Antitrust Regulatory Framework for Excessive Pricing of Off-patent Drugs
Once a drug patent expires,it should enter the public domain.But in order to prevent a decline in profits,pharmaceu-tical companies often resort to"de-branding"and licensed imitations as a commercial strategy to implement excessive pricing,seriously reducing the affordability of medicines for the public and undermining the interests of social public health.In the ab-sence of a regulatory system for drugs,a regulatory framework should be sought from the antitrust law.Starting from Article 22 of the Antimonopoly Act,three levels of analysis should be conducted,including the determination of market dominance,the appli-cation of the"unfairly high price"analysis,and the defense of"unfairly high price"for standard analysis.In determining market dominance,market share should be used as the initial criterion,supplemented by two formal criteria,namely,contractual barri-ers due to exclusive distribution agreements for APIs,regulatory barriers due to drug approval procedures,and the substantive criterion of timeliness of potential competition.When applying the"unfairly high price"analysis method,the cost-price analysis method should be revised and implemented,with the actual costs incurred as the basis for judging the price,and reasonable profit margins defined in cooperation with the regulatory body of the pharmaceutical industry.When the"unfairly high price"defense is narrowed,two non-price factors,consumer reliance due to lack of competition and the fact that the patent on the medicine has not yet recovered its costs,should be excluded.
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维普
