Concetta Fierravanti-Wells (NSW, Liberal Party, Shadow Minister for Ageing) Share this | Hansard source

I rise to speak today on the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011. The coalition will not be opposing this bill. The amendments to the Copyright Act have arisen due to some instances where pharmaceutical companies have launched claims of infringement of copyright in their product information documents. The use of copyright infringement has the potential to provide pharmaceutical companies with an extended period of market exclusivity once the patent over that medicine has ended. This has an effect on generic medicines, because the generic medicines industry in Australia provides important competition for medicines once they come off patent. We recognise the important role that generic medicines and their timely introduction into the marketplace play in the healthcare system. We understand the purpose of these amendments, which is basically to ensure that we still have timely introduction of generics into the market and, in turn, increased affordability and access to pharma­ceuticals in Australia.

This bill introduces two specific exemptions to copyright infringement under Australian law. The first exemption is that the use or lodgement of existing product information documents is not a copyright infringement when used to apply to register a medicine under the Therapeutic Goods Act 1989. This means that, for example, when a pharmaceutical company applies to the TGA for registration of a generic version of a medicine, they will not be infringing copy­right if they submit a draft product informa­tion document that contains text that is similar to the product information already approved for the originator medicine. The second exemption removes copyright infringement to the supply, reproduction, publication, communication or adaptation of the TGA approved product information sheets, provided that the use is for a purpose related to the safe and effective use of the medicine.

There has been some consultation with stakeholders, and there have been concerns raised about some potential unintended consequences. One could be the effect on product information publishers—for example, the publication of the reference handbooks that are widely used by practitioners. The issue is what impact the exemption of copyright will have on these reference books. There is also the potential for unintentional infringements to result in the reduction of intellectual property protections.

We believe that the amendments do not go any further than is necessary to ensure that the TGA continues to have the ability to approve product information sheets that are in similar forms for both the originator and generic brands of the same registered medicine. We will, however, continue to monitor the situation. As I said, there are some concerns, but we believe the bill does provide important exceptions to copyright to protect the timely introduction of generic medicines into the Australian pharmaceutical market. The opposition will not be opposing the bill.