Dr SOUTHCOTT (11:36 AM) —I rise to speak today on the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 Therapeutic Goods Legislation Amendment (Copyright) Bill 2011. The coalition will not be opposing the bill. We understand the importance of the generics medicine industry in Australia and the competition it provides for medicines when they move off patent. The amendments to the Copyright Act have arisen due to some cases of pharmaceutical companies who 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 after the patent over the medicine has ended.

Copyright has a duration of at least 70 years from publication. The delay of generic medicines entering the market after the patent expiry of the original medicine would have significant financial implications for consumers and also for the government. Without these amendments, the moves by pharmaceutical companies to protect their interest under copyright compromises the accuracy, consistency and safety of the product information documents as the generic products seek to alter the already approved product information from the originator company to avoid potential liability under copyright. It also has the potential to damage the pharmaceutical brand substitution policy which was introduced in Australia in 1994.

The opposition recognises the important role that generic medicines and their timely introduction play in the health care system. We understand the purpose of these amendments, which is to ensure that we still have timely introduction of generics to the market and, in turn, increased affordability and access to pharmaceuticals in Australia.

The bill seeks to introduce two very 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 exemption ensures that, for example, when a pharmaceutical company applies to the Therapeutic Goods Administration for registration of a generic version of a medicine, they will not infringe 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.

It is important that the product information documents of the originator and the generic medicines are similar in form. The product information document contains technical information about the medicines, such as active ingredients, precautions, adverse reactions, dosages and storage, as well as details of the medicine’s safe and effective use. Doctors and pharmacists receive and use this information when prescribing and dispensing medications to ensure the safety of the patient. Having product information documents that are similar in form for both the originator and generic brands avoids any perception that differences in the content of the product information sheet reflect differences in the pharmacological or clinical properties of the medicine itself.

The second exemption removes copyright infringement to the supply, reproduction, publication, communication or adaptation of the TGA approved product information sheets, provided that the uses for a purpose related to the safe and effective use of the medicine. The amendments to the Copyright Act proposed in this bill will also bring the Australian law substantially into line with the same labelling requirements for medicines in the United States.

In consultation with stakeholders, while there was no opposition to the bill, there was concern about some potential unintended consequences. One, for example, is what will be the effect on product information publishers. For example, publication of reference work such as the MIMS Annual or the Australian Medicines Handbook. These reference handbooks are widely used by practitioners. The issue is what impact the exception of copyright will have on these reference books. There is also the potential for unintentional infringements such as those mentioned above. There is also the potential to reduce the intellectual property protections by abolishing copyright on a class of documents.

The opposition is satisfied that the amendments do not go any further than 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. However, we will continue to monitor the situation and, if the concerns of some stakeholder groups are justified, we will look at remedying the situation.

Despite the concerns by some stakeholders that I have mentioned, this bill does provide important exceptions to copyright to protect the timely introduction of generic medicines into the Australian pharmaceutical market. That is why the opposition will not be opposing this bill in the parliament.