mit universities allied for essential medicines. © age fotostock / superstock
TRANSCRIPT
MITUniversities
Allied for Essential Medicines
© age fotostock / SuperStock
Flickr/Generation X-Ray
PIH/David WaltonPIH/David WaltonPIH/David WaltonPIH/David Walton
• You bring kindness, and your kindness is good. But it will not cure this AIDS.
• I know there is medicine in your country for people like you. But why not here, for people like me?
Pharmaceutical industry expendituresWorldwide, 1996-2005
12% R&D
25% Profits
30% Operational and material costs
32% Marketing and administration
Impact of Generic Competition:
Uganda
Magnum Photos/Francesco ZizolaMagnum Photos/Francesco ZizolaMagnum Photos/Francesco ZizolaMagnum Photos/Francesco Zizola
MSF/Pep BonetMSF/Pep BonetMSF/Pep BonetMSF/Pep Bonet
Before ARV therapy After six months on ARV therapyPIH/David WaltonPIH/David WaltonPIH/David WaltonPIH/David Walton
• It is acceptable to die • of a treatable infection• so long as you are poor
enough.
“The Scientist’s Story”
““I once helped create a drug that could enable millions of I once helped create a drug that could enable millions of
people to lead better and longer lives…More recently, it people to lead better and longer lives…More recently, it
became apparent that the drug Dr. Lin and I had developed became apparent that the drug Dr. Lin and I had developed
was not reaching millions of desperately suffering people was not reaching millions of desperately suffering people
because they lacked the money to purchase it.”because they lacked the money to purchase it.”
NYTimes Editorial: March 19, 2001 By William Prusoff.
Flickr/MikeBlythFlickr/MikeBlythFlickr/MikeBlythFlickr/MikeBlyth
Flickr/Snap ManFlickr/Snap ManFlickr/Snap ManFlickr/Snap Man
Role of Academic Research
Academic patents in 1 in every 5 of the most innovative Rx (FDA priority review)
Academic patents in 1 in every 4 HIV Rx.
In 44% of cases, universities filed for patent protection in developing world.
Sampat, Am J. Pub. H., 2009
PhRMA Sales by Geographic Area
Gener-X
Patent
GlobalAccess
Licensing
The New “Scientist’s Story”The New “Scientist’s Story”• Dr. Kishor M. Wasan
GSK shaming Harvard
response
Meeting with Harvard’s PresidentJust prior to SPS (October 2009)
The BRIC Wall
The SPS is Born
Yale
Provost
agrees to
articulate
policies
Discuss Stakeholder Meeting,
Committee on Global Access
Licensing with Dean of Public
Health
Crimson
op-ed
exchange
Faculty outreach for Working
Group on Licensing
First meeting
with OTD,
friendly
Yale
monthly
OTD
meetings
The SPS is Born
Yale
Provost
agrees to
articulate
policies
Discuss Stakeholder Meeting,
Committee on Global Access
Licensing with Dean of Public
Health
Crimson
op-ed
exchange
Faculty outreach for Working
Group on Licensing
First meeting
with OTD,
friendly
Petition to
Provost
Yale
monthly
OTD
meetings
Provost and
TTO Head
reveal plans
to develop
multi-
university
agreement
Meeting
with OTD
and
CEOs,
unfriendly
Multi-
University
Roundtable
Say Yes
To Drugs
Campaign
SPS
Launched
Meeting
with
Harvard
President
Current Signatories
Institution Signing DateAssociation of University Technology Managers 11/9/2009Boston Univ 11/9/2009Brown Univ 11/9/2009Harvard Univ 11/9/2009Univ of Pennsylvania 11/9/2009Yale Univ 11/9/2009Oregon Health & Science University 11/9/2009National Institutes of Health 11/10/2009University of Illinois Chicago 11/10/2009University of Illinois Urbana-Champaign 11/11/2009Centers for Disease Control and Prevention 11/12/2009University of Vermont and State Agricultural College 11/19/2009Duke University and Duke Medicine 12/1/2009University of British Columbia 1/10/2010Bilkent University 1/27/2010El Colegio de México 1/27/2010New York University 2/4/2010Tecnologico de Monterrey 2/13/2010Jawaharlal Nehru University 2/18/2010Najit Technologies, Inc. 3/4/2010Brigham & Women's Hospital 3/15/2010Florida State University 3/29/2010Massachusetts General Hospital 3/29/2010
GSK patent pool: 50 LDCs
Mission Statement
The mission of MIT is to advance knowledge and educate students
in science, technology, and other areas of scholarship that will
best serve the nation and the world in the 21st century.
The Institute is committed to generating, disseminating, and
preserving knowledge, and to working with others to bring
this knowledge to bear on the world's great challenges. MIT
is dedicated to providing its students with an education that
combines rigorous academic study and the excitement of
discovery with the support and intellectual stimulation of a
diverse campus community. We seek to develop in each member
of the MIT community the ability and passion to work wisely,
creatively, and effectively for the betterment of humankind.
Our Vision
Universities and publicly funded research institutions will be part of the
solution to the access to medicines crisis by promoting medical
innovation in the public interest and ensuring that all people regardless
of income have access to essential medicines and other health-related
technologies.
Our Mission
As a private non-profit organization rooted in a movement of university
students, UAEM aims to
- promote access to medicines for people in developing countries by
changing norms and practices around university patenting and licensing
- ensure that university medical research meets the needs of the majority
of the world’s population
- empower students to respond to the access and innovation crisis
NIH implementation: HIV drug in patent pool
Harvard: 3 licenses so far
Other successes?
UAEM Framework:
Access to medicines and health-related technologies for all is
the primary purpose of technology transfer of health-related
innovations.
Rhetoric
SPS
- We have created new methods to deploy cutting-edge
knowledge toward potential public benefit
- Licensing practices involved in such commercialization have
expanded to promote explicitly global access to university-
developed technologies, ensuring that advances in health
reach those who need them most.
UAEM Framework:
Technology transfer should protect access to the final end
product needed by patients (e.g., formulated pills or vaccines).
Access to end products
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.”
UAEM Framework:
Generic provision is the best way to ensure access in resource-limited
countries for products that also have markets in developed countries. Legal
barriers to generic production of these products for use in resource-limited
countries should therefore be removed.
Generic provision
SPS
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.
Generic provision, cont.: Exceptions
SPS
…it may be necessary to account for special circumstances (e.g., in India,
China or Brazil) that may warrant patenting in such countries on a case-by-
case basis, including but not limited to:
The existence in a developing country of pharmaceutical
manufacturing capacity suitable to support product distribution both
within and outside the developing world; or
The opportunity to gain greater leverage in seeking concessions, such as
access to others’ intellectual property, that would help to ensure that the
health-related technology can be made available affordably; or
To enable our licensee(s) to implement tiered pricing in those developing
countries where a significant private market exists.
Alternatives to generic provision
SPS
In those cases where we pursue patent rights, we will negotiate license agreements that
draw upon a variety of strategies that seek to align incentives… to promote broad
access … not limited to:
• Financial incentives to licensees (e.g., elimination or adjustments to royalty rates);
• Reserved or ‘march-in’ rights, mandatory sublicenses or non-assert provisions;
• Affirmative obligations of diligence, with license reduction, conversion (i.e., to non-
exclusivity) or termination as the penalty for default; and
• Tiered- or other appropriate pricing on a humanitarian basis (e.g., subsidized, at-cost
or no-cost).
UAEM Framework:
where generic provision is forecast to be technically or economically infeasible, “at-
cost” or other provisioning requirements should be used as a supplement to generic
provisioning terms but should never replace those terms.
UAEM Framework:
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.
Proactive licensing
SPS
Early publication and wide dissemination of results will be encouraged to
reduce opportunities for interfering patents.
…
In those cases where we pursue patent rights, we will negotiate license
agreements that draw upon a variety of strategies [including]…
Reserved or ‘march-in’ rights, mandatory sublicenses or non-assert provisions
UAEM Framework:
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.
Metrics
SPS:
We will work together to develop and apply meaningful metrics to evaluate
the success of our efforts to facilitate global access and support continued
innovation with particular relevance to global health.
Work for us: Living document
SPS
Educate others and encourage their consideration,
endorsement and application of the principles articulated in this
statement; and
[Get your university to sign on?]
Revisit these principles on a biennial basis, to ensure that they
reflect currently-understood best practices.
• What will the SPS mean?
• GOVERNANCE: What type of mechanism does UAEM
need to push for so that GALF principles are implemented
at SPS schools?-Institutional review boards including expert faculty,
research faculty, students, administrators- Other?
• TRANSPARENCY: How can UAEM keep apprised of
licensing deals and promote collaboration among TTOs?- issue of agreement confidentiality- biannual meeting - online database of deals - Other?
Concretization of the SPS
Work for us: Vigilance on Implementation
SPS
1 The decision about precisely which health-related
technologies merit global access licensing is complicated and
will be the subject of ongoing evaluation by our organizations.
While the principles articulated in this statement currently are
directed primarily at therapeutics and vaccines, their
application to medical diagnostics and devices will be
assessed case-by-case on an ongoing basis
UAEM Framework:
Every university-developed technology with potential for further
development into a drug, vaccine, or medical diagnostic should be licensed
with a concrete and transparent strategy
Work for us: Transparency
SPS
[We commit to] Share with one another our collective experiences from
working with our licensees in implementing these principles to continually
advance our goals. To that end, we will cooperate in the creation of:
A compendium of best practices, tools and techniques; and
A consistent means of reporting on our global access initiatives and
activities.
Pushing for SPS Adoption
Pros- Institutions more likely
to sign on- Might lead to other GAL-
like agreement- If endorsed, will
participate in consortium, revisions, best-practices/collaborative activities
ConsSPS Shortcomings!
-GH application-BRIC-Generic prioritization-Access to end product-Transparency/ Accountability(Complacency)
How do we push for SPS Adoption?
Say Yes To Drugs
• Harvard Campaign of Fall 2009 that led to SPS drafting and adoption
• T-shirts, Viral video, petition, benefit dance, op-eds, BRIC-or-Treat, Rally
• Main Challenge: Storytelling • Solution: Provocative T-Shirts!
Meeting with Harvard’s PresidentJust prior to SPS (October 2009)
The BRIC Wall
Storytelling
SPS Advocacy
• How has SPS advocacy been going at your universities?– Successes?
• How did you accomplish it? What made your action effective?
– Obstacles?• Strategies to overcome them?• How can UAEM schools support each other?