Partner, Dr Teresa Nicoletti looks at the APVMA’s new confidential commercial information policy and the far reaching implications that it is likely to have for the generic veterinary chemicals industry.

In September 2014, the APVMA implemented a new policy regarding its management and handling of confidential commercial information (CCI). The new policy has far-reaching implications for the generic veterinary chemicals industry and particularly requires applicants proposing to register generic products to provide written consent, from the owners of CCI of reference products, for the APVMA to use that CCI in the evaluation of generic product applications.

We note that since the introduction of the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) (AgVet Code), the APVMA has used reference product information  for which data protection has expired in the evaluation of generic products. This information has been used internally by the APVMA in confidence, without disclosure to external stakeholders, including the applicant for registration.

In our view, the APVMA’s new policy requiring an applicant seeking to register a generic product to obtain consent from the owner of CCI relating to the reference product, in circumstances where data protection has expired for that product, misapplies the legislation.

Relevant legislation

Section 3 of the AgVet Code provides the following:

confidentialcommercial  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:

  1. a trade secret relating to the constituent or product; or
  2. 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
  3. information (other than trade secrets to which paragraph (a) applies or information to which paragraph (b) applies) that:
  1. concerns the lawful commercial or financial affairs of a person, organisation or undertaking; and
  2. relates to the manufacture, distribution or supply of the constituent or product; and
  3. if it were disclosed, could unreasonably affect the person, organisation or undertaking in an adverse manner;

but does not include:

  1. the making of an application for a permit for the use of an active constituent for a proposed or existing chemical product or for the use of  a chemical product, if the use of the product proposed in the application is:
  1. a minor use; or
  2. an emergency use; or
  1. any prescribed information relating to the making of an application for a permit, as mentioned in paragraph (d).

In relation to information that meets the definition of CCI above, subsection 162(1) of the AgVet Code prohibits the disclosure of such CCI “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” by  “a person who is or has been a director, the Chief Executive Officer, or a member of the staff, of the APVMA, or is or has been a consultant to the APVMA, a mediator or arbitrator appointed under this Code, or a co-ordinator designated for a jurisdiction”, to  another  person.

However, notwithstanding this prohibition, the AgVet Code provides  an exception for staff of the APVMA to use CCI pursuant to subsection 162(1A) in “the performance of [their] functions or duties, or [their] exercise of powers” under the AgVet Code without the need for prior written consent from the owner of the CCI1.

Separate to the CCI provisions in the AgVet Code, there are data protection provisions under Division 4A of Part 2 of the AgVet Code which prevent the APVMA from using information, submitted to it in connection with an application for approval or registration of an innovator product, to make a decision regarding an application for approval or registration for another product (e.g. a generic product). Such protection is only available for the duration of the limitation period provided in the AgVet Code (which varies depending on the type of application and information submitted).

We have advised a number of companies on the scope of the APVMA’s obligations with respect to CCI under the AgVet  Code, particularly in the context of the data protection provisions which restrict the APVMA’s use of CCI for the duration of  the limitation period. After the expiry of the applicable limitation period, the subsequent internal use by the APVMA of CCI in the evaluation of an application for registration of another product (for example, in the assessment of similarity between generic and reference products), in our view, would be consistent with “the performance of functions or duties, or the exercise of powers” under the AgVet Code.

We note that the case of Smith Kline & French Laboratories (Australia) Ltd & Alphapharm Pty Ltd v Department of Community Services and Health (1990) 22 FCR 73 examined the nature of the obligation of confidentiality owed by a regulatory authority to companies in relation to information submitted in support of obtaining marketing approval for a pharmaceutical product. That case is authority for some key propositions which may be used as the basis to challenge the APVMA’s change in policy.

Implications for generics industry

The APVMA’s new policy requiring generic product applicants to obtain consent from the owner of CCI relating to reference products, in circumstances where data protection has expired for those products, is commercially unsustainable and will have a devastating impact on the veterinary medicines industry in Australia.

The practical effect is that it will block, or at least undermine, the registration of generic veterinary medicines in the future, because innovator companies are under no obligation to grant consent to generic companies seeking to rely on the innovator’s CCI to support registration of their products, and would not do so if it means maintaining market exclusivity and/or market share.

Notably, the APVMA’s CCI policy is in stark contradiction to the policy aspirations set out in the letter to the APVMA from the Hon Barnaby Joyce MP on 2 April 2014, which called for a reduction in the regulatory burden for businesses.

In recognition of the problems faced by industry as a result of the shift in the APVMA’s CCI policy, we have assisted clients involved in the manufacture and sale of generic veterinary pharmaceutical products in Australia to navigate this hostile policy environment.