Antitrust in Pharmaceutical Sector Continues to Advance
Highlights and Implications of SAMR’s New Guidelines
On 24 January 2025, the Chinese State Council Anti-Monopoly and Anti-Unfair Competition Committee released the Anti-Monopoly Guidelines for the Pharmaceutical Sector (the “Guidelines”), which became effective on the same day.
The pharmaceutical sector has consistently been a major focus of antitrust enforcement in China, accounting for nearly one-third of all recent cases by the State Administration for Market Regulation (“SAMR”) and its provincial branches. The Guidelines send a clear signal of continuing to strengthen antitrust enforcement in this area, by stating explicitly that enforcement principles include continued enhancement of legal deterrence and aggravated penalties for serious violations. In terms of specific rules, the Guidelines replace the 2021 Anti-Monopoly Guidelines for the Active Pharmaceutical Ingredients Sector, and cover more products, more levels in the supply chain and more forms of business arrangements.
The Guidelines are applicable to the pharmaceutical sector, while the legal framework and analytical approaches also provide considerable reference value for medical devices, medical consumables, and other non-healthcare sectors.