And the EU -- "but does not include a member country with respect to which the country's Annex to the Treaty of Accession to the European Union 2003 includes a transitional measure for the regulation of human pharmaceutical products that has not expired."
Nice try. Parallel trade makes the entire EU a free trade zone when it comes to pharmaceuticals. Consider the over 20% of drugs sold in Great Britain that originate in other, lower cost parts of Europe like Greece and Portugal, Latvia and Estonia.
Senator Flickertail's amendment also demands that approved nations "have statutory or regulatory requirements that require the review of drugs for safety and effectiveness by an entity of the government of the country."
Folks, "requirements" can mean a lot of things from nation to nation. What actually happens can be something altogether different.