Pharmaceuticals - European Commission Publishes Competition Law Enforcement Report and Declares Such Enforcement Continuing Priority
The European Commission published today an overview of the enforcement activities of the European competition authorities, i.e., the Commission itself and the national competition authorities of the 28 Member States (the “Competition Pharmaceutical Enforcement Report” or “CPER”). The CPER covers the period 2009-2017 and follows the Commission’s wide-ranging inquiry into competition in the pharmaceutical sector which in July 2009 gave rise to its sector-inquiry final report
According to the CPER, the competition enforcement activities have focused on two main objectives, namely access to cheaper medicines and access to innovative medicines.
Access to cheaper medicines
The Commission maintains that, in addition to their work in the merger control arena, the European competition authorities have made significant efforts to investigate and penalise practices that result in higher medicine prices. It offers as an example the patent settlement agreements reviewed at the European level and in the UK in order to curb market-entry delaying effects that may result from some agreements of that nature. Only last month, the Commission suffered something of a setback in that respect following the partial annulment by the General Court of decisions which it had adopted in the Servier cases (see, Van Bael & Bellis Life Sciences Newsflash of 24 December 2018).
Other enforcement cases intended to bring down medicine prices include the excessive pricing cases pursued or pending in Denmark, Italy, the United Kingdom and before the European Commission.
Interestingly, the CPER also cites the procedures conducted by the French competition authority against disparaging statements made by incumbents regarding newly launched generic rival products.
Access to innovative medicines and increase of choice
The Commission’s focus under this heading seems to be on preserving competition in pipeline products when applying the merger control rules.
When it comes to classical competition enforcement, the Commission again refers to its actions against attempts to delay generic market entry. The Commission considers such action necessary to guarantee the end of the innovator’s market exclusivity and spur further innovation on the innovator’s part.
The CPER concludes by making it clear that enforcement of the competition rules in the pharmaceutical sector “remains a matter of high priority”. The Commission says it will pay particular attention to new industry practices and to new market trends such as the emergence of biosimilars.
At the same time, the Commission acknowledges that “there are limits to what competition law can do”. It specifies that sustainable access to affordable and innovative medicines will depend on the efforts of all stakeholders, including the pharmaceutical sector, governments and regulators, health care providers and patients. For good reason, the CPER not only discusses the application of the competition rules but also repeatedly refers to regulatory action.
The Commission issued today the following documentation:
- European Commission press release of 28 January 2019;
- Report from the European Commission to the Council and the European Parliament – “Competition enforcement in the pharmaceutical sector (2009-2017)”;
- List of antitrust enforcement decisions in the pharmaceutical sector;
- Market monitoring and advocacy actions in the pharmaceutical sector undertaken by the European competition authorities in the period 2009-2017.