• The Korean Society of Law and Medicine
• /
• v.21 no.2
• /
• pp.163-207
• /
• 2020

Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.

• Journal of Legislation Research
• /
• no.53
• /
• pp.177-211
• /
• 2017

In the course of the emergence and development of new ICT technologies and services such as Big Data, Internet of Things and Artificial Intelligence, the future will change by these new innovations in the Fourth Industrial Revolution. The future of this fourth industrial revolution will change and our future will be data-based society or economy. Since there is personal information at the center of it, the development of the economy through the utilization of personal information will depend on how to make the personal information protection laws. In Korea, which is trying to lead the 4th industrial revolution, it is a legal interest that can not give up the use of personal information, and also it is an important legal benefit that can not give up the personal interests of individuals who want to protect from personal information. Therefore, it is necessary to change the law on personal information protection in a rational way to harmonize the two. In this regard, this article discusses the problems of duplication and incompatibility of the personal information protection law, the scope of application of the personal information protection law and the uncertainty of the judgment standard, the lack of flexibility responding to the demand for the use of reasonable personal information, And there is a problem of reverse discrimination against domestic area compared to the regulated blind spot in foreign countries. In order to solve these problems and to improve the legislation of personal information protection in the era of the fourth industrial revolution, we proposed to consider both personal information protection and safe use by improving the purpose and regulation direction of the personal information protection law. The balance and harmony between the systematical maintenance of the personal information protection legislation and laws and regulations were also set as important directions. It is pointed out that the establishment of rational judgment criteria and the legislative review to clarify it are necessary for the constantly controversial personal information definition regulation and the method of allowing anonymization information as the intermediate domain. In addition to the legislative review for the legitimate and non-invasive use of personal information, there is a need to improve the collective consent system for collecting personal information to differentiate the subject and to improve the legislation to ensure the effectiveness of the regulation on the movement of personal information between countries. In addition to the issues discussed in this article, there may be a number of challenges, but overall, the protection and use of personal information should be harmonized while maintaining the direction indicated above.

• Journal of Legislation Research
• /
• no.54
• /
• pp.193-216
• /
• 2018

Das Leben des Embryos ist als solche ein Rechtsgut, das einen durch das Strafrecht hinreichend $gesch{\ddot{u}}tzt$ werden sollen. Daher versteht es sich von selbst, $da{\ss}$ auch bei der Schwangere die ihren eigenen $empf{\ddot{a}}ngenen$ Embryo beseitigenden Handlungen nicht $unbeschr{\ddot{a}}nkt$ gebilligt werden $k{\ddot{o}}nnten$. Es $k{\ddot{o}}nnte$ bei der Schwangere wegen ihrer $Interessenverh{\ddot{a}}ltnisse$ mit ihrem Embryo z. B. endlosen deren Verantwortlichkeiten nur die $Erlaubnism{\ddot{o}}glichkeiten$ ${\ddot{u}}bergelegt$ werden. Wie der Bundesverfassungsgericht schon ${\ddot{u}}berzeugt$ hat, $k{\ddot{o}}nnte$ das Leben des Embryos keinen vom Strafrechtschutz $ausschlie{\ss}enden$ Teil anerkannt werden, sondern nur in besonderen $F{\ddot{a}}llen$ ausnahmsweise dessen Verletzung erlaubt werden. ${\ddot{U}}ber$ die Reichweite der ausnahmsweisen anerkannten Erlaubnisse gegen einer Rechtsgutsverletzung sollte es im Allgemeinen $abh{\ddot{a}}ngig$ unter Zeitraum und Umwelt konkret ausgefargt werden. Daher kann eine konkrete Diskussion ${\ddot{u}}ber$ Rechtsfertigungsgrund des Schwangerschaftsabbruchs nur erstenmal anfangen, nachdem ein strafrechtlicher Schutz des Embryolebens $pr{\ddot{a}}zis$ ausgeforscht wird. Bis jetzt hat das Strafrecht das Rechtsgut als Leben des Embryos zu leicht bewertet und damit hat die Strafe des Schwangerschaftsabbruchs zu niedrig bestimmt. Die niedrige Strafe des Schwangerschaftsabbruchs $enth{\ddot{a}}lt$ die Gefahr, die die Erlaubnisreichweite des Schwangerschaftsabbruchs ungerecht ausdehnt. Die Handlung der Schwangere sollte minder bestraft werden, um das Sebstbestimmungsrecht der Schwangere hoch $w{\ddot{u}}rdigen$ zu $k{\ddot{o}}nnen$. Letztlich braucht der Versuch des Schwangerschaftsabbruchs zu bestrafen. Der Versuch und die Vollendung ${\ddot{u}}ber$ die Verletzung des Embryolebens sollten deren Unterschiede im ihren Unrechtsgehalt anerkannt werden, weil der Normzweck des Schwangerschaftsabbruchs im Schutz des Lebens des Embryos besteht. Und damit in den $F{\ddot{a}}lle$, die in Folge des versuchten Schwangerschaftsabbruchs die Schwangere verletzt oder gestorben wird, $k{\ddot{o}}nnten$ die Meinungsstreiten $aufgeh{\ddot{o}}rt$ werden.

• The Korean Society of Law and Medicine
• /
• v.23 no.3
• /
• pp.139-207
• /
• 2022

As various state restrictions on individual freedom were imposed during the COVID-19 pandemic, concerns have been raised that excessive infringements on fundamental rights were indiscriminately permitted based on the public interest of preventing infectious diseases. Therefore, the question of how to set acceptable limits of liberty restrictions on individuals has emerged. However, since the phenomenon of infections spreading to the population is only predicted statistically, how to deal with the risk of the infected individual as a subject of legal analysis has become a problem. In the absence of a theoretical framework of legal analysis of risk, the risk of infected individuals during the pandemic was not analyzed strictly, and proportionality review of infection prevention measures was often only an abstract comparison of the importance of public interest and individual rights. Therefore, this research aims to conduct a theoretical review on how risk can be conceptualized legally in a public health crisis, and to develop a theoretical framework for proportionality review of the risk of liberty-limiting measures during a pandemic. Chapter 2 analyzes the legal philosophical concepts of risk, which are the basis for liberty restrictions during a public health crisis, and applies and extends them to the pandemic. Chapter 3 reviews previous studies related to liberty restriction measures in the context of the COVID-19 pandemic, and points out they have a limitation that specific criteria for the proportionality review of public health measures in the pandemic have not been presented. Accordingly, Chapter 3 specifies the methodological framework for proportionality review, referring to the theoretical discussion on risks in Chapter 2. Chapter 4 reviews the legitimacy of gathering restriction orders, applying the theoretical discussion in Chapter 2 and the criteria for proportionality review established in Chapter 3. In particular, Section 4 examines logic of proportionality review in judicial precedents over the ban on gathering restrictions implemented in the COVID-19 pandemic. In analyzing the precedents, the logic of proportionality review in each case is critically reviewed and reconstructed based on the theoretical framework presented in this research.

• Korean journal of communication and information
• /
• v.38
• /
• pp.211-244
• /
• 2007

Article 17 and 18 of the Korean Constitution respectively prescribe the violation of individual's right to privacy and the secrecy of wire communication. Meanwhile, Article 20 of the Criminal Code provides that an act which is conducted within the ambit of laws or pursuant to accepted business practices or which does not violate the social norms shall not be punishable. In 1999, the Constitutional Court held that media reports on public matters of public figures must be given strong constitutional protection, and treated differently from reports on private matters of private figures. In accordance with the decision, the Supreme Court has expanded the scope of constitutional guarantee of freedom of expression since 2002. This study analyzes the issue of media liability for publication of illegally intercepted wire communication by a third person. Particularly, it reviews Seoul High Court's ruling on 'X-file scandal' which disclosed intercepted wire communications between notable public figures regarding a slush fund for a presidential candidate. In the light of this analysis, the study concludes that the media reporting of the intercepted communication does not violate social norms of Article 20, and therefore it is entitled to a constitutional privilege.

• Korean journal of communication and information
• /
• v.48
• /
• pp.5-24
• /
• 2009

This study is aimed to analyze the concept of media consumer and legal principles for consumer movements protection. Based on the concept and legal principles, this research is to review the characteristics of the advertisement boycott campaign. Article 124 of the Constitution prescribes that the state should guarantee the consumer protection movements. According to the Article 4 of the Framework Act on Consumer, consumers have the fundamental right to obtain proper compensation for damages sustained due to use of goods and etc. according to prompt and fair procedure. The type of boycott can be classified into two pattern on the basis of boycott's target or object. They are primary boycott and. secondary boycott. Consumer's boycott independent of primary or secondary, are under the protection of the consumer's right. Media consumers use scarce resources to satisfy their wants and needs to acquire news information and advertising information. Their resources are time and money. Therefore, ads boycott campaign or media boycott campaign is the primary boycott. Consumer's right should be guaranteed to the maximum. The Constitution and consumer protection law should protect the practice of consumer's right, especially consumer's boycott campaign.

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

• The Korean Society of Law and Medicine
• /
• v.24 no.2
• /
• pp.119-145
• /
• 2023

The Pharmaceutical Affairs Act stipulates medication counseling as an obligatory requirement in the case of preparation of medicine. In fact, there are many cases where pharmacists only tell patients the dose and time and do not properly guide them on taking medications. However, in light of the current situation where non-face-to-face treatment is being attempted, there is a high possibility of drug-taking accidents due to insufficient medication guidance. In addition, as an aging society progresses, the need for explanations on pharmaceuticals is increasing. If a pharmacist causes damage to a patient by failing to give appropriate medication guidance, the patient can claim compensation for damages. In addition, if a drug accident occurs due to a conflict between the pharmacist's duty to guide medication and the doctor's duty to explain, a joint tort is established between the pharmacist and the doctor. Nevertheless, there are cases in which only doctors are judged to bear the tort liability. However, the Pharmaceutical Affairs Act includes providing information for the selection of over-the-counter drugs in the medication guidance as part of the medication guidance obligation. Therefore, in order to reconsider the importance of the medication-taking guidance duty, it is necessary to define the medicationaking information provision method and the medication-taking guidance duty as separate concepts. In addition, it is necessary to amend related regulations centered on patients so that medication guidance, such as side effects of medicines and interactions with concomitant medications, can be made in detail.

• Proceedings of the Korean Society of Computer Information Conference
• /
• 2019.07a
• /
• pp.195-198
• /
• 2019

연명의료결정법의 정식 명칭은 '호스피스 완화의료 및 임종 과정에 있는 환자의 연명의료 결정에 관한 법'이다. 이 법은 호스피스 완화의료에 대한 것과 환자의 연명의료 결정에 대한 것을 규정하고 있다. 특히, 후자의 연명의료결정에 관한 부분은 법제정 과정에서 법 종교 의료 윤리 등 다양한 분야에서 논박이 있었지만 2018년 2월 4일부터 시행되고 있다. 법학에서는 이 법이 생명이라는 법익과 관련되어 있어 형사법적, 민사법적으로 중요한 의미를 갖는다. 이 법이 탄생되기 위해 두 번의 변곡점이 있었다. 첫째, 1997년 '보라매병원 사건'에서 의사를 작위에 의한 살인방조죄로 판결한 사건 둘째, 2009년 '김 할머니' 사건에서 회생할 수 없을 경우 가족 등이 진술한 환자 의사에 따라 연명 의료를 중단할 수 있다는 대법원 판결이다. 연명의료결정법은 헌법상 생명권과 자기운명결정권이라는 기본권 충돌이 발생한다. 두 기본권이 서로 상충 할 때에는 어떠한 기본권을 우선해야 하는지가 실질적으로 문제되는데, 이익형량을 통한 규범의 조화로운 해석을 통해 해결해야 한다. 또한 이 법의 흠결과 문제점을 고찰하여 개정작업이 진행되어야 한다.

• Korean journal of communication and information
• /
• v.39
• /
• pp.69-101
• /
• 2007

Some clauses of the prior review rules for broadcasting commercials, which are enforced by the Broadcasting Act violate the right to free speech guaranteed by the Constitution. The range of prohibited expression under the clauses are too vague and overbroad to distinguish between permissible and impermissible broadcasting commercials. The clauses also fail to pass the constitutional principle that restrict government from excessive regulation on constitutional rights. The principle has a four-pronged test on the government action; 1) the validity of its goal; 2) availability of appropriate means; 3) necessity of infringement; 4) and balancing test of interests. Some clauses of the prior review rules that forbid expressions on sensitive political and cultural issues fail to pass none of the four-pronged standards.