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CCI Practice Statement
1. Current Practice Statements
|CCI Practice Statement?||Version 02||28 August 2017|
|Practice Statement Framework||Version 02||28 August 2017|
The APVMA receives, generates and stores a large amount of information when performing its functions under the Agvet legislative framework.? This information can include:
- information which meets the definition of ‘confidential commercial information’ in the Agvet Code (the definition is set out in this Practice Statement below) (Confidential Commercial Information or CCI);
- information that is subject to other specific limitations or restrictions on when and how APVMA officers can use the information under the Agricultural and Veterinary Chemicals Code ?which is scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code) (Limited Use Information); and
- other information that is protected under the general law because it is communicated to the APVMA with an express or implied obligation that the information is not to be disclosed (Other Confidential Information).
Because information can have a regulatory value to the APVMA, or be a trade secret or be confidential and have commercial value to those who provide it, there are range of legal protections for the different categories of information.? These protections include:
- specific protection under the Agvet legislative framework;
- rules about access, use and disclosure of ‘Official Information’ under the Commonwealth’s Protective Security Policy Framework (PSPF); and
- legal obligations under the general law in relation to confidentiality.
Part 1 of this Practice Statement is intended to help ensure that APVMA officers (which include ongoing and non-ongoing Australian Public Service (APS) employees and may include persons who provide services to the APVMA such as contractors and consultants) understand and apply these protections, so that they can properly perform their functions and duties.?
Part 2 of this Practice Statement is intended to provide APVMA officers with further specific guidance about managing information when considering and processing applications involving use of a reference product.
3. PART 1:? General guidance to APVMA officers about managing information
3.1. Understanding the different types of information?
The same piece of information or data held by the APVMA can (and often will) fall under two or more categories of information. These categories, and the different obligations that attach to them, are described in more detail below
3.2. Official Information
Most information received, generated, held or used by the APVMA should be treated by APVMA officers as ‘Official Information’ under the PSPF.? Accordingly, APVMA officers must:
- only access, use and disclose such information where they have a legitimate need to do so in order to perform their duties;
- not disclose information that they are under a duty not to disclose;
- comply with applicable obligations under the APS Code of Conduct in relation to that information (eg not to make improper use of ‘inside information’ in order to gain or seek to gain a benefit or advantage); and
- comply with the APVMA’s general requirements for the storage and handling of information.
There may be serious consequences for not complying with these general obligations (including the commission of an offence and/or disciplinary action). ?However, provided that the general APVMA processes and the requirements set out in this Practice Statement are met, these obligations will be complied with.? APVMA officers are therefore encouraged to seek specific advice from their manager, or the Deputy General Counsel, if they are unsure about these general obligations.
3.3. Confidential commercial information (CCI)
What is CCI?
Section 3 of the Agvet Code defines CCI as:?
“confidential commercial information, in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product or a constituent of a chemical product, means:
(a) a trade secret relating to the constituent or product; or
(b) any other information relating to the constituent or product that has a commercial value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed; or
(c) information (other than trade secrets to which paragraph?(a) applies or information to which paragraph?(b) applies) that:
(i) concerns the lawful commercial or financial affairs of a person, organisation or undertaking; and
(ii) relates to the manufacture, distribution or supply of the constituent or product; and
(iii) if it were disclosed, could unreasonably affect the person, organisation or undertaking in an adverse manner.”
Examples of information that is generally considered to be CCI are as follows:
- the formulation, composition and manufacturing process of a product;
- active constituent specifications; and
- details of the site of manufacture of a product.
Examples of information that is generally not considered to be CCI is as follows:
- the name of the approval holder of an active constituent (publicly available);
- information that will be made public through entry on the APVMA record or register and via publication in the Gazette (e.g. active constituent names); and
- information already in the public domain.
It is important to be aware that CCI is not limited to scientific studies or other information which has a specific restriction on use under the Agvet Code. ?More detail on the different types of information commonly handled by the APVMA, and whether they are likely to be CCI, can be found?here.
What are the restrictions?
Section 162 of the Agvet Code governs the direct and indirect disclosure of CCI and provides a general prohibition on disclosure.? This restricts APVMA officers from disclosing, directly or indirectly to another person, any information about an “active constituent for a proposed or existing chemical product, about a chemical product or any of its constituents, or about a label for containers for a chemical product” that the APVMA officer knows to be CCI, and which was acquired in performance of their functions or duties.
The restrictions apply to disclosure by an APVMA officer to a person within the APVMA when such disclosure is unnecessary for work purposes.? The restrictions also apply to disclosure to persons and entities outside the APVMA.?
When can CCI be disclosed?
Despite the general restriction in section 162 of the Agvet Code, there are situations where APVMA officers may lawfully access and disclose CCI, including:
- where it is necessary to do so to legitimately perform functions or duties, or exercise powers as an APVMA officer under the Agvet Code. The exception will apply where a person is effective required to disclose the CCI in order to carry the Agvet Code into effect. The exception will extend to the duties, powers and functions that may be implied from the administration of the Agvet Code as well as those that are expressly referred to in the Agvet Code
- when APVMA officers are expressly authorised by the Chief Executive Officer (CEO), to disclose (and therefore access, and use) CCI in circumstances set out in s162(3), such as:
- where the ‘Authorising Party’ (that is, a person who would be entitled to bring action for breach of the obligation of confidence if the information was disclosed to someone else, which may be the applicant but could be a third party such as the manufacturer of an active constituent used in a product) has given written consent for the information to be disclosed to another person; ?
- where the Authorising Party seeks to rely on their formulation details or other protected information from another of their registered products, for their current application.
NOTE: Officers should check the CEO’s instrument of authorisation as the authorisation to disclose CCI under section 162(3) varies from officer to officer.
- the CEO has authorised APVMA officers to disclose information in certain circumstances. When the CEO has authorised disclosure of information to a third party, such as to a Commonwealth or State or Territory agency, in particular circumstances (see section 162(7))
- where the information is no longer considered CCI because it is no longer a trade secret or it no longer has commercial value in being kept secret, such as where it is publicly available
- where the information must be disclosed by law, for example to a court or tribunal
- when assisting an APVMA officer authorised by the CEO to disclose CCI, for example accessing the files containing CCI for the authorised person, or when assisting with processing an FOI request, or when undertaking some compliance functions.
What should APVMA officers do?
APVMA officers should, before using or disclosing any information to perform their functions or duties, or exercise their powers:
- consider whether it is, or might be, CCI;
- consider whether using CCI would result in the disclosure of the CCI;
- consider whether the disclosure of the CCI falls within one of the exceptions listed above;
- (if so) consider whether the CEO has authorised them to disclose the information;
- seek advice from their manager, or the Deputy General Counsel, if they are unsure; and
- document the results of their consideration.
3.4. Limited use information
What is limited use information?
Some information has specific limitations or restrictions on when and how APVMA officers may use that information under the Agvet Code.? There are a number of different types of such limitations and restrictions, which are grouped together in this Practice Statement as ‘limited use information’:
- there is a set of restrictions contained in Division 4A of Part 2 of the Agvet Code.? There is a general rule (in section 34G(1)) that the APVMA must not use information given to the APVMA in connection with one application to assess or make a decision on another application.? For the purpose of this provision, 'use' includes applying a decision made, or a conclusion reached, based on the information, and the use of knowledge or understanding gained from the information. An APVMA officer may access and use Limited Use Information which would otherwise be prohibited under this Division of the Agvet Code where:
- written consent of the Authorising Party has been provided; or
- the applicable limitation period has elapsed (noting some of that information may still fall within the definition of CCI); or
- another exception applies, for example where expressly authorised to use the information because it has been determined the use is in the public interest (see sections 59(2)(d) and 34K); or
- the information does not favour the applicant or holder (see sections 59(2)(f) and 34J).
Information that may be protected under these restrictions includes such things as reports, studies, reviews, descriptions of methods of analysis, scientific argument prepared to address relevant criteria, or other scientific work intended to inform assessment of an application, and given in connection with an application. Invariably, this will also include information which is also CCI.
- there are other restrictions contained in Part 3 of the Agvet Code. This Part provides that where:
- information or results which have been obtained because of a trial or laboratory experiment and relate to one active constituent or chemical product; and
- that information or results were given to the APVMA in connection with a reconsideration, or a decision to suspend or cancel a registration,?there is a general rule that APVMA officers must not use that information to determine whether to approve another active constituent or register another chemical product
- Part 7B of the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Administration Act) also places restrictions on when and how certain information may be used by APVMA officers.
Some information associated with approval or registration, such as formulation details, may still fall within the definition of CCI (see above) or be Other Confidential Information even if it no longer is Limited Use Information, for example, where the protection period has elapsed (see below).
What are the restrictions?
The restrictions (and the applicable exceptions to those restrictions) are specific to the type of Limited Use Information. Further detail on the general principles and processes that APVMA officers must apply in relation to performing functions and duties, and exercising powers, under Division 4A of Part 2 of the Agvet Code are set out in the Section 6A Guideline – Limits on Use of Information (and see Part 2 below for further information on dealing with applications involving a reference product).?
What should APVMA officers do?
APVMA officers should:
- check whether information they are considering using is, or might be, Limited Use Information;
- if so, consider whether that Limited Use Information can be used;
- seek advice from their manager, or the General Counsel, if they are unsure; and
- document the results of their consideration.
3.5. Other confidential information
In performing their functions and duties, APVMA officers may become privy to other information which is by its nature confidential or communicated to the APVMA under an express or implied obligation that it is to be kept confidential. Such information may also be CCI under the Agvet legislative framework.?
Generally, the APVMA will be obliged to keep Other Confidential Information confidential unless:
- the information has lost its confidentiality because it is broadly, or publicly, communicated; or
- the person or organisation providing the Other Confidential Information (the confidant) has consented to it being used or disclosed.
APVMA officers should seek specific advice from their manager or the General Counsel, about their obligations in relation to any information that they consider may be Other Confidential Information.
4. PART 2: Guidance on processing applications involving a reference product?
This Part sets out some additional guidance for APVMA officers who are involved in processing and considering applications that involve consideration of a chemical product or active constituent which is claimed to be similar, or closely similar, to a registered product or active constituent (a reference product), including how CCI is to be handled as part of that process.
A reference product file may contain information that is:
- Limited Use Information (including where the protection period has not elapsed);
- CCI; and/or
- Other Confidential Information.
Accordingly, APVMA officers should consider each applicable category and act accordingly as discussed in Part 1, as well as complying with the further guidance in this Part 2.
4.1. Limited use information
APVMA officers should determine whether the reference product file contains any Limited Use Information.? If it does, APVMA officers must not access or use that information except where it is permitted under the Agvet Code.
4.2. Confidential commercial information (CCI)
The Federal Court has confirmed that, generally, any CCI in a nominated reference product file can be used by APVMA officers when conducting their assessment of an application claiming that the product is similar, or closely similar, to the reference product. ?The Federal Court also confirmed that the consent of the holder of the reference product is not required to allow this use.
When corresponding with an applicant, APVMA officers will need to exercise care not to disclose any of that CCI:
- the Federal Court has confirmed that merely notifying the applicant that a chemical product has been registered does not, of itself, disclose CCI about any reference product
- however, when notifying reasons for a decision not to register a chemical product (on the grounds that it is not the same, similar, or closely similar, to a reference product), APVMA officers should not disclose any CCI about the reference product. It is permissible for those reasons to state:
- that the product which is the subject of the application is not the same, similar or closely similar to the reference product; or
- that the reason that the products are not the same, similar or closely similar is because an aspect of the product is not the same, similar or closely similar, but the reasons should not describe any specific details about the differences if this would disclose CCI about the reference product.
The APVMA has developed templates designed to assist APVMA officers to ensure that decision notices do not disclose any CCI.?
In order to ensure APVMA officers are able to meet their obligations in relation to using and disclosing information, APVMA officers should:
- whenever they wish to access, use or disclose information as part of their functions or duties, first consider the categories in this Practice Statement into which the information may fall (i.e. CCI, Limited Use Information or Other Confidential Information);
- then consider:
- what protections apply to each of those categories; and
- whether the conditions applicable to those protections allow the access, use or disclosure of that information
and document that they have considered these things as appropriate;
- only access, use or disclose that information when engaging in the performance of functions or duties, or in the exercise of powers, under the Agvet Code;
- when considering an application involving a reference product, ensure that notices, including any reasons for decisions, do not disclose CCI about the reference product;
- seek advice as required from their manager, or Deputy General Counsel, in relation to any specific circumstances where they are unsure about their obligations;
- follow any additional guidance issued by the APVMA from time to time about managing information (e.g., use templates and follow procedures when assessing applications);
- attend information management training made available by the APVMA; and
- report all issues, complaints or incidents about the management of information by the APVMA to the Deputy General Counsel, through their manager where appropriate.
5. Legal framework
- Protective Security Policy Framework
- Agricultural and Veterinary Chemicals Code Act 1994
- Agricultural and Veterinary Chemicals Code Regulations 1995
- Agricultural and Veterinary Chemicals (Administration) Regulations 1995
- Agricultural and Veterinary Chemicals (Administration) Regulations 1995
- Freedom of Information Act 1982
- Explanatory Memorandum to the Agricultural and Veterinary Chemicals Legislation
- Amendment bill 2013
- Public Service Act 1999
- Crimes Act 1914.