Biologics Provisions Suspended in Signed CPTPP - Big Molecule Watch

We previously reported on the announced agreement to enter into the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP).

As previously announced, the final version of the CPTPP suspended all of the biologics provisions (Article 18.51) that appeared in the TPP.  According to past reports, the biologics provisions were heavily debated.  In particular, the exclusivity period for biologics was a point of contention between some member countries.  The final version of the CPTPP  was released on Feb 21, 2018.

Yesterday, leaders of the 11 member countries signed the CPTPP in Santiago, Chile. In order for the agreement to become effective, at least six of the eleven member countries must ratify the agreement.  The member countries have stated they expect this will occur in early 2019.

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