GSA calendar contracts are governed by the Trade Agreements Act (TAA), i.e. all products listed in the GSA calendar contract must be manufactured or “essentially processed” in the United States or in a country designated by the AAA. The designated countries meet: the Court then found that the tablets – the final product purchased by the US government – were not products of India, because they were not (1) “quite the… India`s manufacturing and (2) have not been extensively converted into tablets in India. Therefore, since the tablets did not correspond to either type of test in the country of origin of the TAA, they were not an Indian product. In order to determine whether a product comes from a country eligible under the TAA, the product must be either “fully the growth, product or manufacture” of a country eligible for the AA TAA, or “essentially transformed into a new or other commercial item, bearing a name, character or use” in a country eligible for the AA TAA. 19 U.S.C 2518 (4) (B). The demonstrator, a contractor for the VA and other agencies, was a distributor of generic drugs. The demonstrative provided entecavir tablets (for the treatment of hepatitis B) manufactured in New Jersey with an active pharmaceutical ingredient manufactured in India.
India is not a “designated country” that receives preferential treatment under the TAA and its terms of application. An article is a product of a country or energy only if it is (i) entirely the growth, product or manufacture of that country or energy, or (ii) when an item composed, in whole or in part, of materials from another country or power, has essentially been transformed into a new or other commercial item bearing a name. , different signs or uses from those of the article or items from which it has been processed. 19 U.S.C No. 2518 (4) (B) (added). While the finding that an article is the “product” of an und designated foreign country generally prevents the government from obtaining it, the law does not require the government to have an article a “product” of the United States or a country designated as a precondition for obtaining that section. 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. The latest case on the federal circuit: Acetris Health, LLC v. United States, No.
2018-2399 (February 10, 2020). There, VA bought entecavir tablets (to treat hepatitis B) from Acetris which makes these tablets in New Jersey with an active ingredient from India.