• The Korean Society of Law and Medicine
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• v.22 no.1
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• pp.91-124
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• 2021

In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

• Journal of Technology Innovation
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• v.20 no.2
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• pp.135-159
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• 2012

To the analysis and discussion whether to conceptualization between the basis and LCM(Life cycle management) of patentability decisions and evergreening through research on patent application strategies and litigation cases. The Stakeholders have said that the LCM and evergreening strategies are an innovative effort to develop new pharmaceuticals, while others say that it is an effort to block generic pharmaceuticals from entering the market and permanently dominate the market by generic pharmaceuticals manufacturers or health economic perspectives. To achieve the goal of research, to discuss for conceptualization LCM and Evergreening strategies through patent application strategies for 14 pharmaceuticals for APIs and case studies for litigations. As a results, the LCM is getting patent rights for the results of research at the initial R&D stage and as such this shall be regarded as part of an effort for technology innovation. However, Evergreening is granting patent rights for the results by making high permission barrier to prevent the market entry of generic pharmaceuticals in the late development period during the pharmaceuticals development process or after their launch. This may lead to the problem of getting weak in health economic aspects and consumer welfare aspects by lowering the market accessibility of cheap generic pharmaceuticals.

• Proceedings of the Korea Contents Association Conference
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• 2007.11a
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• pp.478-481
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• 2007

To date, modern medicine has relied heavily on synthetically or chemically produced drugs to treat or prevent diseases and conditions. However, developments in the field of molecular biology have led to an increase in the knowledge of biological systems and their interactions. Proteins are biomolecules that are essential in determining the structure and carrying out most of the functions in living cells. The future of pharmacy belongs to a special category of protein therapeutics. Based on the result of industry analysis, it is suggested how to commercialize protein therapeutics for biotech-enterprises.

• The Korean Journal of Applied Statistics
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• v.29 no.2
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• pp.279-289
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• 2016

Bioequivalence trials based on higher order crossover designs have recently been conducted for highly variable drugs since the Ministry of Korea Food and Drug Safety (MFDS) added new regulations in 2013 to widen bioequivalence limits for highly variable drugs. However, a statistical discussion of higher order crossover designs have not been discussed yet. This research proposes the statistical inference of bioequivalence based on $3{\times}3$ crossover design and discusses it with the MFDS regulations. An illustrated example is also given.

• YAKHAK HOEJI
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• v.55 no.3
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• pp.195-202
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• 2011

Generic medication market has been increased for economic reasons in Korea. Health authorities worldwide recommend the use of generic medications nowadays. However, patients in Korea are not familiar with the generic medications and considerable percent of those do not know the definition of the generic medications. The purpose of this study was to evaluate adults' knowledge and perception on the generic medications at community pharmacies in Korea. This study was a 11-questionnaire survey conducted from August 9, 2010 to August 27, 2010. Of the 204 respondents, 63 (30.9%) responded that they knew what a generic medication was, but only 16 (25.4%) of those answered that generic medications had the same efficacy as brand medications. When pharmacists were the source of generic medication information, more patients reported having knowledge about the definition of generic medications correctly compared with other sources. Patients with negative experience with generic medications within 6 months were more reluctant to generic substitution suggested by a pharmacist than those with positive experience. Based on the results of this study, further studies should be conducted to establish the best way to provide generic medication information for patients.

• Korean Journal of Clinical Pharmacy
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• v.16 no.2
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• pp.139-146
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• 2006

Objectives: Bio-equivalence(BE) test is important not only to ensure the quality of generic drugs, but also to promote drug substitution under the separation of prescribing and dispensing practice(SPD). This study was intended to investigate the perception of consumers, doctors, and pharmacists on the confidence of bio-equivalence(BE) assured drugs. Methods: Nation-wide telephone interview survey was conducted for 1,018 consumers, 800 doctors, and 806 pharmacists from September to October in 2003. Descriptive analysis and ${\chi}^2$ analysis were conducted. Results: Even though people showed higher confidence level for the Bioequivalent drugs compared with Bio-inequivalent drugs, the confidence was generally low. Among those asked about the therapeutic substitutability of original drugs by BE versions, 95.78% of pharmacists responded "positive", while only 39.33% of consumers and 31.13% of doctors said so. The elderly, the less educated, who takes chronic disease medicine, pays high cost of prescription drugs, and are in the low income responded less aware of that. Also most consumers got information such as effect of drugs from either media or doctors. Conclusions: In order for people to believe that BE drugs and original drugs are equivalent, we need to strengthen health education, and to clarify any misunderstanding. It is also necessary for the national policy to provide accurate information about drugs to the public.

• Journal of Korean Society for Quality Management
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• v.39 no.3
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• pp.365-376
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• 2011

Robust design (RD) has emerged as a key feature in process design and development for more than twenty years. Many researchers and industrial engineers around the world have invested their intensive efforts to develop and apply RD in many fields in order to improve quality of output products. However, there is also room for improvement. The primary objective of this research is to determine "robust formulation" of a medicine by checking its gelation index. In order to achieve this target, based on the nature of problem, at first, a customized experimental format is designed for obtaining data. Second, time-depended responses based models are developed by the proposed inverse problem (IP) methodology. Third, an RD model based on mean square error (MSE) concept is introduced for time-depended responses. Finally, the proposed approach is illustrated by a case study while comparing obtained results to the response surface methodology (RSM) approach.

• Health Policy and Management
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• v.23 no.3
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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.

• YAKHAK HOEJI
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• v.58 no.2
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• pp.99-106
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• 2014

This study explores the prescribing pattern of generic drugs and the relationship between socio-demographic factors and the use of generics in South Korea. The analysis was based on claims data of 2011 from Korean National Health Insurance. We examined utilization, costs, and market share of oral preparations by original and generic product. Multiple logistic regression was performed to evaluate the predictive factors of generic use among multi-source medications. Generics accounted for 37~41% of utilization and 34~41% of costs in the insured market of oral preparations. In the generic market, costly generics made up about 58~61%, 56~66% of volume and value, respectively. Other things being equal, institutional factors affected generic use to the largest degree. The odds of having generics were 6 times higher in clinics, 4 times higher in hospitals, and 1.7 times higher in general hospitals than in teaching hospitals. Those in metropolitan or rural area were more likely to prescribe generics than those in the capital area. While generics were frequently prescribed for off-site pharmacy (OR=1.173), the odds of having generics was 0.88 after weighting the data by units prescribed. This study empirically presented the pattern of generic prescribing, confirming the widely accepted view that costly generics were more likely to be utilized in the Korean market. Up to two thirds of the generic market consisted of costly products. The strongest factors affecting generic use were institutional variables.