It seems Doctors Without Borders (DWB) has more than just one problem with the US of A of late; first, there was that little matter of how the US military had committed a war crime by bombing their hospital in Afghanistan- and DWB had requested that an independent body investigate the matter. Now, DWB is saying that “The TPP will still go down in history as the worst trade agreement for access to medicines in developing countries.”
The TPP will make the carnage to innocent patients from the hospital bombing pale in comparison. Why don’t we just go on and ignore DWB’s advice AGAIN and trust the US government to make the decision for us AGAIN?
And the fact is that they are right; the few leaked details of this horrific agreement underline just how right they are:
So-called data-protection will be enhanced for so-called “biologic” drugs, or treatments that are derived from biological components. Vaccines, anti-toxins, proteins and monoclonal antibodies fall under this umbrella, and treatments for Ebola and cancer would likely be gravely affected as a result because biologic drugs are already some of the most expensive there is, far outside the affordability of the impoverished People.
According to Brookings Institution, biologics are much more structurally complex than regular chemical drugs. They are thus apparently way more difficult and expensive to make- this cost could be up to 22 times more than other drugs.
Because of the high prices of these drugs, companies are very interested in developing “biosimilars” – cheaper copies of the original drugs, similar to generic versions of pharmaceuticals. The reason these biosimilars are so cheap is that manufacturers can usually just rely on data from clinical trials submitted by the maker of the original biologic. But, of course, the maker of the original drug doesn’t want everyone using its data and making cheap knockoffs.
It’s not like we have to cry a river for these “hard-working” pharmaceutical corporations though, they ALREADY have 12 years of data exclusivity in the US! Over this 12 year period, the FDA will not approve a drug derived from the original data. While anyone is free to redo these extraordinarily expensive trials, this renders the whole point of cheap generics moot.
Other countries don’t try quite so hard to bend over backwards for big pharma- Japan only requires generics be held back for 8 years while Brunei requires none at all.
The US of A/ Big Pharma tried to force ALL countries to adopt the 12 years of data protection as part of the TPP (setting an unreasonably long period as a target made the already-extortionate 5-8 years look “reasonable”); however, there was resistance, and the final agreement was made that the data protection would last between 5 to 8 years.
This is bad news for some of the poorest people living in countries bound by the TPP, and the poorest countries everywhere which currently depend on generics.
Judit Rius Sanjuan, the legal policy adviser for Doctors Without Borders:
“Peru, Vietnam, Malaysia, and Mexico – they had zero monopoly protection on data for biologics,” she said. Now they’ll have to wait at least five years before allowing cheaper biosimilars onto the market. “It’s a loss for people in developing countries. They’ll face higher prices for longer periods of time, and there are many products we need that are biologics.”
Not just expensive biologic drug generics will be affected; for normal drugs, patents keep companies from creating generics for several years after they’d just been invented. Patents can be extended, however, and At present, it is entirely at the discretion of countries to decide whether a small change in the molecular formula would warrant an extension.
The TPP would negate the a country’s sovereign right to determine this very important technicality, among many other barriers to the creation of generics, propping up profits for Big pharma at the cost of… well, everybody. This agreement is basically going to prevent good governments from protecting the People, and give bad ones a good excuse to keep backing their corporate sponsors- for the good of free trade and the TPP of course.
“We know from experience that more expansive patent laws end up reducing the availability of generic medicines,” Yale law professor and global health researcher Amy Kapczynski. She had also written about the TTP’s impact on health in the New England Journal of Medicine. “When you start mucking around in the precise ways countries can define your patent laws,” she said, “you limit everyone’s policy flexibility.”
Sources: Zero Hedge
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