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Scientific research aboard the International Space Station: How does this work from an EU and French law perspective?

Thursday 7 October 2021

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

Carlyne Sevestre
De Gaulle Fleurance & Associés, Paris
csevestre@dgfla.com  

Emma Lucas
​​​​De Gaulle Fleurance & Associés, Paris
elucas@dgfla.com

Pascale Altier
General Manager, VBO Consulting
pascale.altier@gmail.com

Introduction: An interview on the evolution of research in Space​​​​​​​

‘Nothing inspires like Space’

Life sciences ecosystem addresses many challenges, in numerous sectors – including biotech, digital health, medical devices and pharmaceuticals – ranging from companies developing and testing treatments and prospective vaccines to those involved in developing biomedical devices or manufacturing personal protective equipment, medical supplies or other key components.

From bench to patient’s bed, many players – public, private, hospitals, universities, investors, technology transfer offices and more – are working on the entire value chain for creation.

The executive has many programmes to finance research and development, massive investments, simplification and decompartmentalisation between public and private research actors in France, and support for the financing and innovation of biotech and medtech companies.

Up to now, most of the developments have happened on Earth, in laboratories. The results obtained are used to improve, modify and develop the next phases of the projects until the final product is commercialised.

To improve product development in life sciences, new concrete solutions also appear, from space, with specific facilities aboard the International Space Station (ISS). Space can indeed provide a unique environment to support and accelerate research and innovation, especially for health applications. Several platforms on the ISS provide strong support for multi-partner innovation projects with applications for health on earth.

Many experiments have already been performed in space in the field of human health, biology or biotechnology. The specific properties of the space environment, in particular the near absence of gravity have a unique effect on many biological and physical systems that cannot be studied on Earth. For example, the lack of gravity induces an environment with no sedimentation, no convection and no phase separation phenomena, but with increased surface tensions.

Among the scientific topics and research conducted in space, one can find aging models, studies on bone or muscle disorders, investigations on immune dysfunction, but also studies on protein crystallisation, stem cell research and disease modelling on biomarkers, microbial studies to name a few.

A variety of life science investigations aim to push the limits of research and innovation both to improve patient care on Earth and to help astronauts live and work in space for future long duration flights.

Up to now, space platforms were mainly used by academic laboratories. European space stakeholders are strongly willing to involve more private actors and companies by providing support into the development of their R&D in space. In the space field, new services and platforms are emerging to answer the needs of the private health sector.

Some initiatives have already been launched to stimulate business partnerships and foster the development of communities between space and non-space actors. The first vertical market selected is the life sciences market.

MEDES, France Biotech and VBO consulting are the stakeholders of a new initiative, dedicated to bridge the gaps between the space and the health sector for innovations, with a specific focus on the biomanufacturing ecosystem.

The past 20 years have allowed a tremendous amount of research and technological development activity aboard the ISS and have demonstrated applications and benefits for medical research on earth and for the development or evaluations of new products and new innovations in the health sectors. The New Space sector offers opportunities with new services and platforms to support industrial research, using the unique properties of space environment to accelerate innovations in life sciences, such as for biomanufacturing.

The International Space Station

In 2020, the International Space Station (‘ISS’) celebrated 20 years of continuous human presence aboard its orbiting laboratory.

Many experiments have been conducted throughout the years in the ISS and have helped significantly develop medical knowledge on diseases such as Alzheimer’s disease, Parkinson’s disease, cancer, asthma or even heart problems. Without the interference of gravity, the space station-grown cells develop themselves better than those on Earth and can help test new properties, behaviours and treatments.[1]

As an example, in 2015, physiological, molecular and cognitive experiments were performed on Scott Kelly during his time in the ISS and on Mark Kelly, his twin brother, who stayed on Earth, in order to compare the effects on the human body of a journey in Space.[2] Over ten billion miles of DNA were involved in the Twins Study.[3]

Important medical experiments have also been conducted in space with regards to the effects of gravity on the human body and particularly on bone loss and vision changes.[4]

Some others focused on the evaluation of new molecules of interest, using the unique properties of space as an accelerated but reversible model of ageing including muscle loss, serving R&D programs on earth, for instance by the Amgen pharmaceutical laboratory.

Astronauts aboard the ISS participate in numerous scientific experiments. For example, Thomas Pesquet (the French astronaut currently present in the ISS) uses the Everywear app, designed by MEDES for the CNES (ie, the French National Space Center), which collects his health data on a daily basis (nutrition, symptoms, sleep quality, etc).[5] He also uses the Echo echographer, which can be operated from Earth and helps study his blood circulation. This may benefit isolated populations in a foreseeable future. Experiments, such as the GRIP-GRASP-Perspectives programme, aim to better understand how the neuro system works and may help people suffering from motricity diseases.

In the middle of the Covid-19 pandemic, experiments in space have proven to be of particular interest. Among others, research on a treatment against Covid-19 is currently being conducted with the Remdesivir drug.[6] This project is led by two Hungarian companies, while Hungary is a Member State of the European Space Agency (ESA) and the EU.

Many questions arise when faced with a scientific experiment aboard the ISS, including that of determining which law shall apply. While there are different international conventions that help understand the legal framework, they do not apply to scientific or even health experiments specifically, which brings us back to applicable law on Earth. Scientific data is used or may be generated during these experiments and leads to wonder how this may be protected by intellectual property while on board the ISS.

1. Applicable law aboard the ISS

Activities in space are ruled by international conventions and only some of them deal with activities aboard the ISS.

1.1 A first key international legal instrument is the International Space Station Intergovernmental Agreement

The first landmark legal instrument relating to the topic of this article is the International Space Station Intergovernmental Agreement, commonly referred to as the ‘IGA’.[7] It was signed on 29 January 1998 by the 15 governments involved in the ISS project (Space Station ‘Partner States’[8]), including Canada, Japan, the Russian Federation, the United States[9] and the ten member states of the ESA.[10] This government-level treaty establishes ‘a long term international co-operative framework on the basis of genuine partnership, for the detailed design, development, operation, and utilisation of a permanently inhabited civil Space Station for peaceful purposes’ (art. 1).

It sets up a legal framework for the ISS’s activities and provides that the ISS shall be operated and developed in accordance with international law (‘including the Outer Space treaty, the Rescue Agreement, the Liability Convention and the Registration Convention’, art.1).

The IGA allows the Space Station Partner States to extend their national jurisdiction in outer space, so that the elements they provide (eg laboratories and equipment) are assimilated to the territories of the Partner States. Under this principle, each partner shall retain jurisdiction and control over the elements it registers and over national personnel in or on the ISS (Article 5 of the IGA). In other words, the owners of the ISS are legally responsible for the respective elements they provide and the nationals representing them aboard.

Note that the European States are being treated as one homogenous group of entities, collectively called the ‘European Partner’ on the ISS. While a European States member of the ESA may extend their respective national laws and regulations to the European elements, equipment and personnel being sent aboard the ISS are subject to an agreement they have signed with the ESA (see below in section 1.2).

This extension of national jurisdiction helps in determining what laws are applicable for activities occurring on a given Partner Spate’s element (eg, a module of the ISS, such as the European Columbus Laboratory). This legal regime recognises the jurisdiction of a given Partner State’s courts and the enforcement of national laws in the various areas of law involved (eg, criminal matters, liability issues and protection of intellectual property rights. On this last issue please see our developments below in section 3). Any conflicts of jurisdiction between the Partner States will then be resolved through the application of other national or international rules and procedures involved.

Among other principles, note that:

  • Article 16 of the IGA provides for a cross-waiver of liability pursuant to which each Partner State, or their related entities,[11] waives all claims against any other Partner State or its related entities. This is based on any damage arising out of ‘Protected Space Operations’, which includes research, design, development and testing, among other activities.[12] This cross waiver applies only if the person, entity or property causing the damage, or being damaged, is involved in such ‘Protected Space Operations’. This obligation is to be reflected in contracts signed between each Partner State and its related entities.
    ​​​​​​​Some exceptions to the cross-waiver of liability exist. Such as exceptions arising between a Partner State and its own related entities, or the ESA and any of its users. This is dependent on separate agreement terms that do not necessarily involve other Partner States. Other exceptions also include claims for damages caused by wilful misconduct, a bodily injury or death or intellectual property.
  • Article 22 of the IGA stipulates that each Partner State is responsible for their nationals and may therefore exercise any criminal jurisdiction over them.

While the US holds the leading role for IGA’s overall management and coordination, four Memoranda of Understanding (‘MoUs’) were signed in 1998 between the National Aeronautics and Space Administration (NASA) and each co-operating Space Agency:

  • European Space Agency (ESA);
  • Canadian Space Agency (CSA);
  • Russian Federal Space Agency (Roscosmos); and
  • Japan Aerospace Exploration Agency (JAXA).

The objective of these space agencies-level agreements is to ‘describe in details the roles and responsibilities of the agencies in the design, development operation and utilisation of the Station. In addition, the agreements serve to establish the management structure and interfaces necessary to ensure effectively the utilisation of the Station’.

Beyond the IGA and those MoUs, various bilateral implementing arrangements between the involved space agencies have been found to implement the MoUs, specifying guidelines and distributing tasks among them on the field.

1.2 Interaction with other general space law treaties

The IGA is not the only legal instrument that needs to be taken into account. Among other texts, the ‘Declaration of Legal Principles Governing the Activities of States in the Exploration and Use of Outer Space’ published in 1962 (Resolution XVIII) established the main principles that should apply in outer space:​​​​​​​

  • The outer space and its exploration should be carried out for the benefit and interests of mankind;
  • The outer space shall remain free for exploration on a basis of equality in accordance with international law;
  • The outer space cannot be subject to national appropriation by claim of sovereignty;
  • The activities led in outer space shall be carried out in accordance with international law;
  • States shall bear the responsibility for national activities led in outer space;
  • States shall co-operate, provide mutual assistance, and respect the interests of other States in outer space; and
  • Any State that launches and registers an object into outer space shall retain jurisdiction and control over that object.

For its part, the ‘Treaty on Principles Governing the Activities of States in the Exploration and Use of Outer Space, including the Moon and Other Celestial Bodies’ (hereafter ‘Space Treaty’) entered into force in 1967. Under this Space Treaty:

  • Signatory countries shall bear responsibility for national activities in outer space carried on by their nationals (astronauts), governmental agencies or non-governmental entities (art. VI);
  • Any signatory country launching an object into outer space may be held internationally liable for damage caused by this object to another signatory country or its naturals (art. VII);
  • A signatory country having registered an object launched into outer space will retain jurisdiction and control over this object (art. VIII).

When the IGA’s signatory countries are involved in ‘Protected Space Operations’, such as research, it is important to keep the IGA’s cross-waiver of liability in mind despite the 1962 Declaration and the 1967 Space Treaty. While the latter provide that States are responsible for the activities led by their nationals in outer space, the IGA brings a derogation regarding the so-called activities conducted aboard the ISS (with the exceptions mentioned above in section 1.1).

In 1972, another treaty called the ‘Convention on International Liability for Damage Caused by Space Objects’ (hereafter the ‘Liability Convention’) entered into force. Under this Liability Convention, ‘In the event of damage being caused elsewhere than on the surface of the earth to a space object of one launching State or to persons or property on board such a space object by a space object of another launching State, the latter shall be liable only if the damage is due to its fault or the fault of persons for whom it is responsible’ (art. III).  

Alongside these international texts, the ‘Convention on Registration of Objects Launched into Outer Space’ (hereafter the ‘Registration Convention’), entered into force in 1976. It aims to provide a framework for the launch of space objects with a registration system.

Pursuant to Article II of the Registration Convention, registration depends on the ‘launching State’, while the launching State is defined in Article I as (i) a State which launches or procures the launching of a space object or (ii) a State from whose territory or facility a space object is launched. The rules are as follows:

‘1. When a space object is launched into earth orbit or beyond, the launching State shall register the space object by means of an entry in an appropriate registry which it shall maintain. Each launching State shall inform the Secretary-General of the United Nations of the establishment of such a registry.

2. Where there are two or more launching States in respect of any such space object, they shall jointly determine who among them shall register the object in accordance with paragraph 1 of this article, bearing in mind the provisions of article VIII of the Treaty on principles governing the activities of States in the exploration and use of outer space, including the moon and other celestial bodies, and without prejudice to appropriate agreements concluded or to be concluded among the launching States on jurisdiction and control over the space object and over any personnel thereof.

According to Article VII of the Registration Convention, ‘references to States shall be deemed to apply to any international intergovernmental organization which conducts space activities if the organization declares its acceptance of the rights and obligations provided for in this Convention’.

The modules that form the ISS may be considered as objects thrown into space and shall be registered by each relevant State/Agency, according to the Registration Convention. As a consequence, aboard the ISS, each country or agency having signed the IGA owns its own module (the United States even has two modules of its own).

It results from the above that:

  • Any object launched into space by one country and its related entities shall be governed by the law of that country, for instance the Japanese module and objects shall be subject to Japanese law, the US modules and objects shall be subject to US law, etc.
  • As for the ESA’s module and objects, a specific law chosen among the national laws of EU Member States being part of the ESA shall be identified, under contracts between ESA and those Member States or users.[13] These contractual provisions will help grasp which law applies to experiments aboard the ISS when conducted by EU Member States and how.

These contracts are apparently not made public.

In practice, the ESA specifies on its website that as part of their contract with ESA, ISS users will agree on a cross waiver of liability, stating that each party will not bring claims in arbitration or sue the other party as a result of ISS activities. The applicable law for disputes and the detailed procedures in case of arbitration will be decided mutually by the ISS users and ESA in the contract they shall sign. The latter will specify the country where the arbitration court shall sit, that is usually in the country where the user has his headquarters.[14]

2. What about the law governing scientific research and more especially clinical trials or investigations or performance studies aboard the ISS?

According to the Space Treaty, ‘A State Party who has registered an object launched into outer space will retain jurisdiction and control over this object’ (art. VIII).

As seen above, if an activity is led in one of the modules aboard the ISS, the law governing that activity should be the law of the country having registered the said module (or the national law chosen in the agreement between the ESA and the ISS user suing the ESA module).

Except for Article 16 of the IGA providing for a cross-waiver of liability for damage sustained as a result of activities aboard the ISS, including research, scientific research is not a subject that is specifically dealt with from a governing law determination point of view.

Therefore, we may conclude from the above general principle that if health research, and more particularly a clinical trial (or clinical investigation or performance study), is led in a given module aboard the ISS [provided that legal and regulatory conditions are met for the research to effectively qualify as a clinical trial (or clinical investigation or performance study)], the national law of the Partner State having registered that module, will apply. Regarding ESA’s module, the national law chosen in the agreement between the relevant ESA module user and ESA, will apply, subject to EU law, as would be applicable on Earth.

Based on this assumption, with respect to drugs, EU Directive 2001/20/EC of 4 April 2001, on the approximation of laws, regulations and administrative provisions of the European Member States relating to the implementation of good clinical practices in the conduct of clinical trials on medicinal products for human use, shall be implemented regarding clinical trials conducted aboard the ISS, subject to specific rules of the national law chosen in the above-mentioned ESA/ISS User agreement. Similarly, EU Regulation 536/2014 of 16 April 2014, on clinical trials of medicinal products for human use, which harmonises rules on clinical trials relating to medicinal products, will have a vocation to apply. For now, Regulation 536/2014 is not yet compulsory as it is dependent  on the development of a fully functional EU clinical trials portal and database, expected to be available in early 2022, which is therefore not yet in place.

These two texts are vague with respect to the geographical location of clinical trials falling within their scope. For instance, Directive 2001/20 refers to the ‘territory where the clinical trial takes place’ (recital, n°9 /art. 11). Article 76 of the Regulation 536/2014 provides that ‘1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a clinical trial conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk’.

With respect to medical devices, Regulation 2017/745 on medical devices and Regulation 2017/746 on in vitro diagnostic medical devices, dated 5 April 2017, which respectively entered into force in May 2021 or shall enter into force in May 2022, also refer to this same notion of ‘territory’. In particular, they provide that ‘Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a clinical investigation conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk’ (article 69 of Regulation 2°17/745), or ‘Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a performance study conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk’ (article 65 of Regulation 2017/746), or even ‘Member States shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory (…) is evaluated centrally (…)’ (article 84 of Regulation 2017/746).

These texts are sufficiently large to allow considering that their provisions applicable on Earth could possibly apply and be extended to activities conducted on the ISS. By the same logic as the one deployed in Section 1 above, the module where the clinical trial (or clinical investigation or performance study) is conducted would be considered as part of the relevant country’s territory in space and, if a clinical trial (or clinical investigation or performance study) were to take place in that module, the law of that country would apply. Similarly, it seems that a clinical trial (or clinical investigation or performance study), as any other experiment that may be led in the ESA module, would depend on the applicable law chosen in the contract between ESA and the ISS user leading the experiment.

3. How does intellectual property protect research data and results used or generated aboard the ISS?

3.1 Intellectual property, one of the key aspects dealt under by the IGA

Intellectual property rights are considered in international space conventions, from their creation to their possible infringement. With respect to the ISS in particular, many intangible assets (data or products) may be used or generated aboard. For example, pictures taken of Earth by the ISS’ astronauts in the Cuppola (ie, the panoramic observation dome) aboard the ISS may be protected by copyright. Pre-existing scientific results may be used aboard for testing purposes. Inventions possibly leading to patents may also be generated through the scientific experiments conducted in ISS’ laboratories.

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 article not only applies to the acquisition of intellectual property rights following the result of an activity led aboard the ISS but also to assets’ protection in case of infringement.

Hence, pursuant to Art. 21 of the IGA, in the event an invention occurs on the ISS, the country of inventorship will be determined by the ownership and registry of the ISS’s element in which the invention has taken place: for example, an invention made in the Japanese Laboratory will be deemed to have occurred in Japan. As a rule applying to EU users, ESA indicates that the industrial and academic users who will have access to the ISS through ESA will have their rights and obligations determined by the contractual framework they will have agreed upon with ESA. As ESA points out, ‘the ownership and the exploitation of any intellectual property - data or product - resulting from the Space Station utilisation will then be highly dependent on the type of contract the users will have signed with ESA’.[15]

This does not impact the ownership of the invention, not does it preclude the right to file for a patent in multiple countries. An inventor may file for a patent in any country he chooses. For example a European researcher inventing a process resulting from his experiment in the Kibo Laboratory (Japanese territory), may file for a patent anywhere in the world to protect his invention. The purpose of the territorial approach (e.g. Japanese components of the Station = Japanese territory) is only to determine the location and country where the invention took place.’ says ESA. With respect to inventions created in the Columbus Laboratory (ie EU territory), any European Partner State may extend its national law to that module and elect to deem the activity to have occurred within its territory. An inventor having used the European laboratory facilities may file for a patent anywhere in the world to protect his invention, but he will need to choose one of the European Partner States’ territories to determine where his invention originally took place.

3.2 Specific approach toward possible infringements

As raised above, article 16 of the IGA Agreement provides for a cross-waiver of liability for damage sustained as a result of ISS activities. However, this waiver does not cover intellectual property claims (art. 16, 3. (d)).

Indeed, as ESA points out, ‘the main objective of the ISS Partners concerning property rights is to avoid the infringement of rights owned by another Partner and their entities (e.g. contractors, subcontractors, users)’.[16] It is interesting to note that in order to mitigate the risk of potential infringement, the ISS Partners have agreed to create specific marking procedures to protect the proprietary and confidentiality of each other’s data and goods, while the ISS Partners have committed to exchange specific technical data and goods, when necessary, to operate and utilise the ISS in a safe manner (Article 19 of the IGA). Under those rules, each space agency and its related partners – for example any industry or academic institution under contract – will be bound to mark their technical data or goods with a notice indicating specific conditions regarding how those data or goods may be used by other Partner States/agencies and their related entities. The marking rules have a vocation to protect the rights of both the ISS Partner States, relevant users and third-parties. Among other measures to enhance that protection, the ISS Partners agreed in September 2000, upon a ‘Crew Code of Conduct’ aimed at setting specific rules and a chain of command for the astronauts and cosmonauts present aboard the ISS.

3.3 Need to take national laws into account to assess the possible infringing action

Based on the above, the law eventually determined as governing the activities conducted in a given module aboard the ISS may be enforced to appraise whether or not the use of an intangible asset is infringing its owner’s intellectual property rights.

That law shall be studied in both its principles and its exceptions. In France for instance, article L. 613-5 of the French Intellectual property Code exempts the following acts or situations from the patent monopoly:

  • acts performed on an experimental basis that relate to the subject matter of a patented invention;
  • studies and tests required in order to obtain a marketing authorisation for a medicinal product, as well as the acts necessary for their performance and for obtaining the authorization (eg, clinical trials); and
  • objects intended to be launched into outer space introduced into French territory.

Other national patent laws may also provide for an exception when it comes to experimental use and clinical trial. [17]

The possible infringement will therefore require a case-by-case legal analysis depending on the national law at stake.

 

[8] This term also involves the Partner States’ cooperating agencies.

[10] The 10 Member States of the European Space Agency are: Belgium, Denmark, France, Germany, Italy, The Netherlands, Norway, Spain, Sweden and Switzerland; the UK joined in 2012, with Hungary and Luxembourg committing to the Space Station programme in 2019 as well as ESA cooperating state Slovenia.

[11] ’Related entities’ means any Partner State’s contractor, sub-contractor, user or customer, or any contractor or sub-contractor of such user or customer (art.16.2 (b) of the IGA).

[12] ‘Protected Space Operations’ are defined as launch vehicles activities, ISS activities, payload activities (ie, all property to be flown or used on or in a launch vehicle or the ISS) on Earth, in outer space, or in transit between Earth and outer space in the implementation of the IGA, the MoUs and the implementing arrangements. It also includes the activities related to evolution of the ISS. It excludes activities on Earth which are conducted on return from the ISS to develop further payload’s product or process for use other than for ISS’s related activities. (art.16.2 (f) of the IGA).

[15] www.esa.int/Science_Exploration/Human_and_Robotic_Exploration/International_Space_Station/International_Space_Station_legal_framework.

[17] For instance in Germany: see Article 11.2 of the ‘Patentgesetz’ (Patent law).