药品专利权的功能异化与修正

高投入、高风险的制药业需要依赖药品专利权激励药品创新并促进药品获得。然而,TRIPs协定下高水平的药品专利保护体系使得药品专利权发生了一系列功能异化,具体表现为减缓药品创新速度、药品获得困难以及国际社会的财富分配不公。因此,有必要反思并重构现有的药品专利国际保护制度,借鉴并创新国际社会诸如公私合作伙伴关系模式与药物研发财税金融支持机制等已有的经验与实践,从而更好地兼顾药品创新与药品持续获得。     

EFFECTIVENESS OF DRUG TREATMENT COURTS: EVIDENCE FROM A RANDOMIZED TRIAL*

Research Summary: Study randomly assigned 235 offenders to drug treatment court (DTC) or “treatment as usual.” Analyses of official records collected over a two‐year follow‐up period show that DTC is reducing crime in a population of drug‐addicted offenders. DTC subjects who participated in treatment were significantly less likely to recidivate than were both untreated drug court subjects and control subjects. Policy Implications: Continued enthusiasm for DTCs is warranted. Both sanctions and treatment are important elements of the DTC model. However, DTCs will not necessarily result in cost reductions because DTC and control cases are incarcerated for approximately equal numbers of days. Implementation fidelity is important, and DTCs can be strengthened if they engage a higher percentage of their clients in drug treatment.     

美国药品责任诉讼中药品缺陷的证明

在美国产品严格责任制度中,药品具有缺陷是药品侵权责任成立的前提条件。在涉及药品责任的诉讼中,对药品缺陷的证明是决定诉讼胜败的关键。“美国第三次侵权法重述”把药品缺陷分为设计缺陷、制造缺陷、使用说明或警示缺陷。其各自不同的判断标准,既能帮助原告理解抽象的缺陷概念,也为原告通过具体的证据去证明缺陷指明了方向。探讨美国药品缺陷判断与证明的法律理论以及判例经验,以期能对我国相关法律的建设与司法实践提供一些有益的参考。     

BREAKING THE CYCLE OF DRUGS AND CRIME: FINDINGS FROM THE BIRMINGHAM BTC DEMONSTRATION

Research Summary: We compared 137 felony defendants arrested before the implementation of Breaking the Cycle, a pretrial intervention with felony defendants that included drug testing, supervision, and drug treatment as needed, to 245 BTC participants. We found Significant lower rates of arrest and self-reported drug use and crime among BTC participants during the next year.
Policy Implications: Systematic intervention aimed at all drug-involved felony defendants, not just selected defendants, is effective, but may encounter substantial challenges in achieving collaboration across criminal justice agencies, services providers, and levels/branches of government.     

Cultivation and Use of Opium in Rural India: Bottom-Up Insights Into Anti-Drug Efforts

Although India is a major supplier of licit (i.e., legally grown) opium, it is also a leading producer of illicit (i.e., illegally grown) opium. To learn who might be involved in both types of production, the researchers interviewed 50 licensed opium farmers in Madhya Pradesh. Those interviews covered, among other aspects, farmers’ opium use, community attitudes towards addiction and trafficking, and knowledge of government-set opium prices and regulations. In general, some of those interviewed outlined both informal social controls and shunning, used against rural addicts, and support, even if grudgingly given, for government regulation. Those same interviews, however, revealed evidence of important social/economic changes that are undercutting the limited efficacy of extant formal controls in curtailing opium use, addiction, and trafficking.     

美国药品责任诉讼中药品缺陷的证明

在美国产品严格责任制度中,药品具有缺陷是药品侵权责任成立的前提条件。在涉及药品责任的诉讼中,对药品缺陷的证明是决定诉讼胜败的关键。美国第三次侵权法重述把药品缺陷分为设计缺陷、制造缺陷、使用说明或警示缺陷。其各自不同的判断标准,既能帮助原告理解抽象的缺陷概念,也为原告通过具体的证据去证明缺陷指明了方向。探讨美国药品缺陷判断与证明的法律理论以及判例经验,以期能对我国相关法律的建设与司法实践提供一些有益的参考。     

Does incarceration-based drug treatment reduce recidivism? A meta-analytic synthesis of the research

This research synthesized results from 66 published and unpublished evaluations of incarceration-based drug treatment programs using meta-analysis. Incarceration-based drug treatment programs fell into five types: therapeutic communities (TCs), residential substance abuse treatment (RSAT), group counseling, boot camps specifically for drug offenders, and narcotic maintenance programs. We examined the effectiveness of each of these types of interventions in reducing post-release offending and drug use, and we also examined whether differences in research findings can be explained by variations in methodology, sample, or program features. Our results consistently found support for the effectiveness of TC programs on both outcome measures, and this finding was robust to variations in method, sample, and program features. We also found support for the effectiveness of RSAT and group counseling programs in reducing re-offending, but these programs’ effects on drug use were ambiguous. A limited number of evaluations assessed narcotic maintenance or boot camp programs; however, the existing evaluations found mixed support for maintenance programs and no support for boot camps.     

CREDIBLE RESEARCH PRACTICES TO INFORM DRUG LAW ENFORCEMENT

Chairing the recent National Research Council Committee on Data and Research for Policy on Illegal Drugs, I learned that our nation has invested little in research on drug law enforcement and that the limited available research does not provide a credible basis for formation of drug control policy. This commentary conjectures reasons for the distressing status quo and recommends changes in research practices that may improve matters.     

"Life expectancy" of "ecstasy" tablets in Israel in the years 2001-2003

3,4-Methylenedioxymethamphetamine (MDMA) tablets known as "ecstasy" became a very popular drug amongst Israeli youth in the last decade. The ecstasy tablets have a simple design impressed on them (logos) making it relatively easy to distinguish between various logos. The life expectancy of ecstasy tablet logos, defined as the period between the first seizure by the police of a certain logo until the last seizure of the same logo, was monitored during the years 2001-2003. During this time interval, 58 different tablet logos were seized. A total of 26 logos, defined as common logos with at least 10 independent seizures, were observed. At any given time interval during this period, 8-10 common logos were found with an average life expectancy of approximately 9 months. Five of the observed 26 common logos were defined as the most common logos that appeared in at least 200 independent seizures each. Plots of the number of seizures and number of tablets seized as a function of time are presented and discussed as well as explanations for the high turnover rate of any given logo.     

Differences in the Validity of Self-Reported Drug Use Across Five Factors: Gender,Race, Age,Type of Drug,and Offense Seriousness

This study expands our knowledge about the validity of self-reported drug use by examining how gender, race, age, type of drug, and offense seriousness interact to affect the validity of self-reported drug use. This study also provides a conceptual framework that can be used to examine the validity of self-reported drug use. Differences in the validity of self-reported drug use are explained by examining differences in underreporting and overreporting. Differences in underreporting and overreporting are then further examined while controlling for differences in base rates of drug use. As shown, whether one controls for base rates of use may drastically affect estimates of underreporting and overreporting. By using hierarchical loglinear, logit, and logistic regression models with the Drug Use Forecasting data, we show that Black offenders provide less accurate self-reports than White offenders. Black offenders do so because they are more likely to underreport crack/cocaine use than White offenders. This difference, however, disappears once differences in base rates are controlled. A Black offender who tests positive is not more likely to underreport crack/cocaine use than a White offender who tests positive. Black offenders are also more likely to overreport both marijuana and crack/cocaine use relative to White offenders. Contrary to the first, this difference is not attributable to a difference in base rates. Methodological and substantive implications of this distinction are discussed. No differences across gender, age, or offense seriousness were found.

药品说明缺陷的法律分析

文章根据产品责任法理论阐述了药品缺陷的含义以及我国对药品说明的有关规定;并根据药品的特殊性,深入分析了药品说明缺陷的判断因素,以及认定药品说明缺陷的注意问题,有助于药品生产者、经营者、医师、药师等在产品和医疗服务中规范行事。提出在司法实践中,要确认生产者、销售者或医师是否存在说明缺陷,应对药品的说明对象、说明方式以及说明时间、说明的充分性以及对明显或众所周知的危险进行警告等方面进行综合考虑评估。     

紫外导数光谱法与吸收光谱法的比较

作者通过导数光谱法与吸收光谱法的对比实验,归纳出导数光谱法不但具有吸收光谱法的一般优点,还具有以下特点;(1)高分辨率和灵敏度;(2)定性准确;(3)能精确测定λmax和“肩”峰的波长;(4)能消除背景干扰;(5)能分析混和样品。     

Pholcodine interference in the immunoassay for opiates in urine

The excretion in urine after single oral therapeutic doses of morphine derivatives was analysed with radioimmunoassay (RIA) and homogeneous enzyme immunoassay (EMIT) for opiates. In contrast to the rapid excretion of ethylmorphine and codeine, pholcodine showed positive results for opiates 2-6 weeks after intake when the urines were analysed with the RIA-method. When analysed with the EMIT-method, positive results were obtained for pholcodine for approximately 10 days. As pholcodine is a common component in cough mixtures, its prolonged excretion could represent a hazard in interpreting the results from drug analyses of urines.     

Drugs in injured drivers in Denmark

As part of the project Impaired Motorists, Methods of Roadside Testing and Assessment for Licensing (IMMORTAL) under the European Commission's Transport RTD Programme of the 5th Framework Programme [I.M. Bernhoft, Drugs in accidents involved drivers in Denmark, D-R4.3 of the project Impaired Motorists, Methods Of Roadside Testing and Assessment for Licensing (IMMORTAL), www.immortal.or.at, 2005], a study regarding drugs in accident-involved drivers was carried out in Denmark. The main objectives of this study were: (1) to collect and analyse samples from injured drivers for the presence of drugs; (2) to give an indication whether drugs may have contributed to traffic accidents; and (3) to get information on the drug-positive drivers and their drug use. This paper focuses on objective 1. Injured drivers who were treated in hospital were asked to give a saliva sample, a blood sample or both. The samples were screened for the following substances: opiates, amphetamines, methamphetamines, incl. MDMA (ecstasy), cannabinoids and metabolites, cocaine and metabolites and benzodiazepines. Screenings were carried out by means of Cozart Microplate EIA kit. Positive screenings were confirmation analysed by gas chromatography–mass spectrometry (GC–MS) or liquid chromatography/tandem mass spectrometry (LC/MS/MS). In total, 26 out of 330 patients were confirmed positive for one or more of the six drug groups. However, three patients were excluded from the survey for various reasons. Of the remaining 23 drug-positive patients 15 were found positive for one drug group, and in five of these cases alcohol was present in a concentration over the legal limit in Denmark (0.05%). The other eight patients were found positive for two drug groups, and in four of these cases, alcohol was also present in a concentration over the legal limit. Alcohol was found both in combinations with medicinal drugs, with illegal drugs and with both. Based on the saliva or blood concentrations, we estimate that there is a strong suspicion of impairment in 9 out of 23 cases, and in another six cases it was likely that the drivers were impaired.     

药物不良反应纠纷处理的困惑和思考

由药物不良反应引起的医疗纠纷日益增多,由于目前没有相应的法律法规来解决此类纠纷,使患者、医院和生产厂家都感到十分困惑和无奈。要处理好药物不良反应所引起的纠纷应该:1防患于未然,积极预防药物不良反应的发生;2依法处理,企盼相关的法律法规尽快出台;3加强监测,应用网络技术加强监测和报告;4更新理念,积极筹措药物不良反应补偿基金。     

毒品犯罪案件中特情侦查的程序控制——以4322件案例为样本的分析

对4322件毒品犯罪案例的统计分析发现,在特情介入方面,我国各省份的认定比例、控辩审三方的认定态度以及特情的身份来源都呈现多样性,特情参与的案件以零包贩毒为主,内心常因被动且多有引诱行为,被告人适用重刑判决较为少见。反映在实务中则表现为特情的选择条件过于宽泛、案件范围背离规范、启动缺乏证据前提、过度介入以及监控失范等问题。就改革思路而言,我国需要对特情的物建制度、适用情形、证据前提、介入程度与后果、监督与对抗程序加以完善。     

A research note: the outcome of GC/MS/MS confirmation of hair assays on 93 cannabinoid (+) cases

This article reports the outcome of gas chromatography/tandem mass spectrometry confirmations for THC and carboxy-THC on 93 hair samples screened by RIA for cannabinoids. The samples were taken from probationers in Pinellas County, FL, who voluntarily provided the research staff with six hair and six urine specimens, collected at 1-month intervals. There were 40 samples that were RIA (+), urinalysis (−). Samples were selected which had cannabinoid (+) outcomes for hair, urine, or both. The THC and/or the carboxy-THC was (+) on confirmation. Of these 40 samples, 22 were (+) for both THC and carboxy-THC, 15 were (+) for THC but not carboxy-THC, and three were carboxy THC (+), but THC (−). Only one sample had a (+) RIA, but was (−) for both THC and carboxy-THC on confirmation. RIA detection of cannabinoids was confirmed in nearly all cases. Most cases that were RIA (−) but urine (+) were cannabinoid (+) when analyzed by GC/MS/MS.     

Community Characteristics and Death by Homicide,Suicide and Drug Overdose in Italy: The Role of Civic Engagement

A number of recent theories suggest that high civicness, civic participation and social capital protect a community from deviant behavior. Most empirical studies of this hypothesis have been conducted in North America. This paper examines to what extent this hypothesis applies to Italy and to three forms of violent death: homicide, suicide, and drug overdose, using the Putnam concept of civicness. Official statistics on civicness, unemployment, per capita G.D.P., urbanization, couples’ separation and age group concentration from the 95 sub-regions (provinces) of Italy were used as predictors of violent death. Among regions, homicide and suicide rates were negatively correlated. Southern provinces had more homicides, while northern provinces had more suicides and deaths from drug overdose. Analyses of interactions among independent variables revealed that certain relationships, which at first sight appeared to concern the whole of Italy, in reality concern only the north or only the south. This suggests the existence of specific effects, whereby some independent variables are only triggered in the particular conditions encountered in the north or in the south of Italy. Civicness was negatively associated with homicide only in the south, where it was also positively associated with suicide. Death by drug overdose was mostly explained by wealth. The overall pattern of results was more complex than present theories suggest.