886 resultados para Tobacco.


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Lung cancer is the leading cause of cancer-related mortality. According to WHO, 1.37 million deaths occur globally each year as a result of this disease. More than 70% of these cases are associated with prior tobacco consumption and/or cigarette smoking, suggesting a direct causal relationship. The development and progression of lung cancer and other malignancies involves the loss of genetic stability, resulting in acquisition of cumulative genetic changes; this affords the cell increased malignant potential. As such, an understanding of the mechanisms through which these events may occur will potentially allow for development of new anticancer therapies. This review will address the association between lung cancer and genetic instability, with a central focus on genetic mutations in the DNA damage repair pathways. In addition, we will discuss the potential clinical exploitation of these pathways, both in terms of biomarker staging, as well as through direct therapeutic targeting.

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The 2014 World Cancer Report, issued by the World Health Organisation (WHO), indicates that the number of new cancer cases has reached an all-time high. On the 19 May 2014, Dr Margaret Chan, the Director-General of the WHO, gave a stirring speech to the 67th Health Assembly on the heavy health burden associated with cancer. Chan was particularly interested in public health measures designed to combat the global tobacco epidemic...

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In his book, The Emperor of All Maladies, Siddhartha Mukherjee writes a history of cancer — "It is a chronicle of an ancient disease — once a clandestine, 'whispered-about' illness — that has metamorphosed into a lethal shape-shifting entity imbued with such penetrating metaphorical, medical, scientific, and political potency that cancer is often described as the defining plague of our generation." Increasingly, an important theme in the history of cancer is the role of law, particularly in the field of intellectual property law. It is striking that a number of contemporary policy debates over intellectual property and public health have concerned cancer research, diagnosis, and treatment. In the area of access to essential medicines, there has been much debate over Novartis’ patent application in respect of Glivec, a treatment for leukaemia. India’s Supreme Court held that the Swiss company’s patent application violated a safeguard provision in India’s patent law designed to stop evergreening. In the field of tobacco control, the Australian Government introduced plain packaging for tobacco products in order to address the health burdens associated with the tobacco epidemic. This regime was successfully defended in the High Court of Australia. In the area of intellectual property and biotechnology, there have been significant disputes over the Utah biotechnology company Myriad Genetics and its patents in respect of genetic testing for BRCA1 and BRCA2, which are related to breast cancer and ovarian cancer. The Federal Court of Australia handed down a decision on the validity of Myriad Genetics’ patent in respect of genetic testing for BRCA1 in February 2013. The Supreme Court of the United States heard a challenge to the validity of Myriad Genetics’ patents in this area in April 2013, and handed down a judgment in July 2013. Such disputes have involved tensions between intellectual property rights, and public health. This article focuses upon one of these important test cases involving intellectual property, public health, and cancer research. In June 2010, Cancer Voices Australia and Yvonne D’Arcy brought an action in the Federal Court of Australia against the validity of a BRCA1 patent — held by Myriad Genetics Inc, the Centre de Recherche du Chul, the Cancer Institute of Japan and Genetic Technologies Limited. Yvonne D’Arcy — a Brisbane woman who has had treatment for breast cancer — maintained: "I believe that what they are doing is morally and ethically corrupt and that big companies should not control any parts of the human body." She observed: "For my daughter, I've had her have [sic] mammograms, etc, because of me but I would still like her to be able to have the test to see if the mutation gene is in there from me." The applicants made the following arguments: "Genes and the information represented by human gene sequences are products of nature universally present in each individual, and the information content of a human gene sequence is fixed. Genetic variations or mutations are products of nature. The isolation of the BRCA1 gene mutation from the human body constitutes no more than a medical or scientific discovery of a naturally occurring phenomenon and does not give rise to a patentable invention." The applicants also argued that "the alleged invention is not a patentable invention in that, so far as claimed in claims 1–3, it is not a manner of manufacture within the meaning of s 6 of the Statute of Monopolies". The applicants suggested that "the alleged invention is a mere discovery". Moreover, the applicants contended that "the alleged invention of each of claims 1-3 is not a patentable invention because they are claims for biological processes for the generation of human beings". The applicants, though, later dropped the argument that the patent claims related to biological processes for the generation of human beings. In February 2013, Nicholas J of the Federal Court of Australia considered the case brought by Cancer Voices Australia and Yvonne D’Arcy against Myriad Genetics. The judge presented the issues in the case, as follows: "The issue that arises in this case is of considerable importance. It relates to the patentability of genes, or gene sequences, and the practice of 'gene patenting'. Briefly stated, the issue to be decided is whether under the Patents Act 1990 (Cth) a valid patent may be granted for a claim that covers naturally occurring nucleic acid — either deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) — that has been 'isolated'". In this context, the word "isolated" implies that naturally occurring nucleic acid found in the cells of the human body, whether it be DNA or RNA, has been removed from the cellular environment in which it naturally exists and separated from other cellular components also found there. The genes found in the human body are made of nucleic acid. The particular gene with which the patent in suit is concerned (BRCA1) is a human breast and ovarian cancer disposing gene. Various mutations that may be present in this gene have been linked to various forms of cancer including breast cancer and ovarian cancer.' The judge held in this particular case that Myriad Genetics’ patent claims were a "manner of manufacture" under s 6 of the Statute of Monopolies and s 18(1)(a) of the Patents Act 1990 (Cth). The matter is currently under appeal in the Full Court of the Federal Court of Australia. This article interprets the dispute over Myriad Genetics in light of the scholarly work of Nobel Laureate Professor Joseph Stiglitz on inequality. Such work has significant explanatory power in the context of intellectual property and biotechnology. First, Stiglitz has contended that "societal inequality was a result not just of the laws of economics, but also of how we shape the economy — through politics, including through almost every aspect of our legal system". Stiglitz is concerned that "our intellectual property regime … contributes needlessly to the gravest form of inequality." He maintains: "The right to life should not be contingent on the ability to pay." Second, Stiglitz worries that "some of the most iniquitous aspects of inequality creation within our economic system are a result of 'rent-seeking': profits, and inequality, generated by manipulating social or political conditions to get a larger share of the economic pie, rather than increasing the size of that pie". He observes that "the most iniquitous aspect of this wealth appropriation arises when the wealth that goes to the top comes at the expense of the bottom." Third, Stiglitz comments: "When the legal regime governing intellectual property rights is designed poorly, it facilitates rent-seeking" and "the result is that there is actually less innovation and more inequality." He is concerned that intellectual property regimes "create monopoly rents that impede access to health both create inequality and hamper growth more generally." Finally, Stiglitz has recommended: "Government-financed research, foundations, and the prize system … are alternatives, with major advantages, and without the inequality-increasing disadvantages of the current intellectual property rights system.’" This article provides a critical analysis of the Australian litigation and debate surrounding Myriad Genetics’ patents in respect of genetic testing for BRCA1. First, it considers the ruling of Nicholas J in the Federal Court of Australia that Myriad Genetics’ patent was a manner of manufacture as it related to an artificially created state of affairs, and not mere products of nature. Second, it examines the policy debate over gene patents in Australia, and its relevance to the litigation involving Myriad Genetics. Third, it examines comparative law, and contrasts the ruling by Nicholas J in the Federal Court of Australia with developments in the United States, Canada, and the European Union. Fourth, this piece considers the reaction to the decision of Nicholas at first instance in Australia. Fifth, the article assesses the prospects of an appeal to the Full Federal Court of Australia over the Myriad Genetics’ patents. Finally, this article observes that, whatever happens in respect of litigation against Myriad Genetics, there remains controversy over Genetic Technologies Limited. The Melbourne firm has been aggressively licensing and enforcing its related patents on non-coding DNA and genomic mapping.

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Government and tobacco companies recently faced off in Australia's High Court over the legality of plain packaging for cigarettes. Stephen Stern and Matthew Rimmer give their contrasting views on the arguments and implications

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The secretive 2011 Anti-Counterfeiting Trade Agreement – known in short by the catchy acronym ACTA – is a controversial trade pact designed to provide for stronger enforcement of intellectual property rights. The preamble to the treaty reads like pulp fiction – it raises moral panics about piracy, counterfeiting, organised crime, and border security. The agreement contains provisions on civil remedies and criminal offences; copyright law and trademark law; the regulation of the digital environment; and border measures. Memorably, Susan Sell called the international treaty a TRIPS Double-Plus Agreement, because its obligations far exceed those of the World Trade Organization's TRIPS Agreement 1994, and TRIPS-Plus Agreements, such as the Australia-United States Free Trade Agreement 2004. ACTA lacks the language of other international intellectual property agreements, which emphasise the need to balance the protection of intellectual property owners with the wider public interest in access to medicines, human development, and transfer of knowledge and technology. In Australia, there was much controversy both about the form and the substance of ACTA. While the Department of Foreign Affairs and Trade was a partisan supporter of the agreement, a wide range of stakeholders were openly critical. After holding hearings and taking note of the position of the European Parliament and the controversy in the United States, the Joint Standing Committee on Treaties in the Australian Parliament recommended the deferral of ratification of ACTA. This was striking as representatives of all the main parties agreed on the recommendation. The committee was concerned about the lack of transparency, due process, public participation, and substantive analysis of the treaty. There were also reservations about the ambiguity of the treaty text, and its potential implications for the digital economy, innovation and competition, plain packaging of tobacco products, and access to essential medicines. The treaty has provoked much soul-searching as to whether the Trick or Treaty reforms on the international treaty-making process in Australia have been compromised or undermined. Although ACTA stalled in the Australian Parliament, the debate over it is yet to conclude. There have been concerns in Australia and elsewhere that ACTA will be revived as a ‘zombie agreement’. Indeed, in March 2013, the Canadian government introduced a bill to ensure compliance with ACTA. Will it be also resurrected in Australia? Has it already been revived? There are three possibilities. First, the Australian government passed enhanced remedies with respect to piracy, counterfeiting and border measures in a separate piece of legislation – the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth). Second, the Department of Foreign Affairs and Trade remains supportive of ACTA. It is possible, after further analysis, that the next Australian Parliament – to be elected in September 2013 – will ratify the treaty. Third, Australia is involved in the Trans-Pacific Partnership negotiations. The government has argued that ACTA should be a template for the Intellectual Property Chapter in the Trans-Pacific Partnership. The United States Trade Representative would prefer a regime even stronger than ACTA. This chapter provides a portrait of the Australian debate over ACTA. It is the account of an interested participant in the policy proceedings. This chapter will first consider the deliberations and recommendations of the Joint Standing Committee on Treaties on ACTA. Second, there was a concern that ACTA had failed to provide appropriate safeguards with respect to civil liberties, human rights, consumer protection and privacy laws. Third, there was a concern about the lack of balance in the treaty’s copyright measures; the definition of piracy is overbroad; the suite of civil remedies, criminal offences and border measures is excessive; and there is a lack of suitable protection for copyright exceptions, limitations and remedies. Fourth, there was a worry that the provisions on trademark law, intermediary liability and counterfeiting could have an adverse impact upon consumer interests, competition policy and innovation in the digital economy. Fifth, there was significant debate about the impact of ACTA on pharmaceutical drugs, access to essential medicines and health-care. Sixth, there was concern over the lobbying by tobacco industries for ACTA – particularly given Australia’s leadership on tobacco control and the plain packaging of tobacco products. Seventh, there were concerns about the operation of border measures in ACTA. Eighth, the Joint Standing Committee on Treaties was concerned about the jurisdiction of the ACTA Committee, and the treaty’s protean nature. Finally, the chapter raises fundamental issues about the relationship between the executive and the Australian Parliament with respect to treaty-making. There is a need to reconsider the efficacy of the Trick or Treaty reforms passed by the Australian Parliament in the 1990s.

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The High Court of Australia’s ruling on the plain packaging of tobacco products is one of the great constitutional cases of our age. The ruling will resonate throughout the world - as other countries will undoubtedly seek to emulate Australia’s plain packaging regime.

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It takes a lot of bravery for governments to stand up to big business. But the Gillard government has shown a lot of guts during its tenure. It stood up to Big Tobacco in the battle over plain packaging of tobacco products and has defended individuals and families affected by asbestos. It took on Big Oil in its Clean Energy Future reforms and stood up to the resource barons with the mining tax. The government is now considering Big Pharma - the pharmaceutical industry and their patents – and has launched several inquiries into patent law and pharmaceutical drugs...

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After much political debate, the Australian Parliament passed the Tobacco Plain Packaging Act 2011 (Cth). Australian legislators, such as Richard di Natale, provided moving accounts for the need for plain packaging of tobacco products.

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“If Hollywood could order intellectual property laws for Christmas, what would they look like? This is pretty close.” David Fewer “While European and American IP maximalists have pushed for TRIPS-Plus provisions in FTAs and bilateral agreements, they are now pushing for TRIPS-Plus-Plus protections in these various forums.” Susan Sell “ACTA is a threat to the future of a free and open Internet.” Alexander Furnas “Implementing the agreement could open a Pandora's box of potential human rights violations.” Amnesty International. “I will not take part in this masquerade.” Kader Arif, Rapporteur for the Anti-Counterfeiting Trade Agreement 2011 in the European Parliament Executive Summary As an independent scholar and expert in intellectual property, I am of the view that the Australian Parliament should reject the adoption of the Anti-Counterfeiting Trade Agreement 2011. I would take issue with the Department of Foreign Affairs and Trade’s rather partisan account of the negotiations, the consultations, and the outcomes associated with the Anti-Counterfeiting Trade Agreement 2011. In my view, the negotiations were secretive and biased; the local consultations were sometimes farcical because of the lack of information about the draft texts of the agreement; and the final text of the Anti-Counterfeiting Trade Agreement 2011 is not in the best interests of Australia, particularly given that it is a net importer of copyright works and trade mark goods and services. I would also express grave reservations about the quality of the rather pitiful National Interest Analysis – and the lack of any regulatory impact statement – associated with the Anti-Counterfeiting Trade Agreement 2011. The assertion that the Anti-Counterfeiting Trade Agreement 2011 does not require legislative measures is questionable – especially given the United States Trade Representative has called the agreement ‘the highest-standard plurilateral agreement ever achieved concerning the enforcement of intellectual property rights.’ It is worthwhile reiterating that there has been much criticism of the secretive and partisan nature of the negotiations surrounding the Anti-Counterfeiting Trade Agreement 2011. Sean Flynn summarizes these concerns: "The negotiation process for ACTA has been a case study in establishing the conditions for effective industry capture of a lawmaking process. Instead of using the relatively transparent and inclusive multilateral processes, ACTA was launched through a closed and secretive “‘club approach’ in which like-minded jurisdictions define enforcement ‘membership’ rules and then invite other countries to join, presumably via other trade agreements.” The most influential developing countries, including Brazil, India, China and Russia, were excluded. Likewise, a series of manoeuvres ensured that public knowledge about the specifics of the agreement and opportunities for input into the process were severely limited. Negotiations were held with mere hours notice to the public as to when and where they would be convened, often in countries half away around the world from where public interest groups are housed. Once there, all negotiation processes were closed to the public. Draft texts were not released before or after most negotiating rounds, and meetings with stakeholders took place only behind closed doors and off the record. A public release of draft text, in April 2010, was followed by no public or on-the-record meetings with negotiators." Moreover, it is disturbing that the Anti-Counterfeiting Trade Agreement 2011 has been driven by ideology and faith, rather than by any evidence-based policy making Professor Duncan Matthews has raised significant questions about the quality of empirical evidence used to support the proposal of Anti-Counterfeiting Trade Agreement 2011: ‘There are concerns that statements about levels of counterfeiting and piracy are based either on customs seizures, with the actual quantities of infringing goods in free circulation in any particular market largely unknown, or on estimated losses derived from industry surveys.’ It is particularly disturbing that, in spite of past criticism, the Department of Foreign Affairs and Trade has supported the Anti-Counterfeiting Trade Agreement 2011, without engaging the Productivity Commission or the Treasury to do a proper economic analysis of the proposed treaty. Kader Arif, Rapporteur for the Anti-Counterfeiting Trade Agreement 2011 in the European Parliament, quit his position, and said of the process: "I want to denounce in the strongest possible manner the entire process that led to the signature of this agreement: no inclusion of civil society organisations, a lack of transparency from the start of the negotiations, repeated postponing of the signature of the text without an explanation being ever given, exclusion of the EU Parliament's demands that were expressed on several occasions in our assembly. As rapporteur of this text, I have faced never-before-seen manoeuvres from the right wing of this Parliament to impose a rushed calendar before public opinion could be alerted, thus depriving the Parliament of its right to expression and of the tools at its disposal to convey citizens' legitimate demands.” Everyone knows the ACTA agreement is problematic, whether it is its impact on civil liberties, the way it makes Internet access providers liable, its consequences on generic drugs manufacturing, or how little protection it gives to our geographical indications. This agreement might have major consequences on citizens' lives, and still, everything is being done to prevent the European Parliament from having its say in this matter. That is why today, as I release this report for which I was in charge, I want to send a strong signal and alert the public opinion about this unacceptable situation. I will not take part in this masquerade." There have been parallel concerns about the process and substance of the Anti-Counterfeiting Trade Agreement 2011 in the context of Australia. I have a number of concerns about the substance of the Anti-Counterfeiting Trade Agreement 2011. First, I am concerned that the Anti-Counterfeiting Trade Agreement 2011 fails to provide appropriate safeguards in respect of human rights, consumer protection, competition, and privacy laws. It is recommended that the new Joint Parliamentary Committee on Human Rights investigate this treaty. Second, I argue that there is a lack of balance to the copyright measures in the Anti-Counterfeiting Trade Agreement 2011 – the definition of piracy is overbroad; the suite of civil remedies, criminal offences, and border measures is excessive; and there is a lack of suitable protection for copyright exceptions, limitations, and remedies. Third, I discuss trade mark law, intermediary liability, and counterfeiting. I express my concerns, in this context, that the Anti-Counterfeiting Trade Agreement 2011 could have an adverse impact upon consumer interests, competition policy, and innovation in the digital economy. I also note, with concern, the lobbying by tobacco industries for the Anti-Counterfeiting Trade Agreement 2011 – and the lack of any recognition in the treaty for the capacity of countries to take measures of tobacco control under the World Health Organization Framework Convention on Tobacco Control. Fourth, I note that the Anti-Counterfeiting Trade Agreement 2011 provides no positive obligations to promote access to essential medicines. It is particularly lamentable that Australia and the United States of America have failed to implement the Doha Declaration on the TRIPS Agreement and Public Health 2001 and the WTO General Council Decision 2003. Fifth, I express concerns about the border measures in the Anti-Counterfeiting Trade Agreement 2011. Such measures lack balance – and unduly favour the interests of intellectual property owners over consumers, importers, and exporters. Moreover, such measures will be costly, as they involve shifting the burden of intellectual property enforcement to customs and border authorities. Interdicting, seizing, and destroying goods may also raise significant trade issues. Finally, I express concern that the Anti-Counterfeiting Trade Agreement 2011 undermines the role of existing international organisations, such as the United Nations, the World Intellectual Property Organization and the World Trade Organization, and subverts international initiatives such as the WIPO Development Agenda 2007. I also question the raison d'être, independence, transparency, and accountability of the proposed new ‘ACTA Committee’. In this context, I am concerned by the shift in the position of the Labor Party in its approach to international treaty-making in relation to intellectual property. The Australian Parliament adopted the Australia-United States Free Trade Agreement 2004, which included a large Chapter on intellectual property. The treaty was a ‘TRIPs-Plus’ agreement, because the obligations were much more extensive and prescriptive than those required under the multilateral framework established by the TRIPS Agreement 1994. During the debate over the Australia-United States Free Trade Agreement 2004, the Labor Party expressed the view that it would seek to mitigate the effects of the TRIPS-Plus Agreement, when at such time it gained power. Far from seeking to ameliorate the effects of the Australia-United States Free Trade Agreement 2004, the Labor Government would seek to lock Australia into a TRIPS-Double Plus Agreement – the Anti-Counterfeiting Trade Agreement 2011. There has not been a clear political explanation for this change in approach to international intellectual property. For both reasons of process and substance, I conclude that the Australian Parliament and the Australian Government should reject the Anti-Counterfeiting Trade Agreement 2011. The Australian Government would do better to endorse the Washington Declaration on Intellectual Property and the Public Interest 2011, and implement its outstanding obligations in respect of access to knowledge, access to essential medicines, and the WIPO Development Agenda 2007. The case study of the Anti-Counterfeiting Trade Agreement 2011 highlights the need for further reforms to the process by which Australia engages in international treaty-making.

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A world leader in public health, Australia introduced plain packaging of tobacco products. Julia Gillard – the Prime Minister of Australia at the time responsible for plain packaging – has observed: “Since 1 December 2012, cigarettes packets in Australia do not sparkle with gold or silver and do not have any other way to catch and please the eye. They’re a uniform drab colour, with most of the box taken up with the most graphic health warnings. Gruesome pictures of disease perhaps better described as real pictures of the ugly truth.”

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The New Zealand Parliament is considering the adoption of plain packaging of tobacco products with the introduction of the Smoke-Free Environments (Tobacco Plain Packaging) Amendment Bill 2014 (NZ). There has been strong support for the measure amongst the major parties – including the National Party; the Maori Party; the Labor Party; and the Greens. The New Zealand parliamentary debate has considered matters of public health and tobacco control; the role of intellectual property law; and the operation of international trade and investment law.

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Electronic cigarette-generated mainstream aerosols were characterized in terms of particle number concentrations and size distributions through a Condensation Particle Counter and a Fast Mobility Particle Sizer spectrometer, respectively. A thermodilution system was also used to properly sample and dilute the mainstream aerosol. Different types of electronic cigarettes, liquid flavors, liquid nicotine contents, as well as different puffing times were tested. Conventional tobacco cigarettes were also investigated. The total particle number concentration peak (for 2-s puff), averaged across the different electronic cigarette types and liquids, was measured equal to 4.39 ± 0.42 × 109 part. cm−3, then comparable to the conventional cigarette one (3.14 ± 0.61 × 109 part. cm−3). Puffing times and nicotine contents were found to influence the particle concentration, whereas no significant differences were recognized in terms of flavors and types of cigarettes used. Particle number distribution modes of the electronic cigarette-generated aerosol were in the 120–165 nm range, then similar to the conventional cigarette one.

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Children in indigenous populations have substantially higher respiratory morbidity than non-indigenous children. Indigenous children have more frequent respiratory infections that are, more severe and, associated with long-term sequelae. Post-infectious sequelae such as chronic suppurative lung disease and bronchiectasis are especially prevalent among indigenous groups and have lifelong impact on lung function. Also, although estimates of asthma prevalence among indigenous children are similar to non-indigenous groups the morbidity of asthma is higher in indigenous children. To reduce the morbidity of respiratory illness, best-practice medicine is essential in addition to improving socio-economic factors, (eg household crowding), tobacco smoke exposure, and access to health care and illness prevention programs that likely contribute to these issues. Although each indigenous group may have unique health beliefs and interfaces with modern health care, a culturally sensitive and community-based comprehensive care system of preventive and long term care can improve outcomes for all these conditions. This article focuses on common respiratory conditions encountered by indigenous children living in affluent countries where data is available.

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The prevalence of human papillomavirus (HPV)–associated head and neck cancers is increasing, but the prevalence of oral HPV infection in the wider community remains unknown. We sought to determine the prevalence of, and identify risk factors for, oral HPV infection in a sample of young, healthy Australians. For this study, we recruited 307 Australian university students (18–35 years). Participants reported anonymously about basic characteristics, sexual behaviour, and alcohol, tobacco and illicit drugs use. We collected oral rinse samples from all participants for HPV testing and typing. Seven of 307 (2.3%) students tested positive for oral HPV infection (3 HPV-18, one each of HPV-16, -67, -69, -90), and six of them were males (p = 0.008). Compared to HPV negative students, those with oral HPV infection were more likely to have received oral sex from more partners in their lifetime (p = 0.0004) and in the last year (p = 0.008). We found no statistically significant associations with alcohol consumption, smoking or numbers of partners for passionate kissing or sexual intercourse. In conclusion, oral HPV infection was associated with male gender and receiving oral sex in our sample of young Australians.