Toward Equitable Innovation in Health and Medicine A Framework (2023) / Chapter Skim
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4 A Governance Framework for Aligning Innovation in Health and Medicine with Equity
4 A Governance Framework for Aligning Innovation in Health and Medicine with Equity
Pages 89-132
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From page 89... ...
The final sections of this chapter translate the governance framework to the phases of technology innovation, provide illustrative examples of these imperatives in practice and a vision for various stakeholders of what is possible, and describe leverage points in innovation life cycles that might be used to shift structural and institutional dynamics to realign those pathways with equity. Chapter 5 presents the committee's recommendations for concrete actions that would advance this more equitable innovation ecosystem.
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From page 90... ...
To these ends, the following five cross-cutting imperatives underpin this new governance framework and will need to be embraced by innovators, funders, investors, purchasers, and users: • broadening participation and sharing responsibility to empower a wider range of stakeholders; • aligning incentives to encourage equitable decision making; • determining how inequities develop along technology innovation life cycles and taking responsibility for mitigating them; • crafting timely guidance for pursuing equitable ends; and • sharpening ongoing, iterative oversight and evaluation along innovation life cycles. Broadening Participation and Sharing Responsibility to Empower a Wider Range of Stakeholders The first imperative focuses on broadening participation and responsibility in technological innovation by empowering groups to take actions that prioritize and center equity.
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Aligning Incentives to Encourage Equitable Decision Making Broadening participation and democratizing the innovation process will require actions that encourage, incentivize, and empower traditional innovation actors to take on new responsibilities for equity. Many people and groups play roles throughout the technology
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From page 92... ...
For example, equity considerations are often distant considerations for private companies, innovators, and some funders. To bridge these gaps in motivations and vested interests will require incentives that invite developers, designers, funders, firms, and other innovation actors to center and prioritize equity in their work.
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From page 93... ...
Determining and Taking Responsibility for Inequities along Technology Innovation Life Cycles People who are responsible for innovation systems need to pursue a more holistic approach to understanding the implications of technologies in society with respect to their impacts on health and well-being. The third imperative in the committee's framework is focused on building and renewing collective curiosity among innovation participants regarding the dynamic causes and patterns of inequity along innovation life cycles.
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From page 94... ...
Tools are needed to assist innovators and other actors in systematically asking and answering questions about the equity impacts of their particular technologies and what practices they can use to mitigate any related concerns. These questions need to be posed along the innovation life cycle to elucidate who holds responsibility for advancing equity and what those responsibilities look like as choices are made during the process -- the moments at which actors' decisions lead to more (or less)
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From page 95... ...
The Imperatives in Context: Learning from a Regenerative Medicine Case Example If equity in innovation is to be advanced the five cross-cutting imperatives detailed above will need to be applied to understand and shape the dynamics of particular technologies as they travel along innovation life cycles. One case study that informed the committee's analysis (see Appendix A)
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From page 96... ...
However, early clinical trials took place before institutional and professional ethics infrastructures for approaches to informed consent and other protections for human participants in research had been developed. Since human pluripotent stem cells were first isolated, the field has seen evolving commitments to ethical practices for communicating and balancing benefits and harms to research participants, and recognition has grown of the importance of patient and public engagement and accountability in the development of new technologies.
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From page 97... ...
Framework imperatives that can aid in addressing this disparity include broadening participation to empower a wider range of innovation stakeholders and aligning incentives to encourage equitable policies and decision making. As noted previously, the inclusion of diverse perspectives in decision making influences how research and innovation priorities are set, how clinical trials are designed, and which incentives and disincentives are used to shape behavior.
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From page 98... ...
As depicted in the figure and described in more detail in Chapter 3, these choices encompass the receipt of FIGURE 4-1 The proposed governance framework for aligning emerging science, technology, and innovation in health and medicine with ethical principles, emphasizing alignment with equity. The five imperatives (left)
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From page 99... ...
While the table is not intended to capture every nuance of a complex ecosystem in emerging science and technology, it provides a guide to the overall system and to the ways in which interventions can nudge innovation toward equity. ILLUSTRATING HOW THE FRAMEWORK CAN INFLUENCE THE INNOVATION ECOSYSTEM This section explores how applying the governance framework described above to the phases of emerging science and technology development supports an innovation system better able to anticipate and address inequities.
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involved in research approvals and funding Researching, Developing, and Assembling a Technology Leverage Points Broadening participation; taking Input equity, evaluation equity, value • Research approvals and responsibility capture equity, contextual equity technology performance • How are the questions answered, • Developers make decisions on assessments and who gets credit? design, cost, speed, and complexity • Intellectual property • Who decides whether the answer is that can intersect with equity.
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From page 101... ...
research and development, and it is important for later phases to incorporate strong evaluative mechanisms so these gaps can be recognized and addressed should they emerge. As described elsewhere in this report, applying the governance framework to innovation requires culture change.
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From page 102... ...
Taking Responsibility for Determining and Mitigating Inequities, Aligning Incentives, and Sharpening Oversight to Support Equitable Innovation How a problem in health and medicine is studied has implications for how the problem is understood. Researchers customarily turn to the techniques with which they are familiar or those seen as most rigorous in their fields.
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From page 103... ...
Applying the framework requires researchers, research institutions, and funders of emerging science and technology to play roles in aligning their work with equity. Consistent with this report's call for culture change, researchers and developers should be mindful of the intersection of their proposed designs with the aspects of equity described in Chapter 2.
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From page 104... ...
Whether by choice, policy guidance, executive order, or legislative mandate, research funders and institutions can require certain projects8 to evaluate equity implications; provide feedback to investigators on how they might address identified equity considerations; and provide investigators with assistance from technical experts, social scientists and humanities scholars, and/or community experts on strategies for ensuring that such projects are designed equitably. Questions might include, for example, how a clinical research project considered the needs and priorities of affected communities in its focus and approach, and what steps can be taken to minimize the likelihood that inequities will arise during the phases of research and development.
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From page 105... ...
The framework imperatives introduce iterative governance and broaden partnerships and engagement in innovation, expanding who is involved in this phase and strengthening innovation by bringing diverse perspectives to bear on an area of emerging science and technology. Broadening Participation Once experts and interested parties have converged on a technology to develop and have received funding and research approvals, the challenge shifts to design and develop
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The Flint Center for Health Equity Solutions (FCHES, 2022) , funded by the National Institutes of Health (NIH)
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From page 107... ...
The CTSA engagement infrastructure played a role during the COVID-19 pandemic though initiatives such as those addressing misinformation and promoting minority par ticipation in COVID-19 clinical trials.b • All of Us Initiative, with the aim of enrolling 1 million people from all backgrounds in an ambitious precision medicine initiative.c NIH's use of equitable benefit sharing and com munity control over genetic material used in the initiative represents one approach that has been proposed to mitigate concerns, particularly from Indigenous communities, about the uses and commodification of genetic data (Fox, 2020)
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. Taking Responsibility for Determining and Mitigating Inequities, Aligning Incentives, and Sharpening Oversight to Support Equitable Innovation How intellectual property is identified, managed, and licensed.
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From page 109... ...
. These practices illustrate expanded approaches the United States could consider adopting to help support equitable innovation in health and medicine, as well as potential opportunities for further transnational discussions of innovation to compare goals, approaches, outcomes, and lessons learned.
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Socially mindful technology licensing initiatives provide one model. An example is the Socially Responsible Licensing Program of the University of California, Berkeley, which aims to stimulate investment in products that bring benefits in developing countries, and to promote "affordability and accessibility of drugs, therapies, diagnostics, crops, and vaccines to the developing world by stimulating investment where it has been traditionally lacking under profit-motivated business models" (Mimura, 2006)
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. Nevertheless, artemisinin provides an example of how social needs and benefits can inform such choices as selection of a research topic, technology transfer and licensing provisions, and commercial production and dissemination strategies for emerging science innovations.
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. Although this effort is not focused on social benefit, it could similarly provide an opportunity to explore how this report's governance framework could be applied to start-up formation.16 Other tools that could be explored as potential strategies for addressing these challenges include the use of patent pools and efforts to mitigate patent ‘thickets" (Mattioli and Merges, 2017; Rai and Price, 2021; Sherkow, 2017)
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From page 113... ...
Fast Track designation: Review of drugs for treating serious conditions and filling unmet medi cal needs is expedited by this designation.d The designation can be used in cases where existing therapies are inaccessible to subpopulations, whether because of cost, logistics, delivery systems, or other factors, thus satisfying the criterion of "unmet need." "Priority review vouchers" (PRVs) : The FDA offers these vouchers to developers of drugs with lower expected profitability, such as those used for rare pediatric diseases, tropical diseases, or some public health emergencies.
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From page 114... ...
Therefore, applying the governance framework to influence such decisions will likely need to connect to ultimate financial returns. In this context, investors are highly attuned to signals from downstream payers; investors are unlikely to prioritize equity if an end payer is not willing to pay for it.
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From page 115... ...
Taking Responsibility for Determining and Mitigating Inequities, Aligning Incentives, and Sharpening Oversight to Support Equitable Innovation Applying the imperatives of the framework at this stage involves asking how performance and outcomes are evaluated; in which subsets of anticipated users; whether there are biases or other issues in the data, metrics, and input considered in the evaluations; and whether the innovation appears to impact equity in positive or negative ways. One example of a failure to take these steps is the recognition during the COVID-19 pandemic that many pulse oximeters inaccurately assessed blood oxygen levels among people with darker (melanated)
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BOX 4-6 DEVELOPMENT OF DRUG THERAPIES FOR HIV/AIDS The history of clinical trials for therapies for HIV/AIDS reflects the action of community mem bers in changing clinical trial practices and governance. By the time the AIDS epidemic emerged in the 1980s, the double-blind, placebo controlled, randomized approach had become the gold standard for testing new pharmaceuticals to determine whether they were safe and effective.
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Broadening Participation. Taking Responsibility for Determining and Mitigating Inequities, Aligning Incentives, and Sharpening Oversight to Support Equitable Innovation A variety of factors can create barriers to equitable access to and use of a technology.
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From page 118... ...
SOURCE: Open Insulin Foundation, 2022. Health care organizations and payers could incorporate equity considerations into health technology assessments to inform purchasing decisions or to support or require postimplementation surveillance that would illuminate impacts on equity as a basis for altering purchasing or coverage decisions.
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From page 119... ...
Its coverage decisions have broad implications for who can benefit from health innovations, how much the innovations cost, and the processes for gaining access to them. With the recent launch of its Framework for Health Equity 2022–2023, CMS established five priorities for advancing its infrastructure for equity-related assessment, fostering structural change, and ensuring equitable access to its services and coverage, positioning the agency to pave the way for the advancement of equity principles (CMS, 2023)
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Taking Responsibility for Determining and Mitigating Inequities, Aligning Incentives, and Sharpening Oversight to Support Equitable Innovation Several existing mechanisms facilitate postmarket data generation and use in the context of health innovations. For some technologies, there are regulatory requirements to evaluate performance in the postmarket context.
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From page 121... ...
. LEVERAGE POINTS FOR INFLUENCING THE SYSTEM TO IMPLEMENT THE FRAMEWORK As the examples presented throughout this chapter illustrate, there are multiple opportunities to take action at every phase of the innovation life cycle to align emerging science, technology, and innovation in health and medicine with equity goals.
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From page 122... ...
Pull incentives make a certain action more enticing. Examples include offering a grant specifically for work that imagines a more equitable version of an existing therapy or delivery system; opportunities for expedited FDA review; policies such as the Orphan Drug Act, which make certain areas of research and development more enticing by enhancing the rewards for success; and the issuance of priority review vouchers for a profitable product in exchange for focusing attention on products for underserved populations.
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From page 123... ...
. In general, interventions supporting equity and mitigating inequities in early phases of emerging science and technology development -- for example, by diversifying the STEM workforce or enhancing substantive research partnerships with affected communities -- are likely to be more impactful than attempts to mitigate inequities that are introduced later and amplified along the way.
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From page 124... ...
Potential levers include • requirements that clinical testing meet minimum standards for geographic, racial, ethnic, and/or other types of study diversity and data representativeness; • use of expedited regulatory reviews in targeted areas; • expansion of current reviews for safety and efficacy to include effectiveness mea sures that reflect equity considerations, such as predicted distribution of use or predicted effectiveness within various subpopulations; and • requirements to evaluate postmarket performance data on effectiveness and uses in order to identify inequities that may arise. Leverage Point: Recruitment for and Participation in Clinical Trials.
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Actions or policies that achieve these outcomes can tip the scales toward investments that advance equity by making such investments more attractive from a financial standpoint. Potential levers include • government policies that stimulate innovation in particular areas by offering favor able market advantages, such as opportunities for expedited FDA review, which shortens the time to market, or the Orphan Drug Act, which incentivizes the devel opment of treatments for rare diseases; • public or philanthropic investment in early-phase science in areas identified as equity promoting, such as the Gates Foundation's funding of nonprofit One World Health to develop yeast-synthesized artemisinin for treatment of malaria, thereby increasing the pipeline of innovations that might be commercialized and reducing downstream risk and uncertainty; • the incorporation of equity implications of a health innovation into the criteria for assessing environmental, social, and governance factors for companies involved in its development, which could potentially improve a company's reputation and attract investors who value these factors; and • the conduct of equity audits or other means of imposing pressure for companies to attend to equity concerns in their investment portfolios by large-scale investors such as managers of university endowments, foundations, and pension funds.
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From page 126... ...
Coverage decisions by insurers are subject to both state and federal law, and health care organizations also make decisions about the products they purchase and use. Potential levers include • government requirements to, for example, cover drugs for certain underrepresented or underserved populations, thus increasing access to such drugs and incentivizing companies to invest in their development, although trade-offs with this approach could include increasing overall drug costs; • public or private payer policies that enable companies to predict the price they will receive and a timeline for reimbursement; • requests or requirements established by health care organizations, CMS, or private health insurers, such as requiring equity-focused health technology assessment as a prerequisite for purchasing, implementation, or coverage determinations (Culyer and Bombard, 2012)
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From page 127... ...
Examples of levers include • government calls for comments on proposed policy and regulatory decisions; and • public opinion surveys on areas of science and technology that may influence researchers and policy makers, such as those informing recent reports on uses of AI, human enhancement, and animal-derived organs for transplant, although not focused on equity issues.23 CHAPTER CONCLUSIONS Conclusion 4-1: A governance framework for aligning emerging science, technology, and innovation with core ethical principles that encompasses equity needs to incor porate five imperatives: • broadening participation and sharing responsibility to empower a wider range of stakeholders; • aligning incentives to encourage equitable decision making; • determining how inequities develop along technology innovation life cycles and taking responsibility for mitigating them; • crafting timely guidance for pursuing equitable ends; and • sharpening ongoing, iterative oversight and evaluation along innovation life cycles Conclusion 4-2: Through their choices and actions, all members of the innova tion ecosystem have opportunities to implement practices that can enhance the alignment of technology development with ethical and equitable considerations. Similarly, levers that can incentivize such actions exist at every phase of the innova tion life cycle.
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2022. Preterm birth drug Makena ignites argument over health equity.
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2022. Diversity plans to improve enrollment of participants from underrepresented racial and ethnic popula tions in clinical trials: Draft guidance for industry.
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2023. FDA to require diversity plan for clinical trials.
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Stem Cells Translational Medicine 11(4)
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2022b. WHO announces first technology recipients of mRNA vaccine hub with strong support from African and European partners.
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