Transcript WHO Technical Briefing Seminar Geneva 29 October- 02 November 2012 WHO Strategy for working with and in countries Dr Gilles Forte Essential Medicines and Health.

WHO Technical Briefing Seminar
Geneva 29 October- 02 November 2012
WHO Strategy for working with and in countries
Dr Gilles Forte
Essential Medicines and
Health Product Department
Medicine Programme Coordination (MPC)
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WHO-Technical Briefing Seminar | October-November 2012
Gilles Forte
Department for Essential Medicines and Health
Products (EMP) - areas of work
Medicines Policy, Information and Country Support
Indicators and tools for pharmaceutical sector monitoring & assessment
Medicines Policy; country collaboration and support
Transparency & Good governance in medicines
Publications & website
Quality Assurance and Safety: Medicines
Norms/standards (nomenclature)
Quality assurance (incl. blood products)
Safety / pharmacovigilance
Prequalification of medicines; Regulation
Medicines Access and Rational Use
Rational use and ant-microbial resistance
Selection of essential medicines
Supply systems; Psychotropics & narcotics, including substance
evaluation
Access controlled meds
Medical Devices and Diagnostics
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Policies, norms/standards
Prequalification, quality and safety
Management; Access & use; Regulation
WHO-Technical Briefing Seminar | October-November 2012
Gilles Forte
Mandate and Resolutions
 WHO Constitution:
Article 1: “The Objective of WHO shall be the attainment by all peoples
of the highest possible level of health”;
Article 2: “(a) to establish and maintain effective collaboration with
governmental health administrations; (b) to assist Governments upon
request, in strengthening health services; (c) to furnish appropriate
technical assistance and, in emergencies, necessary aid upon the
request or acceptance of Governments”;
 Resolutions: Rational use WHA 60.16/2007; Essential Medicines
for Children WHA 60.20/2007; Pricing: WHA 54.11/2001; Availability
WHA 57.14/2004;
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Implementation of the WHO Medium-Term
Strategic Plan 2008-2013 :
Strategic Objective (SO-11) :
To ensure improved access, quality and use of medical products
and technologies
Organization-wide expected results : (OWERs)
11.1 Formulation and monitoring of comprehensive national policies on
access, quality and use of essential medical products and
technologies advocated and supported;
11.2 International norms, standards and guidelines for the quality, safety,
efficacy and cost-effective use of medical products and technologies
developed and their national and/or regional implementation
advocated and supported;
11.3 Evidence-based policy guidance on promoting scientifically sound
and cost-effective use of medical products and technologies by
health workers and consumers developed and supported within the
Secretariat and regional and national programmes.
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WHO-Technical Briefing Seminar | October-November 2012
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WHO added value for working with
countries
 Development of norms, standards, guidelines; (e.g. Expert
Committees; Advisory Committees)
 Access to information and expertise in the health and
pharmaceutical sector for global advocacy (e.g. pool of experts;
collaborating centres).
 Expertise and operational capacity at country level for advocacy,
policy advice and capacity building in line with country needs;
 Convening power for effective collaboration, coordination and policy
dialogue among national and international stakeholders;
 Monitoring and evaluation of policies: development of
methodologies, tools and strengthening of countries' capacities.
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WHO: 193 Member States
Regional and Sub-Regional Offices
Regional Office AFRO
Regional Office EMRO
Regional Office EURO
Regional Office WPRO
Regional Office SEARO
Regional Office AMRO
WHO HQ Geneva
(Source: http://www.who.int/about/regions/en/index.html)
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WHO Country Medicines Advisers and
Collaborating Centres
Medicines Adviser
Collaborating Centre
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Coordination mechanisms
for a sustainable collaboration with countries
Cameroon
AFRO
WHO
HSS
EMP
AMRO
EMRO
EURO
SEARO
WPRO
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Tanzania Mali
Uganda
Ghana
Zambia
Brazil
Lybia Jordan
Egypt Sudan
Pakistan
The WHO Country Medicines Advisers
Network for Africa
50 Medicines Advisers in 40 countries
(15 in Africa) contribute to:
UEMOA
Burundi
Cameroon
Central African Rep.
Congo
Democratic Rep. of the Congo
Ethiopia
Ghana
Kenya
Mali
Nigeria
Rwanda
Senegal
Uganda
United Rep. of Tanzania
Zambia
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CEMAC
EAC
SADC
WHO-Technical Briefing Seminar | October-November 2012
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• Assessing national medicines needs &
priorities;
• Planning, Implementing, Monitoring
and Evaluate WHO interventions;
• Facilitating coordination of partners;
• WHO Regional work on medicines and
health systems;
EMP partners at global, regional and country levels
Coordination mechanisms for a sustainable
collaboration with countries
WHO/HSS
EMP Department
WHO:
WHO Regional Offices
WHO Country Offices
MoH
Outside MOH:
Drug regulatory agencies,
national procurement centres,
insurance, universities,
missions, NGOs, consumers
HIV, MAL,
TB, RH,
Collaborat.
Centres
UN: IPC
NGOs:
UNICEF,
UNAIDS,
UNFPA,
WBank,
GFATM,
UNITAID
MSF, HAI,
MSH, MDM,
JSI, FIP,
etc
Private sector:
IGPA, IFPMA,
etc
National programmes with improved access to quality medicines for patients
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Highlights on major WHO Medicines
Programmes in Countries
 Country Support programmes for improved access to and use of medicines:
– Support to individual countries upon demand (e.g. China; India; Viet
Nam etc.);
– Regional (multi-country) collaboration programmes:
1. EU/WHO/African Countries (15) for Health Related MDGs & UHC;
2. Muskoka Initiative to improve access to and use of essential medicines
for women and children in 7 African countries & contribute to the
achievements of MGDs 4 and 5;
 Support to Transparency and Good Governance in Pharmaceutical Sector:
– Good Governance for Medicines Programme
– Medicines Transparency Alliance initiative
Support to countries Regulatory Authorities and sub-regional
Harmonization
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Renewed Partnership between
EU, WHO & Countries in Africa (2012-2016)
 To contribute to the achievement of health-related MDGs and of Universal
Health Coverage in 15 countries in Africa;
 By improving availability, affordability and use of safe, effective and quality
assured essential medicines;
 Key principles:
–
–
–
–
–
Focus on implementation of national pharmaceutical policies;
Focus on countries and regions' needs and priorities;
Build on work done, ensure sustainability and country ownership;
Improve coordination among key partners and donors;
Promote inter-country collaboration and sharing of expertise in order to
strengthen capacity and reinforce regional integration;
– Improve transparency and good governance of the pharmaceutical sector in
countries;
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Renewed Partnership between
EU, WHO & Countries in Africa (2012-2016)
Expected results:
1) Mean availability of key essential medicines in the public sector increased
by up to 10%;
2) Median consumer price ratio of key essential medicines in the public and
private sector is reduced by up to 10%;
3) Proportion of essential medicines complying with required national quality
& safety regulatory standards increased by up to 5%;
4) Number of prescriptions that comply with National Essential Medicines
List/Standard Treatment Guidelines increased by up to 10%.
5) Reliable data on the pharmaceutical sector of countries is collected,
analyzed and disseminated; trasparency and good governance improved;
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Result from the EU/WHO/ACP Partnership (2004-2010)
Assessment of pharmaceutical situation and development
of national policies and implementation plans
• Data on pharmaceutical situation collected in 68 ACP countries in
2007, data analysed and Regional reports have been published.
• In-depth assessment of pharmaceutical policy at health-centre and
household levels of 20 ACP countries; Large quantity of data collected
and analyzed by national experts for advocacy and for policy
implementation and monitoring.
• 40 countries supported to develop national medicine policies and
implementation plans. 15 of them have officially approved their policies.
Common policies have been developed in CEMAC and SADC.
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Result from the EU/WHO/ACP Partnership(20042010); Regulation and Quality Assurance
Between 2004 and 2010:
 More than 30 countries have received support to evaluate their Medicines
Regulatory Authorities.
 10 countries have installed the software SIAMED for registering
medicines.
 15 countries have been supported to produce laws aimed at better
regulating their pharmaceutical sector (e.g. Mali, Nigeria, Senegal, Sudan,
etc.).
 23 countries have received support to strengthen monitoring of adverse
reactions to medicines.
 15 countries have received technical assistance to test quality of
medicines in the market and to fight counterfeit medicines.
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Result from the EU/WHO/ACP Partnership (2004-2010)
Measuring medicines availability
République du Mali
Ministère de la santé
Systèmes d'approvisionnement des produits pharmaceutiques au MALI. Janvier 2008
100%
MEDICAMENTS
ESSENTIELS
PALUDISME
Y compris CTA
ARVs
TB
ARVs
Ped
IO
REACTIFS
sécurité du sang
(+ test HIV)
MII
VACCINS
Préservatifs
Maladies
tropicales
négligées
Contraceptifs
Dispositifs
Médicaux
Median availability basket of key medicines, public , private & mission
sectors 2004-8
Etat
Bailleurs
bilatéraux
Bailleurs
multilatéraux
75%
ONG/Privé
FONDS
MONDIAL
PPM
ETAT
Sources
de
Financement
G
D
F
O
M
S
U
N
I
T
A
I
D
U
N
I
C
E
F
Malaria
No More
USA
P
F
I
Z
E
R
U
E
E
S
T
H
E
R
G
A
V
I
K
F
W
U
S
A
I
D
I
P
P
F
F
N
U
A
P
M
S
D
S
C
I
Grossistes
privés /
Population
SCI
Grossistes
privés
50%
Structure
d'approvisionnement
1er point
de stockage
2ème point
25%
de stockage
DAF
PPM
DRS
PNLT
GDF
OMS
OMS
CLINTON
UNICEF
UNICEF
DIFLUCAN
DNS
ITI
BIOMALI
JSI
Site
PPM
PSI
USAID
PSI
CAG
IPPF
FNUAP
MECTIZAN
Private medianGrossistes privés
DPM
Public median
CS Ref
3ème point
de stockage
Structure
dispensatrice
DRS
PNLT
DRS
CS Ref
Magasin régional PPM
Mission
Grossistes
privés
DRC
CS Ref
CSCOM
Grossistes privés
CAG
PH
DV CS Ref
DV CSCOM
0%
Site prise en charge
Site de dépistage
Linear (Private median)
Linear (Public median)
Linear
AMPPF (Mission)
OFFICINES
DNS/Vacc
PATIENT
Oct-04
Apr-05 | October-November
Oct-05
Apr-06
WHO-Technical
Briefing Seminar
2012
16 | Apr-04
Gilles Forte
Oct-06
Apr-07
Oct-07
Apr-08
Oct-08
Result from the EU/WHO/ACP Partnership (2004-2010)
Selection and rational use of medicines
Between 2004 and 2010:
 40 countries supported to create or update their Essential Medicines Lists
and Standard Treatment Guidelines.
Standard Therapeutic Guidelines available
 More than 1,000 national personnel trained in rational use of medicines.
90%
 Technical and financial support
to establish Drugs and Therapeutics
80% (Cameroon, Ethiopia, Ghana, Kenya, Nigeria,
Committees in seven countries
Senegal and Uganda.
70%
 Rational use campaigns in60%
9 countries (Mali, Sudan, Zambia, Uganda, Kiribati,
Solomon Islands, Tonga, Tuvalu
and Vanuatu). Between the interventions
50%
there is the approval of laws to regulate medicines promotion (Mali and
40%
Zambia) and information campaigns
using mass-media like radio and journals
(Sudan, Uganda and Zambia).
30% Pacific Islands have used theatre to better
involved the public in rational use issues.
20%
10%
0%
1
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2003
2007
Result from the EU/WHO/ACP Partnership (2004-2010)
Sub-regional collaboration
 CEMAC and Caribbean: assessment and common
pharmaceutical policy.
 EAC, SADC, Caribbean: work on pooled procurement and
on harmonization of registration of medicines.
 UEMOA: work on pharmaceutical policies and harmonization
of registration and inspection procedures.
 PIC: work on pooled procurement of medicines and
harmonization of essential medicines lists.
 Caribbean: establishment of mechanism for joint monitoring
of adverse reactions to medicines (VigiCarib).
Potential for collaboration: CEMAC, ACAME, ISMED
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