国际传统医药知识权益维权案例与思考

1992年联合国环境与发展大会通过的《生物多样性公约》（以下简称CBD），为发展中国家在国际上维护遗传资源和传统知识权益提供了国际法律依据。自该公约生效后，已有不少发展中国家根据CBD的遗传资源（包括传统知识）国家主权原则、事先知情同意原则和惠益分享原则，成功地维护了其传统知识权益。     

获取与惠益分享制度及其在中药领域的运用

目的:提出获取与惠益分享制度在中药领域运用的设想。方法:分析我国中药领域生物多样性保护存在的问题以及获取与惠益分享制度能够解决的基本问题。结果与结论:将获取与惠益分享制度运用于中药领域的初步设想为成立专门的谈判部门、明晰权利及主体、构建登记制度、设立事先知情同意程序、完善来源披露制度以及增加惠益分享规定。     

世界典型国家生物遗传资源管制的借鉴与启示

［摘要］　随着生物技术越来越成为国家进步的基石，作为生物技术发展基础的生物遗传资源成为各国争夺的目标。在生物遗传资源管制上，各国纷纷根据《生物多样性公约》进行本国立法，力求最大限度地发挥本国生物遗传资源的效益，维护国家利益。现通过对美国在生物遗传资资源管制上的立场以及印度、菲律宾、哥斯达黎加等生物遗传资源丰富国家的立法简介，力争勾勒出生物遗传资源立法的要点，在简要分析我国生物遗传资源管制现状的基础上，呼吁尽快加强我国相关立法。     

论药品专利权与药品获得权的发展与冲突及其对我国的意义

 将药品纳入专利保护范围是知识产权制度的一大发展,极大地刺激了制药产业的发展。但是,对药品实施专利保护在给制药企业带来巨额利润的同时,也严重阻碍了发展中国家获得药品及实现本国公民的健康权。文章从专利法与人权法国际发展的高度,回顾了药品专利权与药品获得权的发展及其冲突历程,并着重对TRIPS协议和《多哈宣言》中专利条款的具体内容、相关背景,以及中国药品专利制度尤其是与TRIPS协议和《多哈宣言》相关的部分进行了研究。中国作为发展中大国,应当与其他发展中国家一道积极参与药品专利权与药品获得权的国际谈判,充分利用TRIPS协议和《多哈宣言》赋予发展中国家的优惠和弹性,来保障本国公民的药品获得权,同时促进本国制药产业的发展。     

浅谈新修订《药品管理法》和相关配套制度对国内制药行业的新要求及新影响

新修订《药品管理法》及相关配套制度在药品注册管理制度、流程、药品的全生命周期质量管理、药品上市许可持有人制度、专利链接制度等方面都做出了重大调整和创新,在全面贯彻落实"四个最严"要求下,提升了我国药品研发的效率,加速了国内药品向国际化拓展的进程,加强了药品知识产权的保障,促进了药品研发和生产资源的流转,为我国制药行业的...     

制度创新与区域品牌建设

7月24日～ 25日,以"制度创新·成长潜力再激发"为主题,由中国药店杂志社与广州健林生物科技有限公司联合主办的中国药店商学院苏州峰会圆满举办. 峰会上,中国药店商学院特别大讲堂由国内知名品牌课讲师郑卫国带来《吃亏是福》经典课程分享,先声再康江苏药业有限公司董事长杨孝华携《顺"市"而为的区域品牌创建》、留英零售学专家刘文烽携《赢在机制:药店阿米巴一一如何把小老板机制下沉到货架》、连锁经营管理咨询专家周旭携《连锁系统创新》,对峰会主题进行了深入解析,并着重围绕药店核心竞争力,从连锁药店制度建设、人力资源创新管理到区域品牌建设等,为来自全国各地的400余名医药界人士奉上了一场精彩的知识盛宴.     

《生物医学工程与临床》征订启事

《生物医学工程与临床》是一本连接临床与生物医学工程的综合性刊物。是中国科技论文统计源期刊(中国科技核心期刊),并已被美国《化学文摘》(Chem Abstract)、俄罗斯《文摘杂志》(AJ of VINITI)、英国《国际农业与生物科学研究中心》(CABI)等国际检索系统收录。本刊宗旨是以生物医学工程和临床的理论与实践相结合,涵盖生物医学工程学及其相关的临床医学各学科,注重生物医学工程学在临床医学中的应用研究和新技术、     

从《药品注册管理办法》修订看药品及其相关知识产权保护制度之变化

比较并阐述了由《药品注册管理办法》的修订而引起的药品及其相关知识产权保护制度的变化。结合法律实践中的典型案例，比较了07版和05版《药品注册管理办法》中有关药品及其相关知识产权制度的不同。07版《药品注册管理办法》的修订，将使药品注册过程中有关知识产权方面的规定更趋合理完善。     

山西省人体器官获取与分配服务中心

<正>山西省人体器官获取与分配服务中心于2018年8月28日正式挂牌成立。经山西省卫生健康委员会批准为非营利性独立法人区疗机构,是山西省唯一合法的人体器官获取组织,简称为"OPO",该中心由山西省卫生健康委员会负责监督管理,并在山西省红十字会的大力支持下,山西率先在全国成立了省级人体器官获取组织即OPO组织,并建立了统一管理、统一协调、统一获取、统一分配、统一救助的良好局面,开创全国先河,为及时挽救更多器官衰竭患者的生命提供了服务和保障。山西省OPO根据国家《人体器官移植条例》和《人体捐献器官获取与分配管理规定》,依法依规在全省范围内开展公民逝世后器官捐献、获取及分配的相关工作,包括人体器官捐献政策     

基于扩展语义网的知识资源组织技术研究

采用知识点的方式组织知识资源,有利于知识的获取、分享、分配和存取.但是传统的树型结构对知识的整体关系描述能力不足,不利于分布式环境下对知识资源的查找和定位.语义网是一种可以详细描述本体间复杂关系并具有天然分布式特性的技术.然而一般的语义网本身不是按照知识点的方式进行组建.本文对语义网进行扩展,使其适用于描述基于知识点组织的知识资源.通过应用案例,按照知识点进行扩展的语义网可以有效地描述知识资源间的相互关系,便于知识的理解和利用,并且对知识的查找和定位也变得更加方便.     

医学研究知情同意过程及信息告知的伦理审查要点

提高伦理委员会审查质量与严格执行知情同意是保障受试者权益的主要措施。伦理委员会应依据国际、国内公认的法规,把握充分告知、特殊告知及获取知情同意过程等审查要点,对知情同意的过程及知情同意书告知信息进行审查,达到维护受试者权益和安全的目的。     

Human rights and ethics in genomic research: rethinking the model

Current approaches to the ethical governance of human genetic sample collections for genomic research focus on the protection of sample donors' rights and interests. This reflects three historical influences upon genetic research: uses of genetic information to oppress individuals and communities, the history of regulation of medical research in general and ongoing debates regarding donors' interests in commercial applications of genetic research. Recent international statements and policy-making have applied human rights ideas to generate frameworks for the regulation of genomic research. This article explores the limits of such an approach, recommending a move away from a protection-oriented model of research ethics in genomics towards a development-oriented model. It is suggested that this would retain a human rights focus, but direct it in a more constructive, less risk-averse way.     

Emerging policy contradictions between the United Nations drug control system and the core values of the United Nations

This paper argues that the image of the UN as a benevolent organization is a crucial factor in the functioning of the global drug prohibition regime. It contends, however, that from certain normative perspectives, particularly that of harm reduction, it is possible to identify the emergence of policy contradictions between what can be broadly defined as the United Nations drug control system and the core values of the UN as laid out in the Charter and other key instruments from which the UN derives its image of benevolence. Four interrelated areas of perceived conflict are discussed: sovereignty and jurisdiction; human rights; the promotion of solutions to international economic, social, health and related problems; and the maintenance of international peace and security. It is suggested that such a situation may undermine a key mechanism for regime adherence. The paper concludes by offering some options that may exploit systemic contradictions and assist in instigating incremental change to the regime.     

美国药物治疗管理服务的计费模式

药学服务收费不仅维护了药师的合法权益,也激励药师为患者提供高质量药学服务。我国药物治疗管理(MTM)服务尚处于起步阶段,药学服务计费模式还在摸索之中。美国最早开展MTM服务并建立计费模式,还将MTM服务纳入公共医疗保险Medicare的D部分(Medicare Part D)。该文主要介绍美国MTM服务计费框架及对服务提供者的补偿机制,以期为我国开展MTM服务计费提供参考。     

Ethical and human rights imperatives to ensure medication-assisted treatment for opioid dependence in prisons and pre-trial detention

Opioid dependence is a complex medical condition affecting neurocognitive and physical functioning. Forced or abrupt opioid withdrawal may cause profound physical and psychological suffering, including nausea, vomiting, diarrhoea, extreme agitation and/or anxiety. Opioid-dependent individuals are especially vulnerable at the time of arrest or initial detention, when they may, as a result of their chemical dependency, be coerced into providing incriminating testimony, or be driven to engage in risky behaviour (such as sharing needles in detention) in order to avoid painful withdrawal symptoms. Upon incarceration, many opioid-dependent prisoners are forced to undergo abrupt opioid withdrawal (both from legally prescribed agonist therapy such as methadone as well as illicit opioids). Physical and psychological symptoms attendant to withdrawal may impair capacity to make informed legal decisions, and cause prisoners to risk HIV and other blood-borne diseases by sharing injection equipment. Although prisons must provide at least the standard of care to prisoners that is available in the general population, medication-assisted treatment, endorsed by international health and drug agencies as an integral part of HIV prevention and care strategies for opioid-dependent drug users, is unavailable to most prisoners. Medication-assisted treatment is a well-studied and validated pharmacological therapy for the medical condition known as opioid dependence. The failure to ensure prisoner access to this medical therapy threatens fundamental human rights protections against cruel, inhuman or degrading treatment and rights to health and to life. It also poses serious ethical problems for health care providers, violating basic principles of beneficence and non-maleficence (i.e., do good/do no harm). Governments must take immediate action to ensure access to opioid substitution to prisoners to ensure fulfilment of ethical and human rights obligations.     

我国新药临床试验招募广告管理现状与策略探讨

2002年,全球生物制药企业临床研究花费共计约100亿美元,其中超过40亿元是支付给研究者开展临床试验所用。在过去10年左右的时间中,美国研发一个新药的平均费用已经从2．3亿美元增加到超过84g美元,而且从临床前试验到最后被FDA批准通过一般需要10年时间。考虑到如此巨大的研发费用,企业为了在专利保护期内更早上市而尽可能的加速试验进程成为大势所趋。及时让受试者入组对于整个研究项目的时间管理很关键。医生如何招募受试者,并尽可能让所有合格受试者完成整个试验,这对开展临床试验经验还不足的中国研究者来说,无疑是一个严峻的挑战。     

基于国际经验试论我国处方药网售监管模式

目的：为我国网售处方药政策的落地实施提供监管建议。方法：通过查阅国内外文献，梳理了美国、英国、德国等网上药店准入条件、网售处方药监管模式、网上药店药学服务和消费者权益保护相关规定，并分析当前我国放开网售处方药的机遇和存在的发展瓶颈，参照国际经验提出完善我国网售处方药的监管建议。结果与结论：电子商务的快速发展促进互联网和传统行业深度融合，随着“互联网+医疗健康”“互联网+医保服务”“互联网+药品流通”等新业态的推行，放开网售处方药也是未来趋势， 与之相适应的监管建议包括：完善网售处方药监管法律和监管机制、规范资格准入，建立处方在线查询审核平台，重视发挥执业药师的专业服务，规范物流配送、完善消费者权益保护机制等，为制定我国网售处方药的监管制度提供参考。     

An international perspective on the rights of juvenile offenders or "children living in exceptionally difficult conditions"

Substance user treatment providers, researchers, policy makers, and educators working in the juvenile justice field may be unaware of international policies governing the protection of youthful offenders. This presentation reviews the international rights of detained and incarcerated youth outlined in a variety of United Nations documents. Adolescents in contact with criminal justice systems have the right to the "highest attainable standard of health, both physical and mental." When substance abuse is involved they have the right to receive appropriate community-based treatment. Periods of contact with the criminal justice system may be one among very few opportunities to provide services for youth and these opportunities should not be wasted.     

Racial/Ethnic Differences in Cigarette Use: The Roles of Mental Illness and Health-Care Access/Utilization

Background: Empirical evidence supports a hypothesis that cigarettes may be used to cope with mental illness. Little research, however, addresses how race/ethnicity is linked to mental health and cigarette use. Objectives: This study applied the self-medication hypothesis. It asked whether mental status was associated, via health-care access/utilization, with the cigarette use outcomes of four racial/ethnic groups. It also tested whether race/ethnicity moderated any such associations. Methods: We used nationally representative data from the 2009–2010 and 2011–2012 National Health and Nutrition Examination Surveys to link cigarette use to mental status and health-care access/utilization. The final sample included 3827 White respondents, 1635 African-American respondents, 1144 Mexican-American respondents, and 781 Hispanic American (other than Mexican-American) respondents. Results: Consistent with earlier research and the self-medication hypothesis, we observed a positive relationship between cigarette use and mental status. Associations of cigarette use and health-care access/utilization sometimes failed to take expected directions. Conclusions: We concluded from the findings that race/ethnicity's moderating role in associations between cigarette use and health-care access was generally more advantageous to Whites than other groups examined. Where treatment is delayed by lack of access to, or lack of trust in, care providers, mental health may worsen—and it is often minority Americans who lack access and trust. If minority Americans’ health is to improve, shrinking racial health disparities, then access to adequate health care must be available to them, facilitating prompt treatment of mental and other illness.