The World Trade Organization Technical Barriers to Trade (TBT) Agreement aims to ensure that technical regulations, standards, and conformity assessment procedures are non-discriminatory and do not create unnecessary obstacles to trade. At the same time, it recognizes WTO members’ right to implement measures to achieve legitimate policy objectives, such as the protection of human health and safety, or protection of the environment. The TBT Agreement strongly encourages members to base their measures on international standards as a means to facilitate trade. Through its transparency provisions, it also aims to create a predictable trading environment.

World Trade Organization – Technical Barriers to Trade – Webpage

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World Trade Organization – Technical Barriers to Trade – Agreement Text

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G/TBT/1/REV. 8. Section IXDecision of the Committee on Principles for the Development of International Standards, Guides and Recommendations with Relation to Articles 2, 5 and Annex 3 of the Agreement.

The TBT agreement is a multilateral treaty obligation constituting international law. It is codified in each country of the Americas and its implementation is mandatory. Amongst its provisions, the Coalition notes the following three articles:

  • Article 2.2: Members shall ensure that technical regulations are not prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade. For this purpose, technical regulations shall not be more trade-restrictive than necessary to fulfil a legitimate objective…
  • Article 2.3: Technical regulations shall not be maintained if the circumstances or objectives giving rise to their adoption no longer exist or if the changed circumstances or objectives can be addressed in a less trade-restrictive manner.
  • Article 2.4: Where technical regulations are required and relevant international standards exist or their completion is imminent, Members shall use them, or the relevant parts of them, as a basis for their technical regulations…

For a detailed review of these topics pertaining to the Medical Technology Sector, please access the Training Session held on June 9, 2020: Presentation and Webinar Recording.