MITA Members Positively Impacted by Trans-Pacific Partnership (TPP)

10.14.15

TPP promises new markets, improved transparency for medical imaging industry

This October, U.S. Trade Representative Michael Froman joined trade ministers from 11 other countries to announce that negotiations on the Trans-Pacific Partnership (TPP) have finally concluded.  This is a big victory for MITA members, as the medical imaging industry stands to gain significantly from several aspects of TPP.  MITA advocates for swift Congressional approval of the deal, and encourages members to contact their Senators and Representatives to voice their support directly.

MITA proactively and productively engaged with U.S. negotiators from the moment the United States joined the negotiations in 2009, with the chapters relevant to medical devices among the earliest to be concluded. MITA has successfully advocated in favor of provisions to guarantee that regulatory and coverage systems in the signatory countries are more transparent, predictable, and in line with global best practices and international standards. Although the complete text won’t be made public for another month, we do know that the TPP holds many benefits for the medical imaging industry.

Here are some important highlights of the TPP agreement that impact MITA members:

  • Eliminates import taxes on products made in and shipped between signatory countries. For example, an 8% tariff that adds $240,000 in taxes to a new 3T MRI machine will disappear. Higher end, higher-profit equipment will be more affordable to consumers without companies lowering the price.
  • Streamlines trade paperwork, and eliminates red tape at customs, all of which pose disproportionate challenges to small and new-to-exporting businesses. TPP enables a “single-window” approach to trade; that is, all documentation, testing reports, licenses, etc. needed to get a product sold into country can be submitted to a single place. The amount of documentation required is reduced. This all will save time and resources, and improve predictability of customs clearance.
  • Conformity assessment reports from one signatory country will be accepted by all of them. This will eliminate duplicative EMC testing, impact testing, and other assessments which are costly and destructive to expensive machinery that could otherwise be sold.
  • Eliminates need for product registration in country of origin (COO approval). This means that a product designed for another country than the one in which it was manufactured will no longer need to gain regulatory approval in the country of manufacture before the regulatory application process can be started in the country of sale.
  • Import/export licenses have been abolished in all but a few select instances/countries. This means it is no longer necessary for a company to obtain a license to import or export a product from one country to another for purposes of sale, service, or recalls.
  • Consular transactions also are eliminated. There will be no transaction for which an in-person visit to an embassy or consulate visit is needed, saving countless staff hours and resources.
  • All companies will receive “national treatment.” That means that any special process, lowered fees, or purchase opportunity afforded to domestic industry will be open to all companies regardless of where their headquarters lies. MITA members will see discriminatory barriers turned into business opportunities.
  • Medical device regulations are to be harmonized with international best practices, enabling signatory countries to implement harmonized regulations from the International Medical Device Regulators Forum (IMDRF) and other multilateral organizations. This will enable companies to comply with one set of regulations, but be able to sell products into any signatory country.

A chapter dedicated to supporting small- and medium-sized enterprises goes even further to ensure that all businesses can take advantage of newly opened and growing markets around the world. As health systems around the world grow more mature and sophisticated, medical imaging products are increasingly in demand, and MITA members stand to gain significantly from these dynamic new markets.

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