LS&HC Horizons 2023 - Flipbook - Page 43
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Patents, Litigation, and Beyond
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Updated DOJ compliance guidance offers direction to life sciences
and health care companies
On 15 September 2022, Deputy Attorney
General Lisa Monaco issued an updated
memorandum entitled “Further Revisions to
Corporate Criminal Enforcement Policies”.
The Monaco Memo builds on prior Department
of Justice (DOJ) guidance to companies
seeking to enhance their compliance programs
and mitigate enforcement risks.
Life sciences and health care companies —
due to their interactions with regulators, large
and often international workforces, contacts
with health care providers, and reliance on
third parties — should be aware of the Monaco
Memo’s dictates, including:
• Individual accountability: DOJ
continues to prioritize individual
accountability and will expect complete
disclosures about culpable individuals from
cooperating companies.
• Executive compensation: DOJ will
expect companies to utilize compensation
as a compliance tool and to implement
related policies, such as claw back provisions.
Shelita M. Stewart
Partner, Washington, D.C.
• Corporate recidivism: DOJ will consider
the full range of prior misconduct by a
company when entering into resolutions.
• Timeliness and self-reporting: DOJ will
continue to adopt policies that incentivize
self-reporting, along the lines of the existing
FCPA policy, with an emphasis on how
swiftly evidence is disclosed.
• Personal devices and applications:
DOJ will expect companies to have policies
governing the use of personal devices and
third-party applications (such as WhatsApp)
for corporate communications.
DOJ compliance guidance underscores
the need for life sciences and health care
companies to ensure that their compliance
programs keep pace with their evolving
business activities. External counsel can assist
with risk assessments and enhancements that
can enable LS&HC companies to remediate
both compliance issues and — if necessary —
demonstrate their compliance efforts if later
scrutinized by enforcement authorities.
Matthew C. Sullivan
Partner, New York
Annie Madding
Associate, Washington, D.C.
