Toward Equitable Innovation
in Health and Medicine

A Framework

_____

Committee on Creating a Framework
for Emerging Science, Technology, and
Innovation in Health and Medicine

Board on Health Sciences Policy

Health and Medicine Division

Consensus Study Report

NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This activity was supported by grants between the National Academy of Sciences and the Gordon and Betty Moore Foundation through grant #8938.01, the Greenwall Foundation, the Public Interest Technology Infrastructure Fund through subgrant #01705-2022-09-01, the Robert Wood Johnson Foundation through grant #79541, Schmidt Futures, and Qualcomm Inc. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-70761-9
International Standard Book Number-10: 0-309-70761-7
Digital Object Identifier: https://doi.org/10.17226/27184

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Suggested citation: National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward equitable innovation in health and medicine: A framework. Washington, DC: The National Academies Press. https://doi.org/10.17226/27184.

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COMMITTEE ON CREATING A FRAMEWORK FOR EMERGING SCIENCE, TECHNOLOGY, AND INNOVATION IN HEALTH AND MEDICINE¹

KEITH WAILOO (Co-Chair), Henry Putnam University Professor of History and Public Affairs, Princeton University, New Jersey

KEITH YAMAMOTO (Co-Chair), Vice Chancellor for Science Policy and Strategy; Director, UCSF Precision Medicine; Professor Emeritus, Cellular and Molecular Pharmacology, University of California, San Francisco

AMY ABERNETHY, President, Product Development and Chief Medical Officer, Verily, San Francisco, California

DAVID ASCH, Senior Vice Dean for Strategic Initiatives at the Perelman School of Medicine and the John Morgan Professor at the Perelman School and the Wharton School at the University of Pennsylvania

OLVEEN CARRASQUILLO, Professor of Medicine and Public Health Sciences, University of Miami, Florida

AMITABH CHANDRA, Ethel Zimmerman Wiener Professor of Public Policy and Henry and Allison McCance Professor of Business Administration, Harvard University, Massachusetts

R. ALTA CHARO, Principal, Alta Charo Consulting LLC and Warren P. Knowles Professor Emerita of Law & Bioethics, University of Wisconsin–Madison

HANA EL-SAMAD, Senior Vice President and Director of Science Integration, Innovation and Insights and Founding Principal Investigator, Altos Labs, California

MICHELE BRATCHER GOODWIN, Linda D. & Timothy J. O’Neill Professor of Constitutional Law and Global Health Policy, Georgetown Law School, Washington, DC

ANTHONY RYAN HATCH, Professor of Science in Society, African American Studies, Environmental Studies, and Sociology, Wesleyan University, Connecticut

JIANYING HU, IBM Fellow, Director of HCLS Research, and Global Science Leader, AI for Healthcare, IBM Research, New York

LISA I. IEZZONI, Professor of Medicine, Harvard Medical School, Massachusetts

ALEX JOHN LONDON, Clara L. West Professor of Ethics and Philosophy, Carnegie Mellon University, Pennsylvania

DEBRA MATHEWS, Associate Director for Research and Programs, Berman Institute of Bioethics and Associate Professor of Genetic Medicine, Johns Hopkins University, Maryland

SHOBITA PARTHASARATHY, Professor of Public Policy and Professor of Women’s and Gender Studies, University of Michigan

TIMOTHY M. PERSONS, Partner, PricewaterhouseCoopers LLP, Washington, DC

ARTI RAI, Elvin R. Latty Professor of Law, Duke University, North Carolina

KAUSHIK SUNDER RAJAN, Professor of Anthropology and Social Sciences, The University of Chicago, Illinois

KRYSTAL TSOSIE, Assistant Professor, Arizona State University and Co-founder, Native BioData Consortium, Arizona

___________________

¹ NOTE: See Appendix E, Disclosure of Unavoidable Conflicts of Interest.

NAM Fellows

ANDREW A. GONZALEZ, Gilbert S. Omenn Fellow and Assistant Professor of Surgery, Indiana University

STEVEN LIN, James C. Puffer, American Board of Family Medicine Fellow and Clinical Associate Professor, Stanford University, California

Study Staff

KATHERINE BOWMAN, Study Director, Board on Health Sciences Policy

ANDREW BREMER, Program Officer, Board on Life Science

MELISSA LAITNER, Special Assistant to the President, National Academy of Medicine

CELYNNE BALATBAT, Associate Program Officer, National Academy of Medicine

MICHAEL BERRIOS, Research Associate, Board on Health Sciences Policy

VICTORIA CHEGE, Senior Program Assistant, Board on Health Sciences Policy

CHRISTIE BELL, Finance Business Partner, Board on Health Sciences Policy

CLARE STROUD, Senior Director, Board on Health Sciences Policy

KIMBER BOGARD, Deputy Executive Officer, Programs, National Academy of Medicine

Consultants

RONA BRIERE, Senior Editor, Briere Associates, Inc.

LEE A. BLEVINS ZAJAC, Editorial Assistant, Briere Associates, Inc.

ALLIE BOMAN, Editorial Assistant, Briere Associates, Inc.

JOHN HAWKINS, Editorial Assistant, Briere Associates, Inc.

ANNE JOHNSON, Founder and Lead Science Writer, Creative Science Writing, LLC

PEAK SEN CHUA, Consultant, National Academy of Medicine

Reviewers

This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.

We thank the following individuals for their review of this report:

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by ELISABETH BELMONT, MaineHealth, and ERIC LARSON, University of Washington. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.

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Acknowledgments

The committee would like to express its sincere gratitude to the speakers, panelists, respondents to the call for input, and others who shared their views with the committee, as well as to Alexis Walker and Michael McGovern for authoring commissioned papers presented in Appendixes of this report.

The committee is also grateful for the contributions of Rona Briere, senior editor, Allie Boman, Lee A. Blevins Zajac, and John Hawkins, editorial assistants, Anne Johnson, science writer, and Peek Sen Chua, consultant, along with Christopher Lao-Scott, senior librarian of the National Academies Research Center, for his crucial assistance with fact checking.

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Contents

SUMMARY

1 INTRODUCTION

Past and Current Efforts Toward Advancing Equity

National Academy of Medicine’s Emphasis on Emerging Science, Technology, and Innovation

Beyond Research Ethics: Enhanced Attention to Equity, Justice, and Fairness

Study Scope and Approach

Organization of the Report

References

2 TAKING EQUITY SERIOUSLY IN INNOVATION

Why Equity Is Important Now

Justification for Considering Equity in the Medical Technology System

Definition of Equity: What Equity is, and What It Is Not

Case Study: Equity in Relation to Disability

Applying Equity Principles in Technology Development and Innovation

Chapter Conclusions

References

3 THE INNOVATION LIFE CYCLE IN HEALTH AND MEDICINE AND THE CHALLENGE OF EQUITY

Conceptual Overview of the Innovation Life Cycle

Assessment of the Existing Innovation System

Failure to Address Equity Holistically in the Current System

Chapter Conclusions

References

4 A GOVERNANCE FRAMEWORK FOR ALIGNING INNOVATION IN HEALTH AND MEDICINE WITH EQUITY

Five Imperatives That Guide the Framework

A Framework for Governance of Innovation: Applying the Imperatives to Enhance the Innovation System in Health and Medicine

Illustrating How the Framework Can Influence the Innovation Ecosystem

Leverage Points Influencing the System to Implement the Framework

Chapter Conclusions

References

5 REIMAGINING THE INNOVATION LIFE CYCLE: CONCRETE STEPS TOWARD EQUITY

Introduction to the Recommendations

Galvanizing National Leadership and Setting Priorities

Enhancing the Culture of Ethical Innovation

Making Targeted Use of Governance Incentives

Expanding Who Participates in Innovation

Developing Equity Science

Creating Context-Specific Playbooks

An Action Agenda for Stakeholders in the Innovation System

References

APPENDIXES

A Information Sources and Methods

B Technology Governance and Equity in US History (McGovern and Wailoo)

C Equity in Innovation within NIH and FTC (Walker)

D Committee Member Biographies

E Disclosure of Unavoidable Conflicts of Interest

Boxes, Figures, and Tables

BOXES

1-1 Selected Examples of Recent Publications and Initiatives Exploring Implications and Governance of Emerging Technologies in Health and Medicine

1-2 Statement of Task

1-3 Selected Themes and Comments from a Public Survey

2-1 The Pulse Oximeter: An Example of Inequity in Health Technology

3-1 From Basic Science to Big Business

3-2 Public Funding, Equity, and Treatment for Hepatitis C

3-3 Case Study of Artificial Intelligence/Machine Learning (AI/ML) Technologies in Health Innovation

4-1 Community and Academic Engagement in Flint, Michigan

4-2 Examples of Initiatives Emphasizing Community Participation and Benefit Sharing

4-3 Patent-Level Levers Used in Other Countries

4-4 Equity Considerations in the Production of Artemisinin

4-5 Examples of the Food and Drug Administration (FDA) Mechanisms That Can be Used to Incentivize Medical Product Development with Implications for Equity

4-6 Development of Drug Therapies for HIV/AIDS

4-7 The Open Insulin Foundation

4-8 Expanding Global Access to Emerging Technologies: The World Health Organization’s (WHO’s) mRNA Hub

4-9 Equity Considerations during the Postmarket Phase: Makena

4-10 Unlocking Nursing Knowledge to Develop Front-line Medical Innovations

FIGURES

S-1 The governance framework for aligning emerging science, technology, and innovation in health and medicine with ethical principles, emphasizing alignment with equity

1-1 Principles and commitments articulated by the National Academy of Medicine’s Committee on Emerging Science, Technology, and Innovation in Health and Medicine

2-1 Scenarios conceptualizing equity as something more or other than equality

3-1 A simplified conceptual model of the innovation life cycle

3-2 Varying levels of community engagement

4-1 The proposed governance framework for aligning emerging science, technology, and innovation in health and medicine with ethical principles, emphasizing alignment with equity

TABLES

S-1 Summary of Recommendations

S-2 An Action Agenda for Stakeholders

2-1 Dimensions of Equity Relevant to Innovation

4-1 Examples of Leverage Points and Choices, Questions Raised by the Framework Imperatives, and Applications of the Dimensions of Equity at Each Phase of the Innovation Life Cycle

5-1 Summary of Recommendations

5-2 An Action Agenda for Stakeholders