印度时报：印度阻挠大型制药公司在WHO推行ICH（Julia翻译）

巴西木

原文网址：http://timesofindia.indiatimes.com/india/India-thwarts-Big-Pharma-push-at-WHO-assembly/articleshow/36573586.cms

India thwarts Big Pharma push at WHO assembly

印度阻挠大型制药公司在WHO推行ICH

The author has posted comments on this articleRema Nagarajan, TNN | Jun 15, 2014, 04.04AM IST

India has successfully thwarted Big Pharma's attempt to influence norm-setting for medicines in the resolution passed recently at the World Health Assembly in Geneva. India, along with several other countries, also objected to the World Health Organization's (WHO) involvement with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), a pharma industry initiative.

印度已经成功地阻挠了大型制药公司想要对WHO日内瓦集会通过的药品标准设定的决议案产生影响的企图。印度和其它几个国家一起，同时也反对WHO涉入ICH的技术要求统一活动。

Civil society organizations working for greater access to medicines are pleased with the Indian initiative. According to them, "harmonization", in this context, was just a euphemism for setting of industry-led standards which favour the interests of transnational pharmaceutical corporations and their push to weaken competition from generic medicines.

为更大的药品成功而努力的国内社团组织为印度的活动成功而高兴。据这些社团说，“统一活动”在这种情况下，仅强调设定行业领先标准，只对跨国药企有利，推进统一会弱化仿制药的竞争力。

The original draft of the resolution has several references to "harmonization of technical requirements for registrations of pharmaceuticals for human use" by developing appropriate norms and standards "taking into account the standards created by existing regional and international initiatives". India got all such references dropped before the resolution on regulatory system strengthening for medical products was adopted.

原始的决议案草稿中有几外引用“人用药注册技术要求协调组织”用于建立适当的标准，以及“考虑由已有地区和国际倡议创建的标准”。印度在法规体系强化其对药品要求被采纳前即成功地将这些引用全部抹去了。

"The WHO guidelines are advisory in nature. But if a resolution is adopted, it becomes binding on the member countries. We cannot be party to a resolution where the language is not clear. What exactly do you mean by convergence or harmonization of regulation? Who will harmonize with whom? The needs of different countries are different," said R K Jain, additional secretary in the health ministry. He, along with V G Somani of Central Drug Standards Control Organization (CDSCO), negotiated on India's behalf.

“WHO指南是建议性质的，但如果一个决议案被采纳，则对所有成员国均具有约束作用。我们不能在决议案的用词不明确的时候就同意通过。法规趋同或统一到底确切地想表达什么呢？谁统一谁？不同国家的需求肯定是不同的，”R.K.Jain，卫生部增补秘书说。他与中央药品标准控制组织（DESCO）的V.G.Somani一起，代表印度进行谈判。

"We are world leaders in generics, exporting to over 200 countries. Our exporters meet all the requirements of the importing countries. So, it is not as if we don't have standards but we need to be sure of the implications when we use the language of harmonization. ICH is industry-driven and many countries protested against it being brought into the resolution. We could convince the others and problem areas were ironed out," Jain explained.

“我们是全世界仿制药的先驱，仿制药出口至200个国家。我们的出口产品符合所有进口国家的要求。因此，并不是说我们没有标准，而是说我们需要保证我们在使用统一这个词的时候明白它的意义。ICH是一个企业促成的组织，许多国家抗议将它放入决议案中。我们可以说服其它国家，将有问题的地方清除掉，”Jain解释说。

Dr Gopakumar G Nair of the Indian Drug Manufacturers' Association (IDMA) is of the view that the Indian drug industry, though not happy with the talk of "harmonization" or with the ICH, did not protest much probably because it did not want to be seen opposing quality improvement initiatives. He pointed out that about 300-400 of the 700 odd IDMA members were qualified suppliers of the WHO and met all the good manufacturing standards prescribed by the WHO.

印度药企联合会（IDMA）的Dr Gopakumar G Nair从印度制药行业出发，尽管他并不喜欢“统一”这种说法，也不倾向于ICH，但他并没有提出太多抱怨，因为他不想反对提高质量的行动。他指出，700余家IDMA成员中，约有300-400家是WHO认证供应商，符合WHO的所有GMP要求。

"The WHO has extremely well qualified technical experts who set the standards and check the quality of the medicines supplied. About 70 IDMA members also supply generic medicines to the US and EU. But over the years, the global pharma industry has been 'raising the bar', upgrading benchmarks of quality to create trade barriers. They felt that raising the standards would help reduce competition from India. But then this has made it economically unviable for them to operate from their own countries. For low cost medicines they are forced to outsource to developing countries through contract manufacturing. Several multinational pharma products are contract manufactured by Indian companies," said Dr Nair.

“WHO的技术专家都很有资质，他们设定了标准，对销售的药品进行了质量检查。约有70家IDMA成员企业也向美国和欧盟销售仿制药。但在很长时间里，全球药企‘抬高了门槛’，提升了质量的标杆，形成贸易壁垒。他们以为提高标准会有助于削弱印度的竞争力，但实际上他们已经使得他们自己国家的运转成本不切实际。对于低成本药品，他们被迫通过合同加工方式向发展中国家采购。几个跨国药企的产品实际都是由印度制药公司合同生产的，”Dr Nair说。

Civil society groups like Medicus Mundi and the People's Health Movement had in their letter to WHO pointed out that while ICH sought to raise the bar on acceptable manufacturing standards and to globalize these, higher standards, beyond a point, did not add to the quality of the medicines or public health outcomes. "It adds to the cost of manufacturing and is a barrier to the entry of generics," stated the letter.

印度国内社团组织，如MEDICUS MUNDI和人民健康运动，在其致WHO的信中指出，当ICH在追求抬高其生产可接受标准的门槛，将其在全球推广时，并没有将更高的标准赋予药品质量或公众健康结果。信函声称“它增加生产成本，成为进入仿制药行业的壁垒”。

统一还是霸权？

一个行业创建的倡议妄图使药企“统一”技术要求成为WHO决议的条款

NGO说这就是大型制药公司要设立有利于他们的标准的委婉说法

印度和其它国家抗议，并成功将这些引用去除

syhorchid

顶一下

冰城

翻译的有点急啊，哈哈。
不错的新闻，阿三是很多么

tsingsea

阿三挺硬朗

左司马

印度人，牛……

wjcking123

牛........

道路漫长黑暗

仿制药这部分我们确实要跟印度学习，差距还是挺大的

LK8275610

学习。。。。。。。。。。。。。。

wsx

我们的sfda，哪里去了？想到这些没有。。

zeal602

嗯，一味的照抄欧美的标准，也不考虑实际的国情，劳民伤财，质量也不见得提高

墨石

无阿三不欢乐。终于蔓延到制药论坛了。