Dynamic Governance of Microbiome Innovation

Abstract

Recent studies have shown that the microbiome has vast potential in the improvement of human health, agricultural productivity, and environmental sustainability. However, some microbiome therapeutics, such as fecal microbiota transplantation, raise real safety risks, as they sometimes contain uncharacterized viruses, bacteria, or protozoans that could be pathogenic, particularly for an already sick recipient. Commentators have presented innovations in the microbiome as intermediate healthcare technologies and argued that “a poorly calibrated regulatory structure” with side effects (such as ossifying the technologies at early stage of development) would be harmful to both public health and societal welfare. Nonetheless, existing regulatory frameworks do not accommodate these problems.

This article develops a dynamic model for governing microbiome innovation. It explains whether and how governance affects the quality of evidence generated in microbiome research, addresses regulatory challenges (such as lacking high-quality evidence for evaluating microbial products), and then proposes a form of dynamic governance through an integrated structure composed of major innovation players and other stakeholders (including but not limited to state authorities). The proposed governance model would deploy various mechanisms (such as public-private partnerships) to address new regulatory challenges in human therapeutics and other applications, thereby to help promote innovation and balance diverse interests.

Note:
Funding Information: This research was supported by the Thomas Edison Innovation Law and Policy Fellowship, Center for Intellectual Property x Innovation Policy, George Mason University Law School.

Conflict of Interests: The author has no financial, personal, academic, or other conflicts of interest in the subject matter discussed in this manuscript.

Keywords: dynamic governance, intellectual property, microbiome innovation, public-private partnerships, regulation of biomedical research, responsible research and innovation