EDM support to countries example of the African Region Gilles Forte WHO/EDM Drug Action Programme

2 WHO/EDM - Regional & country collaboration Objectives of this session ä At the end of the session participants will understand: nthe WHO global strategy for working with countries nthe EDM strategy for country support nhow EDM work with countries is co-ordinated across WHO (country offices, regional offices, and headquarters) nthe types of support to countries nhow EDM works with other organisations to achieve common goal

3 WHO/EDM - Regional & country collaboration Mission statement for country support ä 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 Support 5 principles guiding WHO country support in medicines: 1. Co-ordinated efforts within WHO 2. Enhanced expertise in country offices Evidence based planning and interventions 5. Collaboration with partners 3. Support to countries based on needs and priorities

5 WHO/EDM - Regional & country collaboration 1.Co-ordinated efforts within WHO WHO HQROs HTP clusters EDM DAP QSMPAR TRM WRs Countries collaborations with other parties supporting countries departments AFRO AMRO EMRO AFRO EURO SEARO WPRO WHO natural operational partners WHO scientific partners WHO strategic partners UNAIDS UNDP Universities, researchcentres World Bank and other development banks UNCTAD WHO collaboratingcentres in pharmaceuticals Pharmaceutical industry European union International health professional associations UNICEF UNFPA Consumer associations NGOs (public interest) working in health WTO WIPO Bilateral co-operation EDM Advisors

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 Support 5 principles guiding WHO country support in medicines: 1. Co-ordinated efforts within WHO 2. Enhanced expertise in country offices 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 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

9 WHO/EDM - Regional & country collaboration 2-Enhanced expertise in country offices Priorities for intensified country collaboration ä Priority health needs ä Good governance ä Motivated counterparts ä WHO country office capacity ä Partnerships ä Available funding ä Likelihood of sustainable impact

10 WHO/EDM - Regional & country collaboration Maximising Country Support 5 principles guiding WHO country support in medicines: 1. Co-ordinated efforts within WHO 2. Enhanced expertise in country offices 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 regions Type A: Situation analysis & monitoring assessment 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 ä Improving access to information on medicines ä Providing technical advise for policy, tools and guidelines ä Supporting capacity building and training programmes ä Strengthening institutions ä Assisting in assessments & surveys-gathering evidence ä Contributing to planning, management and monitoring ä Facilitating partnerships & collaborations

13 WHO/EDM - Regional & country collaboration Maximising Country Support 5 principles guiding WHO country support in medicines: 1. Co-ordinated efforts within WHO 2. Enhanced expertise in country offices 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 ä Raise awareness about real situation (i.e. MOH, WHO) ä Provide “numbers for advocacy” to convince policy- makers of changes ä Set priorities among possible areas for intervention ä Assess country medicines situation and trends over time ä Measure impact of interventions

16 WHO/EDM - Regional & country collaboration Core indicators to monitor national pharmaceutical situations Level I Structures & processes Level II Outcomes Level III Indicator 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 medicines

18 WHO/EDM - Regional & country collaboration ä Affordability nImprove access to price information & monitoring of drug prices nEnsure inclusion of TRIPS safeguards in intellectual property legislation nPromote use of generic medicines of assured quality Interventions to improve affordability of medicines 2. Plan 3. Implement 1. Assess and Monitor

19 WHO/EDM - Regional & country collaboration Using the results: Monitoring and evaluation Assessment and monitoring Access indicatorsBaselineOutcome (1995) (2001) % of population with access to ED 46% 60% Public per capita expenditure on drugsUS$ 0.04 US$ 0.12 Affordability (cost to treat pneumonia/food basket) Public pharmacies 18% 6% Private pharmacies 82% 39% National drug policy and pharmaceutical implementation plan Strategies implemented to improve access Appropriate selection (EDL) Improved drug procurement and management (training, central medical store, regional bulk procurement) Availability and use of generic drugs Baseline (1995) (To formulate drug policy and implementation plan) Outcome (2001) (To measure impact of strategies)

20 WHO/EDM - Regional & country collaboration Core indicators to monitor national pharmaceutical situations Level I Structures & processes Level II Outcomes Level III Indicator 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 ä Promote analysis of medicines affordability ä Make reliable, up-to-date information on medicines prices available particularly in low income countries ä Improve price transparency and empower actors concerned with health and medicines policy ä Compare retail drug prices both within, among countries and over time

22 WHO/EDM - Regional & country collaboration Price components (total markup as % CIF price)

23 WHO/EDM - Regional & country collaboration Policy options to correct higher prices ä Goverment to establish price regulation - from Manufacturer selling price (MSP) to margins in WHOLESALE and RETAIL and/or profesional fees ä Perform (international) price comparisons and price surveys routinely ä Competition likely to be more effective than regulation in many settings ä Need to introduce degressive mark-ups to encourage the dispensing of generics ä Countries should cease taxing essential medicines

24 WHO/EDM - Regional & country collaboration Brand versus generic price ratios- ciprofloxacin

25 WHO/EDM - Regional & country collaboration ä Governments to use the flexibilities of TRIPS for patentted medicines to introduce generics while patents are in force ä Generic Policy on : - substitution - prescribing - consumer education on availability and acceptability of generics ä 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

27 WHO/EDM - Regional & country collaboration Policy options to improve procurement ä Examine efficiency of national procurement processes to ensure best practice ä Use international reference prices as guidelines ä Competitive purchasing with price transparency ä Pool procurement with other national/international buyers ä Use of pharmacoeconomics and other systems to fix MSP

28 WHO/EDM - Regional & country collaboration Country pricing surveys in the African Region ä Training and planning workshop, Tunis February 2004: Algeria, Chad, Cameroon, Mali, Morocco, Tunisia ä Training and survey to start in Uganda 20 April and in Chad 25 April 2004 ä 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 III Indicator 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 ä Review of drug regulatory situation in Ethiopia, Tanzania, Mali, Senegal, South Africa ä 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 ä Training of two staff in drug registration in Zimbabwe each for one month ä Two weeks training on GMP & drug regulation 27 people (DACA staff and industry production and quality assurance heads) ä 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 training  Purchase of dissolution apparatus for QC lab.

33 WHO/EDM - Regional & country collaboration Promotion of drug regulation harmonization ä Technical and financial support to SADC harmonization ä Support the initiation of harmonization and technical cooperation in pharmaceuticals in UEMOA Member States (Economic and Monitory Union of West Africa) ä Sub-regional training courses on registration of generic drugs with emphasis on antiretroviral drugs ä Sub-regional training courses on GMP ä Training courses on the use of SIAMED ä Training in quality control of drugs

34 WHO/EDM - Regional & country collaboration Maximising Country Support 5 principles guiding WHO country support in medicines: 1. Co-ordinated efforts within WHO 2. Enhanced expertise in country offices 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 Organization HQRegional OfficesCountry Offices Countries Ministries of Health Partners in Country Support WHO operational partners UNAIDS, bilateral and multilateral agencies, public interest NGOs in health, UNDP, UNFPA, UNCTAD WHO scientific partners WHO Collaborating Centres in pharmaceuticals, universities, research centres, international health professional associations WHO strategic partners World 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 ä Learn from our differences-mandates and approaches ä Synergy of expertise & know how- for a greater impact ä Enhance CSO participation in policy development & implementation ä Empower CSO and build capacity in the medicines field ä Forge dialogue & links between MOH & CSO-improve credibility

38 WHO/EDM - Regional & country collaboration Maximising Country Support 5 principles guiding WHO country support in medicines: 1. Co-ordinated efforts within WHO 2. Enhanced expertise in country offices Evidence based planning and interventions 5. Collaboration with partners 3. Support to countries based on needs and priorities