Transcript Slide 1

MIT
Universities
Allied for
Essential
Medicines
© age fotostock / SuperStock
Flickr/Generation X-Ray
PIH/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 expenditures
Worldwide, 1996-2005
25% Profits
32% Marketing
and administration
30% Operational
and material costs
12% R&D
Impact of Generic Competition:
Uganda
Magnum Photos/Francesco Zizola
MSF/Pep Bonet
Before ARV therapy
After six months on ARV therapy
PIH/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
people to lead better and longer lives…More recently, it
became apparent that the drug Dr. Lin and I had developed
was not reaching millions of desperately suffering people
because they lacked the money to purchase it.”
NYTimes Editorial: March 19, 2001 By William Prusoff.
Flickr/MikeBlyth
Flickr/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
Global
Access
Licensing
Patent
Gener-X
The New “Scientist’s Story”
• Dr. Kishor M. Wasan
GSK  shaming Harvard
response
Meeting with Harvard’s President
Just prior to SPS (October 2009)
The BRIC Wall
The SPS is Born
Discuss Stakeholder Meeting,
Committee on Global Access
Licensing with Dean of Public
Health
Faculty outreach for Working
Group on Licensing
Yale
Provost
agrees to
articulate
policies
First meeting
with OTD,
friendly
Yale
monthly
OTD
meetings
Crimson
op-ed
exchange
The SPS is Born
Discuss Stakeholder Meeting,
Committee on Global Access
Licensing with Dean of Public
Health
Faculty outreach for Working
Group on Licensing
Yale
Provost
agrees to
articulate
policies
First meeting
with OTD,
friendly
Yale
monthly
OTD
meetings
Petition to
Provost
Crimson
op-ed
exchange
SPS
Launched
Provost and
TTO Head
reveal plans
to develop
multiuniversity
agreement
Meeting
with OTD
and
CEOs,
unfriendly
Meeting
with
Harvard
President
MultiUniversity
Roundtable
Say Yes
To Drugs
Campaign
Current Signatories
Institution
Association of University Technology Managers
Boston Univ
Brown Univ
Harvard Univ
Univ of Pennsylvania
Yale Univ
Oregon Health & Science University
Signing Date
11/9/2009
11/9/2009
11/9/2009
11/9/2009
11/9/2009
11/9/2009
11/9/2009
National Institutes of Health
University of Illinois Chicago
University of Illinois Urbana-Champaign
11/10/2009
11/10/2009
11/11/2009
Centers for Disease Control and Prevention
University of Vermont and State Agricultural College
Duke University and Duke Medicine
University of British Columbia
Bilkent University
El Colegio de México
New York University
Tecnologico de Monterrey
Jawaharlal Nehru University
Najit Technologies, Inc.
Brigham & Women's Hospital
Florida State University
Massachusetts General Hospital
11/12/2009
11/19/2009
12/1/2009
1/10/2010
1/27/2010
1/27/2010
2/4/2010
2/13/2010
2/18/2010
3/4/2010
3/15/2010
3/29/2010
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?
Rhetoric
UAEM Framework:
Access to medicines and health-related technologies for all is
the primary purpose of technology transfer of health-related
innovations.
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 universitydeveloped technologies, ensuring that advances in health
reach those who need them most.
Access to end products
UAEM Framework:
Technology transfer should protect access to the final end
product needed by patients (e.g., formulated pills or vaccines).
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.”
Generic provision
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.
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-bycase 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
UAEM Framework:
where generic provision is forecast to be technically or economically infeasible, “atcost” or other provisioning requirements should be used as a supplement to generic
provisioning terms but should never replace those terms.
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 nonexclusivity) 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).
Proactive licensing
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.
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
Metrics
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.
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.
Concretization of the SPS
• 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?
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
Work for us: Transparency
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
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
Cons
- Institutions more likely to
SPS Shortcomings!
sign on
-GH application
- Might lead to other GAL-like
-BRIC
agreement
-Generic prioritization
- If endorsed, will participate
-Access to end product
in consortium, revisions, best-Transparency/
practices/collaborative
Accountability
activities
(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 President
Just 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?