Trade Agreements Act Substantial Transformation

Maria Souza

At the same time, Acetris has agreed with VA, on pain of insolvency, to terminate its existing entecavir contract for free. The VA then launched a new appeal for entecavir. In a show by the great Chuzpe, Acetris has positioned itself to compete for the new VA contract. In a number of questions that preceded the proposal, Acetris asked LA to confirm that it would rely on CBP`s provision that the entecavir did not comply with the ATA. The VA obliges. Acetris protested in the United States Federal Court (COFC) against the VA`s decision to exclude its entecavir. The COFC accepted acetris and found that the entecavir was in accordance with the TAA, as it was profoundly transformed in the United States. The COFC found that the VA alleged an error in relying on CBP`s determination to exclude the Acetris product. For countries with which the United States has free trade agreements, the free trade agreement will define its origin. Free trade agreements also use the concept of “essential transformation” to determine the “country of origin,” although they may present the concept in different ways.

B such as changes in tariff classification, value added, certain processing operations or combinations of these criteria. The Court also rejected the government`s argument (which reiterated CBP`s finding) that the protester`s entecavir tablets were products of India, as they were the country of origin of the tablets` pharmaceutical active ingredient. The Court said that the product in question – and the only thing regulated by the TAA – was “the pill itself” and not the various components of the pill. The tablet itself was not a “product of India” because the tablet is not “quite the . . . Manufacturing” From India, it has not been “substantially transformed” in India, as provided for by the TAA test in the country of origin. 19 U.S.C No. 2518 (4) (B).

Since the legal examination of the country of origin applies only in negative – that is.dem prohibition on buying products from a non-designated country – but also does not require that the product be identified as the product of the United States or another designated country – the Court ruled that the law did not prohibit the protester`s product: “Since the TAA excludes only products from public procurement if they are “products” from a foreign country such as India , the law is therefore not excluded. , the TAA does not prohibit the VA from purchasing Acetris products. Acetris had previously received an advisory provision from CBP that applied its own precedents to establish that the active substance (API) named after the detection, imported from India, did not complete the essential processing test when it was converted into pills in the United States, and the pills therefore had to be treated as Indian origin. Nevertheless, this revised framework has effectively made it easier for Acetris to demonstrate compliance with TaA`s drug compliance. The Federal Circuit rejected the government`s argument that Acetris` finished products were products from India because the active substance originated in India, on the grounds that the pills had not been “fully manufactured” in India and therefore could not be considered “Indian products”. The federal circuit added that ingredients from abroad were measured, weighted, blended and assembled in the United States.