Department of Health and Human Services Amends PREP Act Declaration

On December 3, 2020, the U.S. Department of Health and Human Services (HHS) amended its Public Readiness and Emergency Preparedness Act (PREP Act) Declaration for Medical Countermeasures Against COVID-19 in order to clarify several points for the public. As background, the PREP Act (42 U.S.C. § 247d-6d) authorizes the Secretary of HHS to issue a declaration to immunize certain individuals and entities (Covered Persons) against any claim of loss related to “Covered Countermeasures.” The Secretary issued its initial COVID-19 PREP Act Declaration on March 17, 2020.

The Fourth Amendment to the COVID-19 PREP Act Declaration does the following:

• Clarifies that the Declaration “must be construed in accordance with … Advisory Opinions” articulated by the HHS Office of General Counsel. The four Advisory Opinions are available online.
• Incorporates authorizations that HHS’s Office of the Assistant Secretary for Health has issued as an Authority Having Jurisdiction authorizing licensed pharmacists to order and administer COVID-19 tests (i.e., serology tests) the FDA has authorized.
• Adds an additional category of Qualified Persons who may qualify for PREP Act protection under certain circumstances. Specifically, healthcare personnel using telehealth to order or administer Covered Countermeasures for patients outside the state where the healthcare personnel are permitted to practice. Other examples of qualified persons include certain pharmacists, pharmacy interns and pharmacy technicians who order or administer certain COVID-19 tests and vaccines.
• Modifies and clarifies the training requirements for certain licensed pharmacists and pharmacy interns to administer specified routine childhood or COVID-19 vaccinations.
• Makes explicit that Section VI of the Declaration, which outlines the Covered Countermeasures which may qualify for PREP Act protection, covers all qualified pandemic and epidemic products under the PREP Act.
• Adds a third method of distribution providing liability protections for, among other things, additional private distribution channels. Specifically, HHS extends PREP Act protection for the manufacture, distribution, use, etc. of Covered Countermeasures that are “licensed, approved, cleared, or authorized by the FDA … to treat, diagnose, cure, prevent, mitigate, or limit the harm from COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom,” as well as respiratory devices approved by NIOSH “to prevent, mitigate, or limit the harm from COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom.” This provision adds to the previous limitation on distribution methods, which extended PREP Act protection only to Covered Countermeasures related to present or future federal agreements or activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction.
• Makes explicit that there can be situations where not administering a Covered Countermeasure to a specified individual can fall within the PREP Act. The amendment references the example of a COVID-19 vaccine which is in short supply and is preferentially administered to an individual in a more vulnerable population. In this case, the amended COVID-19 PREP Act Declaration now provides that non-administration of the vaccine to a person in a less vulnerable population can constitute “relating to … the administration to … an individual” under the PREP Act and therefore qualify for protection.
• Explicitly notes there are substantial legal and policy issues/interests in having a unified response to the COVID-19 pandemic.
• Revises the effective time period of the Declaration considering amendments to the Declaration.

During a conference call with HHS the same day the amendment was released, the Deputy Assistant Secretary and Associate General Counsel noted that:

• Expanding telehealth was an important consideration in this Amendment in order to assist the diagnosis and treatment of COVID-19 patients across state lines.
• Changes to pharmacists’ training requirements will allow pharmacists to order/administer vaccines if they meet certain PREP Act criteria, even where the state does not have its own requirements. If a state already has established training requirements, the new amendment will defer to the state standards. If there are no explicit requirements in place, the PREP Act provides the necessary requirements for pharmacist training.

Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.