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To the extent this is occurring, the amount that pharmaceutical companies have to spend on researching and developing new drugs decreases, reducing the rate at which new drugs are developed and brought to market. Threats to industry revenue come from what is referred to as the 'patent cliff'. This term is used to describe the expected sharp decline in pharmaceutical company revenues as leading drugs come off patent.36 A significant proportion of total drug revenue earned by pharmaceutical companies comes from a relatively small number of drugs. In Australia, in the 2011- 12 financial year three drugs accounted for 16.7% of total cost to the Government through the PBS. These were Atorvastatin ($593.3 million), Rosuvastatin ($359.2 million) and Ranibizumab ($307.8 million).37 Each of these drugs is patented, with the key patent on Atorvastatin expiring in 2012, patents on Rosuvastatin38 due to expire in 2020 and the key patent on phentermine no prescription mastercard Ranibizumab due to expire in 2020.39 With patent expiry come cheaper generic versions of the drugs, driving prices down and eating into the patentee's market share.

When combined with the automatic 16% PBS price reduction and ongoing Price Disclosure reductions, this leads to price reductions of on average 25%, but in some circumstances well over 50%.40 A number of submissions to the inquiry also refer to the increased costs of bringing a phentermine no prescription mastercard drug to market. A 2012 study by the UK Office of Health Economics reported a general consensus in the literature that there has been a steady increase over the past ten years phentermine no prescription mastercard in the cost of bringing a new drug to market. The report estimated an increase from approximately $1 billion US in 2003 (in 2011 figures) to over $1.5 billion US in 2011.41 Reasons given for the increased costs included decreasing success rates, from a 1:5 success rate phentermine no prescription mastercard in the 1990s to 1:10 in the 2000s, and increased development times, from an average of 6 years in the 1990s to 13.5 years in the 2000, as companies tackle complex and intractable diseases such as cancer and Alzheimer's.42 Recently it has been reported in the media and academic literature that, in response to the current or imminent threat to their income streams, a number of pharmaceutical companies have announced reductions to their in-house R&D 30 programs.43 In submissions at public hearings, a Pfizer representative explained that the company's reported reduction in research staff was associated with a large expected fall in revenues as the patents over its block-buster drugs expired. The Pfizer representative also noted that pharmaceutical companies were looking more to out-source research activities and to look to research done by research institutes and universities to identify promising new drugs.44 This model presents opportunities for a country such as Australia to capitalise on its strong medical and biotechnology research sectors. However, success relies on there being sufficient funding for the research in the first place, from Government, philanthropic or industry sources, and effective mechanisms to capture the benefits from the IP generated through the research and from the industry partnerships and collaborations that develop. It also requires sufficient funding for the pre-clinical and phase 1 and 2 clinical trials that follow-on from the initial research work. This work is often undertaken by research institutes and small biotechnology firms using a mixture of public and private sector funding. In their submissions to the review, Medicines Australia, AusBiotech and representatives from research pharmaceutical companies argue that, in the face of such challenges, any diminution in phentermine no prescription mastercard the levels or duration of IP protection in Australia would risk driving investment in pharmaceutical manufacturing and research offshore, damaging the Australian economy, and increasing the risk of Australian accessing new medicines.



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