Antitrust in pharmaceutical markets & geographical rules of origin

Abstract

This book gathers international and national reports from across the globe on key questions in the field of antitrust and intellectual property. The first part discusses the application of competition law in the pharmaceutical sector, which continues to be a focus for anti-trust authorities around the world. A detailed international report explores the extent to which the application of the competition rules in the pharmaceutical sector should be affected by the specific characteristics of those products and markets (including consumer protection rules, the need to promote innovation, the need to protect public budgets, and other public interest considerations). It provides an excellent comparative study of this complex subject, which lies at the interface between competition law and intellectual property law. The second part of the book gathers contributions from various jurisdictions on the topic of "What rules should govern claims by suppliers about the national or geographic origin of their goods or services?" This section presents an international report, which offers an unparalleled comparative analysis of this topic, bringing together common themes and contrasting the various national provisions dealing with indications of origin, amongst other things. The book also includes the resolutions passed by the General Assembly of the International League of Competition Law (LIDC) following a debate on each of these topics, which include proposed solutions and recommendations. The LIDC is a long-standing international association that focuses on the interface between competition law and intellectual property law, including unfair competition issues. 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