Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 (full text)

Proposed amendments to the Copyright Act could have the effect of preventing pharmaceutical companies from commencing legal proceedings for copyright infringement of their TGA approved pharmaceutical Product Information documents.

What is Product Information ("PI")?

Generally, before a medicine can be lawfully marketed and supplied in Australia, it must be approved by the Therapeutic Goods Administration ("TGA"). As part of this process, companies wishing to introduce a new drug or a new generic version of a drug must submit a Product Information document ("PI") containing information relating to the medicine's characteristics, together with instructions as to its safe and effective use.

The effect of Therapeutic Goods Legislation Amendment (Copyright) Bill 2011

Legislative amendments to the Copyright Act 1968 (Cth) introduced into Australian Federal Parliament on 22 February 2011, will, if passed, enable generic pharmaceutical companies to legally use PIs that have been previously approved by the TGA.

Current proposals to limit copyright protection for medicine Product Information documents – A win for generic pharmaceuticals

Two new exceptions to copyright infringement are proposed:

  1. The use or lodgement of existing Product Information documents (generally first created by 'originator' pharmaceutical companies) for the purposes of applying to register a medicine under the Therapeutic Goods Act 1989; and
  2. The supply, reproduction, publication, communication or adaptation of some or all of TGA approved Product Information, provided that the use is for a purpose related to the safe and effective use of a TGA approved medicine.1

The government's objectives

The Australian government says the proposed amendments are necessary to combat the emerging trend of originator pharmaceutical companies claiming infringement of copyright in their PI documents, in an attempt to further delay the market entry of competitor products. According to the government, such legal actions:

  • compromise the accuracy, consistency and safety of PI documents, as generic products seek to alter approved PI to avoid potential liability;
  • unfairly shift the balance envisioned by the Australian patent protection system in favour of originator pharmaceutical companies;
  • damage the pharmaceutical brand substitution policy introduced in Australia in 1994, and;
  • consequently reduce the affordability and access to pharmaceuticals in Australia.

As such, the proposed exceptions are designed to provide extra protection to generic pharmaceutical companies (and their employees and agents), by enabling them to use existing PIs where necessary for purposes related to TGA regulatory approvals, or the safe and effective use of medicines.

If implemented, the changes will also bring Australian law substantially into line with the 'same labelling' requirements for medicines in the United States.

Debate on the Bill was adjourned in the Federal Parliament on 24 February 2011.

Stay tuned for more information.