（自由贸易区观察研究系列随笔)

前一段，总部设在美国华盛顿的非政府组织“公共公民”（Public Citizens)给我来信，请我帮助他们校订一个关于TPP问题的英文稿件，我觉得这个稿子（实际上是个NGO的立场声明）可以给中国的政策制定者和研究者们一个新视角，即如何从公共卫生服务可及性的角度，来看待TPP可能给亚太地区国家，尤其是落后国家带来的损害。而中国又应该在其中扮演一种什么样的角色，或者说，中国如何能够帮助发展中国家“说话”？对于中国来说，这似乎将是一个全新的历程。公共公民作为一家美国的非政府组织，目前在全球南方国家药物倡导和自由贸易区政策倡导方面，已经开始起着协调和领导的作用。

泛太平洋伙伴关系（TPP）是澳大利亚、文莱、智利、马来西亚、新西兰、秘鲁、新加坡、美国和越南正在进行磋商的一个自由贸易协议（加拿大和墨西哥最近加入了该谈判）。美国更是雄心勃勃地试图将TPP的条款最终适用到约占世界人口一半的整个亚太地区。

TPP谈判各方均承诺，这将是一个“高标准的、21世纪的协议。”美国贸易代表（USTR）的提案将会危及可负担范围内药品的可及性，而提案中的这些措施以前是没有在美国的其他贸易协定里出现过的。这些提案将改变相关国家在专利和数据保护方面的法律。美国贸易代表的这些要求将加强，延伸并扩大药企的垄断。

美国贸易代表的提案还会对TPP国家里潜在的新兴仿制药供应商产生限制。TPP规定在该区域的施行，会限制仿制药品的规模经济，从而阻止仿制药品价格降低。这些风险综合在一起，将尤其会妨碍仿制药的竞争，导致亚太地区包括癌症、心脏病、艾滋病药物在内的药品价格提高而超过人们的支付能力。

已批露的文件显示，美国的提议将会导致：

• 扩大专利范围：通过降低可专利性标准，允许对外科手术、治疗方法以及老药品的细微变化授予专利等措施，扩大专利范围并创造新的药品垄断——尽管上述方法并没有提高效率。

• 延长药品垄断期：如果在专利局或者规制机构的审核时间超过了一定期限，则要求TPP国家延长药品专利保护期。

• 消除防止专利滥用的保障措施：比如取消第三方挑战专利申请的权利（授予专利前的反对）。

• 要求相关国家在批准某一种仿制药的本国市场销售时，需要取决于该药品的专利状况（专利链接），专利链接增加了专利滥用的风险。在专利链接制度下，即使是低质量的专利也会成为仿制药登记的极大妨碍。

• 通过对新药提供至少五年的数据信息保护期，以及对旧药品的新用途提供另外三年的数据信息保护期，以延长对于规制数据的商业控制（数据保护）——即便是这些信息已经进入公共领域。

How the TPP EndangersAccess to Affordable Medicines

By Public Citizens in D.C.

The Trans-Pacific Partnership (TPP) is a proposed free trade agreement under negotiation between Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, the United States and Vietnam (Canada and Mexico have recently joined). The United States has ambitions to eventually apply the terms of the proposed TPP to the entire Asia-Pacific region--roughly half the world’s population.

The negotiating parties to the TPP pledged that it will represent a “high-standard, 21st century agreement.” The U.S. Trade Representative (USTR) has proposed measures harmful to access to affordable medicines that have not been seen before in U.S. trade agreements. These proposals would transform countries’ laws on patents and medical test data, and include attacks on government medicine formularies. USTR’s demands would strengthen, lengthen and broaden pharmaceutical monopolies.  USTR’s proposals could constrain potential and emerging generics suppliers in TPP countries. Applied regionally, the TPP would limit the economies of scale necessary to keep generic medicine prices low. These risks combined make the TPP especially dangerous for generic competition and access to affordable medicines against cancer, heart disease, and HIV/AIDS, among others, in the Asia-Pacific region.

Leaked texts have revealed that the U.S. proposal would:

•  Expand the scope of pharmaceutical patents and create new drug monopolies by lowering patentability standards and requiring patents be available for surgical and treatment methods as well as minor variations on old medicines -- even if they do not enhance efficacy. 

•     Lengthen drug monopolies by requiring countries to extend patent terms if review at the patent office or regulatory authority exceeds a prescribed period. 

•         Eliminate safeguards against patent abuse, including among others, the right of third parties to challenge patent applications (pre-grant opposition).

•Risk facilitating patent abuse by requiring countries to condition marketing approval on patent status (patent linkage). Under patent linkage, even spurious patents may function as barriers to generic drug registration.

•     Extend commercial control over regulatory information (expand “data exclusivity”) by providing at least five years exclusivity for information related to new products and three more in cases of new uses for old medicines -- even when that information is in the public domain.