RW 3/8.) Project Bioshield & PREP Act

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This section is on the US Healthcare Framework 2004 Project Bioshield Act & the 2005 Public Readiness and Emergency Preparedness Act (PREP Act)

Project Bioshield

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We have this, and so we’re going to continue now with the healthcare framework so you guys can understand why I was having such a hard time reconciling how everything was going.

Let’s talk here about additional US healthcare framework. In 2004, we have the Project Bioshield Act, and this is really where we got the CBRN products for civilian use, which stands for chemical, biological, radiological, and nuclear products for civilian use. (01)

We also have the 2005 Prep Act, the 2010 Affordable Care Act, which introduced the ICD-10 codes. We will come back to that one on the global section, even though that was what we call Obamacare, and that was a domestic law. We will come back to those when we get to the global section of healthcare.

Then we have the 2015 Other Transactions Authority, which is denoted legally in 10 USC 4022, the Department of Defense prototypes. We’re going to talk about the nexus of how this all came to be. Finally, we’re going to talk about the 2018 Defense Production Act and a federal regulation that was promulgated by the executive branch related to that 2018 Defense Production Act.

Let’s talk about this 2004 Project Bioshield Act, and you can see right here on the screen, the Project Bioshield Act was an act passed in the United States Congress in 2004, calling for basically a five billion dollar purchasing requisition for medical protocols that would be used in the event of a bioterrorist attack.

It was a ten-year program to acquire medical countermeasures (MCM) to biological, chemical, radiological, and nuclear agents for civilian use.

That’s directly from Wikipedia, and that lets you know that this is sort of how they have moved the CBRN to civilian use. All of these things make sense, right? They were on the heels of 9/11 and then the heels of 2003 SARS, which was sort of a global beginning.

The Project BioShield Act was signed into law on July 21, 2004. Since its inception, the Biomedical Advanced Research and Development Authority (BARDA) within the HHS Administration for Strategic Preparedness and Response has managed the program and worked to develop the strong partnerships, clear direction, and market incentives needed to make the program a success. Project BioShield funding is used to address national security threats as identified by the Department of Homeland Security’s Material Threat Determination process. (Wow, BARDA? Rick Bright? Ring a Bell? “Here’s a hint“) (02)

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. (03)

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. (04)

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.

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Penny... on Health
Penny... on Health

Truth-seeker, ever-questioning, ever-learning, ever-researching, ever delving further and deeper, ever trying to 'figure it out'. This site is a legacy of sorts, a place to collect thoughts, notes, book summaries, & random points of interests.

DISCLAIMER: The information on this website is not medical science or medical advice. I do not have any medical training aside from my own research and interest in this area. The information I publish is not intended to diagnose, treat, cure or prevent any disease, disorder, pain, injury, deformity, or physical or mental condition. I just report my own results, understanding & research.