Local Production and A ccess to Medicines
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Transcript of Local Production and A ccess to Medicines
Public Health, Innovation and Intellectual Property
Local Production and Access to
Medicines EMP - Technical Briefing Seminar
1 November, 2013
WHO HQ, Geneva
Zafar Mirza
EMP - Technical Briefing Seminar 1 November, 2013
WHO HQ, Geneva
Zafar Mirza
Public Health, Innovation and Intellectual Property UnitEssential Medicines & Health Products Department
Public Health, Innovation and Intellectual Property UnitEssential Medicines & Health Products Department
Public Health, Innovation and Intellectual Property
What is local production ?
Does LP improve access?
Public Health, Innovation and Intellectual Property
What is local production ?
Does local production improve access?
Should WHO support LP?
Public Health, Innovation and Intellectual Property
Local production, transfer of technology
and access – some definitions
• Local 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 mechanisms
Public Health, Innovation and Intellectual Property
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…
Public Health, Innovation and Intellectual Property
Local Production and Access to
Medicines and other Health
Technologies• Surge of interest in local production e.g. BP.PMPA
• More international agencies supporting LP
• High political interest vs weak economic feasibility
• Is 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 project
Public Health, Innovation and Intellectual Property
QualityGMP Compliance
Effective National Regulatory Authorities
AccessEssential Medicines
Enhanced Public Procurement
Security of Supply
Affordable Prices
WHO Perspective on LP
It is Government's decision,
But we have to ensure…
Public Health, Innovation and Intellectual Property
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 countries
• Phase 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)
Public Health, Innovation and Intellectual Property
Outputs from Phase I of the Project
1. Local production for access to medical products: Developing a framework to improve public health
2. Local production and access to medicine in low- and middle-income countries: A literature review and critical analysis
3. Trends in local production of medicines and related technology transfer
4. Pharmaceutical production and related technology transfer: Landscape report
5. Local production of pharmaceuticals and related technology transfer: A series of case studies
6. Increasing access to vaccines through technology transfer and local production
7. Increasing access to diagnostics through technology transfer and local production
8. Local production and technology transfer to increase access to medical devices
Available online: www.who.int/phi/publications/local_production
Public Health, Innovation and Intellectual Property
The need for a framework• Industrial development alone is insufficient to
leverage the potential benefits of greater access to medical products in developing countries
• To help develop and foster a common understanding for policy coherence for both industrial and health development
• To help ensure that public investments in national regulatory bodies are made to ensure locally-produced medical products comply with quality standards
• To assist governments to identify and justify incentives to local manufacturers
• To 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 policies
Public Health, Innovation and Intellectual Property
Development of a framework for
local productionPhase 1 Activities
• Analysis: o Pharmaceuticalso Vaccines o Diagnostics
• Mapping the landscape, and trends in Local Production (LP) and Transfer of Technology (ToT) in developing countries
• Examine 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 HEALTHFRAMEWORK FOR ACCESS
Public Health, Innovation and Intellectual Property
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 +
Public Health, Innovation and Intellectual Property
The Framework for local production for
improving access: Policy coherence and
government support
FRAMEWORK
SHARED 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 adaptation
Public Health, Innovation and Intellectual Property
Role for governmentINDUSTRIAL
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 SupportDirect support to reduce the cost of manufacture
Indirect support of local production for improving access
Public Health, Innovation and Intellectual Property
Phase II of the project
• Learning from Phase I
• Guided by the shared goals of the framework
• Cross-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 devices
Public Health, Innovation and Intellectual Property
Phase II - Promote and support public
health oriented local production in
developing countries
1. Policy analysis for policy coherence
2. Global resources on local production, technology transfer and access to medical products
3. Advocacy for the policy framework
4. Capacity building and technical assistance for local production of selected essential medical products
Public Health, Innovation and Intellectual Property
Current Phase II activities
1. Examine countries’ policy coherence between industrial and health policies
2. Analyse the patent landscape for a number of medicines suitable for local production
3. Provide good country case studies on policies and practices on local production: Cuba and Brazil
4. Develop a price comparison methodology between locally produced and imported medicines
5. Provide training and capacity building for manufacturers and national regulatory authorities on quality production of medical products
6. Identify a set of essential medicines most suitable for local production
7. Examine the local production potential of blood products and selected medical devices