LS&HC Horizons 2022 - Flipbook - Page 31
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
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Covid-19 and Pandemic Preparedness
Thinking ahead: Future expiration of the Covid-19 PREP Act Declaration
Since the start of the pandemic, we have published various articles
regarding the Covid-19 Declaration (Declaration) issued by the
Secretary of the Department of Health and Human Services (HHS)
pursuant to the Public Readiness and Emergency Preparedness
Act (PREP Act). The Declaration provides certain “covered
persons” with immunity from liability arising out of or related to
the manufacture, distribution, administration, or use of certain
“covered countermeasures.” The immunity provisions triggered
under the Declaration are set to expire on 1 October 2024.
However, the Declaration provides an additional twelve months
of liability protection at the conclusion of the effective period to
allow manufacturers to “arrange for disposition of the Covered
Countermeasure” and for covered persons to take any other actions
“as are appropriate to limit the administration or use of the Covered
Countermeasures.”1
1
42 U.S.C. 247d–6d(b)(3)(B) and (C).
While it is possible the expiration may be extended, in the event that
it is not, those covered persons continuing to engage in activities
involving covered countermeasures should consider taking steps to
mitigate potential future liability risks, including, for example:
• Ensure accurate tracking measures are implemented and/or
maintained for relevant products to facilitate the return and/or
destruction of those products upon expiration of the immunity period;
• Ensure any existing protocols pertaining to covered
countermeasures are placed under review to confirm compliance
with all applicable laws; and
• Consider liability insurance issues as appropriate.
Lauren Colton
Partner, Baltimore
Julie Schindel
Senior Associate, Baltimore
Megan Dorsch
Associate, Baltimore
