Cécile Théard-Jallu
De Gaulle Fleurance, Paris
ctheardjallu@dgfla.com

Introduction

The health ecosystem - including pharmaceuticals, medical devices, biomedical and (digital) healthcare - involves numerous players collaborating from bench to bedside. Formerly reserved for collaborations with international public organizations since the mid-1940s, life sciences research in space is now expanding commercially, raising increased interest among health industry players. And for good reason: microgravity offers significant advantages for pharmaceutical development, like superior protein crystallization, more realistic three-dimensional tissue modelling and enhanced drug formulation that cannot be replicated on Earth. They accelerate drug discovery—including stem cell research and disease modelling—and improve therapeutic outcomes in domains such as aging, bone and muscle disorders or immune dysfunction. Among others, space experiments have advanced medical knowledge on Alzheimer's, Parkinson's, cancer and heart disease.^[1]

The United States National Aeronautics and Space Administration (NASA) reported in January 2026 that the International Space Station (ISS), whose construction started in 1998, has hosted over 4,000 investigations, mobilised more than 5,000 researchers and involved over 110 countries.^[2] With the ISS to be deorbited theoretically in 2030, space authorities now project towards a new commercial space stations era, ensuring post-ISS continuity for microgravity research. The transition to a commercial low Earth orbit (LEO) is a stated policy objective for both industry players and space authorities.

This shift from an exceptional orbital laboratory to a commercial environment raises fundamental legal questions regarding regulatory compatibility, value chains and the production of results usable on Earth - including pharmaceutical research governance, in-orbit manufacturing, enforcement of GMPs or GCPs and intellectual property (IP) protection. Notably, in March 2026, the United Kingdom government announced a landmark regulatory roadmap confirming that existing medicines regulations can accommodate in-orbit manufacturing, signalling that jurisdictions are beginning to address these challenges proactively. We propose to explore key legal dimensions below.

Space law does not specifically govern life sciences research in LEO but applies to it

General space law treaties

At international level, several foundational treaties govern activities in space based on the principles of peaceful use, cooperation and state responsibility. Among others, the 1967 Space Treaty provides that signatory countries bear responsibility for national activities in outer space and may be held liable for damage caused by objects launched into space. The 1972 Liability Convention and the 1976 Registration Convention further establish that the 'launching state' must register space objects and retains jurisdiction over them. Space law rules are also embedded in national legislations, including in 13 European Union Member States, while a more harmonised framework is forthcoming through the European Union Space Act (EUSA)

The Intergovernmental Agreement (IGA)

The foundational legal instrument for ISS research is the IGA, signed on 29 January 1998 by 15 Partner States, including certain EU Member States through the European Space Agency's ESA’s medium.^[3] The IGA establishes a cooperative framework for a permanently inhabited civil space station for peaceful purposes. A critical principle is that each Partner State retains jurisdiction and control over the elements it registers and over its national personnel aboard. Each ISS module is a registered object, and the owning country applies its own national law to activities conducted therein.

The European states are treated collectively as the 'European Partner', with activities aboard ESA-registered elements subject to agreements between ESA and its Member States. The applicable law for disputes is mutually agreed upon—typically seated in the country where the user has its headquarters. The IGA provides for a cross-waiver of liability for damage arising from 'Protected Space Operations,' with exceptions for wilful misconduct, bodily injury or death and intellectual property infringement.^[4]

EU law governing in-orbit pharmaceutical research, manufacturing, laboratory and vigilance: a still unsolved regulatory challenge

Since life sciences research is not specifically addressed in treaties or IGA beyond the cross-waiver, the general principle applies: if a clinical trial is conducted in a given module in LEO, the national law of the registering Partner State governs. For ESA's ISS module, the applicable law is that chosen in the ESA–user agreement, subject to EU law.

An existing clinical trial framework not specific to LEO

Under EU law, key regulatory texts govern clinical research, including EU Regulation 536/2014 on clinical trials (fully applicable since January 2022).^[5] This regulation streamlines authorisation procedures while maintaining high participant safety. Clinical trials must comply with good clinical practice (GCP) rules as defined by EU Regulation and its implementing measures.

These texts refer to 'territory'—requiring that Member States ensure compensation for subjects in trials 'conducted on their territory'—and to 'clinical site' for authorisation, inspection and adverse events reporting.^[6] By extension of the IGA's jurisdictional principles, the ISS module where a trial is conducted may be considered part of the relevant country's territory. However, GCP rules become difficult to apply when they require a terrestrial clinical site, a competent national authority or physical on-site management by a clinical team.

Pharmaceutical manufacturing in space: calling for a clearer regulatory framework

Another major development concerns in-orbit pharmaceutical manufacturing. Microgravity enables more precise drug formulation, particularly for biologics such as monoclonal antibodies, vaccines and insulin. Merck used the ISS to advance protein crystal growth research contributing to the FDA’s September 2025 approval of a subcutaneous injectable formulation of pembrolizumab (Keytruda®).^[7]

However, good manufacturing practices (GMPs)^[8]—with requirements for suitable facilities, quality controls, documentation, process validation and qualified personnel—were designed for terrestrial settings and assume manufacturing within defined national territory subject to human supervision, competent regulatory authority and on-site inspection. In-orbit automation, limited human access and remote maintenance make their implementation difficult.

Beyond GCPs, GMPs and the like, for ISS modules, the registering Partner State's regulatory authority would presumably apply. For new commercial space stations (for example, Axiom Space, Orbital Reef and Starlab), or even new space manufacturing platforms (for example, Varda Space), the applicable framework will also depend on the launching state's licensing regime and the agreements signed with their clients, services providers and other partners.

Inspiration may come from the UK. In March 2026, the UK government announced a landmark regulatory roadmap: the UK Space Agency, Medicines & Healthcare products Regulatory Agency, Research Integrity Office and Civil Aviation Authority^[9] issued a joint statement confirming that existing medicines regulations can accommodate in-orbit manufacturing ^[10]and that 'While the UK’s existing spaceflight legislation […] has already provided a flexible framework for licensing such missions, the UK government is working to provide additional clarity to support the predicted growth of manufacturing activities in the emerging in-orbit economy […] developing new guidance products and regulatory sandboxes to support innovators and investors'.

Similar challenges for pharmaceutical laboratory governance in Space

Good laboratory practice (GLP) standards in the EU are governed by Directives 2004/10/EC and 2004/9/EC. The core GLP principles—quality systems, standard operating procedures, traceability, personnel qualification and documentation—remain legally transposable to non-clinical drug testing in orbital environments. However, these directives were designed for ground-based facilities and do not account for microgravity, confinement or advanced automation. The inspection regime under Directive 2004/9/EC becomes significantly difficult to implement when testing is partially carried out in orbit. Here again, the UK example may help move forward with adapting EU legislation.

Pharmacovigilance and drug stability in space brings no exception

Pharmacovigilance—the monitoring of pharmaceutical safety post-authorisation—poses further challenges in space. Current EU regulations requirements assume terrestrial distribution chains.^[11] NASA research has demonstrated that some medications degrade more rapidly aboard the ISS, with cosmic radiation, altered packaging and microgravity affecting pharmaceutical integrity; 87 per cent of ISS medications have shelf lives under 24 months.^[12] For drugs manufactured in orbit and returned to Earth, regulators must address traceability, batch release, quality control and adverse event reporting, and determine how inspections can practically be conducted for orbital platforms.

*            *            *

IP protection for research data and results

The IGA's treatment of IP

IP rights are addressed in international space conventions from creation to possible infringement. Many intangible assets—data, products, inventions—may be used or generated aboard the ISS. According to Article 21 of the IGA: ‘for purposes of intellectual property law, an activity occurring in or on a Space Station flight element shall be deemed to have occurred only in the territory of the Partner State of that element’s registry, except that for ESA-registered elements any European Partner State may deem the activity to have occurred within its territory’.

This applies to both acquisition and protection of IP rights. An invention made in Japan’s Kibo Laboratory is deemed to have occurred in Japan, though this does not preclude filing patents worldwide. For ESA-registered elements, there is no autonomous IP regime but an organised application of national rights. ESA indicates that users’ rights and obligations are determined by their contractual framework with ESA, making ownership of results highly dependent on the contract signed.^[13]

Infringement and protective measures

The IGA's cross-waiver under Article 16 expressly excludes intellectual property claims. To mitigate infringement risk, ISS Partners have established marking procedures to protect proprietary data and a 'Crew Code of Conduct' establishes rules for personnel aboard.^[14]

National law considerations

The governing law of a module also applies to IP infringement, including exceptions. In France, Article L. 613-5 of the IP Code exempts experimental acts relating to patented inventions and objects intended for outer space. Germany provides similar experimental use exceptions (Article 11.2, Patentgesetz). Any potential infringement requires case-by-case analysis under relevant national law.

Liability, AI and the responsibility of players

Overlapping liability frameworks

For damage caused in orbit, health law, product liability, contract law and space law all overlap. Article VI of the Outer Space Treaty requires authorisation and supervision of national space activities; the 1972 Liability Convention establishes a fault-based regime for damage in space (Article III). At EU level, Directive (EU) 2024/2853 modernises defective product liability for software and digital technologies.^[15] For medical products manufactured in orbit, damage may be analysed as a product defect—raising the question of which actor bears responsibility. Compensation remains governed by general law and product liability, supplemented by space law and contractual arrangements.

AI and space-based healthcare

The EU AI Act (Regulation (EU) 2024/1689)^[16] establishes an ex-ante compliance framework centred on risk management, data governance, human oversight and post-market monitoring. It does not directly determine who pays in the event of harm but sets obligations whose breach may form the basis for liability.

As for AI-generated results as drug development and manufacturing could lead to, the AI Act regulates systems, not ownership of outputs. In patent law, the inventor must remain a natural person under European law - a principle applying equally to inventions generated with AI assistance in-orbit. The EU AI Act is not designed for in-orbit pharmaceutical activities using AI; however, EMA’s and FDA’s guidance on AI in the drug life cycle could apply to AI-driven manufacturing processes in orbit, making the intersection of space law, pharmaceutical regulation and digital governance an important emerging area.^[17]

Towards a coherent European legal framework that may impact the pharmaceutical sphere

Alongside international treaties, national legislation with dedicated space sector rules also applies. Terrestrial laws governing specific activities such as health regulations, contract law, research law, IP, consumer protection, data protection, cybersecurity, AI or environmental law must also be taken into account. Scientific and commercial space projects must  therefore reconcile international space law with these terrestrial frameworks. Yet the existing legal framework is either not specific to pharmaceutical research in space, or not adapted to it.

Beyond these texts, collaboration between competent authorities—whether from the space, research or health sectors—at national, European and international level, will be indispensable to design an adapted legal framework enabling operators to develop pharmaceutical research and production projects sustainably.

Conclusion: towards a functional adaptation of the regulatory framework

The legal framework governing pharmaceutical innovation aboard the ISS rests on a layered system of international treaties, IGAs and national laws. Territorial jurisdiction over registered elements provides a workable mechanism for determining applicable law across clinical research, manufacturing, drug stability, pharmacovigilance and IP.

However, as private sector involvement accelerates—with commercial platforms being developed ahead of the ISS's retirement around 2030—existing frameworks will face increasing strain. They were designed for localised, inspectable activities on Earth. Each regulatory block—quality, territoriality, ownership, damage, AI compliance—addresses a different issue, but none covers the entire chain of a space health activity from research to return to Earth.

A pragmatic solution would devise targeted adaptation mechanisms rather than creating autonomous space health law such as: sector-specific guidelines for applying GCP, GLP and GMP standards to orbital activities; functional equivalents to on-site inspections (real-time video audits, remote source data access, continuous digital monitoring); and strengthened contractual governance allocating roles, responsibilities, rights to results and data access among the parties involved.

The UK's March 2026 regulatory roadmap and the proposed EUSA demonstrate that authorities are beginning to address these challenges through complementary approaches. International harmonisation between the FDA, EMA and MHRA, combined with a coherent European framework reconciling safety, resilience and sustainability, will be essential to ensure space-manufactured drugs meet terrestrial safety, quality and efficacy standards. The intersection of space law, pharmaceutical regulation, good practices compliance, IP and AI governance will define a new frontier of legal practice for the life sciences industry.