Advancements in the field of biotechnology have accelerated the development of new drugs that are manufactured from cultures of living cells, commonly referred to as ‘biologics’. Due to the complexity of the production process, generic biologics are unlikely to be chemically identical to the reference product, and accordingly are referred to as ‘biosimilars’ or ‘follow-on biologics’.
Encouraging the development of biosimilars has been presented as the key solution to decrease prices and increase access to biologics, but the development and use of biosimilars continues to raise problems, none of which can easily be addressed. In addition to the fact that developing a biosimilar requires considerable time, effort and financial resources, legitimate safety concerns necessitate elaborate clinical testing of (candidate-) biosimilars. As a consequence, the introduction of biosimilars onto the market has not resulted in significant price reductions, and concerns regarding the substitution and interchangeability of original biologics with biosimilars persist.
This seminar will discuss how a unique interplay of patent protection, regulatory exclusivity and trade secrets has so far shielded the biopharmaceutical industry from substantial generic competition. The biologics production process distorts the trade-offs that traditionally guided both patent protection and regulatory exclusivities: disclosure as key condition for benefiting from the corresponding monopoly position. Hence, instead of spending time and resources on the development of something that already exists, we need to consider a more robust mechanism mandating the disclosure of the original biologic’s cell line and the manufacturing process information.
Lisa Diependaele obtained a MA in Moral Sciences (Ethics) at Ghent University in 2011, and a LLM in International and European Law at the Vrije Universiteit Brussel (VUB) in 2012. After completing a traineeship at the European Commission (DG Research & Innovation) in 2013, she was appointed as assistant academic staff at the Department of Philosophy and Moral Sciences at Ghent University. Her research focusses on ethical issues relating to the protection of intellectual property rights (patents and data exclusivity) and investment in international law.