Ms KING (Parliamentary Secretary for Health and Ageing and Parliamentary Secretary for Infrastructure and Transport) (12:50 PM) —in reply—I thank members for their contributions. I think we had contributions from the members for Boothby, Bennelong, Parramatta, Blair, Shortland and latterly the member for Dobell. I thank them for their interest in this important piece of legislation.

I particularly want to thank the member for Boothby for his support of the bill and very much appreciate the opposition’s bipartisan support for these measures. I am glad to see that there is such bipartisan support for the need for Australians to have access to the same product information for whichever brand of prescription medication they are taking. I recognise that the member for Boothby, in his contribution, also highlighted some concerns, including the impacts of the proposed amendments on organisations such as MIMS, which makes product information available to doctors and to health care professionals. I assure the member for Boothby that the amendments will ensure that MIMS and other such organisations can continue to provide that product information without fear of copyright action being taken by the pharmaceutical company, as the exemptions in the amendments extend to any publication for the purposes of safe and effective use of medicines, which of course extends to the publication of MIMS.

I thank the member for Bennelong for supporting the bill. He also raised a query in his contribution around when generic medicines are entering the market in Australia. In response to that I reiterate that the TGA cannot include a generic medicine on the register of therapeutic goods unless the generic company has certified that it will not be marketing the medicine in breach of patent and has notified the patent holder. The originator company can take injunction action if they think their patent has been breached by early introduction of a generic medicine which the patent still exists on.

The member for Bennelong also raised the significance of the pharmaceutical industry in Australia and I would also like to add my words to that, in that the government fully understands the significance of the industry in our country. As Minister Carr outlined quite eloquently in his recent address to Medicines Australia, the government recognises the enormous contribution made by the industry.

Broadly, as the member for Shortland outlined, the pharmaceutical industry is of extreme importance in Australia. It contributes significantly to our economy and provides the innovation necessary for Australians to continue to have access to new and important treatments for their health concerns. The Australian government is committed to ensuring access to new treatments as well as timely access to generic versions of prescription medications once the patent has expired.

The bill, as many members have outlined, is a response to an emerging phenomenon in the Australian pharmaceutical industry. Some companies are taking, or have threatened to take, legal action based on a claim of copyright in the product information of their registered medicines in what appears to be an attempt to delay market access by competitors’ generic versions of those medicines. Members will appreciate the potential for this, if it were to become a practice, to result in substantial detriment to the Pharmaceutical Benefits Scheme and to Australian health consumers.

Copyright is relevant in this situation because of the important practice of TGA to approve for generic versions of high-risk medicines when they are supplied on the Australian market a product information document in a similar form to the approved product information supplied with the original prescription medicine. This practice has developed for public health reasons. Product information contains critical information about the safe and effective use of medicines and is made available to health professionals to guide their prescribing, dispensing and administrating decisions. The practice of requiring similar product information for all brands of a medicine ensures that health professionals receive this same information about the same medicine, irrespective of the brand. Variation in text between different brands of the same medicine might give the impression that there are clinical and/or pharmacological differences between the brands. This may result in confusion amongst prescribers and consumers, with potential for resultant medical errors and patient harm.

No issue of copyright has arisen from this longstanding practice until just recently. In 2008 the Federal Court granted an interlocutory injunction, in effect preventing the market of a generic version of a registered medicine partly on the basis of an alleged infringement of copyright in approved product information. That matter is due to be heard by the Federal Court this month and will be the first time that an Australian court has considered the issue. Legal action of this kind has the potential to delay or prevent the first listing of a generic version of a medicine on the Pharmaceutical Benefits Scheme, thus deferring what is now a 16 per cent statutory price reduction for that medicine under the scheme. This could result in a significant financial cost to the government and Australian health consumers under the scheme and subsequently to the Australian taxpayer.

The amendments in the bill are necessary to ensure that the long-supported and sound public health policy of having consistent, accurate information available for prescribers and consumers is not jeopardised. They provide limited exemptions to copyright infringement, but only for the purpose of approving product information or its later variation or where it is related to the use of approved product information for a purpose related to the safe and effective use of the medicine concerned. Action by companies raised on a claim of copyright in product information can delay, potentially indefinitely, savings to the government and Australian consumers because the price trigger of the first listing of a generic version of a listed medicine on the PBS will not occur. It can also artificially prolong any market exclusivity that the originator may have had through patent law.

Pharmaceutical companies currently receive appropriate patent protection for their medicines under Australian law. A generic medicine cannot be included on the Australian register of therapeutic goods unless the applicant has certified that a patent will not be infringed by the marketing of the medicine or that the relevant patent holder has been notified of the application. The Therapeutic Goods Administration is prevented from using information provided for the purpose of registering a medicine in order to evaluate the generic version of that medicine for five years from that registration. The government believes that these measures safeguard a fair return for the efforts of companies bringing medicines to market.

The proposed amendments reflect the importance the government places on ensuring the highest level of health consumer safety through the provision of accurate information to prescribers and other health professionals about these medicines. The Copyright Act already contains an exemption of this kind relating to the use of approved labels on containers for agricultural and veterinary chemical products. The amendments go no further than is necessary to ensure that the TGA can continue to approve product information that is in a similar form for all versions of the same registered medicine. The government believes that these amendments will restore the appropriate balance between ensuring safe and timely access to medicines for all Australians and encouraging research and development in the pharmaceutical industry for appropriate protection of intellectual property.

At the end of my contribution I want thank both the TGA and the Attorney-General’s Departments, whose staff are with us at the moment, for their work on this bill. It is a very important piece of legislation and I want to thank both of those agencies for their cooperation.

Question agreed to.

Bill read a second time.

Ordered that the bill be reported to the House without amendment.