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Gates Package, p.1040 · gates:exh:00450
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languages can be used, and those rules will vary from place to place.*
For years, there has been a debate in global health about when waiving companies'
intellectual property rights is an effective way to get more vaccines or drugs produced. In some
cases, waivers have helped make low-cost drugs available, such as the story of the HIV
treatments I mentioned in Chapter 5. This history got a lot of attention again in 2021, as
advocates called on the World Trade Organization to waive the intellectual property protections
for COVID vaccines.
Unfortunately, this movement came too late to help close the supply gap. There are a
limited number of facilities and people in the world who can produce vaccines that meet all the
national and global requirements for quality and safety. And, because most vaccines are made
using very specific processes, you can't simply switch a facility from making, say, viral vectors
to making mRNA vaccines. You'll need new equipment, and even then, your facility will still
need to be approved to make the new product.
Suppose the WHO has required companies to release their recipes for approved vaccines,
and now Company A wants to duplicate Company B's approved vaccine and meet all the
necessary standards. But just getting B's recipe won't be enough--they'll also need information
from B like specifics about their manufacturing processes, data from clinical trials, and details
about what they've told regulators. Because some of this information applies to B's other
* During COVID, the Gates Foundation was involved in many efforts to streamline and
standardize labeling requirements.