Therapeutic Goods Legislation Amendment (Copyright) Act 2011

The Therapeutic Goods Legislation Amendment (Copyright) Act 2011 is a short Commonwealth amending Act. It does not create a new standalone copyright regime for medicines. Its main function is to amend the Copyright Act 1968 by inserting section 44BA.

That inserted section creates a targeted copyright exception for certain acts involving approved product information for medicines under the Therapeutic Goods Act 1989. In practical terms, the law says that some acts involving that approved product information are not an infringement of copyright.

For businesses, the key point is that this is a narrow operational exception. It can be very useful if your business needs to handle approved product information in software, databases, pharmacy systems, hospital systems or publication workflows. But it is not a general permission to copy all content about medicines.

Schedule 1 inserts section 44BA into the Copyright Act 1968. The section has four parts that matter for business readers.

Subsection 44BA(1) says certain acts are not copyright infringement where the work is product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine. It covers an act done under that Act in respect of product information relating to restricted medicine, medicine where the applicant for registration has been given a notice of the kind referred to in subparagraph 25(1)(da)(ii), or medicine where subsection 25AA(2) or (3) applies. It also covers an act that is ancillary or incidental to such an act.

Subsection 44BA(2) is the part many businesses will focus on most. It says that supplying, reproducing, publishing, communicating or adapting, in Australia, some or all of approved product information is not copyright infringement to the extent that the act is for a purpose related to the safe and effective use of the medicine.

Subsection 44BA(3) extends that protection to acts done in Australia that are ancillary or incidental to the subsection 44BA(2) activities. Subsection 44BA(4) says that medicine, product information and restricted medicine have the same meanings as in the Therapeutic Goods Act 1989.

This amendment is most relevant to businesses and organisations that directly handle approved product information for medicines. That includes medicine sponsors, manufacturers, importers, distributors, pharmacies, hospitals, prescribing and dispensing software providers, medical publishers and digital health platforms. It can also matter to startups building searchable medicine databases or patient-facing tools that rely on approved product information as official source.

These businesses often need to copy, display, transmit, store, publish or reformat approved product information so clinicians, pharmacists, patients or internal teams can use it. The amendment reduces copyright friction for some of those activities where the statutory conditions are met.

Businesses are usually outside the practical core of this law if they are dealing mainly with material that is not the approved product information itself. Examples can include branding, packaging artwork, promotional copy, editorial commentary, website design, training materials or general health content. The legislation does not say those materials are covered simply because they relate to a medicine.

The legislation has several practical trigger points. A business should check each one before assuming the exception applies.

First, identify the material. The section applies to a work that is product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine. That is narrower than saying the content is about a medicine. If your platform mixes approved product information with summaries, alerts, editorial notes, interface text or marketing content, only part of that material may fall within the section.

Second, identify the act. Under subsection 44BA(2), the listed acts are supplying, reproducing, publishing, communicating and adapting. Under subsection 44BA(1), the relevant act must be done under the Therapeutic Goods Act 1989 and relate to one of the specified medicine categories. Ancillary or incidental acts can also be covered, but only where they are genuinely connected to a covered primary act.

Third, identify the territorial connection. The text repeatedly refers to acts done in Australia for the subsection 44BA(2) and subsection 44BA(3) limbs. If your workflow includes offshore hosting, overseas support teams or cross-border publication steps, you should not assume the whole process is covered without checking the exact legal position.

Fourth, identify the purpose. For the supply, reproduction, publication, communication and adaptation limb, the act is protected only to the extent it is for a purpose related to the safe and effective use of the medicine. That purpose requirement is central, not optional.

This Act does not impose a broad compliance code in the way some regulatory statutes do, but it does create practical checks for any business that wants to rely on the exception safely.

The first practical obligation is document control. Keep clear records showing what source document you are using and why you believe it is product information approved under section 25AA of the Therapeutic Goods Act 1989. If your team cannot identify the approved product information cleanly, reliance on the exception becomes harder.

The second practical obligation is purpose control. If you are relying on subsection 44BA(2), be able to explain how the supply, reproduction, publication, communication or adaptation is related to the safe and effective use of the medicine. This is especially important where the same content appears in a commercial platform that also has advertising or promotional features.

The third practical obligation is workflow control. Check where the relevant acts occur, especially if your systems are cloud-based or involve overseas contractors. The legislation uses Australia-specific wording for key parts of the exception.

The fourth practical obligation is content integrity. The section expressly includes adaptation, which is helpful for businesses that need to reformat information for software or searchable databases. But adaptation can still create separate risks if the meaning changes, if warnings are obscured, or if the presentation becomes misleading.

The fifth practical obligation is legal separation. Copyright coverage under section 44BA does not remove the need to comply with therapeutic goods law, accuracy requirements or general consumer law. A use may be protected from copyright infringement and still create another legal problem.

Many ordinary business activities line up with the verbs used in subsection 44BA(2). A pharmacy software provider may reproduce and communicate approved product information inside a dispensing system. A hospital information service may publish or communicate it to clinicians. A medicine database operator may adapt the format so the information works in a searchable interface. A digital health platform may supply or publish the information to Australian users.

Those examples show why the amendment matters commercially. Without a specific exception, businesses may face more copyright uncertainty when they need to move approved product information through operational systems. The amendment reduces that uncertainty for defined uses.

But the section should still be read carefully. The law does not say every use by a health business is covered. It protects the listed acts only to the extent they are for a purpose related to the safe and effective use of the medicine. If the same content is used in a way that is mainly promotional, unrelated to medicine use, or mixed with other content that is not approved product information, the analysis becomes more cautious.

The most important limit is subject matter. The section applies to product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine. It does not extend on its face to all medicine-related content or general health information.

The next limit is purpose. For subsection 44BA(2), the listed acts are protected only to the extent they are for a purpose related to the safe and effective use of the medicine. That wording means businesses should be careful with uses that are strongly promotional or otherwise disconnected from medicine use.

Another limit is geography. The section refers to acts done in Australia for the operational limb and for ancillary or incidental acts connected to that limb. Businesses with international workflows should check whether the relevant act they are relying on is actually occurring in Australia.

There is also a structural limit. Ancillary or incidental acts are covered only where they are connected to a covered primary act. A business should not assume that any supporting step is protected if the main act itself does not fit the section.

Finally, this is a copyright exception only. It does not replace therapeutic goods compliance, and it does not guarantee that an adapted or reformatted presentation is accurate, balanced or lawful under other rules.

A pharmacy or prescribing software business may want to display approved product information inside a workflow used by pharmacists or clinicians. That kind of use may fit comfortably within the verbs in subsection 44BA(2), especially where the information is being supplied, reproduced or communicated in Australia to support medicine use.

A database operator may also want to convert approved product information into a searchable format. The section expressly refers to adapting some or all of the approved product information in Australia, which is commercially important for businesses that need structured data, searchable fields or different display formats. Even so, the business should still check that the adaptation remains tied to safe and effective use of the medicine and does not alter the substance in a way that creates separate risk.

By contrast, if a business lifts approved product information into a broader promotional campaign, the legislation does not expressly say that promotional reuse is covered. The wording in subsection 44BA(2) is tied to a purpose related to the safe and effective use of the medicine. That means a mixed-purpose or marketing-heavy use should be approached carefully rather than assumed to be protected.

The Act received Royal Assent on 27 May 2011. Under section 2, it commenced on the day after Royal Assent, which was 28 May 2011.

Schedule 1 item 2 deals with application. It says that subsections 44BA(1), (2) and (3), as inserted by the Act, apply in relation to acts done on or after the day the item commences, regardless of whether the relevant product information was approved before, on or after that day. That means the timing question is focused on when the act was done, not only on when the product information was approved.

This timing point can matter for businesses with older databases, archives or long-running publication systems. If your business is reviewing legacy workflows, the key date question is the date of the relevant act, such as supply, reproduction, publication, communication or adaptation.

The Act is recorded as in force. Even so, businesses should check the latest consolidated legislation before relying on this page for a current product, publication process or software workflow.

Schedule 1 also includes a compensation clause. It says that if the operation of the Schedule would result in an acquisition of property from a person otherwise than on just terms, the Commonwealth is liable to pay a reasonable amount of compensation. If the amount cannot be agreed, the person may bring proceedings in a court of competent jurisdiction for recovery of a reasonable amount determined by the court.

For most businesses, this is not the day-to-day practical feature of the Act. It is better understood as a constitutional safeguard built into the legislation. The Act defines acquisition of property and just terms by reference to paragraph 51(xxxi) of the Constitution.

Businesses should not read this as a general damages pathway for ordinary copyright disputes. It is a specialised provision that would only matter in unusual circumstances.

This amendment can be very helpful for businesses that need to work with approved product information at scale. But it should be used carefully and precisely. The safest approach is to map the exact document, the exact act, the location of the act and the business purpose against the wording of section 44BA before relying on the exception.

If your workflow combines approved product information with other material, keep those categories separate. The legislation is document-specific and purpose-specific. Treating all medicine-related content as if it were covered creates avoidable risk.

This page is based on the text of the Therapeutic Goods Legislation Amendment (Copyright) Act 2011 as published on the Federal Register of Legislation. That source supports the explanation of the amendment, commencement, application clause and compensation provision.

This page does not go beyond the enacted text when describing practical operation. It should be read as general information only. Before relying on the exception for a live product or workflow, check the latest consolidated legislation and the current position under the Therapeutic Goods Act 1989.