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    禽流感准备会议取得进展 知识产权问题有待解决

    Published on 22 December 2008 @ 1:47 pm

    By , Intellectual Property Watch

    作者:卡特琳·玛拉 (Kaitlin Mara)

    世界卫生组织12月份召开了流感大流行准备(PIP)会议,会议取得显著进展。在有必要疏通病毒和其他生物材料的渠道以及有必要获得疫苗和其他利益问题上,各成员国意见分歧较大;各国代表聚集一堂,寻找并发现了一条可以协调各成员国意见分歧的途径。
    然而,包括知识产权和定义在内的争议性较大的问题仍未解决。代表们希望在明年五月重启会议时,会议间歇时开展的非正式工作将有助于寻找共识。
    有关病毒和共享利益的妥协文字说:“认识到成员国承诺平等共享H5N1和其他具有向人类传播潜力的流感病毒并共享为全球公共卫生采取集体行动的同等重要部分的利益。”撰写出这段文字被视为12月8日至13日流感大流行准备政府间会议的核心成功指标。
    此前,会议文件措辞涉及到了对于“自愿性”还是“强制性”框架的辩论,而辩论无果而终,没有形成共识。成员国之间进行的非正式讨论 – 主要是印度尼西亚与美国之间的非正式讨论 – 产生了互相可以接受的语言,在这次会议中被广泛颂扬为推动会议取得进展的核心步骤之一。
    印尼得到了其他发展中国家和几个非政府组织的支持。它认为源自于其境内的病毒知识产权允许它为病毒的使用提出条件。作为“捐赠”禽流感病毒毒株的回报,印尼认为自己应当得到一项担保,保证根据这些毒株研究出来的疫苗将按照付得起的价格共享。因为各国缺乏自己开发疫苗的能力,所以,其他国家也认为有必要共享病毒。
    尼日利亚公共卫生主任阿布杜萨拉姆·纳西迪(Abdulsalam Nasidi)说,病毒和收益共享之间的联系是两国之间的“争执要点”。
    另一个代表说,承诺语言是“一个突破”。但是,知识产权问题“仍然悬而未决”,由于关于这些问题的各方立场代表着完全相左的认识,所以解决这些问题非常困难。

    知识产权问题仍待解决

    印尼卫生与公共政策部长顾问韦德加贾·卢其托(Widjaja Lukito)说,知识产权是“另一个艰难问题”,问题“太大”,不是这次会议能够解决的。但是,他补充说,实现利益共享是初步优先,就此找到妥协代表着取得显著进展。
    一个发达国家代表说,这次会议“避开了[知识产权问题],因为大家认识到这些问题争议很大。”该代表补充说,这一问题将不得不在一个有关生物材料转移的标准材料转让协议中得到解决,协议将是政府间会议的一项核心成果,但有待最后完成。
    在12月12日上午召开的全会上,会议主席澳大利亚代表简·哈尔顿(Jane Halton)告诉与会代表们说,成员国面临的核心知识产权问题与哪些材料可能获得专利有关 – 即整个病毒、病毒的部分、或技术与从这些病毒或病毒部分中开发出来的产品 – 也与一个病毒来源国或研究人员能够从所有权中获得的利益有关。她补充道,在有可能就知识产权找到书面语言之前,还需要澄清一些技术性问题。
    “这些是核心问题,”一名美国代表在全会上说道,“甚至还有人提出这是否是讨论知识产权事宜的合适论坛的问题。”
    然而,一位巴西代表声称,“这是合适场所。”这位代表提醒全会说,今年早些时候批准了公共卫生、创新和知识产权全球战略,而这一战略改变了世界卫生组织能够讨论的权限。该代表进一步说道:“巴西维持在世界卫生组织讨论任何与公共卫生相关问题的立场。”
    纳西迪在最后一次全会上说,或许“知识产权并不是最重要的问题。”如果各国达成协议,疫苗生产商根据协议将向能够生产疫苗的所有国家免费赠予疫苗生产许可,尤其是在发生流行病的情况下达成这样的协议,以便挽救生命,那么这将使公共卫生成为优先,而无须争议知识产权的所有权问题。

    标准材料的转让和定义

    一位来自发展中国家的代表在12月13日会议结束时提醒大家不要“过于乐观”,因为尽管完成很好的工作,但是挑战犹存。该代表说,尤其存在使协议框架适用于可能接受流感大流行准备生物材料的世界卫生组织机构和研究中心网络之外的机构和研究中心的问题。这就要求在尚未最终达成的标准材料转让协议(SMTA)中设置一种内在的机制。
    解决标准材料转让协议的部分困难是,对于协议所涉及的“流感大流行准备生物材料”,尚需找到为各方都同意的定义,这对于确定流感大流行准备框架,尤其是标准材料转让协议的许多条款的范围都是十分关键的。美国正在推动对此类材料采取一种狭隘的定义。其中,定义排除病毒蛋白质以及其他部分、基因排序信息、细胞和细胞部分、抗体和源于病毒的蛋白质,赞成一种侧重于“野型”流感病毒和病毒分离株的定义。
    根据一个人士的观点,美国立场就是把重点维持在公共卫生问题上,而不是政治方面,一个广泛的定义会造成对知识产权所有权问题的辩论。美国把自己的建议视为为实现公共卫生目标所需的最低定义,但却是可以达成共识的一个定义。
    但是,其他成员国担心,一个较为狭隘的定义会减少政府间会议任何成果的范围。一名印尼代表说,生物材料定义应当与这些材料在技术开发中的实际使用相匹配。例如,被感染血样除了仅仅是一种野型病毒之外,还含有有用的遗传物质。该代表说,该定义应当包括所有这些物质。
    一名重要的发展中国家的代表说,对狭隘定义的一种担心是,它可能会为逃脱使用这一定义的最终流感大流行准备框架所规定的义务提供一个漏洞。
    会议还讨论了通过这一框架提供或接受生物材料的机构、组织和实体是否会谋求对这些材料主张拥有知识产权的问题。美国在全会中说,它要保证标准材料转让协议不会影响源于知识产权的“义务或限制条件”;而巴西随之指出,它想要得到保证,即在体系内共享的生物材料的知识产权不会被人所主张。
    尼日利亚说,如果发展中国家能够免费获得“在所有时候 。。。使用从”。。。通过这一框架共享的“生物材料中开发的产品和工序”的许可证的话,那么它可以接受知识产权。
    另一个与会代表解释说,标准材料转让协议是一个作为不具有约束力的建议书框架附件的具有约束力的合同。另一名人士说,这就给谈判增加了相互矛盾的因素,它意味着没有包含在标准材料转让协议内的框架各方面将拥有轻得多的分量。
    最后一场全会决定暂停政府间会议,到安排在2009年5月召开的下届世界卫生大会期间再行召开会议讨论。会议的结论性进展报告指出,政府间会议与两个工作组都在主席文件中获得了进展。主席文件是一个关于共享流感病毒和获得疫苗与其他利益的流感大流行准备框架草案。工作组也接近于最后完成了框架的指导原则,首先是承诺共享病毒和利益的原则。
    同时,该机构还请求总干事采取几个技术措施,为下一届会议做好准备,包括进一步开发病毒追踪机制,为世界卫生组织的流感合作中心、世界卫生组织H5参照实验室、核心规范实验室和国家流感中心制定职责范围(TOR);修改标准材料转让协议的技术部分,并准备一份明确需求和各项优先包括筹资方案以及关于流感大流行准备框架文本中提议的各种利益方面的报告。

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