(1) Page 4 (after line 11), after clause 3, insert:

(1) Before the entry into force of the Australia-United States Free Trade Agreement (the Agreement), the Commonwealth is required by this section to make a reservation or interpretive declaration in the terms set out in subsections (2) to (10).

(2) Nothing in the Agreement is contrary to, or is to be interpreted in a way which undermines the objectives of, the National Medicines Policy and in particular the first objective of that Policy which is to ensure timely access to the medicines that Australians need, at a cost individuals and the community can afford.

(3) Nothing in the Agreement is contrary to, or is to be interpreted in a way which undermines, the Declaration on the TRIPS agreement and public health adopted at the Ministerial Conference of the World Trade Organization at Doha on 14 November 2001.

(4) Article 17.10.4 of the Agreement must not be interpreted so as to permit the practice of “evergreening” brand name pharmaceutical products.

(5) For the purposes of subsection (4), evergreening means the practice whereby a brand-name manufacturer stockpiles patent protection, for the purpose of extending the period of time for which patent protection is granted, by obtaining separate patents on multiple attributes of a single product.

(6) The review process set out in Article 2(f) of annex 2-C of the Agreement is to be interpreted as referring to a process which is not binding.

(7) Annex 11-B of the Agreement is to be interpreted so that regulatory actions by the Commonwealth, a State or a local government, designed and applied to achieve legitimate public welfare objectives, including the protection of public health, safety, or the environment, will not constitute indirect expropriations.

(8) Under Article 11.16 of the Agreement, consultations on investor-state dispute settlement, on any matter, will not include arbitration between an investor and a party.

(9) Nothing in the Agreement is contrary to, or is to be interpreted as infringing, Australia's right to ensure local content in broadcasting and audiovisual services, including new media formats, at or above the standard specified in section 9 of the Broadcasting Services (Australian Content) Standard 1999 or section 5 of the Television Program Standard 23—Australian Content in Advertising as in force on 4 August 2004.

(10) The Committee on Sanitary and Phytosanitary Matters established under Article 7.4 of the Agreement and the Standing Technical Working Group on Animal and Plant Health Measures established under Annex 7-A of the Agreement will adopt the precautionary principle when assessing bilateral animal and plant health matters, notwithstanding Article 4(a) of Annex 7-A of the Agreement.

(11) An instrument that gives effect to, or interprets, any provision of the agreement is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act.

(12) The minister must cause the terms of the reservation or interpretive declaration required by subsection (1) to be tabled in both Houses of the Parliament not later than two sitting weeks before the Commonwealth signs the Agreement.

(13) The reservation or interpretive declaration required by subsection (1) is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901.