Transcript Slide 1

Implementing
the SPS…
One Year Later
Karolina Maciag (Harvard Medical MIT)
Jillian Irwin (Harvard College)
UAEM International Conference
October 9, 2010
How did we get here?
What does this document say?
How will TTOs implement the Principles?
What does this document mean for UAEM?
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
GSK  shaming Harvard
response
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
The SPS in its first year
16 additional institutions
sign on to the SPS
CONFERENCE!
SPS
Launched
UAEM
publishes
response to
SPS
Say Yes
To Drugs
Rally
OTDUAEM
6-month
meeting
OTD
patent
pool
chat
OTD
Participates
at UAEMBrazil
meeting
OTD UAEM
biannual
meeting
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
Implementation
Transparency
16 additional institutions
sign on to the SPS
CONFERENCE!
SPS
Launched
UAEM
publishes
response to
SPS
Say Yes
To Drugs
Rally
?
OTDUAEM
6-month
meeting
OTD
patent
pool
chat
OTD
Participates
at UAEMBrazil
meeting
OTD UAEM
biannual
meeting
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.
SPS vs. Something Stronger
• Should UAEM at non-signatory institutions demand SPS +
concessions…
• or a document (and practices) that are more GALF-like?
• Risk of falling short:
GSK patent
pool:
50 LDCs
Risk of falling short without the SPS
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?