전 세계적인 코로나19의 확산으로 인해, 진단시약 등과 같은 감염병 의료 및 의료기기 신제품이 비약적으로 개발·출시되고 있으며, 이의 빠른 수급을 위해 각 국가들은 수입규제를 완화하거나 신속한 인·허가를 위한 정책을 펼치고 있다(NIDS, 2020). 반면, 신종감염병과 관련 없는 신개발 의료기기의 경우 오히려 시험검사 등 지연 및 취소되는 사례가 발생하고 있는 등 여전히 엄격한 인·허가규제를 통해 시장에 진출하고 있다. 이에 본 연구는 의료기기신제품이 시장에 진출하면서 마주하게 되는 정부소관법률에 특화하여 규제강도 영향요인을 도출하고 규제강도를 분석하여 규제대응 프레임워크를 제안하였다. 연구방법은 문헌연구, Failure Mode and Effects Analysis(FMEA)기법 적용, 전문가인터뷰(1차):아이디어수집, 전문가인터뷰(2차) : 타당성검증의 방법으로 진행하였으며, FMEA기법의 적용프로세스를 통해 우선 규제단계별 영향요인의 발생영향도와 규제사무 유형별 부담영향도를 곱하여 규제요인의 중요도를 구하고, 규제영향 심각도를 곱하는 방식으로 규제강도 정량화방법을 제시하였다. 시사점은 최근 해외 주요 국가들 및 우리나라 정부가 코로나19에 따른 신개발의료기기의 신속한 인·허가를 위한 특별규제정책 및 완화정책을 펼치며 적극적으로 대응하고 있는 시점에 본 연구에서 제안된 프레임워크를 통해 향후 기존 의료기기 신제품의 인·허가 정책 규제프로세스에도 보다 적극적이며 선제적인 대응이 될 수 있도록 규제의 개선방향과 규제대응 방안이 이루어지길 기대한다.

Despite the continued and increasing relevance of public policy and regulatory issues in managerial marketing, legal topics related to marketing are often covered in little detail. “Business law” or “legal environment of business” courses typically address marketing issues superficially, while courses for marketing majors may include a few references to legal or regulatory topics as anecdotes or archaic history (e.g., Sherman Antitrust Act). Managerially germane topics such as consumer privacy, antitrust, consumer protection, product safety, or intellectual property may be cursorily included in an introductory business law course or principles of marketing course, but this does not insure connection of these concepts with “real life” significance. Many practical factors, such as globalization, and academic factors, such as those related to the establishment of a broad domain of research and conceptual development in “marketing and public policy,” have expanded the domain of marketing from a pure business orientation to one through which law, regulation, and public policy are worthy of more in-depth treatment of these topics in the tertiary marketing education curriculum. This paper outlines why and how “marketing and public policy” can be taught and how it can complement the broader curriculum of the business school. From the manager’s perspective, the legal environment of business often represents a series of challenges or impediments to the manager’s decisions and to a business’ success. At the same time, whether or not a consumer is aware of it, these same business impediments often represent protections to the consumer from financial or physical harm. Criminal sanctions in a global (or national) marketing context can include imprisonment for managers or multimillion dollar judgments against companies; this should provide sufficient incentive for marketing practitioners in the business community to develop an interest in marketing law, and this interest can be fostered through examples, cases, and student research. Public policy topics often compel decision makers to consider broad questions (“what is a market?”) as much as they must bear in mind matters related to consumers and competitors (“Is comparative advertising effective?”). Teaching marketing students to be concerned and informed about the law can produce marketing managers who are aware of their social and legal environments. Incorporating public-policy related examples across courses can also satisfy pedagogical objectives.

In today’s global marketplace, few consumers would bat an eye at a Central European retailer selling products manufactured in the US from raw materials purchased in Asia and Africa. Recently, Finnish connoisseurs of local craft beer were shocked to discover that even their local microbreweries were getting in on the act, albeit somewhat involuntarily. Strict regulations that govern the sale of alcoholic beverages in Finland essentially prevent the smallest breweries from distributing their products in the local market. Ironically, the only way for these small businesses to reach their local customers is through internationalization – setting up an online store across the border and serving the Finnish market from abroad. Drawing on the context of alcohol policy in Finland as an illustrative example, this study demonstrates how global markets can offer small businesses a way to counter unfavorable or discriminative local public policy. The study also illustrates the potential impact that businesses can have on policy by drawing public attention to its shortcomings, and offers implications for practitioners by highlighting the importance of thorough evaluation of policies for possible inconsistencies and outlining possible indicators that such inconsistencies may be present.