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      • R&D 정책 시너지를 위한 부처 간 협력의 새로운 접근

        이명화(Myong Hwa Lee),조현대,안두현,박기범,양승우,양현채,우청원,이혁,강민지,김태경,나다영 과학기술정책연구원 2019 정책연구 Vol.- No.-

        Interministerial cooperation has been a major challenge in science and technology policy field for a long time. As policy issues become more complicated with rapid development of technology, interminsterial cooperation has been frequently raised as a significant policy option, but many collaborative trials were not successful. One reason of failure would be broad and ambiguous approaches that have a lack of specific purpose and deep understanding of collaboration across government agencies. This research aims to provide a new approach of interministerial cooperation for R&D policy synergy. As a new approach, this research tries to classify interministerial cooperation in science and technology field based on complexity of R&D supply and of R&D demand. Here complexity means whether more than three ministries have involved. For example, the fine dust issue has high complexity of R&D supply and high complexity of R&D demand because several ministries are related to resolve the fine dust problem, for example, the Ministry of Environment, the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Foreign Affairs. We expect that the classification would help understand the features of various types of interministerial cooperation. We utilize several research methods, including literature review, data analysis relating to R&D programs and plans, survey, case study and review of international cases. The survey was conducted for policy experts from governmental, academic, research, and industrial, etc. 150 among a total of 300 participants were governmental officials. For the case study, we selected three cases such as fine dust, biohealth, and drone. We assume that fine dust is a case of high complexity of R&D supply and demand; biohealth is a case of high complexity of R&D supply and low complexity of R&D demand; drone is a case of low complexity of R&D supply and high complexity of R&D demand. From the case study, this study finds out the fact that three cases have different features in target, contents, and approach. Thus, we suggests to develop new approaches based on the features of interministerial cooperation. Also, from the case study, survey and international cases, this study recommends that 1) strengthening coordinating power of Science, Technology and Innovation Office under Ministry of Science and ICT, 2) strengthening legal bases for interministerial cooperation, 3) revising the National Finance Act for providing a legal base for interministerial R&D programs, 4) setting up a certain percentage of government budget for interministerial work, 5) coordinating interministerial committees relating to find dust, 6) integrating similar interministerial committees in the biohealth area, 7) strengthening a linkage of R&D and regulation in the drone issue, 8) securing independent power and responsibility of program managers of large interministerial R&D program, 9) providing additional points for interministerial work in government performance evaluation, and 10) developing evaluation indicators that the features of interministerial programs are considered.

      • 과학기술 정책평가 모형 탐색

        이명화(Myong Hwa Lee),이혜진,강민지 과학기술정책연구원 2017 정책연구 Vol.- No.-

        In South Korea, the government’s R&D investment have been increased 4 percent annually on average since 2011. The total amount of the government’s R&D investment has been more than 19 billion US dollar since 2016. Despite the increase of the government’s R&D investment, the outcome has not been good enough. R&D productivity in South Korea is still around a half of the one in the U.S. in terms of patent. According to IMD, the world rank of South Korea in the science and technology competitiveness has worsen from 6th to 8th in 2016. The government would need to find out the causes of this poor achievement. This study aims to provide useful policy evaluation models to figure out the factors which have influenced policy outcome. This study focuses on policies which are inter-ministerial and multi-instrumental. The policy in this study means the one at the higher level than projects or programs. The projects and programs have been frequently evaluated, but policies at the high level are not the case. Because of the ambiguity of input and outputs and complexity, the policy at the high level can be hardly evaluated. Even policy evaluation models have not been actively developed. The study addresses the 2nd Biotechnology Promotion Plan (2007 - 2016) as a case of this policy evaluation model. The Plan is the highest national policy across ministries in the field of biotechnology. The plan includes R&D investments, human resources, regulation reform, etc. There were good achievements, but others were poor. The evaluation models are based on logic models of program theory and CMO(Context, Mechanism, Outcome) models of realist evaluation theory. The logic models are good to show the flow from input to outcome. On the other hand, the CMO models systematically show causal relations among factors which would seem to influential to the performance in the biotechnology field. This study provides only early version of policy evaluation models, but it would be good starting points to develop more solid models. Also, this study would shed a light on policy evaluation studies by providing new approaches like CMO models. New approaches for more systematic evaluation would finally contribute to improve the R&D productivity and the S&T competitiveness.

      • KCI등재

        바이오 분야에서의 새로운 규제 방식에 대한 모색

        이명화(Myong Hwa Lee),이혜진(LEE HYE JIN) 한국규제학회 2016 규제연구 Vol.25 No.2

        최근 바이오 분야 규제개혁에 대한 요구가 증대되고 상당부분 규제개선이 추진되었지만, 아직까지도 어떤 방식의 개선이 적절할지에 대한 논의는 충분하지 않은 상황이다. 바이오 분야는 생명을 다루기 때문에 보수성, 개별성, 복잡성과 같은 특성에 대한 이해를 바탕으로 다양한 규제 방식에 대한 종합적인 이해가 필요하다. 이를 위해 본 연구는 지금까지 다양한 기준에서 논의되어 온 바이오 분야의 규제 방식들과 쟁점들을 분석하여, 큰 방향성 차원에서 새로운 규제방식을 제시하고자 하였다. 구체적으로는 바이오 분야의 규제를 규제수립 주체(규제자 vs. 피규제자), 규제수립 방식(포지티브 vs. 네거티브), 의견수렴방식(open vs. closed), 규제수립 시기(reactive vs. proactive), 규제 정당화 근거(과학적 근거 vs. 해외 유사제도), 규제적용 대상(process vs. product), 규제적용 시기(pre-marketing vs. post-marketing)라는 일곱 가지 기준으로 구분하였다. 우리나라의 바이오 분야는 이 일곱 가지 기준의 관점에서 피규제자가 자율적으로 규제를 수립하는 방식, 보완장치가 마련된다는 전제 하에 원칙적 허용과 예외적 금지의 네거티브 규제, 사회적 합의가 중시되는 개방형 방식, 신기술의 급속한 발전에 따른 선제적 대응, 과학적 근거에 기반을 두는 규제 수립, 최종산물과 함께 프로세스에 대한 규제, 시판 후 규제로의 변화가 고려될 필요가 있다. There is increasing demand for reforming biotechnology regulations but insufficient discussion regarding effective ways of biotechnology regulations. Dealing with living organisms, biotechnology regulations have following unique features: conservative, diverse, and complicated. Based on such features, biotechnology needs a more comprehensive understanding of various ways of regulation. This paper attempts to offer an integrated classification scheme of biotechnology regulation in terms of who regulates, how to regulate, whether to open, when to design, how to support, what to regulate, and when to regulate. In these seven perspectives, the Korean government would need to consider more self-regulation, negative approach, open decision-making, proactive approach, science-based, regulations for process, and post-marking regulation.

      • 정부 R&D 사업체계 진단 및 정책 대안: 바이오헬스 분야를 중심으로

        이명화(Myong Hwa Lee),안두현,박기범,하태정,황석원,양현채,우청원,이혁,한웅규,이혜진,나다영 과학기술정책연구원 2020 정책연구 Vol.- No.-

        Recently the Korean government has greatly increased the R&D budget. Next year, the total government R&D budget will reach 27.2 trillion KRW, which is an increase of 12.3% from this year. In order to more effectively implement this increased R&D funding, a more systematic approach is necessary. This paper aims to review the government R&D system and provide policy recommendations. In this review we focused on the R&D program structure and governance. The R&D program structure refers to the composition and relation of R&D programs. The R&D governance refers to interdependency, collaboration, network, cooperation, and coordination between diverse actors which participate in policymaking and implementation processes relating to the government R&D programs. We specifically analysed the biohealth R&D programs because biohealth is a top-priority policy issue. Biohealth R&D funding has dramatically increased and there were many changes regarding biohealth R&D programs. For a deep analysis of the biohealth R&D programs, we utilized several methods, including data analysis relating to biohealth R&D programs, a survey of 85 experts, and focus group interviews. This study found that the biohealth R&D program structure is quite unstable and too many small programs are being operated especially in the Ministry of Health and Welfare. Also, the biohealth R&D governance is fragmented with multiple ministries and several high-level committees, which results in system inefficiency. In comparing Korea with other countries such as the U.S.A, Japan, and the U.K. these countries seem to have been able to establish more systematic R&D systems. In the U.S.A, the bioethics R&D system is centralized in the NIH (National Institutes of Health), which is composed of diseases-focused research institutes and general research institutes. Japan recently established the AMED (Japan Agency for Medical Research and Development) in order to integrate the management of biohealth R&D programs. The biohealth programs of the AMED are similar to the NIH in the U.S.A. That is, the R&D programs of the AMED have two categories: diseases-focused and general research activities. The U.K. has multiple funders and one cannot easily identify the biohealth R&D program structure. For resolving this problem, the U.K. developed the HRCS (Health Research Classification System), which is composed of health categories and research activity codes. From the analysis, this study concludes that the government should establish sustainable diseases-focused biohealth R&D program structures and governance for an integrative policy. For sustainable diseases-focused biohealth R&D program structures, this study suggests a biohealth research classification system, which can be used in all biohealth ministries. Also, it suggests a pilot study to identify the feasibility of the diseases-focused biohealth R&D program structure. In addition, this study recommends that a new biotechnology committee be formed under the President. This study also includes two general policy recommendations. First, the sunset regulation for R&D programs should be more flexible so that certain R&D programs can be continued. Second, a program budget system should be applied to the R&D area by creating additional procedures for reviewing high-level R&D programs.

      • 바이오경제시대 과학기술정책의제 연구사업(6차년도)

        이명화(Myong Hwa Lee),신은정,정기철,정일영,이민형,김석관,이주량,양승우,손재원,이유현,이혜진,현재환 과학기술정책연구원 2016 정책연구 Vol.- No.-

        Recently, the Korean government has initiated many policies to support the bio-health R&D and industry to achieve global competitiveness after the big license deal of South Korea’s Hanmi Pharmaceutical and Sanofi in 2015. Some expect that bio-health would be a Korea’s new core industry in the near future. However, there are also strong concerns and criticisms against such positive expectations because competition over bio-health industry has been much more fierce and many advanced countries have established more new policies to support bio-health industry. In order to achieve global competitiveness, the Korean government should figure out the core problems in the Korea’s bio-health innovation system first and then search for the best solutions. This study aims to find out why the Korea’s bio-health innovation system has not been very successful by analysing bio-health policy governance, R&D actors, infrastructure policies, and health care delivery system. To address this question, we conducted a survey for bio-health experts from academic, industrial, governmental fields, and etc. 104 experts participated in this survey. The survey revealed several problems such as ineffective strategies and policies, inefficient government structure and funding system, inactive collaboration among R&D actors, inefficient management of bio-health infrastructure such as human resource, equipment, and research resources, unnecessary regulations and low drug price. Also, we found out that the core problem of the Korea’s bio-health innovation system is the absence of no clear long-term direction of bio-health policies and the weak linkage of R&D outputs and health care delivery system. After reviewing opinions of the survey participants and major bio-health policies in advanced countries, this study recommends that 1) strategic decision-making based on the understanding of the bio-health sector, 2) effective policy coordination and policy evaluation for long-term strategies, 3) strong inter-ministerial coordination as a control tower, 4) the reform of the government structure, 5) regulation monitoring system, 6) the revision of user fee for prescription drug, 7) platform in the bio-health ecosystem, 8) role change of the government-funded research institutions, 9) new research evaluation system, and 10) demand-based management of bio-health human resource and infrastructure.

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