• 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.

• 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.

• 한국임상약학회지
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• 제23권3호
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• pp.185-196
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• 2013

This study aims to explore the difficulties of evidence-based pharmaceutical policy-making in the Korean context where several pharmaceutical policies were introduced within a short period. Semi-structured in-depth interviews were performed with eight experts in the Korean pharmaceutical arena. The key challenge in Korean situation might be the apparent lack of available evidence caused by the limited resources, the lack of policy consistency and coordination ability in the authorities and distrust across stakeholders. To build an evidence-based tradition, it is essential to resolve the tangible lack. At once, more fundamental changes seem to be required in the intangible policy environments.

• Journal of Preventive Medicine and Public Health
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• 제56권4호
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• pp.377-383
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• 2023

Objectives: Korea and Japan have managed the spread of coronavirus disease 2019 (COVID-19) using markedly different policies, referred to as the "3T" and "3C" strategies, respectively. This study examined these differences to assess the roles of active testing and contact tracing as non-pharmaceutical interventions (NPIs). We compared the proportion of unlinked cases (UCs) and test positivity rate (TPR) as indicators of tracing and testing capacities. Methods: We outlined the evolution of NPI policies and investigated temporal trends in their correlations with UCs, confirmed cases, and TPR prior to the Omicron peak. Spearman correlation coefficients were reported between the proportion of UCs, confirmed cases, and TPR. The Fisher r-to-z transformation was employed to examine the significance of differences between correlation coefficients. Results: The proportion of UCs was significantly correlated with confirmed cases (r=0.995, p<0.001) and TPR (r=0.659, p<0.001) in Korea and with confirmed cases (r=0.437, p<0.001) and TPR (r=0.429, p<0.001) in Japan. The Fisher r-to-z test revealed significant differences in correlation coefficients between the proportion of UCs and confirmed cases (z=16.07, p<0.001) and between the proportion of UCs and TPR (z=2.12, p=0.034) in Korea and Japan. Conclusions: Higher UCs were associated with increases in confirmed cases and TPR, indicating the importance of combining testing and contact tracing in controlling COVID-19. The implementation of stricter policies led to stronger correlations between these indicators. The proportion of UCs and TPR effectively indicated the effectiveness of NPIs. If the proportion of UCs shows an upward trend, more testing and contact tracing may be required.

• 보건행정학회지
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• 제23권3호
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• pp.210-223
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• 2013

Backgrounds: Escalating pharmaceutical expenditure has threatened the sustainability of National Health Insurance system in Korea. Generic medicines allow patients to access safe, effective, high-quality medicines at low cost, thus insurers could achieve significant financial savings by promotion of generics, if they are priced much lower than the originator. The purpose of this study was to review generic pricing as well as promotion policies in other countries and assess the implication of those policies. Methods: We reviewed the main measures adopted by the developed countries such as Austria, Belgium, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Sweden, United Kingdom, especially in countries where governments are the largest third-party payers or insurance finance resource is the national health insurance. Results: The foreign countries's experience with generic medicine policy shows that demand-side policies such as physician budgets, international nonproprietary name prescribing, generics substitution, patients co-payment as well as supply-side policies relating to pricing and reimbursement seems to play a critical role in developing the generic medicines market. Conclusion: Various strategy should be implemented to promote generic drug use.

• 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.

• International Journal of Human Ecology
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• 제12권2호
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• pp.1-12
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• 2011

Many pharmaceutical products are available through prescription (Rx) only status. As a result, access to physicians and insurance coverage play a key role in the use of these products, and therefore may affect the population to whom advertising is targeted at. The movement of pharmaceutical products from prescription (Rx) to Over-the-Counter (OTC), or Rx-to-OTC switch changes the cost of acquiring the drug and therefore may change the incentives manufacturers have at targeting particular population segments. This study examines whether Rx-to-OTC switch changes the frequency and the distribution of who is exposed to pharmaceutical advertising. Using an archive of pharmaceutical advertisements and National Consumer Survey, this study examines how individuals with particular demographic characteristics are exposed to pharmaceutical advertisements before and after drugs are moved from Rx to OTC. The results provide evidence that individual's advertising exposure increases after Rx-to-OTC switch. Moreover, the increase in advertising exposure is greater for the low socioeconomic status (SES) consumers which implies they may get more information about the disease, treatment and product after the Rx-to-OTC switch through advertising. If low SES consumers have more exposure to the advertising after products switched to OTC, then FDA policies regulating this switch should recognize the potential role of advertising providing access to health-related information.

• 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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• 제28권2호
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• pp.146-153
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• 2018

Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.