실증을 위한 규제특례의 부가조건과 갈등조정에 관한 연구 ― 일반의약품 화상투약기 사례를 중심으로 ―

This study examines the extensive use of Additional Conditions amid competing interests and conflicts surrounding Regulatory Exceptions for Demonstration and seeks to identify the limitations of such conditions. It argues for the necessity of a prior review mechanism for Additional Conditions and further contends that procedural rules for conflict adjustment, together with institutional mechanisms such as a conflict adjustment body, should be complemented to effectively manage and resolve regulatory conflicts. To substantiate these claims, the study analyzes the case of Telepharmacy Vending Machines for over-the-counter drugs. In the context of Demonstration Exceptions, Additional Conditions are sometimes imposed that lack substantive relevance to the purpose of the designation, are not grounded in reasonable justification, or are excessive in scope. In certain cases, conditions are attached in order to reflect the positions of stakeholders for the purpose of conflict adjustment, or in ways that unduly constrain the implementation of demonstration projects. Even under such circumstances, it is practically difficult for business operators to explicitly challenge these conditions. Moreover, where multiple Additional Conditions of unclear legal nature are imposed, it becomes ambiguous whether the conditions themselves are subject to legal challenge, or how legal remedies may be pursued against measures taken in response to the non-compliance with a specific condition. For these reasons, a prior review procedure for Additional Conditions is required before the conditional designation of Demonstration Exceptions, in order to ensure that such conditions do not exceed the doctrinal limits of Subordinate Clauses. Regulatory innovation inherently entails conflicts across diverse industrial sectors. This is particularly true in the healthcare sector, where multiple social security systems are interconnected and where regulatory issues are closely linked to differences in human-rights-related values, including the right to health. As a result, conflicts in this field tend to exhibit more subtle and complex characteristics than conflicts based solely on economic interests. One of the critical factors determining the success or failure of regulatory innovation is the effective adjustment of such conflicts. As the demand for conflict adjustment intensifies in the context of Regulatory Sandbox policies, it becomes essential, in order to secure the legitimacy, trustworthiness, and acceptability of administrative decisions, to institutionally guarantee opportunities for parties and stakeholders to submit their opinions during the deliberative process. In addition, the deliberation process and its outcomes should be documented and formally notified, and issues requiring broader social consensus should be subject to public deliberation. Finally, for matters that cannot be effectively coordinated at the ministerial level, the governance of Demonstration Exceptions should be reinforced so that conflict adjustment and policy coordination may be carried out by the Regulatory Reform Committee.