This content is current only at the time of printing. This document was printed on 23 June 2021. A current copy is located at http://www.plural-consulting.com/node/581
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Data handling by the APVMA
The Australian Government Protective Security Policy Framework requires the Australian Pesticides and Veterinary Medicines Authority (APVMA) to classify the information it receives. How that information is classified determines how it will be disclosed or accessed as well as how it is to be stored or disposed of.
Data and other confidential information received with an application (for example, details of safety or efficacy studies) is generally classified as sensitive – confidential commercial information. This classification requires us to securely store application information, and when using an external reviewer, send the information using commercially approved couriers who are responsible for its carriage and safekeeping or by secure email transmission.
Confidential commercial information
Section 162 of the Agvet Code prohibits the APVMA (or any member of its staff) from disclosing confidential commercial information, subject to certain exemptions set out in the Agvet Code (for example, when the person who owns the information provides their consent for it to be disclosed). Confidential commercial information in relation to an active constituent or a chemical product is defined in section 3 of the Agvet Code to mean:
- a trade secret relating to the active constituent or chemical product, or any other information relating to the active 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
- information that concerns the lawful commercial or financial affairs of a person, organisation or undertaking and relates to the manufacture, distribution or supply of the active constituent or chemical product that if disclosed could unreasonably affect the person, organisation or undertaking in an adverse manner.
The definition of confidential commercial information under the Agvet Code does not include:
- the making of a permit application for the use of a proposed or existing active constituent or chemical product, if the use proposed in the application is a minor or emergency use; or
- any of the following information associated with a minor or emergency use permit application (as specified under regulation 3C of the Agvet Code Regulations):
- the name of the applicant;
- the application number;
- the chemical product number;
- the name of each of the active constituents of the chemical product; and
- a short description of the application and its purpose, including a description of the way in which the chemical product is intended to be used.
The APVMA takes reasonable precautions to ensure that its staff do not release confidential commercial information to, or enable access to confidential commercial information by, unauthorised people.
Confidential commercial information in materials given to the APVMA
Documents or samples provided to the APVMA for any purpose under the Agvet Code become the property of the APVMA under section 169 of the Agvet Code. This includes information relating to applications that have been refused or withdrawn. While the physical documents or samples may not be the property of the person who gave them to the APVMA, they may nonetheless contain information which is confidential commercial information for the purposes of the Agvet Code.
Other protections for information
Separate to the concept of information being confidential commercial information, some information associated with applications to the APVMA attracts protection under the Agvet Code. There are a number of different types of protection:
- The limits on use of certain information under Division 4A of Part 2 of the Agvet Code;
- The information protections provided under Part 3 of the Agvet Code;
- Restrictions on the use of information, where that information is subject to protection under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) under Part 7B of the Agricultural and Veterinary Chemicals (Administration) Act 1992; and
- The restrictions on using information provided to the APVMA to register similar products under section 14B of the Agvet Code.
It is very important to remember that any one piece of information can be covered by more than one of the above protections for information.
The APVMA, as a commonwealth authority, is required to?keep all documentation?(paper and electronic) in accordance with the?Archives Act 1983?(the Archives Act). The Archives Act is administered by the?National Archives of Australia.