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USTR Engagement on Pharmaceutical And Medical Device Issues
The 2018 Special 301 Report highlights concerns regarding intellectual property (IP) protection and enforcement and market access barriers affecting U.S. entities that rely on IP protection, including those in the pharmaceutical and medical device industries.
In order to promote affordable healthcare for Americans and the innovation to preserve access to the cutting-edge cures and therapies, USTR has been engaging with trading partners to ensure that U.S. owners of IP have a full and fair opportunity to use and profit from their IP.
USTR has sought to ensure robust IP systems and reduce market access barriers to pharmaceutical products and medical devices so that trading partners contribute their fair share to the research and development of new cures and therapies.
This includes fighting against measures that discriminate against U.S. companies, are not adequately transparent, or do not offer sufficient opportunity for meaningful stakeholder engagement, as well as pressing trading partners to appropriately recognize the value of innovative medicines. The Report also highlights concerns regarding unfair uses of compulsory licenses.
Examples of USTR actions include:
- Seeking strong IP provisions, which are important to incentivizing innovation, in the renegotiation and modernization of the North American Free Trade Agreement (NAFTA) with Canada and Mexico. USTR is also seeking provisions to ensure that federal government regulatory reimbursement regimes are transparent, provide procedural fairness, are nondiscriminatory, and provide full market access for U.S. products.
- Obtaining under the new U.S.-Korea Free Trade Agreement (KORUS FTA) Korea’s commitment to reform a key measure to better implement its KORUS FTA obligations to provide fair and non-discriminatory treatment of pharmaceutical products. This includes imported products, under certain medical pricing and reimbursement programs.
- Engaging with Japan in the context of the U.S.-Japan Economic Dialogue to ensure transparency and fairness and address other concerns with respect to pharmaceutical pricing and reimbursement policies.
- Pressing China on a range of issues affecting the pharmaceutical sector, including providing for effective protection against unfair commercial use, as well as unauthorized disclosure, of test or other data generated to obtain marketing approval for pharmaceutical products. USTR is also pressing China to expedite its implementation of an effective mechanism for the early resolution of potential patent disputes.
- Engaging with India to secure meaningful IP reforms on longstanding issues, including patentability criteria, criteria for compulsory licensing, protection against unfair commercial use, and unauthorized disclosure, of test or other data generated to obtain marketing approval for pharmaceutical products.
- Pressing Indonesia to resolve concerns regarding revisions to Indonesia’s patent law, such as its patentability criteria, local manufacturing and use requirements, and the grounds and procedures for issuing compulsory licenses.
- Raising concerns with Argentina regarding the scope of patentable subject matter and effective protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products, among other issues.
- Engaging with Saudi Arabia regarding the protection and enforcement of patents and effective protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical products, among other issues.
- Seeking confirmation that the United Arab Emirates will continue to protect pharmaceuticals through local procedures and the Gulf Cooperation Council (GCC) patent system.