79075 - Legal Issues in Pharmaceutical Markets

Learning outcomes

At the end of the course the student is expected to reach a detailed knowledge of the enforcement of EU antitrust rules in the field of pharmaceuticals. In particular, he/she is aware of the main antitrust issues dealt with at the EU level in this field. The student especially becomes familiar with the case law developed by the EU jurisprudence in the field of pharmaceuticals. This requires from him/her an interdisciplinary approach to legal issues that touches upon intellectual property law, trade law, commercial law, and competition policy. The course is based on a Law & Economics approach that should help student in fully understanding the impact of the rules of EU competition law on national pharmaceutical policies and especially how EU institutions and Member States attempt to solve the trade-off between equity and efficiency in the provision of pharmaceutical therapies.

Course contents

Lecture 1

Introduction to EU competition law

• What is competition law?
• The notion of relevant market
• Agreements restrictive of competition
• Abuse of a dominant position

Lecture 2

The interaction between EU competition law and pharmaceutical regulation

• Economic features of the pharmaceutical market
• Forms of competition among pharmaceuticals
• Intrabrand competition: parallel traded drugs
• Mechanism of competition among pharmaceuticals: the therapeutic interchangeability
• Interbrand competition: generic drugs and biosimilar drugs
• Interbrand competition: off-label drugs
• The definition of the relevant market in pharmaceutical antitrust cases

Lecture 3

Parallel trade of medicines

• A single market for pharmaceuticals: the free movement of drugs
• Parallel trade and trademark rights
• Parallel trade and patents rights
• Anticompetitive agreements hampering parallel imports of pharmaceuticals – the Glaxo case
• Refusal to supply parallel traders as an abuse of dominant position – the Lélos case

Lecture 4

Generic and biosimilars’ competition

• Regulatory obstacles to generics
• Marketing authorization procedures
• Pricing and reimbursement policies
• Patent laws and generic entry
• Obstacles to therapeutic equivalence among biosimilars
• Biosimilars and public procurement

Lecture 5

Firms’ obstacles to generic competition

• Refusal to license IPRs – the Merck and the Glaxo cases
• Regulatory gaming – the Astrazeneca case
• Abuse of patent filing – the Pfizer case and the Copaxone case

Lecture 6

Firms’ obstacles to generic competition

• Other life-cycle management strategies: patent evergreening, patent thickets, product hopping
• The US cases on patent evergreening - product hopping

Lecture 7

Firms’ obstacles to generic competition

• “Pay-for-delay” agreements – the Lundbeck case, the J&J case, the Paroxetine case, the Teva case and the Servier case
• The US experience – the Actavis case

Lecture 8

Competition from off-label drugs

• Competition between off-label and on-label drugs – the Avastin case

Lecture 9

Excessive pricing in the pharmaceutical market

• The Aspen case
• The Flynn case
• The Leadiant case

Lecture 10

International experiences: the developing countries

• Striking the balance between innovation and accessibility 1: drug compulsory licensing – the South Africa AIDS Controversy
• Striking the balance between innovation and accessibility 2: the Indian legislation establishing therapeutic innovation as a requirement for the patentability of drugs – the Novartis case

Readings/Bibliography

Studying material can be found at https://virtuale.unibo.it. Additional reading material is indicated in the syllabus that will be uploaded in the same website.

Teaching methods

Teaching will be provided by the lecturer, but significant time is also allocated for collective discussion of the case law.

Assessment methods

Students are required to attend at least 50% of the classes.

Students who cannot fulfill this requirement shall communicate by email it at the beginning of the course. The communication shall be sent to: claudia.desogus3@unibo.it and to the tutor.

At the end of the course students have to pass a written exam lasting 1 hours and a half.

The written exam comprises multiple choice questions and open questions.

Office hours

See the website of Claudia Desogus