2005 Public Readiness and Emergency Preparedness Act (PREP Act)
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Let’s talk about the Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act authorizes the Secretary of the Department of Health and Human Services (HHS) – that’s the Secretary of HHS – to issue a PREP Act declaration.
The declaration provides immunity from all liability, except for wilful misconduct, for claims of loss arising out of, relating to, or resulting from administration or use of countermeasures to disease threats and conditions determined by the Secretary to constitute a present or credible risk of a future Public Health Emergency, and the entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.
In other words, the PREP Act declaration is specifically for the purpose of providing immunity from liability, and it is different from all other emergency declarations.
So, this is when we need groups to go out and create these therapeutics on an emergency basis. If there’s a public health emergency that’s declared, we need to shield those same entities, just like we did in 1986 under the traditional long-running model – they’re not going to make them if we don’t provide liability for them. So, we need to entice these people to make this for us, and we can’t commercially do it if we don’t protect and shield them from liability because they’re going to bypass all this testing that they would normally go through when it’s an EUA.
So, this PREP Act pulls in the liability protections. You can actually go and find the current existing PREP Act declarations, what’s covered by them.
So, if there are any therapeutics that are developed by groups that fall into this list, they are now shielded from liability. What I’ve noticed is that everything that is a public health emergency of international concern, which we’ll get to when we get to the international stuff, it gets added. Like, it just immediately gets added.
So, you have smallpox, monkeypox, orthopox, Marburg virus, Ebola, nerve agents and insecticides, Zika, pandemic influenza, which would be like what we’ve experienced, anthrax, and then I just expanded this one because this was a new updated one: acute radiation syndrome medical countermeasures updated January of this year, and then botulin toxin.
So, these are existing PREP Acts, and if any therapeutics come out related to these, they are all been already declared as covered.