Louis Fazen Yale University UAEM Universities Allied for Essential Medicines Access Metrics Index.

Louis FazenYale University

UAEM Universities Allied for Essential Medicines

Access Metrics Index

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)

Global Access Licensing Framework

1. Access to medicines and health-related technologies for all is the primary purpose of technology transfer of health-related innovations.

2. Technology transfer should protect access to the final end product needed by patients

3. Generic provision is the best way to ensure access to medicines in resource-limited countries

4. Proactive licensing provisions are essential to ensure that follow-on patents and data exclusivity cannot be used to block generic production.

5. 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.

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


Signed by:– Association of University Technology Managers

– Boston University

– Brown University

– Harvard University

– Oregon Health & Science University

– University of Pennsylvania

– Yale University

– NIH OTT

Metrics?

Outline

1. Access Metrics Initiative Objectives• Strategic Alignment: Policy vs. Practice• Process Outputs vs. Health Outcomes

2. 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

Outline



• Prospective Survey• Retrospective Survey



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

AMI Objectives







• Ensuring Long-term Growth

Strategic Alignment

Nine Points to Consider1. Retain the right to practice, use, and transfer university technologies

2. Grant the minimal rights necessary for development in exclusive licenses

3. Minimize rights to improvement and follow-on patents

4. Manage responsibility for conflicts-of-interest & maintain open communication

5. Promote the widest possible access to research tools

6. Encourage licensee to develop technologies for the benefit of society and if necessary enforce the principles by litigation

7. Consider federal export laws to ensure effective TT for the public interest

8. Require due diligence of licensee to develop and commercialize technologies

9. Consider the needs of marginalized population groups and include provisions to ensure no or low-cost access to adequate quantities of university inventions


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

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 HealthPolicy, 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 E ective IP Management: ff

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


1. Develop licensing strategies to promote global access to health-related technologies

2. University IP should not become a barrier to essential health-related technologies

3. Use patents to promote broad access to health-related technologies

4. Preserve future right to negotiate effective global access terms

5. 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

Strategic Alignment

Consensus:

“most institutions wish to measure their success by demonstrating their contribution to public benefit”

-AUTM 2007 Survey

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.

AUTM Metrics

AUTM Annual Licensing Surveys

• Licensing Revenue• Invention Disclosures• Patent Applications• Patents Issued• Licenses Executed• Startup Companies Formed

Value of Licensing Revenue

“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

Strategic Misalignment

AMI Objectives







• Ensuring Long-term Growth

Metrics of Tech Transfer

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

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

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

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

Outline



• Prospective Survey• Retrospective Survey



AMI Prospective Survey

Institutional Policy

Licensing

Transparency

Knowledge Commons

Research Programs

TTO Administration


Licensing PolicyA. Term SheetB. DefinitionsC. PreambleD. PatentingE. RestrictionsF. ManufacturingG. DistributionH. PricingI. Licensing RevenueJ. Reservation of RightsK. Sub-licensesL. Licensee Information DisclosureM. Accountability and Enforcement


Licensing PolicyE. Restrictions

1. Field of use limitations2. Territorial limitations3. Research Exemption

• Reservation of right to use the invention in non-profit institutions for research purposes

Access Metrics IndexResearch ExemptionExample 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:1. NIH Best Practices of Licensing Genomic

Inventions2. NIH Guidelines on Obtaining and

Disseminating Biomedical Research Resources

3. OECD Guidelines for the Licensing of Genetic Inventions

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

TTO Director Survey

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

UAEM Student Survey

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

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

UAEM Universities Allied for Essential Medicines


Thank You!

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Louis Fazen Yale University UAEM Universities Allied for Essential Medicines Access Metrics Index.

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