EMP Technical Briefing Seminar 1 November 2013 WHO HQ Geneva Zafar Mirza Public Health Innovation and Intellectual Property Unit Essential Medicines amp Health Products Department ID: 731673
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Slide1
Local Production and Access to Medicines
EMP - Technical Briefing Seminar 1 November, 2013WHO HQ, GenevaZafar Mirza
Public Health, Innovation and Intellectual Property UnitEssential Medicines & Health Products Department Slide2
What is local production ?Slide3
What is local production ?
Does LP improve access?Slide4
What is local production ?
Does local production improve access?Should WHO support LP?Slide5
Local production, transfer
of technology and access – some definitionsLocal production: geography and/or ownership – this project uses jurisdiction as a basis for defining local production rather than ownership Transfer of technology: broadly defined to include education, training, licensing, movement of persons, supply of materials and equipment, through various mechanismsSlide6
To increase access, especially for the poor in developing and least developed countries to medicines, vaccines and diagnostics of importance to public health, and especially for neglected diseases of the type II and type III categories as well as the specific needs of developing countries in relation to type I diseases.
Element 4: Promote the transfer of technology and production of health products in developing countries…Slide7
Local Production and Access to Medicines and other Health Technologies
Surge of interest in local production e.g. BP.PMPAMore international agencies supporting LP High political interest vs weak economic feasibilityIs local production good for public health?Long standing work of WHO in supporting quality production (NRA strengthening; GMP trainings etc.)Our renewed involvement in local production issues through WHO/EC projectSlide8
Quality
GMP ComplianceEffective National Regulatory AuthoritiesAccess
Essential MedicinesEnhanced Public Procurement
Security of SupplyAffordable Prices
WHO Perspective on LP
It is Government's decision,
But we have to ensure…Slide9
WHO/EU Project on LP &improvement in ATM
Linked with GSPA-PHI and EU Parliament resolution on improving access to medicines through supporting local production in developing countriesPhase I - Identified main trends and barriers to local production of pharmaceuticals, vaccines and diagnostics. Published 8 reports. (2009-2011)Phase II - Activities envisaged to promote greater policy coherence between government policies that affect the local production
in order to improve access. (2012-2014)Slide10
O
utputs from Phase I of the ProjectLocal production for access to medical products: Developing a framework to improve public healthLocal production and access to medicine in low- and middle-income countries: A literature review and critical analysisTrends in local production of medicines and related technology transfer
Pharmaceutical production and related technology transfer: Landscape report Local production of pharmaceuticals and related technology transfer: A series of case studies Increasing access to vaccines through technology transfer and local productionIncreasing access to diagnostics through technology transfer and local production
Local production and technology transfer to increase access to medical devices
Available online: www.who.int/phi/publications/local_productionSlide11
The need for a framework
Industrial development alone is insufficient to leverage the potential benefits of greater access to medical products in developing countriesTo help develop and foster a common understanding for policy coherence for both industrial and health developmentTo help ensure that public investments in national regulatory bodies are made to ensure locally-produced medical products comply with quality standardsTo assist governments to identify and justify incentives to local manufacturersTo address a possible future scenario where the global supply of affordable generic medicines may be uncertain.
To better coordinate international support for complementary industrial and health development policiesSlide12
Development of a framework for local production
Phase 1 ActivitiesAnalysis: Pharmaceuticals
Vaccines DiagnosticsMapping the landscape, and trends in Local Production (LP) and Transfer of Technology (ToT) in
developing countriesExamine in detail examples local manufactures in developing countries
Regional workshops with stakeholders
Reports
Literature
Review
Mapping & Landscape
trends in
LP
and
ToT
Country
case studies
Pharmaceuticals
Vaccines
Diagnostics
PUBLIC HEALTH
FRAMEWORK
FOR ACCESSSlide13
INDUSTRIAL
POLICY Competitive Reliable Innovative Productive Responsible Strategic
HEALTH POLICY Access Availability Affordable
Quality Supply Rational
The Framework for local production for improving access: Policy coherence and government support
FRAMEWORK
+Slide14
The Framework for local production for improving access: Policy coherence and government support
FRAMEWORKSHARED GOALS HEALTH POLICY
+ INDUSTRIAL POLICY Strategic selection of essential medical products
Pricing of local products that governments & people can afford
Strict compliance to quality standards Effective National Regulation Authorities
Health
security
Innovation
for local adaptationSlide15
Role for government
INDUSTRIAL
POLICY
Competitive
Reliable
Innovative
Productive
Responsible
Strategic
HEALTH
POLICY
Access
Availability
Affordable
Quality
Supply
Rational
SHARED GOALS HEALTH + INDUSTRY
Strategic
selection of
essential
medical products
Pricing
of local products
that
governments & people can afford.
Strict
compliance to quality standards
Effective
NRAs.
Health
security
Innovation
for local adaptation
Government Support
Direct
support to reduce the cost of manufacture
Indirect support of local production for improving accessSlide16
Phase II of the project
Learning from Phase IGuided by the shared goals of the frameworkCross-WHO, WHO regional offices, partner agencies, governments and governmental bodies Align with the African Union and its Pharmaceutical Manufacturing Plan for Africa (PMPA)Full range of medical products: Medicines, vaccines, in-vitro diagnostics, blood derived therapeutic products and medical
devicesSlide17
Phase II - Promote and support public health oriented local production in developing countries
Policy analysis for policy coherenceGlobal resources on local production, technology transfer and access to medical productsAdvocacy for the policy frameworkCapacity building and technical assistance for local production of selected essential medical productsSlide18
Current Phase II activitiesExamine countries’ policy coherence between industrial and health
policiesAnalyse the patent landscape for a number of medicines suitable for local productionProvide good country case studies on policies and practices on local production: Cuba and BrazilDevelop a price comparison methodology between locally produced and imported medicinesProvide training and capacity building for manufacturers and national regulatory authorities on quality production of medical
productsIdentify a set of essential medicines most suitable for local productionExamine the local production potential of blood products and selected medical devicesSlide19
This project is supported with funding from the European Union and undertaken with many partners
World Health Organization Public Health, Innovation and Intellectual Property http://www.who.int/phi