Policy ForumRegulation

Downgrading of regulation in regenerative medicine

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Science  16 Aug 2019:
Vol. 365, Issue 6454, pp. 644-646
DOI: 10.1126/science.aax6184

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Summary

Science is fundamental to ensuring the safety and demonstrating the efficacy of newly developed medicines. Government agencies play a key role in establishing standards for safety and efficacy. But in a climate of international economic competition, this function comes under frequent scrutiny and pressure. We suggest that in response to this competitive pressure, regulations in some countries have become more permissive. Drawing on controversies over the regulation of regenerative medicine products in Japan and elsewhere, we consider whether the policies that have developed from such tensions can simultaneously protect patients, strengthen health markets, and enhance national competitiveness. These developments shed light on global drivers of a policy phenomenon we call “regulatory brokerage” (1). We argue that when regulation does not support the scientific effort to establish the safety and efficacy of medical products, it may be brokered by interest groups, including industry, particular groups of scientists and patients, and policy-makers. In an international context, regulatory changes for short-term economic or political reasons in one country can have a cascading effect, leading to unforeseeable, detrimental consequences for the field of regenerative medicine at the global level.

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