LSHC Horizons Brochure 2024 - Flipbook - Page 69
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Cross-jurisdictional
69
Life sciences exports in an era of geopolitical risk
Exporting clinical products is increasingly
fraught with trade-related risks.
With Russia’s invasion of Ukraine, western
countries have imposed broad and deep
sanctions on exports to Russia, certain regions
of Ukraine, and Belarus, which make certain
clinical exports practically difficult, or even
outright illegal. For example, trading with these
territories often involves payments to Russian
banks, many of which are subject to UK, U.S.
and/or EU asset freezes. More broadly, it is
often the case that while a medical product
is not sanctioned (as is generally the case for
medicine to Russia), associated items such as
packaging or temperature monitors required to
accompany such items are.
Relatedly, life sciences companies often have to
contend with a myriad of similar, but different,
sanctions regimes in exporting their products; by
way of illustration, while EU sanctions generally
exempt exports where they are for medical or
pharmaceutical purposes (provided certain
requirements are met), UK sanctions do not.
Life sciences companies exporting to these
high-risk locations have often adopted policies
and procedures to ensure they comply with the
ever-evolving sanctions landscape. However,
such companies should not forget the ongoing
need to comply with export controls.
Export controls, which can be of global
application, are intended to regulate the export
of certain products, software, or technology
which could have military applications;
however, they do not have to be designed, or in
fact used, for such applications. Health carerelated products, be it complex machines or
certain vaccines, can be subject to requirements
to obtain authorization prior to export. While
export controls are often conceived of in the
context of the physical export of products,
technology (broadly, know-how) can also be
“exported”, including via a simple e-mail or
phone call.
Whether because of the difficulty in
determining which, if any, state license is
required, or simply a lack of awareness as to
the requirement generally, many companies
have left state licensing unaddressed and
many states are paying an increasing level
of attention and are increasingly pursuing
enforcement action instead of being satisfied
with companies remediating the situation.
Ajay Kuntamukkala
Office Managing Partner
Washington, D.C.
Aline Doussin
Partner
London, Paris
Ashley Roberts
Counsel
Washington, D.C.
Daniel Shapland
Associate
London
Band One for Life Sciences:
Multi-Jurisdictional in
Chambers Global, 2024
