AFRICAN DIALOGUE ON TECHNOLOGY TRANSFER FOR LOCAL MANUFACTURING CAPACITY ON DRUGS AND VACCINES Organised with the support of the World Health Organization and the European Commission 10-11 December 2009, Cape Town, South Africa TRENDS & INITIATIVES IN TECHNOLOGY TRANSFER FOR LOCAL PRODUCTION LOCAL PRODUCTION OF DRUGS & VACCINES BY SUERIE MOON BY SUERIE MOON RESEARCH FELLOW AND DOCTORAL CANDIDATE SUSTAINABILITY SCIENCE PROGRAM, CENTER FOR INTERNATIONAL DEVELOPMENT KENNEDY SCHOOL OF GOVERNMENT, HARVARD UNIVERSITY Comments & questions welcome at: suerie_moon@hksphd.harvard.edu
Overview 1. Key research questions & methods 1. Key research questions & methods 2. Findings: Therapeutic areas Therapeutic areas Transferors Transferees Transferees Facilitators 3 Key Issues 3. Key Issues 4. Conclusions
1. Key research questions y q What are the major technology transfer initiatives j gy that have taken place over the past 5-10 years? Who is transferring what, to whom, how , and why ? How is IP managed? Environmental protection? Challenges & opportunities Work in progress W k i Study did NOT directly address: Pros & Cons of local production of drugs & vaccines Pros & Cons of local production of drugs & vaccines (e.g. Economic & technical feasibility; Impact on access, quality, price; Human development; Industrialization)
1. Methods No uniform data source exists on TT initiatives Searched and reviewed: Academic literature: Economic, Public Health, Medical, Social Sciences Multilateral agency websites (eg World Bank, WHO, UNIDO, UNCTAD, etc.) Donor websites (eg DFID GTZ SIDA USAID JICA etc ) Donor websites (eg DFID, GTZ, SIDA, USAID, JICA, etc.) Government websites of low/middle-income countries with established pharmaceutical industries as potential transferors (eg India, China, Brazil, etc.) Pharmaceutical company & industry websites (both patent-based and large generic firms) i fi ) Public-Private Product Development Partnerships (eg. DNDi, Aeras, MMV, etc) Mainstream international and regional media through LexisNexis Reports of high-income WTO Members on compliance with TRIPS Art. 66.2 Reports of high income WTO Members on compliance with TRIPS Art. 66.2 Selected interviews and personal referrals
1. Methods Strengths: Strengths: Relatively comprehensive Recent Recent Weaknesses: Non-uniform data sources Non uniform data sources English-language bias (searches included French, Spanish, Portuguese, but not non-Western languages, eg Mandarin, Thai) No guarantee that coverage is comprehensive
1. Methods Need for methodical, ongoing, centralized data N , g g, collection to: Enable evidence-based analysis of TT policies (Kaplan & Laing 2005) & 200 ) Measure change over time Help connect people to each other (transferors/ ees) Help connect people to each other (transferors/-ees) Help track TRIPS Article 66.2 compliance Precedents: Initiative on Public-Private Partnerships for p Health, Global Funding of Innovation for Neglected Diseases project
2. Findings: Overview g Included: intentional technology transfer initiatives with direct/proximate link to local production: Voluntary licensing for products on-patent Direct transfer of know-how, machinery, data, training , y, , g Targeted education and training for pharmaceutical production Joint ventures or subsidiaries located in low/middle-income countries ( in progress ) ( p g ) Excluded: R&D (e.g. clinical trials, university licensing) General education and training not directly linked to production General education and training not directly linked to production Reverse engineering Confidential commercial transactions, e.g. contract manufacturing (for lack of data not lack of relevance) (for lack of data, not lack of relevance)
2. Findings: Overview g Very difficult to generalize, as projects differ along y g , p j g multiple dimensions: North-South, South-South, South-North Private-private, public-private, private-public, public- P i t i t bli i t i t bli bli public Goals & interests of transferor/transferee Technical capacity of transferee Complexity of transferred technology Technical value of transfer (e g gain for transferee) Technical value of transfer (e.g. gain for transferee) Economic value of transfer (e.g. product market) Scale and duration of transfer
2. Findings: Therapeutic Areas g p Generally, newer products (some exceptions) Drugs: Emphasis on: AIDS: antiretrovirals TB MDR TB one project for first line TB drug TB: MDR-TB, one project for first-line TB drug Malaria: artemisinin-based combination therapy Visceral leishmaniasis (kala azar) (paramomycin) Chagas disease (benznidazole) Pandemic flu (avian and H1N1): oseltamivir, vaccine Absent: Absent: Almost no Type 1 disease products ( exceptions : joint ventures in oncology, metabolic) No biotech drugs No biotech drugs Some traditional medicines but largely commercial
2. Findings: Therapeutic Areas g p Vaccines: Established vaccines: Measles , Mumps & Rubella; Oral Polio Newer, more complex vaccines: Rotavirus Haemophilus influenza b (Hib) Hepatitis B Pandemic influenza (H1N1) Pandemic influenza (H1N1) Pneumococcal Meningococcal Rabies Combination products (eg DTP-HepB-Hib) Products in development against: TB, malaria, dengue, cholera, Japanese encephalitis, hookworm, rabies-leishmania, HPV, cellular pneumoccal, rotavirus, hepatitis A aerosol measles meningitis A tyhpoid hepatitis A, aerosol measles, meningitis A, tyhpoid
2. Findings: Transferors g Who are the transferors? Major multinational pharmaceutical companies Transitioning out of product area (SQV, capreomycin, cylcoserine) Voluntary license with or without TT (e.g. tenofovir, large volume supply to developing world) d l ld) Supply national/regional markets via joint ventures (GSK in China) Public or non-profit institutions: NIH, Netherlands Vaccine Institute, universities i iti Public-private product development partnerships (PDPs): Aeras (TB vaccine), DNDi (malaria FDCs), IoWH (paramomycin) Generally, few products on market so little TT for production G ll f d k li l TT f d i NGOs: action medeor, OTECI Individuals: Dr. Krisana Kraisintu
2. Findings: Transferees g Who are the transferees? Big generics firms in BRICS: Many projects in India All stages of production (raw materials to finished product) for both drugs and vaccines vaccines Smaller generics firms in smaller or less developed countries: Wide distribution across Sub-Saharan Africa, some focus on East Africa, particularly for malaria-drugs Later stages: formulation, packaging, GMP , documentation Joint ventures & subsidiaries: Wide-range of products and countries, Limited information on websites, regarding contract manufacturing Li it d i f ti b it di t t f t i Trends in larger developing countries (e.g. India, China) Universities/research institutes: Education training small-scale lab production Education, training, small-scale lab production
2. Findings: Facilitators g Transferee countries: Various levels of government engagement MoH/FDA, Trade, Industry, Science & Technology, Education, or none Transferor countries (funders): European Commission, Germany, Thailand, Brazil European Commission, Germany, Thailand, Brazil Multilaterals: African Union, UNCTAD, UNIDO, UNICEF, WHO, World Bank NGOs: ICTSD, InWent, OTECI, action medeor
3. Key issues: Why transfer? Why receive? y Why transfer? (categories not mutually exclusive): Commercial Corporate social responsibility Product no longer of interest to technology-holder Legal or regulatory action Non-profit social motivation & objectives Reduce barriers to national adoption of new medicines Why receive? (categories not mutually exclusive): Wh ? ( ll l ) Access to technology, know-how Reduced time/cost to develop in-house Employee skills upgrade E l kill d Reputational benefits of partnering with major firm/organization Spillovers into other products, distribution networks, business opportunities Industrialization/economic development I d t i li ti / i d l t
3. Key issues: IP & Environment y Intellectual Property Patents pose a barrier for more advanced firms interested in producing newer patented products in non-LDCs LDC extended deadline of 2016 is very salient (e.g. Bangladesh, Uganda Ethiopia) Uganda, Ethiopia) Need to consider extending deadline beyond 2016, given long timeframes for tech transfer and developing pharmaceutical industry. Despite Doha Declaration, some uncertainty in LDCs regarding legal and policy space to produce drugs widely patented elsewhere. Environmental standards: National-level regulation is standard. Compliance/enforcement of national standards bigger issue than standards themselves (one interviewee) Action medeor/Graz University: cleaner artesunate derivitization process developed for potential transfer process developed for potential transfer
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