신약승인체계에 대한 미연방 식품의약품청의 규제

박수헌(Park Soo-Hun) 한국토지공법학회 2008 土地公法硏究 Vol.40 No.-

Before a new therapeutic drug can be commercialized in the United States, it must meet the safety and effectiveness requirements of the Food and Drug Administration(FDA). Therefore, it is virtually impossible to put a new drug on the market without FDA"s review and approval. In consequence, FDA is routinely blamed for delays in the availability of useful new drugs, and is sometimes charged with preventing access altogether. The expense of the studies FDA requires before granting approval coupled with the substantial time spent conducting these studies and waiting for agency approval is among the common explanations for the cost of new drugs. Thus, the current statutory criteria and administrative procedures for approval of drugs, which have been the causes of increasing health care costs and delays of using new drugs, have become target for would-be reformers. The FDA"s regulation on drugs started with the Federal Food and Drugs Act of 1906. Now, the Federal Food, Drug and Cosmetic Act(FD&C Act) plays a role in the regulation of drugs as a general statute after suffering numbers of amendments. In this article, I accept the reformers" hypothesis that legal structure has a critical bearing on the rate of new product introduction, and on the cost of those products that are introduced. According to this acceptance, I recount the evolution of these standards and procedures and, in the process, seeks to identify the activities of Congress and FDA that have influenced this evolution. In doing so, especially, I focus on the efforts of Congress and FDA that have attempted to improve the contents and problems of new drug approval in 1962 Amendment. As a consequence, I reveal that Congress has amended FD&C Act all the time in order to meet the safety and effectiveness requirements for pre-marketing and post-marketing new drugs. On top of that, FDA"s effort to improve the approval procedures more efficiently would be suggested.

특허권 존속기간 연장등록 대상이 되는 발명 - 구 특허법 시행령 제7조 제1호 ‘신물질’의 의미

이진희 사법발전재단 2022 사법 Vol.1 No.62

특허발명 중에는 다른 법령에 정한 허가 등의 절차를 거쳐야만 비로소 그 발명을 실시할 수 있는 유형이 있다. 그 대표적인 예가 의약품에 관한 특허발명이다. 의약품에 관한 특허발명의 경우 약사법에 따른 의약품 품목허가에 소요되는 기간 동안 이를 실시할 수 없기 때문에 특허권자가 특허발명을 독점적으로 실시할 수 있는 기간이 다른 유형의 발명에 비해 사실상 단축되는 결과가 발생할 수 있다. 특허권 존속기간 연장제도는 이러한 불이익을 구제하기 위한 제도이다. 특허법 시행령은 의약품과 관련한 특허권 존속기간 연장등록 대상 발명을 특허발명을 실시하기 위해 신물질을 유효성분으로 하여 최초로 품목허가를 받은 의약품의 발명이라고 규정한다. 또한 약효를 나타내는 활성부분의 화학구조가 새로운 물질을 신물질이라고 지칭한다. 위와 같은 규정 형식에 의할 때 특허권 존속기간 연장등록 대상 발명의 범위를 확정함에 있어서는 신물질에 해당하는지가 핵심 쟁점이 된다. 그런데 특허법령에는 신물질의 의미가 명확하게 정의되어 있지 않고, 그에 따라 실무상 특허권 존속기간 연장등록 대상 발명의 범위를 둘러싸고 다양한 해석이 이루어지고 있다. 이 논문에서는 신물질이 의미하는 바를 어떻게 이해하는 것이 타당한지를 특허법령의 규정 형식에 기초하여 검토하였다. 먼저 특허법 시행령과 약사법의 규정 형식을 대비할 때 특허법 시행령의 신물질과 약사법의 신약은 서로 구분되는 개념으로 이해된다. 또한 신물질 해당 여부는 물질의 화학구조를 대비하는 것에 의해 판단되어야 한다. 신물질에 해당하기 위하여 기존의 허가 의약품과 상이한 치료효과를 가져야 한다거나 약효의 개선이 있어야 한다는 것과 같은 추가적인 요건은 필요하지 않다. 신물질을 규정짓는 요소 중의 하나로서 약효는 그 통상적인 의미에 따라 의약품의 약리작용에 따른 효과를 의미한다. 여기에는 정성적인 효과뿐만 아니라 정량적인 효과도 모두 포함된다. 신물질을 규정짓는 요소로서 활성부분은 유효성분에 관한 약사법의 규정 형식 및 활성성분과 활성부분의 관계에 관한 미국 FDCA 시행규칙 등을 참고할 때, 내재된 약리작용에 의하여 그 의약품이 나타내는 효능·효과의 직접 또는 간접적인 원인이 되는 부분으로 해석된다. 결국 신물질은 내재된 약리작용에 의하여 그 의약품이 나타내는 효능·효과의 직접 또는 간접적인 원인이 되는 부분의 화학구조가 새로운 물질이라고 정의될 수 있다. 다만 현재의 해석상 논란이 입법의 불완전성에서 비롯되었다는 점을 고려한다면, 이 문제의 궁극적인 해결책은 특허법령에 사용된 용어의 정의 규정을 도입하는 방법 등을 통해 특허권 존속기간 연장등록 대상 발명의 범위를 보다 명확하게 정하는 것이라고 생각된다. For some inventions, getting a patent is only half of the game. They demand more attention from the applicant before they are ready for exploitation, e.g. going through approval process under the laws other than the Patent Act. A typical example is a patented invention related to a pharmaceutical drug. In such cases, the invention must await drug approval under the Pharmaceutical Affairs Act before it can be practiced and the patentee often ends up with a shorter period of time to enjoy the patent monopoly in effect when compared to other types of inventions. The patent term extension regime is designed to address such disadvantages. The Enforcement Decree of the Patent Act stipulates that an invention eligible for a patent term extension is an invention of a drug approved for the first time with a new substance as an active ingredient to practice the invention. A “new substance” is defined as a substance whose chemical structure of the active moiety that exhibits the drug effect is new. The languages of the laws and regulations are designed in a way that put the definition at the center when determining which inventions are eligible for patent term extension. However, it would not be an overstatement to say that the meaning of the term “new substance” is far from clear under the current scheme of applicable laws, as various interpretations were crafted surrounding the scope of eligible inventions. This article examines the proper meaning of a new substance under the current scheme of applicable laws. Comparing how the languages of the Enforcement Decree of the Patent Act and the Pharmaceutical Affairs Act are designed leads to the conclusion that the term “new substance” in the Enforcement Decree of the Patent Act and the term “new drugs” in the Pharmaceutical Affairs Act are two distinct concepts. Whether a substance is a new substance should be judged by examining the chemical structure of the substance. In order to qualify as a new substance, there is no need for additional requirements, such as that it has to have a different therapeutic effect from that of a previously approved drug or that it should have an improved effect. Effect, as a defining factor of a new substance, has the usual meaning of the result generated by the pharmacological action of the drug product, qualitative or quantitative. Active moiety, which determines whether a substance falls within the above definition of a new substance, is interpreted as the part directly or indirectly generating the efficacy and effect of the pharmaceutical drug by its intrinsic pharmacological action, according to the relevant language of the Pharmaceutical Affairs Act on active ingredients and Title 21 of U.S. Code of Federal Regulations (Food and Drugs) on the relationship between active ingredient and active moiety. Putting them altogether, a new substance can be defined as a substance whose chemical structure, directly or indirectly causing the efficacy and effect of the drug by its intrinsic pharmacological action, is new. As such, close examination of the statutory and regulatory languages yields some clues to understand the meaning of the term. However, given that the live controversy over interpretation of the term arises from the gap in legislation, the ultimate solution would be statutory amendment, namely by introducing a provision defining the term to the Patent Act to more clearly define which inventions are eligible for patent term extension.

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.

신약도입에 따른 약품비 증가요인 분석

권혜영 ( Hye Young Kwon ),양봉민 ( Bong Min Yang ) 한국보건경제정책학회(구 한국보건경제학회) 2011 보건경제와 정책연구 Vol.17 No.2

신의료기술의 발전은 질환의 치료기회를 새로이 제공하는 등 국민건강을 보호하고 환자의 삶의 질을 개선하는 등 긍정적 영향을 미치는 것으로 알려져 있다. 그러나 신의료기술의 고비용은 건강보험의 지속가능성에 대한 문제를 제기하기도 한다. 신약의 도입은 약품비의 증가에 기여하고 있으며 그 효과를 계량적으로 측정하여 신약이 약품비에 얼마만큼 기여하는지를 평가할 필요가 있다. 본 연구에서는 4개의 약효군을 통해 신약이 약품비 증가에 미친 영향을 살펴보았다. 먼저, 약품비를 가격, 수량, 처방약구성(drug mix)으로 분해한 결과, 가격은 감소되고, 수량은 증가하며 대체효과(drug mix로 측정)가 증가하면서 신약으로 대체되는 경향을 보였다. 단, 과민성방광증상 치료군에서는 가격이 증가하고 대체효과는 오히려 감소하는 결과를 보였다. 더불어 신약으로 인한 대체효과(drug mix)와 수량증가(치료 확장)를 세부적으로 분석하기 위해 상대적 지표(K)를 만들어 살펴보았다. 신약을 제외한 기존 등재약품의 약품비는 가격과 수량이 모두 증가하였으나, 신약을 포함한 전체 약품비의 변화는 기존 약품비에 비해 상대적으로 더 크게 나타나 신약도입에 따른 대체효과(drug mix)와 치료 확장을 확인할 수 있었다. 신약도입의 효과가 거의 없었던 편두통치료군의 경우 예상대로 신약의 효과는 거의 없었다. 반면, 신약도입이 가장 활발한 과민성방광증상치료군은 저가신약의 적극적인 진입으로 drug mix는 오히려 감소한 것으로 나타났다. 이는 비교적 낮은 가격의 신약이 고가의 기존 약을 대체한 것에 기인한다. 하지만 감소한 비용부담에 의해 수량지표가 크게 증가한 점이 주목할 만하다. Rapidly increasing pharmaceutical expenditure has been continuously challenging the sustainability of health insurance system. A major concern is the role of newly introduced drugs into the reimbursement list. What is the impact of those drugs on drug expenditures in Korea? This study aims to investigate their impact on the growth of drug expenditures by looking at the substitutability of the new expensive drugs for lower priced existing drugs. We termed such a substitutability as ``drug mix``. Using NHI claims data of four therapeutic classes (TC); Hepatitis, Diabetes, Overactive bladder(OAB), Migraine, pharmaceutical spendings of 2009 were compared with those of 2006. Each TC is characterized by different levels of new drug adoption. Growth of drug expenditures was decomposed into three parts; price effect, quantity effect and drug mix effect. The results are the followings. Impact of new drugs on the growth of drug expenditures for each TC between 2006 and 2009 ranges 0%~32%. Since new drugs were rarely introduced into TC of Migraine, its impact was negligible. Drug mix effect of newly introduced drugs in all TCs was positive, except OAB. Positive drug mix implies that lower cost existing drugs had been substituted for higher cost new drugs during the period under study. The quantity effect was positive for all TCs with increasing rate of 1%~52%. This positive quantity effect implies that the demand induced by new drugs was greater than that of the incumbent drugs. An exception to the above results is TC of OAB, with the negative drug mix effect, however with the positive quantity effect. In this case, the quantity of consumption grew. But with the introduction of lower priced new products coupled with the substitution of new products for the existing drugs, drug mix effect of new drugs was contributed to the savings of drug expenditure for OAB during the two periods, 2006 and 2009. This study is unique in its use of drug mix effect in estimating the impact of newly introduced drugs on drug expenditure. Through it, we could observe how old drugs are substituted for newly introduced drugs, and see its effect on the growth of drug expenditure. The methodology is unique and the results are rather informative for both researchers and policy makers.

신종마약류 범죄의 특징에 따른 제도적 대응방안 연구

염건웅 한국법학회 2019 법학연구 Vol.76 No.-

In order to study the institutional countermeasures according to the characteristics of new drug crimes, this study identifies the characteristics and status of traditional drug types and new drug types and compares the current status of overseas responses such as the United States, EU, and U.K. and domestic responses. The emergence of the dark Web, social networking services, bitcoin and new drugs has led to Korea being removed from its status as a drug purveyor at a time when the age range of first-time drug users is decreasing to those in their teens and 20s, and ordinary-looking people such as office workers and students become drug-related criminals. To cope with these new drugs, therefore, transnational institutions with a unified one-stop system, such as the U.S. Presidential Committee on Drug Control (PCCN) and the National Organization for Drug Control (ONDCP), should be introduced in the country to help integrate the current system of crackdowns divided into police, prosecution, maritime police and customs offices. In addition, the government should analyze the characteristics of new drug crimes to refine the criteria for punishment for temporary drugs and seek legislative measures to punish the inhalation of unspecified hallucinogenic substances. Drug crimes have the characteristic that they cannot distinguish between perpetrators and victims. This means that drug dealers can make financial gains and buyers can experience pleasure with drugs, so there is nothing to lose from each other. Because of the nature of these drug crimes, such close-knit trading relationships will inevitably last unless they are caught in the investigative network. In particular, since narcotics are addictive drugs, even if they are subject to legal punishment, they often fall back into narcotics after returning to society. In the end, the launch of a one-stop integration agency that can manage the entire drug supply is seen as essential, given that rehabilitation and ongoing management of drug crimes is crucial. 본 연구는 신종마약류 범죄의 특징에 따른 제도적 대응방안을 연구하기 위해 전통적인 마약류의 종류와 신종마약류의 특징과 현황을 파악하고 미국, EU, 영국 등 해외의 대응 현황과 국내의 대응 현황을 비교한다. 마약류을 처음 접하는 연령대가 10대~20대로 낮아지고 있고 사무직과 학생 등 평범해 보이는 사람이 마약류 관련사범이 되는 현실에서 다크웹과 SNS, 비트코인과 신종마약류의 등장은, 결국 한국을 마약청정국 지위에서 내려오게 만들었다. 따라서 이러한 신종마약류에 대처하기 위해서는 미국의 마약퇴치대통령위원회(PCCN)와 국가마약통제정책기구(ONDCP)와 같은 일원화된 원스톱(One-Stop)시스템을 갖춘 초국가적 기관을 국내에도 도입하여 현재 경찰, 검찰, 해양경찰청, 관세청 등으로 나누어져 있는 단속 기관의 시스템을 통합할 수 있는 계기를 마련해야 한다. 또한 신종마약류 범죄의 특성을 분석하여 임시마약류에 대한 처벌기준을 세분화하고 지정되지 않은 환각물질의 흡입 등에 대해서도 처벌할 수 있는 입법방안을 모색해야 한다. 마약류 범죄는 가해자와 피해자를 구분할 수 없다는 특성이 있다. 마약류 판매자는 금전적 이득을 취할 수 있고 구매자는 약물로 쾌락을 경험할 수 있으니 서로에게 손해 볼 것이 없다는 의미이다. 이런 마약류 범죄의 특성 때문에 수사망에 걸리지 않는 한 이와 같은 친밀한 거래 관계는 지속될 수밖에 없다. 특히 마약류는 중독성 약물이기 때문에 법적 처벌을 받는다 해도 사회로 복귀한 이후 다시 마약류에 빠지는 경우가 많다. 결국 마약사범에 대해 치료재활과 지속적인 관리가 중요하게 요구된다는 점에서 마약류 전반을 관리할 수 있는 원스톱 통합기관의 출범은 반드시 필요하다고 보여지는 대목이다.

Policy Response to the CRISIS of New Drugs Crime

Gunwoong Yeom J-INSTITUTE 2021 International Journal of Crisis & Safety Vol.6 No.4

Purpose: Drugs made for medical purposes could have been a mysterious potion if they were used only for their original purpose, but the reason why many people are concerned about the safety of mankind due to the enormous destructive power of drugs. It may be close to instinct for people to avoid pain and discomfort, chase joy, and pleasure, but if they borrow the power of drugs for this pleasure, the price will return to tremendous harm like boomerang. Research policy countermeasures against new drugs crime in Korea. Method: Traditional drugs are usually classified into natural drugs, synthetic drugs, and psychotropic drugs. Through the classification and definition of drugs, the characteristics of new drugs are identified and the current status of distribution of new drugs is analyzed. Policy countermeasures are derived through foreign cases. By analyzing the characteristics of crimes against new drugs, the government will subdivide punishment standards for temporary drugs and study ways to prepare bills to quickly punish the inhalation of unspecified hallucinogenic substances. Results: In order to cope with new drugs at this point, the priority introduction of a unified one-stop system through transnational institutions is required. Through this, it is necessary to establish a system that can focus on responding to crimes related to new drugs by integrating the system of crackdown agencies that are currently sporadically divided, such as the police, prosecutors, the Korea Maritime Police Agency, and the Korea Customs Service. In addition, continuous management is needed through linkage with treatment and rehabilitation facilities. Conclusion: Laws should be prepared to analyze the characteristics of crimes against new drugs to subdivide punishment standards for temporary drugs and to promptly punish the inhalation of unspecified hallucinogenic substances. In addition, crackdown and punishment on drug offenders are important, but it should not be forgotten that continuous management through connection with treatment and rehabilitation facilities is necessary to fundamentally prevent recidivism of drug offenders.

진입 신약의 유형이 질환별 의약품 상한금액 및 의료이용에 미치는 영향

황소정 ( So-jung Hwang ),이태진 ( Tae-jin Lee ) 한국보건경제정책학회 2021 보건경제와 정책연구 Vol.27 No.4

신의료기술의 진입이 보건의료분야가 직면하는 중요한 현상 중 하나로 주목받고 신약의 진입에 대해 긍정적인 평가와 부정적인 평가가 모두 제기되는 현 시점에서 새롭게 보험급여 적용되는 신약의 유형에 따른 보건의료적 영향을 고찰해볼 필요가 있다. 본 연구에서는 질환별로 신약 진입의 영향을 분석하기 위해 2011년 이후 약제급여목록에 진입한 신약을 혁신성의 유형에 따라 임상적 유용성 개선된 계열최초성분, 임상적 유용성 개선 없는 계열최초성분, 임상적 유용성 개선된 계열후속성분, 임상적 유용성 개선 없는 계열후속성분으로 구분하고, 필수성의 유형에 따라 필수약제, 비필수약제로 구분하여 2011년 이후 신약이 진입한 질환 별로 혁신성 유형 및 필수성 여부에 따른 선발약제 상한금액 인하율, 1인당 요양급여비용, 1인당 내원일수에 미치는 영향을 분석하였다. 연구결과, 혁신적 약제 중 임상적 유용성 개선된 계열최초 성분 진입 시 1인당 요양급여비용 13.2%의 증가와 임상적 유용성 개선된 계열후속성분 진입시 선발약제 상한금액 1.29%의 인하, 1인당 요양급여비용 20.3%의 감소 및 1인당 내원일수 6.94%의 감소를 보였다. 또한, 필수 약제 진입 시 선발약제 상한금액 3.04%의 인하, 1인당 요양급여비용 18.5%의 감소 및 1인당 내원일수 6.94%의 감소를 보였다. 본 연구의 분석 결과는 의약품의 혁신성 유형 및 필수성 여부에 따라 약품비, 요양급여비용 및 내원일수에 미치는 영향이 상이할 수 있음을 함의하며, 약품비를 증가시키지 않고 의료이용에 긍정적인 영향을 주는 유형의 신약의 진입이 있을 수 있음을 시사한다. As the entry of new medical technology is noted as one of the important phenomena in the healthcare sector, the impact of new drugs on healthcare sector needs to be assessed according to their types. In this study, in order to analyze the impact of entry of new drugs by disease, new drugs that have entered the list of the reimbursed drugs since 2011 are classified by their types of innovation: first-in-class ingredient with improved clinical benefit, first-in-class ingredient without improved clinical benefit, later-in-class ingredient with improved clinical benefit and later-in-class ingredient without improved clinical benefit and by necessity; essential drugs and non-essential drugs. And we performed analysis to evaluate the effect of new drugs entry on the frontier drug's list price, per capita health expenditures and per capita days of outpatient visits or hospitalization. The result indicates that entry of the first-in-class ingredient with improved clinical benefit causes per capita health expenditures to increase by 13.2% while entry of the later-in-class ingredient with improved clinical benefit reduces the frontier drug's list price by 1.29%, per capita health expenditures by 20.3%, and per capita days of outpatient visits or hospitalizations by 6.94%. And the result also indicates that entry of the essential drug reduces the frontier drug's list price by 3.04%, per capita health expenditures by 18.5% and per capita days of outpatient visits or hospitalization by 6.94%. The finding of this study implies that the effect on the drug list price, health expenditures and number of days of outpatient visits or hospitalization could be different depending on the new drug's type of innovation and necessity. This suggests that we could identify the types of new drugs that wouldn't increase pharmaceutical costs and have a positive effect on healthcare sector.

청소년의 신종마약류중독 실태 및 대응방안 연구

이무송 한국중독범죄학회 2022 한국중독범죄학회보 Vol.12 No.2

This study presents effective preventive measures through analysis of the actual condition of adolescents' new drug addiction. Compared to a decade ago, Korea's status and status of the Drug Administration is falling sharply, and official statistics and surveys prove that demand for new drugs among teenagers is increasing along with the increase in drug offenders. As a result of the study, psychological, personal, social, and cultural and environmental causes such as stress, curiosity, entrance examination, and employment were combined to obtain the characteristics of access to drugs, and the number of adolescents approaching new drugs for stronger and cheaper reasons was also derived. Therefore, this study aimed to examine the relationship between the increase in juvenile crimes caused by new drug addiction and the problems of the government's response method and to present efficient measures for prevention.As a prevention and response plan, first, a plan to overhaul the youth drug control system. Second, the establishment of strict penalties for suppliers of new drugs. Third, strengthening monitoring and monitoring of new distribution channels. Fourth, strengthening the treatment of juvenile drug offenders. Fifth, strengthening prevention education for youth new drug addiction was suggested. Finally, the institutional mechanism that can effectively and intensively operate the proposed measures and the interest of our society should be premised. 이 연구는 청소년의 신종마약류중독 실태분석을 통하여 효과적인 예방대책을 제시하는 것 이다. 우리나라는 10년 전과 비교하여 마약청정국의 지위와 위상이 급격하게 추락하고 있으 며 공식적인 통계자료와 조사결과 마약사범의 증가와 더불어 청소년들 사이에 신종마약류의 수요가 증가하는 것으로 이를 증명하고 있다. 연구의 결과, 청소년들은 스트레스, 호기심, 입 시, 취업 등 심리적, 개인적 원인과 사회·문화 환경적 원인이 복합적으로 작용하여 마약류 에 접근하는 특성이 도출되었으며 신종마약류가 보다 강력하고 저렴한 이유로 접근하게 되는 청소년들이 증가하고 있는 특성도 도출되었다. 따라서 이 연구는 신종마약류중독에 따른 청 소년범죄의 증가의 관계와 정부의 대응방법상의 문제점을 살펴보고 예방대책에 관한 효율적 인 방안을 제시하는데 궁극적인 목표로 두었다. 이에 대한 예방 및 대응방안으로 첫째, 청소년 신종마약류 단속 시스템 정비하는 방안. 둘 째, 신종마약류 공급자에 대한 엄격한 처벌의 확립. 셋째, 신규 유통경로에 대한 모니터링 및 감시 강화. 넷째, 청소년 마약사범 처우강화. 다섯째, 청소년 신종마약중독의 예방교육 강화 등을 제시하였다. 마지막으로 이와 같이 제시한 방안들을 효과적이고 집중적으로 운영할 수 있는 제도적 장치와 우리사회의 관심이 전제되어야 한다.

한약ㆍ생약제제 품목허가신고심사 규정 변화에 관한 고찰

엄석기(Seok Ki Eom) 한국의사학회 2014 한국의사학회지 Vol.27 No.2

Objectives : The purpose of this study was to analyze and identify the problems of the changes in regulations that are relevant to approval, notification, and review of herbal medicinal preparations and crude drug preparations. Methods : I collected the regulations of approval, notification, and review of medicinal products mostly from official gazettes, analyzed enactment and amendments regarding herbal medicinal preparations and crude drug preparations, and studied it from the view point of Korean medicine field. Results : Regulations in regards to approval, notification, and review of herbal medicinal preparations and crude drug preparations were first established in 1978. Herbal drugs started to be categorized as crude drug preparations in 1981 and the regulatory outlines were completed in 1999. From 2008 to 2012, the regulatory standards that let crude drug preparations be new drugs from natural products were established. Through those procedures, the followings became crude drug preparations: 1) wholly new prescriptions that are not recorded in Korean Medical Classics, 2) prescriptions that are recorded in Korean Medical classics but prepared with new standard, composition and efficacy, 3) prescriptions that are recorded in Korean Medical classics but prepared with new formulation, and 4) herbal drugs. In case of herbal medicinal preparations, however, only regulations that are related to 1) drugs prepared with new compositions that are not recorded in Korean Medical Classics, 2) drugs with same prescription and same formulation, and 3) drugs with new formulation were arranged. Conclusions : Actual circumstances on crude drug-oriented regulations regarding approval, notification and review and future forms of prescription and drug administration in Korean Medical Institutions can be expected due to expansion in range of herbal medicinal preparations and shrink in that of on-site preparations. Reasonable improvement in efficient usage of modernized herbal medicinal preparations in Korean medical institutions and prospective cooperation from related pharmaceutical industry are needed.

신약 채택에 영향을 미치는 요인에 관한 연구:개원의들의 커뮤니케이션 채널에 대한 인식을 중심으로

이현석,김현주,Hyun Seok Lee,Hyun Joo Kim 한국헬스커뮤니케이션학회 2011 헬스커뮤니케이션연구 Vol.5 No.-

The purpose of this study is to examine the process by which medical information is diffused among doctors. The focus was given on the process of drug prescription for chronic disease, i.e. cardio-vascular disease(including hypertension, angina), hyper-lipidemia and endocrine disease (including diabetes mellitus). Based upon the review of diffusion literature in the field of medical studies, following research questions were formulated. Data were collected from 1,080 local clinicians of internal medicine, regardless of medical board categorization. Q1. What are the relative importance of drug related factors? Q2. What are the relative imporatnce of communication channels? Q3. How do drug related factors influence the prescription of new drugs? Q4. How do communication channels influence the prescription of new drugs? Results showed that for physicians in general, drug effect is the most important factor, followed by the possibility of adverse effect. Among various communication channels, medical journals and textbooks, seminars held by academic organizations and general hospitals were particularly important. Reliance on internet sites is comparatively low. Communication channels were more important than drug factors for the prescription of drugs. Prescription of new drugs is determined by price and the patients' opinion rather than drug efficiency and its possible adverse effects. This study also showed that the prescription of new drugs is mainly promoted by interpersonal channels (i.e., pharmacy salesman, seminars held by general hospitals, and meeting with other physicians). While medical experience generates positive influence, medical sites on internet, medical journals, textbooks, medical newspapers elicit negative influence. It can be argued that interpersonal channels largely convey drug mechanism whereas internet and printed media may lack specific clinical documentations or data for the new drugs of interest. 국민소득 증가와 인구 고령화에 따라 건강 에 대한 관심이 증대하고 있다. 양질의 진료란 의사가 환자와 충분한 대화를 통하여 많은 정보를 얻어낸 후 최신 의학 지식을 바탕으로 정확한 진단을 내리고 적절한 치료법을 선택하도록 도와주는 것이 핵심 이다. 이를 위해서는 다양한 분야의 커뮤니케이션 능력이 필요하다. 최신 지식을 얻 기 위한 의사들간의 커뮤니케이션, 질병 퇴치라는 공동의 목표를 향해 의사와 환자가 동반자 관계를 맺도록 하는 의사-환자 커뮤니케이션, 의료 행위에 참여하는 다양한 직역(의사, 간호사, 의료 기사 , 약사 등)들간의 커뮤니케이션, 의료계와 보건 당국 사이의 커뮤니케이션, 그리고 일반인을 대상으로 하는 건강 캠페인 등이 모두 의료 커뮤니케이션 영역에 해당한다. 이중에서 상대적으로 연구가 많이 이루어진 의사-환 자 커뮤니케이션과는 달리 의사들이 평소 어떤 커뮤니케이션 채널을 선호하고, 커뮤 니케이션 채널을 통하여 전달되는 의학 정보의 어떤 부분을 중요하게 여기는지에 대한 연구는 미흡했다. 따라서 본 연구는 신약에 대한 정보를 습득하는 과정을 중심으로 연구를 진행하였다. 구체적으로 신약 확산 과정에서 약품 요인과 커뮤니케이션 채널 요인이 신약 처방률에 미치는 영향을 알아 보았다. 연구를 위한 자료는 전국의 개원의 1,080명을 대상으로 실시한 설문조사를 통하여 수집하였다. 연구 결과 , 의사들은 약품 요인을 평가할 때 일반적으로 약효의 우수성을 가장 중요하게 생각했지만 기존 약품 대체성도 함께 고려하였다. 개원의들은 학술 저널 및 전문서적과 학회 혹은 대학병원 주최 세미나, 동료 의사들을 중요한 커뮤니케이션 채널로 인식하였으나 인터넷은 상대적으로 중요도가 낮았다. 신약 처방에 있어서 약품 요인보다 커뮤니케 이션 채널의 중요도 인식이 더 큰 영향을 미쳤다. 또한 신약을 처방할 때 대인 채널 에 속하는 제약 회사 영업사원, 대학병원 주관 세미나, 다른 의사들의 사용 경험은 정적인 영향이 있었으나 미디어 채널에 속하는 의료 관련 인터넷 사이트, 학술저널 및 전문서적, 의사 대상 정기간행물은 오히려 부적인 영향이 있었다. 이것은 대인 채널의 경우 약품의 작용기전(機轉, mechanism)에 관한 정보를 주로 다루지만 연구 자료를 중점적으로 싣는 인터넷과 인쇄매체는 신약에 대한 정보량이 상대적으로 적 기 때문인 것으로 해석된다. 본 연구 결과는 약품 정보를 공급하는 주체 인 학술지, 의학 전문지, 각종 세미나와 연수 강좌를 주최하는 학회와 대학병원, 세미나를 개최 하는 또 다른 주체인 제약회사, 의사를 상대로 운영하는 의료 관련 인터넷 사이트, 그리고 제약 회사 영업 사원들에게 도움을 줄 것으로 기대한다.