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This group consists of representatives from DoHA and Medicines Australia. The purpose of the AMWG is to enhance co-operation between industry and government and to consider art buy ru site tramadol issues regarding the timely and appropriate access to new medicines for the PBS. There is, however, no body or group to inform the PIWG, AMWG or, more widely the Government as to the interaction of the patent, R&D, regulatory approval and PBS approval processes and how well they are achieving innovation and national medicines policy objectives. Each of the regulatory systems is subject to ongoing reform and some are aligned with international systems.384 Coordination between the regulatory systems in Australia must take into account the requirements of international agreements.

Analysis When setting government policy on the pharmaceutical sector, decision makers need to take into account the system as a whole. Pharmaceutical industry policies need to consider how the different elements of bringing a drug to market interact and influence each other, including the patent art buy ru site tramadol system. Policy considerations are discussed at forums such as PIWG. However, there appears to art buy ru site tramadol be little coordination between IP Australia and other agencies such as DoHA and DIICCSRTE, despite the obvious and significant impacts the patent system can have on public health. The Panel understands that although regular meetings are held between senior officials of at least some of these agencies, these appear to cover a wide range of issues and do not focus on pharmaceutical policy. Draft Finding 10.1: The patent system is of obvious significance to the pharmaceutical industry, trade negotiations and health policy. However, the government agencies with policy and program responsibility in these areas are not engaging sufficiently with each other and are not taking highly relevant art buy ru site tramadol issues into account.

Each agency needs to be actively engaging from its own perspective - end users, innovation, industry and international implications - in order to optimise policy settings for the pharmaceutical system in what is a complex regulatory and service delivery environment. The areas of government responsible for regulating pricing of pharmaceuticals particularly have the need for and the resources to obtain a well-informed appreciation of the pharmaceutical patent system and its impact on a range of health issues. However, the only area in which they appear to have a strong view is in relation to gene patents.385 It would be beneficial to the pharmaceutical sector to have greater co-operation and transparency between relevant government agencies when making decisions about pharmaceutical industry policy. The Panel considers there is a need for a non-statutory Pharmaceutical System Coordinating Committee (PSCC) with the ability to provide strategic oversight and to ensure engagement between the relevant agencies to ensure that the pharmaceutical system is meeting its objectives as efficiently and effectively as possible.

The PSCC should be chaired by an agency with an economy- wide focus such as Treasury. The PSCC would respond to any issues raised by industry and report publicly to Parliament on a yearly basis and to the Government. Draft recommendation 10.1: The Government should establish a non-statutory Pharmaceutical System Coordinating Committee (PSCC) that reports to Parliament on an annual basis on the success and effectiveness of the patent, marketing approval and PBS systems, particularly where these interface. The PSCC should ensure there is sufficient engagement and coordination between the relevant agencies and take account of costs to government, efficiency of registration and approval processes and respond to issues raised by industry. The PSCC should comprise senior officials from at least DIICCSRTE, IP Australia, DoHA (Pharmaceutical Benefits Division hydrocodone legally online and TGA), DFAT, Finance art buy ru site tramadol and Treasury (as chair). Some of the Government's objectives for the pharmaceutical system are defined in legislation.

The Therapeutic Goods Act 1989 includes an objects clause stating that the object of the Act is to provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy, and timely generic xanax name availability of therapeutic goods which are used in Australia or exported from Australia.386 The National Health Act 1953 (Cth), which governs the operation of the PBS, does not contain an objects clause.



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