MIT Universities Allied for Essential Medicines. © age fotostock / SuperStock

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?