UKs Point of Care Manufacture is another trojan horse for gene therapies

On the surface, this seems an excellent idea

This new initiative from UK Government seems an excellent idea:

Government response to consultation on proposals to support the regulation of medicines manufactured at the Point of Care. This is how it’s described:

“New types of innovative products, such as those with very short shelf lives, are required to be manufactured and supplied at the point where a patient receives care (POC). The current human medicines legislation is geared for products which can be manufactured at a very small number of sites and supplied globally. In contrast, POC products, may only have a shelf-life of minutes or need to be highly personalised, so have to be manufactured on demand when the patient is present. This could mean manufacturing a POC product at hundreds of sites across the UK alone. A new regulatory framework will support the manufacture and supply of these innovative products.”

Are these weasel words?

It basically says these ‘innovative products’ can’t be manufactured like other medicinal products, so they will do something different. That something different is to throw away the rule book and do something never attempted before.