Antitrust Guidelines for the Pharmaceutical Sector Issued, Establishing a Full-Chain Regulatory System

On January 23, 2025, the State Council Anti-Monopoly and Anti-Unfair Competition Committee issued the Antitrust Guidelines for the Pharmaceutical Sector (the “Guidelines”), effective immediately, targeting prominent monopoly issues in the pharmaceutical sector. The Guidelines cover the production and business activities of all pharmaceutical fields, including traditional Chinese medicine, chemical drugs, and biological products, establishing a full-chain regulatory system for pre-event, in-event, and post-event supervision.

The Guidelines further detail typical monopoly agreement behaviors in the pharmaceutical sector in the chapter on monopoly agreements, explicitly prohibiting pharmaceutical operators from jointly setting prices, dividing sales markets, restricting the production or supply of pharmaceuticals, and other actions to effectively regulate related issues. In the chapter on abuse of market dominance, the Guidelines prohibit behaviors such as unduly raising drug prices through multiple layers of invoicing, delaying or stopping drug supply to gain unfair competitive advantages, and hold accountable parties involved in illegal activities in related distribution links, thereby increasing the specificity and authority of law enforcement. The issuance of the “Guidelines” helps pharmaceutical sector operators deepen and unify their understanding and recognition of the application of the Anti-Monopoly Law in this field. The rules are comprehensive, clear, and explicit, helping pharmaceutical companies effectively prevent and mitigate legal risks, and jointly create a market environment of fair competition in the pharmaceutical sector.