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Ludwig Jung - The Political Economy of International Prohibition Regimes

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Ludwig Jung

The Political Economy of International Prohibition Regimes

Series: Nomos Universitätsschriften - Volkswirtschaftslehre

Volume 7 2021

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3. International Drug Control S. 151-268

„… International Drug Control Current public debates about drug control primarily focus on the …” „… international drug control system are observable, the core of the international drug control regime persists.449 …” „… . For a critical assessment of U.S. drug policy’s effects on U.S. society, see Boyum and Reuter 2003 …”

6. References S. 391-411

„… . Killer High – A History Of War In Six Drugs. Oxford, UK: Oxford University Press. Arrow, Kenneth J. 1963 …” „… Thony. 1999. "The International Drug Control System". In International Criminal Law. New York, NY …” „… ., and John Walsh. 2014. "Marijuana Legalization Is An Opportunity To Modernize International Drug …”

Titelei/Inhaltsverzeichnis S. 1-20

„… areas of narcotic drugs and small arms/light weapons (SALW). The analysis focuses on the contractual …” „… for the institutional outcome of the international drug control regime, in accordance with existing …” „… interest in pursuing further research into international drug and small arms control. The University of …”

5. Summary S. 375-390

„… realize mutually beneficial cooperation.1377 In the case of narcotics drugs and small arms, the goal of …” „… began with an examination of transaction cost approximations in the policy areas of drug and small …” „… arms/light weapons (SALW) control. Next, the actual prohibitive regime structures for both drugs and SALW …”

1. Introduction: The case for an economic theory of international regimes S. 21-65

„… thesis, the international regimes in the areas of international drug prohibition, and in the control of …” „… .13 In this thesis, the focus will be on international measures to curb the flow of narcotic drugs and …” „… analyses with regard to the international drug control regime have emphasized this normative approach, much …”

4. Control of Small Arms and Light Weapons (SALW) S. 269-374

„… .11. 269 to the estimated sizes of illicit drug markets.958 However, the potential negative …” „… psychotropic drugs, due to certain similar characteristics: negative externalities originating from a small …” „… the underlying transaction costs. However, unlike drug trafficking, the international con- 958 As …”

2. Transaction cost theory and the analysis of international institutions S. 66-150

„… international drug control regime proved only moderately successful in limiting the consumption or supply of …” „… analysis of international institutions 72 national drug prohibition regime, a rich debate has emerged about …” „… the international drug regime’s effects on societal costs and benefits.189 This is not the aim of this …”

doi.org/10.5771/9783748926344

Monica Donghi - Patent Strategy in Pharmaceutical Industry: Are additional patents valuable?

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Monica Donghi

Patent Strategy in Pharmaceutical Industry: Are additional patents valuable?

Series: Munich Intellectual Property Law Center - MIPLC Studies

Volume 20 2014

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Generic Drugs Approval. S. 19-20

„… the centralized procedure is mandatory.22 Generic Drugs Approval. As far as generics are concerned …” „… exclusivity +1 for new indication] in a Member State or in the Community”. C. Generic Drugs Approval. 19 …”

New Drug Approval Regulations S. 18-19

„… ), the clinical phases do exceed them several times. As part of the preclinical development of a drug …” „… interactions with other drugs is desirable, such studies are oftentimes not being carried out before the …” „… completion of Phase I clinical trials.16 New Drug Approval Regulations The European system offers three …”

Pharmaceutical Industry – The Development of a New Drug. S. 16-18

„… Background Pharmaceutical Industry – The Development of a New Drug. The development of a new drug …” „… been bringing the current estimated average cost of researching and developing a new drug to about 1 …” „… billion €.11 Since the chance of a chemical entity becoming a marketable drug is about 1 in 10000 and for …”

Innovation Tracks S. 45-62

„… Strategy: Commercial Value Further research to improve properties of a drug and to address unmet needs …” „… a blockbuster drug might present various problems also on the side of the originator. Such problems …” „… class (follow-on drugs) were launched in the U.S. with a price discount and the discount rate was on …”

Periodical Materials in English S. 77-80

„… week 40, 12 Curr. Pat. Gaz. 1, (2009). Anonymous, Patent expiries to hit glaucoma drug market growth …” „… old Drugs, 448 Nature 645, 645 (2007). Ami J. Claxton, Joyce Cramer, Courtney Pierce, A systematic …” „… ). Patrick J. Crowley, Luigi G. Martini, Formulation design: new drugs from old, 1 Drug Discovery Today …”

Summary: Taxotere v Xalatan S. 69-72

„… under fire by generic drug providers and in the end got revoked or was held unenforceable. In this …” „… example with respect to Xalatan first, several follow-on drugs based on prostaglandine derivatives have …” „… drugs Taxotere and Xalatan can be made. Successive to the filing of their respective basic patent …”

Lifecycle Management: Criticism and Supports S. 42-45

„… few years, patent exclusivity will expire for drugs with combined annual sales of $140 billion.”108 …” „… entities (NCEs) into successful drugs, drug companies are forced to maximise the value of their product …” „… ” strategies.112, 113, 114 This negative connotation stems from the impression, that the originator drug …”

Patent Strategy and Innovation S. 66-69

„… percentage of children who need such drug is low (around 1%) it is duty of the health system to guarantee …” „… that a safe drug is available to them. The scope of paediatric extension is to give an incentive to …” „… companies to provide such drugs, therefore the ICA point of view cannot be shared and Pfizer’s use of …”

Xalatan SPC Request: a Case for Competition Law? S. 62-66

„… further protect the use of the concerned drug in connection with the patented system and do not create any …” „… traditional drug or the use of other versions belonging not to the originator company. The economic success of …” „… climate of legal uncertainty with respect to the possibility of commercializing equivalent drugs based on …”

Introduction S. 13-15

„… directed towards new chemical and biological entities (drugs) and their development to bring forth new …” „… targets to be addressed by a drug to treat a given disease, but also much more is known about potential …” „… . Maloteaux, 5 Impact of genomics on drug discovery and clinical medicine, 93 QJM. Int. J. Med. 391, 394 (2000 …”

Patent Portfolio S. 33-37

„… The compound has been originally disclosed in EP 0364417 B175 belonging to Kabi-Pharmacia. The drug …” „… Xalatan were taken from Sajiv K. Nair, Kevin E. Henegar, Modern Drug Synthesis 329-330 (Jie Jack Li …” „… dosage in form of a disintegrating tablet with the effect that the drug is taken up via the oral mucosa …”

Titelei/Inhaltsverzeichnis S. 2-10

„… portfolio regarding two commercially successful drugs of significant importance for public health. The …” „… is often referred to by generic drug manufacturers as “evergreening”. Lifecycle management arises in …” „… new drugs. Between the various strategies being pursued this thesis analyses and evaluates two of them …”

Final Remarks S. 73-76

„… drug at a cost for society.262 In both the cases at present analysed this could not be confirmed. Also …” „… party, desiring to provide the original drug not anymore covered by a patent, is free to offer it to the …” „… placed on the research and development cost. The development cost of a new drug is very high, the …”

General S. 21-23

„… course of developing a drug. This study will be conducted by highlighting the patent portfolio of two …” „… randomly selected successful drugs whose basic patent protection has been expired: Taxotere® and Xalatan …” „… European yew tree (Taxus baccata L.). It was designed as an alternative to the drug Taxol (paclitaxel …”

Acronyms and Abbreviations S. 11-12

„… New Drug Application Art. Article CDK inhibitor Cyclin dependent kinase inhibitor CI Clinical …” „… Convention EPO European Patent Office FDA Food and Drug Administration FDLI Food and Drug Law Institute Fed …” „… Drug Application NHS National Health System O.J. Official Journal PGF2α Prostaglandin F2 alpha SPC …”

Others S. 83-84

„… http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/jacob.pdf. Press release Press release, AGCM, Drugs: Pfizer sanctioned with 10.6 million Euro fine for abuse …” „… . Dickson, J.P. Gagnon, The Cost of New Drug Discovery and Development, available at …” „… : http://www.discoverymedicine.com/Michael-Dickson/2009/06/20/the-cost-ofnew-drug-discovery-and-development/. Angelo DePalma, Patent expiration …”

Patent Portfolio S. 23-27

„… Another problem to be dealt with after the discovery of a potential drug during preclinical and clinical …” „… , clinical studies of product combinations can be quite complex due to potential drug interaction.47 About 10 …” „… , From Discovery to Market: The Development of Pharmaceuticals, in BURGER’S MEDICINAL CHEMISTRY AND DRUG …”

Use of Procedural Provisions S. 37-39

„… edge with respect to ease of application, this method of administering the drug to the eye would …” „… filled with the drug per se. It appears, that there existed a need to stabilise the packaged drug and …” „… application has been filed with respect to the packaging of a combination of the drugs timolol and latanoprost …”

Conclusion and Suggestions S. 72

„… keted drugs. This situation could change only by the development of drugs with novel mechanism of …” „… . 260 Anonymous, Patent expiries to hit glaucoma drug market growth until 2018, The Pharma Letter, Sept …”

Speeches and Reports S. 83

„… http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/jacob.pdf. Press release Press release, AGCM, Drugs: Pfizer sanctioned with 10.6 million Euro fine for abuse …” „… . Dickson, J.P. Gagnon, The Cost of New Drug Discovery and Development, available at …” „… : http://www.discoverymedicine.com/Michael-Dickson/2009/06/20/the-cost-ofnew-drug-discovery-and-development/. Angelo DePalma, Patent expiration …”

Press release S. 83

„… http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/jacob.pdf. Press release Press release, AGCM, Drugs: Pfizer sanctioned with 10.6 million Euro fine for abuse …” „… . Dickson, J.P. Gagnon, The Cost of New Drug Discovery and Development, available at …” „… : http://www.discoverymedicine.com/Michael-Dickson/2009/06/20/the-cost-ofnew-drug-discovery-and-development/. Angelo DePalma, Patent expiration …”

General S. 32-33

„… compounds, i.e. derivatives of the taxan core with great resemblance of the marketed drug. Bilder/image …” „… originally disclosed in EP 0364417 B175 belonging to Kabi-Pharmacia. The drug was launched in 1996 in the U.S …” „… Xalatan were taken from Sajiv K. Nair, Kevin E. Henegar, Modern Drug Synthesis 329-330 (Jie Jack Li …”

Statutes S. 82-83

„… http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/jacob.pdf. Press release Press release, AGCM, Drugs: Pfizer sanctioned with 10.6 million Euro fine for abuse …” „… . Dickson, J.P. Gagnon, The Cost of New Drug Discovery and Development, available at …” „… : http://www.discoverymedicine.com/Michael-Dickson/2009/06/20/the-cost-ofnew-drug-discovery-and-development/. Angelo DePalma, Patent expiration …”

Conclusion S. 30-32

„… Nitto Denko Corp. (7), were very active in this area. The same trend can be seen in the field of drug …” „… . derivatives of the taxan core with great resemblance of the marketed drug. Figure 2: Patent filing trends …” „… the marketed drug. Bilder/image002.jpg Figure 2: Patent filing trends: docetaxel73 …”

Use of Procedural Provisions: Supplementary Protection Certificates (SPCs)/Patent Term Extension S. 27-30

„… research around docetaxel did not diminish the efforts in basic research to find new innovative drugs …” „… more than eight years of research to determine safety and efficacy of the drug in various clinical …” „… of drugs. A. Taxotere 29 months) for the treatment of solid tumours extended the patent protection of …”

Periodical Material in German S. 80

„… Development of Pharmaceuticals, in BURGER’S MEDICINAL CHEMISTRY AND DRUG DISCOV- ERY, (1995). Philip W. Grubb …” „… , Modern Drug Synthesis, (1st ed. 2010). Kristof Roox, Julia Pike, Andrew Brown, Stefan Becker …”

Non Periodical Material S. 80

„… Development of Pharmaceuticals, in BURGER’S MEDICINAL CHEMISTRY AND DRUG DISCOV- ERY, (1995). Philip W. Grubb …” „… , Modern Drug Synthesis, (1st ed. 2010). Kristof Roox, Julia Pike, Andrew Brown, Stefan Becker …”

Table of books S. 80-81

„… Development of Pharmaceuticals, in BURGER’S MEDICINAL CHEMISTRY AND DRUG DISCOV- ERY, (1995). Philip W. Grubb …” „… , Modern Drug Synthesis, (1st ed. 2010). Kristof Roox, Julia Pike, Andrew Brown, Stefan Becker …”

doi.org/10.5771/9783845251288

Christian Igel, Wolfgang G. Lange, Walter Ried, Volker Ulrich - Effizienz, Qualität und Nachhaltigkeit im Gesundheitswesen

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Christian Igel (ed.), Wolfgang G. Lange (ed.), Walter Ried (ed.), Volker Ulrich (ed.)

Effizienz, Qualität und Nachhaltigkeit im Gesundheitswesen

2007

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J-Matthias Graf von der Schulenburg German drug pricing policy: a critical comment S. 585-599

„… 565 German drug pricing policy: a critical comment J.-Matthias Graf von der Schulenburg Content 1 …” „… .................................................................................................................... 565 2. Health Care Costs: Reference Price Schemes for Drugs …” „… instance in 2005, the reference price (RP) system has been was extended to patented drugs and …”

Direkte Patienteninformationen für verschreibungspfl ichtige Arzneimittel – Erfahrungen aus dem Ausland und Anwendungsmöglichkeiten für Deutschland S. 655-681

„… unterliegt in den USA der staatlichen Regulierung, zuständig ist die US Food and Drug Administration (FDA …” „… zu den Indikationen des Produktes macht. Im August 1997 erließ die FDA mit dem Food and Drug …” „… Verhaltenskodex „Rules Governing Drug Information - Veröffentlichung von Informationen über die Zusammensetzung …”

Effizienzoptimierung in der Arzneimittelversorgung – Für mehr Rationalität und Wirtschaftlichkeit in der Therapie mit Medikamenten – S. 571-585

„… ) Arzneiverordnungs-Report 2005. Heidelberg. S. 879 Gerd Glaeske 565 German drug pricing policy: a critical comment …” „… .................................................................................................................... 565 2. Health Care Costs: Reference Price Schemes for Drugs …” „… instance in 2005, the reference price (RP) system has been was extended to patented drugs and …”

Inhaltsverzeichnis S. 15-20

„… Wirtschaftlichkeit in der Therapie mit Medikamenten – ................................. 553 Gerd Glaeske German drug …”

Barbara Sickmüller, Christine Lietz Methoden der Nutzenbewertung von Arzneimitteln national und im internationalen Vergleich – Übersicht S. 599-613

„… Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of …” „… ) Kanada: Patented Medicine Prices Review Board (PMPRB) und das Canadian Expert Drug Advisory Committee …”

Innovationen und ihre Perspektiven im Spannungsfeld zwischen Finanzierung und Versorgungsfortschritt im Gesundheitswesen S. 859-874

„… Drug-Eluting Stents, in: Cardiovasc Nr. 3, 2006, S.9; s. auch Interview mit Christoph Kaiser, Das Märchen von …” „… England Journal of Medicine, 2003, S. 1315 – 1323 als auch Nordmann, A.J., Safety of Drug-Eluting stents …”

doi.org/10.5771/9783845202648

Anne Kristin Kant - Rechtliche Instrumente zur Verbesserung der Arzneimittelversorgung in der Pädiatrie

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Anne Kristin Kant

Rechtliche Instrumente zur Verbesserung der Arzneimittelversorgung in der Pädiatrie

Series: Marburger Schriften zum Gesundheitswesen

Volume 17 2012

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Arzneimittel für seltene Leiden – Orphan Drugs S. 140-144

„… Entwicklungsbereichen entsteht.530 III. Arzneimittel für seltene Leiden – Orphan Drugs Der Anwendungsbereich des Art. 36 …” „… Arzneimittel für seltene Leiden, auch bezeichnet als Orphan Drugs, ausgewiesen sind. Für diese …” „… eine ähnlich gelagerte Problematik auch im Zusammenhang mit den so genannten Orphan Drugs vor:531 Auch …”

Ebenenüberschreitende Verfahrensaspekte S. 123-129

„… von Entscheidungen der U. S. Food and Drug Administration Der Inhalt der vorliegend analysierten …” „… amerikanischen Zulassungsbehörde, der U. S. Food and Drug Administration, über ein Präparat auf die Entscheidung …” „… der Food and Drug Administration auf die Entscheidungen der Europäischen Arzneimittel-Agentur Einfluss …”

Literaturverzeichnis S. 199-214

„… , Der neue Vorschlag für eine Verordnung über Arzneimittel für seltene Krankheiten (Orphan Drugs …” „… , Oliver, Orphan Drugs, in: Schöffski/Fricke/Guminski (Hrsg.), Pharma-betriebslehre, 2. Aufl., Berlin u. a …” „… Wettbewerbsrechts, Baden-Baden 1989. Hiltl, Christoph, Orphan Drugs – Zwischenbilanz und Konfliktfelder, PharmR 2001 …”

Geschützte Arzneimittel S. 134-140

„… Leiden – Orphan Drugs Der Anwendungsbereich des Art. 36 VO (EG) Nr. 1901/2006 schließt Arzneimittel aus …” „… Orphan Drugs, ausgewiesen sind. Für diese Arzneimittelgruppe ist stattdessen eine eigene Bonus- und …” „… Zusammenhang mit den so genannten Orphan Drugs vor:531 Auch hier besteht für einen pharmazeutischen Unternehmer …”

Genehmigung für die pädiatrische Verwendung S. 144-152

„… vorzugswürdigem Weg in gleichem Ausmaß erreichbar.547 Sofern Inhaber des Patents und der Orphan Drug-Ausweisung in …” „… auf die speziellere und spätere Regelung in der Orphan Drug-Verordnung zu verneinen.548 Ein …” „… Arzneimittelmarkt schützen, sofern er eine Orphan Drug-Ausweisung für sein Produkt zu einem Zeitpunkt erwirkt, der …”

Ergebnis S. 195-196

„… Gruppe ist eine Übertragbarkeit jedoch theoretisch möglich. So wie Aspekte der Orphan Drug-Verordnung (EG …” „… , Pediatric Drug Development, S. 153 ff. Auch hier wäre eine Vorbildfunktion des europäischen Modells denkbar. …”

Erreichbarkeit der Zielsetzung durch die vorgesehenen Maßnahmen S. 184-186

„… , Ärzte Zeitung online vom 09.02.2010. Vgl. auch Rose, in: Mulberg/Silber/van den Anker, Pediatric Drug …” „… . Vgl. auch Rose, in: Mulberg/Silber/van den Anker, Pediatric Drug Development, S. 148. 719 Nahnhauer …”

Titelei/Inhaltsverzeichnis S. 2-14

„… Prüfungssektor 126 c) Bewertung 126 3. Exkurs: Leitfunktion von Entscheidungen der U. S. Food and Drug …” „… 137 3. Verlängerung der Zertifikatslaufzeit 138 III. Arzneimittel für seltene Leiden – Orphan Drugs …”

Bewertung des Bonus- und Anreizsystems S. 157-160

„… Schutzzertifikatsverlängerung, der Regelungen betreffend die Marktexklusivität in Verbindung mit Orphan Drugs sowie des …” „… Maßnahme in Verbindung mit Orphan Drugs führt zu einer konsequenten Weiterführung der Anwendung der …”

Art. 50 VO (EG) Nr. 1901/2006: Erfolgsanalyse des Bonus- und Anreizsystems S. 157

„… Schutzzertifikatsverlängerung, der Regelungen betreffend die Marktexklusivität in Verbindung mit Orphan Drugs sowie des …”

Abkürzungsverzeichnis S. 15-20

„… Sozialausschuss f./ff. folgende/fortfolgende FAZ Frankfurter Allgemeine Zeitung FDA U.S. Food and Drug …”

Verhältnismäßigkeit des Eingriffs in die unternehmerische Freiheit S. 129-131

„… Entscheidungen der U. S. Food and Drug Administration damit zwar zu verneinen ist, ist den Entscheidungen dennoch …”

Datenbanken, Verzeichnisse und Register S. 161-164

„… : Mulberg/Silber/van den Anker, Pediatric Drug Development, S. 145 f. 632 Abrufbar unter …”

Zusätzliche Bonus- und Anreizmechanismen S. 153-157

„… Schutzzertifikatsverlängerung, der Regelungen betreffend die Marktexklusivität in Verbindung mit Orphan Drugs sowie des …”

Ursachen für den Mangel S. 23-40

„… : Mulberg/Silber/van den Anker, Pediatric Drug Development, S. 133 ff.; Nahnhauer, BKK 2005, S. 404; Grabar, Dt Ärztebl …”

doi.org/10.5771/9783845234809

Jonathan H. Adler - Marijuana Federalism

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Jonathan H. Adler (ed.)

Marijuana Federalism

2020

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Introduction: Our Federalism on Drugs S. 1-14

„… DrugsWhen alcohol prohibition was repealed, states retained the ability to pro-hibit or regulate alcohol …” „… DrugsLisa N. Sacco and others, “The Marijuana Policy Gap and the Path Forward,” Congres-sional Research …” „… Adler_Marijuana Federalism_i-viii_1-195.indd 12 1/29/20 11:43 AM13Our Federalism on DrugsIlya Somin, “Free to …”

Public Opinion and America's Experimentation with Cannabis Reform S. 15-34

„… dangerous than other drugs.THE LANGUAGE OF LEGALIZATIONOften in discussions around cannabis reform …” „… cannabis’s status as an illicit drug would change any time soon. Public support for legalization had grown …” „… to other drugs. A 2018 NBC News/Wall Street Journal poll asked respondents to select the substance …”

The Effect of State Marijuana Legalizations: An Update S. 35-84

„… other drug or alcohol use, increases crime, diminishes traffic Adler_Marijuana Federalism_i-viii_1-195 …” „… of marijuana use, other drug or alcohol use, marijuana prices, crime, traffic accidents, teen …” „… often associated with the use of the drug. Prohibition advocates attributed terrible crimes to marijuana …”

Index S. 187-0

„… Alabama marijuana laws, 5Alaska: car accidents in, 49, 64f; decrimi-nalization of marijuana in, 38; drug …” „… Anti-Drug Abuse Act of 1986, 37Anti-money laundering laws, 140–42, 148Arizona, legal representation of …” „… , 171Bitcoin, 148Black market drug trade, 2, 46, 47, 172, 176Blockchain technology, 148Blumenauer, Earl …”

The Smoke Next Time: Nullification, Commandeering, and the Future of Marijuana Regulation S. 85-102

„… heavy lifting when it comes to drug enforce-Adler_Marijuana Federalism_i-viii_1-195.indd 85 1/29/20 …” „… to fill the gap. The dependence of federal drug enforcement on state cooperation has enabled states …” „… like Colo-rado, Washington, and California not only to sit out the federal drug war on marijuana but …”

The Contingent Federal Power to Regulate Marijuana S. 171-184

„… federalism, state regulation should have a role in determining how far the federal drug laws may reach …” „… and regulates a drug in a way that minimizes the risk of spillovers into the interstate black market …” „… , the federal drug laws should not be able to reach within that state. This better squares with the …”

Preface

„… D. Baker-Baker & Hostetler Chair in Law, Moritz College of Law, Director of Drug Enforcement and …” „… : Drug legalization—United States. | Marijuana—Government policy—United States. | Marijuana—Law and …” „… AMCONTENTS Acknowledgments viiIntroduction Our Federalism on Drugs 1Jonathan H. Adler1 Public Opinion and …”

Legal Advice for Marijuana Business Entities S. 155-170

„… effectively to reduce violent crime, stem the tide of the drug crisis, and dismantle criminal gangs.” In the …” „… referred to the client as a “drug dealer” and stated that the lawyer looked forward to “the many nights and …”

Murphy's Mistake, and How to Fix It S. 103-122

„… strict ban on the drug. Appealing to another constitutional principle— the Supreme Court’s anti …” „… only with respect to relatively small quantities of the drug (one ounce).27 In other words, Amendment …”

Federal Nonenforcement: A Dubious Precedent S. 123-138

„… government is declining to enforce. Leasing property for a drug operation is a federal crime, for instance …”

Banks and the Marijuana Industry S. 139-154

„… prosecute those who deal directly with illegal drugs.22 In addi-tion, financial institutions are supervised …”

doi.org/10.5771/9780815737902

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