EU Law of Competition and Trade in the Pharmaceutical Sector, Edward Elgar, 2019, xlix + 804 pages
Edited by Pablo Figueroa and Alejandro Guerrero
The research-based pharmaceutical industry has played a critical role in the last twenty years in the European economy. Just to give a rough idea of the economic relevance of this sector, the size of the pharmaceutical market has grown from €89 billion in 2000 to €202 billion in 2016. It directly employs 750,000 people and generates three to four times more employment indirectly – upstream and downstream. On top of that, the pharmaceutical industry is highly innovative, which means that research and development (R&D) is a crucial and very costly element for the sector. In 2017 the pharmaceutical industry invested an estimated €35 billion in R&D in Europe. Considering the economic impact and the obvious concerns for consumers’ health, it is no surprise that competition authorities look at this sector very closely and that it is heavily regulated.
Published in the excellent Elgar Competition Law and Practice series, the book provides a systematic and up-to-date analysis of the law and practice of EU competition and trade in the pharmaceutical sector. It is edited by two experienced practitioners, Pablo Figueroa and Alejandro Guerrero, and contains twenty contributions authored by leading private practitioners, economists, scholars and officials at competition regulators.
Looking at the content, the first contribution that addresses a fundamental competition issue for the sector: the role of innovation in the assessment on competition and market outcomes is particularly interesting. With a remarkably simple and clear style, the author explains the tension between innovation and price competition, and how patents play a pivotal role in finding the right and sustainable balance. It also addresses the tension between the price setting of medicines and the objective of market integration, as well as the other fundamental issue of exercising market power. Reading this first chapter is highly recommended as it provides the essential tools to better understand the legally complex discussions in the following chapters.
Practitioners and in-house counsel dealing with merger filings will be delighted to know that two contributions (Chapters 6 and 7) are dedicated to mergers in the pharmaceutical and medical device sectors, respectively, providing a thorough examination of the Commission’s practice. Chapter 9, on EU trade law with regard to pharmaceuticals, addresses the uncomfortable and difficult balance between the protection of intellectual property rights and free trade and public health.
Other notable topics addressed are: reverse payment settlements, from a comparative perspective (EU and US); competitive assessment of IP licensing in the pharmaceutical sector; and the regulatory framework for medical products for human use.
The table of cases is worth mentioning. It includes, in addition to references from EU and US courts, many cases from several European jurisdictions. This element gives an idea of the thorough consideration of jurisprudential developments in some of the prominent and most active jurisdictions in Europe. Also worth mentioning is the extremely detailed index (44 pages) that helps navigate the numerous topics and issues addressed in the book.
In conclusion, the topics are very interesting, the contributions are well researched and practical in their approach and are very readable in style. A must-have book for academics and practitioners involved in the pharmaceutical sector.
Riccardo Sciaudone
Head, European Law Observatory
Reviewed June 2020