Further to our legal update in March, the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 has been passed by both Houses of Parliament, and has received royal assent. The amendments to the Copyright Act came into force on 27 May 2011.
As a result, generic pharmaceutical companies will be able to use originators' Product Information documents (PI) that have been previously approved by the Therapeutic Goods Administration (TGA), without infringing the copyright in the original PI. The scheme has been implemented by the insertion of a new section 44BA in the Copyright Act 1968 (Cth) as follows:
- Subsection 44BA (1) provides that the copyright subsisting in TGA approved PI is not infringed by a direct or incidental act (done on or after 27 May 2011) that is undertaken to register a medicine or restricted medicine under the Therapeutic Goods Act 1989 (Cth);
- Subsection 44BA (2) provides that the supply, reproduction, publication, communication or adaption of some or all of TGA approved PI on or after 27 May 2011 does not constitute an infringement of the copyright subsisting in the PI, if the PI is used for a purpose related to the safe and effective use of a TGA approved medicine;
- Subsection 44BA (3) provides that any acts that are incidental to those set out in ss. 44BA (2) also do not infringe any copyright subsisting in TGA approved PI; and
- Subsection 44BA (4) explains that for the purpose of the above provisions, the terms "medicine", "product information" and "restricted medicine" have the same meanings as in the Therapeutic Goods Act 1989 (Cth).
These changes bring Australian law substantially into line with the 'same labelling' requirements for medicines in the United States.