Law, Space and Pharmaceuticals: Inside a New Government Initiative to Boost Sector Growth

UCL Law for All Society
Mar 15
3 min read

By Stephane Duponcheele

Last week, the UK government announced a new initiative aimed at providing “a supportive regulatory environment to space, biopharma and pharmaceutical companies”. This initiative, announced at the Space-Comm Expo in London, aims to boost innovation in the UK’s pharmaceutical sector by using the unique conditions of microgravity to revolutionize drug development and patient care.

The microgravity provided by orbiting the Earth, experts argue, offers manufacturing conditions that cannot be replicated on the surface. These conditions have the potential to transform how complex biologic medicines are developed and produced. One of the most significant advancements is the process of "super crystallization." In microgravity, crystals can form much more slowly and uniformly than on Earth, over weeks or even months. This process can produce highly pure and stable drug formulations, particularly for biologics like monoclonal antibodies and vaccines. For example, BioOrbit, a UK-based startup, is exploring how super crystallization can improve cancer treatments, potentially allowing patients to self-administer injections at home instead of undergoing lengthy hospital sessions. Early research suggests that microgravity can also improve drug stability and potency.

The UK government’s initiative is led by the UK Space Agency (UKSA), in collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA), the Regulatory Innovation Office (RIO), and the Civil Aviation Authority (CAA). This effort includes: new regulatory guidance for space-manufactured medicines; a regulatory sandbox for testing innovative approaches while managing risk; and stronger engagement with UK industry and supply chain partners. The UKSA has already invested in early-stage projects, including a £250,000 feasibility study for BioOrbit. The government has also designated in-orbit servicing, assembly, and manufacturing as a national priority area for economic growth and security.

The UK’s drive for leadership in space-enabled pharmaceuticals should be seen in the context of its broader £2 billion Life Sciences Sector Plan. By fostering innovation and collaboration between the space and pharmaceutical sectors, the UK government is aiming to anchor high-value manufacturing and research within the UK and strengthen international competitiveness in both the life sciences and Space. The UK has so far struggled somewhat with keeping its success stories national.

The sale of the UK start-up OneWeb to France’s Eutelsat, after the company experienced financial difficulties in 2020, resulted in the untimely loss of a low-Earth-orbit connectivity provider, at a time when such products were beginning to show their influence over national sovereignty and the global economy. Eutelsat has since managed to stabilize its acquisition and develop it further, seeing demand for its OneWeb services skyrocket in the aftermath of the politicisation of Elon Musk’s starlink — a rival US constellation operator. A merger between the ambitious Munich-based startup The Exploration Company (TEC) and Orbex, a private launch provider based in Scotland fell through last month. TEC’s statement on the matter suggests the UK government's decision to prevent the merger from going ahead suggests that the government is indeed concerned about this trend. Whilst these sales do not represent sovereignty concerns, they nevertheless work to build a sentiment that, whilst the UK is an excellent source of human capital, companies are better of being based in the deepening and accelerating aerospace silicon-valleys of the Eurozone, such as Toulouse, Munich or Helsinki.

The UK’s space economy, particularly in the realm of space-based pharmaceutical manufacturing, does not operate in isolation. Its regulatory and research landscape is deeply intertwined with both the European Union and the United States. The EU’s emerging Space Act, which aims to harmonize space regulations across member states, will indirectly impact the UK’s approach to in-orbit pharmaceutical manufacturing. While the UK remains a member of the European Space Agency (ESA), its post-Brexit status means it no longer has direct influence over EU space regulations; alignment with these regulations will be critical for maintaining access to the European market and supply chains. This creates a risk of misalignment: as the EU standardizes rules for space manufacturing including safety, environmental, and licensing requirements. The UK’s strong incentive to engage with the US pharmaceutical market may reduce room for maneuver between the UK’s largest trading partners. That the regulation of drugs and their prices is a contentious topic in both the UK and the EU and US does not help the UK with its predicament either. The UKSA and the MHRA will have to frequently engage with US agencies like NASA and the FDA to align on standards for space-manufactured drugs, ensuring that UK innovations can meet US regulatory requirements. Being drawn between these two economies could result in additional compliance burdens for UK companies seeking to market their products in Europe as well as the US, potentially delaying approvals or increasing costs, the opposite of what the government aims to accomplish through this announcement.

Sources:

Edited by Artyom Timofeev

Image source: https://www.bioorbit.space/news

Law, Space and Pharmaceuticals: Inside a New Government Initiative to Boost Sector Growth

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