Overview of EU regulatory and competition law in the Pharma sector

We are pleased to announce that, for the fourth consecutive year, our in-depth guide to EU pharmaceutical competition and regulatory law, drafted by our competition and IP life sciences teams, has been published in Lexology's Panoramic guide (formerly Getting the Deal Through): Pharmaceutical Antitrust.

This publication provides a comprehensive overview of competition law and regulation relevant to the pharmaceutical sector across several jurisdictions. It covers legislation and enforcement authorities, public and private enforcement and remedies, sector inquiries, involvement of health authorities and NGOs; mergers review; anti-competitive agreements; anti-competitive unilateral conduct; pharmaceutical regulatory law (framework, authorities, pricing, distribution and intersection with competition law); as well as recent trends.

This year's edition includes the latest updates on EU competition law and regulatory developments in the sector, including:

• Concluded investigations by the Commission into abuse of dominance through disparagement campaigns against competitors – in the Vifor Pharma and Teva/Copaxone cases – the first of their kind brought by the Commission. In a landmark decision, the Commission found that Teva had abused its dominant position by artificially extending patent protection through the strategic use of divisional patents and litigation. The Teva/Copaxone case is particularly significant, given the frequent use of such strategies in the pharmaceutical sector.
• Ongoing antitrust investigations by the Commission, including those into Edwards Lifesciences for allegedly employing anti-competitive patent strategies to exclude 'copycat' competitors, and Zoetis, a global animal health company, for allegedly abusing its dominant position to block the launch of a rival product.
• The Commission’s first cartel sanction in the pharmaceutical sector, concerning the N-butyl bromide scopolamine/hyoscine (SNBB) cartel.
• Recent EU case law, including the CJEU’s ruling in the long-running Illumina/Grail case, which overturned the Commission’s use of Article 22, and further challenge to the Commission’s ‘call-in’ powers in Nvidia/Run:ai.
• The CJEU's recent ruling in Servier and Advocate General's opinion in Teva/Cephalon which provide further guidance on the Commission’s approach to pay-for-delay agreements.
• The Commission's review of several key instruments that will affect the application of competition law to the sector, including its horizontal and non-horizontal merger guidelines with focus on innovation, efficiency, resilience, investments, intensity of competition in certain strategic sectors, sustainability and other transformational priorities of the European economy. The review also includes the Technology Transfer Block Exemption Regulation.
• The impact of strategic reports—including the Letta Report, the Draghi Report, and the Competitiveness Compass—on shaping the priorities of the new European Commission.
• The Foreign Subsidies Regulation and its implications for pharmaceutical transactions.

Our EU chapter can be accessed online here. The full guide can be accessed here (subscription required).