监管多元主义的挑战
Sandra Gillner1, Katharina Elisabeth Blankart2, Florence Tanya Bourgeois3
1KPM Center for Public Management, University of Bern, Freiburgstr. 3, 3010 Bern, Switzerland; Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel), Freiburgstr. 3, 3010 Bern, Switzerland; Harvard-MIT Center for Regulatory Science, Harvard Medical School, 200 Longwood Ave, Armenise Building Rm 109, Boston, MA 02115, USA.
Health policy (Amsterdam, Netherlands)
|September 21, 2024
概括
监管依赖和监管多元主义为较小的监管机构带来了战略困境. 监管多元化可能导致监管逃避和政策碎片化,倡导加强当局之间的合作.
科学领域:
- 卫生政策 卫生政策
- 监管科学 监管科学
- 国际卫生健康国际卫生
背景情况:
- 小规模和资源较少的监管机构在医疗产品监管方面面临着战略性挑战.
- 两个主要策略包括监管依赖主要系统和监管多元主义,承认多个司法管辖区.
研究的目的:
- 分析监管多元主义对监管机构的潜在局限性和长期影响.
- 倡导加强监管机构之间的合作,作为一种可持续的替代方案.
主要方法:
- 对监管策略的政策分析.
- 讨论潜在的限制,包括监管逃避,碎片化和谈判权力的损失.
- 支持合作方法的论点,以减轻行政压力.
主要成果:
- 监管多元化可能会导致制造商利用监管变化 ("监管逃避").
- 这种方法可以增加碎片化和复杂性,可能导致不一致的监管流程.
- 采用监管多元主义可能会削弱政策制定中的国际谈判权.
结论:
- 监管多元主义带来了重要的长期影响,政策制定者并不总是能看到.
- 监管机构之间的加强合作为减轻行政负担提供了有价值的替代方案.
- 合作支持国内监管和监管多元化战略,促进可持续监管.
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