Recent US efforts to introduce Most Favored Nation (MFN) drug pricing are creating new layers of uncertainty for transactions involving the commercialization of prescription medicines in the US. These policies – designed to align US drug prices with the lowest prices available in comparable countries – have the potential to reshape deal economics, launch strategies, and global pricing structures. This article outlines the current MFN policy landscape and explores how these developments may affect both…
Tariffs and shifting trade dynamics continue to disrupt healthcare and life sciences supply chains. But in addition to affecting operational and commercial outlooks for business, they are also revealing new opportunities for innovators and investors. In the final article of the series, we explore five key questions:
I. Overview of proposed key changes The Swiss Federal Act on Medicinal Products and Medical Devices (Swiss Therapeutic Products Act, TPA), which has been in force since 2002, is currently undergoing its third revision. The proposed changes are designed to improve the safety and quality of medicinal products and medical devices (therapeutic products). The changes will update the legal framework to match current scientific and technological standards, as well as international laws, especially those…
In brief In its decision of 12 September 2022 (C-1256/2020), the Swiss Federal Administrative Court (FAC) confirmed that interpretive software that uses indicators such as calendar days and body temperature to monitor fertile and infertile phases of a menstrual cycle to achieve natural conception or prevent undesired pregnancy, qualifies as a medical device. This means that such software is subject to a conformity certification procedure with a notified body. In its reasoning, the FAC primarily focused…