IP/N/1/AUS/C/11  
 
18 June 2013  
(13-3149)  Page: 1/11  
Council for Trade-Related Aspects 
of Intellectual Property Rights  Original: English/anglais/inglés  
 
MAIN DEDICATED INTELLECTUAL PROPERTY LAWS AND 
REGULATIONS NOTIFIED UNDER ARTICLE 63.2 
OF THE AGREEMENT 
AUSTRALIA  
This document reproduces the text1 of the Therapeutic Goods Legislation Amendment (Copyright) 
Act 2011, No. 39, 2011 - An Act to amend the Copyright Act 1968 , and for related purposes , as 
notified by Australia on 22 May 2013 under Article 63.2 of the Agreement (see document IP/N/1/AUS/5). 
 
Conseil des aspects des droits de propriété 
intellectuelle qui touchent au commerce 
 
PRINCIPALES LOIS ET RÉGLEMENTATIONS CONSACRÉES À 
LA PROPRIÉTÉ INTELLECTUELLE NOTIFIÉES AU TITRE 
DE L'ARTICLE 63:2 DE L'ACCORD 
AUSTRALIE  
Le présent document contient le texte1 de la Loi n° 39 de 2011 portant modification de la 
législation relative aux produits thérapeutiques (droit d'auteur) – Modification de la Loi de 1968 sur 
le droit d'auteur  et objectifs connexes, notifiée par l'Australie le 22 mai 2013 au titre de 
l'article 63:2 de l'Accord (voir le document IP/N/1/AUS/5). 
 
Consejo de los Aspectos de los Derechos de Propiedad 
Intelectual relacionados con el Comercio 
 
PRINCIPALES LEYES Y REGLAMENTOS DEDICADOS A LA 
PROPIEDAD INTELECTUAL NOTIFICADOS EN VIRTUD 
DEL PÁRRAFO 2 DEL ARTÍCULO 63 DEL ACUERDO 
AUSTRALIA  
En el presente documento se reproduce el texto1 de la Ley de 2011 que modifica la legislación 
relativa a productos terapéuticos (derecho de Autor), Nº 39, 2011 – Ley para modificar la Ley 
de 1968 de Derecho de Autor y para fines conexos, notificado por Australia el 22 de mayo de 2013 
en virtud de lo dispuesto en el párrafo 2 de l artículo 63 del Acuerdo (véase el documento 
IP/N/1/AUS/5). 
                                               
1 In English only./En anglais seulement./En inglés solamente. IP/N/1/AUS/C/11 
 
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Note: An electronic version of this Act is available in ComLaw (http://www.comlaw.gov.au/) 
 
 
 
 
 
 
 
 
Therapeutic Goods Legislation 
Amendment (Copyright) Act 2011 
 
No. 39, 2011 
 
 
 
 
 
An Act to amend the Copyright Act 1968 , and for 
related purposes 
   
   
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i       Therapeutic Goods Legislation Amendment (Copyright) Act 2011       No. 39, 2011 Contents 
1 Short title ...........................................................................................  1 
2 Commencement .................................................................................  2 
3
 Schedule(s) ........................................................................................ 2 
Schedule 1—Amendments  3 
Copyright Act 1968  3 
 
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Therapeutic Goods Legislation Amendment (Copyright) Act 2011       No. 39, 2011       1 
 
 
 
Therapeutic Goods Legislation 
Amendment (Copyright) Act 2011 
No. 39, 2011 
  
 
An Act  to amend the Copyright Act 1968 , and for 
related purposes  
[Assented to 27 May 2011 ] 
The Parliament of Australia enacts:  
1  Short title 
  This Act may be cited as the Therapeutic Goods Legislation 
Amendment (Copyright) Act 2011 . 
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2            Therapeutic Goods Legislation Amendment (Copyright) Act 2011       No. 39, 2011 2  Commencement 
  This Act commences on the day after this Act receives the Royal 
Assent. 
3  Schedule(s) 
  Each Act that is specified in a Schedule to this Act is amended or 
repealed as set out in the applicable items in the Schedule 
concerned, and any other item in a Schedule to this Act has effect 
according to its terms. 
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         - 8 -Amendments  Schedule 1  
   
 
 
Therapeutic Goods Legislation Amendment (Copyright) Act 2011       No. 39, 2011            3  
Schedule 1— Amendments 
   
Copyright Act 1968  
1  After section 44B 
Insert: 
44BA  Acts done in relation to certain medicine 
 (1) The following acts are not an infringement of any copyright 
subsisting under this Part in a work that is product information 
approved under section 25AA of the Therapeutic Goods Act 1989 
in relation to medicine: 
 (a) an act that is done under that Act  and that is in respect of 
product information in relation to: 
 (i) restricted medicine; or 
 (ii) medicine in respect of which the applicant for the 
registration of that medicine under that Act has been 
given a notice of the kind referred to in subparagraph 
25(1)(da)(ii) of that Act; or 
 (iii) medicine in respect of which subsection 25AA(2) or (3) 
of that Act applies; 
 (b) an act that is ancillary or incidental to an act referred to in 
paragraph (a). 
 (2) The following acts are not an infringement of any copyright 
subsisting under this Part in a work that is product information 
approved under section 25AA of the Therapeutic Goods Act 1989 
in relation to medicine: 
 (a) supplying, in Australia, some or all of any product 
information that is approved under that section  in relation to 
medicine; 
 (b) reproducing, in Australia, some or all of the information 
referred to in paragraph ( a); 
 (c) publishing, in Australia, some or all of the information 
referred to in paragraph ( a); 
 (d) communicating, in Australia, some or all of the information 
referred to in paragraph ( a); 
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4            Therapeutic Goods Legislation Amendment (Copyright) Act 2011       No. 39, 2011  (e) adapting, in Australia, some or all of the information referred 
to in paragraph ( a); 
to the extent that the supply, reproduction, publication, 
communication or adaptation is for a purpose related to the safe 
and effective use of the medicine referred to in paragraph ( a).  
 (3) An act done in Australia that is ancillary or incidental to a supply, 
reproduction, publication, communication or adaptation referred to 
in subsection (2) is not an infringement of any copyright subsisting 
under this Part in the work referred to in subsection ( 2). 
 (4) For the purposes of this section, medicine , product information  
and restricted medicine  have the same meanings as in the 
Therapeutic Goods Act 1989 . 
2  Application 
Subsections 44BA(1), (2) and (3) of the Copyright Act 1968 , as inserted 
by this Act, apply in relation to acts done on or after the day on which 
this item commences (regardless of whether the product information 
referred to in subsection 44BA(1) or (2) of that Act was approved 
before, on or after that day). 
3  Compensation for acquisition of property 
(1) If the operation of this 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 to 
the person. 
(2) If the Commonwealth and the person do not agree on the amount of the 
compensation, the person may institute proceedings in a court of 
competent jurisdiction for the recovery from the Commonwealth of 
such reasonable amount of compensation as the court determines. 
(3) In this item: 
acquisition of property  has the same meaning as in paragraph 51(xxxi) 
of the Constitution. 
just terms  has the same meaning as in paragraph 51(xxxi) of the 
Constitution. 
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Therapeutic Goods Legislation Amendment (Copyright) Act 2011       No. 39, 2011            5  
[Minister’s second reading speech made in — 
House of Representatives on 24 February 2011  
Senate on 25 March 2011 ] 
 
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