edm support to countries example of the african region gilles forte who/edm drug action programme

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


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.


Maximising Country Support5 principles guiding WHO country support in medicines:

1. Co-ordinated efforts within WHO2. Enhanced expertise in country offices.

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4.Evidence based planning and interventions

5. Collaboration with partners

3. Support to countries based on needs and priorities


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.




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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




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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


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




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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


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


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.


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


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




processes

Level II Outcomes





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


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


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


Brand versus generic price ratios-ciprofloxacin

0102030405060708090

100

Price ratio

Armenia Brazil Peru Sri Lanka

Originator brandGeneric


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


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


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...




processes

Level II Outcomes





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


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


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.


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




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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


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


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




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edm support to countries example of the african region gilles forte who/edm drug action programme

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