1. MIT Universities Allied for Essential Medicines

2. © age fotostock / SuperStock

3. Flickr/Generation X-Ray

5. PIH/David Walton

6. 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?

7. Pharmaceutical industry expenditures Worldwide, 1996-2005 12% R&D 25% Profits 30% Operational and material costs 32% Marketing and administration

8. Impact of Generic Competition: Uganda

9. Magnum Photos/Francesco Zizola

10. MSF/Pep Bonet

11. Before ARV therapyAfter six months on ARV therapy PIH/David Walton

13. It is acceptable to die of a treatable infection so long as you are poor enough.

14. “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.

15. Flickr/MikeBlythFlickr/MikeBlyth

16. Flickr/Snap Man

17. 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

18. PhRMA Sales by Geographic Area

19. Gener-X Patent Global Access Licensing

21. The New “Scientist’s Story” Dr. Kishor M. Wasan

23. GSK  shaming Harvard response

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

27. The BRIC Wall

29. 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

30. 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

31. Current Signatories InstitutionSigning Date Association of University Technology Managers11/9/2009 Boston Univ11/9/2009 Brown Univ11/9/2009 Harvard Univ11/9/2009 Univ of Pennsylvania11/9/2009 Yale Univ11/9/2009 Oregon Health & Science University11/9/2009 National Institutes of Health11/10/2009 University of Illinois Chicago11/10/2009 University of Illinois Urbana-Champaign11/11/2009 Centers for Disease Control and Prevention11/12/2009 University of Vermont and State Agricultural College11/19/2009 Duke University and Duke Medicine12/1/2009 University of British Columbia1/10/2010 Bilkent University1/27/2010 El Colegio de México1/27/2010 New York University2/4/2010 Tecnologico de Monterrey2/13/2010 Jawaharlal Nehru University2/18/2010 Najit Technologies, Inc.3/4/2010 Brigham & Women's Hospital3/15/2010 Florida State University3/29/2010 Massachusetts General Hospital3/29/2010

33. GSK patent pool: 50 LDCs

36. 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.

37. 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

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

41. 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.

42. 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.”

43. 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.

44. 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.

45. 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.

46. 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

47. 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.

48. 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.

49. 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

50. 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

51. 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.

52. 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)

53. How do we push for SPS Adoption?

54. 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!

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

58. The BRIC Wall

59. Storytelling

60. 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?