Page:Special 301 Report 2015.pdf/29

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enacted in some European countries that involve required remuneration or authorization for certain online activities relating to publishing excerpts from others' websites. The United States is closely monitoring these developments.

Market Access and Pharmaceutical and Medical Device Innovation

Among other mechanisms to support pharmaceutical and medical device innovation, USTR has sought to reduce market access barriers, including those that discriminate against U.S. companies, are not adequately transparent, or do not offer sufficient opportunity for meaningful stakeholder engagement, in order to facilitate both affordable health care today and the innovation that assures improved health care tomorrow. This year's Report highlights concerns regarding market access barriers affecting U.S. persons that rely on intellectual property protection, including the pharmaceutical and medical device industries, particularly in Algeria, India, and Indonesia.

Measures, including those that are discriminatory, nontransparent or otherwise trade-restrictive, have the potential to hinder market access in the pharmaceutical and medical device sector, and potentially result in higher healthcare costs. For example, taxes or tariffs may be levied – often in a non-transparent manner – on imported medicines, and the increased expense associated with those levies is then passed directly to healthcare institutions and patients. According to an October 2012 WTO report titled More Trade for Better Health? International Trade and Tariffs on Health Products, India maintains the highest tariffs on medicines, pharmaceutical inputs, and medical devices among the WTO members identified in the report. These tariffs, combined with domestic charges or measures, particularly those that lack transparency or opportunities for meaningful stakeholder engagement or that appear to exempt domestically-developed and -manufactured medicines, can hinder the Indian government's efforts to promote increased access to healthcare products.

Moreover, unreasonable regulatory approval delays and non-transparent reimbursement policies can impede a company's ability to exercise its rights, and thereby discourage the development and marketing of new drugs and other medical products. The criteria, rationale, and operation of such measures are often nontransparent or not fully disclosed to patients or to pharmaceutical and medical device companies seeking to market their products. USTR encourages trading partners to provide appropriate mechanisms for transparency, procedural and due process protections, and opportunities for public engagement in the context of their relevant health care systems.

U.S. industry has expressed concerns regarding the policies of several trading partners, including Algeria, Austria, Belgium, China, Colombia, Czech Republic, Ecuador, Hungary, Italy,

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