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혁신생태계 조성을 위한 규제개혁

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Title 혁신생태계 조성을 위한 규제개혁
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Material Type Report
Author(Korean)

이주호; 최창용

Publisher

세종 : 한국개발연구원

Date 2018-06
ISBN 979-11-5932-389-8
Pages 475
Subject Country South Korea(Asia and Pacific)
Language Korean
File Type Documents
Original Format pdf
Subject Government and Law < General
Government and Law < Political Systems
Holding 한국개발연구원; KDI국제정책대학원
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Abstract

This research project is planned under the recognition that establishment of innovative ecological system is an urgent task for Korea facing the Fourth Industrial Revolution, and that government reform and regulatory reform are at the core of the challenging future. In this backdrop, KDI published a book entitled Reinventing the Government to Foster Innovative Ecosystem as the first phase of the research in 2017, and this study is the result of the research focusing on regulatory reform as a follow-up study.
Although Korea has taken various measures related to regulatory reform over the past decades, it has not made significant progress in streamlining regulations in particular in the areas of labor market, service industry, and bio-health industry, among others. Furthermore, regulations affecting society and the market as a whole are either too high or there are still a large number of regulations that exist only in Korea compared to other developed countries. Accordingly, Korea's regulatory reform should pay attention to these fundamental areas. The government should be more active in challenging high-level regulatory tasks such as ideological conflicts or conflicts of interest among stakeholders, and thereby come up with reasonable improvement measures.
This study was conducted through collaboration by professional researchers in the relevant fields, and consisted of three parts and ten chapters according to the subject of the study. The first part approaches the topic based on a new perspective of regulatory reform on the implementation and evaluation systems of regulatory reform, and the model to facilitate civic engagement or more active public participation. Part 2 focuses on the institutional improvement for enhancing innovation activities. To this end, the direction of regulatory reform corresponding to the Fourth Industrial Revolution is studied by comparing with developed countries, and the optimal regulatory design to promote innovation is presented. In addition, the R&D sector presents alternatives to the content and level of appropriate regulations, and furthermore, measures to reform auditing system for the creation of innovative ecosystems. Part 3 deals deeply with the task of regulatory reform for health care innovation. More specifically, the bio-health industry and bio-ethics, the issues and alternatives of the new medical technology evaluation system, and the regulatory reforms to create an innovative ecosystem of smart health care, which have recently been drawing attention.
The research also expands the scope of previous studies and discussion on regulatory reform in terms of how to encourage civic participation and approach regulatory reform from a public perspective, which has been a major issue of the discussion on regulatory reform. In the process of regulatory reform, imperative is the open-minded communication and sharing information with the public, which ultimately promote democracy through cooperation among the government-business-civil society. In this regard, key challenge is how to bring the public to the arena of the regulatory reform in manners of voluntary participation of citizens equipped with collective intelligence.
Chapter 1: Regulatory Reform and Deliberative Democracy
This study stresses that the creation of innovative ecosystems is urgent in order to enhance Korea’s national competitiveness, and there is regulatory reform at its core. The government should focus on drastically reducing control and direct support to enterprises, and creating an innovative ecosystem in which up-down innovation continues to take place while large businesses, small and medium-sized enterprises, financiers, scientists, public servants and civil society communicate and cooperate through various channels. This chapter described the background of the present research project and present the main points of the study and policy alternatives suggested by the authors. First, the first section emphasizes that future regulatory reforms should focus clearly on the creation of an innovative ecosystem, the second section proposes optimal regulatory design measures for emerging technologies and R&D, the third section suggests measures to strengthen the government's regulatory reform capabilities through the innovation of audit and civic participation, and the last section discusses in depth new regulations for bio-health industry.
Chapter 2: New Implementation and Evaluation Systems for Regulatory Reform
Korea is still regarded as a country with high demand for regulatory reform among OECD countries. Why? This is because regulatory reform has been concentrated in areas where conflicts of interest are low, while the important and fundamental impacts of regulatory problems have not been solved. Even with decades of regulatory reform, rationalization of metropolitan areas, flexibility of labor market, deregulation of service industry entry, and improper regulation of qualification have not been improved. At the same time, regulations on specific areas such as games, private education, workplace safety, and mobile phones has been being tightened. Therefore, Korea's regulatory reforms need to pay more attention to these fundamental fields. On the other hand, the regulatory reform system in Korea shows structural problems such as the ups and downs of regulatory reforms, the inadequate implementation of important regulatory reforms because the regulatory reform committee is not operated on a permanent basis. In order to solve this problem, it is necessary to shift from the current non-standing committee system to the standing and independent committee. There are areas that are excluded from the scope of regulatory reform, such as insufficient regulatory review on legislative legislation, similar administrative regulations, and policy evaluation indicators. Finally, in order for regulatory reform to take place systematically, The human resources and budget should be expanded while strengthening the expertise of human resources required for regulatory reform. Regulatory reform is not "cheap" reform. For proper regulatory reform, appropriate investment should be made accordingly.
Chapter 3: Regulatory Reform and Deliberative Democracy
This study focuses the implications of regulation as a representative means of policy for establishing socioeconomic orders and overcoming market failure, if the government intervention in corporate and individual actions is inevitable. Moreover, this study emphasizes the importance of ‘participation’ as a means of achieving the policy objectives. Positing the ‘systematization of conflict’ as part of democracy, it is key for citizens to participate in seeking for alternatives and in the arena of conflict resolution, through which the interests of a particular group will not be sought at the expense of citizens’ welfare. Furthermore, in order to evolve into a two-way symmetrical policy process that enables to foster democratic citizenship and integrate the public and private sector, it is required to promote the citizens’ voluntary participation and deliberation as well as a process of understanding and reaching a consensus. This is in line with the principle of deliberative democracy that encourages the collective intelligence of ordinary citizens and facilitates the public awareness centered on social problem-solving, in order to minimize the possible side effects and absurdities derived from the majority rule throughout the policy process. In this vein, this study attempts to explore the forums for debate where the collective intelligence is being developed, formed and expressed, which may contribute to facilitate the citizen engagement for a regulatory reform, resolve public issues, and further create the government and society built upon values and trust. The study also aims to seek communication strategies that can effectively promote voluntary participation and deliberative rationality. In particular, we will present policy implications for developing participatory democracy and for formalizing the open, shared, communicating and cooperative process of the regulatory reform, by eliciting processes and/or possibilities of the outcomes of the deliberative discussions to be formalized into party policies, government systems and agendas.
Chapter 4: The Fourth Industrial Revolution and Its Regulatory Reform: The Way Forward
Since the Fourth Industrial Revolution was pronounced as a new paradigm for human life in the World Economic Forum in 2016, many developed countries have been putting together their resources into developing and exploiting the science and technologies with prominent potentials. As this international race for technological innovation progresses, the need for the appropriate regulatory framework becomes salient. In this context, this study was carried out to propose a feasible way for the regulatory reform to aptly respond to and thus shape the Fourth Industrial Revolution in our best interests. The first focus of this study was on whether a regulatory ‘reform’ is truly necessary. To this end, it analysed the objects and objectives of the regulation based on the charactertistics of the emerging technologies which are the main impetus for the idea the Fourth Revolution and description of the challenges they pose to the existing regulatory system, and contemplated the role of the government as a regulator. Then this study suggested the ‘principle based regulation’ as a path for the regulatory reform and elaborated the rationales by examining inter alia the current regulatory approach in the US and the UK. Moreover, having considered the existing regulatory framework and practice in Korea, it further suggested to implement the ‘risk-based regulation’ as a principal regulatory principle with a note of two pre-conditions: One is to develop working principles guiding the regulatory practice, and the other is to finely tune the regulatory governance for, in particular, the information-knowledge building, law and institution, and regulatory culture.
Chapter 5: Optimized Regulation Design for Innovation Facilitation
Although it is known that regulation impedes innovation, the relationship between regulation and innovation is not simple. Environment regulation has promote the development of green technology, and even emerging technology, such as cryptocurrency or sharing-economy based platform, has resulted in the development of new regulation system. In this respect, it is necessary for us to optimize regulation design to encourage new innovation and successfully transform to the industry 4.0 economy. European Union (EU) member countries have paid much attention to this issue. They have renovated regulation system from order/prescription based to objective/performance-oriented regulation and introduced smart regulation, such as innovation procurement or innovation deal program. The analysis results of Korean firm data report that market uncertainty negatively moderates the relationship between innovation investment in firms and government regulation, which suggests that a new types of government regulation is necessary in highly uncertain environment, such as the industry 4.0. To date, negative system, regulation sand box has been widely discussed, but this chapter suggests innovation procurement, stakeholder participation platform and intelligent regulation (e.g., RegTech) to address the increasing conflicts between regulation and innovation.
Chapter 6: R&D Regulations ― A Possible Taxonomy and Its Implications
In this research, R&D regulations are identified and analyzed to suggest a possible taxonomy that aims to enhance our understanding of those. Although R&D regulations have not been paid much attention in comparison with regulations for emerging technologies, they can affect every R&D activity from the very early stage of technological development, and even scientific research. A part of these regulations relates ethical or societal issues, especially in bioscience, aiming to apply ‘precaution principle.’ Another big part of these regulations are about research misconduct and R&D expenditures. Inappropriate R&D regulations may discourage R&D activities and hinder creative and innovative research. For policy implications, the paper concludes to propose; 1) comprehensive modification of R&D regulations, 2) participatory regulation governance, 3) autonomous regulation by S&T community, 4) abolition of micro-regulations, 5) revision of ethical regulations based on social consensus.
Chapter 7: Reforming Auditing System for Innovative Ecosystem
This study attempts to provide an analysis of how 'audit' affects the behavioral responses of decision-makers and researchers and in that process impedes the formation of innovative ecology. Based on this analysis, this study proposes the future direction of audit reform. The existing theories and practices of 'audit' are implicitly based on the very simplistic understanding of the motivational bases of decision-makers and researchers. Without an adequate understanding of the motivational bases of auditees, however, audit may result in unintended consequences such as 'formalistic response,' 'managing to audit,' and 'research to audit.' This study utilizes the newly developed concept of 'blame avoidance' and the so-called 'audit explosion' hypothesis to delve into the complex relationship between audit and innovation.
Chapter 8: Bio-Health Industry and Bioethics
The current 「Bioethics and Safety Act」 oversights ‘the research on human’ and ‘the research with biospecimen derived from human’ with the purpose of protecting people who are participating the clinical research or providing research biospecimen from any harm to their dignity and safety. Most controversial issues regarding this law are i) designation of specifics diseases allowed for the research on human embryo, gene therapy, and genetic tests (positive system); ii) excessive restriction of research-purpose embryo production; iii) detail-oriented specification with the roles of the National Bioethics Committee; and iv) lack of specific guide for deidentification and reidentification of personal data that is suitable for health and medical field. We propose the following modification of current regulatory framework. The current 「Bioethics and Safety Act」 would be separated into one basic law and several specific laws. The basic law stipulates actions that government should prohibit, government’s responsibilities to promote international bioethics, and the role of the National Bioethics Committee in providing national level solutions for questions arising continuously from the mismatch between the current regulation and the new technologies. Each specific law includes specific regulations applied to research on human subject (including biospecimen derived from human), human embryo production and utilization, emerging bio-therapy (stem cell and gene therapy), and genetic tests, respectively. We also propose that stored biospecimen obtained originally under the consent of providers can be used without re-consent for secondary purpose or transfer to a third party, and the decision of approval would be discretion of the Internal Review Board at each institute. In order to facilitate processing and utilizing healthcare data to build big data, proper standard and clear and specific guidance on deidentification and reidentification should be set forth by law.
Chapter 9: Issues and Options in New Health Technology Assessment in South Korea
Bio-health area has been emerging as a dominant driver for economic growth and better quality of life, but for many years HTA has been criticized as a major barrier before market entry in South Korea. This chapter addresses core issues regarding the Korea HTA system and brings some policy recommendations. Specifically, we examined the concept of HTA and background in the Korean context, comparing with other advanced countries. Also, this chapter shows specific HTA processes and current status. We tried to thoroughly review diverse arguments surrounding the Korean HTA system based on documents from relevant organizations. To resolve the problem regarding HTA, we finally recommend risk-based HTA, transition to post-market evaluation, and value-based reimbursement.
Chapter 10: Regulatory Reform for the Innovative Smart Healthcase Ecosystem in Korea
Smart healthcare uses various technologies such as biotechnology and ICT(Information and Communications Technologies) to overcome limitations of time and place and to monitor and diagnose personal health conditions. It also utilizes diverse products and services to provide personalized healthcare and medical services. Smart healthcare is intended not only for patients, but also for the healthy people. These days, smart healthcare is under the spotlight because of its potential to lower the national healthcare cost burden in this aging society, also as one of the important growth engines that could lead global economic growth in the era of the 4th Industrial Revolution.
Korea, the world's fastest aging nation, must urgently respond to soaring healthcare costs. It is considered necessary to reconstruct the national healthcare system while introducing smart healthcare. Yet, the entry barrier to construct the smart healthcare ecosystem seems very high in Korea. The study begins from this critical point of view. In this study, we examine the current situation and problems of the smart healthcare ecosystem in Korea, to secure global competitiveness. Especially, the legal and policy environment for buffering the smart healthcare ecosystem is reviewed in depth and some implications are suggested to improve the policy and regulatory measures in Korea.