delays and potentially unfair reimbursement policies can discourage the development 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 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 industrialized trading partners, including Finland, France, Italy, Japan, Korea, New Zealand, Poland, and Taiwan, on issues related to innovation in the pharmaceutical sector and other aspects of health care goods and services. For example:
- With respect to Japan, pharmaceutical and medical device issues are an integral part of bilateral discussions. While Japan has made progress on these issues, the United States continues to press for improved transparency, which would facilitate the introduction of innovative pharmaceuticals and medical devices into Japan's market. Ways to improve transparency include ensuring meaningful opportunities for interested stakeholders to provide input into important regulatory, reimbursement, and pricing matters.
- With regard to Poland, the United States remains concerned about Poland's enactment in 2006 of a regulation that appears to reduce the official maximum wholesale and retail prices for imported drugs by 13 percent, while generally leaving the prices for drugs of Polish origin unchanged. The U.S. pharmaceutical industry reports that this regulation has had a significant impact by reducing prices for numerous products manufactured outside Poland. The United States is concerned that this regulation created an impediment to market access for this industry and will continue to monitor the situation in Poland throughout the coming year.
The United States is seeking to establish or continue dialogues with Organization for Economic Cooperation and Development (OECD) members and other developed economies to address these and other sectoral concerns, and encourage a common understanding on questions related to innovation in the pharmaceutical and medical device sectors. For example, the United States-Korea Free Trade Agreement, once in force, would improve access to innovative medical products and ensure the transparent, predictable, and non-discriminatory pricing and reimbursement of innovative and generic pharmaceutical products, and medical devices. Separately, the United States is also continuing its engagement with China to promote fair and transparent policies in this sector.
The United States shares policy goals and concerns related to health care with other countries, including challenges surrounding aging populations and rising health care costs. The United
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