Lot of debate going on globally on the subject of compulsory licensing of pharmaceuticals.
Most of the chatter focuses on what's going on in Thailand and Brazil -- but what about Switzerland?
Switzerland? Well, actually to be more specific -- Geneva. And to be even more direct, the World Health Organization (WHO).
The issue at hand is, who's going to make the drugs whose patents have been stolen by Brasilia and Bangkok?
And who's going to certify that these pirated products are safe and effective, manufactured to the highest public health standards?
In many cases, that certification process is handled by the WHO. But, while the WHO does say who passes their GMP tests -- the organization does not say who fails.
According to the folks at WHO, such transparency would deter facilities from applying for certification. That's nonsense. All that allows is for facilities that have failed to gain WHO certification to claim that they have applied for that global imprimatur.
And that allows many substandard facilities to fake it so they can make it. The result -- counterfeit and substandard medications for the less developed world. Not acceptable. Kind of like claiming "patent pending." (But maybe talking about "patents" is a mixed metaphor considering the circumstances.)
(Could you imagine if the FDA only sent out public notification for medicines that the agency approved?)
The folks down in WHOville need to step up to the plate and embrace transparency in their pharmaceutical GMP certification process.
Most of the chatter focuses on what's going on in Thailand and Brazil -- but what about Switzerland?
Switzerland? Well, actually to be more specific -- Geneva. And to be even more direct, the World Health Organization (WHO).
The issue at hand is, who's going to make the drugs whose patents have been stolen by Brasilia and Bangkok?
And who's going to certify that these pirated products are safe and effective, manufactured to the highest public health standards?
In many cases, that certification process is handled by the WHO. But, while the WHO does say who passes their GMP tests -- the organization does not say who fails.
According to the folks at WHO, such transparency would deter facilities from applying for certification. That's nonsense. All that allows is for facilities that have failed to gain WHO certification to claim that they have applied for that global imprimatur.
And that allows many substandard facilities to fake it so they can make it. The result -- counterfeit and substandard medications for the less developed world. Not acceptable. Kind of like claiming "patent pending." (But maybe talking about "patents" is a mixed metaphor considering the circumstances.)
(Could you imagine if the FDA only sent out public notification for medicines that the agency approved?)
The folks down in WHOville need to step up to the plate and embrace transparency in their pharmaceutical GMP certification process.
