The American Bioeconomy and What Can be Done to Support It by Texas A&M School of Veterinary Medicine & Biomedical Sciences

The American Bioeconomy and

The views expressed and opinions presented in this paper are those of the Scowcroft Institute of International Affairs and do not necessarily reflect the positions of The Bush School of Government & Public Service or Texas A&M University.

Scowcroft Institute of International Affairs | The Bush School of Government & Public Service Texas A&M University | College Station, Texas, USA | bushschoolscowcroft@tamu.edu | bush.tamu.edu/scowcroft

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What Can be Done to Support It Contents

THE AMERICAN BIOECONOMY AND WHAT CAN BE DONE TO SUPPORT IT Scowcroft Institute of International Affairs Annual White Paper • 2021 Introduction...................................................................................................................................................................................... 4 Topic Area 1: Critical Supplies and Supply Chains........................................................................................................................ 6 Pharmaceutical Supply Chain.................................................................................................................................................... 6 Counterfeit Medical Products.................................................................................................................................................... 7 Counterfeit COVID-19 Vaccines.................................................................................................................................................. 7 Utilizing the Defense Production Act........................................................................................................................................ 8 Topic Area 2: Intellectual Property and the Bioeconomy........................................................................................................... 9 Intellectual Property Rights in Times of Crisis...................................................................................................................... 10 Topic Area 3: The Changing World of Biological Data................................................................................................................12 Cybersecurity in the Biological Sciences - The US and China...............................................................................................12 DIY Bio: The National Security Challenges of Citizen Science............................................................................................. 14 Conclusion....................................................................................................................................................................................... 16 References........................................................................................................................................................................................17 The Scowcroft Vision...................................................................................................................................................................... 21 In Memoriam................................................................................................................................................................................... 22

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The American Bioeconomy Introduction and

INTRODUCTION For the past five years the Scowcroft Institute for International Affairs at the Bush School of Government and Public Service has been hosting an Annual Pandemic Policy Summit. The goal of these summits is to address the most pressing issues facing scientists, policymakers, and the overall pandemic preparedness and response enterprise. This year, the summit was held virtually in the midst of the COVID-19 pandemic and while the pandemic was discussed at length, we set a goal to look beyond the current crisis and address the next pandemic coming down the road. While we may not be able to predict what disease will cause the next pandemic, we have pinpointed three major topic areas that we believe should be addressed in order to learn the lessons of COVID-19 and strengthen pandemic response in the future. These topic areas are: 1) critical supplies and supply chains; 2) intellectual property and the bioeconomy; and 3) the changing world of biological data. This paper discusses each of these topic areas in detail and provides recommendations to improve pandemic preparedness and response.

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What Can be Done to Support It Introduction

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TOPIC AREA 1: CRITICAL SUPPLIES AND SUPPLY CHAINS The COVID-19 pandemic has demonstrated the extensive reliance that the United States has on other countries for the production, either in whole or in part, of vital pharmaceuticals and medical supplies. This dependence has not only contributed to a shortage of supplies, equipment, and pharmaceuticals, but has opened the door for an influx of substandard or falsified medical supplies. The proper functioning of the US healthcare system requires that hospitals, clinics, and emergency personnel have adequate supplies of personal protective equipment (PPE), pharmaceuticals, medical supplies, and other necessary medical equipment (Mirchandani, 2020). The COVID-19 pandemic, however, has severely disrupted this supply and hampered the ability for healthcare professionals and institutions to provide the highest level of care. Since the beginning of 2020, the Food and Drug Administration (FDA) has noted over one hundred pharmaceuticals in short supply throughout the country (FDA, 2021).

Pharmaceutical Supply Chain In 2001 the American Society of Health System Pharmacists (ASHP) established guidelines to identify and track pharmaceutical drugs due to increasingly common drug shortages. While this was a step forward in understanding our pharmaceutical supply chains and tracking any issues with medications, it still relies on gathering information from manufacturers on the federal level rather than from consumers or healthcare providers at the state or local level (Choe et al., 2020). There are additional databases maintained by either the FDA or nonprofit organizations with an interest in pharmaceutical distribution and quality. These databases collect information from different consumers and systems but have no mechanisms to crossreference each other. One such piece of legislation that was targeted at enhancing the FDA’s ability to monitor drug quality was the 2013 Drug Supply Chain Security Act. This Act outlined steps for creating a system that

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would better identify and trace specific pharmaceuticals distributed in the United States (FDA, 2021c). Creating one system drawn from various databases would provide the US government, the healthcare system, and private industry with a better understanding of shortages and counterfeit alerts, among other things. When the COVID-19 pandemic exposed the existing gaps in our pharmaceutical monitoring system, the FDA was granted authority to collect and evaluate quality metrics on pharmaceuticals at a larger scale than previously possible (Choe et al., 2020). One of the important components of this expanded authority was the FDA’s ability to require applicants to label their product with the longest possible expiration date that is scientifically justified (Hahn, 2020). FDA’s authority to require information on critical infrastructure, such as manufacturing quality and capacity, was also expanded (Hahn, 2020). This temporarily expanded authority is an opportunity to build a system that can more effectively measure the quality of pharmaceuticals coming into the United States and coordinate and share that information with relevant stakeholders nationwide (Choe et al., 2020). Measuring and tracking the quality of pharmaceuticals is important to the health of Americans because there are numerous points along the supply chain where drug quality metrics either do not exist or are insufficient. Substandard or falsified drugs can have implications beyond the ability to adequately address immediate health needs. They can also lead to increased antimicrobial resistance. A study by Homedes and Ugalde (2012) found that a lack of regulations and training at 32 pharmacies in Ciudad Juárez, which sits right across the border from El Paso, Texas, led to the over-prescribing of antibiotics. This over-prescribing correlated with higher rates of drug-resistant tuberculosis among individuals residing along the US-Mexico border (Homedes and Ugalde, 2012). Problems in the US pharmaceutical supply chain can also result from disruptions in the movement or production of generic drugs or active pharmaceutical ingredients (API), most of which are produced outside the US (Schondelmeyer et al., 2020). Such disruptions can be caused by natural disasters, human behavior, or cross-contamination. On average the US experiences 160 new drug shortages per year (Schondelmeyer et al., 2020). During the COVID-19 pandemic, China

suggested that they may stop exporting important pharmaceuticals and APIs, and India did stop exporting 26 pharmaceuticals and 13 APIs in order to prioritize their population during the pandemic (Choe et al., 2020; Schondelmeyer et al., 2020). Stopping exports led to concern that vital pharmaceuticals would not be available for the American population.

Counterfeit Medical Products While shortages of medical supplies and pharmaceuticals pre-dates the COVID-19 pandemic, the increased demand for certain products that was brought on by the pandemic has led to a growth in counterfeit products looking to exploit weaknesses of the supply chain. For example, the shutdown of essential manufacturers in Mexico led to a flood of counterfeit medical products into the US healthcare system (Sganga, 2021; Rodriguez, 2020). In 2020, US Customs and Border Protection seized almost 13 million counterfeit masks, 180,000 counterfeit COVID-19 test kits, and over 38,000 falsified chloroquine tablets (CBP, 2020). Additionally, in the earliest months of the pandemic, the FDA issued a warning that hand sanitizers coming from Mexico were toxic to the point where they might be life-threatening (FDA, 2021b). Despite the magnitude of the problem, very little data exists on the quantity of counterfeit pharmaceuticals and medical supplies coming into the United States, particularly for those coming over the US-Mexico border. Most of the information obtained relates to opioids and drugs such as Adderall or Viagra (DEA, 2018). Given the weaknesses and gaps exposed by the COVID-19 pandemic, it is important to collect comprehensive data and research on the risk of counterfeit pharmaceuticals and medical supplies coming into the United States.

Counterfeit COVID-19 Vaccines Beginning in the spring of 2021, the World Health Organization, Interpol, and local law enforcement agencies began to face a rise in counterfeit COVID-19 vaccine distribution. In early March 2021, police in South Africa in collaboration with Interpol, seized hundreds of doses of counterfeit vaccines. The individuals arrested in the South African case were linked to a network of individuals selling counterfeit vaccines in China (Dludla, 2021). In China, more than 80 individuals connected to the network were arrested at a factory that was

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producing counterfeit vaccines (BBC, 2021). More recently, WHO issued a warning that counterfeit vaccines were being sold on the dark web (Miao, 2021). During the press conference, WHO encouraged people to only purchase vaccines from government-run programs. Like other counterfeit medical products, counterfeit COVID-19 vaccines are dangerous not only because they may contain components that harm an individual’s health, but also because the individual will wrongfully believe that they are protected from SARS-CoV-2.

Utilizing the Defense Production Act The Defense Production Act is a law that allows the President of the United States to require private companies to prioritize orders from the federal government. The law, which was passed in 1950, is modeled after the War Powers Acts of 1941 and 1942, which gave President Roosevelt broad authority over the US economy during World War II (Siripurapu, 2021). The purpose of the War Powers Acts and the current Defense Production Act is to focus US economic and manufacturing power on national security, when necessary. While the Defense Production Act has been used in the past, it was employed by President Trump during the COVID-19 pandemic in order to increase production of ventilators and N95 masks, prevent hoarding of essential supplies, and increase domestic

Members of TMD’s 6th WMD-Civil Support Team inspect N95 respirator masks at a TX DPS Warehouse in Austin on March 26, 2020. (Photo credit: US Army National Guard)

production of vital health products. Use of the Defense Production Act can continue to be an important legislative tool in future pandemics.

RECOMMENDATIONS 1) Identify medical and pharmaceutical supply chains as an issue of national security and produce and/or source more raw materials within the United States The COVID-19 pandemic further exposed the United States’ reliance on other countries for the production and distribution of vital pharmaceuticals and medical supplies. The United States government, in collaboration with private industry, should begin exploring options to on-shore the production of specific products that are a threat to US national security if their supply chains are disrupted. Conceptualizing our medical and pharmaceutical supply chains as an issue of national security and creating the ability to produce such products within the US will reduce our overall vulnerability in future pandemics or in other times of disruption. 2) Create an integrated system for tracking pharmaceuticals The US lacks a unified, integrated tracking system for pharmaceuticals that would provide greater depth and breadth of data on drug shortages and falsifications. Creation of a unified, integrated tracking system would provide better data on drug shortages and falsification nationwide. Better data could help prevent drug shortages in the future and reduce American vulnerability. 3) Improve tracking of counterfeit medical supplies The sheer quantity of seized counterfeit medical supplies in 2020 raises alarms about protection of American healthcare workers and the proper functioning of the American healthcare system. Steps, such as creating an integrated e-commerce enforcement framework as suggested by DHS in 2020, should be taken to improve the system for identifying and tracking counterfeit medical supplies to improve US Customs and Border Protections’ ability to prevent such supplies from entering the country.

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TOPIC AREA 2: INTELLECTUAL PROPERTY AND THE BIOECONOMY The COVID-19 pandemic has increased discussions centering on the US bioeconomy, but the development of treatments and vaccines to fight the virus has also illuminated critical issues of intellectual property rights. The debate surrounding intellectual property rights in the bioeconomy is multifaceted and involves an understanding of biopiracy, the Bayh-Dole Act (an important piece of intellectual property rights legislation), and capacity disparities between nations. One of the primary challenges in intellectual property rights within the bioeconomy is defining what is an invention versus natural (Straus, 2017). This determination was established in 1980 when the Supreme Court ruled that live, man-made organisms

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(for example, genetically-modified food products) could be patented (Straus, 2017). And while this ruling opened the doors for large-scale biotechnology development and the expansion of the formal bioeconomy, it also led to increasing claims of biopiracy. Biopiracy is defined as “the appropriation of the knowledge and genetic resources of farming and indigenous communities by individuals or institutions who seek exclusive monopoly control (patents or intellectual property) over these resources and knowledge” (Hamilton, 2008, p. 1-2). For example, the patenting of plant breeding has been considered by some to be biopiracy. In essence, biopiracy and intellectual property within the bioeconomy both purport that one cannot patent nature, but there are

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disagreements about at what point an element of nature can be considered man-made (Hamilton, 2008; Straus, 2017). Another important element of intellectual property in the bioeconomy is the Bayh-Dole Act of 1980. This US legislation allowed small businesses, nonprofits, and universities to keep intellectual property rights from federally-funded research and, some have argued, is the single most important reason for the expansion of intellectual property rights in the bioeconomy (Straus, 2017). Straus (2017) states that it is not until after the passage of the Act that the biotechnology industry began to grow into what it is today. Others, however, have argued the Bayh-Dole had a much smaller impact than it is often given credit for. Gold et al. (2007) states “While Bayh-Doyle is often credited with the rise of the biotechnology industry, this is clearly false...the world’s experience in transplanting Bayh-Doyle to other countries – without marked effect on innovation – indicates that Bayh-Doyle is not responsible for changes in research and development outside the United States” (p. 8). Thus, technology transfer was already occurring before the legislation was passed and therefore didn’t have as large an impact as it is credited with. Regardless of the exact impact of Bayh-Dole on the expansion of the bioeconomy, most scholars believe that patents and other intellectual property protections have

had an important impact on biotechnology development. Some remaining challenges include the relatively arbitrary nature of the intellectual property system and the difference in capabilities between countries (Gold et al., 2007). The current intellectual property system has a tendency to overprotect some patent holders, but under protect others (Gold et al., 2007). This problem is further exacerbated when examining how intellectual property functions differently in different countries. Some countries, like the US and many countries in Europe, have implemented a strong intellectual property rights system and others, such as China and Brazil, have acquired the industrial and scientific capability to do so recently. Some, such as Kenya and Indonesia, may still consider the establishment of such a system as a cost rather than a benefit, because such a system would be expensive to create and enforce at a time when there is limited intellectual property to protect (Gold et al., 2007). In order to continue promoting development within the bioeconomy it is important to address these intellectual property mismatches and continue strengthening the intellectual property system.

Intellectual Property Rights in Times of Crisis The COVID-19 pandemic raised a number of questions about how intellectual property rights should function in times of global crisis. In the face of these questions, scholars have developed several suggestions for paths that might be taken in times of extreme crisis, such as the COVID-19 pandemic. The first, called compulsory licensing, has been implemented by several countries including Canada. Under compulsory licensing, patents are issued by the government but other individuals are able to make, use, sell, or import the product without permission from the patent holder (Molloy, 2020). In this scenario, the product is able to be more widely distributed than it would be under normal patent conditions and the government typically reimburses the patent holder in the form of royalties. The second way to address intellectual property issues in the bioeconomy may be patent pledges. In this case the holder of the intellectual property makes a public statement saying that others have permission to use their intellectual property. While this allows for widespread use of intellectual property, the patent

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holder often sets limits on usage (Molloy, 2020). Lastly, intellectual property might be shared through “IP pooling.” In this case patent holders make their intellectual property available to a select group. All three of these actions – compulsory licensing, patent pledges, and IP pooling – can provide some intellectual property protections, while also making it more available in a crisis like the COVID-19 pandemic.

RECOMMENDATIONS 1) Address the importance of patent protection in the development of the bioeconomy While there is debate about the extent of the effectiveness of the Bayh-Dole Act in expanding the biotechnology industry, research is in agreement that patent protection leads to greater investment in research

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and development within the bioeconomy. We must continue looking for ways to strengthen the intellectual property rights system to foster greater development. 2) Develop mechanisms that balance intellectual property protection with information sharing during a crisis The COVID-19 pandemic has shown why information sharing is important in a crisis. It has also, however, demonstrated the feelings of researchers and firms that intellectual property protection should still be a priority in a crisis. For these reasons it is important that we examine ways to create a system, such as compulsory licensing, patent pledges, or IP pooling that appropriately balances intellectual property protection with information sharing during a national or international crisis.

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TOPIC AREA 3: THE CHANGING WORLD OF BIOLOGICAL DATA Over the last decade, developments like CRISPR and gene drive have spurred increasing concerns regarding the bioeconomy. This increased interest and concern has, in turn, led to greater focus in the realm of cybersecurity for the biological sciences. Growing technological advancement in the biological sciences combined with the increasing storage of biological data online has led to threats of hacking and data theft. A focus on strengthening cybersecurity around biological data acknowledges the national security vulnerabilities of storing biological data in the cyber realm. The bioeconomy and cybersecurity are closely connected in that protecting and safely disseminating life science research and data helps to stimulate the bioeconomy and protect from the worst negative

outcomes that can result from it. Weaknesses in cybersecurity as it pertains to biological data can harm the bioeconomy because malicious actors can obtain, use, and/or disseminate sensitive biological information or data. If such breaches occur and biological data is obtained by those malicious actors, it can be used to create new biothreats to the United States and the global community.

Cybersecurity in the Biological Sciences The US and China The United States currently sits as the global leader in science and technology, but over the last several decades China has acknowledged the power of the bioeconomy and has begun investing heavily in research and

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development within the life sciences. Between 1996 and 2013 the United States spent an average of 2.61 percent of its GDP on life science research and development (World Bank, 2020a). During the same period, China’s investment in life science research and development increased from approximately 0.5% of GDP to 2% of GDP (WHO, 2020). Additionally, eight of the ten institutions considered “rising stars'' of the life sciences are based in China (Crew et al., 2020). The increasing importance of the bioeconomy and cybersecurity has led China to focus much of its resources on the challenge, and many American experts worry that the United States risks falling behind and becoming beholden to China in this realm.

The United States The publication of the 2012 National Bioeconomy Blueprint made the United States the first country to identify biotechnology as a primary driver of the bioeconomy. At the time, domestic revenue of biotechnology to the United States was $324 billion and it has been estimated that this value has increased 10 percent annually since then (Carlson, 2016; World Bank, 2020b). The benefits of biotechnology and the broader bioeconomy have also expanded to include breakthroughs in everything from new treatments for Hepatitis C to emerging technologies for military applications. Due to the increasing importance of the bioeconomy, President Trump issued Executive Order 13800, which was aimed at improving management of cybersecurity for the biological sciences. This included improving reporting requirements for cybersecurity in federal networks and infrastructure critical to the bioeconomy. Despite the passage of this order, a 2019 report by the Government Accountability Office (GAO) found that more than half of the areas on the High-Risk List remained unchanged and only 7 out of the total 35 areas showed any improvement (GAO, 2019). The current cybersecurity framework in the United States is made up of a patchwork of federal and state laws. The core foundational policies of this framework are the 1996 Health Insurance Portability and Accountability Act (HIPAA), the 1999 Gramm-Leach-Bliley Act, and the Homeland Security Act. HIPAA requires the protection of personal information, Gramm-Leach-Bliley

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relates to security and privacy for financial institutions, and the Homeland Security Act makes the Department of Homeland Security responsible for cybersecurity and all related infrastructure. These pieces of legislation are bolstered by the Sarbanes-Oxley Act, which requires public companies to provide their cybersecurity credentials, and the Defense Federal Acquisition Regulation, which requires DOD contracts to provide adequate security for their data. While these laws are a good start, they work mainly to protect generalized data and do not focus specifically on the protection of research and development within the life sciences. Pieces of legislation that do attempt to address the life sciences directly, such as the Coordinated Framework for Regulation of Biotechnology and the 2016 National Biodefense Strategy, struggle to keep up with the rapid pace of biological research development. Additionally, the authority for maintaining and enforcing the safety and security of biological data is divided between numerous agencies depending on the type of data. For example, the EPA is responsible for protecting biotechnology related to environmental health while USDA is responsible for protecting biotechnology related to plant and animal health (Monast, 2018). The outdated nature of policy and the division of responsibility has made it difficult for the United States to develop and maintain adequate cybersecurity for the biological sciences.

China The Chinese government has made support for research and development in the life sciences a central priority of its Five-Year Plans for most of the 21st Century. As a result, the investments that the Chinese have made

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in the bioeconomy have surpassed investments made by the United States. In 2019, private investors alone in China provided $14.4 billion for the Chinese bioeconomy compared to the United States total investment of $10.4 billion (Cumbers, 2020). In (BY) investing heavily in the bioeconomy, China has also acknowledged the importance of protecting biological data. Many of the recent Five-Year Plans have prioritized the strengthening of the country’s cybersecurity infrastructure. In the latest addition of the plan, strengthening cybersecurity was given the highest priority, further demonstrating China’s willingness to invest in not only the bioeconomy, but cybersecurity for the biological sciences. In 2014, China established the Cybersecurity Administration of China, which is dedicated to security and control of the Internet. Three years later, in 2017, the Cybersecurity Law was enacted, which requires personal information and other important data that is collected and/or generated in China to be stored within the country’s borders (KPMG, 2017). This law also requires that network operators agree to government-led security checks and that cyber equipment or cybersecurity products cannot be sold without security certificates (KPMG, 2017). In coordination with this law, the Chinese government has also created and enforced numerous

regulations to prevent and punish the sharing of certain types of data. For example, in late 2018, the Ministry of Science and Technology began enforcing regulations that forbid the sharing of citizens’ genetic information, even for the purposes of collaborative research (Cyranoski, 2018). Data sharing was even further restricted in 2020, when the Cybersecurity Administration began requiring a national security review for the procurement of products or services. Part of the review examines the potential of leakage of important data. Most recently, following the use of CRISPR by a Chinese scientist to edit the genes of twins in order to make them resistant to HIV, China has begun drafting new regulations to strengthen cybersecurity for the biological sciences. The yet-to-be-implemented regulations set restrictions for gene editing in humans and enhance safety regulations around biotechnology (Cryanoski, 2019). Chinese investment in the bioeconomy and cybersecurity combined with the United States’ lack of investment, threatens to leave the United States trailing China in a centrally important element of biodefense.

DIY Bio: The National Security Challenges of Citizen Science Do-it-yourself, or DIY, bio is a citizen science phenomenon that has increased in popularity throughout the world. It now exists on almost every continent, but it began as an official movement in Boston in 2008 (Landrain et al., 2013). Those who comprise the DIYbio world are interested in biological and life sciences research, but they often do not have formal training in scientific institutions. Instead, they are amateurs or “hobbyists” (Landrain et al., 2013). DIYbio is founded on the idea that science should be easy and accessible to individuals who are interested in it and that knowledge and equipment should be open source (Delgado, 2013). Today, there are more than 50 DIYbio spaces (labs) in the United States and more than 30,000 members of the American DIYbio community (Kolodziejczyk, 2017). Individuals across the spectrum from academia to private industry have noted the potential of DIYbio. There is a belief among some that DIYbio could help further biological innovation by having individuals who can think outside the traditional academic box. DIYbio is seen by many as a way to increase scientific innovation,

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creativity, and science literacy among the general public. Additionally, there has been no shortage of money for startup incubators in the DIYbio realm (Labiotech.eu, 2018). This effort to remove the biological sciences from formal institutions and education is not popular with everyone, however. There are concerns about the biosafety challenges that arise from the DIYbio community because they have “...little to no formal training in safety and ethics” (Kolodziejczyk, 2017). Low-cost equipment that is easy to obtain has helped those in the DIYbio community gain access to laboratory supplies that used to be reserved only for institutional labs (Delgado, 2013). That, combined with an increasing amount of open-source academic literature, has raised concerns among some that there is not sufficient regulation of the DIYbio community. Singapore and a few other countries have considered requiring biohackers and other members of the DIYbio community to go through ethics training and receive a license before they can participate in

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any DIYbio work. Despite these discussions, no policy action has yet been taken to regulate the community in Singapore or elsewhere in the world. In the United States, the FBI has taken the lead in engaging the DIYbio community to promote the safeguarding of science. Rather than developing a set of requirements and regulations (the FBI is not a regulatory body), the FBI has served to educate and raise awareness to empower the DIYbio community to be vigilant for potential misuse or exploitation of biological research and to develop partnerships to foster reporting to the FBI of any suspect activity (Tocchetti & Aguiton, 2015). Connecting the network of DIYbio with the FBI and building trust in that relationship allows the national security community to lessen the risk of DIYbio, though those that support DIYbio believe that the risks have been exaggerated. Understanding the community and addressing synthetic biology risks, whether in DIYbio or in formal institutions, is still an area in need of development (Gronvall, 2018).

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RECOMMENDATIONS 1) Increased US investment in cybersecurity for the biological sciences Over the last decade, China has increased their investment in the bioeconomy and cybersecurity more broadly. And while the United States still has a larger biotechnology industry, the mismatch in investment puts the US at risk of being outpaced by China, thus making us dependent on the Chinese for most medical and pharmaceutical products. For this reason, it is important for the United States to increase our investment in cybersecurity as a way to protect biological and life sciences data that is produced through research and development efforts.

2) Develop formal oversight programs for DIY bio The DIY bio, or citizen science community, has expanded significantly in the last 10 years. While the DIYbio community can be a great source of innovation and can increase science literacy through the general public, the current method of oversight for this community is the development of trusting relationships between the FBI and members of the community. It relies heavily on self-reporting of incidents or suspicious behavior. Instead of continuing to rely on this method in the future, formal ethics and practice laws and regulations should be developed. Such laws will allow citizen scientists to continue exploring and learning within the life sciences, but will provide strong biosecurity and biodefense protections.

CONCLUSION As technology continues to advance and reliance on globalized supply networks continues to be a central aspect of the global economy, it is vital that pandemic preparedness addresses the vulnerabilities inherent in these systems. The recommendations provided in this

paper offer straight-forward and realistic solutions to address some of the most complicated issues at the intersection of globalization, technology, and pandemic response.

Authors of The American Bioeconomy and What Can be Done to Support It Primary Author: Christine Crudo Blackburn Deputy Director of the Pandemic & Biosecurity Policy Program

Secondary Author: Gerald Parker, DVM, PhD Director of the Pandemic & Biosecurity Policy Program

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6. Cumbers, J. (2020, February 3). China’s Plan To Beat The U.S. In The Trillion-Dollar Global Bioeconomy. Forbes. https://www.forbes.com/sites/johncumbers/2020/02/03/china-now-out-invests-america-in-the-globalbioeconomy-by-30/#65286a687440 7. Cyranoski, D. (2018). China’s crackdown on genetics breaches could deter data sharing. Nature, 563(7731), 301–302. https://doi.org/10.1038/d41586-018-07222-2 8. Cyranoski, D. (2019). China set to introduce gene-editing regulation following CRISPR-baby furore. Nature, d41586019-01580–01581. https://doi.org/10.1038/d41586-019-01580-1 9. DEA. (2018). 2018 National Drug Threat Assessment. Retrieved from https://www.dea.gov/sites/default/ files/2018-11/DIR-032-18%202018%20NDTA%20final%20low%20resolution.pdf 10. Delgado, A. (2013). DIYbio: Making things and making futures. Futures, 48: 65-73. https://www.sciencedirect.com/ science/article/pii/S0016328713000281 11. Dludla, N. (2021, March 4). Hundreds of fake COVID-19 vaccines seized in South Africa, Interpol says. Reuters. Available at https://www.reuters.com/article/us-health-coronavirus-safrica-crime/hundreds-of-fake-covid-19vaccines-seized-in-south-africa-interpol-says-idUSKBN2AW27Q 12. FDA. (2021, March 5). Drug Shortages. Retrieved from www.fda.gov/drugs/drug-safety-and-availability/drugshortages 13. 13. FDA (2021b). March 2021 Global Update. (pp. 1-27). Retrieved from https://www.fda.gov/media/146765/ download 14. FDA. (2021c, June 4). Drug Supply Chain Security Act (DSCSA). Retrieved from https://www.fda.gov/drugs/drugsupply-chain-integrity/drug-supply-chain-security-act-dscsa#:~:text=The%20Drug%20Quality%20and%20 Security,Congress%20on%20November%2027%2C%202013.&text=This%20will%20enhance%20FDA's%20 ability,%2C%20contaminated%2C%20or%20otherwise%20harmful. 15. Gold, E.R., Herder, M., and Trommetter, M. (2007). The Role of Biotechnology Intellectual Property Rights in the Bioeconomy of 2030. OECD International Futures Project on “The Bioeconomy to 2030: Designing a Policy Agenda.” Retrieved from https://www.oecd.org/futures/long-termtechnologicalsocietalchallenges/40925999.pdf 16. Government Accountability Office. (2019). HIGH-RISK SERIES: Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas (GAO-19-157SP; High-Risk). Government Accountability Office. https://www.gao.gov/products/GAO19-157sp#summary 17. Gronvall, G.K. (2018). Safety, security, and serving the public interest in synthetic biology. Journal of Industrial Microbiology & Biotechnology, 45(7): 463-466. 18. Hahn, S.M. (2020, February 27). Coronavirus (COVID-19) Supply Chain Update. US Food and Drug Administration. Retrieved from https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-supply-chainupdate

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19. Hamilton, C. (2008). Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genomics, Society and Policy, 4(26): 1-19. 20. Homedes N, Ugalde A. Mexican Pharmacies and Antibiotic Consumption at the US-Mexico Border. Southern Med Review (2012) 5;2:9-19 21. Kolodziejczyk, B. (2017, October 9). Do-it-yourself biology shows safety risks of an open innovation movement. Brookings Institution. Available at https://www.brookings.edu/blog/techtank/2017/10/09/do-it-yourself-biologyshows-safety-risks-of-an-open-innovation-movement/ 22. KPMG. (2017). Overview of China’s Cybersecurity Law. KPMG. https://assets.kpmg/content/dam/kpmg/cn/pdf/ en/2017/02/overview-of-cybersecurity-law.pdf 23. Labiotech.eu. (2018). Can DIY Biology Ever Become a Big Player in Biotech? Available at https://www.labiotech.eu/ in-depth/diy-biology-biohacking-biotech/ 24. Landrain, T., Meyer, M., Perez, A.M., and Sussan, R. (2013). Do-it-yourself biology: challenges and promises for an open science and technology movement. Systems and Synthetic Biology, 7(3): 115-126. https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC3740105/

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25. Ledford, H. (2020). CRISPR treatment inserted directly into the body for first time. Nature, 579(7798), 185–185. https://doi.org/10.1038/d41586-020-00655-8 26. Miao, H. (2021, March 26). WHO warns against sales of counterfeit Covid vaccines on the dark web. CNBC. Retrieved from https://www.cnbc.com/2021/03/26/who-warns-against-sales-of-counterfeit-covid-vaccines-on-the-dark-web. html 27. Mirchandani, P. (2020). Health Care Supply Chains: Covid-19 Challenges and Pressing Actions. Annals of Internal Medicine, 173(4), 300-301. doi:10.7326/m20-1326 28. Molloy, J. (2020). New Prepring: Crisis-Critical Intellectual Property: Findings from the COVID-19 Pandemic. Open Bioeconomy Lab. Retrieved from https://openbioeconomy.org/news/new-preprint-crisis-critical-intellectualproperty-findings-from-the-covid-19-pandemic/ 29. Monast, J. (2018). Editing Nature: Reconceptualizing Biotechnology Governance. Boston College Law Review, 59(7). https://lawdigitalcommons.bc.edu/cgi/viewcontent.cgi?article=3701&context=bclr 30. Murch, R. S., So, W. K., Buchholz, W. G., Raman, S., & Peccoud, J. (2018). Cyberbiosecurity: An Emerging New Discipline to Help Safeguard the Bioeconomy. Frontiers in Bioengineering and Biotechnology, 6(39). https://doi.org/10.3389/fbioe.2018.00039 31. Rodriguez, S. (2020, April 27). Sweeping Mexican factory shutdown strains U.S. production of critical supplies. Retrieved from https://www.politico.com/news/2020/04/27/mexico-american-production-coronavirus-212971 32. Schondelmeyer, S.W., Seifert, J., Margraf, D.J., Mueller, M., Williamson, I., Dickinson, C., . . . Osterholm, M.T. (2020, October 21). COVID-19: The CIDRAP Viewpoint, Part 6: Ensuring a Resilient US Prescription Drug Supply. Retrieved from https://www.cidrap.umn.edu/sites/default/files/public/downloads/cidrap-covid19-viewpoint-part6.pdf 33. Sganga, N. (2021, February 18). Homeland security seizes more than 11 million counterfeit N95 in NATIONWIDE SCAM. Retrieved from https://www.cbsnews.com/news/n95-masks-counterfeit-homeland-security/ 34. Siripurapu, A. (2021, January 26). What is the Defense Production Act? Council on Foreign Relations. Retrieved from: https://www.cfr.org/in-brief/what-defense-production-act 35. Straus, J. (2017). Intellectual property rights and bioeconomy. Journal of Intellectual Property Law & Practice, 12(7): 576-590. https://academic.oup.com/jiplp/article/12/7/576/3823280 36. Tocchetti, S. and Aguiton, S.A. (2015). Is an FBI Agent a DIY Biologist Like Any Other? A Cultural Analysis of a Biosecurity Risk. Science, Technology, & Human Values, 40(5): 825-853. 37. World Bank. (2020a). Research and development expenditure (% of GDP). https://data.worldbank.org/indicator/ GB.XPD.RSDV.GD.ZS 38. World Bank. (2020b). GDP (Current US$). The World Bank. https://data.worldbank.org/indicator/NY.GDP.MKTP.CD

Scowcroft Institute of International Affairs

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President George H.W. Bush & Lt. Gen. Brent Scowcroft “We live in an era of tremendous global change. Policy makers will confront unfamiliar challenges, new opportunities, and difficult choices in the years ahead. I look forward to the Scowcroft Institute supporting policy-relevant research that will contribute to our understanding of these changes, illuminating their implications for our national interest, and fostering lively exchanges about how the United States can help shape a world that best serves our interests and reflects our values.”

— Lt. Gen. Brent Scowcroft, USAF (Ret.)

White Paper • 2021

In Memoriam/The The American Bioeconomy Scowcroft Vision and

In Memoriam Lieutenant General

Brent Scowcroft (March 19, 1925 - August 6, 2020)

The George H.W. Bush Presidential Library & Museum and The Bush School of Government & Public Service at Texas A&M University, College Station, Texas, USA

Scowcroft Institute of International Affairs

What Can be Done to Support It

White Paper • 2021

The American Bioeconomy and What Can be Done to Support It

Articles inside

Conclusion

Topic Area 2: Intellectual Property and the Bioeconomy

Intellectual Property Rights in Times of Crisis

DIY Bio: The National Security Challenges of Citizen Science

Utilizing the Defense Production Act

Introduction

References