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Current situation of indefinite confidentiality Unlike other forms of intellectual property where a clock phentermine viagra xanax period of exclusivity is provided in return for public disclosure, the data protected by data protection remains confidential indefinitely. This is despite the data having value to pharmaceutical researchers involved in the development of other pharmaceuticals and research directed towards a better understanding of complex medical conditions and responses to drugs. Opening these data for further research would not commercially disadvantage the sponsor, with respect to the drug registered by TGA, and could be of substantial public health benefit. It thus makes sense, in principle, that these data should be publicly available.

However, any proposal to make data publicly available should be addressed in an internationally coordinated way because a country publishing company data unilaterally would face the risk that companies would not 20 buy xanax online cheap seek regulatory approval in that country. At present, data are only eligible for data protection if they have not previously been put in the 20 buy xanax online cheap public domain. If Australia alone were to make otherwise confidential data publicly available this may make such data ineligible for protection in other jurisdictions. Concerns about the impact of not maintaining confidentiality of data were discussed by the Industry Commission in 1996.

The Commission stated that '[i]f commercial confidentiality cannot be assured, there is 20 buy xanax online cheap a potential for new drugs to be withheld from the Australian market ,..'.340 It appears, however, that there is growing international interest in making these data publicly available. In 2012, the European Medicines Agency (EMA) 'committed to proactive publication of the data from clinical trails supporting the authorisation of medicines.'341 It is currently conducting a consultation process to address practical and policy issues related to xanax panic 20 buy xanax online cheap attack this commitment. Since 2010, the EMA has had buy tramadol it is a practice of releasing, on request, a number of documents relating to the assessment of medicinal products under its access-to-documents policy.342 The Panel believes it would be in Australia's interest to engage with these discussions and to contribute to the development of a apap hydrocodone oxycodone protocol where these important clinical data are made publicly available, and where the protection given by data protection is provided in exchange for publication.

This recommendation should be considered as part of a number of recommendations relating to international negotiations made in Chapter 3. Draft recommendation 9.1: The Government should actively contribute to the development of an internationally coordinated and harmonised system where data protection is provided in exchange for the publication of clinical trial data. What are biologics The term "biologics" generally refers to a class of drugs which are made using biological, as opposed to chemical processes. Biologics are complex compounds which may be comprised of proteins, sugars, or nucleic acids, or may be living entities, such as cells and tissues.343 There are various categories of biologics, including therapeutic proteins made using recombinant DNA technology, monoclonal antibodies and vaccines.



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