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However, the practice can also frustrate generic entry to the market, resulting in consumers and the government paying more than they should for medicines.

This process is colloquially called 'evergreening' and is discussed further in chapter 7 2.hydrocodone online vicodin 7. The extending scope and length of patents Further challenges to optimising the patent system arise from the increases in term and scope of protection and decreases in patent thresholds. For instance, although patents were primarily granted for mechanical inventions and industrial processes, the scope of patenting has gradually broadened, and in the last few decades has been extended by judicial decision to areas like business methods, software and biological materials. Likewise patent lengths for pharmaceuticals were further extended in 1999 with extensions of the standard patent term of 20 years of up to 5 years for inventions relating to eligible pharmaceutical substances.

A broader hydrocodone test example, one relevant to all technologies in Australia, is a gradual lowering of patent thresholds in Australia as compared to patent thresholds elsewhere. Addressing this divergence has been the focus of reforms introduced by the Raising the Bar Act 2012. A more pervasive example, and one whose relevance extends beyond pharmaceuticals, is that of IP provisions in trade agreements. As a member of TRIPS, Australia agreed to set minimum standards for IP protection, including extending the patent term from 16 hydrocodone test to 20 years.47 In 2005 the AUSFTA came into effect.

In agreeing to AUSFTA Australia agreed to "TRIPS-plus" provisions that further strengthen IP protection. In its 2010 report Bilateral and Regional Trade Agreements the Productivity Commission suggested that there had been clear net costs to Australia in adopting IP requirements agreed to in the TRIPS and AUSFTA agreements and recommended that the Government avoid the inclusion of IP in future agreements unless overall net benefits could be demonstrated. A number of submissions raised concerns about the constraints imposed by trade agreements, particularly in light of Australia's participation in current negotiations on the TPP. International agreements are discussed in chapters 3 and 4.

Regulatory complexity A further challenge for the pharmaceutical system arises from regulatory complexity. The pharmaceutical system in Australia is regulated at a number of different levels. It is indirectly regulated through the patent system, which gives a patentee control over who can enter the market during the life of their patent. The market advantages from patent protection also extend beyond the life of the patent because of the brand reputation and market power hydrocodone test established by the patentee, or their licensee, during the period of market exclusivity prior to expiry of the patent.

The system is also directly regulated through the market regulatory approval process administered by TGA. A pharmaceutical product must obtain TGA approval before it can be registered on the ARTG and marketed. The PBS provides a further layer of indirect market regulation. Under the PBS, patients pay a set price for all medicines listed on the PBS, and a further reduced price for all concession card holders. The Australian Government pays the remaining cost of the product. An application to have a drug listed on the PBS can be made for a medicine for any use for which the medicine is listed on the ARTG. Although listing of a drug on the PBS is not a prerequisite for marketing the drug, listing has the practical effect of increasing the size of the market for the drug because, food phentermine viagra xanax in the absence of PBS hydrocodone test subsidies, consumers might not be prepared to pay, or be able to pay, the prices charged for the drug. In this respect, the Australian market is very different to the US market. The challenge is to ensure that these layers of regulation work together to maintain diet phentermine pill xenical a pharmaceutical system that: •encourages investment in finding new medicines and treatments and/or bringing them to the Australian market; •provides Australian consumers with safe and efficacious medicines without undue delays; and •supports a level of competition sufficient to promote affordable pricing of medicines for consumers and the Government.



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