Concentrations in the EU pharmaceutical sector : The protection of effective competition under Council Regulation No 139/2004 on the control of concentrations between undertakings

Sammanfattning: A central element of competition law consists in the control of concentrations, that is, the changes in the competitive structure resulting from mergers and acquisitions. By controlling concentrations with a Union Dimension, the European Commission ensures that effective competition will not be significantly impeded, in particular by the creation or strengthening of dominant positions. Within the EU, the central legislation is Council Regulation (EC) No 139/2004 of 20 January 2004 on the control of concentrations between undertakings. Under the Regulation, the Commission has the power to declare concentrations incompatible with the internal market and prohibit them in whole or in part. The dissertation examines the Commission's application of the Regulation in the pharmaceutical industry. The pharmaceutical industry exhibits many special features in comparison with other economic sectors, not least because it comprises extensive sector-specific regulation governing the development, manufacture and sale of pharmaceutical products.The study comprehensively explores situations where the control of concentrations is affected by the special conditions characterising the market for pharmaceuticals. Besides providing an overview of the reasons why mergers and acquisitions should be checked, the contents of the Merger Regulation, and the relevant sector-specific regulation, the dissertation examines the definition of the relevant market for pharmaceutical products, how the substantive test in the Regulation is interpreted and applied, and the remedies that may be necessary when pharmaceutical companies merge.