Strategy for working with countries Work in progress

Dr Gilles ForteEssential Medicines and Pharmaceutical Policies

WHO Geneva

Technical Briefing Seminar Geneva, 20 November 2008

World Health Organization

Better access to medicines through health systems Strengthening

Multi stakeholders approach

Enhanced capacity in regions

and countries

Support countries for strengthening systems and capacity

to achieve sustainable

availability of affordable, quality, safe, efficacious medicines

and their appropriate use

OBJECTIVE

Based on country needs

strategy & plans

Robust information systems and evidence

Quality health service delivery

Well performing health workforce

Sustainable health financing

Leadership and Governance

HSS

EMP

Other WHO

Clusters

Coordinated efforts within WHO for efficient and sustainable collaboration with Countries

AFRO

AMRO

EMRO

EURO

SEARO

WPRO

Country Offices

NPO

NPO

NPO

NPO

Headquarters:

•Strategy and policy making

•Planning & monitoring

•Partnerships and Collaboration

•Resource Mobilisation

•Provide specific technical& policy support

• Support in HR development & training

Roles and responsibilities for supporting implementation of WHO Medicine Strategy

Roles and responsibilities for supporting implementation of WHO Medicine Strategy

Strategy, policy guidance, support and collaborations

Regional Offices:

• Oversee country operations • Planning and monitoring of country support

• Technical, policy and management support to countries

• Human resources development & training

• Partnerships and collaborations at regional level

Country Offices:

• Assess needs and identify priorities for technical support

• Plan & implement WHO work

•Provide technical and policy support to countries

• Assist in coordination

•Partnerships & collaborationsin countries

•Feedback and report

Ministries of Health:

• Identify needs & priorities

• Plan, implement and monitor action

• Coordinate with other Ministries and national bilateral and multilateral agencies and CSO's.

Planning, implementation, monitoring

Economic Country Groupings in the EMR Low income

countriesUS $ 765 or less

High income countries

$ 9385 or more

Lower middleincome countries from US $ 765 to 3035

Upper middle income countries from $ 3036 to 9385

1. Afghanistan2. Pakistan 3. Somalia 4. Sudan 5. Yemen

1. Djibouti 2. Egypt3. Iran4. Iraq5. Jordan6. Morocco7. Syria8. Tunisia

1. Lebanon2. Libya3. Oman4. Saudi Arabia

1. Bahrain2. Kuwait3. Qatar4. UAE

World Bank list of economies, July 2004

Country Groupings in the EMRNon-Arabic countries

•

GCCcountries

Arab League•

Countries in emergencies

Big countries with sizable pharma industry

1. Afghanistan2. Iraq3. Pakistan4. Somalia 5. Sudan6. oPt

1. Afghanistan2. Iran3. Pakistan

22 / 57 countries are in the EMR

1. Egypt2. Iran3. Pakistan

1. Bahrain2. Kuwait3. Oman4. Qatar5. Saudi Arabia6. UAE

20 / 22 countries of the League are in the EMR

Franchophone countries

OIC

1. Morocco2. Tunisia3. Djibouti

Out of 22 EMR countries 14 are in Asia and 8 are in Africa

Enhanced expertise in countries & sub regional economic blocks in Africa

• Assessment of needs and priorities • Support planning, implementation

and monitoring of medicines policies• Coordination of stakeholders

involved in pharmaceuticals

WHO Medicines advisers in 16 countries, in sub regional economic blocks to assist in:

BurundiCameroonCentral African Rep.ChadCongoDemocratic Rep. of the CongoEthiopiaGhanaKenyaMaliNigeriaRwandaSenegalUgandaUnited Rep. of TanzaniaZambia

EAC

UEMOA

Subregional post IntlCaribbean

WHO CC Drug Supply

Subregional post IntlMERCOSUR

Subregional post National Officer

Subregional postCentral America

WHO CC Drug Policies

WHO CC Rational Use

WHO CC Drug Supply

WHO CC Drug Policies

Sub-regional offices for the Program of Essential

Medicines, in the Americas

Regional Office

Pacific island countries

1. Cook Islands1. Cook Islands2. Fiji2. Fiji3. Kiribati3. Kiribati4. Marshall Islands4. Marshall Islands5. Micronesia5. Micronesia6. Nauru6. Nauru7. Niue 7. Niue 8. Palau 8. Palau 9. Papua New Guinea9. Papua New Guinea10. Samoa 10. Samoa 11. Solomon Islands11. Solomon Islands12. Tonga12. Tonga13. Tuvalu13. Tuvalu14. Vanuatu14. Vanuatu

Support to policy changes based on evidence

data used to identify gaps - set objectives & priority interventions – develop work plans and estimate resource needed

Regional/country plans implemented in coordination with all partners: bilateral and multilateral agencies, NGOs, and other stakeholders

WHO developed Level I, Level II, level III indicators & tools to assess & monitor pharmaceutical sector in countries (structures, process & outcomes)

Type B: Specific technical support

• Ad hoc or regular support usually focused on specific 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 national programme officer• Covers most or all of the EMS areas: policy; access, quality, safety & efficacy, and rational use

Type A: Situation analysis & Monitoring

• Assessment of pharmaceutical situation, identify priority needs – recommendations for interventions

Type IC: Inter-country

• Ad hoc or regular support involving two or more countries often in the same region • Usually focused on specific areas: policy; access; quality, safety & efficacy; and rational use

Activities Driven by Country Needs & PrioritiesActivities Driven by Country Needs & Priorities

Activities are identified in conjunction with countries and responsive to country needs Activities are also based on WHA & EB Resolutions

Seeking evidence for transparency and policy making in countries

Collaborate with countries & build capacity to:

• Establish evidence on strengths & weaknesses of country pharmaceutical sector, prioritize policy and advocacy interventions for improving efficiency of pharmaceutical systems (policy makers, donors)

• Measure trends of pharmaceutical sector over time and among countries

• Make information available for increased transparency & accountability and improving governance

• Household survey– Cost, availability, affordability– Patients attitudes– Rational use for acute and chronic

conditions

Level I Core structure &

process indicators

Level II Core outcome/impact indicators:

access to, rational use of medicines

Level III In-depth assessment of specific components

of the pharmaceutical sector

. Pricing Medicines for children . Supply chain Assessing regulatory capacity

Systematic surveys (facilities, HH)

Questionnaire (Health officials)

Assessing pharmaceutical situations in 2008

At global level: 2007 Level 1 survey completed and analysed – WMS 2009; Level 2 package finalised and published

At Regional level:

Training on monitoring in St Vincent and Accra

At country level: Level 2 & House Hold piloted in 9 countries (Gambia, Ghana, Kenya, Uganda, Nigeria, Jamaica, The Philippines, Trinidad & Tobago, Tonga)

2007 Level 1 survey in the African Region

NMPComparison 2003 - 2007

In all middle income countries a NMP has been available in both 2003 and 2007

Among the low income countries an increase in countries with NMP can clearly be noted

Countries with NMPs in 2003-2007a

25

8

30

8

50.0% 75.0% 100.0%

Low income

Middle income

Coun

trie

s with

NM

P by

in

com

e le

vel

Percentage

2007

2003

a For countries with data on both years .a for countries with data on both years

2007 Level 1 survey in the African Region

National STGsa

19

6

25

7

0.0% 25.0% 50.0% 75.0% 100.0%

Low income

Middle income

Coun

trie

s w

ith

nati

onal

ST

G b

y in

com

e le

vel

Percentage

20072003

a for countries with data on both

Primary Health Care STGsa

4

14

7

15

0.0% 25.0% 50.0% 75.0% 100.0%

Low income

Middleincome

Coun

trie

s w

ith

PHC

STG

s by

inco

me

leve

l

Percentage

20072003

a for countries with data on both

Hospital STGsa

2

13

5

7

0.0% 25.0% 50.0% 75.0% 100.0%

Low income

Middleincome

Coun

trie

s with

hos

pita

l ST

Gs b

y in

com

e le

vel

Percentage

20072003

a for countries with data on both years

STGsComparison 2003 - 2007

Both middle and low income country show an increase of all STGs

Level 2 surveys for setting targets

% availability of key drugs in public sector

46%

78%73% 72%

25%

55%

75%

15%

0%

20%

40%

60%

80%

100%

Rural 1 Rural 2 Rural 3 Kampala

Health Facility

Warehouse

Ministry Target =

90%

House hold surveys indicators of geographic access

Procurement prices – public sectorLowest Priced Generic

0.57

0.95

0.61

0.88

3.29

1.69

0.66 0.710.8

1.3

0

2

4

6

Cam

eroon (n=12)

Chad (n=17)

Ethiopia (n=22)

Ghana (n=26)

Kenya (n=24)

Mali (n=33)

Nigeria (n=18)

Senegal (n=33)

Tanzania (n=32)

Uganda

Pric

e (M

PR

)

75th percentile

25th percentile

Median

n= number of medicines

Procurement prices – public sectorof Lowest Priced Generic

Patient price vs procurement price in the public and private sector (LPG) - matched

pairs of same medicines

9.3

14.9

5.3

3.1

4.0

2.9

4.0 3.9

2.61.8

1.3

7.3

2.12.0

3.5

1.3

3.3

2.4 2.02.9

3.5

00

4

8

12

16

C ameroon(n=17)

C had(n=5)

Mali(n=30)

Tanzania(n=28)

S enegal(n=20)

G hana(n=30)

E thiopia(n=36)

K enya(n=28)

Zimbabwe(n=25)

Nigeria(n=19)

Uganda(n=38) (*)

Pri

ce (M

PR

)

P rivate

P ublic

n = number of medicines

Components of medicines prices

ComponentComponent Kenya*Kenya* Uganda**Uganda**

Manufacturer’s Manufacturer’s selling priceselling price (MSP) (MSP)

43-59%43-59% 24-77%24-77%

Landed costsLanded costs 2-4%2-4% 5-14%5-14%

WholesaleWholesale 1-43%1-43% 3-23%3-23%

RetailRetail 17-50%17-50% 0-68%0-68%

Dispensed (final) Dispensed (final) price: VAT, GSTprice: VAT, GST

0%0% 0%0%

Price components and essential medicines in Kenya. WHO 2006Price components and essential medicines in Kenya. WHO 2006**Levison L. Investigating price components, WHO**Levison L. Investigating price components, WHO 20062006

Ethiopia: 71 days

Kenya: 24 days

Nigeria: 30 days

Ghana: 107 days

South Africa: 9 days

Affordability of medicines in the private sector for a family* : Originator Brand

* an asthmatic child with a respiratory infection, an adult with diabetes and hypertension and another adult with a peptic ulcer

It would take more than 2 weeks wages in 6 out of 7 countries for a month treatment (where Originator brands were found)

Cameroon 47 days

Senegal: 18 days

Affordability and financing in 2008

• At global level: update of the medicines prices surveys methodology and tools

• At regional level: UEMOA, EAC

• At country level:

Support provided to monitor and disclose medicines prices: Ghana, Uganda, Tanzania, Kenya

Support for establishing sustainable financing including through health insurance: Burundi, Ghana, Kenya, Nigeria, Tanzania, Uganda

Surveys on patients prices and & components: Zambia, Malawi, Mauritius, Rwanda; Barbados, Bahamas, Trinidad & Tobago

Sub regional collaboration - expected benefitsand opportunities

• Sharing information and experience on medicines policy• Sharing information on medicines quality & suppliers performance • Promoting transparency and good governance

• Efficient pooling of resources & expertise – financial, technical and human• Stronger negotiating & purchasing power – economies of scale• Joint assessments, inspections, dossier evaluation

• Alignment of policies and regulations for improving access • Harmonize standard treatment guidelines and medicines lists

Pre requisites for efficient sub regional collaboration

• Shared political commitment from countries• Regional structures and capacity• Coordination mechanisms among countries • Human resources available in countries • Countries medicines policies and guidelines

developed and endorsed e.g. PSM; EML - • Legal and regulatory framework - disparities• Information sharing mechanisms e.g. regulation,

pricing & patents• Sustainable financing mechanisms • Capacity building plan

Collaboration with sub regional groups

• CEMAC, Caribbean, PIC: medicines policy assessments (Level 1 & 2) & alignment

• EAC, SADC, Caribbean, PIC: procurement & regulations

• UEMOA: medicines policies & regulations

HQHQ Regional Offices Regional Offices Country OfficesCountry Offices Ministries of HealthMinistries of Health

Partners in Country SupportPartners in Country Support

WHO operational WHO operational partnerspartnersUN agencies e.g. UN agencies e.g. UNDP, UNFPA, UNDP, UNFPA, UNICEF; UNICEF; NGOs, NGOs, CSOsCSOs

WHO scientific WHO scientific partnerspartnersWHO Collaborating WHO Collaborating Centres in Centres in pharmaceuticals, pharmaceuticals, universities, research universities, research centres, international centres, international health professional health professional associationsassociations

WHO strategic WHO strategic partnerspartnersWorld Bank and World Bank and development banks, development banks, Donor Agencies Donor Agencies e.g. EU, DFID, e.g. EU, DFID, pharmaceutical pharmaceutical industry, WTO, industry, WTO, WIPO, TGF, WIPO, TGF, UNITAIDUNITAID

Links with partners at global, regional & country level

Links with partners at global, regional & country level

WHO Countries

WHO/HAI Africa Regional Collaboration

Goal Improved policies and practices to increase ATM

Purpose Improved collaboration among MOH, WHO and HAI Africa/network of CSOs (to increase availability and affordability of medicines in selected countries)

Output 1 Activities

Collaboration mechanisms operational at global and country levelManagement mechanisms in place at global and country levels Effective processes implemented for collaborative planning, budgeting, management, implementation and monitoring

Output 2 Activities

Access to quality information and collaborative activities related to affordability, availability and rational use increasedResearch and data collection: Pricing surveys and medicines price monitoring Policy advocacy and communications: At least two communication and advocacy activities per country; policy and guidelines revision; rational drug use promotion; intellectual property rights and public health safeguards in place/maintained.

WHO/HAI Africa Regional Collaboration

MOHPharmacy Division

EDP

WHOTCM – EDM AFRO& national advisers

HAI AfricaCS members

Improved collaboration for impact on better

policies and practices for ATM

WHO/HAI Africa Regional Collaboration-qualitative analysis

Hypothesis: collaborative working enhances the impact of diverse stakeholders on common goals

The review found the Collaboration added value as:

• a forum to generate synergies among stakeholders with diverse interests and expertise

• an enabling mechanism for the MOH and civil society to increase mutual trust and respect and to engage as strategic partners in policy processes

• a dynamic process for consultative, policy-relevant research to meet country needs and increase the likelihood of policy implementation

Goal: increased access to medicines

Purpose: promote a multi-stakeholder approach to improve transparency, governance, efficiency and accountability, and encourage responsible business practices.

Objectives: establish multi-stakeholder process in 7 countries and internationally; encourage progressive disclosure of data on availability, price, quality and promotion of medicines; use the evidence to improve policies and practice; design a sustainable approach

The MeTA “model”

MeTA’s Focus

• MeTA’s focus will be on strengthening country capacity to collect, analyse, disseminate and use data on medicine quality, availability, pricing and promotion/use.

• This will help improve transparency and accountability around the way medicines are selected, regulated, procured, distributed, supplied and then sold to and used by patients.

32

Incentives for MeTA stakeholders

Ministries & Gov. agencies

Civil society

Private sector

Int. institutions

DPs

Pharmaceutical companies (generic and patent)

•Access to more information on medicines needs•Active role in national policy agenda•Visibility & concerned by public health issues•Address quality matters

•Improve health systems efficiency & access to medicines •Commitment to good governance & transparency agenda•Promote multi stakeholders inclusive approach

• Active role in national policy agenda

•Supportive environment for advocacy•Financial and other support•Improved dialogue with public and private sectors

Good governance agendaTackle corruptionIncrease access to medicinesSupport responsible business

•Promote transparency & good governance agenda•Improve health systems efficiency & access to medicines

Wholesales, distributors, retailers

•Access to more information Opportunity for building capacity & improve business practices•Active role in policy agenda