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Table of Contents
Preface; Contents; List of Contributors; Abbreviations; Part I: Antitrust in Pharmaceutical Markets; 1: International Report; 1.1 Introduction and Summary; 1.1.1 Scope to Differentiate Pharmaceutical Cases as a Matter of Law; 1.1.2 Enforcement Patterns and Consumer Protection in Pharmaceutical Cases; 1.1.3 Innovation and Competition Nexus; 1.1.4 Public Finance and Other Considerations; 1.2 Summary of Questionnaire Responses; 1.2.1 Legal Differentiation of Pharmaceutical Cases in Competition Law; 1.2.1.1 Differences in Underlying Legal Standards; 1.2.1.2 Market Definition
Classification Systems, the SSNIP Test and Other Substitution EvidencePhysician, Pharmacist and Consumer Choice; Insurance and Price Regulation; 1.2.2 Enforcement Patterns, Specialist Bodies and Reviews, and Consumer Protection Interplays; 1.2.2.1 Enforcement Patterns; 1.2.2.2 Public Enforcement and Fines; 1.2.2.3 Private Enforcement; 1.2.2.4 Sector-Specific Measures and Reviews; 1.2.2.5 Sector-Specific Guidelines; 1.2.2.6 Patent Settlement Register; 1.3 Interaction of Competition Law and Consumer Protection Law; 1.3.1 Innovation and Competition Nexus; 1.3.1.1 Scope of the Patent Test
1.3.1.2 Assessment of Settlements1.3.2 The Role of Public Finance and Insurance and the Promotion of Generic Entry; 1.3.2.1 Insurers and Other Protected Bodies; 1.3.2.2 Price Regulation; Mandatory Drug Pricing; Blended Systems; Models Setting Specified Price Adjustments; Reference Pricing; Reference Pricing as a Meaningful Excessive Price Cap; Reference Pricing as a Reference Point for Predatory Pricing Cases; Market Interdependency from Blended Pricing (Potential MFN Effect); Information Exchange Concerns; 1.3.2.3 Regulation of Distribution Margins and Monopoly Distribution
Parallel Trade Restrictions1.3.2.4 Generic Entry Promotion; Legal Protection of the Substitution of Generics for Branded Drugs; Barriers to Entry from Supply Obligations; Protection of Generic Products from Reputational Denigration; 1.4 Conclusion and Draft Recommendations; 2: Australia; 2.1 The Pharmaceutical Industry and Competition Law; 2.1.1 Legislation; 2.1.2 Cases and Misuses of Market Power; 2.2 Enforcement Mechanisms, Remedies and Consumer Protection; 2.2.1 Enforcement Patterns Regarding Pharmaceutical Competition Law Issues; 2.2.2 Interaction Between Competition and Consumer Laws
2.2.2.1 Unfair Term Legislation2.2.2.2 Unconscionable Conduct; 2.2.2.3 Misleading Conduct; 2.2.3 Sector-Specific Reviews of Competition Law in the Pharmaceutical Sector; 2.2.3.1 Pharmaceutical Patents Review 2012-2013; 2.2.3.2 Competition Policy Review 2014-2015 (Harper Review); 2.2.3.3 Productivity Commission Review of Intellectual Property; 2.2.3.4 Review of Pharmacy Remuneration and Regulation 2015-2017; 2.2.4 Competition Law Guidelines Relevant to the Pharmaceutical Industry; 2.3 Patent Protection and Competition; 2.3.1 Patent Owners and Generic Drugs in Australia
Classification Systems, the SSNIP Test and Other Substitution EvidencePhysician, Pharmacist and Consumer Choice; Insurance and Price Regulation; 1.2.2 Enforcement Patterns, Specialist Bodies and Reviews, and Consumer Protection Interplays; 1.2.2.1 Enforcement Patterns; 1.2.2.2 Public Enforcement and Fines; 1.2.2.3 Private Enforcement; 1.2.2.4 Sector-Specific Measures and Reviews; 1.2.2.5 Sector-Specific Guidelines; 1.2.2.6 Patent Settlement Register; 1.3 Interaction of Competition Law and Consumer Protection Law; 1.3.1 Innovation and Competition Nexus; 1.3.1.1 Scope of the Patent Test
1.3.1.2 Assessment of Settlements1.3.2 The Role of Public Finance and Insurance and the Promotion of Generic Entry; 1.3.2.1 Insurers and Other Protected Bodies; 1.3.2.2 Price Regulation; Mandatory Drug Pricing; Blended Systems; Models Setting Specified Price Adjustments; Reference Pricing; Reference Pricing as a Meaningful Excessive Price Cap; Reference Pricing as a Reference Point for Predatory Pricing Cases; Market Interdependency from Blended Pricing (Potential MFN Effect); Information Exchange Concerns; 1.3.2.3 Regulation of Distribution Margins and Monopoly Distribution
Parallel Trade Restrictions1.3.2.4 Generic Entry Promotion; Legal Protection of the Substitution of Generics for Branded Drugs; Barriers to Entry from Supply Obligations; Protection of Generic Products from Reputational Denigration; 1.4 Conclusion and Draft Recommendations; 2: Australia; 2.1 The Pharmaceutical Industry and Competition Law; 2.1.1 Legislation; 2.1.2 Cases and Misuses of Market Power; 2.2 Enforcement Mechanisms, Remedies and Consumer Protection; 2.2.1 Enforcement Patterns Regarding Pharmaceutical Competition Law Issues; 2.2.2 Interaction Between Competition and Consumer Laws
2.2.2.1 Unfair Term Legislation2.2.2.2 Unconscionable Conduct; 2.2.2.3 Misleading Conduct; 2.2.3 Sector-Specific Reviews of Competition Law in the Pharmaceutical Sector; 2.2.3.1 Pharmaceutical Patents Review 2012-2013; 2.2.3.2 Competition Policy Review 2014-2015 (Harper Review); 2.2.3.3 Productivity Commission Review of Intellectual Property; 2.2.3.4 Review of Pharmacy Remuneration and Regulation 2015-2017; 2.2.4 Competition Law Guidelines Relevant to the Pharmaceutical Industry; 2.3 Patent Protection and Competition; 2.3.1 Patent Owners and Generic Drugs in Australia