Transcript Essential Medicines in the Americas: Regional and

ESSENTIAL MEDICINES IN THE AMERICAS
Regional and sub-regional
perspective and experiences
Jorge Bermudez, MD, PhD (Unit Chief)/Nelly Marin, Pharmacist (Regional Adviser)
WHO/UNICEF Technical Briefing on Essential Medicines Policies
September 2006
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Health
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OUTLINE
• STRUCTURE AND PROCESS
• SYNERGY, ADDED VALUE AND SHARING
EXPERIENCES
• CHALLENGES AND THE WAY FORWARD
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STRUCTURE AND PROCESS
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What is PAHO?
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One of the oldest health organization with 103 years in existence
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Part of the United Nations System (WHO/AMRO)
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Also part of the Inter-American System
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PAHO's directing council is made up of Ministers of Health who
establish technical and administrative policies
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There are 35 member governments from the Americas
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Office of the
Assistant Director
Assistant Director
Dr. Carissa Etienne
Family and Community
Health
FCH
Gina Tambini
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Disease Prevention
and Control
DPC
John Ehrenberg (acting)
Sustainable Development
and Environmental Health
SDE
Luiz Augusto Galvão
Technology and
Health Service Delivery
THS
Jose Luis Di Fabio
Technology and Health Service Delivery
Assistant Director
Carissa Etienne
Technology and Health Service Delivery
Area Manager
Jose Luis Di Fabio
Administrative Officer
Lucia Jimenez
Executive Secretary
Jeannette Bolaños
Organization of
Health Services
Unit Chief,
Hernan Montenegro
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Essential Medicines, Vaccines
and Health Technologies
Unit Chief
Jorge Bermudez
Mental Health and Rehabilitation
Unit Chief
Jose Miguel Caldas de Almeida
Technology and Health Service Delivery Framework
Essential
Vaccines & medicines
Biologicals
Technologies
Ocular
Health
Hospitals
Primary Health
Goods
Care
Radiological
Oral
Services
Safe Blood
Services
Health
Network of
Laboratories
services
Disabilities
Indigenous
Elderly
health
Vulnerable Mental
populations Health
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Alcohol &
Drugs
Situation analysis
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Medicines represent the largest public spending in healthcare after
personnel costs (represents less than one-fifth of total public and
private health spending in most developed countries, 15 to 30% of
health spending in transitional economies and 25 to 66% in
developing countries).
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Lack of access to essential drugs, irrational use of drugs, and poor
drug quality remain serious global public health problems.
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In rich and poor countries alike, health technologies form the
backbone of health services.
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Access to health technologies is one of the most distinct
differences among rich and poor countries.
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Some technologies are inherently safe, but the vast majorities are
not. Therefore they require established quality assurance and
quality control.
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Our Framework For Technical
Cooperation Strategy Implementation
Addressin
g the
Unfinished
Agenda
“For the last
time”
National Health
Development
“For the first
time”
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Facing
New
Challenge
s
Protecting “Forever”
Achievements
Examples of working our
cooperation framework in AMRO
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Addressing the unfinished agenda:
 Supporting the National Medicines Policy in the Dominican
Republic (a Presidential effort)
 WHO/EC project for ACP countries;
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Protecting achievements:
 ARV price negotiation involving 11 MoH and 27 pharmaceutical
companies, price reductions from 15 to 55%.
 PANDRH and the SF
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Facing new challenges:
 Mechanism of informal dialogue with NRA from MEX, CUB, BRA,
ARG, CHI (joint inspections with PANDRH guidelines, addressing
new products)
 Negotiation, approval and implementation of FTA in the Region
(TRIPS Plus)
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Strategic clustered lines of action:
• Access to products of quality
• Policies and regulation
• Essential health technologies
• Unit Management and inter-programmatic initiatives
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Access to medicines (AMRO)
Strategic lines of action
(Document CD45/10, 2004)
• Promoting coherent generic medicines strategies as a
means to increase the availability and use of quality
essential medicines
• Developing cost-containment strategies for Essential
Public Health Supplies, with focus on two areas: pricing
and intellectual property
• Strengthening public health commodity supply systems to
ensure continuity and availability
• Strengthening regional pooled negotiations and
procurement mechanisms, including PAHO Strategic Fund
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SYNERGY, ADDED VALUE AND
SHARING EXPERIENCES
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Areas of synergy between AMRO and
WHO
WHO
AMRO
THS/EV
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HTP/PSM
HTP/TCM
HTP/EHT
HTM/HIV
Areas of synergy between AMRO
and WHO
• Medicines Strategy 2004-2007
• Development and use of WHO frameworks on Essential
Medicines:
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Model List for Essential Medicines
National Medicines Policies
Rational Use of Medicines
Medicines indicators (levels I and II)
Technical documents: GMP, BE
• WHO:EC project (ACP countries)
• Trade and Health
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AMRO’S ADDED VALUE
• Experience in sub-regionalization
• Strong support from the Collaborating Centers
• Facilitate resource mobilization for inter-country horizontal
cooperation (South-South)
• Solid regional programs and initiatives:
– Pan-American Network on Drug Regulatory Harmonization (PANDRH)
– Strategic Fund for Procurement of Essential Public Supplies
– Regional negotiation of ARV prices (11 countries and 27
pharmaceutical companies)
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Cont….
AMRO’S ADDED VALUE
• Inter-programmatic initiatives (FCH/AI, DPC/NCD,
DPC/CD)
• Ad-hoc Working Group on Access to Medicines
with two subgroups:
– Generic strategies
– Intellectual Property Rights
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WHO CC Policies
Regional Office
WHO CC Supply
Subregional post
Central America
WHO CC Supply
Andean
(Pending)
Sub-regionalization of
the Program of Essential Medicines,
Vaccines and Technologies
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Subregional post Intl
Caribbean
WHO CC information
Subregional post Intl
MERCOSUR
WHO CC Policies
WHO CC Rational Use
Pan American Network for
Drug Regulatory Harmonization
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PANDRH: Pan American Network for
Drug Regulatory Harmonization
1.
Establishes a Pan American Forum of Drug Regulatory Agencies (DRA) to discuss
and search for solution of common problems, with DRAs leading and participating
in the process.
Strengthens the establishment of priorities in drug regulatory harmonization
processes and encourage convergence of drug regulatory systems in Region.
Improves access to quality, safety & efficacy drugs to improve quality of
pharmaceutical markets.
Promotes technical cooperation where more developed DRA share knowledge and
experiences with less advanced DRA
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3.
4.
Working Groups
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Good Manufacturing Practices
Bioequivalence and Bioavailability
Good Clinical Practices
Drug Classification
Counterfeit Drugs
Good Laboratory Practices
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Pharmacopoeia
Medicinal Plants
Drug Registration
Pharmacovigilance
Vaccines
Promotion and Marketing
The Strategic Fund:
A Country Initiative:
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2000: established by the Director of PAHO at the request of Brazil
during the 42nd Meeting of the Directing Council
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2004: Resolution CD45R7 of the 45th Directing Council on Access to
Medicines:
– Strengthen capacity in programming and planning of supplies
– Facilitate the achievement of economies of scale
– Promote continuous availability of Strategic Public Health Supplies
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2004 & 2005: Resolutions of the 45th and 46th Directing Councils in
HIV/AIDS:
– Critical Line of Action #4 of the Regional Plan in HIV/AIDS for the Health
Sector, 2006 – 2015.
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PAHO Strategic Fund
Objectives
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To improve national capacity in procurement and supply management of
Strategic Public Health Supplies
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To improve availability and affordability of Strategic Public Health Supplies in
Member States
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To promote concepts of quality assurance in procurement and supply
management
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To strengthen national priority health programs and facilitate the application of
PAHO/WHO normative mandates
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Technical Cooperation &
The Strategic Fund
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Evaluation of national supply systems for strategic public health supplies
Information on suppliers and products
Price referencing
Definition and estimation of needs (products and technical support)
Estimation of budget requirements and resource programming
Procurement planning and programming of deliveries
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The Procurement Plan
A New Perspective - 2005
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17 Countries now participating: Barbados, Belize, Bolivia, Brazil, Dominican Republic,
Ecuador, El Salvador, Guatemala, Haiti, Honduras, Jamaica, Nicaragua, Panama, Paraguay,
Peru, Trinidad & Tobago, Surinam.
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A renewed focus on technical cooperation: procurement and supply management of
Strategic Public Health Supplies
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Implementation of a Sub-regional strategy: Central America, Andean, Caribbean and the
Southern Cone
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Integrated work program with key partners, COHAN and MSH. Key coordination with WHO
and Clinton Foundation.
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Coordination of activities through PAHO country offices and with PAHO Washington /
Brazil, involving technical staff in medicines and disease management, as well as
administrative personnel.
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www.paho.org/StrategicFund
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Inter-programmatic initiatives
• PAHO HIV/AIDS. Regional HIV/STI Plan for the Health
Sector. Critical Line of action 4:improving access to
medicines, diagnostics, and other commodities
• Pandemic influenza preparedness and response
• Supply systems, pooled procurement and the PAHO
Strategic Fund
• NDC Regional Strategy
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CHALLENGES AND THE WAY
FORWARD
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Main challenges tabled for PAHO
• Protect the achievements:
– Sustainability of the Sub-regional approach, increasing
decentralization
– Sustainability of PANDRH, Strategic Fund
– Adequate funding for staffing (HQ, sub-regions and countries)
• Expand access and sustainability in a multidiverse Region and changing environment:
– Support all countries: Canada, Brazil vs Haiti, Nicaragua
– Address, with other organizations (WHO, UNAIDS, UNDP,
UNICEF), Trade (FTA) and Health
• Building capacity to reach national technological
infrastructure in Health (negotiating loans, donations, etc)
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Cont….
Main challenges tabled for PAHO
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Public Private Partnership as many stakeholders are available
(and NGO partnerships)
– Pharmaceutical Industry, Technology Industry, Academia,
Funding Agencies and Foundations, Public-based NGOs,
networks, etc.
Respect the inter-regional and intra-regional diversity and
cultures
Joint programming especially with WHO, increasing
reallocation of WHO funds and collaboration for resource
mobilization.
Learning lessons from inter-regional sharing of experiences
(WHO retreats, GMC, EHT, multiple dialogues).
Can we rebuild shared agendas (PAHO-WHO-UNAIDS-UNDP
[Trade and Health]; PAHO (SF)-UNICEF [procurement and
supply]; PAHO-WB-IDB [Health Regulation])?
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THE WAY FORWARD
• Clear and permanent channels of communication
• Resource mobilization
• Support for minimum structure for RO and country support
• Decentralization of resources (human and financial)
• Lessons such as ICDRA and RO participation
• Support for inter-programmatic and inter-regional actions
and activities (sharing experiences)
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THANK YOU!!!!!
MUCHAS GRACIAS!!!!!
[email protected]
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