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

1. Implementing the SPS… One Year Later Karolina Maciag (Harvard Medical MIT) Jillian Irwin (Harvard College) UAEM International Conference October 9, 2010

2. How did we get here? What does this document say? How will TTOs implement the Principles? What does this document mean for UAEM?

3. The SPS is Born Discuss Stakeholder Meeting, Committee on Global Access Licensing with Dean of Public Health Yale Provost agrees to articulate policies Yale monthly OTD meetings Faculty outreach for Working Group on Licensing Crimson op-ed exchange First meeting with OTD, friendly

4. GSK  shaming Harvard response

5. The SPS is Born Provost and TTO Head reveal plans to develop multi-university agreement Discuss Stakeholder Meeting, Committee on Global Access Licensing with Dean of Public Health Yale Provost agrees to articulate policies Yale monthly OTD meetings Meeting with Harvard President Faculty outreach for Working Group on Licensing Petition to Provost Crimson op-ed exchange Meeting with OTD and CEOs, unfriendly First meeting with OTD, friendly Multi-University Roundtable Say Yes To Drugs Campaign SPS Launched

7. The SPS in its first year 16 additional institutions sign on to the SPS OTD Participates at UAEM-Brazil meeting UAEM publishes response to SPS OTD -UAEM biannual meeting Say Yes To Drugs Rally OTD patent pool chat OTD-UAEM 6-month meeting CONFERENCE! SPS Launched

10. Implementation Transparency 16 additional institutions sign on to the SPS ? OTD Participates at UAEM-Brazil meeting UAEM publishes response to SPS OTD-UAEM 6-month meeting OTD -UAEM biannual meeting OTD patent pool chat Say Yes To Drugs Rally CONFERENCE! SPS Launched

11. NIH implementation: HIV drug in patent pool Harvard: 3 licenses so far Other successes?

12. 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 university-developed technologies, ensuring that advances in health reach those who need them most.

13. 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.”

14. 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.

15. 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.

16. Alternatives to generic provision • 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. • 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).

17. 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

18. 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.

19. 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.

20. Concretization of the SPS • What will the SPSmean? • 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?

21. 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

22. 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.

23. 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

24. Risk of falling short without the SPS

25. 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 • Cons • SPS Shortcomings! • GH application • BRIC • Generic prioritization • Access to end product • Transparency/ • Accountability (Complacency)

26. How do we push for SPS Adoption?

27. 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!

30. Meeting with Harvard’s President Just prior to SPS (October 2009)

31. The BRIC Wall

32. Storytelling

33. 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?