Excessive pricing of medicines is a problem for all developed and developing countries alike. Some jurisdictions promote access to medicines through price control under competition law. However, excessive pricing creates conceptual and practical difficulties for competition authorities and practitioners especially when it involves dynamic markets. Article 102(a) TFEU and the principles set down in the seminal United Brands case of the ECJ have influenced the enactment of Section 8(1)(a) of South Africa’s Competition Act, No. 89 of 1998. However, there is uncertainty about the application of these excessive pricing rules to pharmaceutical markets. Whilst an ex-post intervention by competition authorities can make drugs more affordable, it can negatively affect the sustenance of innovation and the availability of new and improved medicines in the future. This is especially the case when the intervention concerns products still under patent protection.
Excessive pharmaceutical pricing cases in the EU, so far, mostly relate to small-molecule off-patent medicines. By a systematic review, the project answers a preliminary question on the status and nature of exploitive excessive prices rules under competition law. It views the EU and South African laws from a global perspective. However, the main research question is whether control of excessive pharmaceutical prices is justified under competition policy, and if so, in which cases, and under what conditions it ought to be done. The project explores this question in respect of patent and off-patent versions of small molecule medicines and biological medicines that are applied in conventional medical treatment models and personalized medicine treatments. It also deals with how the excessive exploitative rules should be applied to biosimilar markets as well as personalized medicine markets under competition policy. These research questions are answered using a normative approach. It also adopts a comparative analysis to provide new insights into the state of the practice in other jurisdictions.
The scope of the project covers competition law, patent law, pharmaceutical regulation, and their respective policy considerations regarding access to medicines. Further, the research analyzes the economic, public health, and human rights perspectives of access to medicines.
Besides the introduction and conclusion, each chapter of the dissertation addresses a separate research question. The expected project outcome will provide specific guidance for applying exploitative excessive pricing rules to all pharmaceutical markets under competition policy.