China introduces new anti-monopoly rules for the pharmaceutical sector

Anti-Monopoly Commission has issued new regulations targeting the pharmaceutical industry. One of the key aspects of the new guidelines is the regulation of online platforms involved in pharmaceutical e-commerce and telemedicine. For the first time, measures have been introduced to prevent monopolistic practices in online medicine sales, prohibiting platforms from misusing data, algorithms, or platform rules to limit competition.

The guidelines also expand their scope to cover the entire pharmaceutical supply chain, including traditional Chinese medicine, chemical drugs, and biological products. This marks a significant change from the previous regulations, which focused primarily on active pharmaceutical ingredients (APIs).

Another major focus is addressing “false innovation” through a practice known as “product hopping.” This occurs when pharmaceutical companies introduce a slightly modified version of a patented drug just before the original patent expires. This strategy can delay the entry of generic alternatives and potentially constitute an abuse of market dominance. The new rules set criteria to assess whether a new patented drug represents a substantial improvement in efficacy, safety, or utility.

The guidelines consist of seven chapters and 55 articles, providing detailed interpretations of monopolistic practices, enforcement principles, and violation criteria. The aim is to create a comprehensive framework to combat anti-competitive behavior in the pharmaceutical sector.