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澳大利亚的大流行病、抗病毒药物储备与生物安全:通用选项如何?

Pandemics, antiviral stockpiles and biosecurity in Australia: what about the generic option?

作者信息

Lokuge Buddhima, Drahos Peter, Neville Warwick

机构信息

Regulatory Institutions Network, Australian National University, 3rd Floor, Coombs Building Extension, cnr Garran and Fellows Roads, Canberra, ACT 0200, Australia.

出版信息

Med J Aust. 2006 Jan 2;184(1):16-20. doi: 10.5694/j.1326-5377.2006.tb00089.x.

Abstract

In view of the possibility of a human pandemic of avian influenza, a first-line strategy for many countries is stockpiling of antiviral neuraminidase inhibitors (oseltamivir [Tamiflu] and zanamivir [Relenza]), which can reduce mortality, morbidity and influenza transmission. However, global supply of the antivirals is controlled by the European-based patent owners, Roche and GlaxoSmithKline. This prevents competition in the manufacturing and distribution of antivirals and has reduced global supply capacity and affordability. The Australian Government has acknowledged that, in the event of a pandemic, its own stockpile of antivirals will be limited and reserved for those on a confidential rationing list. Pharmacies are running out of stocks, limiting opportunities for individuals to secure supplies privately. Compulsory licensing provisions, permitted under domestic patent law, would allow Australian generic manufacturers to start producing antivirals locally or import them from generic producers at affordable prices. Australia also has an opportunity and a responsibility to promote compulsory licensing and generic antiviral production in the Asian region, to ensure our neighbours can establish pandemic stockpiles in a timely and affordable manner.

摘要

鉴于禽流感可能在全球范围内大流行,许多国家的首要策略是储备抗病毒神经氨酸酶抑制剂(如奥司他韦[达菲]和扎那米韦[瑞乐沙]),这些药物可以降低死亡率、发病率并减少流感传播。然而,抗病毒药物的全球供应由总部位于欧洲的专利所有者罗氏公司和葛兰素史克公司控制。这阻碍了抗病毒药物生产和分销领域的竞争,降低了全球供应能力和可及性。澳大利亚政府已承认,一旦发生大流行,其自身储备的抗病毒药物将很有限,并将留给列入机密配给名单的人。药店的库存即将耗尽,限制了个人私下获取药物的机会。根据国内专利法允许的强制许可规定,将使澳大利亚的非专利药生产商能够在当地开始生产抗病毒药物,或以可承受的价格从非专利药生产商处进口。澳大利亚还有机会和责任在亚洲地区推动强制许可和非专利抗病毒药物的生产,以确保我们的邻国能够及时且经济地建立大流行储备。

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