• 보건의료산업학회지
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• 제9권4호
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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.

• 약학회지
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• 제56권2호
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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.

• 지식경영연구
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• 제19권3호
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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.

• 한국사회복지학
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• 제57권3호
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• pp.5-30
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• 2005

세계화는 제약정책에 모순적인 영향을 미친다. 세계화에 따른 '국민적 경쟁국가'로의 변화는 약제비 절감 정책을 강화하는 한편 다국적 제약자본의 영향에 의한 WTO TRIPS 협정은 신약에 대한 특허 보호를 강화하여 약제비를 증가시킨다. 현재 다국적 제약자본의 이해를 반영하는 초국적 기구(예로, 유럽연합)가 산업적 목표 때문에 국민국가 제약정책에 규제를 가함으로써 국민국가의 약제비 절감 정책의 자율성이 침해당하고 있는 실정이다. 우리나라도 예외는 아니다. 1990년대 후반까지 우리나라 제약정책의 특징은 성장제일주의 이데올로기에 의한 원가수준의 약제비 통제 정책이었으며 이는 우리나라의 고유한 발전국가적 정책수단이었다. 그러나 세계화로 인한 다국적 제약자본의 힘의 강화는 우리나라 제약정책 자율성을 침해하고 있다. 값비싼 수입의약품은 건강보험 급여 목록에서 제외되었으나 미국 정부의 오랫동안의 압력에 의해 1999년부터 수입의약품도 건강보험 급여 목록에 등재되었다. 또한 의약분업 실시 이후 값비싼 고가약 사용이 증가하자 건강보험 재정절감 차원에서 참조가격제 도입 방안이 마련되었으나 미국 정부 및 다국적 제약회사의 압력에 의해 제도 실시가 유보되어졌다. 뿐만 아니라 미국 정부의 압력에 의해 우리나라 보건의료정책 결정 과정에 영향을 미치는 워킹그룹이 만들어지게 되었다. 지금까지 세계화와 관련된 논의들은 주로 세계화에 따른 국민적 경쟁국가로의 변화가 복지지출을 축소시켰는가에 관한 것들이었다. 그러나 본 연구는 세계화가 약제비 절감정책을 통해 보건의료비 지출을 감소시킨 측면 뿐만 아니라 세계화가 민간영리 복지서비스 제공자인 다국적 제약자본의 힘을 강화시켜 복지지출을 증가시키는 측면에도 주목하였다. 본 연구는 세계화가 일국의 제약정책에 미치는 모순적인 측면에 주목하면서 이 모순이 어떻게 다국적 제약자본의 이해로 관철되는지를 우리나라의 사례를 통해 살펴보았다.

• 약학회지
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• 제57권3호
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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.

• 한국임상약학회지
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• 제31권4호
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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.

• 대한한의학방제학회지
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• 제21권2호
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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.

• 경영과정보연구
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• 제35권4호
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• pp.141-153
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• 2016

본 연구는 Bootstrapped Malmquist 지수를 이용하여 국내 의약품산업의 생산성 변화 추이를 측정하고 이러한 변화를 기술효율성 변화와 기술변화 요인으로 분해함으로써 의약품산업의 생산효율성을 제고하기 위한 시사점을 제시하고자 한다. 특히 기존의 연구들과 달리 투입 및 산출요소의 여분을 반영하여 투입최소화와 산출최대화를 측정할 수 있는 투입산출지향 비방사적 Malmquist 지수를 분석에 활용한다. 또한 평활부트스트랩 방법을 적용하여 Malmquist 지수와 그 구성요인의 통계적 신뢰구간을 추정한다. 실증분석을 위해 2005년에서 2014년까지 10개년의 균형패널자료를 수집하였으며, 분석에 사용된 투입요소는 종사자수, 유형자산, 주요생산비를 선정하였고, 생산액을 산출요소로 사용하였다. 분석 결과, 의약품산업의 생산성은 분석기간 동안 하락한 것으로 나타났으며, 이러한 생산성 하락은 기술진보의 둔화에 기인한 것으로 나타났다. 또한 의약품산업의 기술적 효율성은 순수효율성보다는 규모효율성에 보다 많은 영향을 받은 것으로 분석되었다. 따라서 향후 의약품산업의 경쟁력 강화를 위해서는 효율적 R&D 투자와 산업구조의 선진화를 통해 기술혁신역량을 강화하는 정책적 지원이 요구된다.

• 한국산학기술학회논문지
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• 제19권8호
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• pp.360-369
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• 2018

국내 제약 산업에는 2012년부터 혁신형 제약기업 인증 지원 정책이 시행되고 있다. 이 연구는 이 정책의 형성과정 및 정책만족도에 대한 이해관계자와 관련 전문가의 인식을 파악하고, 정책만족도를 설명하는 요인을 파악하기 위해 수행하였다. 혁신형 제약기업을 포함하여 제약기업, 대학, 정부출연연구소 관계자를 대상으로 이메일, 팩스 등을 통해 설문조사하였으며, 유효 응답률은 38.4% (61/159) 였다. 연구결과 정책형성과정 중 정책필요성(정책문제설정 단계)에 대한 인식이 가장 긍정적이었으며, 다른 모든 단계와 정책만족도에 대한 인식은 보통 수준이었다. 응답자 개인 변인 및 정책형성과정에 대한 인식 변인 중 정책만족도와 관련이 있는 변인을 대상으로 다중회귀분석을 통해 영향 요인을 살펴본 결과, 정책결과 및 정책집행 단계의 일부 변인이 주요 요인으로 분석되었다. 구체적으로 정책만족도에 가장 큰 영향을 미치는 요인은 인증기업의 성과(정책결과 단계)에 대한 인식인 것을 확인하였다. 또한 적정성 및 사후관리 능력(정책집행 단계)에 대한 인식 역시 정책만족도에 미치는 영향력의 크기가 유사했다. 이는 수요자의 정책만족도에는 정책결과뿐만 아니라 정책집행과정에 대한 인식이 중요하다는 것을 시사한다. 다만 정책 시행 초기에 수행되는 등의 한계로 인해 향후 추가 연구를 통해 검증 및 보완이 필요하다.

• 보건행정학회지
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• 제21권3호
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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.