LS&HC Horizons 2022 - Flipbook - Page 42
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
42
Patents, Litigation, and Beyond
Compliance issues unique to life sciences companies
With combating bribery and corruption set as an important Biden
administration foreign policy priority, you can count on the U.S.
Department of Justice (DOJ) enhancing its investigatory coordination
with foreign governments and increasing its scrutiny of potential
Foreign Corrupt Practices Act (FCPA) activity.
This will greatly impact multi-national life sciences companies, which
should review, update, and enhance their FCPA compliance programs
accordingly. Companies that determine they have an issue will also
have to grapple with the ever-present and problematic question of
self-disclosure under the FCPA Corporate Enforcement Policy
if they seek to gain the putative benefits of cooperation.
Gejaa Gobena
Partner, Washington, D.C.
Greg Noonan
Partner, Boston
Several factors unique to multi-national life sciences companies
should be kept in mind, including:
• T
he multitude of touchpoints life sciences companies have with
government officials;
• O
verseas clinical trials, often under the auspices of foreign officials;
• S
ponsorship of educational speaker programs overseas that involve
HCPs working for nationalized health systems; and
• E
xtent of reliance on overseas third parties.
If issues are identified, be sure to consider the following questions:
• D
oes self-disclosure in the United States trigger disclosure
obligations elsewhere?
• W
hat is the true cost-benefit of self-disclosure?
• W
hat happens if, despite a company fulfilling all the elements of
the disclosure policy, DOJ pushes for a criminal conviction? Is
exclusion a live issue?
Because the risk profiles for life sciences companies are unique, they
need to ask themselves a very different set of questions when
determining whether and when to self-disclose.
Check out the Global Bribery
and Corruption Outlook
2022 for more information.
