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Dissertation
Immaterialgüter- und Wettbewerbsrecht

The Application of Competition Law in the Control of Excessive and Unfair Pricing of Pharmaceuticals: An EU and South African Perspective

The promotion of access to medicines through price control under competition law has enormous social and innovation policy implications, but there is no certainty regarding which cases and under what conditions competition law should be applied to control excessive prices in pharmaceutical markets.

Letzte Änderung: 26.10.21

The seminal United Brands case of the ECJ set down some principles pursuant to Article 102(a) TFEU, which have influenced the enactment of Section 8 of South Africa’s Competition Act, No. 89 of 1998 on prohibition of excessive prices, in particular, and the development of exploitative excessive pricing cases in many  markets. The outcomes of these cases have not only created uncertainty in the application of the existing principles in both theory and practice, but have also questioned the effect that such ex-post intervention by competition authorities may have on innovation. The existing excessive pricing cases on pharmaceuticals in the EU and South Africa involve small molecule-based generic medicines, which patients receive under the traditional medical care model in particular. The scope of this research covers both generic and patented small molecule and biological molecule-based drugs, which patients receive under different medical models including personalized medicines. The main research question is whether competition law should be used to control excessive or unfair prices of pharmaceuticals and if so, to what extent?

The research contextualizes and provides an understanding of EU and South African exploitive excessive prices provisions from a global perspective. It also analyses the case law principles espoused by competition authorities from multidisciplinary perspectives including economics, competition law, patent law, pharmaceutical regulation, price regulation and public health. The analysis takes into consideration the varying policy objectives of the applicable laws and regulations as well as the socioeconomic circumstances of the said jurisdictions. The research discusses two broad themes - the sustenance of innovation in the pharmaceutical industry and access to affordable medicines. The research balances the underlying interests of the key pharmaceutical market players.

One part of the research sets a theoretical framework using the doctrinal research approach. The other main parts cover the categories of medicines that I have identified and their use under different medical models. In order to ascertain the possible outcomes of applying existing legal principles to patented medicines and other medical models, the research uses a normative approach. The project also discusses remedies for excessive pricing regarding pharmaceuticals. Generally, the research uses comparative analysis that provides new insights about the state of the practice in other jurisdictions.

The expected outcome of this research is that competition law authorities may intervene in excessive pricing cases involving pharmaceutical markets under some specific circumstances. The research conceptualizes what the criteria for intervention by competition authorities in pharmaceutical markets ought to be.

Personen

Doktorand/in

Isaac Kundakogo Kunko

Forschungsschwerpunkte

I.4 Fairness als Rechtsprinzip