斯洛文尼亚辅助生殖规则——生物医疗辅助生殖立法与组织和细胞安全和质量相关法规之间的冲突

IF 0.2 Q4 LAW
Urban Vrtačnik
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引用次数: 0

摘要

过去20年来,斯洛文尼亚的辅助生殖监管格局发生了变化。尽管自2000年通过以来,领域立法(《不孕不育治疗和生物医疗辅助生殖程序法》——ZZNPOB)没有被修改或减损,但监管框架已得到立法的补充,实施了欧盟关于治疗中使用的组织和细胞的安全和质量的指令。后者的实施(也是通过2007年通过的《医疗用人体组织和细胞质量和安全法》——ZKVČTC)主要没有承认辅助生殖的具体情况(由ZZNPOB监管),导致监管框架缺乏法律确定性和可预测性。因此,文章讨论了ZZNPOB和ZKVČTC之间的冲突,并提出了拟议法律的解决方案,以避免现有法规的缺陷。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Rules on Assisted Reproduction on Slovenia – Collision Between Legislation on Biomedically Assisted Procreation and Regulation Relating to Safety and Quality of Tissues and Cells
Regulatory landscape on assisted reproduction (AR) has changed over the last 20 years in Slovenia. Notwithstanding the fact that in-field legislation (Infertility Treatment and Procedures of Biomedically Assisted Procreation Act – ZZNPOB) has not been amended or derogated since its adoption in 2000, the regulatory framework has been supplemented with legislative acts, implementing EU Directives on safety and quality of tissues and cells used in treatment. Implementation of the latter (also through adoption of Act on Quality and Safety of Human Tissues and Cells for the Purposes of Medical Treatment – ZKVČTC in 2007) has predominantly failed to acknowledge the specifics of assisted reproduction (regulated by ZZNPOB), resulting in regulatory framework which lacks legal certainty and predictability. Article therefore addresses the collision between ZZNPOB and ZKVČTC and proposes solutions de lege ferenda to avoid shortcomings of existing regulation.
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