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HHS OGC Issues Important Advisory Opinions on the PREP Act

On October 23, 2020, the US Department of Health and Human Services Office of the General Counsel (HHS OGC) issued two important Advisory Opinions, 20-03 and 20-04, about the Public Readiness and Emergency Preparedness (PREP) Act and the HHS Secretary’s March 10, 2020, Declaration under the PREP Act for medical countermeasures against COVID-19.

Advisory Opinion 20-03 addresses three vaccination-related issues:

  1. Whether the PREP Act preempts pharmacy-related state licensing laws that are less stringent than federal standards under the Third Amendment to the Secretary’s March 2020 Declaration[1].
    • HHS OGC notes that relevant state-licensing laws that are less stringent than those in the Declaration are not preempted.
  2. Whether a state may require a pharmacist to enter into a collaborative-practice agreement with a licensed physician as a condition of administering vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) for children between ages 3 and 18.
    • HHS OGC states that “any state or local law requiring a pharmacist to enter into a collaborative-practice agreement would be preempted if that requirement prohibits or effectively prohibits a pharmacist from ordering and administering vaccines as set forth in the Third Amendment and related issuances.”
  3. Whether epinephrine, when used to treat a severe acute vaccine reaction, is a “covered countermeasure” as defined in the PREP Act.
    • HHS OGC indicates that epinephrine is a “covered countermeasure” under the PREP Act when used to treat severe acute reactions to an ACIP-recommended vaccine.

Advisory Opinion 20-04 focuses on who is a “program planner” under the PREP Act and the Secretary’s March 10, 2020, Declaration, as amended, and the activities authorized by an “Authority Having Jurisdiction.” The Advisory Opinion indicates that any individual or organization can potentially receive PREP Act coverage as a program planner when they act in accordance with the PREP Act and the Declaration. Regarding activities authorized by an Authority Having Jurisdiction, the Advisory Opinion expands examples provided in an earlier Advisory Opinion with ways in which activities might be authorized and notes that all the examples may collectively be considered “guidance.” The Advisory Opinion also provides examples of how a program planner may or may not qualify for PREP Act immunity when local, state, and/or federal Authorities Having Jurisdiction issue conflicting guidance.

[1] The Third Amendment identifies, as Qualified Persons covered under the PREP Act, certain state-licensed pharmacists and state-licensed or registered pharmacy interns acting under the supervision of a state-licensed pharmacist. The Amendment authorizes those pharmacists to order and administer, and authorizes those pharmacy interns to administer, any vaccine that the ACIP recommends for ages 3 through 18, according to ACIP’s standard immunization schedule. The Amendment clarifies that “the category of disease, health condition, or threat for which [the Secretary] recommends the administration or use of the Covered Countermeasures includes not only COVID-19…but also other diseases, health conditions, or threats that may have been caused by COVID-19…including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.”

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