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    拉米看到《TRIPS协议》与公共卫生 的进展并敦促运用好审议制度

    Published on 22 December 2008 @ 1:45 pm

    By , Intellectual Property Watch

    作者:牛威廉 (William New)

    最近,世界贸易组织总干事帕斯卡尔·拉米对贫困国家获得药品能力取得进展大加称赞。他说,对知识产权和公共卫生规则不满的任何世贸组织成员都应该通过规则年审表达抱怨意见。
    “世贸组织成员之所以对这一制度进行定期评审达成协议,恰恰就是为了处理这类情况,”拉米在一个仿制药产业聚会上发言。“我要提请大家注意一点,在上次对该制度运行的年度审议中,世贸组织成员没有提出关切。实际上,在非洲组带领下,世贸组织成员在该制度实行两年之后重新予以确认。”
    国际仿制药品制造联盟第11届大会于12月8日至10日在日内瓦召开,拉米在大会上做了发言。拉米作为世贸组织总干事的四年任期将于2009年底结束,不过他正在争取连任,至今好像无人匹敌。
    在世贸组织,1994年的《与贸易有关的知识产权协议》(简称《TRIPS协议》)制定了有关获取药品渠道问题的规则。2003年8月,世界贸易组织总理事会通过了《关于< 与贸易有关的知识产权协议>与公共卫生的2001年多哈宣言第6段的实施决议》。第6段呼吁解决缺乏制药能力国家的问题,但明确了通过强制性许可证获得较低廉药品的必要性。对于世贸组织关于依照强制性许可生产产品必须绝大部分用于国内市场的规则,2003年的《决议》开创了一个豁免条件。
    2003年《决议》第8段要求,《与贸易有关的知识产权协议》理事会应当对《决议》中确定的制度运行情况进行年度审议,以保证其有效运行,并应当就其运行情况向总理事会提交年度报告。
    拉米说,迄今尚无一个国家在审议中提出重大关切。但在听完他发言之后,一个发展中国家的官员对审议过程的有效性提出了质疑。
    在过去五年中,只有卢旺达一个国家在九月份针对加拿大出口运用了第6段的条款。卫生活动家再三声称豁免条款太过繁杂,无法发挥效用。
    发言后当被问及发达国家的威胁是否会制约较小经济体运用灵活性时,拉米告知“知识产权观察”,卢旺达的案例说明情况恰恰相反。
    关于世贸组织的连续改进程序是否会最终导致进一步变化可能性的问题,他在发言中留有余地。他说:“正如任何世贸组织协议一样,第6段确定的制度应当定期审议,在评估中吸取教训,使世贸组织能够继续努力使其有效运转,为改善药品获得能力做出贡献。”
    “我们对审议并就各方面效果吸取教训保持开放姿态,”拉米说。“我接受我应当是《与贸易有关的知识产权协议》灵活性的监护人这一说法。”一位活动的组织者把拉米描绘为“《与贸易有关的知识产权协议》灵活性的监护人”,对仿制药工业发挥着重要作用。
    拉米坦诚,所谓的《与贸易有关的知识产权协议》外加条款,即那些超出《与贸易有关的知识产权协议》之外的条款,可能对与小国达成的双边贸易协议产生消极影响。“某些条款可能会影响到获得药品的能力,也可能会影响到药品仿制工业,”他说。
    但是,拉米给出了一个经常被品牌工业再三表示的观点:知识产权“仅仅构成确定某个国家药品获得水平的特大拼图当中的一个拼片而已。”其他因素还包括基础设施和国家卫生体系或采购制度。他特别指出工业界的一个论点,即医疗产品进口关税就很成问题;另外,他还引述了对假冒伪劣产品采取更强有力打击的必要性。
    同时,世界知识产权组织总干事高锐(Francis Gurry)周三在会议闭幕式上发言说:“谁都不应当混淆不达标药品、假冒伪劣药品和仿制药品。”说到这里引起与会者一片掌声。

    其他观点

    其他与会人员特别指出了当前知识产权制度和《与贸易有关的知识产权协议》在获得医药能力方面的缺陷。“无疆界医师组织”(MSF)的米歇尔·切尔兹(Michelle Childs)指出专利关联的问题。她说,美欧创始机构产业正向医药主管部门施加压力,力促把仿制药品的市场批准过程与参照产品的专利现状联系起来。她认为,这可以发挥不假思索即可提升专利的作用,干扰了运用《与贸易有关的知识产权协议》灵活性的能力,因而属于《与贸易有关的知识产权协议》的外加条款。切尔兹女士讨论了医药专利统筹(patent pool)策略建议,该策略建议是由国际药品采购机制(UNITAID)提出,并得到了世界卫生组织核心机构的认可。
    联合国贸易发展会议的克里斯托夫·斯本曼(Christoph Spennemann)与其他一些人都对仿制药生产数据排他性的影响进行了描述,而创始公司过去曾成功获得对其测试数据拥有5至10年的独家使用权,从而可以在专利期满之后推迟仿制药产品的问世。
    仿制药品经销商霍斯匹拉公司(Hospira)的知识产权部主任兼法律顾问茱莉亚·派克(Julia Pike)对世界各地仿制药品公司与品牌药品公司之间发生的斗争进行了描述。她与仿制药生产商梯瓦制药公司(Teva Pharmaceutical)的专利法律总顾问耶胡达·利乌尼(Yehuda Livneh)都指出,要对专利持有人形成震慑从而防止其滥用专利权,除了让他们输掉官司之外,还必须让他们看到更大的资金方面的影响。派克认为,让第三方涉入和计算损失都可以提高这一影响。有人指出,梯瓦公司在荷兰打赢了对雅培制药厂(Abbott)的一场很大的法律官司,但是雅培公司并没有为此付出很高代价。
    世贸组织的罗杰·坎弗(Roger Kampf)以个人名义发表观点,对工业界是否很有兴趣参加专利统筹提出了质疑。他说,派克提出的关于制定共同程序的全欧洲共同诉讼框架的建议就是一个《与贸易有关的知识产权协议》外加条款。坎弗说道:“这表明,《与贸易有关的知识产权协议》外加条款不仅会来自于研发业,同样也会时不时地由你们方面提出来。”
    另外,一位中国与会代表以统计数字说明,中国将于2012年成为仅次于美国的仿制药品业第二生产大国。与此同时,日本的仿制药品业代表指出,日本正实行一个新的举措,以便使日本增长乏力的仿制药品生产重获生机。
    同时, 《与贸易有关的知识产权协议》问题在目前正在进行的这轮世贸组织谈判的剩余部分谈判中处于焦灼状态。一名官员说,拉米再次请求挪威外交大臣约纳斯·斯托勒(Jonas Støre)主持《与贸易有关的知识产权协议》问题的讨论,但是该外交大臣将等待时机,只有在一个部长级会议中才愿出头。

    拉米提供一个可能的“口子”

    尽管拉米的发言远非激进,听众在他有关世贸组织《与贸易有关的知识产权协议》当中的公共卫生要运用灵活性的发言中还是看到了希望的迹象。
    无疆界医师组织的亚历桑卓雅·赫姆拜(Alexandra Heumber)说,拉米有关第6段决议的发言中有“一个口子”。赫姆拜支持拉米的如下论点:8月30日机制并非改善医药获得水平的唯一解决办法,各利益攸关方不应该盲目信任这一机制,如果成员国要求审议,那么就应该予以审议。拉米指出,制造假冒伪劣产品虽然是一个问题,但显然不是一个专利问题,而是一个与商标有关的问题,这一观点给赫姆拜女士和其他活跃分子留下了积极印象。
    他们还喜欢拉米有关给予药品测试数据独家权利的观点。赫姆拜女士说,拉米指出《与贸易有关的知识产权协议》第39.3款关于未透露信息的保护规定应该在《多哈宣言》背景下加以解释,而该宣言呼吁对《与贸易有关的知识产权协议》的实施应该有利于公共卫生。
    仿制药品业大会上还有众多其他代表发言,例如南非仿制药生产商西普拉·麦德普罗公司(Cipla Medpro)的首席执行副官斯库姆布佐·恩高兹瓦纳(Skhumbuzo Ngozwana)。他描述了该国的专利政策。他说,尽管违反专利的问题很重要,专利的滥用也同样应该得到认真审查。他还指出,“伪仿制药品”即由品牌制药公司制造的药品正呈现出上升的趋势,对仿制药业构成威胁。另外,他说,对仿制药品的轻蔑言论正有所抬头。
    德国联邦经济合作发展部(BMZ)的弗兰克·史密德臣(Frank Schmiedchen)则讨论了德国通过在发展中国家运用《与贸易有关的知识产权协议》灵活性来促进制药生产的计划。他说,最不发达国家的商业机会是非常独特的。由于这些国家采用《与贸易有关的知识产权协议》的等待期很长(2016年才要求实行),协议允许这些国家至少在2016年之前对任何高度创新性产品合法进行仿制改型和生产。

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