Legal development

The TGA comes down hard on misleading use of its adverse event reports for COVID vaccines

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    What you need to know

    • Content published on the TGA's website, including its adverse reports regarding COVID-19 vaccines, is often protected by copyright.
    • Reproduction of such works without the consent of the Commonwealth of Australia as the copyright owner, is likely to be considered copyright infringement unless one of the defences in the Copyright Act applies, such as a fair dealing for the purpose of criticism or review or for news reporting, or an exception applies such as that allowing the reproduction of product information for pharmaceuticals.

    On 15 September 2021, the Therapeutic Goods Administration issued a statement advising that it had written to Mr Craig Kelly MP, as the leader of the United Australia Party (UAP), and demanded that it stop distributing extracts from various adverse event reports relating to COVID-19 vaccines that were incomplete.  The TGA asserted that such use was a breach of copyright and that it could be seriously misleading to consumers.

    The TGA has alleged that the UAP took extracts of the adverse event reports published on the Database of Adverse Event Notifications (DAEN), and sent those extracts to members of the public via text message.  This unauthorised reproduction of sections from the adverse event reports also purportedly left out critical information as well as the TGA's copyright statement.  

    The Commonwealth of Australia claims copyright ownership over the content on the TGA's website, including the reports published on the DAEN, in its copyright statement.  The statement allows for the limited reproduction of the copyright works for personal and internal organisation use in accordance with the Copyright Act 1968 (Cth), but explicitly prohibits the retransmission, distribution or commercialisation of the material for any other purpose, without the Commonwealth's prior written approval.

    Copyright subsists in adverse event reports

    Copyright subsists in the reports published on the DAEN as literary works under the Copyright Act, provided they are sufficiently original.  Assuming it is the owner of the copyright in the reports, the Commonwealth has the exclusive rights to reproduce and communicate the reports, or a substantial part of them, for a period of 50 years from the year it was first published.  

    Is it really infringement?

    The reproduction of the extracts from the reports falls outside of the limited user licence set out in the TGA's copyright statement, which means that such reproduction (if of a substantial part) requires the Commonwealth's prior written consent.  Without consent, reproduction of the protected works is considered infringement unless a defence or exception applies.  

    Defences available under the Copyright Act include fair dealing for the purpose of criticism or review or for the reporting of news.

    There are also exceptions under the Copyright Act, such as that the reproduction of product information for pharmaceuticals does not constitute copyright infringement.  However, this exception does not go so far as to protect adverse event reports for such products.  

    A recurrent issue for the UAP

    In April this year, the chairman of the UAP, Mr Clive Palmer, was also found to have infringed the rights of Universal Music Publishing Pty Ltd after the Federal Court determined that he reproduced the music and lyrics of the Twisted Sister song We're Not Gonna Take It, without a licence or authorisation to do so.  Read more about that decision here.

    Authors: Kellech Smith, Partner; and Daele Tyler, Lawyer.

    The information provided is not intended to be a comprehensive review of all developments in the law and practice, or to cover all aspects of those referred to.
    Readers should take legal advice before applying it to specific issues or transactions.


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