Reframing Biotechnology: The BIOSECURE Act and National Security Governance

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Although the American biotechnology industry has historically maintained a leading position in global innovation, China is quickly becoming a strong competitor. Biotechnology’s increased involvement in defense, healthcare, agriculture, energy, and manufacturing elevates the importance of biology research and has led the U.S. to view the sector with a more critical biosecurity lens. Currently, the strong U.S.-China biotechnology partnerships heighten political anxiety regarding potential supply-chain vulnerability and the inherent geopolitical significance of biotechnology.  

American biotechnology law comprises two parallel pillars: intellectual property protection and public health regulation. Patent law protects IP innovation and scientific discovery while the Food and Drug Administration (FDA) regulates safety, efficacy, and market entry of novel pharmaceuticals. This fundamental structure operates clearly as a collaborative interface between academia, innovation, industry, and public health, while prioritizing healthcare issues. 

The BIOSECURE Act (the Act) introduces national security as a third governing pillar within this structure, reframing biotechnology as strategic infrastructure. Other sectors of the American market, such as semiconductor manufacturing, artificial intelligence, and telecommunications, have undergone similar shifts. The BIOSECURE Act differs from the previous legislation in that it is company-specific, indirectly reshapes the biotechnology supply chain, and regulates research partnerships as well as technology manufacturing. These departures coupled with the lack of a coherent regulatory framework forebodes the significant restructuring of the global biotechnology industry.

As defined by the Food and Agriculture Organization of the United Nations (FAO), biosecurity is “a strategic and integrated approach that encompasses the policy and regulatory frameworks (including instruments and activities) for analysing and managing relevant risks to human, animal, and plant life and health, and associated risks to the environment.” The principal aim of the BIOSECURE Act is to prohibit U.S. federal agencies and federally funded biotechnology entities from engaging, collaborating, or using biotechnology products and services from foreign powers, and, more specifically, from explicitly listed foreign companies. The companies listed, which include BGI, MGI, Complete Genomics, WuXi AppTec, and WuXi Biologics, each maintain Chinese origin or affiliation. The Act seeks to forestall China and other currently unlisted foreign powers from accessing biotechnology data and infrastructure through company partnership. 

Removing federal funding heavily impacts the current American biotechnology industry, which largely operates through federally-funded grants and Chinese manufacturing and supply chain reliance; the National Institutes of Health (NIH) invests nearly $47 billion dollars annually into biomedical research and 79 percent of U.S. biotech companies rely on Chinese contract research and manufacturing services. 

The targeted nature of this policy introduces and possibly prioritizes security law over the two existing frameworks via disruption of the current American biotechnology research and manufacturing machine. As the origin of innovation and manufacturing greatly increases in its importance, biotechnology’s role in our societal and economic sphere is increasingly reframed by policymakers as a strategic technology with implications for both economic competitiveness and national security. This centralization is derived from the belief that biotechnology has the power to shape geopolitical competition. This calls for greater involvement of the Department of Defense, Office of Management and Budget, and congressional national-security committees. Whether this shift will be fruitful or restricting will depend on the initial strength of the independent U.S. market. 

Contrastingly, the benefits to the policy change introduced by the Act include reducing reliance on foreign biotechnology contractors, which allows for the preemptive stabilization of supply chains vulnerable to geopolitical disruption. Greater emphasis on security compliance may stimulate domestic research and workforce development. While international scientific collaboration has customarily accelerated innovation, biosecurity is indeed a meaningful concern, especially with the emergence of the rapid integration of AI into biotechnology research. For biotechnology specifically, some researchers have called for stronger governance frameworks in regards to AI, and this may be a strong solution to that issue. This strong government interference has the potential to reshape existing markets, although it cannot yet be determined if the change will be positive or negative.

Within the industry, the BIOSECURE Act is viewed as the beginning of a new structural framework which prioritizes the reassessment of supply chain transparency. The Act does not require immediate implementation through a phased model, and prohibitions will take full effect between 2027 and 2028. The short term effects of the Act are largely internal. 

Scientific innovation has long depended on global collaboration and international clinical trials, playing a central role in facilitating scientific progress. Regional isolation from this global network has predominantly created a ‘lag’ effect, as evidenced by the technological lag of the Soviet Union during the Cold War and scientific stagnation during Japan’s Sakoku period (1639-1853). However, growing geopolitical tensions between the United States and China have led to an increasingly negatively shaped perspective of scientific collaboration and technology policy. The BIOSECURE Act is primarily focused on domestic safety via scientific isolation, but these restrictions could increase research costs, reduce efficiency, and limit access to specialized manufacturing expertise currently concentrated abroad. 

The BIOSECURE Act seeks to safeguard national security considerations as they increasingly intersect with scientific research, exhibiting a ubiquitous shift in biotechnology governance. The long-term impact of the Act within the American biotechnology industry depends on lawmaking success in the equilibrium of openness and protection.

Isabella Grande is a graduate student at Brown University, concentrating in Biotechnology. She is a staff writer for the Brown University Undergraduate Law Review and can be contacted at isabella_grande@brown.edu. 

Daniel Shin is a junior at Brown University studying English and Economics. He is an Associate Editor for the Brown Undergraduate Law Review blog and can be reached at sangjun_shin@brown.edu.

Emily Walsh is a sophomore at Brown University from Minneapolis studying Philosophy and International and Public Affairs. She is an Associate Editor for the Brown University Undergraduate Law Review and can be reached at emily_m_walsh@brown.edu.