• The Korean Society of Law and Medicine
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• v.23 no.4
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• pp.3-28
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• 2022

Recently, the targets and clauses of negotiation between 'National Health Insurance Service (NHIS)' and Pharmaceutical companies has been expanded. Due to newly adopted 'Quality management clause', 'Compulsory supply maintenance clause' and 'Penalty for breach of contract clause', not only 'Ministry of Health and Wellfare (MOHW)'s 'drug listing' and 'Price cap' announcement, but also 'negotiation between NHIS and pharmaceutical companies' can be a legal sanction to the suppliers. Once secretary of MOHW order NHIS to negotiate with pharmaceutical company, NHIS notify this order to the company and enter into the negotiation. 'The order' exists in the public domain between the government (MOHW) and public institutions (NHIS) and does not constrain the legal rights of companies (Therefore companies cannot pile a lawsuit about the order). However, 'the notice' or 'negotiation' is an act which has a counterpart, can be a target of administrative litigation if the company get some disadvantages from the talks. Negotiations can be divided into four types according to "the target (whether it is listed on the insurance benefit list)" and "the purpose (whether the target is price or conditional)." In particular, negotiations on listed drugs, whose goal is to set unfavorable conditions for companies, can be illegal if there is no price. So we need to consider compensation for the company as an incentive to negotiate.

• Knowledge Management Research
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• v.14 no.1
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• pp.39-55
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• 2013

As the importance of intellectual property rights for the 21st century challenge became prominent, many companies have been trying to secure many rights competitively. In particular, application numbers of patent that represents technology has been increased continuously. Korean companies were not exception; mainly in large companies, there have been continued the efforts to grow the number of patent applications in quantitative volume. But the issues that how viable patents the companies have, how effectively the companies manage, and how economically usable the patents are, are totally different from quantitative management level. As such, the issue is connected to how to assess the patent management level of companies. On the other side of quantitative growth of patent that companies hold, there are some problems such as the difficulties to determine if the patents hold substantial values, and the difficulties to determine whether the patent are managed effectively. In addition, as the numbers of patent application and registration of companies are increased, the cost for patent holding and managing increase. It is required to pay continuous attention to the cost of patent management because patent registration fee has a property that increases rapidly with time and burden for patentee become heavier. As a result of analysis and interpretation, we confirmed that quantitative management, particularly the number of patent applicant does not make positive impact on how to use patent after application. Rather, it is observed that the economical usage is influenced positively by the efforts of patent applicants such as considering for the time of patent examination, paying attention to receive patent registration decision. Therefore, this study shows that efforts patent applicants provide in management level after application time are important to maintain the value of patents.

• 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.

• Korean Journal of Clinical Pharmacy
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• v.30 no.3
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• pp.177-184
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• 2020

Background & objective: The Korean government has expanded its benefit coverage to enhance patients' access to orphan drugs and cancer medicines. However, the number of new drugs whose indications were not applied to reimbursement in health insurance was increased. This study aimed to understand the perspectives of experts and various stakeholders on the introduction of a new funding program for cancer treatment and orphan drugs. Methods: We conducted email surveys comprising 19 questions, from September 9 to 26, 2016. We distributed questionnaires to members of the Pharmaceutical Benefit Appraisal Committee and Cancer Assessment Committee. We also conducted a qualitative study through group interviews with stakeholders, including pharmaceutical companies and some patient groups for diseases. Results: A total of 35 survey respondents recommended the introduction of a funding program for orphan drugs, whereas 66% recommended the launch of funding for anticancer drugs. In addition, most pharmaceutical companies and patient groups recommended the introduction of new funding programs targeting patients with cancer and rare diseases. However, some participants asserted that it would be more appropriate to modify the existing reimbursement scheme than launch new funding. Conclusion: This study concluded that introducing new funding needs a social consensus to relieve financial hardships at the patient level.

• Journal of Korea Port Economic Association
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• v.35 no.3
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• pp.41-60
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• 2019

This study aims to identify factors that pharmaceutical logistics companies must consider when selecting a logistics center; it also aims to analyze the importance-satisfaction-of these factors by using IPA. The main results are as follows. First, overall, the aforementioned factors are divided into logistics factor, economic factor, environmental factor, and policy factor, and most of the specific attributes of each main factor are less satisfied than the importance. Second, the users of pharmaceutical logistics are divided into producers, distributors, clinics, and pharmacies. The analysis of each user shows a need to improve logistics factors as well as an overinvestment in environmental factors. The results can provide drug distribution companies directions for selecting logistics centers as well as strategic implications.

• Journal of Korean Society for Quality Management
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• v.50 no.3
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• pp.373-386
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• 2022

Purpose: This study proposes the application of Six Sigma management innovation method for more systematically enhanced execution of Quality by Design (QbD) activities. QbD requires a deeper understanding of the product and process at the design and development stage of the drug, and it is very important to ensure that no fault is fundamentally generated through thorough process control. Methods: Analyzing the background and specific procedures of quality improvement based on the drug design basis, and analyzing the key contents of each step, we have differentated and common points from the 6 Sigma methodology. We propose a new model of Six Sigma management innovation method suitable for pharmaceutical industry. Results: Regulatory agencies are demanding results from statistical analysis as a scientific basis in developing medicines to treat human life through quality improvement activities based on drug design. By utilizing the education system to improve the statistical analysis capacity in the Six Sigma activities and operating the 6 Sigma Belt system in conjunction, it helped systematically strengthen the execution power of quality improvement activities based on pharmaceutical design based on the members of the pharmaceutical industry. Conclusion: By using QbD Six Sigma, which combines quality enhancement based on pharmaceutical design basis and Six Sigma methodology suitable for pharmaceutical industry, it is possible to obtain satisfactory results both by pharmaceutical companies and regulators by using appropriate statistical analysis methods for preparing scientific evidence data required by regulatory.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.21 no.10
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• pp.471-479
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• 2020

In this paper, we analyze features of radical innovative businesses using their patents. Although patents have been used to evaluate outcomes of businesses from the 1980s, it is challenging to use patents for radical innovations. We examined the possibility of taking advantage of patents for an indicator that represents a radical innovation in pharmaceutical industry. To this end, we collected FDA approval data from the U.S. Food and Drug Administration and patent data of 18 pharmaceutical companies. For analysis, we utilized the network centrality analysis and Wilcoxon signed ranked test, which is a non-parametric statistical hypothesis test used to compare two related samples. We observed that a radical innovative company typically cooperates with other research groups, such as universities and companies, and acts as a hub for connectivity in pharmaceuticals. Also, we found that there are differences in centrality between radical firms and non-radical firms. Thus, we expect that the results of this study will help in developing strategies for research and development of pharmaceutical companies and identifying factors affecting radical innovation in the future.

• The monthly packaging world
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• s.271
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• pp.107-109
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• 2015

• The monthly packaging world
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• s.232
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• pp.74-79
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• 2012

• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.59-88
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• 2021

The National Assembly of the Republic of Korea recently enacted laws to fortify sanctions about data manipulation of pharmaceutical companies. The medicine approval system is the result of legislative efforts to prevent accidents that caused damages to patients' life and health. The medicine approval system is based on the trust that the data submitted by pharmaceutical companies is not manipulated. The Supreme Court of Korea clarified that strict standard shoud be required to secure the medicine safety in Supreme Court Decision 2008Du8628 decided November 13, 2008. We agree. This paper suggest legislation to weaken the economic incentives for pharmaceutical companies to choose data manipulation by minimizing the expected profit. In addition to revoking the marketing authorization of the medicine, the 'unfair' profits the pharmaceutical company has earned must be recovered. In addition, in order to increase the possibility to discover data manipulation, it is necessary to strengthen the review capacity and to activate the whistle-blowing.