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Contact:
Wanda Moebius
202-434-7240
wmoebius@advamed.org
April 24, 2013

Enhancements to Trans-Pacific Partnership Agreement Needed

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) today submitted testimony to the Senate Finance Committee on the Trans-Pacific Partnership agreement, outlining specific objectives that AdvaMed believes should be addressed in the final agreement to help ensure full access to safe, effective and high-quality medical devices and diagnostics while advancing public health in the region.

“We applaud the Senate Finance Committee for holding hearings on this important, next-generation Asia-Pacific trade agreement,” said Ralph F. Ives, AdvaMed executive vice president, global strategy and analysis.

“Ongoing negotiations on the Trans-Pacific Partnership (TPP) agreement offer the opportunity for the U.S. to build on the high-standard free trade agreements it already has in the region to increase U.S. exports, boost economic growth and improve the quality of life for patients throughout the TPP member countries,” Ives said. TPP member countries include the U.S., Australia, Brunei Darussalam, Canada, Chile, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam.

AdvaMed would like to see the following objectives addressed in the final TPP agreement:

  • Non-tariff barriers: It is important for the TPP agreement to address non-tariff barriers affecting the medical device industry, especially non-transparent or discriminatory regulatory procedures.
  • Efficient regulatory processes: AdvaMed supports inclusion of provisions in the TPP agreement that will ensure that TPP countries grant efficient regulatory approvals while also ensuring product safety.
  • Harmonization: Provisions to encourage harmonization among the TPP countries of regulations that are necessary for determination of safety and efficacy, consistent with international norms, should be included in the TPP agreement.
  • Intellectual property rights protection: Intellectual property (IP) is a major contributor to economic growth, employment and success in the global economy, including health care. To promote U.S. competitiveness, a successful TPP agreement should incorporate state-of-the-art IP protections at a level similar to that of U.S. law. The TPP agreement should build on, but not diminish, IP protections found in each of the existing U.S. trade agreements with TPP countries.
  • Tariff elimination: The TPP agreement should provide for the most expeditious elimination of tariffs possible. Tariffs on medical devices simply serve to increase the cost of health care provided to patients.
  • Transparency and procedural fairness: AdvaMed supports the inclusion of provisions in the TPP agreement that would establish procedural fairness in the process by which national health care authorities establish reimbursement for medical devices. Such provisions would provide for a fair, predictable process that would limit disputes and enhance confidence in decision-making processes, thus contributing to good governance.

“Addressing these objectives will help meet 21st-century challenges facing U.S. businesses, support the creation and retention of high-quality American jobs and improve the quality of life for more patients around the world,” Ives said.

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