Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1698943689855.pdf (New Zealand)
Agricultural Compounds and Veterinary Medicines Amendment Bill Government Bill Explanatory note General policy statement The Agricultural Compounds and Veterinary Medicines Act 1997 (the ACVM Act) protects confidential information given in support of an application to register an in- novative trade name product.

The ACVM Act currently protects the information for 5 years after an application is decided.

Under certain conditions, this Bill extends the period of protection from 5 to 8 years.
The Bill also expands the scope of data protec- tion coverage to include confidential information provided in support of applications to register non-innovative trade name products and uses.

The policy objective of the changes in the Bill is to encourage businesses that own trade name products to regis- ter new trade name products and to register more uses for existing trade name prod- ucts.

The changes are being made to support primary sector productivity and inter- national competitiveness.
The changes represent a balance between the objectives of— • • encouraging competition in the innovative and generic agricultural compounds markets so that New Zealand businesses can access reasonably priced products; and encouraging registration of innovative products, and new uses of registered products, needed by the New Zealand agriculture sector, particularly smaller industries, to be competitive internationally.
Innovative trade name products The ACVM Act currently confers 5 years’ protection for confidential information provided in support of applications to register innovative trade name products.

An in- novative trade name product is one that contains an active ingredient that has not pre- viously been referred to in any other application.
54—1 2 Agricultural Compounds and Veterinary Medicines Amendment Bill Explanatory note The Bill would extend protection by 1 year for each new use that is subsequently add- ed to the registration (up to a maximum of 8 years).

Non-innovative trade name products The ACVM Act does not currently protect confidential information provided in sup- port of applications to register non-innovative trade name products or new uses for non-innovative trade name products.
The Bill would introduce data protection for both those categories by conferring— • • 3 years’ protection for confidential information provided in support of applica- tions to register non-innovative trade name products, including reformulations; and 3 years’ protection for confidential information provided in support of applica- tions to register new uses of non-innovative trade name products.
New uses Applications to vary conditions on the registration of a trade name product may be made under section 9(2) of the ACVM Act.

This Bill confers data protection on confidential information provided in support of a variation application only if the granting of the application authorises the product to be used on a new species.
Consequential amendments Data protection under the Hazardous Substances and New Organisms Act 1996 (the HSNO Act) is provided by cross-referencing the relevant parts of the ACVM Act.

The Bill makes minor consequential amendments to the HSNO Act to maintain gen- erally consistent data protection arrangements under the ACVM Act and the HSNO Act.

It also makes a minor consequential amendment to the Medicines Act 1981.
Departmental disclosure statement The Ministry for Primary Industries is required to prepare a disclosure statement to assist with the scrutiny of this Bill.

The disclosure statement provides access to infor- mation about the policy development of the Bill and identifies any significant or un- usual legislative features of the Bill.

A copy of the statement can be found at http://legislation.govt.nz/disclosure.aspx?

type=bill&subtype=government&year=2015&no=54.


Regulatory impact statement The Ministry for Primary Industries produced a regulatory impact statement on 12 September 2012 to help inform the main policy decisions taken by the Govern- ment relating to the contents of this Bill.
A copy of this regulatory impact statement can be found at— Explanatory note Agricultural Compounds and Veterinary Medicines Amendment Bill 3 • • http://www.mpi.govt.nz/law-and-policy/legal-overviews/regulatory-impact- statements/ http://www.treasury.govt.nz/publications/informationreleases/ris Clause 1 is the Title clause.

Clause by clause analysis Clause 2 provides that the Bill comes into force on the day after the date on which it receives the Royal assent.
Clause 3 provides that the Bill amends the Agricultural Compounds and Veterinary Medicines Act 1997 (the principal Act).

Part 1 Substantive amendments to principal Act Clause 4 inserts new section 2A, which clarifies the status of examples.

Clause 5 repeals section 56(4) of the principal Act (and makes a consequential amendment to section 56(3)).

Section 56(4) is redundant because it relates to provi- sions of the principal Act that have been repealed.
Clause 6 replaces Part 6 of the principal Act, which provides for the protection of confidential information provided in support of innovative agricultural compound ap- plications.

New Part 6 also protects that information, although it uses the term inno- vative TNP application to refer to applications to register innovative trade name prod- ucts (in place of the term innovative agricultural compound application).
In addition, new Part 6 provides for the protection of— • • confidential information provided in support of applications to register non-in- novative trade name products (non-innovative TNP applications); and confidential information provided in support of applications to vary conditions imposed on the registration of trade name products (variation applications).
The provisions contained in new Part 6 are as follows: • • • new sections 72 to 74 define the terms used in new Part 6: new section 74A provides that, during a protected period, the Director-General of the Ministry for Primary Industries must take steps to prevent protected con- fidential information from being disclosed and that he or she must not use the information when deciding other innovative TNP applications, non-innovative TNP applications, or variation applications: new section 74B sets out the protected period for confidential information sup- porting an innovative TNP application.
The basic period, which lasts for 5 years after an application is decided, may be extended by 1 year for each new use authorised as a result of 1 or more successful variation applications.
The period may be extended in this way up to a maximum of 8 years: 4 • • • • • Agricultural Compounds and Veterinary Medicines Amendment Bill Explanatory note new section 74C sets out the protected period for confidential information sup- porting an innovative TNP application for provisional registration: new section 74D sets out the protected period for confidential information sup- porting a variation application relating to an innovative trade name product.
If conditions set out in new section 74D are met, the period has the same end date as applies under new section 74B to the information that supported the applica- tion to register the product: new section 74E sets out the protected period for confidential information sup- porting a non-innovative TNP application for full or provisional registration: new section 74F sets out the protected period for confidential information sup- porting a variation application relating to a non-innovative trade name product: new section 74G re-enacts (with minor changes in form and terminology) the current section 74 of the principal Act, which provides for the use and disclos- ure, in specified circumstances, of otherwise protected confidential informa- tion.
Clause 7 updates a cross-reference in section 81 of the principal Act.

Part 2 Consequential amendments Clause 8 and Schedule 1 provide for consequential amendments to the principal Act.

Clause 9 and Schedule 2 provide for consequential amendments to the Hazardous Substances and New Organisms Act 1996 (the HSNO Act) and the Medicines Act 1981.
The amendments to the HSNO Act amend provisions that apply the informa- tion protection requirements under the principal Act and the Medicines Act 1981 to the Environmental Protection Authority.

The amendment to the Medicines Act 1981 aligns the definition of confidential information in that Act with the definition of that term in new section 73 of the principal Act.
Hon Jo Goodhew Agricultural Compounds and Veterinary Medicines Amendment Bill Government Bill Contents Page Title Commencement Principal Act Part 1 Substantive amendments to principal Act New section 2A inserted (Status of examples) 2A Section 56 amended (Penalties) Part 6 replaced Status of examples Part 6 Protection of confidential information about trade name products Interpretation 72 73 74 Interpretation Meaning of confidential information Meaning of protected period Director-General must protect confidential information during protected period 74A Director-General must protect confidential information during protected period 54—1 2 2 2 3 3 3 3 3 4 4 5 1 cl 1 Agricultural Compounds and Veterinary Medicines Amendment Bill Protected periods for information about innovative trade name products Innovative TNP application for full registration Innovative TNP application for provisional registration Variation application Protected periods for information about non-innovative trade name products Non-innovative TNP application for full or provisional registration Variation application Director-General may disclose or use confidential information Director-General may disclose or use confidential information 74B 74C 74D 74E 74F 74G 7 8 9 Section 81 amended (Principles of cost recovery) Part 2 Consequential amendments Consequential amendments to principal Act Consequential amendments to other enactments Schedule 1 Consequential amendments to principal Act Schedule 2 Consequential amendments to other enactments The Parliament of New Zealand enacts as follows: 5 6 6 7 7 8 9 9 9 10 12 Title This Act is the Agricultural Compounds and Veterinary Medicines Amendment Act 2015.
Commencement 5 This Act comes into force on the day after the date on which it receives the Royal assent.

Principal Act This Act amends the Agricultural Compounds and Veterinary Medicines Act 1997 (the principal Act).
10 1 2 3 2 Agricultural Compounds and Veterinary Medicines Amendment Bill Part 1 cl 6 Part 1 Substantive amendments to principal Act 4 New section 2A inserted (Status of examples) After section 2, insert: 2A Status of examples (1) An example used in this Act is only illustrative of the provisions to which it relates.

It does not limit those provisions.

(2) 5 (1) (2) 6 If an example and a provision to which it relates are inconsistent, the provision prevails.
Section 56 amended (Penalties) In section 56(3), replace “Subject to subsection (4), every” with “Every”.

Repeal section 56(4).
Part 6 replaced Replace Part 6 with: 5 10 Part 6 Protection of confidential information about trade name products 15 Interpretation 72 (1) Interpretation In this Part, unless the context otherwise requires,— confidential information has the meaning given to it in section 73 innovative TNP application means an application under section 9(1) or 26 to register or provisionally register a trade name product that includes an active ingredient to which the following applies: 20 (a) (b) the ingredient is referred to in the application as an active ingredient of the trade name product; and 25 at the time the Director-General receives the application, the ingredient has not previously been an active ingredient of— (i) (ii) (iii) a trade name product registered under section 21; or a pesticide that was registered under the Pesticides Act 1979; or an animal remedy that was licensed under the Animal Remedies Act 1967 (other than by a provisional licence) 30 innovative trade name product means a trade name product registered on the granting of an innovative TNP application 3 Part 1 cl 6 Agricultural Compounds and Veterinary Medicines Amendment Bill new use has the meaning given to it in section 74B(6) non-innovative TNP application means an application under section 9(1) or 26 to register or provisionally register a trade name product (other than an in- novative TNP application) non-innovative trade name product means a trade name product registered on the granting of a non-innovative TNP application 5 protected period has the meaning given to it in section 74 variation application means an application under section 9(2) to vary 1 or more conditions imposed on a registered trade name product.
(2) The grant of an experimental use permit for a pesticide under section 25 of the Pesticides Act 1979 does not constitute the registration of that pesticide for the purposes of paragraph (b)(ii) of the definition of innovative TNP application.
10 73 Meaning of confidential information (1) In this Part, confidential information means information received by the Dir- ector-General that— 15 (a) (b) is provided in support of an innovative TNP application, a non-innova- tive TNP application, or a variation application; and is confidential information about the trade name product that is the sub- ject of that application.
(2) For the purposes of subsection (1)(b), confidential information includes— (a) trade secrets; and (b) information with a commercial value that would, or would be likely to, be diminished by disclosure of the information.
74 Meaning of protected period In this Part, protected period means,— (a) (b) (c) (d) (e) for confidential information supporting an innovative TNP application made under section 9(1), the period specified in section 74B: for confidential information supporting an innovative TNP application made under section 26, the period specified in section 74C: for confidential information supporting a variation application made in respect of an innovative trade name product, the period specified in sec- tion 74D: for confidential information supporting a non-innovative TNP applica- tion, the period specified in section 74E: for confidential information supporting a variation application made in respect of a non-innovative trade name product, the period specified in section 74F.
20 25 30 35 4 Agricultural Compounds and Veterinary Medicines Amendment Bill Part 1 cl 6 Director-General must protect confidential information during protected period 74A Director-General must protect confidential information during protected period (1) The Director-General must, during the protected period that applies to confi- dential information,— 5 (a) (b) take reasonable steps to ensure that he or she does not disclose the confi- dential information; and not use the confidential information in determining whether to grant any other innovative TNP application, non-innovative TNP application, or variation application.
10 (2) This section is subject to section 74G.

Protected periods for information about innovative trade name products 74B Innovative TNP application for full registration This section applies to confidential information supporting an innovative TNP application made under section 9(1).

15 Basic protected period The protected period starts on the date on which the Director-General receives the application.
The protected period ends on the date that is 5 years after the date on which the Director-General grants or refuses to grant the application if that decision is made within 5 years after the date on which the Director-General receives the application.

The protected period ends on the date that is 5 years after the date on which the Director-General receives the application if a decision to grant or refuse to grant the application has not been made by that time.
Extended protected period The end date that applies under subsection (3) is extended by a period of 1 year for each new use authorised by the granting of a variation application that— (a) (b) is made in respect of the relevant innovative trade name product; and is received within 3 years after the date on which the Director-General granted the application to register the product (the original application).
(6) A new use is authorised if the conditions on the registration of a product are varied so as to authorise the product’s— (a) use on a species of plant or animal on which the product could not be used under the conditions as they were before the variation was granted: 5 20 25 30 35 (1) (2) (3) (4) (5) Part 1 cl 6 Agricultural Compounds and Veterinary Medicines Amendment Bill (b) labelling for use on a species of plant or animal on which the product could not be labelled for use under the conditions as they were before the variation was granted.
(7) The end date of the protected period may be extended under subsection (5) to no more than 8 years after the date on which the Director-General granted the original application.

5 Example The Director-General grants an innovative TNP application (the original applica- tion) within 5 years of receiving it.

The Director-General registers the innovative trade name product subject to the condition that it be labelled for use only on spe- cies A.
Within 3 years of granting the original application, the Director-General receives an application to vary the condition so that the product may also be labelled for use on species B and C (the variation application).

The Director-General grants the variation application.
When the Director-General grants the variation application, the end date of the protected period for the confidential information supporting the original application is extended from 5 years to 7 years after the date on which the Director-General granted the original application.

74C Innovative TNP application for provisional registration 10 15 20 (1) (2) (3) This section applies to confidential information supporting an innovative TNP application made under section 26.
The protected period starts on the date on which the Director-General receives the application.

The protected period ends on the date that is 5 years after the date on which the Director-General receives the application.
25 74D Variation application This section applies to confidential information supporting any variation appli- cation made in respect of an innovative trade name product, unless the Direct- or-General receives the variation application more than 3 years after the date on which the innovative trade name product was registered.

The protected period starts on the date on which the Director-General receives the variation application.
The protected period ends on the same date as the protected period for the con- fidential information that supported the original application (as determined under section 74B, taking into account any extension of the protected period under section 74B(5)) if— (a) the variation is granted within 3 years after the date on which the Direct- or-General receives the variation application; and 30 35 (b) the granting of the application results in a new use being authorised.
40 (1) (2) (3) 6 Agricultural Compounds and Veterinary Medicines Amendment Bill Part 1 cl 6 (4) (5) (6) The protected period ends on the date that is 3 years after the date on which the Director-General receives the variation application if a decision to grant or re- fuse to grant the application has not been made by that time.

In any other circumstances, the protected period ends on the date on which the Director-General grants or refuses to grant the variation application.
5 To avoid doubt, there is no protected period for confidential information that supports a variation application made more than 3 years after the date on which the Director-General registered the innovative trade name product to which the variation application relates.
Protected periods for information about non-innovative trade name products 10 74E Non-innovative TNP application for full or provisional registration (1) (2) (3) (4) This section applies to confidential information supporting a non-innovative TNP application made under section 9(1) or 26.

The protected period starts on the date on which the Director-General receives the application.
15 The protected period ends on the date that is 3 years after the date on which the Director-General grants or refuses to grant the non-innovative TNP application if that decision is made within 3 years after the date on which the Director- General receives the application.

The protected period ends on the date that is 3 years after the date on which the Director-General receives the application if a decision to grant or refuse to grant the application has not been made by that time.
20 74F Variation application (1) (2) (3) (4) (5) This section applies to confidential information supporting any variation appli- cation made in respect of a non-innovative trade name product.

25 The protected period starts on the date on which the Director-General receives the variation application.
The protected period ends on the date that is 3 years after the date on which the Director-General grants the variation application if— (a) the variation is granted within 3 years after the date on which the Direct- or-General receives that application; and 30 (b) the granting of the application results in a new use being authorised.
The protected period ends on the date that is 3 years after the date on which the Director-General receives the variation application if a decision to grant or re- fuse to grant the application has not been made by that time.

35 In any other circumstances, the protected period ends on the date on which the Director-General grants or refuses to grant the variation application.
7 Part 1 cl 6 Agricultural Compounds and Veterinary Medicines Amendment Bill Director-General may disclose or use confidential information 74G Director-General may disclose or use confidential information (1) In this section, application means an innovative TNP application, a non-inno- vative TNP application, or a variation application, as the case may be.

(2) Despite section 74A, the Director-General may, during a protected period, disclose or use confidential information in accordance with this section.
5 (3) The Director-General may disclose the information, or use it in determining whether to grant an application other than the application to which the informa- tion relates or related, if— (a) (b) the applicant who made the application to which the information relates or related has consented in writing to the disclosure or use of the infor- mation; or the Director-General forms the opinion that the disclosure or use is ne- cessary to protect the health or safety of members of the public.
(4) The Director-General may disclose the confidential information to 1 or more of the following persons or organisations if the Director-General is of the opinion that they will take reasonable steps to ensure that they will not disclose the in- formation to any other person: 10 15 (a) (b) (c) (d) (e) (f) (g) a government department or statutory body for the purposes of that gov- ernment department or statutory body: 20 an adviser for the purposes of obtaining advice about the agricultural compound to which the information relates: the World Health Organization: the Office International des Epizooties: the Food and Agriculture Organization: 25 a regulatory agency of a country that is a party to the Agreement Estab- lishing the World Trade Organization adopted at Marrakesh on 15 April 1994 (commonly known as a WTO country): a prescribed person or organisation or a person or an organisation within a prescribed class or prescribed classes of persons or organisations.
30 (5) For the purposes of subsection (3)(a), a person other than the applicant may grant consent to the disclosure or use of the confidential information if— (a) (b) the applicant has notified the Director-General in writing that the person may grant consent (and the applicant has not withdrawn that permis- sion); or 35 the applicant’s rights in respect of the information have been transferred to the person and the applicant or the person has notified the Director- General in writing of the transfer.
8 Agricultural Compounds and Veterinary Medicines Amendment Bill Part 2 cl 9 7 Section 81 amended (Principles of cost recovery) In section 81(1), replace “83” with “81L”.

Part 2 Consequential amendments 8 9 Consequential amendments to principal Act Amend the principal Act as set out in Schedule 1.

Consequential amendments to other enactments Amend the enactments specified in Schedule 2 as set out in that schedule.
5 9 Schedule 1 Agricultural Compounds and Veterinary Medicines Amendment Bill Schedule 1 Consequential amendments to principal Act s 8 Section 4A In section 4A(2)(a), after “and its registration”, insert “(as a trade name product)”.

5 In section 4A(3)(a), after “agricultural compound is registered”, insert “(as a trade name product)”.

Cross-heading above section 9 In the cross-heading above section 9, after “agricultural compounds”, insert “as trade name products”.
10 Section 11 In section 11(2), replace “73” with “74A”.

Section 13 In section 13(2), replace “73” with “74A”.

Section 14 In section 14(2)(f), replace “73” with “74A”.

Section 16 In section 16(2), replace “agricultural compound” with “trade name product contains an agricultural compound that”.

Section 20 In section 20(a), replace “73” with “74A”.

Section 21 15 20 In section 21(1)(c), replace “decline the application” with “refuse to grant the applica- tion”.
In section 21(1)(d), after “in every other case,”, insert “grant the application and”.

25 In section 21(2), replace “decision to register a trade name product” with “decision to grant an application”.

Replace section 21(4) and (5) with: (4) The Director-General must not grant an application without the consent of the Director-General of Health if the trade name product to which it relates is a prescription medicine within the meaning of section 3 of the Medicines Act 1981.
30 (5) The Director-General must not grant an application if— 10 Agricultural Compounds and Veterinary Medicines Amendment Bill Schedule 1 Section 21—continued (a) (b) the trade name product to which it relates contains an agricultural com- pound that is also a hazardous substance or new organism; and that substance or organism has not been approved under the Hazardous Substances and New Organisms Act 1996.
Section 22 5 In section 22(1)(c), replace “and declined” with “and the Director-General refuses to grant the application”.

Section 24 In the heading to section 24, replace “agricultural compounds” with “trade name products”.

10 In section 24(2)(c), replace “73” with “74A”.

Section 26 In section 26(1), delete “of an agricultural compound”.

Section 27 In section 27(2), after “The Director-General must”, insert “grant the application and”.
15 Replace section 27(7) with: (7) The Director-General must not grant an application if— the trade name product to which it relates contains an agricultural com- pound that is also a hazardous substance or new organism; and 20 that substance or organism has not been approved under the Hazardous Substances and New Organisms Act 1996.

(a) (b) Section 75 In section 75(1)(i), replace “section 74(1)(c)” with “section 74G(4)(g)”.
11 Schedule 2 Agricultural Compounds and Veterinary Medicines Amendment Bill Schedule 2 Consequential amendments to other enactments Hazardous Substances and New Organisms Act 1996 (1996 No 30) In section 2(1), insert, in their appropriate alphabetical order: s 9 5 innovative medicine application has the meaning given to it in section 23A of the Medicines Act 1981 innovative TNP application has the meaning given to it in section 72(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 In section 25(6), replace “that is the subject of an innovative agricultural compound application” with “that is or has been the subject of an innovative TNP application”.
10 Replace section 25(7) and (8) with: (7) Subsection (6) ceases to apply in respect of a hazardous substance or new or- ganism on the date that section 55(3) or (4), as the case may be, ceases to apply to the Authority.
Replace section 55(3) to (7) with: (3) Sections 23A to 23C of the Medicines Act 1981 apply (with the necessary modifications) to the Authority in relation to confidential information received in respect of an application made under this Act if— (a) (b) (c) the hazardous substance or new organism to which the application re- lates is or has been the subject of an innovative medicine application; and the confidential information is about that substance or organism; and the Minister of Health is, at the time the Authority wants to disclose or use the information, required under section 23B of the Medicines Act 1981 to protect that information.
(4) Part 6 of the Agricultural Compounds and Veterinary Medicines Act 1997 ap- plies (with the necessary modifications) to the Authority in relation to confi- dential information received in respect of an application made under this Act if— (a) (b) (c) the hazardous substance or new organism to which the application re- lates is or has been the subject of an innovative TNP application; and the confidential information is about that substance or organism; and the Director-General is, at the time the Authority wants to disclose or use the information, required under section 74A of the Agricultural Com- pounds and Veterinary Medicines Act 1997 to protect that information.
(5) Despite subsections (3) and (4),— 15 20 25 30 35 12 Agricultural Compounds and Veterinary Medicines Amendment Bill Schedule 2 Hazardous Substances and New Organisms Act 1996 (1996 No 30)—continued (a) (b) the Authority must make available a summary of the effects of a hazard- ous substance or new organism for the purposes of section 53(3)(c) if the Authority is required to publicly notify the application that relates to that substance or organism under section 53: the Authority may disclose confidential information to prescribed per- sons or organisations or persons or organisations within prescribed classes of persons or organisations.
5 (6) For the purposes of subsection (5)(b), the Governor-General may, by Order in Council, make regulations prescribing persons, organisations, or classes of persons or organisations.

10 (7) In this section,— confidential information means information that includes either or both of the following: (a) (b) trade secrets: information with a commercial value that would, or would be likely to, be diminished by disclosure of the information.

15 In section 141(1), replace “section 55(7)” with “section 55(6)”.
Medicines Act 1981 (1981 No 118) In section 23A, replace the definition of confidential information with: confidential information includes— 20 (a) (b) trade secrets; and information with a commercial value that would, or would be likely to, be diminished by disclosure of the information Wellington, New Zealand: Published under the authority of the New Zealand Government—2015 13