Netherlands proposes copyright reform 28/04/2011

The Government of the Netherlands has proposed a substantial package of changes to the nation's copyright law, including measures to strengthen protection for rights-holders as well as measures that will be favourable for consumers of copyright material.


The passage of any such legislation will be of interest to a variety of stakeholders over the coming months, as the Netherlands currently has less stringent laws in relation to internet downloading than many other jurisdictions. Also, a proposal for a new fair use exception - for non-commercial re-use - will no doubt be monitored by other countries considering the viability of such an exception.


The amendments, announced by State Secretary for Security and Justice Fred Teeven on 11th April, are outlined in a government press release and include:


Making the downloading of content from infringing websites unlawful: the government intends to make downloading of unauthorised film and music content on the internet unlawful, but not a criminal offence. The focus will be on websites and services (rather than individuals casually or infrequently downloading files). The Government further notes that: “The Netherlands will not adopt the kind of 'three strikes' legislation introduced in France and proposed in the UK to deny users internet access.” [1]


Blocking foreign websites: Rights-holders will be able to seek a court order blocking overseas-based websites that offer unauthorised content. Such an order can only be issued by the court if the website operator and hosting provider is unresponsive and if the website's unlawful activity can be demonstrated. This effectively extends current Dutch law, which at present only allows the blocking of domestic websites for infringing activities.


Reforms for Collecting Societies: Better oversight and transparency over Dutch copyright collecting societies will be implemented. Rights-holders will have to develop a “single digital contact point...for copyright users to report their usage, submit complaints or negotiate payments”. If this single contact point has not been established by mid-2012, then statutory measures may be brought in.


Abolishing private copying levies: The Government’s view is that there is no longer a future for private copying levies as technology has made the system obsolete. Consequently, it has flagged the abolition of the private copying levy on devices such as MP3 players, laptops, DVD recorders and USB sticks, and on ISP subscriptions. Rights-holders will be expected to make up for the shortfall in revenue either by adding it to the cost of products or by implementing more stringent TPMs.


Pan-European licences: In a possible precursor to future measures, the Government has also stated its support for single, EU-wide licences: “New online services now have to obtain a licence in each of the 27 EU member states. The State Secretary believes that this is contrary to the cross-border nature of the internet and forms a barrier to the legal digital provision of creative services.”


Additional fair use: Another positional statement in the package calls for a new fair use exception “to encourage creative, non-commercial reuse of intellectual property”.


Greater supervision of artists’ income streams: the State Secretary has also flagged that better protection of, and access to, revenue streams for authors and performing artists in their dealings with distributors and publishers will be on the table in the reform process.


The full text of the announcement can be found at:





[1] All quotes taken from “State Secretary Teeven plans copyright law update” Government of the Netherlands Press Release 11/4/2011 -

Back to top | Permalink

New Zealand Parliament moves against illegal filesharing 14/04/2011

With the passing of the Copyright (Infringing File Sharing) Amendment Bill this morning, New Zealand has become the latest country to enact a legislative framework to combat online copyright infringement.


The bill allows copyright owners to send evidence of alleged infringements to internet service providers (ISP), who will then send up to three notices to the account holder, informing them that they may have infringed copyright. If the notices are ignored, copyright owners will be able to take their claim to New Zealand’s Copyright Tribunal, which will have the power to make awards of up to $NZ15,000 against an account holder, based on damages sustained by the copyright owner.


Importantly, this system, in the first instance, steers away from suspension of service of the account holder. According to New Zealand’s Commerce Minister, Simon Power, the bill includes a power for a district court to suspend an internet account for up to six months, but this element of the legislation will only be brought into force if the notice process and Copyright Tribunal remedies are ineffective.


“This will enable the Government to work with stakeholders to monitor and review the situation and determine whether a further deterrent may be needed,” Power said.


The new regime will come into effect on 1 September 2011. It will not apply to cellular mobile networks until October 2013.




To view the New Zealand bill go to:

Back to top | Permalink

Copyrighting Google 28/03/2011

By Jerome John and Fiona James,

Australian Copyright Council



Hot on the heels of the US decision on Google Books, this month’s feature article tracks the intriguing journey Google has made in the world of copyright. We look at Google Books, YouTube, Google News and Google Search, where the internet giant has pioneered various strategies – both criticised and applauded – to try to reconcile the rights of content owners with its mission to “organize the world‘s information and make it universally accessible and useful” [1].


Google has been forced to address the perennial copyright question – how to balance the rights of creators and users – through the development of four of its highest profile services: YouTube, Google Books, Google News and Google’s search platform. As in many other areas, its journey in copyright has been one of a corporation seeking to grapple with issues that are unprecedented in scale and scope.




YouTube, the world’s largest online video site, enables users to view and share video content on a grand scale. The site was founded in 2005 by three individuals (Jawed Karim, Chad Hurley and Steve Chen) and acquired by Google in 2006, for a whopping US$1.65 billion. From its first ever video in April 2005 (Me at the Zoo, uploaded by Karim) it has grown into a massive database of video footage, registering more than 2 billion views per day [2] and more than 24 hours of new video uploads every minute. YouTube is now in an interesting position in terms of copyright, with a vested interest in both making content widely available to the public and protecting the rights of its content owner partners.


At its inception, YouTube was not a pin-up for copyright compliance. Various internal documents uncovered and widely publicised indicate that Google, prior to purchasing YouTube, was worried about the legitimacy of the service. The New York Daily News reported that a paper written by Google’s video division had referred to YouTube as a “’rogue enabler’ of content theft” and claimed that YouTube's business was "completely sustained by pirated content" [3]. How then has the YouTube model continued and flourished without being shut down?


The greatest progress has been made through YouTube’s partnership program, which now allows its content owner members (such as the Universal Music Group and Sony Pictures) to upload video and monetise content through advertising revenue. This is facilitated by the copyright management tool “Content ID”, launched in October 2007, which allows owners to search out their content and when identified, choose from a series of options for what action is to be taken. The options include blocking content, leaving it up or choosing to monetise it.


YouTube presently states that whenever it becomes aware of an infringing video, the video will be taken down. Also, to encourage the legitimate use of others' material it now offers a library of authorised music that users can access and sync with the videos they upload. But leaving aside its content partners, YouTube still faces the possibility that it will incur massive legal liabilities through inadequate protection of copyright owners at large.


Most notably in 2007, media conglomerate Viacom (parent of MTV Networks and Paramount Pictures) launched a case against YouTube, arguing that “tens of thousands of videos on YouTube, resulting in hundreds of millions of views, were taken unlawfully from Viacom’s copyrighted works without authorisation” [4]. Viacom collected evidence over a period of months of about 100,000 allegedly infringing videos and then sent YouTube a mass takedown notice. YouTube removed nearly all of them by the next business day. Viacom then complained that YouTube took down only those videos that had been specifically identified while doing nothing about other videos still featured on the YouTube service containing unauthorised Viacom works [5]. At issue was whether YouTube was required to act on the basis of a general awareness or alternatively, whether United States law requires knowledge of specific and identifiable infringements before action is taken. [Similar questions about the extent of knowledge necessary for service providers to be liable in cases of infringement have been considered in Australia's iiNet litigation.]


Judge Louis L. Stanton concluded that “knowledge of specific and identifiable infringements of particular individual items,” was required and that “mere knowledge of a prevalence of such activity in general is not enough” [6]. YouTube was therefore not liable, although the battle is not over yet: Viacom filed an appeal in December 2010 in the Federal Appeals Court in New York and it remains to be seen whether the Appeals Court will overturn the decision [7].


While YouTube’s copyright problems have certainly not been solved from many rightsholders’ perspective, the site has taken steps and employed policies that are moving in the right direction. This trend may well continue to evolve if we consider the merging of interests evident in YouTube’s current vision statement: “To give everyone a voice, to evolve video, and to make our partners and advertisers successful” [8].


Google Books


The Google Books story that has unfolded over the past six years is another example of the corporation testing the boundaries of copyright in the digital space. And, as with YouTube, the story involves a shifting of perspective as the interests of Google start to align more closely with content creators through the emergence of new business models.


In December 2004, Google announced that it had entered into agreements with several libraries for a large-scale book digitisation project (the initial libraries included Harvard, Stanford, Oxford University and the New York Public Library). Google planned to scan the books and make snippets available on their websites, as well as integrate the material into its search platform under a variety of revenue streams.


Google stated its rationale as follows: “For publishers and authors, this expansion of the Google Print program will increase the visibility of in- and out-of-print books, and generate book sales via "Buy this Book" links and advertising. For users, Google's library program will make it possible to search across library collections including out-of-print books and titles that weren't previously available anywhere but on a library shelf.” [9] But a large number of the books in library collections were still protected by copyright and many publisher and author organisations saw the project as a breach of their rights. This culminated, in September 2005, with the American Author’s Guild suing Google in The Authors Guild, Inc., et al. v. Google Inc., Case No. 05 CV 8136 (S.D.N.Y.) and several publishers following suit the next month in The McGraw-Hill Companies, Inc. v. Google Inc., No. 05 Civ. 8881 (S.D.N.Y).


Authors and publishers argued that Google's digitisation of books without permission constituted an infringement of their copyright in those works. In response, Google argued its digitisation of books and display of snippet extracts from the books was permitted under US "fair use” exceptions. This would have been a very interesting case to watch but as it happened, the question was not tested in court after all, as the author groups, publisher representatives and Google agreed to negotiate a settlement, thereby avoiding a trial.


The last incarnation of this settlement was released in November 2009 and is referred to as the ‘amended settlement agreement'. Briefly, this agreement (which applied to works published in the USA, UK, Canada and Australia before 6th January, 2009) involved the establishment of an independent non-profit organisation called the Book Rights Registry (BRR), which was to collect revenue generated by Google from digitised books and either distribute it to rightsholders or hold the money for unknown authors that might later be identified. Under the settlement, in-print and out-of-print books were to be treated differently when revenue streams and royalties were calculated. Proceeds from in-print books were to be determined by an agreement between the author and their publisher, whereas revenues from out-of-print works were to be divided, with 37 per cent going to Google and 63 per cent to the BRR to pass on to the author/s. For the initial scan of the full book, rightsholders were to be paid $60. In one of the most unconventional elements of the agreement, authors’ works were to be included for digitising unless the authors specifically opted-out.


However, this amended settlement was not to be the end of the story. Those in favour argued that the resource created by digitising and making searchable a large volume covering thousands of years of knowledge would be a resource of great public benefit, and would break down barriers to access to material. Other supporters put forward a more market-driven argument, that the project would spawn a new market for out-of-print books that had not previously been generating revenue and were otherwise difficult to access.


Opponents argued that the settlement fundamentally changed the nature of copyright law by encouraging a reversal of the principle that permission is required before a rights-holder’s material can be used. There was also keen interest in how any judicial ruling on the case would affect future interpretations of fair use, as well as concern that a large number of orphan works would be able to be profitably utilised by Google without recompense to the rights-holders. Criticisms also extended to areas beyond copyright, such as privacy and antitrust.


The US Government instigated a fairness hearing on the settlement and a large number of submissions, both for and against, were received by the New York District Court. It was only after 13 months of deliberation that a decision was finally announced, on 22 March this year. The highly anticipated decision rejected the settlement agreement on several grounds, including matters of copyright, privacy, antitrust and international law. Judge Denny Chin concluded that the settlement was “not fair, adequate and reasonable” [10].


The key copyright concern was that the amended settlement would constitute an unacceptable reversal of longstanding principles of copyright, expressed in Fox Film Corp. v. Doyal [11] as: “The owner of the copyright, if he pleases, may refrain from vending or licensing and content himself with simply exercising the right to exclude others from using his property” [12]. Judge Chin held that under the amended settlement agreement, “if copyright owners sit back and do nothing, they lose their rights” [13]. The decision concluded with Judge Chin noting that, “many of the concerns raised in the objections would be ameliorated if the [amended settlement agreement] were converted from an ‘opt-out’ settlement to an ‘opt-in’ settlement…I urge the parties to consider revising [it] accordingly” [14]. As can be seen, the door has been left open for the development of a further amended settlement.


So where to next? The parties may choose to appeal Judge Chin’s decision or seek a different outcome in a higher court; author and publisher groups may decide to resurrect the original copyright infringement proceedings and have these tested against Google’s fair use claim; or the parties may try to flesh out a new agreement based on an opt-in, rather than opt-out, approach.


Aside from these possibilities, it could very well be that the court is not the most appropriate venue for the issues to be settled. In the decision Judge Chin wrote that, “the establishment of a mechanism for exploiting unclaimed books is a matter more suited for Congress than this Court” [15], and further stated that “questions of who should be entrusted with guardianship over orphan books, under what terms, and with what safeguards are matters more appropriately decided by Congress than through an agreement among private, self-interested parties” [16]. So the decision may herald a drive for change at the legislative level. Reform in the orphan works area is certainly on the agenda in the US, the EU and Australia.


In any case, the decision does not mean that the Google Books story is over by any means. If anything, the rejection of the amended settlement may be the catalyst for another innovative chapter in Google’s copyright journey.


Before leaving Google Books we will briefly mention developments in Europe, which have been running in parallel to the US proceedings. Google was sued for copyright infringement in France by a number of publishers and author groups (including Editions du Seuil SAS and the French Authors Guild) whose books had been scanned. While the case was eventually decided in the publishers’ favour (with the court ordering Google to pay a fine and remove the digitised material), Google has appealed the decision and the appeal is yet to be decided.


Despite the French litigation, there have been announcements from the Netherlands [17], Austria [18] and Italy [19] about cooperating with Google on digitisation projects for their respective national libraries. Also, in France, Google announced a digitisation deal with large French publisher Hachette Livre late last year [20]. Digitisation is very much on the cards in Europe, which has seen the development of other digital repositories such as the EU-based Europeana and French-backed Gallica.


Mass digitisation may appear inevitable but Google Books is not the only player and governments, digitisers and rights-holder groups, especially in Europe and the US, are beginning to seriously consider how such schemes should function and who should bear responsibility. Should they be privately operated or publicly owned? Is pre or post rights clearance the best option? Many questions remain unanswered but Google is one of the chief catalysts that is posing them.


Google’s Search Platform


Google Images is a search service that allows users to view the results from searches as images (be it photographs, artworks or other visual items). Results from a Google Images search are displayed as a series of ‘thumbnail’ images which, when clicked on, take the user to a page displaying the image in context of its website and provide a link to the original location of the image file. In order to provide this service, Google uses a webcrawler that visits websites and indexes their content.


Google’s image search has been the subject of a number of lawsuits in the US and Europe which generally centre around two issues that concern rights-holders:

• Google’s caching of the image during the webcrawler stage;

• its display of these images as thumbnails in search results.


One of the key US decisions on such questions resulted from a series of cases between Google and adult entertainment company Perfect 10. Perfect 10 alleged that Google was making unauthorised reproductions of its images and displaying these as thumbnails. While prior decisions went in Perfect 10’s favour, on appeal, the Ninth Circuit Court of Appeal ruled in favour of Google.


Similarly, in 2008, a German Federal Supreme Court ruled that Google’s image search did not infringe the copyright in the works of an artist that saw thumbnails of her artworks appear when her name was typed into the Google’s search. As in the US, the artist won at first instance but the final decision by the Federal Supreme Court went in Google’s favour with the Court finding that the artist had impliedly consented to her images being made available for indexing to search engines as she had not availed herself of available options to block search engine webcrawlers from indexing the images on her site (such as a ‘robots.txt’ file). The court also held that Google was not liable under the EU’s E-commerce Directive, as it was given no notice as to its possession of unauthorised material [21]. Google’s victory came after a number of earlier losses in cases relating to Google’s content caching.


Google News


Google News, an aggregation service that provides users with quick access to news stories through its search function, has been embroiled in numerous legal battles over allegations of copyright infringement. Issues that have been canvassed in the disputes include whether Google infringes copyright in the headlines, ledes and photos it displays as part of the service, as well as whether it infringes by caching versions of articles. These disputes have led to Google signing licensing agreements with key news providers, including AFP and Associated Press. [For a detailed account of Google’s news aggregation battles, go to]


Similar to its approach with YouTube, the Google News response to conflict seems to be a ‘join-em’ approach, whereby it endeavors to reach mutually beneficial partnerships in order to stave of legal repercussions and still continue to offer its services.


Google News also provides content owners various options to determine how their content might be used. These options include taking down specific content, opting out of Google News altogether, or blocking content from being picked up by the Google News program [22]. Depending on your perspective this is either a positive step in Google’s journey as a copyright citizen, or another example (as with Google Books) of Google pushing a controversial opt-out approach that challenges traditional notions of copyright law.


Where to from here?


Google attempted to directly address rights-holder concerns in December 2010, when the company’s General Counsel, Ken Walker, posted an article on the company’s public policy blog entitled Making Copyright Work Better Online. The article highlighted four areas in which the company was planning to take action to address rights-holder concerns [23]:


(i) A commitment to a quick turnaround time (24 hours of less) and more streamlined processes for legitimate DMCA takedown and counter-notification requests. This would allow rights-holders that discover unauthorised material to get it removed in a faster period of time;


(ii) Increased efforts in working with rights-holders to disqualify those using Google advertising on pages with infringing material. Many rights-holders had complained that a number of websites were able to attract people by offering access to unauthorised content whilst using Google’s Ad-Words system to make money from the visitors;


(iii) A development focus on processes for better indexing and discovering legitimate material online;


(iv) A commitment to “prevent terms that are closely associated with piracy from appearing in Autocomplete” [24]. This was a particularly interesting technological move by Google, which was supported by rights-holders but criticised by some within Google’s user base who argued that it was a case of Google censoring results. Google clarified that whilst certain terms would be removed from the autosuggest feature, the results would not be removed if the user typed in the full search term [25].


These measures are still quite new and it is still too early to draw many conclusions about their effectiveness.


As more consumers switch to solely digital content, and as content is increasingly delivered through the cloud and away from traditional platforms and onto new ones, it will ultimately be cooperation between rights-holders and operators such as Google that will yield the most favourable results for stakeholders. But as the journey progresses, there is a role for governments and public policy discussion to determine issues in the public interest, as the Google Books settlement demonstrates. As the Director General of the World Intellectual Property Organisation (WIPO), Francis Gurry, noted in a recent visit to Australia, technology is evolving at such a pace that without more discussion on these issues, we run the risk of a “survival of the fittest” business model occurring in a public policy vacuum.





[3] New York Daily News, Associated Press. “Google dubs YouTube a 'rogue enabler of content theft', juicy docs from Google-Viacom case reveal”:

[4] Viacom v YouTube, pp.6-7

[5] Ibid, p.28

[6] Ibid v YouTube, p.15

[7] New York Post, AP:


[9] Google Press Release, 14/12/2004 -

[10] The Authors Guild et al. v Google Inc. US District Court SDNY 05 Civ. 8136 (DC) page 45

[11] Fox Film Corp. v. Doyal, 286 U.S. 123, 127 (1932)

[12] The Authors Guild et al. v Google Inc. US District Court SDNY 05 Civ. 8136 (DC) page 32

[13] Ibid page 33

[14] Ibid page 46

[15] Ibid page 22

[16] Ibid page 23





[21] The Court’s press release is available from





Back to top | Permalink

Life is but a stream 28/03/2011

Faster internet speeds and the increased convergence of media platforms are making online movie streaming an increasingly viable option for consumers. This March we have seen the launch of three quite different streaming services (some more controversial than others), which move away from the current model of rights-holders licensing their content to a internet provider, who then offers it to consumers.


(i) Warner Bros Facebook Rentals: Warner Bros has begun a trial distribution model that allows users to rent a movie and directly stream it through social networking platform Facebook [1]. How does the system work? Users go to the movie’s fan page on Facebook and click a button to pay to watch the movie within a 48-hour period. The movie is accessed through an app developed by Warner Bros. [Facebook allows developers to create independent applications on the Facebook platform, taking a 30 per cent share of revenues generated in return(2).]


There are two particularly interesting elements in this model: firstly, users can pay for the rental using Facebook Credits, a type of virtual currency that is accepted through the Facebook platform; secondly, although it receives a commission, Facebook does not license the content from Warner Bros – rather, Warner Bros is selling directly to the consumer via its own independent app on the platform.


(ii) Fandor: Like other models, Fandor streams movies from its website upon payment by a user. The movies available are curated, with the title selection focusing on independent films, documentaries and other niche content that is not otherwise widely distributed. What makes Fandor’s model somewhat different is that the platform contains tools that enable users to cut a segment from the film and then post clips to their Facebook profile [3]. The idea is that this electronic word-of-mouth will generate buzz for the film and related content on the Fandor site.


Fandor’s chief financial officer summarises how revenue is distributed: “50 per cent of all gross revenue goes into a filmmakers’ pot. That money is then doled out according to the percentage of Fandor viewers who watched the movie, how much of the movie is watched and how many people shared clips” [4]. This model requires agreements between rights-holders and the content delivery platform, both to make the content available for viewing and to allow the extra feature of being able to post clips of that content offsite.


(iii) Zediva: unlike the two previous models, Zediva streams movies to consumers without direct permission from the rights-holders. The Zediva model is a controversial one that appears to rely on something of a legal loophole, so how does it work? Zediva purchases DVDs and lists these as available for rental on its website. When a user requests one for rental, the DVD is played through a physical DVD player operated by Zediva, and the output is then streamed to the user, who is able to control the DVD player remotely via software. If a DVD is being rented out, then another user must wait until the DVD becomes available for rental again [5].Content owners receive no further revenue from the movies other than Zediva’s initial purchase of the DVD.


Zediva is relying on a combination of the first sale doctrine, US jurisprudence allowing rental of copyright materials, and some ambiguities in US law relating to the distribution of copyright material over the internet. It safe to say that film studios lawyers will definitely be looking into this model.


Unauthorised distribution of movies online remains a major challenge for content owners. Internet industry representatives argue that new models are needed to shift consumers away from illegitimate content, and many different models are indeed being introduced. As we are still very much in the early stages of consumption of legitimate movie content online, the revenue-sharing models between rights-holders and content delivery platforms are still evolving.


The Warner Bros Facebook Rentals, Fandor and Zediva models demonstrate that revenues are divided in a number of ways and that content can be sourced either through direct licensing deals, going directly to the consumer or in the case of Zediva, not officially licensing material at all. The market and/or the legal system will ultimately decide which models succeed. Longer-term success will depend not only on who offers the cheapest price, but on what is sustainable for the creators of content as well as those who provide access to it.





[4] Castillo, M. “Introducing Fandor: Netflix-Meets-Sundance Online” Techland 9/3/2011 at

[5] “Zediva taps loophole, offers new movies online” Associated Press via Yahoo! News – 16/3/2011 at

Back to top | Permalink

A Global Database for Music Rights? 28/03/2011

Plans are afoot to create the first online Global Repertoire Database (GRD), which would provide a common framework of information on the ownership of rights to musical works across the globe. Determining who owns the rights to musical works can be a challenge for those seeking permissions to use the works, particularly in countries (such as Australia) where there is no registration of copyright.


In September 2008, participants in the Online Commerce Roundtable met with the [then] European Competition Commissioner, Neelie Kroes, to discuss opportunities and barriers to online music retailing. In October 2009, the Roundtable – which was chaired by Alcatel-Lucent CEO Ben Verwayen, and whose participants included Roger Faxon of EMI, Steve Jobs of Apple Inc. and Sir Mick Jagger – issued a joint statement entitled “General principles for the online distribution of music” [1]. The aim was to promote discussion on how to ensure the “greatest possible global diffusion” of artists’ work, whilst “maintaining certainty that their rights are properly secured and paid for.” [2]


According to the joint statement, the extensive fragmentation of rights and the lack of effective rights’ clearance mechanisms create challenges to efficient and transparent music licensing. The GRD offers a possible way forward by combining the rights ownership information held by various national organisations and rightsholders.


From April 2010, the GRD Working Group began sending Request for Information forms, with more than 30 responses received [3]. A Request for Proposals (RFP) was then published on the GRD website, with submissions due by 15 October 2010 and a recommendations document published in December 2010.


The RFP form provided the detailed business, functional and technical requirements needed for the development, and on-going management of a GRD. Section 3.1.2 details the general scope of the proposed repository, setting out the following information for inclusion:

- All known copyright musical works including arrangements of public

domain works

- the writer(s) of each musical work,

- the ownership of rights shares for each party based on territory,

- the entity authorised to grant licences based on territory,

- all known sound recording and music video data, and

- the links between each musical work and all sound recordings or music videos on which it appears.


In order to facilitate what will no doubt become a vast sea of information, the GRD Working Group hopes to create a simple search-identification-presentation system that will also provide safeguards against the disclosure of confidential information [4].


For more information see:



[2] Joint statement from the Online Commerce Roundtable participants on "General principles for the online distribution of music"



Back to top | Permalink

Copyright Act amendment proposed to cure confusion over pharmaceutical product information 28/03/2011

February 25 saw the introduction of the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 to the House of Representatives. The amendment is designed to eliminate confusion about what manufacturers of generic brand medicine can submit as Product Information (PI) when applying for registration of their products with the Therapeutic Good Administration (TGA).


It is common practice for the TGA to approve the text of the PI of certain medicines for use by other companies that produce ‘generic’ versions of the same product – if that PI is essentially the same text as for the original brand. PI constitutes information that includes: “characteristics of the active ingredient, its indications and contraindications, a description of clinical trials that support the indications, precautions, possible adverse reactions, dosages and storage, and other information relating to the medicine’s safe and effective use.” [1]


A number of pharmaceutical companies that make original products have threatened legal action against generic manufacturers for infringement of copyright in the text of their PI.


The Bill’s explanatory memorandum states that: “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”. [3]


If passed, the Bill will see a new provision inserted in section 44BA of the Copyright Act 1968, which will exempt from infringement the PI used by generic brands for the “purposes of applying to register a medicine…varying the approved PI of a medicine, or any related incidental or ancillary acts”. The exemption will also apply to third parties “supplying, reproducing, publishing, communicating or adapting an approved PI for a medicine if it relates to the safe and effective use of the medicine”[4].


The Bill and Explanatory Memoranda are available from:


[1] Explanatory Memorandum for Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 - page 1

[2] ibid

[3] ibid

[4] ibid

Back to top | Permalink