• How global regulations are written

    In secret, during “trade” negotiations. Just one example: the 12 years of data exclusivity for biologics is currently US law, but that may get carved into stone in the new Trans-Atlantic Trade and Investment Partnership (TIIP). Once enshrined in a trade agreement, this rule and thousands more will be immune to change by any national democratic process.

    Who participates in this process? Generally, only “cleared advisors” from the Fortune 500.

    A partial (leaked) list of the initial bargaining positions for the EU are downloadable here. In the Initial Positions Papers, the EU notes that they have approved 16 biosimilars which have not yet been recognized as such in the US. Other topics include generic approvals, GMP inspections, and regulatory science for drug approvals.

    All of decisions have immense potential impact for consumer welfare. My concern is the undemocratic lack of transparency for the entire process.


    • International trade agreements require no congressional approval? Can you fill in the details a bit more Kevin?

      If a US law says one thing, and a deal brokered with the EU requires something difft, what happens?


      • Congress gets an up or down vote, but it is a huge package deal. No real opportunity for amendment or debate.

      • International treaties “outrank” congressional statute, so to speak, but are still subject to presidential approval and an up-or-down vote in the Senate, and are still subordinate to the US federal constitution, from the US legal perspective.

    • These agreements are not treaties under the Constitution, but executive agreements of the President that are never submitted for ratification to the Senate. Congress passes enabling legislation to bring US domestic law into conformity with the new international obligation.