In order to encourage the development and availability of experimental Ebola vaccines, the U.S. Department of Health and Human Services (HHS) has offered liability protection to drug makers who are currently developing Ebola vaccines.
The announcement was made as part of the Public Readiness and Emergency Preparedness (PREP) Act. The goal of this measure is to encourage the development and availability of Ebola vaccines.
As per this protection, companies will have immunity under the US law against any legal claims related to the manufacturing, testing, development, distribution and administration of these vaccines. However, they will not enjoy the same immunity for claims that are brought in courts outside the United States.
Similar protection has been offered previously to vaccine makers in the US with the same objective: to encourage the development of childhood vaccines. This particular announcement is part of an effort by the HHS to address issues in the US and in other countries with respect to the development and use of Ebola vaccines. The HHS Secretary Sylvia Burwell has encouraged other countries to follow suit and to offer similar liability protections.
“As a global community, we must ensure that legitimate concerns about liability do not hold back the possibility of developing an Ebola vaccine, an essential strategy in our global response to the Ebola epidemic in West Africa,” she said in a statement.
Thus, as per this law, anyone who is allegedly injured by a vaccine can only sue in federal court if the FDA or the Justice Department investigates and finds definite proof of misconduct by the drug company.
Also, this declaration will apply to three specific countermeasures. First, the liability immunity will protect manufacturers and distributors regardless of whether it’s administered and applied without geographic limitation. This protection will last until December 10, 2015. Any individual who sustains a serious physical injury as a result of the vaccine can seek compensation through a Countermeasures Injury Compensation Program but such a claim will have to be supported with reliable and valid evidence.
This measure is expected to encourage more companies to invest in research and development efforts for an Ebola vaccine without the fear that they may be subject to lawsuits and compensation claims in case the vaccine does not provide the necessary results.