TRENDS & INITIATIVES IN TECHNOLOGY TRANSFER FOR LOCAL - - PowerPoint PPT Presentation

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

W k i

 Work in progress

 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

i fi ) generic firms)

 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

& 200 ) & Laing 2005)

 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  P i

t i t bli i t i t bli bli

 Private-private, public-private, private-public, public-

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

d l ld) to developing world)

 Supply national/regional markets via joint ventures (GSK in China)

 Public or non-profit institutions: NIH, Netherlands Vaccine Institute,

i iti universities

 Public-private product development partnerships (PDPs):

 Aeras (TB vaccine), DNDi (malaria FDCs), IoWH (paramomycin)

G ll f d k li l TT f d i

 Generally, few products on market so little TT for production

 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,  Li it d i f

ti b it di t t f t i

 Limited information on websites, regarding contract manufacturing  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,

• r 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?

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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

Wh ? ( ll l ) Why receive? (categories not mutually exclusive):

 Access to technology, know-how  Reduced time/cost to develop in-house

E l kill d

 Employee skills upgrade  Reputational benefits of partnering with major firm/organization  Spillovers into other products, distribution networks, business opportunities

I d t i li ti / i d l t

 Industrialization/economic development

• 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

• 3. Key issues: Economic & Utility

y y

 Economic

 Cost of locally produced products: e.g. cycloserine  Market size of transferred products: e.g. saquinavir  Li it ti

t k t ith VL LDC l SSA

 Limitations on export markets with VL: LDCs only or SSA

• nly

 Usefulness of TT

 Biotech: TT would be more useful for technologically

difficult to produce biotech products, no need for help with small molecules (Indian industry sources) ( y )

 Smaller firms or those with less advanced in-house R&D

capacity benefit more directly.

• 3. Key issues: Timelines & Quality

y y

 Time horizons

 Long-term outlook: general consensus on need for building trust

and human capacity, relationships with local authorities

 Pharmaceutical production is long-term process: e.g. formulation

R&D bili di WHO PQ/US FDA i i R&D, stability studies, WHO PQ/US FDA process, registration

 Process of increasing levels of complexity in transfer/production

is gradual

Q li d d /R l i

 Quality standards/Regulation

 How important Is access to global or donor-funded markets?

Disagreement on relative importance of national or various international regulatory standards international regulatory standards.

 Effective regulation required to incentivize firms to meet quality

standards, otherwise, can incur additional cost vis-à-vis competitors without additional profit. p p

• 3. Key issues: Success?

y

 How do we measure success in TT?  Competitive or affordable price?  Quality standards?

I d i f l l l ?

 Improved security of local supply?  Ongoing production?  Increased human capacity?  Capacity to produce newer products? More complex products?  How much local production is ‘enough’?  How much technology transfer is ‘sufficient’?  How much technology transfer is sufficient’?

• 4. Conclusions



Research & Monitoring:

O h d l h d ll d d



Ongoing, methodical, comprehensive data collection needed



Drugs:



Relatively limited TT initiatives, but growth over past decade



Activities concentrated in three disease areas; few in other therapeutic categories



Vaccines:



More established mechanisms for tech transfer, potential lessons for drug TTI



Production concentrated in a few countries



IP: impact varies by project can be barrier as well as pull factor for LDC based



IP: impact varies by project, can be barrier as well as pull factor for LDC-based production



Advanced technologies: consider exploring how to induce tech transfer to BRICS for more complex technologies, such as biotech/newer vaccines C f d b d



Criteria for success need to be agreed upon



Clear demand for human capital investment: capacity building & training



Clear need to take relatively long-term approach, including revisiting 2016 WTO LDC deadline C dead e

Th k f i

Q i & C l

Thank you for your attention

Questions & Comments welcome at: suerie.moon@gmail.com