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HHS Issues Advisory Opinion Clarifying PREP Act Immunity

Client Alert

Authors: Judith L. O'Grady, Sharon R. Klein and Abigail L. Yeo

4/28/2020
HHS Issues Advisory Opinion Clarifying PREP Act Immunity

In response to a wave of questions from organizations looking to contribute to the fight against COVID-19, HHS recently clarified the bounds of immunity under the Public Readiness and Emergency Preparedness (PREP) Act, which shelters covered persons from some legal claims related to the provision of COVID-19 countermeasures. In an advisory opinion, HHS emphasized that covered persons and countermeasures include those that an entity “reasonably believed” were covered. HHS encouraged entities to document and publicly disclose precautions taken for the safe use of covered countermeasures.

Our previous publication on the PREP Act remains current, and introduces the topics discussed below.

PREP Act Imposes Reasonable Belief Standard, Not Strict Liability

HHS advised that an entity that complies with all other PREP Act requirements and the HHS Secretary’s COVID-19 declaration will not lose immunity — even if the product at issue or the entity itself is not covered by the PREP Act definitions — if that entity could have reasonably believed the product or entity was covered.1

For example, a distributor of COVID-19 diagnostic tests or respirators that appear to comply with an Emergency Use Authorization (EUA) will retain immunity — even if the products are counterfeit — so long as the person has taken reasonable steps “under the current, emergent circumstances” to authenticate the product.2

Similarly, a pharmacy that allows its licensed pharmacists to order COVID-19 tests, pursuant to federal guidance, will be immune from lawsuit — even if one of its pharmacists inadvertently allowed his license to expire — as long as the pharmacy maintained reasonable licensure-compliance measures under the circumstances.3

HHS encourages all covered persons to document and disclose the precautions taken to use covered countermeasures.4 For example, a medical product distributor may wish to provide a purchaser with the distributor’s assessment of the supplier’s facility and quality-control processes.5

What Products Are Covered?

Entities receive legal immunity for losses deriving from covered countermeasures, which are drugs, devices or biological products that mitigate COVID-19, including products that limit transmission.6 Products must be approved, licensed or cleared by the FDA; authorized under an EUA;7 described in an Emergency Use Instruction;8 or used under an Investigational New Drug application or Investigational Device Exemption.9

Facial masks or respirators are explicitly covered by the PREP Act as covered countermeasures, pursuant to amendments by the CARES Act, if they are approved by the National Institute for Occupational Safety and Health and subject to an EUA.10

What Entities Are Covered?

PREP Act immunity covers countermeasure “manufacturers,” “distributors,” “program planners,” “qualified persons” and their officials, agents and employees.11

The advisory opinion confirmed that private entities can be “program planners” if they assist in administering covered countermeasures.12

The advisory opinion clarified that public agencies with “legal responsibility and authority for responding to an incident,” including city and county authorities and law enforcement, are authorized under the PREP Act to extend immunity to additional “qualified persons.”13 Entities authorized by such a public agency to assist in the emergency response, for example through requests for assistance or agreements, are considered “qualified persons.”14

PREP Act Immunity Is Not Absolute

HHS noted again that PREP Act immunity only covers claims of loss (e.g., personal injury or property damage); it does not cover civil, criminal or administrative claims or claims for equitable relief.15 The PREP Act also does not act as a defense against federal enforcement actions brought by the federal government,16 nor presumably state government. Covered claims of loss, as mentioned above, will be mandatorily dismissed.17

HHS also clarified that, while entities are liable for willful misconduct that causes death or serious injury, the following acts or omissions will not be considered willful misconduct:

  • “Program planners” and “qualified persons” will not have engaged in willful misconduct if these entities acted in a manner “consistent with applicable directions” and notified the HHS Secretary, or a state or local health authority, of information pertaining to a serious physical injury or death within seven days of discovering such information.18

  • “Manufacturers” and “distributors” will not have engaged in willful misconduct if the HHS Secretary and U.S. Attorney General do not initiate an enforcement action against them or an enforcement action is initiated and the action terminates or is resolved without a covered remedy.19

Endnotes

1 “Advisory Opinion on the Public Readiness and Emergency Preparedness Act and the March 10, 2020 Declaration Under the Act,” at 2, https://www.hhs.gov/sites/default/files/prep-act-advisory-opinion-april-14-2020.pdf (Apr. 14, 2020).

2 Id. at 4-5.

3 Id. at 7.

4 Id. at 8.

5 Id.

6 “Declaration for Public Readiness and Emergency Preparedness Act Coverage for Medical Countermeasures Against COVID-19,” https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx (Mar. 10, 2020); 42 U.S.C. § 247d-6d(i)(1)(A); “Advisory Opinion” at 3.

7 HHS provided appendices listing products currently covered by an EUA. See Appendix A, https://www.fda.gov/media/136702/download (listing medical devices); Appendix B, https://www.fda.gov/media/136832/download (listing therapeutics).

8 An emergency use instruction (EUI) can take the place of an EUA and is issued by the Centers for Disease Control and Prevention (CDC). “Emergency Dispensing Orders,” https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-dispensing-orders (Apr. 30, 2019). For example, after the CDC issued an EUI for doxycycline during the anthrax emergency, the FDA terminated its EUA on mass dispensing of doxycycline. Id. EUIs describe the FDA-approved conditions of use for the countermeasure. Id.

9 “Advisory Opinion” at 3-4; see also 42 U.S.C. § 247d-6d(i)(7).

10 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) § 3103, Pub. L. No. 116-136 (Mar. 27, 2020); see also “Advisory Opinion” at 3.

11 See 42 U.S.C. § 247d-6d(i)(2).

12 “Advisory Opinion” at 5-6.

13 Id. at 6; see “Declaration,” Section VII.

14 “Advisory Opinion” at 2.

15 Id.

16 Id.

17 “PREP Act Q&As,” https://www.phe.gov/Preparedness/legal/prepact/Pages/prepqa.aspx (Sept. 5, 2019).

18 42 U.S.C. § 247d-6d(c)(4); “Advisory Opinion” at 7.

19 42 U.S.C. § 247d-6d(c)(5); “Advisory Opinion” at 7.

The material in this publication was created as of the date set forth above and is based on laws, court decisions, administrative rulings and congressional materials that existed at that time, and should not be construed as legal advice or legal opinions on specific facts. The information in this publication is not intended to create, and the transmission and receipt of it does not constitute, a lawyer-client relationship.

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