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    对世贸组织体系和药品运输关切四起 TRIPS会谈重燃

    Published on 9 February 2009 @ 4:10 pm

    By , Intellectual Property Watch

    作者: 牛威廉

     巴西和印度的世界贸易组织大使控诉道,在过境国家,其他世贸组织成员国没有理由以可能发生知识产权冲突为名阻止仿制药的合法运输。他们还说,最近发生在荷兰的这种做法案例令人对世贸组织规则产生疑问。在世贸组织总理事会在23的会议上,这一关切得到其他17个发展中国家政府的支持。

     同时,根据一位官员的说法,巴西、印度、欧盟和瑞士的大使们在24会晤,讨论在世贸组织内就如下两项建议开始谈判的方式问题:一项建议是把高知名葡萄酒和烈性酒的地域标示保护扩大到其他产品,第二项建议是修改世贸组织有关知识产权的规则,以要求在专利适用上明确仿制材料的原产地。100多个世贸组织成员国已经呼吁就这些题目进行谈判,而一小部分成员国反对。

            该官员说,16个有关方面组成的小组于25就同一题目召开了大使级会议。世贸组织关于知识产权的规则主要承载在《与贸易有关的知识产权协议》(即TRIPS)中。    

             此轮会谈授权谈判的问题有地域标示登记的提议,而这两个问题的倡导者们希望在登记中加入这两个问题。上周,与巴巴多斯大使特利沃·克拉克(Trevor Clarke)就地域标示问题举行会议,克拉克大使就此事主持了此次专门会议。欧盟很可能仍然处于防御态势,因为各方正在要求其解释它有关地域标示登记的建议。与克拉克的会议好像已经达成协议,在下一届在3月初举行的《与贸易有关的知识产权协议》理事会上,举行一个与此相关的《与贸易有关的知识产权协议》特别会议。

           在一次有些让人冷静的会议上,大使们和世贸组织干事长帕斯卡尔·拉米(Pascal Lamy)都强调指出,有必要在世贸组织继续举行自由贸易会谈,以此抵挡愈益消极的全球经济局势。有关仿制药运输问题的争论就是在这一背景下发生的。拉米说,预计贸易将达到自1982年以来的最低水平。各国政府已经重新开始谈判。

            除巴西和印度外,对药品获取和海关问题表达关切声音的国家如下:阿根廷、玻利维亚、布基纳法索、中国、哥斯达黎加、古巴、厄瓜多尔、埃及、印尼、以色列、尼日利亚、巴基斯坦、巴拉圭、秘鲁、南非、泰国和委内瑞拉。

           巴西、印度和欧洲委员会在总理事会上的发言稿,请参看www.ip-watch.org

            同时,欧盟大使谋求为其行动进行辩护,并对发生之事达成更好的谅解。双方计划就此事进行进一步讨论。

            124,荷兰海关当局扣押了一批由印度仿制药生产商莱帝博士药业公司(Dr Reddy’s)从印度空运至巴西的仿制药,据说以怀疑为假药的名义扣押长达36天。这批重500公斤的氯沙坦钾货物是用于生产动脉性高血压的活性原料,欧盟估计价值为5.5万欧元。欧盟说,这是应一家在荷兰拥有专利的公司(很可能是品牌制药商默沙东公司即Merck, Sharp and Dohme)的请求采取的一项行动。原料并没有在印度或巴西注册专利,因此不可能违反这些市场的知识产权。最后,这批药品货物被退还给印度货主,然后货主又决定把货物运回了印度。

           仿制药贸易在全世界都是完全合法的。各国政府和活跃分子一直在极力澄清仿制药与假冒伪劣药品之间的任何混淆。与仿制药不同的是,假冒伪劣药品可能不达标准或者是非法的。他们认为,根据《与贸易有关的知识产权协议》,药品根据其欲商业化的国家即巴西或印度而言被视为仿制药品。巴西辩称说,过境国的法律在这里没有意义。

            荷兰当局的行动“明显违反过境自由,而过境自由是《关税总协定》第V条赋予的一项权利”,巴西大使罗伯特·阿泽沃多(Roberto Azevêdo)在世贸组织总理事会上发言说。“只有非常例外的情形才允许对这一自由施加限制。巴西不知道在这一具体事例中存在任何此类情形。”

            欧盟大使爱卡特·顾斯(Eckart Guth)在总理事会上反驳说,荷兰扣押药品“是被《与贸易有关的知识产权协议》所允许的,其基础就是欧盟海关法律规定。如果欧盟的海关怀疑任何商品违反知识产权,那么欧盟海关法允许海关临时扣押这些货物。 由于货物最终被确定为并不进入欧盟市场,所以货物被退还给了货主。

           但是,阿泽沃多表示,对目的地并不是荷兰市场的仿制药运输加以阻拦的决定“是不能接受的,它制造了一个危险的先例。”他说,有迹象显示这并不是一个孤立的案例。因此,如果世贸组织规则无法阻止一个过境国家干扰合法贸易,那么这就引起有关世贸组织规则的系统性问题的关切。印度也声称这不是一个孤立事件。

           “巴西对设立这样一个对知识产权的治外法权先例表示严重关切。”阿泽沃多说道。“把专利赋予的权利扩大到国境之外的企图具有至关重要的系统性影响。”

             巴西说,进一步来讲,专利权的治外法权与2001TRIPS与公共卫生的多哈宣言》。该宣言强化了各国采取措施来保护公共卫生的主权,其中包括获取医药的问题。

            荷兰的行动还可能削弱对所谓世贸组织第6段制度的运用,这一制度是指TRIPS和公共卫生协议的第6段,按照一个强制性的交叉许可安排,这一制度使那些缺乏制造能力的国家能从其他成员国进口所需要的医药。

    世界海关组织和世界卫生组织的“视知识产权为最高纲领派”

            在诸如设立于布鲁塞尔的世界海关组织、世界卫生组织和万国邮政联盟,对一些国家就过境货物加强执行和模糊仿制药与假冒伪劣药界限的做法,一些成员国也提出了关切。

            印度表示,这些组织正在共同努力来“促进知识产权为最高纲领的议程”,这正在打乱1994《与贸易有关的知识产权协议》中达成的微妙平衡。

            “有一种企图,要扩大假冒伪劣药品的定义,使其超越《与贸易有关的知识产权协议》内的定义,以便设立最高的执行标准,其中包括了地区贸易协议(即RTAs)中的TRIPS-递增条款,”印度大使乌扎尔·辛格·巴蒂亚(Ujal Singh Bhatia)说道。“这些都是限制《与贸易有关的知识产权协议》灵活性的微妙和协作的方式。《与贸易有关的知识产权协议》是一个最低标准的协议,而这些做法与《与贸易有关的知识产权协议》的精神相违背。当然,这肯定与《与贸易有关的知识产权协议》谈判时给予发展中国家的认识相对立。

           “世界海关组织和世界卫生组织都不是讨论知识产权执行的论坛,”阿泽沃多说道。“在世界卫生组织,重点应该放在医药的质量、安全和效力以及医药获取问题上。”他说,世界海关组织“应该把重点放在制定提高海关绩效的方法上,而不是放在冒险制定TRIPS-递增的标准问题上。”

            印度大使说,如果一再发生荷兰这样的行动可能造成出口商改变路线,并可能对发展中国家获取关键药品和公共卫生预算产生消极影响。他补充说,如果贫困人口的药品遭到障碍,他们的健康就可能遭到危险。

           “如果各国开始在错误主张的基础上为仿制药的合法贸易制造障碍,而主张认为仿制药贸易违反国家专利权,那么这样会发生什么呢?”阿泽沃多说道。“这种情况下,仿制药贸易将基本上是不可能的。”

            对这些指责之词, 欧盟大使顾斯回应道,“在引发高度情绪化辩论之前”,巴西和印度最好首先要双边提出问题,以便澄清事实。顾斯也提到了《与贸易有关的知识产权协议》第51条,该条款使海关当局能暂缓货物放行。他说,按照欧盟法律,货物被错误扣押的公司有资格得到赔偿。

           “让我非常清楚地说明,欧盟绝对没有障碍任何仿制药合法贸易或制造法律壁垒以阻止药品向发展中国家流动的意图,我们的措施也没有这一影响,”顾斯说道。“我们绝对致力于为药品获得提供便利。”

           但是,印度指出,它在总理事会上提出问题,“只是期望欧洲理事会将紧急审查相关规定和在此类规定基础上审查国家当局的行动,使之与TRIPS协议内容和精神以及建立在规则基础之上的世贸组织体系相一致。”

      译者:劳玉军

     


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