Innovation in the global pharmaceutical industry: the role of regulations in the EU

Abstract

We examine whether EU and its regulatory peculiarities is a driving or inhibiting force to global innovation. We focus on the pharmaceutical industry to assess whether the existing laws impair or enable factors that drive innovation in the industry. We first examined the EU institutional framework in the discovery phase of a new drug, focusing on the speed and regulatory complexity of clinical trials in the EU. We were unable to conclude that both the regulatory status quo and planned regulatory changes stimulate healthcare innovation in the EU. Second, we examined the process of obtaining marketing authorization in Europe. We concluded that it is less efficient than in the US, introducing unreasonable delays and thus stifling innovation. We conclude that EU legislation that facilitates innovation rather than hampers it should be of primary concern for EC as this would lead to a more efficient management of innovation in health care.