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Wednesday, 23 March 2011
Page: 3056


Ms HALL (12:13 PM) —Like the previous speaker, I rise to support the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011, which is before the House today. The bill amends the Copyright Act 1968, and the amendments are intended to enable the Therapeutic Goods Administration, the TGA, to continue the longstanding practice that supports the quality use of medicines. The practice is to approve under the Therapeutic Goods Act the information for the generic version of a registered medicine that is similar in form to that approved for the originator registered medicine.

This legislation seeks to continue the longstanding practice of allowing generic medicines to be available to Australians. The member for Bennelong may have touched on this, but to really understand this issue we need to look at the importance of the pharmaceutical industry, which is one of the larger industries in Australia. The Australian medicine industry contributes $18 billion a year to the Australian economy and makes a significant contribution to the health of Australians. Some 14,000 Australians are employed in the industry, which exports $4.12 billion a year. The industry continues to export more goods around the world than any other high-tech industry, including the car, wine, scientific and medical equipment industries. In 2009, 18,000 Australians participated in clinical trials. It is a really big industry; it is an important industry for Australia. Part of that industry is the generic medicines industry. Generic medicines are substitute medicines that doctors can prescribe, or that can be bought by Australians, which are similar to the original medicine that was developed. These generic medicines can only be prepared and sold once the original medicine comes off copyright.

Since 1994, substitute, or generic, medicines have been prescribed within Australia. As the member for Blair pointed out, an overwhelming majority of Australians will accept a generic medicine as opposed to a branded medication. I know that, from a personal perspective, if I go to a pharmacy and I am asked whether I will have generic or a branded medication, I will choose the generic medication except in cases where there may be an ingredient that does not quite agree with me, which can be the case. That is why it is important that proper product information is available to doctors when they are prescribing the medication. Doctors need to be absolutely certain that there will not be any unwanted side effects and that the medication will actually target what they seek to treat in their patient.

For a very long time, since 1994, that has worked extremely well in Australia. But in recent times concern has arisen, particularly with the case that is currently before the courts and which I believe is due to be heard this month—although, as the member for Blair said, it could be up to six months before the findings are handed down. An injunction was granted by the Federal Court in 2008. If this case were to be successful, it would have enormous implications for the availability and the prescribing of generic medicines. In turn, that would have an enormous impact on the costs and, I would argue, on the availability of pharmaceuticals in Australia, because it would increase the cost to government. With an increased cost to government, in the long run it would lead to fewer medications being listed on the PBS.

This is an exceptionally important piece of legislation because it ensures the ongoing viability and availability of generic medicines within Australia. Mr Deputy Speaker, I know that you are particularly interested in health matters, and we have discussed this issue of generic medicines on a number of occasions. I know your feelings are that the availability of generic medicines is exceptionally important to Australian people. Bearing that in mind, I know that you would want to be associated with the contributions that everyone has made to this debate, but you are unable to make a contribution because you are in the chair.


The DEPUTY SPEAKER (Mr S Georganas)—I thank the member for Shortland for thinking of me.


Ms HALL —As well as making a contribution in savings to government and therefore making medications more readily available, this also provides a saving of approximately $3 for each general prescription to Australians over a period of some 10 years. That is a very significant saving on an individual basis. There is a saving of $1.9 billion to the government and to the individual. I do not think there can be any argument that there is a strong need for generic medicine, and if any barriers were being put in place to stop people accessing generic medicines those barriers should be removed. Delay to generic medicines entering the market also delays their listing with the Pharmaceutical Benefits Scheme, which in turn leads to those costs that I alluded to a moment ago.

This legislation also ensures that all Australians receive the best advice with regard to their essential prescription medication, and the TGA requires pharmaceutical companies to submit a product information document that advises health professions about the medicine.

This legislation will ensure that the correct information is out there, that the consumers of the medication will have the best information, as will doctors. The outcome of the case before the High Court will not be impacted on by this legislation. This legislation takes effect once royal assent is given. This case has received widespread interest throughout the medical community and industry. The generic medicine companies have been watching the case before the court, and they know that any successful infringement of copyright case would mean that suppliers of generic medicines would be unable to provide information substantially similar to that from the originating company’s information. It could prevent generic companies from supplying essential information that must accompany medicines, and therefore prevent them from supplying generic medicines to the Australian market which, in turn, as I have already pointed out, will increase the cost of the medication.

The bill introduces an amendment that specifically relates to certain medicines, and states that there is no infringement of copyright where the supply, reproduction, publishing, communication or adapting of the information is for the purpose related to safety and effectiveness of medicines. So it is covering all bases. It is making sure that information is out there. It is ensuring that Australians can access generic medicines. It ensures that there is a cost saving to consumers, and it also ensures that there is a cost saving to government. I note that the Parliamentary Secretary for Health and Ageing has come into the House. I want to put on record, as I did about you, Mr Deputy Speaker, that she is a person who has made a long-term commitment in this area of therapeutic goods. I think she would be one of the people in this parliament who has the greatest amount of knowledge on this issue, and a person whom I know is committed to ensuring that all Australians can access generic medicines and to ensuring the safety of those medicines. I congratulate the parliamentary secretary on the legislation we have before us today. It is good legislation. It is legislation that will ensure the financial viability of the Pharmaceutical Benefits Scheme.