Part 1: Life Sciences & National Security

This article is Part 1/3 of the Life Sciences & National Security Series- For more articles like this one, make sure to sign up for our newsletter or follow us on Linkedin.

Insight from:

Erika D. Trujillo, Co-Founder & Managing Director at SEIA

I have been consistently seeing an increase in regulations in the life sciences sector with national security as the basis for restrictions. This was evident not just from newly introduced rules themselves, but also the language and mechanisms used to bring those regulations into place. For years now we have been heavily concentrated on critical materials and technology, like rare earth minerals and semiconductors; however, if this trend is any indication, with the rise of AI, we can expect to see biodata as the next strategic category and it being regulated accordingly.

This is the first of a short series of articles on Life Sciences and National Security, as I will be watching this trend carefully in the coming months.

Life Sciences & National Security

For most of the past three decades, the life sciences industry operated in a relatively permissive international trade environment, leveraging a wide berth of exceptions and exemptions. A pharmaceutical company selling a drug, a CRO shipping a sample, a medical device manufacturer supplying a hospital in Shanghai until recently engaged in commercial transactions, governed by quality standards and regulatory approvals certainly, but typically have not faced the same level of trade compliance scrutiny seen in industries like semiconductors, defence technologies, energy infrastructure, and rare earths.

That assumption is now being dismantled by a convergence of factors, namely: biological data becoming analytically powerful at smaller and smaller scales, the laboratory instruments that generate that data being increasingly listed as dual-use, and pharmaceutical supply chains being recognised as strategic dependencies.

The conclusion is not new in principle, as the Biological Weapons Convention dates to 1972, and export controls on certain biological agents and equipment have existed for decades. What is new is the breadth of the concern, the speed at which the threat potential is developing, and the extent to which it now reaches into the ordinary commercial activities of companies. Governments are therefore, rightly, viewing it as an increasingly strategic domain.

The result is a compliance regulatory landscape being scraped together with duct-tape across Beijing, Washington, and Brussels, as governments seek to chase developments with legal controls.  These changes mean that the Life Sciences sector needs to starting thinking about their work as strategically sensitive, updating their complaince frameworks to mange the obligations that will be coming.

The result is a compliance regulatory landscape being scraped together with duct-tape across Beijing, Washington, and Brussels, as governments seek to chase developments with legal controls.

1. Bio Data Restrictions

For most of the history of biotechnology regulation, dual-use concern focused on discrete items like a specific pathogen, a piece of equipment, or a specified compound. The control architecture was designed around identifying those items and restricting their movement. That architecture worked reasonably well when the dangerous items were identifiable, scarce, and required specialised facilities to use.

However today the dangerous capability is increasingly associated with the combination of biological data, laboratory instruments, and AI-enabled biological design tools. Each element is, in isolation, commercially legitimate and widely distributed, but together they unlock critical threat potential for targeted biological weapons. This topic will be further explored in the second article of this series, with a deep dive into the growing importance of genomic data and regulatory updates, like the BIOSECURE ACT, to control its transfer.

For a life sciences company, this changes their compliance posture question in a fundamental way. The question regulators are now trying to answer, one that companies will eventually be expected to deal with, is how can we shape regulations that treat this data like the critical commodity it is? The likely solution will be to adapt existing frameworks from industries like semiconductors.

2. Dual-Use List Updates for Life Sciences Equipment

In most pharmaceutical research laboratories, there is a piece of equipment called a flow cytometer. It measures multiple characteristics of individual cells simultaneously, like size, granularity, protein expression, viability, and can process tens of thousands of cells per second. It is standard equipment in immunology, oncology, and drug development. It is also, as of January 2025, a controlled dual-use item under U.S. export regulations.

On January 16, 2025, the U.S. Bureau of Industry and Security issued an Interim Final Rule placing new export controls on high-parameter flow cytometers and liquid chromatography mass spectrometers designed for proteomics research. Both were reclassified into a new Export Control Classification Number, ECCN 3A069, requiring export licences for shipments to countries of concern. The instruments affected include products manufactured by Thermo Fisher Scientific, Bruker, BD Biosciences, and Agilent, companies whose equipment sits in research laboratories across the life sciences sector globally.

The BIS rationale deserves to be read carefully, because it signals something important about the current state of regulatory thinking, not just the addition of the classifications.

The BIS rationale deserves to be read carefully, because it signals something important about the current state of regulatory thinking, not just the additional classification. The agency stated that the instruments themselves are "highly suitable for generating large, detailed biological datasets which can be analysed to discover complex patterns governing the function of biological molecules," and further that certain countries "are actively pursuing a strategy to exploit these technologies for asymmetric military advantage."

A tool used every day to characterise proteins for drug discovery has been formally classified as a potential input to AI-driven biological weapons development.

This reasoning is insightful, as it shows indications that biodata, and the associated instrumentation, may follow a similar regulatory playbook to existing controls for the development of semiconductors.

The EU has also reached a parallel conclusion independently, following the November 2025 update to the EU Dual-Use Control List, enacted through Commission Delegated Regulation (EU) 2025/2003, added peptide synthesisers to the list of controlled items for the first time, alongside quantum technologies and advanced semiconductor manufacturing equipment.

Peptide synthesisers are used to manufacture short chains of amino acids, the building blocks of proteins, and are fundamental tools in drug discovery, vaccine development, and basic research. Their inclusion in the dual-use list reflects the same underlying judgment that drove the U.S. BIS rule, that standard life sciences equipment combined with biological data and AI-enabled design tools contributes to evolving national security concerns.

3. The API Supply Chain

While regulators have been drawing new lines around laboratory instruments and biological data, a more fundamental national security concern has also been building in the pharmaceutical supply chain.

China accounts for approximately 40% of global API production by volume.

China accounts for approximately 40 percent of global active pharmaceutical ingredient (API) production by volume. For specific compound classes, the concentration is considerably higher.

According to a Progenerika report, for 93 APIs required in Europe there are no CEPs in Europe, and this "high concentration of API manufacturers within India and China can have a negative impact on continuity of supply in case of disturbances."

The United States in 2024 relied on China for 92 percent of its imported penicillin and streptomycin antibiotics, 99 percent of its imported prednisone, and near-total supply of certain antibiotic and statin intermediates. A 2023 Pentagon study found that more than a quarter of military drug purchases trace to Chinese-sourced ingredients. India, which supplies around half of all U.S. generic prescriptions, itself sources approximately two-thirds of its own API inputs from China.

China's own regulatory architecture, including the Biosecurity Law of 2020 and the Export Control Law of the same year together grant Beijing broad statutory authority to restrict pharmaceutical exports, a capability that analysts at the Atlantic Council have described as a potential coercive instrument in the event of geopolitical conflict, comparable to the rare earth restrictions that gave governments their first clear demonstration of supply chain weaponisation.

China's own regulatory architecture grants Beijing broad statutory authority to restrict pharmaceutical exports comparable to the rare earth restrictions

In the wake of COVID-19, and now compounded by rising geopolitical tensions between Washington and Beijing, concerns are also rising realted to potential supply chain disruptions as a security threat. In 2025, the Trump administration launched a Section 232 investigation into pharmaceutical imports and issued executive orders stating that drug supply chain concentration constitutes a national security concern while directing the establishment of a Strategic Active Pharmaceutical Ingredient Reserve.

Most life sciences companies have mapped their direct Chinese supplier relationships. Far fewer have mapped the Chinese dependency embedded in their Indian suppliers, their European contract manufacturers, or the key starting material producers that sit two or three steps upstream of the API they actually purchase. What makes this particularly difficult to manage is that it does not fit the existing architecture of either export compliance or procurement risk management.

A Sector Catching Up With Its Own Strategic Significance

The life sciences industry has historically understood itself as a humanitarian enterprise operating under scientific and regulatory constraints. Drug development does save lives, and the international research collaborations that drive it depend on the relatively open movement of data, materials, samples, and people across borders. However, life Sciences is now at the frontier of national security developments, and compliance professionals must start thinking strategically about how to manage the growing regulatory focus.

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