Excessive pharmaceutical pricing cases in EU have progressed from a theoretical possibility to becoming a recurrent enforcement reality, following heightened law and policy attention on affordability of medicines. This matter gained considerable momentum in the wake of COVID-19 crisis as result of the increased health spending, with debates on affordability raging at WTO and WIPO levels. Unfair pricing in European competition law under Article 102a TFEU denote prices set by a dominant undertaking, capable of affecting trade between member states or in a substantial part of the Union, which do not have a reasonable relationship with their ‘economic value. The main points of dispute in previous jurisprudence and doctrine have concerned the definition of ‘reasonable’ and ‘economic value’ and the calculation of ‘excessiveness’ and ‘unfairness’, as per the seminal assessment test developed by the CJEU in its United Brands case. Although previously described as a ‘rarity’ in competition law, such excessive pricing cases can now be found in Italy, UK, Denmark and Netherlands but also on the DG Competition level. The investigation into Aspen's pricing practices by the European Commission, ending in a commitment decision whereby Aspen reduced prices by 73%, represents a historic case, capable of providing some guidance in this area of law and policy, seen against the doctrinal adversity to the prohibition. As intellectual property law and competition law, on the one hand, and policy issues related to Right-to-Health, affordable healthcare and pharmaceutical innovation on the other hand, interact to a high degree in this context, there is room for reflection on the role of competition law related to fair pricing of medicines. Following the introduction, the article will briefly recount the legal framework in European competition law related to excessive pricing. The third section will elevate the law and economics arguments related to excessive pharmaceutical pricing . The fourth section will detail the recent excessive pricing cases in the pharmaceutical sector. The fifth section will depict the assessment and decision by European Commission in the Aspen case. The sixth section analyses the Commission decision regarding definition of relevant market, dominance, thresholds and benchmarking and other unresolved issues relating to such enforcement. The seventh section concludes.

Towards Fair Pricing of Medicines?

ivySCI AI Smartly Parses PDF, Answers Researchers' Questions, and Helps You Understand Papers in Seconds

Journal Info