US Free Trade Agreement Implementation Act 2004 (120 of 2004)

Schedule 2   Agricultural and veterinary chemicals amendments

Part 1   Limits on use of information

Agricultural and Veterinary Chemicals Code Act 1994

1   After Division 4 of Part 2 of the Schedule

Insert:

Division 4A - Limits on use of information

Subdivision A - Preliminary

34B Explanation of Division

(1) This Division limits for a period the use the NRA can make of information given to it:

(a) in connection with an application under section 10 or 27 relating to:

(i) approval of an active constituent for a chemical product; or

(ii) registration of a chemical product; or

(iii) approval of a label for a container for a chemical product; or

(b) under section 161 in connection with a registered chemical product.

(2) During the period, the NRA cannot use the information for granting another application, or for a reconsideration of an approval or registration, unless:

(a) the NRA is given a written statement made by a person who can authorise the use of the information consenting to the use; or

(b) certain other conditions are met.

(3) The object of limiting use of the information in this way is to encourage innovation by making it easier for a person who made an investment in finding out the information to get a return on that investment.

Subdivision B - Limits on use of information

34C NRA must not use some information during some periods for some purposes

(1) During the period described in an item of the table, the NRA must not use information described in the item for a purpose described in the item.

Note 1: Section 34D sets out exceptions to this subsection.

Note 2: Section 161 may require an interested person for an approved active constituent to give the NRA information in connection with the constituent, even though this table does not deal with that requirement.

(2) This section applies only to information given to the NRA:

(a) in connection with an application made after the commencement of this section; or

(b) under section 161 in connection with a chemical product that was registered as a result of an application made after the commencement of this section.

(3) The use of information in contravention of subsection (1) for making a decision does not affect the validity of the decision.

(4) An action or proceeding does not lie against any of the following for any loss directly or indirectly sustained because of the use of information in contravention of subsection (1):

(a) the Commonwealth;

(b) the NRA;

(c) a person who is or has been:

(i) a director of the NRA; or

(ii) the Chief Executive Officer of the NRA; or

(iii) a delegate of the NRA; or

(iv) a member of the staff of the NRA.

Subdivision C - Exceptions to limits on use of information

34D Exceptions

(1) Section 34C does not prevent the NRA from using information for making a decision:

(a) under section 14 or 29 about an application; or

(b) under section 34 about a reconsideration of an approval or registration;

if a condition in subsection (2), (3), (4), (5) or (6) of this section is met.

Evidence of consent for use

(2) One condition is that the applicant, an approved person or the interested person for the approval or registration gives the NRA a written statement by the authorising party of that party's consent to the NRA using the information for making the decision. This condition is met even if the authorising party:

(a) later states that it has not consented; or

(b) withdraws the consent (whether before or after the NRA is given the statement of consent).

Note: Chapter 7 of the Criminal Code creates offences relating to false and misleading statements and forgery.

Use in the public interest

(3) Another condition is that the NRA is satisfied, having regard to the criteria (if any) prescribed by the regulations, that the use of the information is in the public interest.

Note: Section 34E sets out other rules that are relevant to the exception based on this condition.

Information does not favour the applicant or interested person

(4) Another condition is that:

(a) the decision relates to:

(i) a proposed or existing approval of an active constituent for a proposed or existing chemical product; or

(ii) a proposed or existing registration of a proposed or existing chemical product; and

(b) the information meets a condition in paragraph 160A(4)(b) or (c) or 161(2)(b) or (c) (which are about showing that use or dealing with the product may have adverse effects or that the product may be ineffective), whether or not the information was given to the NRA under section 160A or 161.

Identical information whose use is not limited

(5) Another condition is that the NRA is satisfied that there is identical information, or information to the same effect, whose use is not prevented by section 14B or 34C or Part 3.

Information given to NRA in connection with certain applications

(6) Another condition is that the application mentioned in subsection 34C(1) was one of the following:

(a) an application for approval, as an active constituent for a chemical product, of a substance that was a previously endorsed active constituent on the commencement of this Division;

(b) an application for the variation of the relevant particulars or conditions of the approval of an active constituent for a chemical product;

(c) an application for the registration of a companion animal product each active constituent for which was a previously endorsed active constituent at the time of the preliminary assessment of the application under section 11A;

(d) an application for variation of the relevant particulars or conditions of the registration of a companion animal product;

(e) an application for the approval of a label for a container for a companion animal product each active constituent of which was a previously endorsed active constituent at the time of the preliminary assessment of the application under section 11A;

(f) an application for variation of the relevant particulars or conditions of the approval of a label for a container for a companion animal product.

34E Further rules about public interest exception

(1) This section applies if the NRA is satisfied under subsection 34D(3) that it is in the public interest to use information that section 34C would otherwise prohibit the NRA from using for making a decision:

(a) under section 14 or 29 about an application; or

(b) under section 34 about a reconsideration of an approval or registration.

(2) As soon as practicable after becoming satisfied, the NRA must give written notice of its satisfaction to:

(a) the applicant, an approved person or the interested person for the approval or registration; and

(b) the person whom the NRA believes is the authorising party for the information.

(3) Section 168 provides for additional matters to be included in the notice.

(4) The NRA must not make the decision using the information before the end of 28 days after the day on which the notice is given.

(5) However, subsections (3) and (4) do not apply if:

(a) the NRA believes it is necessary to make the decision before the end of 28 days after the notice is given, to prevent imminent risk to public health or occupational health or safety; and

(b) states that belief in the notice.

Subdivision D - Period of limit on use of information

34F Period of limit on future use of information relied on in granting application

(1) Subsection 34C(1) prohibits the NRA from using, during the period described in an item of the following table, information that:

(a) was given to the NRA by the applicant or an approved person in connection with an application described in the item; and

(b) was given as required by the NRA or section 160A; and

(c) was relied on by the NRA to grant the application.

The period starts when the application was granted.

Note 1: This section has effect for the purposes of item 3 of the table in subsection 34C(1) (and not for any of the other items in that table).

Note 2: This section is not relevant to information if section 34D provides an exception to the prohibition in subsection 34C(1) on the NRA using the information.

Extension of 8-year limits

(2) The period mentioned in item 1 or 2 of the table in subsection (1) in relation to:

(a) an application for an approval of an active constituent (a key constituent ); or

(b) an application for registration of a chemical product containing an active constituent (also a key constituent ) that had not been approved when the application was acknowledged; or

(c) an application for approval of a label for a container for a chemical product containing an active constituent (also a key constituent ) that had not been approved when the application was acknowledged;

is extended by 1 year for each 5 distinct uses that meet the requirements in subsections (3), (4) and (5).

(3) The first requirement is that the uses are uses of a chemical product (an extension product ) for which the following conditions are met:

(a) the key constituent is an active constituent for the product;

(b) the product was registered as a result of an application that:

(i) was made by the applicant mentioned in subsection (1); and

(ii) was acknowledged before the approval of the key constituent.

(4) The second requirement is that each of the uses is included in an approved label for a container for an extension product as a result of an application that:

(a) is for:

(i) the approval of the label; or

(ii) the variation of the relevant particulars or conditions of approval of the label; and

(b) was made by the applicant mentioned in subsection (1) or by the interested person in relation to the approval of the key constituent; and

(c) was acknowledged before the end of 6 years after the date of the approval of the key constituent as a result of an application by the applicant mentioned in subsection (1).

(5) The third requirement is that all 5 of the uses are prescribed by the regulations at the latest time an application described in subsection (4) is granted.

(6) However, the period mentioned in item 1 or 2 of the table in subsection (1) cannot be extended so that it exceeds 11 years.

Subdivision E - Ancillary provisions

34G Identifying information relied on in advice NRA relied on

(1) This section has effect if:

(a) the NRA made a decision under subsection 14(1) or 29(1) to grant an application made after the commencement of this section; and

(b) in making the decision, the NRA relied on advice given by a person, body or Government the NRA consulted under section 8 or 8A of the Agricultural and Veterinary Chemicals (Administration) Act 1992.

(2) The NRA must cause to be published a summary of the advice.

(3) The summary must:

(a) identify the information that the person, body or Government relied on in giving the advice; and

(b) include the matters (if any) prescribed by the regulations.