Health and other WTO Agreements

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9.3 The Agreement on Technical Barriers to Trade (TBT)

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The TBT Agreement aims to ensure that product requirements, and procedures that are used to assess compliance with those requirements, do not create unnecessary obstacles to trade. The Agreement applies to product requirements that are mandatory as well as voluntary. It covers product requirements developed by governments (at the central or local level) or private entities, whether at the national or the regional level.

All Members have the right to develop mandatory product requirements for legitimate objectives. These legitimate objectives include the protection of human health or safety, the protection of animal or plant life or health, the protection of the environment, national security interests, and the prevention of deceptive practices.

The Agreement lays out a number of principles which Members are to observe in the preparation, adoption and application of technical requirements, and the procedures to assess compliance with those requirements (known as conformity assessment procedures). The first requirement is the non-discrimination principle. With respect to technical requirements, non-discrimination means that if a Member applies certain requirements to imported products, it has to apply the same requirements to like domestic products (national treatment). If it applies a requirement to imports from one source, it has to apply it to like imports from all other sources as well (most-favoured-nation treatment). With respect to conformity assessment procedures, the principle means that Members must not subject like imported goods to more stringent testing and inspection requirements based on their source, or subject domestically produced goods to more lenient ones than like imported goods.

The second requirement is that of the avoidance of unnecessary obstacles to trade. With respect to mandatory technical requirements and conformity assessment procedures that means that Members must design these in the way that is the least trade restrictive, making them proportional to the objectives which they are trying to fulfil. The third principle is harmonization, by which the Agreement encourages Members to use international standards. The objective of using international standards is to avoid the creation of undue layers of technical requirements and conformity assessment procedures at the national level which can obstruct trade. Fourth is the principle of equivalence of mandatory requirements. The Agreement calls upon Members to recognize as equivalent the technical requirements of other Members even if they differ from their own, provided that they fulfil the same final objective. The Agreement also calls upon Members to recognize each others’ conformity assessment procedures, so as to avoid subjecting products to multiple tests. The last principle is transparency. Members have to notify the WTO of requirements whose adoption they are considering if those requirements might have a significant effect on trade and are not based on an international standard. They have to allow time for other Members to comment on these requirements, and take comments into account.


The TBT Agreement and health  back to top

Protection of human, animal, plant and environmental health are among the legitimate objectives for which product requirements may be developed. Examples of measures that Members have notified that have human health as their objective include regulations related to radio communications equipment to reduce human exposure to electromagnetic radiation; regulation to reduce substances used in cosmetics which may instigate allergies; regulation of chemicals that may cause occupational health hazards. Of all TBT regulations notified to the WTO in 1997, 37% had human health as their objective. Measures taken for the protection of animal and plant life or health usually fall under the SPS Agreement, and thus less than 0.5% of all TBT notifications had these objectives.

There is a difference in coverage between the TBT Agreement and the SPS Agreement. The SPS Agreement covers a narrower, or more precisely defined set of measures relating to human, animal and plant life or health than does the TBT Agreement. To assess whether or not a health measure is covered by the TBT Agreement it is best to first figure out if it is an SPS measure. If it is an SPS measure, then it is not a TBT measure.


International harmonization  back to top

One of the main principles of the TBT Agreement is harmonization. The TBT Agreement does not contain a list of international organizations whose standards are considered international standards; it leaves the decision up to Members. Members do not have to use an international standard if they consider it ineffective or inappropriate to achieve their objective. They are free to set standards at a level they consider appropriate, but have to be able to justify their decisions if requested to do so by another Member. The Agreement also calls upon Members to play an active role in the process of international standardization.



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