특허무효심판에서의 심판물(subject matter) = 청구취지(특정 청구항) + 청구이유(무효사유+주요증거)

왕로(Lu WANG),정차호(Chaho JUNG) 원광대학교 법학연구소 2021 圓光法學 Vol.37 No.4

소송에서 소송물이 무엇인지가 매우 중요하듯이, 특허무효심판에서도 심판물이 무엇인지가 매우 중요하다. 그 심판물을 기준으로 기판력(일사부재리), 기속력, 중복심판 등이 판단된다. 특허무효심판의 심판물을 청구취지로 넓게 보는 견해와 청구취지 및 청구이유로 좁게 보는 견해가 존재하나, 그 쟁점에 대해 본격적으로 논의된 바는 없는 것으로 관측된다. 이 글은 특허무효심판에서의 심판물을 이해하기 위해, 우리 민사소송법에서의 소송물 이론 및 주요국에서의 소송물 이론을 분석하고, 나아가 주요국 특허무효심판에서의 심판물 이론을 분석하였다. 그러한 분석의 결과 이 글은 다음과 같은 법리적 개선방안을 제시한다. 첫째, 특허무효심판에서의 심판물은 청구취지로만 구성되는 것이 아니라 청구이유까지도 포함한다. 그 청구이유는 특정 청구항에 대한 특정 무효사유 및 주요증거로 구성된다. 둘째, 특허법 제163조는 일사부재리 원칙이 ‘동일 사실 및 동일 증거’에 적용된다고 규정하는데, 심판물의 견지에서 그 규정은 정확하지 않다. 일사부재리 원칙은 ‘동일 심판물’에 적용된다고 규정되어야 한다. 셋째, 특허법 제186조 제6항은 특허무효심판의 심결의 취소를 청구하는 소는 ‘심결’에 대한 것이어야 한다고 규정한다. 그 규정에서의 ‘심결’이 무엇인지가 명확하지 않다. 그 규정은 ‘심판물’에 대한 것이어야 한다고 개정되어야 한다. 넷째, 특허법 제158조의2가 (민사소송법 관련 규정의 준용을 통하여) 적시(適時)제출주의를 규정한다. 적시제출주의가 실현되기 위해서는 심판절차의 초기에 심판물이 확정되어야 한다. 그런 견지에서 청구이유의 수시 보정을 허용하는 특허법 제140조 제2항 제2호는 개정되어야 한다. 다섯째, 특허법 제159조는 당사자 또는 참가인이 신청하지 아니한 이유에 대해서도 직권으로 심리할 수 있다고 규정한다. 그러나, 특허무효심판에서는 처분권주의가 적용되어 청구인만이 심판물을 특정할 수 있어야 하며, 심판부는 관련 자료를 직권으로 탐지하는 것만 허용되어야 한다. 그런 내용을 담도록 제159조는 개정되어야 한다. As the subject matter in a litigation is very important, the “subject matter in a patent invalidation trial” (‘trial subject matter’) is also very important. Based on the trial subject matter, res judicata (claim preclusion), restriction ability, double litigation, etc. are decided. Until now, two conflicting theories have existed, one of which regards the trial subject matter as purport of petition and the other of which regards the trial subject matter as purport of petition and grounds of petition. However the issue has never been seriously debated in Korea. This paper, to understand the trial subject matter, has analyzed the subject matter jurisprudence in Korea and other countries’ civil procedure laws, and has further analyzed trial subject matter jurisprudence in major countries. As results of such analysis, this paper suggests the following legal improvement plans. Firstly, the trial subject matter consists not only purport of petition but also ground of petition. In addition, the ground of petition consists of a specific invalidation ground of a specific claim and primary evidences. Secondly, section 163 of the Korea Patent Act (KPA) prescribes that res judicata principle applies to the same fact and the same evidence. In respect of the trial subject matter, the provision is not correct. Res judicata principle shall be applied to the same trial subject matter. Thirdly, section 186(6) of the KPA prescribes that a suit for trial revocation should be on “trial decision”. Meaning of the “trial decision” in the provision is ambigous. The provision should be amended to mean “trial subject matter.” Fourthly, section 158-2 of the KPA (adapting relevant provisions of the Korea Civil Procedure Act) prescribes the timely submission principle. For the principle to be realized, the trial subject matter must be finalized in the early stage of the trial. In that respect, shall be amended section 140(2)(2), which allows amendment of petition ground from time to time. Fifthly, section 159 of the KPA prescribes that the trial board can sua sponte examine a ground which was not petitioned by the petitioner or joinder. However, in the patent invalidation trial, principle of disposition should be applied and therefore, only the petitioner shall specify the trial subject matter. The trial board is only allowed to sua sponte examine relevant evidences. Section 159 of the KPA shall be amended accordingly.

말기 암 환자에 대한 임상시험과 피험자의 자기결정권의 본질

송영민 대한의료법학회 2014 의료법학 Vol.15 No.1

Because of unpredictability and high possibility of abnormal results by clinical trials compared to general medical behaviors, a procedure for ensuring with sufficient explanations by investigators must be secured. Therefore, in a sequence of clinical trials, what kinds of scope, stage, and method of explanations provided by investigators, including doctors or researchers, to trial subjects are closely related to the compensation for damages by violation of liability for explanation. In case of application of clinical trials to patients who have critical illness such as cancer, issues of 「Quality of Life」 regarding trial subjects, cancer patients, should be discussed. Especially, in case of clinical trials for terminal cancer patients, the right of subjects' self- determination, which is a fundamental principle in medical behaviors, should be discussed. The right of self- determination includes participation in clinical trials for the possibility of life-sustaining even a little bit, or no participation in clinical trials in order to have a time for completing the rest of his life. Like this, if the extent and scope of explanations related to the issues of 「Quality of Life」 are raised as main issues, the evaluation of 「Quality of Life」 , should be a prerequisite. In many occasions, realistically, despite bad results such as deaths or serious adverse drug reactions after clinical trials, it may not be easy for compensating to trial subjects or their survivors, who requested civil compensation for damage. Futhermore, in abnormal results after concealment of clinical trials or performance of clinical trials without permission, and in the case of trial subjects' failures of proving proximate cause between the clinical trials and abnormal results, problematic results such as no protection to the trial subjects could be occurred. In performing clinical trials, investigators should provide sufficient explanations for trial subjects and secure voluntary informed consents from the trial subjects. Therefore, clinical trials without trial subjects' permissions and the informed consent process violate trial subjects' rights of self-determination, and the investigators shall be liable for compensation for damages. Then, issues might be addressed are what are essential contents of patients' 「rights of self-determination」 infringed by clinical trials without subjects' permissions. Two perspectives about patients' rights of self-determination might be considered. One perspective regards physical distress of patients (subjects) from therapies without sufficient explanations as the crux of the matter. The other perspective regards infringement of human dignity caused by being subjects without permission as the crux of the matter irrespective of risks' big and small influences. This research follows perspective of the latter. Forming constant fiduciary relation between investigators (doctors) and subjects (patients) pursuant medical contracts, and in accordance with this fiduciary relation, subjects, who are patients, have expectations of explanations and treatments by the best ways. If doctors and patients set this forth as a premise, doctors should assume civil liability when doctors infringe patients' expectations.

의약품 임상시험에서 피험자 보호

위계찬 대한의료법학회 2012 의료법학 Vol.13 No.2

This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.

의약품 임상시험에서의 피험자의 자기결정권 확보방안

송영민(Song Young-Min) 동아대학교 법학연구소 2010 東亞法學 Vol.- No.46

임상시험은 본질적으로 실험의 성격을 갖고 있으므로, 실험과정상 피험자에게 미칠 직접적 이익의 유무ㆍ정도, 위험성 등에 대하여 불명확한 것이 많다. 그러므로 임상현장에서 임상시험에 참가할 피험자의 진정한 의사가 반영되었는가 하는 점은 구체적인 의료행위의 경우보다 더욱 더 중요한 문제이다. 동의능력을 갖고 있는 성인의 경우에는 신체에 대한 자기결정권의 내용으로서 스스로의 판단하에 자율적인 결정으로 임상시험에 참여할 수 있을 것이다. 그러나 소아나 중증의 치매환자와 같이 본인에게 동의능력이 없는 경우에는 원칙적으로 피험자로서의 적격성을 인정할 수 없다. 그러나 당해 임상시험의 목적상 그러한 피험자를 대상으로 해야만 임상시험의 목적을 달성할 수 있는 경우에는 예외적으로 허용될 수 있을 것이나, 이러한 경우에도 치료를 목적으로 하는 경우에만 허용된다. 한편, 본인에게 동의능력이 없는 경우에는 의료현장의 관행으로서 대행결정이 이루어진다. 그러나 대행자에 의한 동의는 피험자본인의 입장에서는 ‘자기’의 결정이 아닌 ‘타인’의 결정이다. 그러므로 대행자의 선임에는 ①사전에 본인의 임상시험에 대한 참가의사가 있거나 후견계약이 있었는지의 평가 ②본인의 의사가 불명확한 경우에도 본인의 희망ㆍ가치체계를 알고 있는 근친자가 선임되는지에 대한 평가가 있어야 한다. 그리고 연구자는 대행자에게 임상시험에 관한 설명을 하기 전에 본인에게 동의능력이 결여되어 있다는 판정결과를 알리고, 대행자가 동의한 경우에는 본인에 대하여 그러한 취지를 알려야 한다. 이러한 추가적 절차를 두는 이유는 피험자의 동의능력의 유무에 대한 불명확성이 높기 때문이다. 또한 본인이 거부하지 않아야 한다. 본인이 거부한 경우에는 거부권은 존중되어야 한다. Owing to the experimental characteristic of clinical trials, it is not obvious how much the benefit and riskiness would affect to the trial subjects in the process of experiments, thus whether the intentions of trial subjects are reflected is more important issue than medical treatments in clinical services. The adults who have the consent abilities would be able to take part in clinical trials with their own decision as the rights of self determination to their bodies, however those who are not capable of consenting for themselves like the underage or serious dementia patients should not be admitted their eligibility as the trial subjects. Nevertheless it could be permitted exceptionally in case the result of clinical trials could come out only when those people take part in as the trial subjects to achieve the aims of clinical trials, but still in this case it should be allowed if it is only for treatment. In addition, the substituted determinations are made in accordance with custom in medical services in case of not having consent abilities, however the consents of agents should be considered as other's decision not his(her) own decision in the position of trial subjects. Thus, there need to be a couple of assessments in the designation of agents. those are as follows. ① the assessment whether there is the intention to take part in clinical trials of himself(herself) or the contract of guardianship in advance. ② the assessment whether there is the designation of a close relative who knows his(her) value systems although it is unclear to be his(her) own intention. Furthermore, the researchers should inform the trial subjects of the result of judgement that he(she) lacks the ability to consent before explaining the clinical trials to the agents and let the trial subjects know the intents in case the agents agreed with it. The reason additional procedures should be made is that the consent abilities of trial subjects are too obscure. I also suppose that the trial subjects should not refuse the procedures and the rights of refusal should be respected in case of his(her) refusal.

Korean Regulations of Clinical Trials and Research with Human Subjects

Park, Soo Hun 이화여자대학교 생명의료법연구소 2012 BIOMEDICAL LAW & ETHICS Vol.6 No.1

Clinical trials and research with human subjects are conducted throughout the world including both the developed and the developing countries. Clinical trials and research with human subjects have the common concerns on how to protect the rights, safety, and welfare of the human subjects properly and adequately. In this article, I examined government regulations of Korea that formulate the basic frame and minimal requirement for the researchers to comply with when they conduct clinical trials and research with human subjects. Especially, I explored Constitutional Law, the Bioethics and Safety Act, the Pharmaceutical Affairs Act, the Medical Device Act, and Korea Good Clinical Practice. As a result, I found some defaults in our laws and regulations in protecting human subjects. In case of Constitutional law, there is no principle of beneficence necessary for researchers to protect human subjects by analyzing the risk and benefit of making them participate in clinical trials and research unlike the global standards. In case of BEASA, it has limited jurisdiction in research with human subjects in the specific life science areas such as human embryonic research, genetic testing, and gene therapy. In addition, BEASA is not applied to human behavioral research and does not have a definition on research. As to PAA, it has a “swiss cheese” syndrome in three ways: no provision on vulnerable populations, no provisions on Informed Consent and IRBs, and no provision on the research participants’ protected health information. Finally, KGCP also needs to insert some provisions such as much more specified kinds of vulnerable populations, types of conflict of interest, and the use of placebo, to protect human subjects in accordance with the global standards.

〔특집논문〕의료법의 현대적 과제 : 임상시험과 피험자보호에 관한 연구

박민제 ( Min Je Park ),박정인 ( Jung In Park ) 홍익대학교 법학연구소 2014 홍익법학 Vol.15 No.2

오늘날 인간 대상연구나 임상시험은 과학이나 의학발전을 위해서는 필요한 부분 중 하나이다. 그런데 피험자가 임상시험에 참여할 경우 피험자의 권리, 안전, 복지를 보호하기 위한 추가적인 조치가 필요하다. 특히 의학연구 분야는 법규제 측면을 본다면 일부 의사나 연구자들이 반발할 가능성도 있다. 그러나 적절한 규제는 피험자를 보호하는 동시에 의사나 연구자들도 보호하는 기능도 있다. 또한 각 관계가 있는 (행정)기관과 연대하여 우수한 임상시험의 물적·인적육성, 의뢰자에게 공정하면서 피해방지 및 설명, 동의의 정보가 충분히 제공할 수 있는 시스템구조 등을 위한 노력이 더욱 더 필요하다. 한 측면만 살펴보면, 피험자 개인의 이익과 반드시 연결되어 있지 않다. 오히려 피험자 자신에 대한 위험과 그 희생으로 이루어진다고 해도 결코 지나치지 않다. 한편 의사 입장에서 임상시험을 실시할 경우, 의료과학 발전에 기여할 의무와 환자의 이익을 위해서 보호할 의무가 있다. 의사는 이 양쪽 의무 사이에 서 있다고 보아도 무방할 것이다. 이 양쪽 의무가 서로 충돌하는 측면이 있기 때문에 상호연결해서 조화롭게 일치시켜 나아간다는 것은 결코 쉽지는 않다. 만약 피해가 피험자에게 발생한 경우, 모든 구제가 가능할 수 있도록 완벽한 체제를 준비해 두어야 한다. 인간 대상연구나 임상시험은 피험자보호를 위하여 그 구조적 결함을 보완하여 행정 및 법에 의한 규제와 임상시험심사위원회의 판단 등을 고려하여야 한다. 그러므로 피험자 보호를 위하여 입법론으로 충분히 정비하여야 할 것이다. 그리고 외국 경우처럼 보험등을 통한 피해구제의 체제를 정비한 다음, 과학이나 의학발전을 위하여 노력하여야 할 것이다. 실질적으로는 각 국가마다 임상시험이 다를 수 있기 때문에 더욱 더 지속적으로 피험자보호를 위해 노력해야 한다. In today` society, it is necessary to take a clinical trial on humans in order to carry out scientific and medicinal research. In the event that subjects participate clinical trial, additional measures should be taken to protect subjects` right, safety and welfare. Especially in the sphere of medicinal research, some parts of doctors and researchers, possibly, oppose to legal regulations. But appropriate regulations play an important role to protect not only subjects but also doctors and researchers. By collaborating with the related Ministry, we can secure excellent human and material resources to take a clinical trial, and at the same time, provide fair and damage-preventing system and informed consent for the subjects. At the first glance, clinical trial on the subjects have damaging interests to the subjects individuals. In fact, clinical trial are carried out by the sacrifice of the subjects individuals. On the other hand, doctors who carry out clinical testings have the duty to contribute to the development of medical science and to protect subjects` interests. Doctors who carry out experiments should make a good adjustment these two conflicting interests. These two`s interests are conflicting each other, so it is not easy to coordinate interests between them. If damages occur to the subjects, we should prepare to take perfect legal remedy measures to compensate for the damaged subjects. Clinical trial on humans should lay down administrative and legal regulations and pass the judgement of Institutional Review Board, and so on. Because of these reasons we should modify various laws and regulations to protect the subjects. As taken effect to the foreign countries it is desirable to introduce insurance system and take measures to advance science and medicine. Substantially, as every country has different clinical trial system, we should make a greater effort to protect the subjects.

의약품 임상시험의 계약적 일고찰

송영민 대한의료법학회 2011 의료법학 Vol.12 No.1

This thesis has studied about the legal characteristic of injection of the trial drug, the position of the pharmaceutical firm as a contractor of the clinical trial, the possibility of compulsory performance of consistent injection of the trial drug, and the damage claim caused in the process of the clinical trial from the viewpoint of protecting the trial subject in the clinical trial. According to court's judgement in the United States, the lawsuit of the trial subject, although the trial subject had expected consistent injections, was dismissed because there was no direct contract between pharmaceutical and trial subject. However, Helsinki Declaration prescribe the medical research as follows. 'All patients who participated in the research should be able to use the best precaution, diagnosis, and treatment proved by the final outcome of the research'. The trial subject is entitled to demand only the pharmaceutical firm which developed and provided the trial drug, and the pharmaceutical firm has the obligation to supply the trial drug to the trial subject. Therefore, it would be not enough to protect the trial subject if the pharmaceutical firm which makes the trial drug is ruled out. In addition, especially, in case the trial drug has a constant effect with the aim of treatment, if the injection of the trial drug is suddenly stopped, the trial subject would not have the benefit of treatment by the trial drug. In this case, the best remedy against the damage is to urge a constant injection of the trial drug. Thus, in certain case, it is reasonable to consider that the pharmaceutical firm has the obligation to supply the trial drug to the trial subject constantly, and it is also necessary to compel it through effective means in case the pharmaceutical firm do not fulfill its obligation to supply the trial drug. However, as an essential prerequisite for the assertion mentioned above, it should be judged under the principle of good faith considering the concrete situation, that is, what roles the pharmaceutical firm has played.

임상시험 대상자 모집방법에 관한 법적·윤리적 검토

박태신(Park Tae Shin) 한국법학원 2020 저스티스 Vol.- No.178

임상시험은 사람이 가진 질병을 예방, 치료, 개선하기 위해 반드시 필요한 절차이다. 그런데 특정한 조건을 충족시켜야 하거나 대상질병 자체가 희귀질환이라는 등의 사정으로 인해 임상시험대상자 등록에 시간과 비용이 예상 외로 많이 소요되는 경우들이 발생하고 있다. 이러한 대상자등록의 어려움은 임상시험을 중단케 하거나 그 비용을 높이는 원인의 하나로 거론된다. 대상자등록은 잠재적대상자모집을 통해 임상시험 참여의사를 밝힌 잠재적 대상자들을 대상으로 하므로 결국 원활한 대상자등록을 위해서는 효율적인 대상자모집이 필요하다. 따라서 효율적인 대상자모집방법의 모색이 중요하다. 한편 임상시험에 참여하는 대상자는 잠재적인 위험을 감수하고 임상시험에 참여하는 것이므로 임상시험에서 대상자의 안전과 복지가 최우선적으로 고려되어야 하는데, 대상자의 존중, 배려, 보호는 대상자의 참여의 자발성 확보에 기초한다는 점에서 대상자의 진정한 임상시험 참여의사를 왜곡해서는 안 된다. 그런데 최근 새로운 방법으로 대두되는 소셜미디어를 이용한 대상자모집이나 시험대상자모집전문회사를 통한 시험대상자 모집은 잘못된 정보의 확산이나 금전적 보상 등으로 인한 부당한 유인이 되는 방법을 이용한 경우가 상당한 실정이다. 이와 같은 문제점에 대처하기 위해서는 임상시험심사위원회의 심사가 좀 더 정밀하고 엄격하게 이루어져야 할 필요가 있고, 시험대상자모집전문회사 인증제나 종사자에 대한 의무적인 교육이 있어야 할 것이다. A clinical trial is a necessary procedure to prevent, treat, and improve a person"s disease. However, due to circumstances such as the need to meet specific conditions or the rareness of target disease itself, there are cases in which the registration of clinical trial subjects takes a lot of time and money unexpectedly. The difficulty of enrolling subjects is considered as one of the reasons to stop the clinical trial or increase its cost. Subject registration is targeted at potential subjects who have revealed their willingness to participate in clinical trials through potential target recruitment, and in the end, efficient subject recruitment is necessary for smooth subject registration. Therefore, it is important to find an efficient method of recruiting subjects. On the other hand, the subjects participating in the clinical trial take potential risks, so the safety and welfare of the subjects should be considered as the top priority in the clinical trial. In the sense that it is based on, the subject’s intention to participate in the clinical trial should not be distorted. However, recruitment of subjects through social media, which is emerging as a new method, or recruitment of subjects through specialized subject recruiting companies may be misused. In many cases, wrong methods are used, which are emphasizing financial rewards or spreading misinformation. In order to cope with these problems, the review by the Institutional Review Board needs to be carried out more precisely and rigorously. And there must be mandatory training for the workers of the companies or certification system for the recruitment company.

임상시험 대상자의 건강상 피해에 대한 배상 및 보상에 관한 소고

박태신 홍익대학교 법학연구소 2023 홍익법학 Vol.24 No.3

임상시험 대상자 보호제도로서 매우 중요한 의미를 갖는 대상자가 입은 피해에 대한 보상⋅배상제도가 제대로 기능하기 위해서는 제도의 내용상, 체계상 모순이 없어야 할 것인데, 현행 제도는 다음과 같은 몇 가지 점에서 개선이 필요하다. 먼저 현행법령은 의약품 임상시험의 경우에만 보험가입의무를 규정하고 있는데, 그 외 의료기기나 의료행위와 관련된 임상시험의 경우에도 보험가입의무를 규정할 필요가 있다. 또한 가입보험의 적정성을 심사할 전문인력의 양성이나 위원회 설치를 규정할 필요가 있다. 다음으로 배상절차와 보상절차의 균형 문제와 관련하여 보상절차 뿐만 아니라 배상절차에 관해서도 대상자에게 정보를 제공할 필요가 있고, 배상절차의 경우에도 보상절차와 같이 간이한 피해구제절차를 마련할 필요가 있다. 다른 한편으로는 대상자의 보상청구권의 근거를 명확히 하여 다툼의 소지를 제거할 필요가 있고, 「임상시험 피해자 보상에 대한 규약 및 절차 마련을 위한 가이드라인」 중 규정의 불명확성으로 인해 대상자에게 불리하게 해석될 소지가 있는 부분은 명확하게 정리할 필요가 있다. 또한 임상시험에서 의뢰자나 시험자 등에 비해 상대적으로 대상자의 열세적인 위치에 있는 대상자 보호를 위해 객관적이고 중립적인 조사 및 감정기구, 보상・배상심의위원회의 설치와 인과관계 추정제도를 도입할 필요가 있다. The system of compensation or indemnification for health damage or harm of clinical trial subjects has a very important meaning as a protection system for subjects in clinical trials. Therefore, in order for the compensation/ indemnification system to function properly as a protection system for the target person, there should be no contradiction, so the current system need to be improved in some ways. First of all, the current law stipulates the insurance subscription obligation only in the case of drug clinical trials, but it is necessary to regulate the insurance subscription obligation in the case of other clinical trials related to medical devices or medical practices. In addition, it is necessary to regulate the training of experts or the establishment of a committee to review the adequacy of subscription insurance. Next, it is necessary to provide information to the clinical trial subject regarding not only the compensation procedure but also the indemnification procedure, and in the case of the indemnification procedure, it is necessary to prepare a simple procedure like the compensation procedure. On the other hand, it is necessary to clarify the basis of the subject's right to claim compensation to eliminate the potential for dispute. And it is necessary to clearly organize the parts that may be interpreted unfavorably to the subject due to unclear regulations in the 「Guidelines for Establishing Regulations and Procedures for Compensation for Victims of Clinical Trials」. In addition, it is necessary to establish an objective and neutral investigation and appraisal body, a compensation/indemnification review committee, and introduce a causal relationship presumption system to protect subjects who are in a relatively inferior position compared to sponsors or investigators in clinical trials.

국민참여재판의 개시요건에 대한 비판적 고찰

김봉수(Kim, Bong-Su) 한국형사정책학회 2011 刑事政策 Vol.23 No.1

Our criminal justice system introduced a new system that is called "The Judicial Citizens' Participation Trial" in 2008. The citizens' participation trial as new trial is testing now. That test operation period is over in 2012 and one year later, we had to decide whether to abolish this new trial system after reviewing test results for five years. However The prospects for this participation trial system are not bright. Because the judicial citizens' participation trial come face to face with a crisis right now. Especially, more than all, it is a typical example of this crisis that the implementation rate of participation trial is very low. The cause of this crisis is as in the following. 1. low rates of application 2. high rates of withdrawal 3. high rates of exclusion Therefore, one year later, to prevent from being abolished this new trial system, we need to come up with measures to vitalize the Judicial Citizens' Participation Trial. In line with this thinking, something to notice here is the opening requirements of the Judicial Citizens' Participation Trial. Under current law, to initiate criminal proceedings as the Judicial Citizens' Participation Trial, the following requirements must be satisfied. 1. the case should be belong to the subject range of application in Article 5 2. the accused should submit an application including expressions that he want to receive the Judicial Citizens' Participation Trial 3. the exclusion reasons provided in Article 9 should be no From among these opening requirements, the second requirement is largely responsible for critical situations that the implementation rate of participation trial is very low. Thus, to overcome this kind of situation, we need to (1) scale down the subject range of application of Article 3 under current law, (2) carry out the obligatory citizens' participation trial within the demagnified range of application. In short, something needed to vitalize the Judicial Citizens' Participation Trial is the selection and concentration through the reduction of application case and the compulsory opening of the citizens' participation trial than an increase in quantity by the expansion of application case.