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ovations to market. The free flow of data is lack of strong digital trade rules could impact the
critical to facilitating this collaboration, as it enables development, availability, and safety of innovative
researchers and developers to share information, medical products to patients in the U.S. and around
insights, and expertise across borders. the world.

Under this international R&D structure, Manufacturing
semiconductor designs, design tools, engineering
skills, research methodologies, and other data When offering industrial software supporting
associated with component development design, testing, and execution for customers of all
are transferred from location to location, sizes, U.S. companies’ source code and algorithms
crossing multiple international borders along allow their products to function and provide
the way. Digital trade barriers will threaten value to customers by increasing efficiency and
this collaboration that has helped to generate lowering total costs, in some cases as much as
new innovations and technologies that fuel the 20%. The customers these companies serve make
advancement of this industry. up the backbone of economies from automotive to
aerospace to food and beverage.
Biopharma & Medtech
If a third-party government were to have access
For biopharmaceuticals and medical technologies, to the kernels of these companies’ products—as
the picture is similar. Biopharmaceuticals are the administration’s move portends to do—it would
increasingly developed, tested, and analyzed essentially create a competitor with a duplicate
for safety and efficacy in different countries. To product in the market, hurting their market
perform this R&D, scientists, regulators, and others opportunities and ability to continue to reinvest in
depend on the capability to transfer data securely their products and U.S. business. Industry leaders
across international IT networks. are stunned that the Biden administration, despite
its oft-repeated commitment to manufacturing in
Even before the launch of preclinical studies and America, seems in this instance to be supporting
clinical trials, the global R&D ecosystem depends on the forced transfer of U.S. technologies to our
cross-border access to medical journals, scientific competitors abroad.
collaboration, and real-world evidence. Cross-border
R&D collaboration has also proliferated in response On the other hand, the protections included in the
to the COVID-19 pandemic, which saw the rapid USMCA’s digital trade chapter would, if applied
development of vaccines that often include inputs more broadly, prohibit countries from requiring the
from more than a dozen countries. disclosure of source code to software (including
algorithms) as a condition for selling or using that
Cross-border data transfers help improve software in the member state’s territory.
preclinical studies and clinical trials by reducing
development cycles, improving data quality, Financial Services
facilitating participant adherence, and leading to
more conclusive safety and efficacy findings. The The United States is an established leader in the
cross-border transfer of clinical study data includes provision of financial services globally. The American
data at all stages of the trial, including supply chain financial services industry generally accounts for
transparency, such as when samples are delivered 15-20 percent of U.S. GDP and is an increasingly
to and from patient facilities and laboratories. digitally-enabled and data-intensive sector.

Limits on cross-border data flows would also There is an opportunity through digital trade
require reconfiguring the global logistics to support workers and businesses that are
networks that have been developed so that such increasingly reliant on the use of digitally enabled
medical technologies can arrive at hospitals and financial services. For example, as a result
reach patients with the latest software. It would of the pandemic, firms of all sizes – including
likely require the abandonment of some locations small, minority-owned, and rural- businesses
and stages in the processes in ways that would – dramatically increased their use of digital
forgo the talent and innovation they provide— payments. Digital payments often serve as the
and it could dramatically raise costs and depress first point of access to formal financial services for
innovation. Such limits could furthermore limit these small businesses and allow them to become a
the development and delivery of cutting-edge part of global value chains and reach customers in
digital medicines. international markets.

Finally, overly strict cross-border data flow Policies that restrict digital trade — including
restrictions could inhibit the collection of medical data localization and similar measures — are
product safety data from across markets and proliferating. Restrictions on the free flow of data
reporting of that data to the FDA and other negatively impact growth and productivity, which
regulators. This further demonstrates that the

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