The HHS Office of the General Counsel has released an important Advisory Opinion that provides insight regarding the interpretation and application of the Secretary’s March 17, 2020 Declaration, which is retroactively effective beginning February 4, 2020. (HL Pulse discussion here). The Declaration provides immunity to certain individuals and entities for liability against “all claims for loss caused by, or, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure.” The Advisory Opinion is not binding and only represents the current view of the HHS Office of the General Counsel.
The Advisory Opinion states that where “all requirements of the PREP Act and the declaration are met, immunity covers claims for loss sounding in tort or contract, as well as claims for loss relating to compliance with local, state, or federal laws, regulations, or other legal requirements.” Appendix A and Appendix B provide lists of covered countermeasures subject to an Emergency Use Authorization.
The Advisory Opinion also:
- Advises that an entity or individual who complies with all other requirements of the PREP Act and the conditions of the Secretary’s declaration will not lose PREP Act immunity—even if the medical product at issue is not a covered countermeasure—if that entity or individual reasonably could have believed that the product was a covered countermeasure;
- Advises that a person who complies with all other requirements of the PREP Act and the conditions of the Secretary’s declaration will not lose PREP Act immunity—even if the person at issue is not a covered person—if the entity or individual reasonably could have believed that the person was a covered person; and
- Sets forth HHS’s view that covered persons should take, and document, reasonable precautions under the current emergent circumstances to facilitate the safe use or administration of covered countermeasures and to make those documents publicly and easily available.
The Advisory Opinion closes with the important reminder that “[p]ersons seeking PREP Act immunity are responsible for determining whether their products are covered countermeasures, whether a person or entity is a covered person, whether reasonable precautions have been taken to facilitate the safe use of covered countermeasures, and in general, whether immunity applies to them and their activities.”
On April 21, the U.S. National Institutes of Health published treatment guidelines for COVID-19. The NIH stated that “[a]t present, no drug has been proven to be safe and effective for treating COVID-19” and that “definitive clinical trial data are needed to identify optimal treatments for this disease.” The announcement provides a list of therapeutic options that are under investigation. The panel does recommend against several treatments, including combining hydroxychloroquine plus azithromycin “because of the potential for toxicities.”
Norton Rose Fulbright attorneys will continue to provide relevant updates for healthcare providers on the Health Law Pulse during the COVID-19 public health crisis.