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December 03, 2019


"The Trump Administration"... as if The Donald has on his radar an issue at this level of detail.

For those of us in countries (Australia, for my part) that have been pressured in the not-so-distant past to extend data exclusivity periods to match those of the US, this is a joke. Apparently, these days, you need a "strong arm" leader (Russia, Turkey, the Philippines, North Korea) to earn any respect. Trump already dumped the TPPA, after the US gained numerous gains on this, and other, issues.

We won't forget that decades of dedicated allegiance counts for little, or nothing, under the current regime.

"[T]he data exclusivity period in the BPCIA (and prior biosimilars legislation packages) was a hotly contested topic of debate, with some supporting a 14-year period, the Obama administration preferring a 7-year period..."

For completeness' sake, one should also note that the Obama administration pushed hard for ratification of the TPP, which would have codified an *8-year* minimum as an obligation of a vast, multi-party treaty.

Hm, I wonder if the proposed change to U.S. law is still in the hopper, now that the data exclusivity provisions have simply been removed from the USMCA?

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