses on registration of generic drugs with emphasis on antiretroviral drugs
Sub-regional training courses on GMPTraining courses on the use of SIAMEDTraining in quality control of drugs
34 WHO/EDM - Regional & country collaboration
Maximising Country Support5 principles guiding WHO country support in medicines:
1. Co-ordinated efforts within WHO2. Enhanced expertise in country offices.
5.
4.Evidence based planning and interventions
5. Collaboration with partners
3. Support to countries based on needs and priorities
35 WHO/EDM - Regional & country collaboration
World Health OrganizationHQ Regional Offices Country Offices
Countries Ministries of Health
Partners in Country SupportWHO operational partnersUNAIDS, bilateral and multilateral agencies, public interest NGOs in health, UNDP, UNFPA, UNCTAD
WHO scientific partnersWHO Collaborating Centres in pharmaceuticals, universities, research centres, international health professional associations
WHO strategic partnersWorld Bank and development banks, pharmaceutical industry, WTO, WIPO, EU
Collaboration with partners
36 WHO/EDM - Regional & country collaboration
WHO/EDM-HAI Africa Regional collaboration for action on essential medicines in Africa
1. Increased access to essential medicines through improved policies and practices - joint priority areas of work: pricing and IPR issues
2. Increased capacity and participation of NGOs and consumers in the development and implementation of medicines policy in countries
3. Expanded CSO participation in and strengthened coordination of the HAI Africa Network
4. Project countries: Uganda, Kenya and Ghana
37 WHO/EDM - Regional & country collaboration
Rationale for WHO-CSO collaboration in countries
Learn from our differences-mandates and approaches Synergy of expertise & know how- for a greater impact Enhance CSO participation in policy development &
implementationEmpower CSO and build capacity in the medicines fieldForge dialogue & links between MOH & CSO-improve credibility
38 WHO/EDM - Regional & country collaboration
Maximising Country Support5 principles guiding WHO country support in medicines:
1. Co-ordinated efforts within WHO2. Enhanced expertise in country offices.
5.
4.Evidence based planning and interventions
5. Collaboration with partners
3. Support to countries based on needs and priorities