House of Representatives

Explanatory Memorandum

(Circulated by authority of the Hon Mark Vaile MP, Minister for Trade)

Schedule 2 - Agriculture and Veterinary Chemicals

Agricultural and Veterinary Chemicals Code Act 1994 (Code Act)

Part 1: Limits on use of information

18. Item 1 inserts Division 4A - Limits on use of information that sets out limits on the uses the NRA can make of certain information given to it in connection with an application per existing section 10 and 27 and other information provided to it under sections 160A and 161.

19. Specifically, the table in subsection 34C(1) sets out those limits (by specifying the identity of the information, the period of constraint and the nature of the restricted purpose) that apply to the NRA, unless the NRA is given a written statement authorising the use of the information (refer subsection 34D(2)) or certain other conditions are met as set out in section 34D.

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Subsection 34C(2) provides that section 34C applies only to information given to the NRA in connection with an application made, or given under s161, after the commencement of this section;

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Subsection 34C(3) provides that the use of information in contravention of subsection (1) does not affect the validity of the decision; and

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Subsection 34C(4) provides that no action will lie against the Commonwealth, the NRA or other specified persons for any direct or indirect loss because of the use of the information in contravention of subsection (1).

20. Section 34D sets out a suite of exceptions to the limits on use of information established by section 34C. Specifically, when:

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an applicant, an approved person or the interested person provides a written statement by the authorising party (defined at Item 4) authorising its use [subsection 34D(2)];

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use of the information is in the public interest (under rules and requirements specified in subsection 34D(3) and section 34E) [subsection 34D(3)];

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information does not favour the applicant or interested person in the circumstances where the information meets certain conditions in s160A or s161 dealing with adverse effects or that the product may be ineffective [subsection 34D(4)];

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the NRA is satisfied that there is identical information or information to the same effect that is not limited by section 14B or 34C or Part 3 dealing with compensation for providers of certain information in respect of continued registration of certain chemical products [subsection 34D(5)];

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the information was given to the NRA in connection with certain applications mentioned in subsection 34C(1) [subsection 34D(6)], being an application for:

a)

a previously endorsed active constituent [refer Item 6] that was endorsed prior to the commencement of this Division, whether or not the approval or registration was a result of an application by a particular person;

b)

a variation of the relevant particulars or conditions of an approval of an active constituent as this information is not generally useful (within the purpose of the data protection scheme) for the purpose of a subsequent application by another person;

c)

registration of a product containing a previously endorsed active constituent; approval of labels for containers of chemical products containing a previously endorsed active constituent; variations to the relevant particulars or conditions of a registration of a chemical product or a label for a container of a chemical product, where that chemical product is a companion animal product (refer Item 5).

1. Further to the exemption provided at subsection 34D(3) dealing with use in the public interest, section 34E provides that the NRA may use information that would be otherwise prohibited by section 34C, if it is satisfied that the use of such information is in the public interest provided that it gives a notice to the applicant, an approved person or an interested person and the person whom the NRA believes is the authorising party. The NRA must not make a decision using the information before the end of 28 days after the day on which it gives notice.

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Subsection 34E(5) provides that the NRA may use the information if it believes it is necessary to make the decision before the end of the 28 days to prevent imminent risk to public health or occupational health or safety and it states that belief in the notice.

2. Subsection 34C(1) sets out, in part, the period of limitation on future use of certain information in certain circumstances. The table in Section 34F provides the specifics of the period of limitations (as years) upon the use of information in the particular circumstances of when that information was required by the NRA or s160A and relied upon by the NRA in making a decision under sections 14, 29 or 34 (i.e. as anticipated in table item 3 of subsection 34C(1)).

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Subsection 34F(1) provides that the period of protection for the information referred to above starts when the application was granted.

3. Distinction in the length of protection is made within the table in section 34F by reference to particular types of applications made under sections 10 and 27:

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providing a period of 8 years protection for information relating to new innovation in the form of an approval of an active constituent(s) that had not previously been endorsed (refer Item 6) and registration of chemical products and approvals of labels for containers of those chemical products that contained at least one active constituent that was not previously endorsed, when the application was acknowledged (refer Item 3) [table item 1 and 2]; and

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providing lesser lengths of protection in other circumstances relating to innovation that springboards off the original innovation anticipated in table items 1 and 2. [table items 3 to 6].

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In doing so, the table establishes different periods of protection for agricultural (5 years) and veterinary (3 years) chemical products.

4. As a driver for greater innovation in information to support uses in the minor crop sub sectors of agriculture, Subsection 34F(2) introduces a mechanism to enable the base periods of protection offered to the information submitted in support of an application mentioned in table item 1 and 2 within subsection (1) to be extended in certain circumstances.

5. The period offered in the table item 1 and 2 may be extended by 1 year (up to a total of 11 years) for each 5 distinct uses (to be prescribed in regulation) that meet certain criteria relating to:

a)

The active constituent (a key constituent), the chemical product (the extension product) and the approved label must be captured within the scope of the table Item 1);

b)

The chemical product (the extension product) for which the new use is proposed:

(i)

must contain a key constituent mentioned in a); and

(ii)

was registered as a result of an application that was made by the same applicant that made the application for the same key constituent; and

(iii)

must have had the application to register it acknowledged (refer Item 3) prior to the approval of its key constituent.

c)

The proposed distinct uses:

(i)

Each of the proposed uses must be included in an approved label for a container for an extension product as a result of an application for an approval of a label or a variation of the particulars or conditions of an approval of a label; and

(ii)

The application was made by the same applicant that made the application for the key constituent mentioned in b); and

(iii)

The application was acknowledged by the end of the sixth year after the date of the approval of the key constituent.

(iv)

Furthermore to gain the extension of each one-year, all five uses must be prescribed at the time of granting of the latest application to approve or vary a label.

Part 2: Provisions relating to limits on the use of information

1. Item 2 amends paragraph 69EX(a) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Admin Act) by including a reference to new Division 4A of Part 2 in the provisions of the Admin Act setting out Australia's previous mechanism to comply with the obligations arising from paragraph 3 of Article 39 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (for full title refer s69EW of the Admin Act). Division 4A is that part which is inserted by Part 1 of this Bill. The purpose of this inclusion is to limit the application of the existing Part 7B of the Admin Act to that time prior to the commencement of Division 4A of Part 2 of the Code Act as included by this Bill.

2. Part 2 also inserts the following new definitions in Section 3 of the Code Act:

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acknowledge as the means of identifying which applications may be relevant to the mechanism to extend the period of protection per section 34F [Item 3];

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authorising party as the means to identify that person who may bring an action if the information was disclosed by someone else to the NRA [Item 4];

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companion animal product as a means to identify a veterinary chemical product that is one used solely for administration to animals that are not food-producing and not prescribed in the regulation so as to exclude them from the data protection regime [Item 5]. and

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previously endorsed active constituent as the means to identify those active constituents that had already been dealt with (endorsed) previously, in the existing chemicals management regime, or a previous State or Territory chemicals management regime, so as to ensure that only new innovation attracts the higher levels of data protection, including the capacity to attract an extension of the base period of attraction [Item 6].

3. Item 7 inserts new section 11B in the Schedule to the Code Act that provides that the NRA must publish summaries of each application as soon as practicable after the application is acknowledged. The details to be included in the summary will be prescribed by regulations (if any).

4. Item 8 inserts new section 14B in the Code Act that gives effect to the terms of Article 17.10:1(e) of the AUSFTA by providing that the NRA is not to use, for a period of 10 years [subsection 14B(2)], certain information, that has been given to it in connection with an application for registration of certain new agricultural chemical products, to approve the same or similar product when that information has been disclosed by a government entity or an entity acting on behalf of a government and that information was not previously publicly available.

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New subsection 14B(3) provides that use of the information contrary to subsection 14B(2), does not affect the validity of the registration.

5. Item 9 repeals and substitutes subparagraph 15(1)(a)(i) of the Schedule to the Code Act so as to prohibit the NRA from registering a chemical product unless it also grants, or has granted, an approval for each active constituent for the product. The purpose of the amendment is part of the mechanism to encourage earlier applications for new chemical products containing a new active constituent, thereby facilitating earlier entry into the market with the consequent benefits for agriculture.

6. Item 10 introduces new section 28A and section 28B. Section 28A provides for the preliminary assessment of applications lodged under section 28 of the Code Act for a variation of relevant particulars or of conditions of approval or registration. Section 28B provides for the NRA to publish summaries of each application, unless satisfied that the application does not relate to use or dealing with a chemical product, as soon as practicable after the application is acknowledged. The details to be included in the summary will be prescribed by regulations (if any). Both clauses duplicate the mechanism to ensure the quality of applications provided in section 11A as it relates to applications for approvals of active constituents and labels and registrations of chemical products.

7. Item 11 amends subsection 58(1) to provide that the exception to the limits upon the NRA in using information is extended to include the requirements of section 14B, Division 4A of Part 2.

8. Section 167 of the Code Act is amended by Item 12 to ensure that a decision made by the NRA under section 28A to defer, treat as withdrawn or to reject, an application is a reviewable decision before the Administrative Appeals Tribunal (AAT).

9. Section 34D of the Bill provides that the NRA may use information in certain circumstances, in particular in relation to the public interest and risk to health and safety. Item 13 amends s167 to provide that a decision under proposed subsection 34D(3) to use information in the public interest is a reviewable decision before the AAT. Item 14 inserts new section 2A in Section 167 to provide that an application may not be made to the AAT to review a decision of the NRA to use information if the use of that information was considered necessary to prevent imminent risk to public health or occupational health or safety.

Part 3: Change of name from NRA to APVMA.

10. The Agricultural and Veterinary Chemicals Legislation Amendment (Name Change) Bill 2004 is presently before Parliament. This Name Change Bill changes the name of the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) to the Australian Pesticides and Veterinary Medicines Authority (APVMA).

11. Part 3 (Items 15 - 21) may be omitted and Parts 1 and 2 will be amended to refer to the APVMA if it becomes certain that the provisions of the Name Change Bill will commence before the commencement of the amendments to be made by Parts 1 and 2 of this schedule.