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KMID : 1142220190140020143
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Regulatory Research on Food, Drug & Cosmetic
2019 Volume.14 No. 2 p.143 ~ p.157
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A Discussion on the on Value Chain-based Policies and Regulations, for the Globalization in the Korean Pharmaceutical Industry
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Jung Yun-Taek
Cho Jin-Young
Cho Hun-Che
Chang Kwan-Young
Hong Sung-Hyun
Choi Young-Hyun
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Abstract
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The government designated the bio-health industry as one of the three new industries and has been pursuing efforts to cultivate it. Domestic pharmaceutical industry has a movement for change from domestic-oriented industries to industries where capacity for export and development of new drug is strengthened. The increase in exports, big deal of technical transfer to global big pharma, and the expansion of new drug approvals in US and Europe make the bio-health industry a major industry in the future. The pharmaceutical industry is researchoriented commercialization linked closely with basic scientific research results, and has the industrial characteristics of a strong industry regulated by the government as a high risk, high return industries. And It has organizational features that scarcities entering and exiting the market, formation of Segmented markets and active acquisitions and mergers. In the pharmaceutical industry, new drug development divides the drug discovery and drug development stages based on the value chain. Therefore, in order to achieve the policy goals of the pharmaceutical industry, it is important to understand this industrial specificity. Because pharmaceutical policy has complex goals of providing consumers with safe and efficacy qualified medicine, balancing health insurance budget through controlling drug production costs and drug prices, and promotion for the pharmaceutical industry, to take a balanced policy approach. Also, most of all, pharmaceutical industry should secure global competitiveness by meeting global standards through improvement of policy and institutions based on value chains. This paper proposes a direction for improving policies and institutions effectively discussed by analyzing current status and problem of 8 issues with a balanced perspective, based on the value chain categorized into R&D stage, clinical trial stage and technology commercialization stage.
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KEYWORD
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Pharmaceutical Industry, Biotechnology, Value Chain, Policy, Regulation, New Drug Development, Clinical Trial
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