Abstract
BackgroundReverse innovation, or the importation of new, affordable, and efficacious models to high-income countries from the developing world, has emerged as a way to improve the health care system in the United States. Reverse innovation has been identified as a key emerging trend in global health systems in part because low-resourced settings are particularly good laboratories for low-cost/high-impact innovations that are developed out of necessity. A difficult question receiving scant attention is that of legal and regulatory barriers. ObjectivesThe objective of this paper is to understand and elucidate the legal barriers faced by innovators bringing health interventions to the United States. MethodsSemistructured qualitative interviews were conducted with 9 key informants who have directly participated in the introduction of global health care approaches to the United States health system. A purposive sampling scheme was employed to identify participants. Phone interviews were conducted over one week in July 2016 with each participant and lasted an average of 35 minutes each. FindingsPurely legal barriers included questions surrounding tort liability, standard of care, and concerns around patient-administered self-care. Regulatory burdens included issues of international medical licensure, reimbursement, and task shifting and scope of work challenges among nonprofessionals (e.g. community health workers). Finally, perceived (i.e. not realized or experienced) legal and regulatory barriers to innovative modalities served as disincentives to bringing products or services developed outside of the United States to the United States market. ConclusionsConflicting interests within the health care system, safety concerns, and little value placed on low-cost interventions inhibit innovation. Legal and regulatory barriers rank among, and contribute to, an anti-innovation atmosphere in healthcare for domestic and reverse innovators alike. Reverse innovation should be fostered through the thoughtful development of legal and regulatory standards that encourage the introduction and scalable adoption of successful health care innovations developed outside of the US, particularly innovations that support public health goals and do not have the benefit of a large corporate sponsor to facilitate introduction to the market.
Highlights
Innovation is a hallmark of our species and just as old, the term is a buzzword in most professional fields today and used to denote new ways of thinking that have the potential to improve people’s lives and, in some cases, impel important societal change.[1]
This paper reports on a survey of key global health informants to identify barriers to reverse innovation and initiate the process of making recommendations to facilitate the global spread of good ideas
The barriers identified by the key informants fell into 3 general categories: purely legal, regulatory, and perceived legal and regulatory concerns
Summary
Innovation is a hallmark of our species and just as old, the term is a buzzword in most professional fields today and used to denote new ways of thinking that have the potential to improve people’s lives and, in some cases, impel important societal change.[1]. Major global health organizations, including the Gates Foundation,[3,4] the Program for Appropriate Technology in Health (PATH),[5] and USAID’s Global Development Lab, have embraced innovation since the mid-2000s as a critical interprofessional approach to understanding and reducing health disparities and strengthening health systems in communities across the globe.[6] These and other organizations take multiple approaches to support innovation, including providing financial support to innovations developed in the US, investing funds to identify and catalyze innovation in developing countries, and creating educational pathways to develop the generation of innovators, and identifying innovations likely to accelerate progress toward the health targets of the Sustainable Development Goals.[7] In large part, these efforts are focused on the promise of innovation to improve the health of communities in low-resourced countries. The concept of adapting global innovations for use in the Global North is often referred to as reverse innovation
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