| 引用本文：冯磊.未成年人参与保健食品试食试验的立法探索——以“黄金大米”事件为例[J].中国卫生政策研究,2014,7(5):7-11 |
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| 未成年人参与保健食品试食试验的立法探索——以“黄金大米”事件为例 |
| 投稿时间：2014-02-17 修订日期：2014-03-24 PDF全文浏览 HTML全文浏览 |
| 冯磊 |
| 重庆医科大学公共卫生与管理学院 重庆 400016 |
| 摘要:“黄金大米”事件反映了我国保健食品试食试验制度中未成年人参与保护的法律缺陷。目前，我国试食试验制度与医学人体试验制度混同适用。但混同立法难以体现二者试验利益的差别，不能充分保护难以正确表意的未成年人的健康权利，也与儿童保健品监管的现实问题脱节。域外立法一般将两者区分。在国外关于与试食试验利益类似的“非治疗性试验”的法律规定中，对未成年人健康利益保护的立法模式包括限制模式、监护人决定模式以及风险利益评估模式，其中保护未成年人权利的立法宗旨和具体规定均值得借鉴。我国立法应以试验利益为依据，对未成年人参与试食试验采取原则上限制并辅以个别例外情形的立法模式，以切实保护其合法权益。 |
| 关键词:保健食品 试食试验 未成年人 非治疗性人体试验 |
| 基金项目:重庆市教育委员会人文社科一般项目（13SKD04） |
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| On the legislation about juveniles participating in the health-care food feeding test：From the perspective of the “golden rice” event |
| FENG Lei |
| College of Public Health and Management, Chongqing Medical University, Chongqing 400016, China |
| Abstract:The "golden rice" event reflects the legal defects about juveniles' protection in health-care food feeding test.In the area of Chinese law application,there is the same legislation on the both.But the legislation is not able to reflect the significant difference in the test benefit and protect the juveniles who can not express their will properly.The legislation of the countries out of China usually distinguish the both.There are three legislative models on the non-therapeutic research in the world which is similar to feeding test, and they are the limited model,the legal guardian-deciding model and the risk and benefit-assesing model.We should refer to the legislative purpose and specific provisions on the juveniles of the models above.We should perfect the legal model of juveniles' participance in health-care food feeding test by limit in principle with individual exception. |
| Key words:Health-care food Feeding test Juveniles Non-therapeutic research |
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