Hogan Lovells sets out blueprint for pharma and biotech companies to navigate the legal challenges of space-based drug research

“Decommissioning of the International Space Station (ISS) may be at least six years away, but already there’s a strong impetus among the pharmaceutical and biotechnology community to set up their own commercial space stations,” Garcia observes. “This will generate a fresh set of issues such as: will governments assert jurisdiction for actions on board their own space entities?” But the crucial query here, says Garcia, “is navigating the regulatory steps that will be taken to ensure that the data generated in space can be used for further development of the asset on Earth”.

The whitepaper notes that groundbreaking scientific discoveries have attracted the interest and attention of global companies and governments, thereby making access to space much more affordable. This ‘NewSpace’ movement brings with it new and emerging legal challenges, including on export control, commercial law, contract law, and IP issues.

Additionally, the whitepaper delves into the international and U.S. legal frameworks at play in the drug research and development process. There is a focus on pre-clinical research and two critical areas: research results and intellectual property, and legal and regulatory matters. With this front of mind, Garcia sets out his recommendations for best practice and the key steps that are intrinsic to space-based drug research and discovery projects.

Recommendations include:

• Corporate formalities – ensuring proper incorporation and qualification to conduct transactions in relevant jurisdictions
• Intellectual Property Rights – making sure the company has either ownership or control over the asset or biological material
• Permits and Authorizations – what types need to be secured before any space-related activity
• Logistics and Transportation Services and Contracts with Commercial Space Stations – negotiating suitable protection including standards of performance, contractual remedies, confidentiality, intellectual property rights, generation and storage of research results, regulatory compliance, limitation of liability, insurance coverage, indemnification obligations, governing law, and jurisdiction

The full whitepaper can be found here. 

Hogan Lovells’ Space and Satellite offering helps clients to navigate the challenges that high-profile and ‘NewSpace’ industry participants face, bringing a robust inventory of winning resolutions, unparalleled complex deal experience, a cohesive global team approach, and deep industry experience. The team is led by partners Randy Segal, Steven Kaufman, and Alexis Sainz, and senior associate George John.