In most if not all countries it is illegal to sell unlicensed medicines and medical treatments. It is however legal to sell the reagents, equipment and instructions to individuals for them to create the medicine or perform the procedure. Is it defined where the line is between these situations?
Two fairly high profile examples of this are:
- CRISPR
- There are available kits that allow you to perform CRISPR/Cas9 gene editing.
- COVID vaccine
- There is an open source method for producing a nasal COVID-19 vaccine.
The RaDVaC vaccine is a good example. Currently it is only available as a free open source (CC BY-SA 4.0 and OCL-P v1.1) white paper, and all the ingredients and equipment must be sourced individually. I presume from the CRISPR example it would be legal to sell "kits" with all the necessary items. Just this step would cover most of the "methods" section of the instructions, as that is dominated by the choice of epitopes. I could probably perform a number of further steps, such as preparation of the appropriate dilutions of reagents and possibly creation of the the chitosan nanoparticles, prior to shipping. I could perhaps reduce the instructions from a 90 page document to "mix this powder with water, wait an hour, spray it up your nose".
Is it possible to work out a priori which of these "kits" would be legal to sell? Any jurisdiction would be interesting, I guess if this is on the internet "somewhere with an extradition treaty with the US" is probably the important factor.
If I need to say it, I think doing this would be a really bad idea from a public health standpoint for many fairly obvious reasons. Perhaps not as bad as selling CRISPR kits though.
