Excessive pharmaceutical pricing and repercussions on paediatric health services

Context: Paediatric pharmaceutics have a significant share in expensive drugs. Recent years have seen significant calls for interven- tion against high prices for pharmaceutical products. The prohibition of prices that are excessive as a form of abuse of dominance is considered as Competition law violation in the European Union Law and national legal orders of its Member States. Majority of the Organization for Economic Cooperation and Development (OECD) member countries have similar prohibitions in their respective Competition laws with important exemption of United States (US) Antirust Law, although there is some indication of change in US exactly in the area of pharmaceutical sector. Regulation of excessive prices also exists in Competition laws of all BRICS (Brazil, Russian Federation, India, China, and South Africa) countries. The problem of excessive prices in pharmaceutics is one of the emerging themes in Competition law literature and case law development. This is the area where intellectual property rights, usually patent protection, collide with competition rules. Costs of research and development for such pharmaceutics are often very high emphasizing the need for balance between colliding legitimate interests: access to health and research development. Aim: To present regulatory and case law development of application of excessive prices as form of abuse of dominance in pharma- ceutical sector with emphasis on paediatric health services. Data source: OECD, PubMed, Google Scholar, Scopus. Conclusion: Balance between competition rules on excessive prices as form of abuse of dominance and intellectual property rights in the area of expensive paediatric pharmaceutics can be regarded as suboptimal. Thus, there is a need for further regulatory devel- opment and application of rules on excessive prices in that field.

Read more