Implementing the SPS… One Year Later Karolina Maciag (Harvard Medical MIT)

Implementing

the SPS…

One Year LaterKarolina Maciag (Harvard Medical

MIT)

Jillian Irwin (Harvard College)

UAEM International Conference

October 9, 2010

What does this document say?

How will TTOs implement the Principles?

What does this document mean for UAEM?

How did we get here?

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

GSK shaming Harvard

response

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

SPS

Launched

Say Yes

To Drugs

Rally

OTD-

UAEM

6-month

meeting

16 additional institutions

sign on to the SPS

OTD

Participates

at UAEM-

Brazil

meeting

OTD -

UAEM

biannual

meeting

CONFERENCE!

The SPS in its first year

UAEM

publishes

response to

SPS

OTD

patent

pool

chat

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

SPS

Launched

Say Yes

To Drugs

Rally

OTD-

UAEM

6-month

meeting

16 additional institutions

sign on to the SPS

OTD

Participates

at UAEM-

Brazil

meeting

OTD -

UAEM

biannual

meeting

CONFERENCE!

Implementation

Transparency

?UAEM

publishes

response to

SPS

OTD

patent

pool

chat

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.

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- 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?