Safety first: Copyright exemption for generics


The safe and effective use of medicine relies on doctors, pharmacists and other health professionals receiving consistent safety information about each medicine, regardless of its brand.

The Therapeutic Goods Legislation Amendment (Copyright) Act 2011, ensures generic versions of prescription and pharmacist-only medicines can adopt essentially the same product information as the ‘original’ (branded) medicine without risk of copyright infringement.

The legislation achieves its aim by creating an exemption to copyright infringement of product information documents (‘PIs’) for restricted medicines.  Restricted medicines are those medicines that may only be prescribed by a medical practitioner and pharmacist-only medicines.

It is important to note that the exemption does not apply to any product information or documents other than product information approved under section 25AA of the Therapeutic Goods Act 1989. That is, product information documents related to the restricted medicine in question.

The exemption to copyright infringement is limited to the purpose of applying to register a restricted medicine, other purposes related to the safe and effective use of the medicine as well as incidental or ancillary acts.  It also applies irrespective of when the product information was approved by the Therapeutic Goods Administration, so existing PIs may be copied within the scope of the exemption.

Explanation for the exemption

In explaining the rationale behind the changes, the Explanatory Memorandum to the amendment states:

It has been a long-standing practice in the Therapeutic Goods Administration (TGA) for delegates to approve the text of the PI of generic versions of a prescription medicine that is essentially the same as the approved PI of the “original” medicine.  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.

By removing the basis upon which a copyright infringement claim could be mounted, the amendment is intended to help the TGA achieve its objective of ensuring the Australian public have access to medicines that are consistently safe, effective and of high quality.

Compensation for acquisition of property

In certain circumstances, the exemption may amount to an acquisition of property by the Commonwealth.  Where the application of the exemption would result in an acquisition of copyright other than on ‘just terms’, the Commonwealth must pay a reasonable amount of compensation to the copyright owner. 

As drug companies invest a lot of skill and effort in developing these documents, it will be interesting to see whether any challenges are made against the level of compensation required or whether the industry will now simply set aside consideration of PI copyright infringement altogether.

The content of this publication is for reference purposes only. It is current at the date of publication. This content does not constitute legal advice and should not be relied upon as such. Legal advice about your specific circumstances should always be obtained before taking any action based on this publication.

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James Cameron

Special Counsel. Brisbane
+61 7 3228 9752