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    在WHO就假冒伪劣药品问题吹风会上观点激烈交锋

    Published on 3 April 2010 @ 8:51 pm

    By , Intellectual Property Watch

    世界卫生组织就处理假冒伪劣(conterfeit)药品问题继续开展工作,但是上周晚些时候召开的一个会议暴露出一些方面对该组织的工作方式表示担心。

    各方都认为不能对市场上的危险药品置之不理;争论焦点主要是到底有哪些药品构成最大的危险,如何能够确定这些药品。在好几个国家,对“假冒伪劣”一词颇有争议,也引起了公共卫生与非政府团体的关心,因为该词的定义与世界卫生组织的商标法有关。

    他们认为,这意味着对假冒伪劣问题的讨论有可能逐渐脱离公共卫生领域,从而进入知识产权执法领域,这一点很危险,因为这样一来,它既不是世界卫生组织的职责范围,最终也对公共卫生毫无益处。重点应该放在次级标准药品上,一般来说,放在药品的质量、安全和有效性问题上。

    另一些人认为,世界卫生组织对假冒伪劣的定义并不适用于自身。另外,他们发言指出,“假冒伪劣”与诸如低价仿效药一样的合法药品是不相同的。

    “世界卫生组织有很多工作可做,以便帮助各国政府加强其卫生监督机制,”巴西代表在世界卫生组织3月26日就该组织国际药品反假冒伪劣工作组(IMPACT)的工作吹风会上说道。

    “在巴西,制作假药是针对公共卫生的严重犯罪行为”,巴西代表指出,那些犯有“对药品伪造、毒害、掺假或改变”之罪的人可被判监禁10至15年。

    但是巴西代表说,“当然,我们并不使用假冒伪劣一词。”在世界卫生组织对该词并没有达成任何共识。如果要确定该词定义,就必须经过世界卫生组织理事会参与并通过一个“全面、由成员国主导和开放的”程序完成。

    “我们对‘假冒伪劣’的使用抱有忧虑,”印度代表在会议发言中表示同意。这些忧虑包括与商标相联系,以及存在对这一问题通过知识产权的隐形眼镜来看待质量、安全和有效性诸方面的危险。印度代表把它称之为那些谋求扩大知识产权执法机制者的“故意模糊”策略。

    印度代表还认为,国际药品反假冒伪劣工作组要界定世界卫生组织关于危险药品的工作“缺乏合法性”,因为它既没有成员国的行动授权,其工作资金来源和决策也不透明。

    印度代表在发言中指出,“印度并不把国际药品反假冒伪劣工作组视为一个公共卫生动议,因为它并没有直截了当地解决[质量、安全和有效性]的问题”,该代笔建议,如果该工作组纳入世界卫生组织或者正在进行谈判的多边反假冒伪劣贸易协议框架之内,可能更好一些。

    还有一个问题,就是“对我们正在讨论问题的严重性并没有什么数据,”智利常驻联合国日内瓦代表团的佛尔南多•穆诺兹(Fernando Munoz)如是说,他也同时代表智利出席世界卫生组织执行委员会工作。

    穆诺兹告诉《知识产权观察》说,尽管世界卫生组织自从1988年以来就讨论假冒伪劣药品问题,然而,至今没有有关缴获假冒伪劣药品情况、存在的假冒伪劣药品数量、哪些国家有效治理假冒伪劣药品问题以及哪些经常是假冒伪劣药品诸多方面的数据。

    穆诺兹认为,各国都应该能够保障本国人民在市场上获得的药品是安全有效的。“这是一个现实的问题”,世界卫生组织也“应该把主要精力放到这一问题上。”

    穆诺兹补充说,这就意味着有必要努力加强药品监管系统的能力。巴西代表则指出,能力建设和改善实验室基础设施也是世界卫生组织可以支持的活动。

    一位欧洲代表告诉《知识产权观察》说,由于可能会出现对药品性质和产地的虚假宣传问题,所以,这些数据是很难收集的。

    然而,这位欧洲代表指出,看标签可能是至少确认一些假药的低成本方法。他解释说,“与必须通过化学分析才能确定一个药品是否为次品相比,确认其是否贴错标签所付出的成本要低。”他补充说,对跨越边界的所有产品进行化学测试很难。

    “打击假冒伪劣药品”仍是《世界卫生组织2008年至2013年药品战略草案》(PDF文本)的重要部分。在使用‘假冒伪劣’词汇的同时,世界卫生组织的战略文件写到,“与药品制造的公共卫生问题相比,更重视其经济要素的国家政策”很可能会提高假药出现的概率,同类问题还包括“极端分散的流通渠道,基本脱离监管和执法视线的治外法权贸易区;为非正规从业者创造机会的卫生服务短缺和不可靠药品供应渠道问题;文盲与贫困问题。”

    世界卫生组织将于今年5月就这些问题向世界卫生大会提交报告。

    会上出现的另一个问题也是在世贸组织经常讨论的问题:欧洲港口对大部分源于印度的仿制药品运输延误的问题。

    印度代表在发言中指出,收缴仿效药问题造成的一个后果就是混淆假冒伪劣药品与仿效药。欧盟在3月份向印度通报了欧洲各国因知识产权侵权而发生的大约26次收缴药品事件,但是,印度仍然等候这些药品是否为次品的消息。欧洲则反驳说,从2008年以来没有出现对合法的仿效药进行错误收缴的事件。

    劳玉军译

     


    Leave a Reply

    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website. By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website.

    By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    1. You agree that you are fully responsible for the content that you post. You will not knowingly post content that violates the copyright, trademark, patent or other intellectual property right of any third party or which you know is under a confidentiality obligation preventing its publication and that you will request removal of the same should you discover that you have violated this provision. Likewise, you may not post content that is libelous, defamatory, obscene, abusive, that violates a third party's right to privacy, that otherwise violates any applicable local, state, national or international law, that amounts to spamming or that is otherwise inappropriate. You may not post content that degrades others on the basis of gender, race, class, ethnicity, national origin, religion, sexual preference, disability or other classification. Epithets and other language intended to intimidate or to incite violence are also prohibited. Furthermore, you may not impersonate others.

    2. You understand and agree that Intellectual Property Watch is not responsible for any content posted by you or third parties. You further understand that IP Watch does not monitor the content posted. Nevertheless, IP Watch may monitor the any user-generated content as it chooses and reserves the right to remove, edit or otherwise alter content that it deems inappropriate for any reason whatever without consent nor notice. We further reserve the right, in our sole discretion, to remove a user's privilege to post content on our site. IP Watch is not in any manner endorsing the content of the discussion forums and cannot and will not vouch for its reliability or otherwise accept liability for it.

    3. By submitting any contribution to IP Watch, you warrant that your contribution is your own original work and that you have the right to make it available to IP Watch for all purposes and you agree to indemnify IP Watch, its directors, employees and agents against all damages, legal fees and others expenses that may be incurred by IP Watch as a result of your breach of warranty or of these terms.

    4. You further agree not to publish any personal information about yourself or anyone else (for example telephone number or home address). If you add a comment to a blog, be aware that your email address will be apparent.

    5. IP Watch will not be liable for any loss including but not limited to the following (whether such losses are foreseen, known or otherwise): loss of data, loss of revenue or anticipated profit, loss of business, loss of opportunity, loss of goodwill or injury to reputation, losses suffered by third parties, any indirect, consequential or exemplary damages.

    6. You understand and agree that the discussion forums are to be used only for non-commercial purposes. You may not solicit funds, promote commercial entities or otherwise engage in commercial activity in our discussion forums.

    7. You acknowledge and agree that you use and/or rely on any information obtained through the discussion forums at your own risk.

    8. For any content that you post, you hereby grant to IP Watch the royalty-free, irrevocable, perpetual, exclusive and fully sub-licensable license to use, reproduce, modify, adapt, publish, translate, create derivative works from, distribute, perform and display such content in whole or in part, world-wide and to incorporate it in other works, in any form, media or technology now known or later developed.

    9. These terms and your posts and contributions shall be governed and interpreted in accordance with the laws of Switzerland (without giving effect to conflict of laws principles thereof) and any dispute exclusively settled by the Courts of the Canton of Geneva.

     

     
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