Louis Fazen Yale University

1. UAEMUniversities Allied for Essential Medicines Access Metrics Index Louis Fazen Yale University

2. Philadelphia Consensus Statement • Promote equal access to research. • Promote research and development for neglected diseases. • Measure research success according to impact on human welfare. • Access Metrics Initiative (AMI)

3. Global Access Licensing Framework • Access to medicines and health-related technologies for all is the primary purpose of technology transfer of health-related innovations. • Technology transfer should protect access to the final end product needed by patients • Generic provision is the best way to ensure access to medicines in resource-limited countries • Proactive licensing provisions are essential to ensure that follow-on patents and data exclusivity cannot be used to block generic production. • 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.

4. Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies 6. Develop and apply meaningful metrics to evaluate the success of our efforts 7. Share with one another our collective experiences, educate others, and revisit these principles on a biennial basis http://www.autm.net/AM/Template.cfm?Section=Global_Health&Template=/CM/ContentDisplay.cfm&ContentID=3848

5. Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies Signed by: • Association of University Technology Managers • Boston University • Brown University • Harvard University • Oregon Health & Science University • University of Pennsylvania • Yale University • NIH OTT

6. Metrics?

7. Outline • Access Metrics Initiative Objectives • Strategic Alignment: Policy vs. Practice • Process Outputs vs. Health Outcomes • Access Metrics Initiative Current Work • TTO Director Survey on TTO Activities • Prospective Survey • Retrospective Pilot Survey • UAEM Student Survey on University Policy http://www.autm.net/Nine_Points_to_Consider.htm

8. Outline • Access Metrics Initiative Objectives • Strategic Alignment: Policy vs. Practice • Process Outputs vs. Health Outcomes • Access Metrics Initiative Current Work • TTO Director Survey on TTO Activities • Prospective Survey • Retrospective Survey • UAEM Student Survey on University Policy http://www.autm.net/Nine_Points_to_Consider.htm

9. AMI Objectives • Strategic Alignment • Feasible to Collect • Valid Measurements of TTO Activity • Generalizeable to other TTOs • Employee Communication and Education • University and Public Awareness • Ensure Long-term Growth of University

10. AMI Objectives • Strategic Alignment • Feasible to Collect • Valid Measurements of TTO Activity • Generalizeable to other TTOs • Employee Communication and Education • University and Public Awareness • Ensuring Long-term Growth

11. Strategic Alignment Nine Points to Consider • Retain the right to practice, use, and transfer university technologies • Grant the minimal rights necessary for development in exclusive licenses • Minimize rights to improvement and follow-on patents • Manage responsibility for conflicts-of-interest & maintain open communication • Promote the widest possible access to research tools • Encourage licensee to develop technologies for the benefit of society and if necessary enforce the principles by litigation • Consider federal export laws to ensure effective TT for the public interest • Require due diligence of licensee to develop and commercialize technologies • Consider the needs of marginalized population groups and include provisions to ensure no or low-cost access to adequate quantities of university inventions http://www.autm.net/Nine_Points_to_Consider.htm

12. Strategic Alignment Institutional Global Access Principles • UBC: Principles for Global Access • UC Berkeley: Socially Responsible IP Management Program • Emory University: Guiding Principles for Ensuring Global Access • NIH Research Tools Guidelines • NIH Best Practices for Licensing of Genomic Inventions • NIH Uniform Biological MTA • OECD Guidelines for the Licensing of Genetic Inventions • Gates Foundation • AUTM Global Health Licensing Language

13. Strategic Alignment Academic Articles • Ashley J. Stevens and April E. Effort, “Using Academic License Agreements to Promote Global Social Responsibility.” Journal of the Licensing Executives Society (Les Nouvelles) (June 2008). • Jill Sorensen and Donald Chambers. “Evaluating academic technology transfer performance by how well access to knowledge is facilitated––defining an access metric.” Journal of Technology Transfer. 2008, vol. 33, issue 5 • Nelson, L. The Role of University Technology Transfer Operations in Assuring Access to Medicines and Vaccines in Developing Countries. Yale Journal of Health
Policy, Law, and Ethics. III: 2. 9/12/2003 • Bennett, AB. 2007. Reservation of Rights for Humanitarian Uses. MIHR Handbook of Best Practices • Brewster, AL, Hansen, SA, and Chapman, AR. 2007. Facilitating Humanitarian Access to Pharmaceutical and Agricultural Innovation. MIHR Handbook of Best Practices • Eiss R, Hanna KE, and Mahoney RT. 2007. Ensuring Global Access through Effective IP Management: Strategies of Product-Development Partnerships. MIHR Handbook of Best Practices • Clift C. 2007. Patenting and Licensing Research Tools. MIHR Handbook of Best Practices • Stevens AJ. 2007. Valuation and Licensing in Global Health. MIHR Handbook of Best Practices • Hope J. 2007. Open Source Licensing. MIHR Handbook of Best Practices • Oehler J. 2007. Using Milestones in Healthcare Product Licensing Deals to Ensure Access in Developing Countries. MIHR Handbook of Best Practices • Krattiger A and Kowalski SP. 2007. Facilitating Assembly of and Access to Intellectual Property: Focus on Patent Pools and a Review of Other Mechanisms. MIHR Handbook of Best Practices

14. Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies • Develop licensing strategies to promote global access to health-related technologies • University IP should not become a barrier to essential health-related technologies • Use patents to promote broad access to health-related technologies • Preserve future right to negotiate effective global access terms • Support the development of new health-related technologies aimed at developing world diseases http://www.autm.net/AM/Template.cfm?Section=Global_Health&Template=/CM/ContentDisplay.cfm&ContentID=3848

15. Strategic Alignment Consensus: “most institutions wish to measure their success by demonstrating their contribution to public benefit” -AUTM 2007 Survey

16. Current Tech Transfer Metrics: • AUTM Annual Licensing Surveys • AUTM Better World Project • Milken Institute: Mind to Market Report • NSF: Science and Engineering Indicators; Academic Research & Development Survey • AUCC: Momentum Report • Statistics Canada: Commercialization of Intellectual Property in the Higher Education Sector • UNICO: UK University Commercialisation Survey • Library House: 2008 Metrics for the Evaluation of Knowledge Transfer at Universities • HEFCE: Higher Education-Business and Community Interaction Survey.

17. AUTM Metrics AUTM Annual Licensing Surveys • Licensing Revenue • Invention Disclosures • Patent Applications • Patents Issued • Licenses Executed • Startup Companies Formed

18. Value of Licensing Revenue

19. Strategic Misalignment “If you measure success in terms of social impact or awareness and you count things such as gifts, research collaborations, global impact and boost to your reputation, it changes your orientation. If you measure success only by the amount of royalties and fees you bring in, then your licensing practices will reflect that.” -Carol Mimura

20. AMI Objectives • Strategic Alignment • Feasible to Collect • Valid Measurements of TTO Activity • Generalizeable to other TTOs • Employee Communication and Education • University and Public Awareness • Ensuring Long-term Growth

21. Metrics of Tech Transfer

22. Outcome Measures • Cumulative effect on the environment • Benefit to the local and global community • Stimulation of the economy • Number of people with access to technology • QALYs increased • Reductions in morbidity and mortality • Demonstrate value of technology • Case studies (eg. Better World Project) • SROI Model

23. Outcome Measures: Challenges • Data collection • Resources, availability of data, and time lag • Confounding variables • Licensee IP portfolio, R&D resources • Industry marketing, product competition • Political stability and policy • Local and global market fluctuations • Disease epidemiology, comorbid conditions • Local beliefs and customs

24. AMI as Performance Measurement • Measurement & communication tool for achieving access strategy • Defines success as the dissemination of university innovation • Improves awareness of access concerns in knowledge and technology transfer • Inform prevailing best practices within licensing activities, • Provide incentives for excellence in technology transfer • Publicize the access policies that universities regularly employ. • Enable technology transfer offices to achieve success in accordance with their university mission

25. AMI Principles • Focus on Process Metrics • Institutional Policy & TTO licensing strategies • Provide Incentive and Accountability • Use of multiple sources of university information extending beyond the TTO • Publicize the access policies that technology transfer are implementing

26. Outline • Access Metrics Initiative Objectives • Strategic Alignment: Policy vs. Practice • Process Outputs vs. Health Outcomes • Access Metrics Initiative Current Work • TTO Director Survey on TTO Activities • Prospective Survey • Retrospective Survey • UAEM Student Survey on University Policy http://www.autm.net/Nine_Points_to_Consider.htm

27. Outline • Access Metrics Initiative Objectives • Strategic Alignment: Policy vs. Practice • Process Outputs vs. Health Outcomes • Access Metrics Initiative Current Work • TTO Director Survey on TTO Activities • Prospective Survey • Retrospective Survey • UAEM Student Survey on University Policy http://www.autm.net/Nine_Points_to_Consider.htm

28. AMI Prospective Survey Institutional Policy Knowledge Commons Research Programs Licensing Transparency TTO Administration

29. Access Metrics Index Licensing Policy • Term Sheet • Definitions • Preamble • Patenting • Restrictions • Manufacturing • Distribution • Pricing • Licensing Revenue • Reservation of Rights • Sub-licenses • Licensee Information Disclosure • Accountability and Enforcement

30. Access Metrics Index Licensing Policy • Term Sheet • Definitions • Preamble • Patenting • Restrictions • Manufacturing • Distribution • Pricing • Licensing Revenue • Reservation of Rights • Sub-licenses • Licensee Information Disclosure • Accountability and Enforcement

31. Access Metrics Index Licensing Policy • E. Restrictions • Field of use limitations • Territorial limitations • Research Exemption • Reservation of right to use the invention in non-profit institutions for research purposes

32. Access Metrics Index • Research Exemption • Example Licensing Language: • “The patent shall not be used to prohibit the use or innovation of the patent compound for the purposes of experiment or research, including commercial research, except for ensuring access to the derivative innovations, data, and technologies.” • References: • NIH Best Practices of Licensing Genomic Inventions • NIH Guidelines on Obtaining and Disseminating Biomedical Research Resources • OECD Guidelines for the Licensing of Genetic Inventions

33. AMI Retrospective Survey • Framework: • Follows a more general question format • Selective set of questions • Filled out by TTO directors or their staff • Approximately 15 minutes to fill out • To be sent out to collect data from 2009

34. TTO Director Survey

41. UAEM Student Survey • Objectives: • Encourage UAEMers to investigate and learn more about their own institution • Collect qualitative information on university policy, and TTO mission / vision statements • Categorize university access policies to enable comparison between schools • Collect locally available statistics as background and to enable comparisons within TTO survey • Provide initial university data in absence of TTO responses • Act as standing resource on policy information to inform UAEM activities

42. UAEM Student Survey

43. AMI TTO and Policy Surveys • Objectives: • Provide basic information on TTO practices in global health licensing in the short term • Encourage buy-in from TTOs for ongoing data collection • Correlate policy information with executed licenses and actual TT practices • Recognize and advertise those strategies that are being successfully implemented • May allow UAEM to advocate for improved prospective data collection • May allow UAEM to push for incremental local change, e.g. greater transparency

44. AMI Objectives • Collaborate with TTOs and academics to develop access-oriented metrics. • Conduct a pilot project of access-oriented metrics among voluntary universities • TTO Director Survey • UAEM Student Survey • Publicize access-oriented metrics to increase awareness of licensing for global health • Include access-oriented metrics in existing surveys and implement at universities more broadly

45. Thank You! UAEMUniversities Allied for Essential Medicines Access Metrics Index Louis.Fazen@Yale.edu