• The Korean Journal of Health Service Management
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• v.9 no.4
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• pp.157-169
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• 2015

Objectives : The aim of this study was to investigate the effect of various Republic of Korea policies, including the medicine cost rationalization policy implemented By investigating the management strategy/performance changes of the industry caused by such policies. Methods : Pharmaceutical companies listed on the national stock exchange and the KOSDAQ were examined for 10 years from 2004 to 2013. Their financial statements were collected and market changes before and after drug price policy implementations were compared. Results : From the result of this research, among the medicine related policies, the drug price rationalization policy was found to have a significant effect on business management strategies in terms of safety, profitability and growth potential after its implementation. After the drug pricing transparency policy was implemented, management strategies were affected significantly in terms of safety and profitability. Conclusions : As a result, all of the medicine related policies were found to have regulatory effects. Based on these findings, implications, research limitations and future study plans are presented.

• YAKHAK HOEJI
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• v.56 no.2
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• pp.116-125
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• 2012

Local pharmaceutical companies in Korea, which have grown focusing on domestic markets, have recently faced difficulties such as market saturation, price control policies and market-opening pressures by FTA. It seems to be an urgent issue for them to export pharmaceuticals to developed countries comprising the greater part of the global pharmaceutical market. Hence, this research was conducted to investigate and benchmark the strategies employed by India industry for the successful access to the global pharmaceutical markets. Drug policies as well as their influences on pharmaceutical market changes between India and Korea for the last 40 years have been searched and the differences have been comparatively analyzed. The pharmaceutical industry of India has the following strengths: low costs; experienced labor pool; excellent reverse-engineering skills; powerful IT; marketing capability; and established distribution network. After 2000, consolidations, M&A and alliances with domestic and multinational companies have been sharply increased in the industry of India. Indian companies unfolding both competition and cooperation with multinational corporations currently move up the value-added chain, and this enthusiastic strategy should be learned by local pharmaceutical companies.

• Knowledge Management Research
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• v.19 no.3
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• pp.189-223
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• 2018

This paper examined the effect of innovation networks comprising research and development (R&D) collaboration on innovation performance of Korean pharmaceutical firms. As co-assigned patents and co-affiliated publications are common technical outcomes of successful R&D collaboration in the pharmaceutical industry, social network analysis technique was applied for analyzing innovation networks through patent and publication data. Results of Social network analysis indicated that a small set of highly innovative firms in the Korean pharmaceutical industry were actively involved in patenting and publishing. And the analysis of structural equation model found the followings: (1) R&D intensity significantly affected patenting, publication and new drug development, (2) the activity of patenting and publishing was positively related with the innovation performance measured by new drug development, and (3) R&D collaboration in terms of degree centrality of co-patent network played significant moderating roles on the relationships among R&D intensity, patenting, and new drug development. These findings are expected to be helpful to researchers as well as policy-makers to devise innovation-promoting policies in the Korean pharmaceutical industry. Discussions and limitations of the study are provided in the last part.

• Korean Journal of Social Welfare
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• v.57 no.3
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• pp.5-30
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• 2005

Globalization has conflicting effects on pharmaceutical policies. A change into a 'populist competitive nation' due to globalization strengthens policies to reduce drug manufacturing costs while the WTO's TRIPS Agreement that is affected by multinational pharmaceutical companies increases drug manufacturing costs by bolstering the patent rights on new drugs. Currently, the independency of populist nations' policies to reduce drug manufacturing cost is being compromised because multinational organizations(such as the European Union) which represents the interests of the multinational pharmaceutical companies put restrictions on the pharmaceutical policies of populist nations for purposes of promoting the industrial goals of the multinational companies. Korea is no exception. Up until the late 1990s, the main feature of the pharmaceutical policies in Korea was keeping the drug price at the cost level based on a growth-driven ideology, and this was Korea's unique policy tools as a developing nation. However, the increase in the power of multinational pharmaceutical companies currently infringes on the independency of Korea's pharmaceutical policies. Expensive imported drugs were originally covered by the national health insurance plan, but starting from 1999 such drugs began to be covered by the plan. After separation of medical and pharmaceutical services, the use of expensive drugs was increased, and the Korean government planned to introduce the reference price policy in order to contain the cost of the national health insurance plan. However, due to pressures from the U.S. government as well as multinational pharmaceutical companies, implementation of the policy has been postponed. In addition, due to a pressure from the U.S. government, a working group was created which would affect the health care policy of the Korean government. Discussions so far on globalization was about whether the change into populist competitive nations due to globalization resulted in the reduction of welfare spending. However, this study shows not only the reduction of health care cost through policies to reduce drug manufacturing costs but increase in welfare spending by raising the strengths of multinational pharmaceutical companies that are for-profit providers of welfare service. While focusing on the contradictory effects of globalization on pharmaceutical policies of a nation, this study looked at how these conflicting effects end up promoting the interests of multinational pharmaceutical companies by examining the Korean case.

• YAKHAK HOEJI
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• v.57 no.3
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• pp.213-218
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• 2013

This study examines factors associated with fixed budgets for pharmaceuticals and clawback system for pharmaceutical industry in European countries. We used information from a survey held in 2005~2006 by Austrian Health Institute. Several information including pharmaceutical pricing policies, marketing conditions for pharmaceutical industry and patient' choice of drugs was collected. Five out of twenty five countries in EU were considered as countries with fixed budgets for pharmaceuticals and remaining 20 countries were considered as countries without fixed budget system. Comparisons were made for each information. Countries with fixed budgets for pharmaceuticals were more likely to have internal (or external) reference pricing system and other pricing mechanisms. In addition, they were more likely to permit pharmaceutical industry to be engaged in public advertising and information provision towards patients. They guaranteed patient participation in drug choice decisions. The countries with fixed budgets for pharmaceuticals were more likely to have conditions that enable the fixed budget system to work better compared to those without fixed budget system. Therefore, the study results imply that we need to check whether we have similar conditions to the countries that already have fixed budgets for pharmaceuticals when we want to introduce fixed budget mechanism for pharmaceuticals in Korea in the future.

• Korean Journal of Clinical Pharmacy
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• v.31 no.4
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• pp.257-267
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• 2021

Background: The need for regulatory science development to evaluate advanced regulatory products is gradually increasing without hindering the technological development. Creating a research environment and fostering experts through the establishment of regulatory agency-led policies are essential for the development of regulatory science. Method: This is a comparative study of the United States, Japan, Singapore, and Korea. The literature and websites of each regulatory agency were reviewed, and the focus was on advantages and comparing advantages based on definition, development trends, and expert training projects. Results: The United States is striving to develop regulatory science in response to changes in the new pharmaceutical industry through the regulatory science report, and to foster expert both inside and outside the Food and Drug Administration (FDA). Japan is promoting regulatory science centered on regulatory science centers, and is focusing on researching work-related regulatory science within the Pharmaceuticals and Medical Devices Agency (PMDA) and improving employees' ability to make regulatory decisions. Singapore was aiming to improve Southeast Asia's regulatory capabilities under the leadership of Centre of Regulatory Excellence (CoRE) within Duke-NUS University. In 2021, Korea is in its early stages, starting to run a university's degree program related to regulatory science this year. Conclusion: Regulatory science should be developed with the aim of improving the regulatory ability of the Ministry of Food and Drug Safety with Korea's independent concept of regulatory science.

• Herbal Formula Science
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• v.21 no.2
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• pp.29-43
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• 2013

Objectives : The aim of this study is reviewing the past legal definition and regulations, to provide basis for the future desirable direction of Korean herbal pharmaceutical industry and national herbal drug policies. Methods : We reviewed how concept of herbal medicinal preparation has been utilized and changed along with various national laws and regulations. And this study also reviewed problems related herbal medicinal preparation policies. Results : Since 1990s, especially inauguration of Korea Food & Drug Administration (KFDA) at 1998, the concept of crude drug preparation has constantly expanded and distorted the scope of herbal medicinal preparations. This resulted in decline of herbal medicinal preparation industry. Conclusions : It means policies related herbal medicinal preparation which was driven steadily during this decade have lost their consistency. Also, it restricted the various medical options which can guarantee people's health rights.

• Management & Information Systems Review
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• v.35 no.4
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• pp.141-153
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• 2016

This study estimates the productivity change of pharmaceutical industry and decompose the change into technical efficiency change and technological change to explore ways to improve the productive efficiency. Unlike most previous studies, this study employs the non-radial and non-oriented slacks-based Malmquist productivity index which can deals directly with the input excesses and output shortfalls. In addition a smoothed bootstrap method is applied to estimate statistical confidence intervals for the Malmquist Index and its components. For the empirical analysis a balanced panel data set is constructed covering ten years over the period from 2005 to 2014. The input variables used in this study are number of workers, tangible assets and major production cost. The gross production is selected as a main output variable. The empirical results suggest that the productivity of pharmaceutical industry has decreased due mainly to decline in the technological progress rather than improvements in technical efficiency. An analysis result shows that the scale efficiency outweighs the pure efficiency in determining the technical efficiency of pharmaceutical industry. Therefore, in order to enhance the competitiveness of domestic pharmaceutical industry, it is important to continue supporting policies to promote the technology innovation capability through efficient R&D investment and industry reform strategy.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.19 no.8
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• pp.360-369
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• 2018

Innovative pharmaceutical company certification support policies have been implemented since 2012. This study was conducted to identify the perceptions of stakeholders and related experts on the formation process and policy satisfaction of this policy, and to identify factors that explain policy satisfaction. The survey was conducted by e-mail and facsimile of the pharmaceutical companies, universities, and government - affiliated research institutes. The effective response rate was 38.4% (61/159). As a result of the cross-sectional survey, the perception of policy necessity was the most positive among the policy formation process, and all the other stages and perception of policy satisfaction were at the medium level. As a result of examining the influential factors related to the variables of the respondents' personal variables and the policy formation process, it is confirmed that the factors that have the greatest influence on the policy satisfaction are the perception of the performance of the certified company. Also, perceptions of appropriateness and follow - up ability were similar in magnitude of impact on policy satisfaction. This study can be used as a basic data to systematically and effectively improve the certification and support policies of innovative pharmaceutical companies based on the consumer's perception. However, due to limitations such as being carried out at the beginning of policy implementation, verification and supplementation are necessary through further research.

• Health Policy and Management
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• v.21 no.3
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• pp.425-456
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• 2011

Background: Organizations in the pharmaceutical industry are highly dependent on the institutional environment. The introduction of pharmacoeconomics to the decision-making on the price and reimbursement decisions became strong constraints to pharmaceutical companies in Korea. As little is known about the issue on organization-environment interaction in the healthcare field, this study aimed to figure out how pharmaceutical companies adapted to the environmental changes. Methods: A multicase study method was used, selecting eight cases among multi-national pharmaceutical companies in South Korea. In-depth interviews were conducted with the managers of these organizations, and secondary data were reviewed to complement the interviews. Results: Pharmaceutical companies viewed the new policies as a big threat and sought for actions against them. One of the most distinguishing organizational changes was to construct a Market Access department. Other strategies managing the environment such as co-optation, forecasting, and bargaining were also implemented. These changes were consistent with the predictions of Resource Dependency Theory and Institutional Theory. Conclusions: The interactions between pharmaceutical companies and institutional environments in healthcare were first explored. This study presents a new perspective on how organizations change and the motives for the changes. The findings of this case study will form the basis of further empirical studies.