Transcript UAEM`s Framework for Advancing University Policy, Changing

Solutions:
UAEM’s Framework for Advancing University Policy,
Changing Practices & Closing the Research Gap
Michael Lin and Gloria Tavera
UAEM National Conference 2010
October 9, Duke University
Overview
 Changing University Licensing Policy
 What is the EAL?
 What is the GALF?
 Facilitating Access to Intellectual Property
 Patent Pools
 Closing the Research Gap
 Neglected Disease Innovation Mechanisms
 Where do we stand now?
 The Statement of Principles and Strategies
Changing University Licensing Policy
Equitable Access License (EAL)
The Global Access Licensing
Framework (aka GALF)
A flexible document of 5 points to guide university
licensing negotiations
1) Access to medicines and health-related technologies for
all is the primary purpose of technology transfer of
health-related innovations.
1) Technology transfer should protect access to the final
end product needed by patients (e.g., formulated pills or
vaccines).
The Global Access Licensing
Framework (aka GALF)
3) Generic provision is the best way to ensure access in
resource-limited countries for products that also have
markets in developed countries.
The Global Access Licensing
Framework (aka GALF)
4)Proactive licensing provisions are essential to ensure that
follow-on patents and data exclusivity cannot be used to
block generic production. Other barriers may need to be
addressed for the licensing of biologics.
4)University licensing should be systematic in its
approach, sufficiently transparent to verify its
effectiveness, and based on explicit metrics that measure
the success of technology transfer by its impact on access
and continued innovation.
Patent Pools: What are they?
 A method to streamline the licensing of IP-
protected technology in order to reduce
transactional costs
 Patents relating to a particular technology are
licensed to a patent pool, who then sublicenses the patents to manufacturers
There Is A Solution, Here's How A Patent Pool
Could Work (Patent Pool 4 of 4)
http://www.youtube.com/watch?v=dXdCSKeWAO
A
Patent Pools: An example
Neglected Disease Innovations
The Role of Universities:
• By increasing funding not only for global health research, but also for
research in NTDs, universities could make an impact twice as strong
• Universities should develop new seed funds for NTD research
• Universities should eliminate barriers concerning intellectual property
around neglected diseases
• New metrics for faculty appointments that value neglected disease
research should be implemented
The Role of Industry:
• There is some industry interest (i.e. Novartis’s Fund for R & D in
Neglected Disease) aims to:
– Allocate resources to the discovery and development of the promising
compounds to address neglected diseases, whether placed with
pharmaceutical industry/ biotech players, public research institutes or
product development partnerships (PDPs).
Product Development Partnerships
(PDPs)
A non-profit drug research and development
organization that creates new treatments for NDs
UAEM in Action!
Neglected Disease & Innovation Symposium
Washington, D.C., on November 20, 2010!
American University, Washington College of Law, Washington, D.C
UAEM is holding a symposium on the role of universities as non-profit
institutions in the medicine innovation system (PDPs and pharmaceutical
stakeholders), particularly related to their role in finding cures for neglected
diseases as well as open-source research methods.
The meeting will bring together product development partnerships (PDPs),
university administrators, researchers, industry actors, technology
transfer officials, funding institutions and students to explore the role of
universities in the broader innovation system and directions for university policy
to best improve both innovation and access to medicines.
Bridging the Gap: Increasing Access to Neglected Tropical Disease
Diagnostics, Treatment and Care Through Improved University, PDP and
Industry Collaboration
American Society of Tropical Medicine and Hygiene Meeting Symposium
Thursday, November 4th, Atlanta Georgia
Will communicate to a large and broad audience in the NTD research and medical fields on:
•
•
•
Methods to increase access to neglected tropical disease (NTD) research
Recent collaborative academic efforts to increase neglected tropical disease
research and development.
Current barriers, and their proposed solutions, surrounding the translation of
therapies specific to neglected tropical diseases.
Presenters
Dr. Peter Hotez (GW/PLoS)
Dr. Bernard Pécoul (ED, DNDi)
Dr. Anthony D. So (Duke, SPH)
Dr. Rebecca Goulding (UAEM UBC)
Dr. Michael Gretes
Gloria Tavera
Statement of Principles and Strategies for the Equitable
Dissemination of Medical Technologies (SPS)
 Drafted and signed by a
consortium of 7
universities in Fall 2009
 Since then, signatories
include 18 universities and
hospitals in the US,
Canada, Mexico, and
Turkey; plus the CDC,
NIH, AUTM, and 1 private
institution.
Bilkent University
•Boston University
•Brigham & Women's Hospital
•Brown University
•Duke University and Duke Medicine
•El Colegio de México
•Florida State University
•Harvard University
•Jawaharlal Nehru University
•Massachusetts General Hospital
•New York University
•Oregon Health & Science University
•Tecnologico de Monterrey
•University of Pennsylvania
•University of British Columbia
•University of Illinois Chicago
•University of Illinois Urbana-Champaign
•University of Vermont and State Agricultural College
•Yale University
•
Association of University Technology Managers
•Centers for Disease Control and Prevention
•National Institutes of Health
•Najit Technologies, Inc.
•
Statement of Principles and Strategies for the Equitable
Dissemination of Medical Technologies (SPS)
“Our intellectual property should not become
a barrier to essential health-related
technologies needed by patients in
developing countries. In cases where
universities can fully preclude intellectual
property barriers to generic provision by not
patenting in developing countries, or by
filing and abandoning patents, we will
pursue these strategies.”
Statement of Principles and Strategies for the Equitable
Dissemination of Medical Technologies (SPS)
It is not always possible at the time of
license negotiation to anticipate all of the
ways a health-related technology may be
used in developing countries. Accordingly,
we will strive to preserve our institutions’
future rights to negotiate effective global
access terms through implementation of
such measures as notice requirements
coupled with “agreements to agree.”
Statement of Principles and Strategies for the Equitable
Dissemination of Medical Technologies (SPS)
Without regard to the economic value to
our respective institutions, we will further
support the development of new healthrelated technologies aimed at diseases that
disproportionately burden individuals in
the developing world.
Statement of Principles and Strategies for the Equitable
Dissemination of Medical Technologies (SPS)
Share with one another our collective experience from
working with our licensees in implementing these
principles to continually advance our goals. To that
end, we will cooperate in the creation of:
1. A compendium of best practices, tools and
techniques; and
2. A consistent means of reporting on our global
access initiatives and activities.
3. Revisit these principles on a biennial basis, to
ensure that they reflect currently-understood
best practices
Questions or comments?