The recent introduction of the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 (the Bill) to the Federal Parliament seeks to amend the Copyright Act 1968 (Cth) by introducing new exemptions to infringement of copyright in Australia.
Before therapeutic goods can be legally marketed and supplied in Australia, these goods face scrutiny by the Therapeutic Goods Administration (TGA).
As part of the TGA’s review process, applicants are required to submit a Product Information document (PI) including technical information about the medicine including the characteristics of the active ingredient, its indications and contraindications, a description of clinical trials that support the indications, precautions, possible adverse reactions, dosages and storage, and other information relating to the medicine’s safe and effective use.
As a matter of public policy and as noted in the Explanatory Memorandum accompanying the Bill, “it is important for the safe and effective use of the medicine that doctors, pharmacists and other health professionals receive the same information about a medicine regardless of the brand, thus avoiding any perception that differences in the text of the PIs reflect clinical and/or pharmacological differences”.
Given the overarching policy considerations, the TGA has traditionally approved the text of a PI of a generic version of an originator medicine. However in view of recent attempts by originator companies to assert copyright in the text of an approved PI where it is used in the PI of a generic version of the same medicine, the Australian government has deemed it necessary to introduce the exemptions.
The new section 44BA entitled ‘Acts done in relation to certain medicine’ provides that it will not be held to be copyright infringement where a person uses the text of PI “…for the purposes of applying to register a medicine, or for the purpose of varying the approved PI of a medicine, or any incidental or ancillary acts. The exemption applies to these acts irrespective of when the PI was approved. The exemption will also apply to third parties supplying, reproducing, publishing, communicating or adapting an approved PI for a medicine where such acts are for purposes related to the safe and effective use of the medicine”.
By closing this avenue of copyright action to originator companies, the Australian Government has removed an area of uncertainty which had the potential to impede or delay generic entry into the Australian market.
Scott Sloan | Partner
T +61 2 8233 9554
F +61 2 8233 9555
Stuart Green | Associate
T +61 2 8233 9586
F +61 2 8233 9555
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