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出自识林

2015-07-31 识林

7月31日纽约时报新发表一篇关于TPP（跨太平洋合作伙伴协议）谈判的文章。所谓的最后一次谈判会议正在毛伊岛举行。然而，时报报道“数十个问题仍然没有得到解决”。其中之一就是美国推动延长药品专营期，并完全，从而制药公司可以设定任何“市场将承担”的价格。

美国显然正在推动专营期（他们称之为数据保护）延长至12年，并引证美国生物类似物立法给予生物制品12年而不是由来已久的Hatch-Waxman给予小分子药物5年的专营期。报告指出，美国谈判代表认为，他们不能去对抗现行美国法律中12年的专营期，通常忽略了一个事实，在美国绝大部分药品仅有5年的专营期。

根据报道，澳大利亚率先反对这一专营期，坚持现有5年专营期的坚定立场。澳大利亚谈判代表指出，需要“6年或7年时间开发复杂生物制剂”，因此真正的保护周期远长于“数据保护”期。许多国家在专利到期之前不能开始开发，专营权到期之前不能提交。

报道指出，“谈判观察员认为12年数据保护窗口几乎可以肯定将被缩减至五到七年，这将既无法令制药公司及其盟友满意，也无法令敦促推翻整个专利体系的激进分子们满意。”提到“激进分子”，是那些相信人人都应该有机会获得拯救生命的药品，并认为药品不应该有专利的组织。

就澳大利亚本身而言，其大多数医药费用涵盖在国家卫生计划中，更长的数据保护期所产生的更高费用将直接由纳税人支付，而这些钱大部分直接进入了美国制药公司。澳大利亚国会议员声称会一直坚持现有的5年专营期，将不会支持任何更长的期限。在美国的药品费用是由并不真正在乎支付多少钱的私人保险公司支付的（不管怎样，他们都有盈利），而在像澳大利亚这样的国家，药费是由真正关心花销的纳税人支付的。

幸运的是我们不需要等待很久就可以得知最终会达成什么样的妥协，但需要再稍微等等看都是哪些国家选择进入TPP。

作者：识林-Pepper
翻译：识林-椒
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TPP Goes Down to the Wire!
Dr. Pepper

The New York Times published a new article on the TPP negotiations today (July 31, 2015). What is being called the final negotiating session is underway in Maui. However the Times reports that “dozens of issues remain unresolved”. One of these is the US push to extend exclusivity periods for pharmaceuticals and to free up pricing so that pharmaceutical companies can set any price that “the market will bear” as they like to say. The US is apparently pushing the extension of exclusivity (Data Protection as they call it) to 12 years and citing the biosimilar legislation in the US which gave biologicals 12 years rather than the long standing 5 years the Hatch-Waxman gave to small molecule drugs. The report states that US negotiators are saying that they can’t go against the 12 years in current US law, conveniently ignoring the fact that the vast bulk of pharmaceuticals in the US have only 5 years of exclusivity.

According to the report Australia is leading the push back against this exclusivity and are holding a firm line at the existing 5 years. Australian negotiators point out that it takes “6 or 7 years to develop complex biologicals” so the real period of protection is significantly longer than the period of “data protection”. In many countries development cannot begin until patents expire and you cannot file until exclusivity expires. The report states that “Observers to the negotiations say the 12-year data-protection window almost certainly will be scaled back to five to seven years, a move that will probably satisfy neither the pharmaceutical firms and their allies nor the activists pressing to overturn the whole patent system.” The reference to “activists” is to groups who believe that everyone should have access to life saving drugs and so think there should be no patents on drugs.

Australia for its part points out that in countries where the majority of pharmaceutical costs are covered by a national health scheme the much higher costs that would come from a longer period of data protection would come directly from the taxpayers of those countries and go to largely American pharmaceutical companies. They are holding firm on the current 5 years stating that Australian lawmakers will not support anything longer. This serves to point out the big problem here, in the US the cost of pharmaceuticals is paid by private insurance companies who don’t really care how much they cost (they make a profit anyway) whereas in countries like Australia the cost is paid by taxpayers who do really care how much they cost.

With luck we will not have to wait much longer to find out what the compromise will be in the final agreement, but somewhat longer to see which countries will vote to support their entry into the TPP.

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