886901
Australian National University, Canberra, ACT, Australia.
Med J Aust. 2015 Apr 6;202(6):306-8. doi: 10.5694/mja14.01682.
Intellectual property (IP) protections proposed by the United States for the Trans-Pacific Partnership Agreement (TPPA) have sparked widespread alarm about the potential negative impact on access to affordable medicines. The most recently leaked draft of the IP chapter shows some shifts in the US position, presumably in response to ongoing resistance from other countries. While some problematic provisions identified in earlier drafts have been removed or mitigated, major concerns remain unresolved. Three of the greatest concerns for Australia in the recent draft include provisions that would further entrench secondary patenting and evergreening, lock in extensions to patent terms and extend monopoly rights over clinical trial data for certain medicines. Data from the 2013 Pharmaceutical Patents Review, and from various submissions made to it, show that pharmaceutical monopoly protections already cost Australian taxpayers hundreds of millions of dollars each year. Provisions still being considered for the TPPA would further entrench and extend costly monopolies, with serious implications for the budget bottom line and the sustainability of the Pharmaceutical Benefits Scheme.
美国提议在《跨太平洋伙伴关系协定》（TPPA）中对知识产权（IP）提供保护，这引发了人们对获得平价药物的潜在负面影响的广泛担忧。最近泄露的知识产权章节草案显示，美国的立场有所转变，这可能是对其他国家持续抵制的回应。虽然早期草案中确定的一些有问题的条款已被删除或减轻，但主要问题仍未得到解决。最近的草案中，澳大利亚最关心的三个问题包括：进一步强化二次专利和专利常青化、锁定专利期限的延长以及对某些药物临床试验数据的垄断权的延长。2013 年药品专利审查的数据以及对该审查的各种意见表明，药品垄断保护每年已使澳大利亚纳税人花费数亿美元。TPPA 中仍在考虑的条款将进一步强化和延长昂贵的垄断，这对预算底线和药品福利计划的可持续性都将产生严重影响。
