Professional Documents
Culture Documents
of Pharmaceutical
Manufacturers & Associations
TECHNOLOGY
TRANSFER:
A COLLABORATIVE
APPROACH TO
IMPROVE GLOBAL HEALTH
The Research-Based Pharmaceutical Industry Experience
Table of Contents
I II III
6 8 20
14 Innovation-friendly environment
with sound intellectual property
rights
17 Skilled workforce
Foreword
Dear Reader,
Increased use of modern technology by countries is vital to their
economic and social development. It raises the quality of production,
generates new knowledge, improves living standards, and boosts
the productivity or efficiency of export companies. The process
of technology transfer stimulates investment, for example, in the
IV production of food, medicines, steel, cars, and electronics, as firms
gain access to the technology of others, learn and absorb it, and
22 implement it in production.
Technology transfer of medicines and vaccines shares many
of the challenges of other advanced industries. Moreover, the
research-based pharmaceutical industry strives to ensure that the
transfer of technology also reflects its commitment to global health. It
aims to devise sustainable ways not only of bridging research-and-de-
velopment gaps but also of increasing the availability of vaccines and
medicines in the developing world. In recent years, the research-based
pharmaceutical industry has pushed forward with this unique type of
The Role of IFPMA and its technology transfer, at the cutting edge of business practices today.
Member Companies In an increasingly globalized world, creating the right conditions
for the transfer of technology is an important consideration for
all countries at all income levels. Many multilateral organizations,
IFPMA members want to contribute
including the United Nations, the World Bank, the World Trade
to the sustainable development
Organization, and the World Intellectual Property Organization, have
of the world economy and to the
a role to play, while technology transfer as it applies to medicines and
improvement of the health and living
vaccines is of vital interest to the World Health Organization and the
standards of people in all regions.
broader public health policy-making community.
Based on their experience, IFPMA member companies have
identified the main factors determining a country’s attractiveness
for transferring technology and have compiled a list of policy recom-
mendations for consideration by the relevant institutions at national
and international levels.
Eduardo Pisani
Director General
4 | Technology Transfer: A Collaborative Approach to Improve Global Health
Executive Summary
Creating a win-win process
Transfer of technology is a Technology transfer can increase transfer to improve a country’s ability
key component of economic the reliability of supply and decrease to use innovative medicines, by
reliance on imports, raise the strengthening the expertise of the local
development. It is one competence of the local workforce, scientific and medical communities
means by which low- and and reverse the “brain drain” from and, where possible, working to
low- and middle-income countries improve the health infrastructure. The
middle-income countries can by increasing local “high-tech” rewards to companies transferring
accelerate the acquisition employment opportunities. pharmaceutical technology can be
of knowledge, experience Beside the beneficial impact on reputational or commercial, or both.
economic and social development However, while some decisions to
and equipment related normally credited to technology transfer technology may be taken
to advanced, innovative transfer, transferring pharmaceutical on a philanthropic basis, to prove
technology can also help improve sustainable these collaborations
industrial products and the health of recipient countries’ have also to be driven by commercial
processes. populations by increasing access to rationales and market conditions,
innovative medicines and vaccines. which are in turn heavily influenced
Many research-based pharmaceutical by policy and regulatory decisions by
companies have used technology national governments.
Technology Transfer: A Collaborative Approach to Improve Global Health | 5
The decision by research-based can encourage technology transfer of specialized knowledge and
pharmaceutical companies to by focusing on attracting technology skills, thereby contributing to
transfer technology depends on for which there is already a demand economic development and public
a wide variety of factors, most of from local companies, and by adopting health of the recipient country.
which are influenced by the local mutual recognition of regulatory
• Transferring not only
policy environment. While an decisions, within regions and between
manufacturing technology but
overall prerequisite for transferring high- and low- and middle--income
also other forms of acquired
technology is the existence of a countries (LMICs), which can help expertise.
suitable local partner, eight factors increase the local market and/or
emerge as critical enablers for reduce regulatory barriers. IFPMA calls on:
pharmaceutical technology transfers:
In addition, high-income countries can • Governments in low- and
1. A viable and accessible local help LMIC experts to increase their middle-income countries to
market; technical expertise and familiarity provide policy support for
with international standards. Public the development of national
2. Political stability and transparent
sector institutions can also increase private sectors and implement a
economic governance;
technical and financial assistance to welcoming policy environment for
3. Appropriate capital markets; LMICs to strengthen local technical global partner firms.
4. Innovation-friendly environment competence. • Governments in high-income
with sound intellectual property The importance of transferring countries to increase aid funding
rights; technologies for medicines is for health and healthcare in the
recognized in the 2008 Global developing world as a platform for
5. Proper access to information;
Strategy and Plan of Action on Public economic development. This can
6. Adherence to high regulatory Health, Innovation and Intellectual be innovative at the same time as
standards; Property Rights of the World Health affordably addressing basic needs.
7. Skilled workforce; Organization (WHO). An agreed
action under the strategy is “to
8. Clear economic development promote transfer of technology
priorities. and production of health products
Many newly industrialized countries in developing countries through
and other middle-income countries identification of best practices, and
are developing a suitable policy investment and capacity building
environment and are witnessing the provided by developed and developing
benefits of access to advanced foreign countries where appropriate”.2 1 Charles River Associates, Policies that
technologies and expansion of their IFPMA member companies support encourage innovation in middle-income
domestic capabilities.1 countries, Tim Wilsdon, Jim Attridge, Eva
technology transfers by:
Fiz, Satomi Ginoza, October 2012.
However, low-income countries
• Creating new technology through
may not always be able to offer
research and development of 2 World Health Assembly Resolution 61.21
the preconditions required for
innovative pharmaceuticals and which includes the WHO Global Strategy
successful uptake of technology
vaccines. and Plan of Action on Public Health,
transfer. The experience of IFPMA
Innovation, and Intellectual Property,
member companies suggests that • Delivering programs that offer a
Element 4, Sub-Element 4.1 c.
governments of low-income countries range of products and the transfer
6 | Technology Transfer: A Collaborative Approach to Improve Global Health
for the pharmaceutical skills and human aspects all techniques related to organizational and
industry this would include of technology management knowledge, information, procedural knowledge
the transfer of physical and learning, such as and technology, in the form needed to operate a given
objects such as equipment training for researchers of a technology license.4 technology relating to
for use in research or general practitioners a chemical or biological
laboratories or production Technology transfer compound.
equipment for the can also create positive
manufacture of pharma- spillover effects into
ceuticals ingredients, or the associated industries
formulation or packaging of and into the supporting
final products. public sector research
infrastructure.
Commercial opportunities
are paramount for the private
sector when considering
technology transfer. However,
if the basic conditions are right, A VIABLE AND POLITICAL STABILITY AND
ACCESSIBLE LOCAL TRANSPARENT ECONOMIC
non-commercial reasons may also MARKET GOVERNANCE
play a part in decision-making.
TRANSFERRING
standards
• High-quality facilities and
TECHNOLOGIES
equipment for scientists and
healthcare professionals
FOR MEDICINES
• Promotion of inward
investment through incentives
designed to encourage
APPROPRIATE
CAPITAL MARKETS
ADHERENCE TO
HIGH REGULATORY
STANDARDS
• Educated workforce
with engineering and
management skills
• Free movement of
scientists and other ex-
pertsstrengthen healthcare
system capacity
SKILLED
WORKFORCE
• Internationally recognized
regulatory standards in place
• Efficiency in processing
product registrations and other
applications
Technology Transfer: A Collaborative Approach to Improve Global Health | 11
• Promotion of
CLEAR ECONOMIC technology transfer
DEVELOPMENT matching overall
PRIORITIES economic policy
goals
• Investment in
domestic healthcare
systems and
infrastructure as
a priority in the
development agenda
PROPER ACCESS
TO INFORMATION
INNOVATION-FRIENDLY
ENVIRONMENT WITH
SOUND IP RIGHTS
can be a different story unless it is tempered by transfer, in compliance with international trade
the views of technology providers. rules. Global institutions, such as the International
Finance Corporation and the World Bank, provide
certain options geared towards medium-term
3. Appropriate capital markets investments in the private health sector.
For many governments seeking to expand
technological capacity, attracting direct
4. Innovation-friendly environment with sound
investment is very important, but there is also
intellectual property rights
the need to maximize the spillover benefits of
that investment, which requires adequate capital To successfully attract imported technology and
markets. For example, a local pharmaceutical to build the necessary preconditions for adapting
manufacturer receiving a product license must imported technology, countries need a supportive
have sufficient resources to meet high standards environment that includes strong intellectual
of quality and safety controls, good manufacturing property (IP) protection. Effective implementation
practices, sophisticated human capital, and of any intellectual property laws and regulations
so on. Likewise, benefits from the transfer of already in force provides transparency and
clinical skills increase when scientists or medical certainty for investors, licensees, and customers.
personnel have access to high-quality facilities The level of intellectual property protection tends
and equipment. All of these require financing. to be directly and positively linked to the rate of
technology transfer.
When local private capital markets are
insufficient, the public sector or global institutions To a large extent, this was the rationale
may provide alternative solutions. However, in behind the negotiation of the Agreement on
the case of healthcare and the pharmaceutical Trade-Related Aspects of Intellectual Property
industry, the long time horizons and high Rights (TRIPS Agreement). Article 7 of the
investment risks raise unique challenges for Agreement addresses the relationship between
sustainable public sector involvement. Where intellectual property and technology transfer,
such public sector investments are made, economic welfare, and the need for a balance of
whether in production capacity or in underpinning rights and obligations. It reads:
research activities, participation of foreign
“The protection and enforcement of intellectual
organizations should be encouraged.
property rights should contribute to the
A number of emerging economies have made promotion of technological innovation and to
strategic decisions to attract research-based the transfer and dissemination of technology, to
pharmaceutical investment. This can be a the mutual advantage of producers and users
natural evolution from existing chemicals or of technological knowledge and in a manner
generics production capabilities. In some cases, conducive to social and economic welfare, and to
encouragement for foreign direct investment has a balance of rights and obligations”.
been coupled with government help to nurture
Governments are responsible for putting in place
indigenous scientific expertise. R&D-based
the proper legal environment and economic
pharmaceutical companies have on occasion
conditions to facilitate private commercial
been able to contribute to this process by
transactions, while high-income countries should
providing training in the scientific and business
introduce measures such as technical support
disciplines relevant to strengthening research
to facilitate technology transfer (TRIPS articles
capacity and transforming scientific ideas into
66 and 67). The sum total of private deals and
commercial opportunities.
government facilitation should lead to technology
Governments can also promote inward transfer and capacity-building.5 While technical
investment through tax breaks and other forms capacity is more widely distributed around the
of incentives designed to encourage technology world than was the case before TRIPS, it has
5 This strategy was successfully employed by the Asian Tigers and some of the Eastern European countries, which adopted the necessary legal
infrastructure, followed sound economic policies, and incorporated technology transfer initiatives in their national development programs.
Technology Transfer: A Collaborative Approach to Improve Global Health | 15
and are also major suppliers to the substantial emigrated to more technologically sophisticated
donor-funded market for antiretrovirals (ARVs) environments in higher-income countries. The
and anti-malarial medicines. healthcare sector has been particularly hard hit
by this “brain-drain”.
Although building strong regulatory and
administrative capacity for pharmaceuticals Migration is a mixed blessing for many
requires a substantial investment by countries. By improving the prevailing
governments, the failure to do so can inhibit the conditions, individuals may be more inclined
ability of the local industrial sector to attract to return home. Flexible work structures
technology and can isolate the country from a and international fellowships can also help.
globalizing world. The pharmaceutical industry High-income countries can play a major role
has undertaken initiatives to enable LMIC both by providing access to the best centers
researchers, manufacturers, and regulators to of higher education, as they do now, and by
align their practices to international norms. supporting sustainable solutions to human
resource issues. Through scholarships and
other initiatives, IFPMA members have sought
7. Skilled workforce to strengthen the human resources available to
Human capital is an essential element of the low- and middle-income countries. One good
technology transfer process. The successful example is the EDCTP-TDR Clinical Research
absorption of technology or know-how in the and Development Fellowship (hyperlink: http://
recipient country and its translation into greater partnerships.ifpma.org/partnership/edctb-tdr-
economic development hinge on the availability clinical-research-development-fellowships).
in the host country of an educated workforce This program, developed with the help of
with, for example, engineering and management IFPMA, offers targeted training to enhance
skills. Certain low- and middle-income competencies in clinical trials for medicines,
countries are disadvantaged because a large vaccines and diagnostics on a broad range of
proportion of their highly trained workers have infectious diseases of poverty.
18 | Technology Transfer: A Collaborative Approach to Improve Global Health
Across all advanced technology The immediate objective in policy planning should
be to strengthen capacity and understanding of the
sectors, including pharmaceuticals, appropriate framework to facilitate technology transfer.
there is a large base of evidence and The newly industrialized countries that are now at the
point where they have a significant domestic stake
consensus that technology transfer is in promoting innovation as part of their economic
strongly influenced by the conditions development will have a key role to play over the
medium term.
in the host country described above.
To optimize their national technology bases, enhance
Adherence to international norms sustainability, and realize maximum benefits from
will positively influence the level and globalization, the IFPMA calls on:
• Focus on technology for which there is a demand from • Commit to greater access to standards-setting bodies
local companies and markets as this will motivate for experts from low- and middle- income countries;
local companies to develop innovation projects to suit
• Increase technical and financial assistance for
local needs and markets, and will generate spillover
improving the ability of low- and middle-income
benefits that can be captured by the local economy;
countries to absorb technology and trade;
• Institute progressive development of a national
• Ensure that tax deductions are available for technology
intellectual property system, which is integral to
contributions to non-profit entities engaged in
efforts to promote learning from technology transfer
technology transfer in low- and middle-income
and follow-on innovation;
countries;
• Allow foreign companies to participate in relevant
• Offer fiscal incentives to encourage enterprises
projects where public funding is being deployed to
to employ, at least temporarily, recent scientific,
strengthen industrial capacity;
engineering, and management graduates from low-
• Consider using mutual recognition of administrative or and middle-income countries;
regulatory decisions, both within regions and between
• Develop grant programs that support meaningful
high- and middle- and low-income countries.
involvement of research teams from low- and
middle-income countries.
Technology Transfer: A Collaborative Approach to Improve Global Health | 21
Enabling access to
appropriate therapies
and technical know-how, by
implementing programs to
improve the health of patients
and build capacity around the
world;
Technology Transfer: A Collaborative Approach to Improve Global Health | 23
Case Studies
Technology Transfer Track Record
This may include transfer of physical material, equipment Technology transfer is also performed through
or an entire factory, provision of information, know-how collaboration in the scientific field, including sharing of
and performance skills to allow recipient countries to knowledge. Much of the research being conducted by
produce medicines and vaccines locally. IFPMA member companies into diseases dispropor-
tionately affecting people in low- and middle- income
Voluntary licenses can also be a valuable tool for
countries is being conducted on a collaborative basis, with
transferring technology. Voluntary license agreements may
public and private sector partners.
or may not entail transfer of manufacturing know-how.
IFPMA 2014 Status report on pharmaceutical R&D to address
To learn more about IFPMA position on voluntary licenses
diseases that disproportionately affect people in low- and
and non-assert declarations please visit IFPMA website.
middle-income countries lists 186 R&D projects supported
by IFPMA members to develop new or improved medicines
and vaccines for 11 neglected conditions that each year kill
or disable millions of people in low- and middle-income
countries. Eighty-eight percent of these R&D projects are
collaborative efforts, involving partnerships between IFPMA
member companies and more than 80 partners from
universities, public and private sector institutes and non-gov-
ernmental organizations. More information on collaborative
research can also be found in the IFPMA website.
Technology Transfer: A Collaborative Approach to Improve Global Health | 25
www.ifpma.org
ISBN 978-2-940498-39-0
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