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Korea, Lithuania, New Zealand, Portugal, Romania, Spain, Taiwan, and Turkey, on issues related to pharmaceutical innovation and market access. Examples of these concerns include:
- In Algeria, a ban on a number of imported pharmaceutical products and medical devices in favor of local products is a trade matter of paramount concern in this market and is the primary reason why Algeria remains on the Priority Watch List. The United States urges Algeria to remove this market access barrier that is also reportedly adversely affecting access to legitimate medicines;
- With respect to Turkey, U.S. industry continues to express significant concerns regarding the lack of efficiency, transparency, and fairness in the pharmaceutical manufacturing inspection process;
- With respect to the EU, U.S. industry continues to identify a series of concerning measures in several Member States, including Austria, Belgium, Czech Republic, Finland, Hungary, Italy, Lithuania, Portugal, Romania, and Spain. Such measures raise concerns with respect to the transparency and the opportunity for meaningful stakeholder engagement in policies related to pricing and reimbursement, which reportedly create uncertainty and unpredictability that adversely impact market access and incentives for further innovation;
- In Colombia and Ecuador, proposals designed to enhance domestic manufacturing capacity for pharmaceuticals could adversely affect market entry and investment and, in effect, limit access by consumers to the latest generation of medicines. One of the Ecuadorian proposals appears to limit the use of trademarks on off-patent and other pharmaceutical products, which has the potential to adversely affect both generic and innovative manufacturers, and generate consumer confusion; and
- With respect to New Zealand, U.S. industry has expressed serious concerns about the policies and operation of New Zealand's Pharmaceutical Management Agency (PhARMAC), including, among other things, the lack of transparency, fairness, and predictability of the PhARMAC pricing and reimbursement regime, as well as the negative aspects of the overall climate for innovative medicines in New Zealand.
The United States seeks to establish, or continue, dialogues with trading partners to address these and other concerns and to encourage a common understanding on questions related to innovation in the pharmaceutical and medical device sectors. The United States also looks forward to continuing its engagement with our trading partners to promote fair and transparent policies in this sector.
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