department of technical cooperation for essential drugs and traditional medicine (tcm) roles and...
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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
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 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 OfficesInteractions 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. UAE
World 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