Beyond Earth’s Gravity: Navigating legal hurdles in space-based drug research and development

Insights and Analysis

Beyond Earth’s Gravity: Navigating legal hurdles in space-based drug research and development

30 January 2024

In the Space and Satellite arena, technology is ever-evolving, expanding, and combining in ways never before contemplated. These innovations bring many legal, regulatory, and contractual challenges and considerations that need to be kept in mind to support the successful launch of a new business. Along with new business models (some fully or partially still on the drawing board), often come new hurdles, paradigms, and new approaches to partnering and capital raising.

In this whitepaper, we explore the history of drug development and research in space, opportunities for pharmaceutical & biotechnology companies in space, corresponding laws and regulations, and other legal considerations for companies operating in this emerging arena. We also offer tips for best practices, including corporate formalities, IP rights, permits & authorizations, logistics and transportation services, and compliance with the Law of Outer Space, with a focus on research activities occurring in low-Earth orbit (LEO).

Authored by Daniel Garcia, Mike Druckman, Andrew Strong, Barry Burgdorf, Melissa Schwaller, Randy Segal, Steven Kaufman, Alexis Sainz, and George John.