Government Shields Makers of Andes Virus Treatments
Published Date: 5/27/2026
Notice
Summary
The government is protecting doctors, nurses, and companies who make or use medicines to fight Andes virus, a rare but serious lung disease spread mainly in South America. This protection means they won’t be sued for most problems related to these medicines, starting right now. This helps speed up efforts to keep people safe without worrying about legal troubles.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 1 costs, 1 mixed.
Legal Immunity for Makers and Providers
The Declaration gives liability immunity to "Covered Persons" (manufacturers, distributors, program planners, qualified persons, and the United States) for manufacture, testing, development, distribution, and voluntary administration of the covered countermeasure (favipiravir) related to Andes virus exposures. Immunity is in effect as of the date of signature and extends through July 18, 2026, plus one additional month for disposition activities.
Patients' Limits on Suing for Injuries
If you receive the covered countermeasure (favipiravir) in accordance with this Declaration, most claims for loss against manufacturers or providers are precluded—negligence claims are barred except for claims involving "willful misconduct." This limitation on lawsuits applies without geographic limitation and is in effect through July 18, 2026 (plus one month).
Countermeasures Injury Compensation Program Rules
The Countermeasures Injury Compensation Program (CICP) may provide benefits to individuals who sustain a serious physical injury or die as a direct result of a covered countermeasure, but causation must be shown with "compelling, reliable, valid, medical and scientific evidence." For countermeasures given outside the U.S., only otherwise eligible individuals at U.S. embassies, military installations abroad, or NATO installations may be considered for CICP benefits.
Covered Countermeasure and Distribution Limits
The Declaration identifies favipiravir as the Covered Countermeasure and limits liability immunity to Recommended Activities involving countermeasures obtained for voluntary administration in accordance with an approved IND application. For governmental program planners, immunity applies only when countermeasures are obtained through voluntary means (donation, commercial sale, federal stockpile deployment, or state/local/private stockpiles).
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Key Dates
Department and Agencies
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