Department of Technical Cooperation for Essential Drugs and Traditional Medicine (TCM)

Department of Technical Cooperation for Essential Drugs and Traditional Medicine (TCM)

Roles and responsibilities in implementing the WHO Medicines Strategy 2004-2007

Technical Briefing Seminar, Geneva, September 2006

World Health Organization

WHO Medicines Strategy 2004 – 2007: 4 objectives, 7 components, 44 expected outcomes

OBJECTIVES• Policy

• Access

• Quality and safety

• Rational use

COMPONENTS1. Implementation and monitoring of medicines policies2. Traditional and complementary medicine

3. Fair financing and affordability4. Medicines supply systems

5. Norms and standards6. Regulations and quality assurance systems

7. Rational use by health professionals and consumers

Support countries to attain sustainable, uninterruptible,

supply of affordable, quality, safe, efficacious medicines

and their appropriate use

OBJECTIVE

Priorities Identified in WHA:1. Maternal, neonatal, child and

adolescent health 2. Reproductive health3. HIV/AIDS4. TB5. Malaria6. Non-communicable diseases

Strategic areas of work and principles

Ethical practices

Collaboration/cooperation/Building complementarities

Principles

Good governance/accountability/transparency

Support countries to attain sustainable, uninterruptible,

supply of affordable, quality, safe, efficacious medicines

and their appropriate use

OBJECTIVEDemand/need

driven

Consistent message

from WHO: HQ, RO's, CO's

Promote appropriate use of essential medicines including traditional medicines

Guide promoting local production and innovation (R&D) of new medicines for

public health needs

Assist in strengthening Pharmaceutical HR

Provide technical guidance and support on TM

National medicine policies:Support countries to develop, implement,

evaluate & integrate NMP in health systems plan

Assist countries in developing sustainable financing mechanisms

Strengthen national capacity in drug and herbal medicines regulationto ensure quality, safety, efficacy

Assist countries to protect public health in the negotiation and implementation of

international, regional and bilateral trade agreement.

Guide pricing policiesand drug supply management

Assist countries in developingmedicines financing mechanisms

Support initiatives on local production & innovation (R&D) for fulfilling

public health needs

Assist in strengthening Pharmaceutical Human Resources

Provide technical guidance and support on TM

Support countries to develop, implement, evaluate NMP&

integrate them in health systems plans

Promote appropriate and safe use of Essential Medicines

Help strengthen national capacity in medicines regulation

to ensure quality, safety, efficacy

Guide countries to protect public health and implement flexibilities

of trade agreements.

Assist in implementing relevant pricing & supply management policies

HTP

TCM

PSM

Other WHO

Clusters

Interactions with HQ Departments, Regions & Country Offices

Primary interaction

Secondary interaction

AFRO

AMRO

EMRO

EURO

SEARO

WPRO

Country Offices

NPO

NPO

NPO

NPO

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. Sudan

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

Economic Country Groupings in the Region 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. Jordon6. Morocco7. Syria8. Tunisia

1. Lebanon2. Libya3. Oman4. Saudi Arabia

1. Bahrain2. Kuwait3. Qatar4. UAEWorld Bank list of economies, July 2004

Enhanced expertise in countries

CCaammeerroooonn CChhaadd EEtthhiiooppiiaa GGhhaannaa KKeennyyaa MMaallii NNiiggeerriiaa SSeenneeggaall RRwwaannddaa TTaannzzaanniiaa UUggaannddaa DRC

Congo Zambia

• assessing needs and priorities• planning, implementation and

monitoring support on medicines policies

• coordination of stakeholders involved in pharmaceuticals

• feedback and reporting

WHO Medicines advisers in about 30 countries to assist in:

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-regionalization ofthe Program of Essential Medicines,

Vaccines and Technologies

Regional Office

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

Level I, Level II, level III core indicators and tools to assess & monitor pharmaceutical sector in countries

WHO hierarchical approach to monitoring and assessing country pharmaceutical situations

Level I Core structure

& process indicators

Level II Core outcome/impact indicators

Level III

Indicator tools for specific components of the pharmaceutical sector

●Household survey for access●Pricing ●Traditional medicine●Assessing regulatory capacity●Procurement and supply management ●Medicines for children

Systematic survey

Questionnaire (Health Officials)

ObjectivesTo develop prioritized pharmaceutical policy objectives based on evidenceTo determine the effects, impact of pharmaceutical policy implementation over timeTo establish pharmaceutical situation evidence for advocacy ( managers, policy makers, donors)

Indicator for evidence based planning Systematic data gatheringEnables comparisons between facilities, districts, regions, countries depending on samplingFacilitates measuring trendsProvides evidence for prioritising, planning and identifying interventionsUse as indicators for 2000-03 & 04-07 WHO Medicines Strategy

Medicines prices surveys to inform policy changes

Surveys carried out using WHO/HAI methodology in 12 countries in the WHO African Region - March 04/05

Collecting and analyzing medicines prices in 3 sectors - measuring availability, affordability and price components

Surveys carried out by countries to inform policy decisions & change for improving availability and affordability

Cameroon, Chad, Ethiopia, Ghana, Kenya, Mali, Nigeria, Senegal, South Africa, Tanzania, Uganda & Zimbabwe

Support to Medicines Regulatory Authorities

NRA Assessmentusing jointassessment

tools(Drug & vaccine)

NRA Assessmentusing jointassessment

tools(Drug & vaccine)

Follow up visits

Follow up visits

I nstitutional development

plan toaddress gaps

I nstitutional development

plan toaddress gaps

Training needs

Training needs

Technicalsupport

Technicalsupport

5 days assessment 3 months exposureTraining packagesPre-Q programme

NRA Network of regulatory experts

Department of Technical Cooperation for Essential Drugs and Traditional Medicine

Documentation & Information Centre

Medicine Regulatory

Support

Medicine Policy & Supply

Management

Director: TCM

Traditional

Medicines

Associate Director:Finance & TradeDocumentation &

Information Centre

Medicine Regulatory

Support

Medicine Policy & Supply

Management

Director: TCM

Traditional

Medicines

Associate Director:Finance & TradeDocumentation &

Information Centre

Medicine Regulatory

Support

Medicine Policy & Supply

Management

Director: TCM

Traditional

Medicines

Associate Director:Finance & Trade

Medicine Regulatory

Support

Medicine Policy & Supply

Management

Director: TCM

Traditional

Medicine

Associate Director:Finance & Trade

Functions: Team A

POLICY AND MEDICINES SUPPLY MANAGEMENT

• Development, implementation, evaluation of National Medicines Policy (NMP) and integration in health systems plans

• Improvement of procurement and supply management, of drug pricing policies and monitoring

• Identify and implement strategies to promote appropriate use of medicines

• Identify mechanisms to ensure that qualified staff are available to help meet the objectives of the pharmaceutical sector

Functions: Team B

MEDICINE FINANCING AND TRADE• Protection of public health interests in negotiations and

implementation of international, regional and bilateral trade agreement

• Development/strengthening of financing and cost containment mechanisms for medicines

Functions: Team C

MEDICINE REGULATORY SUPPORT • Development/strengthening of national medicine

regulatory and quality assurance systems, to enable them to ensure the safety, quality and efficacy of medicines and combat the circulation of substandard and counterfeit medicines

• Assessment of local production capacity and support

Functions: Team D

TRADITIONAL MEDICINE

• Provide guidance on policy and technical support on Traditional Medicine

• Support inter-country, interregional and international sharing experiences and information and harmonization