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Wednesday, 23 March 2011
Page: 3053


Mr NEUMANN (12:00 PM) —I speak in support of the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011. Competition is good for consumers and information is power. Information is important for doctors and pharmacists. It is important for consumers. It is important for good, sound health concerns and for public safety. Generics make medicine cheaper. Doctors and pharmacists are at the front line of primary health care not just across the country but in the various communities that I represent—Ipswich and the Somerset region.

This bill is a pretty simple one. It amends the Copyright Act to allow the Therapeutic Goods Administration to continue what has been a longstanding custom of approving product information in similar terms for all brands of a medicine. In fact, it really ends ambiguity and deals with a potential problem caused by litigation.

We have in this country a great health system that we intend to make even better. Medicare and the PBS are world firsts. These are great Labor initiatives. These are great initiatives that make the care of people in my electorate and the various communities across the country safer. They are supported fervently by Labor. Labor strongly believes in health care. We hear speeches by those opposite, even the last speech by the new member for Bennelong, that show they really are not fair dinkum when it comes to issues of health care. While they support this legislation, there is not fulsome support. We even had as recently as 20 or 30 years ago coalition members in this place actually deriding Medicare as a rort. The previous Prime Minister, John Howard, actually once described it infamously as a rort. They really are not as committed to our system of pharmaceutical care, health care and hospital care as we are. We know that, because whenever they are in power they rip money out of the health system. That is exactly what they do, and that is the reality. Do not just trust me. The Institute of Health and Welfare has found that on repeated occasions while the coalition has been in power.

When prescription and other high-risk medicines are approved for marketing in Australia by the Therapeutic Goods Administration a product information document is produced. It is approved for use by health professionals. This is important for doctors and pharmacists. As I said, this bill ensures that the practice of the TGA approving product information in a similar form for all brands of a registered medicine can continue.

What does that product information contain? It is fairly technical, but it contains information in relation to the ingredients in a product. It contains information about what has happened in terms of clinical trials and a description of those types of trials. Further, it contains information about what has happened in terms of potential reactions to medicine and various precautions. It contains information about what should happen in relation to storage of that medicine and dosages patients can have. It is critical for doctors and pharmacists to have that sort of information, because that is good for public health care. It is good for consumers and it is good for the pharmacies across the country. There is a problem if that arrangement does not continue. As I said, the product information statement actually approved for a medicine assists in health care, particularly for health professionals, to prescribe and dispense accurate, appropriate and safe dosages of that medicine. Any pharmacy across the country knows that to be the case. It is important for high-quality and good clinical care that we do this.

This bill does provide a limited exemption and it puts in place what we always thought to be the case, and what litigation potentially could upset. It provides a limited exemption from copyright for product information, as I said. There is an emerging trend. In fact, a court case is currently being heard in relation to pharmaceutical issues. A company is claiming infringement of copyright for product information, a move that often when done or even threatened is simply designed to perpetrate, if not perpetuate, a problem for our health system. They want in fact effectively to delay the entry of any competitor or any competitor’s products into the market. So, competition is limited, and their listing on the PBS could be delayed.

Such legal action could in fact compromise the accuracy, consistency and safety of product information documents as generic products seek to alter the approved product information to avoid potential liability. As I said before, product information contains information about safety and effective use of medicine, and so it is vital. Product information is required for prescription, and it is important, as I said, for doctors and pharmacists.

In 2008, an interlocutory injunction—a temporary injunction—was granted by the Federal Court partly on the basis of an argument that the approved product information for a generic version of a medicine breached the copyright in the approved product information in the original version of the medicine. This injunction has effectively prevented the marketing of the generic medicine for more than two years, and the hearing of that case commenced in March 2011, after the introduction of the bill into the House of Representatives. The litigation referred to is Sanofi-Aventis v Apotex, which is being finalised this week with closing submissions being made today or tomorrow in relation to the litigation.

In 2008, Sanofi argued that Apotex would infringe their own copyright with respect to the product information for its originating medicine if Apotex were allowed to market its generic version. It also argued that Apotex would infringe the Sanofi patent in relation to inclusion of the treatment for psoriatic arthritis in the registered indications.

In the current hearing, Apotex has argued that there could be no copyright in Sanofi’s product information, because no authors could be identified; that it was not an original document, resulting from cutting and pasting from many different sources; that it did not result from an independent intellectual effort; and, finally, in any event, there was an implied licence for its use because of the custom and practice over many years in relation to the use of the product information which had not been challenged.

It was recognised during that hearing that, under the proposed amendments in the bill, it would not be possible in future to prevent an approved product information being used on the basis that it infringes copyright in another product information. However, the copyright matter was fully argued in the hearing because one of the issues in the case is whether the interlocutory injunction in 2008 was justified. Indeed, when courts look at matters in terms of interlocutory injunctions they often grant those on the basis of urgency or on a different basis to a final injunction. The decision of the Federal Court is not likely to be handed down for three to six months. I think three to six months is optimistic, in my experience in terms of the Federal Court. Even if the Federal Court finds that there was no copyright or that there was no breach of any copyright, there is still no certainty in relation to this matter and litigation could be initiated by other pharmaceutical companies or other interested parties in relation to that. The proposed amendment to the Copyright Act 1968 will ensure that the legal situation is clarified for the future and will ensure that the highest level of consumer safety can be provided through the provision of accurate information to health professionals such as doctors and pharmacists.

We have rigorous, scientifically based evaluation procedures for generic medicines. The Pharmaceutical Society of Australia strongly supports any moves to clear up any confusion surrounding generic drugs. Healthcare professionals have a key role, as I have said before, in helping consumers understand the real or perceived differences, or indeed the lack thereof, between different brands of medicine. Prescribing generic brand medicines is important to contain health costs. As I said previously, generics actually reduce health costs.

The impact for residents in my electorate of Blair is most keenly felt by our pensioners and seniors, by carers and by working families generally. About 14,000 people who are 65 years of age or older reside in my electorate of Blair, and about 23,000 people are reliant on some form of pension. That is a lot of people in an electorate of about 125,000 people. By enabling generic pharmaceutical companies, and their employees and agents, to use the existing product information documents, prescribers of these drugs, pharmacists and patients can be confident that the same standards for safe and effective use of medicine apply across the country.

It can be incredibly confusing for a senior person in my electorate who might be ageing. They might be concerned about taking a form of medication. The potential for what I would describe as medication ‘misadventure’ is heightened by confusion. Indeed, the third intergenerational report said that by 2050 there will be about 2.7 working Australians for every person over the age of 65. This is not a hypothetical; this is a real challenge now and it is likely to be more of a challenge in the future.

Senior residents of Blair tell me they are often confused when they go to take their typically red and blue capsule in the morning because it might be green and yellow. That is not a criticism, it is a fact for many people. Often as we get older we take more medication, and unfortunately this can be a challenge for people of all ages. There are cases when pensioners have told their local pharmacist that they just stopped taking a drug because they were unfamiliar with it. They do not know what it means and they do not know its side-effects. It is important that information is the same for equivalent drugs.

A recent Galaxy poll of more than 500 people commissioned by a drug company in Australia found that when visiting a pharmacy 42 per cent accepted the offer of a generic every time, while 32 per cent did most times. One in five, or about 21 per cent, said that they worried that a generic drug could lead to getting the wrong medicine, while only about eight per cent in that poll said they never accepted a generic. So generics are widely accepted.

As medication experts have said, pharmacists are there to help consumers and to answer questions about their medication. Any person who represents a community in this parliament knows that when people go to a pharmacy they ask questions of the pharmacist. They ask questions about the drugs they take, often more freely and willingly than they ask questions of the doctors who actually prescribe the drugs.

This legislation clears up confusion. It simply puts in place what we have always thought to be the case and it will address the challenges of future litigation to make sure that public health and safety is better provided across the communities of Australia.