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    希望世界卫生组织在五月大会前针对假冒伪劣产品行动达成共识

    Published on 29 January 2009 @ 9:42 am

    By , Intellectual Property Watch

    作者:凯特林·玛拉 (Kaitlin Mara)

    上周,世界卫生组织关于假冒伪劣医疗产品的一项报告和决议草案引起了热烈辩论,尽管仍未找到一种妥协办法来弥补关于防假冒伪劣报告背后协商程序的分歧和弥补关于令人感到混乱的侵犯知识产权恶行风险的分歧,而这些侵权恶行有可能造成医药误用的危险。
    在1月23日召开的世界卫生组织执行理事会上,各成员国一致同意,世界卫生组织秘书处将提出进一步报告,以便解决假冒伪劣药品的公共卫生层面的问题,并提交没有决议的更多的信息文件,供五月世界卫生大会进一步讨论。如果届时达不成共识,成员国可能要考虑成立一个政府间工作组的可能性,以便在会议间歇时会晤。

    世界卫生组织执行理事会于1月19日至27日召开会议

    尽管所有成员国都在1月23日强调保护公共卫生免遭假药造成风险的重要性,但是一些成员国质疑,决议草案(12月18日发布,请点击这里[pdf版本])是否可以保护公众利益,还是对知识产权权利人的保护给予不必要的过分关注。另一些成员国则想知道聚焦假冒伪劣问题是否会分散对其他公共卫生问题的关注度,例如合法药品批量不达标问题或质量瑕疵问题。
    各方提出的首要关切是关于世界卫生组织背景下对假冒伪劣的确切定义的实质性讨论,以及关于国际医疗产品反假冒伪劣工作组(IMPACT)工作的程序性讨论。该工作组成立于2006年,由反假冒伪劣代理人联合而成。工作组的技术工作[pdf版本]对报告草案影响甚大,但是一些发展中国家感到该工作组未能充分代表它们的声音。
    世界卫生组织总干事陈冯富珍告诉理事会说,世界卫生组织的新报告将论述成员国在1月23日讨论中提出的各种问题。报告还将就世界卫生组织《关于公共卫生、创新和知识产权的全球战略和行动计划》的平行程序进行了审查,以便确定这份已经通过谈判达成共识的文件能否就有关假冒伪劣医药产品的知识产权问题进行充分讨论。

    “假冒伪劣”的麻烦

    “假冒伪劣是对一项知识产权的侵犯,[并]伤害了商标权利人,”巴拉圭在讨论开幕式中代表拉丁美洲与加勒比国家小组发言说。“这种侵权行为的典型化不包括卫生标准。”
    世界贸易组织的《与贸易有关的知识产权协议》内假冒伪劣的法律定义与违反商标明确挂钩。好几个成员国和非政府机构都把这一问题作为一项严重关切提出来。如果你想了解该问题的更多背景资料,请参看2008年1月16日《知识产权观察》“世界卫生组织”一文。
    它们关切的是,这样挂钩既为世界贸易组织涉入知识产权的执行打开大门,又造成了仿造药品生产商可能面临知识产权挑战的风险。最近有一个案子,涉及到一只装载仿制高血压药品从印度运至巴西的船只在荷兰被拦截,该案加重了人们的这一关切。与其如此,许多国家都要求援助药品监管机构的能力建设,并把精力集中于处理假造、贴假标签和不达标药品问题上。
    非政府机构第三世界网络出台的一个报告题为“世界卫生组织:‘假冒伪劣’药品策略可能影响获取医药渠道”,该报告列举了一些关于世界卫生组织定义或许会限制使用仿制药品的方式问题。
    其他方面则提到了埃及所谓的“关于界定性问题缺乏清晰”的问题。“我们不知道在世界卫生组织背景下假冒伪劣的含义是什么,”巴西代表说。该代表补充道:这是“这一过程中最大的罪过”而且“在我们弄明白这一点之前我们不能继续[谈判下去]。”
    其他方面对世界卫生组织报告原稿中后来发现的一个错误表示担心,报告声明“关于知识产权的争议或者对知识产权的侵犯不要与假冒伪劣相混淆。” 国际医疗产品反假冒伪劣工作组的报告版本使用了“专利”而不是“知识产权”的表述。
    “我们感到担忧的是,世界卫生组织起初散发了一个文件,该文件大幅把排除范围扩展到了所有知识产权,”美国代表发言说道。
    世界卫生组织散发了一个文件纠正这一错误,把措辞改为“专利”。
    “药品的虚假化”被视为“一种丑陋的犯罪”,巴西代表表示,世界卫生组织是寻找保障药品质量、安全与效果途径的论坛。但是,该代表补充说,它并不是讨论执行知识产权的论坛,尽管《全球战略》所界定的知识产权政策讨论也有一席之地。
    知识产权的执行最好由一个专业国际机构负责处理,这是其他代表团表达的一个观点,包括阿根廷、孟加拉、埃及、泰国和乌拉圭代表团。
    两个发展中国家分别告诉《知识产权观察》说,这与此前推动把知识产权执行权通过世界海关组织交给边防警察类似,而世界海关组织是另一个通常不涉足知识产权政策的国际机构(参阅2008年4月25日;2009年1月8日《知识产权观察》“执行”)。
    但是“执行并不是我们的初衷,”一个支持报告初稿的发展中国家代表这样告诉《知识产权观察》。尽管为停止假冒伪劣医药的行动“或许会间接地帮助商标权利人,”其主要目的却是公共卫生,这里没有“暗藏的议程”。
    “知识产权是我们作为执行时用来在适当时机打击假冒伪劣药品的工具,” 国际医疗产品反假冒伪劣工作组与国际刑警组织联合合作项目经理阿琳·普朗松(Aline Plançon)说道。自2008年3月以来,她一直在世界卫生组织全日工作,负责打击假冒伪劣药品。“我们还运用毒品管理法,或者运用洗钱法 – 运用一切可用的法律工具,”她说道。一位工业界代表表示同意这一看法,说“商标有助于打击虚假标签”。
    瑞士代表团建议,修改“假冒伪劣”一词或许从政治上来说是不可行的,使用“假冒医疗产品”整个词组这个世界卫生组织特定的定义很可能有助于减少理解混乱。
    在国际医疗产品反假冒伪劣工作组进程中,匈牙利代表欧盟表示,它“积极支持世界卫生组织的努力及其在国际医疗产品反假冒伪劣工作组中发挥的领导作用。”美国说该工作组在打击假冒伪劣工作中发挥了“出色的”作用,英国对该工作组“对提高认识并使各利益攸关方面参与这项工作做出的巨大贡献”表示祝贺。
    但是,其他方面可不那么自信。国际医疗产品反假冒伪劣工作组的决策机构“主要包括发达国家和医药工业界代表,而发展中国家代表性不足,”印尼代表东南亚地区局发言说道。
    根据最新的宣传册子[pdf版本],国际医疗产品反假冒伪劣工作组决策机构成员来自于澳大利亚、德国、尼日利亚、新加坡和美国政府,还包括国际医药制造商及协会联合会(IFPMA)和国际制药联合会的代表,以及世界卫生组织的两名雇员和国际刑警组织的一名雇员。
    一个引起人们抱怨的主要问题是工作组在世界卫生组织之外进行谈判,因此,这没有遵循正常情况下文件撰写都应该由成员国主导的程序。孟加拉表示“任何决定都应该由成员国加以讨论和做出”。巴西、印尼(代表东南亚地区局)、泰国和委内瑞拉也表达了类似的感受。
    “在埃及有对国际医疗产品反假冒伪劣工作组的忧虑”,该国一名代表说道,因为它“没有从世界卫生组织的任何理事机构获得授权”。智利对该工作组的资金来源以及为何其会议“只在日内瓦”举办提出了质疑,而阿根廷则说它拒绝对各种为控制假冒伪劣的机制进行国际协调。
    瑞士承认在国际医疗产品反假冒伪劣工作组的动机、职权、包容性和资金来源存在问题,但同时指出,国际医疗产品反假冒伪劣工作组的技术工作质量没有受到质疑。进一步说,“五月份如不通过一项决议将给那些假冒伪劣产品的制造商和营销商发出一个信号,即它们应该继续干下去。”会议主席表示赞同,说他担心“[执行管理机构]达不成任何决议”,因为这“让那些假冒伪劣产品的制造者们感到很大的宽心。”
    此外,在该工作组与世界卫生组织就执行工作负责协调的普朗松说,“工作组是开放式的,只要它们愿意,任何国家都可参加。”她把为终止假冒伪劣行为而进行的斗争称作与有组织犯罪分子的“赛跑”,她说“如果你要有所作为,你就不能化几周的时间讨论细枝末节。我们失去的越多,他们就赚得越多。”

    为合法药品制造障碍吗?

    一位发展中国家的外交官向《知识产权观察》指出,报告没有提及以可承受价格获得高质量药品的问题,从而显示促进合法药品并非享有同等的优先。
    另外,巴西表示“我们不知道高价格对假冒伪劣问题的影响”,阿曼则请求提供关于专利有效期和非法药品贸易水平方面的信息。
    一个非政府渠道的人士表示,聚焦于假冒伪劣可能会分散人们对其他更重要问题的关注。这些问题包括并非属于欺诈但质量很低的药品的贸易,之所以出现质量低的问题,主要因为出现生产问题或储藏问题,或者因为对一个国家向外出口的药品质量控制较低造成的。
    埃及认为,不达标药品对公共卫生的影响要大于假冒伪劣。无疆界医生组织最近出台的一个报告[pdf版本]也得出了同样的结论。
    一名非洲代表说,“这不应该是一个政治游戏。”该代表补充道,我们所需要的是投入资金,以提高主管部门的监管能力,终止质量糟糕药品的流入,而非洲恰恰就是这些低质药品的“倾销地”。

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