Healthcare in and from space: legal rules, trends and challenges

A webinar presented by the IBA Healthcare and Life Sciences Law Committee and the IBA Space Law Committee 

Space is no longer only the final frontier for exploration – it is fast becoming a new frontier for healthcare innovation. This webinar will take viewers on a journey through the legal rules, emerging trends and practical challenges shaping healthcare activities in, and from, space, from the development of life-saving health products to the critical role lawyers play in bringing these projects to life.  

Expect a wide-ranging discussion covering:
• regulatory frameworks;
• intellectual property;
• contracts;
• data and cyber security;
• telecoms;
• insurance and liability; and
• the wave of new legislation that has emerged in various regions worldwide to support the growth of healthcare in the space economy.

Our panel will bring together perspectives from around the globe – North America, Europe, the Middle East and Asia – to explore how healthcare legislation on drugs and medical devices intersects with space law, and how health and space authorities, together with leading industry players, interact on the ground (and in orbit).

A dedicated segment will zoom in on the legal dimensions of manufacturing in space that matter most for healthcare – think biomanufacturing in microgravity, protein crystallisation and sterile bioprocessing. Our speakers will unpack how international treaties and national space laws govern authorisation, ongoing supervision, insurance and liability for these activities (with a few examples such as the Italian, French, UAE and Japanese national space legislation). We will also address the impact of the proposed EU Space Act and make a transatlantic comparison with US frameworks to identify where approaches converge and where they diverge.

From there, the conversation will come back down to Earth – literally – with a look at GCP, GMP, GLP and pharmacovigilance requirements once space-manufactured products return home (and how they could rather directly apply in orbit). This will include a look at the UK government's recent initiative to bring in-orbit manufacturing into its legal framework for pharmaceutical products.

In addition to the jurisdictions represented by the panel’s co-moderators, this webinar’s international line-up illustrates just how far the space-healthcare conversation now reaches. From the US, Christie Cox brings the perspective of NASA itself, drawing on her role within the International Space Station (ISS) Division. From France, Angélique Verrecchia shares the perspective of MEDES, the space hospital that also runs the European Space Agency’s (ESA) BGSN Life Sciences Accelerator. Two industry voices, both collaborating with ESA, complete the European picture: Cyril Wyon-Boyault of Onetreck and Paul Kamoun of Space Pharma, who are developing in-orbit medical AI and drug manufacturing experimental projects, respectively. And from Asia, Ryo Okubo brings a cross-practice perspective spanning Japan and the US, rounding out a panel that truly spans continents.

We are grateful to all our speakers and moderators for lending their time and expertise to what promises to be a rich and thought-provoking session.