Globalization and Access to Drugs - Health Economics and Drugs Series, No. 007
(1998; 97 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentAbbreviations and acronyms
Open this folder and view contentsPART I: GLOBALIZATION AND ACCESS TO DRUGS: IMPLICATIONS OF THE WTO/TRIPS AGREEMENT
Close this folderPART II: PRESENTATIONS AT THE AD HOC WORKING GROUP ON THE REVISED DRUG STRATEGY HELD IN GENEVA ON 13 OCTOBER 1998
View the document1. Speech of the WHO Director-General, Dr Gro Harlem Brundtland
View the document2. World Intellectual Property Organization (WIPO)
Close this folder3. World Trade Organization (WTO)
View the document3.1 Pharmaceutical Patents and the TRIPS Agreement
View the document3.2 Overview of the WTO Agreement on Technical Barriers to Trade
View the document4. South Centre
View the document5. Health Action International (HAI)
View the document6. International Federation of Pharmaceutical Manufacturers Associations (IFPMA)
View the document7. International Generic Pharmaceutical Alliance (IGPA)
View the documentOther documents in the DAP - Health Economics and Drugs Series
View the documentBack cover
 

3.2 Overview of the WTO Agreement on Technical Barriers to Trade

Speaker: Doaa Abdel Motaal

Overview

The WTO Agreement on Technical Barriers to Trade (TBT) entered into force in 1995, with the establishment of the WTO itself. It was developed in response to the rise of non-tariff barriers to trade, and addresses product technical requirements and conformity assessment procedures.

The TBT Agreement is premised on an acknowledgement of the right of WTO Members to develop technical requirements and conformity assessment procedures. However, it has as its objective ensuring that unnecessary obstacles to international trade are not created. This is achieved through a delineation of a number of legitimate objectives for which mandatory technical requirements may be developed, and through a number of principles which govern the preparation, adoption and application of mandatory and voluntary requirements and conformity assessment procedures, such as: non-discrimination, the avoidance of unnecessary obstacles to international trade, harmonization, the equivalence of technical regulations, mutual recognition, and transparency. The scope of the Agreement extends to central and local governmental standardizing bodies, as well as to non-governmental ones. A more detailed presentation of the Agreement is provided in the following sections.

Coverage and Definitions

The TBT Agreement divides technical requirements into two categories: technical regulations and standards. According to the Agreement, a technical regulation is a:

“Document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.”

On the other hand, a standard is a:

“Document approved by a recognized body, that provides for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.”

The main difference between technical regulations and standards is that compliance with technical regulations is mandatory, while compliance with standards is voluntary. While technical regulations are addressed through the main body of the Agreement, standards are addressed separately through a Code of Good Practice contained in an annex to the Agreement. Many of the principles applied by the Agreement to technical regulations apply to standards through the Code. However, the Code is open to acceptance by all central, local, and non-governmental standardizing bodies falling within the territory of a WTO Member, as well as to regional ones.

The Agreement also applies to conformity assessment procedures, and defines these as:

“Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled.”

Legitimate Objectives

Under the Agreement, technical regulations may only be developed for one or more of the objectives considered ‘legitimate’ by the Agreement. Legitimate objectives include: “inter alia, national security requirements, the prevention of deceptive practices, protection of human health or safety, animal or plant life or health, or the environment.” The risks associated with legitimate objectives are assessed against a number of factors, including: “inter alia, available scientific and technical information, related processing technology or intended end-uses of products.”

Non-discrimination

The principle of non-discrimination constitutes the backbone of the international trading system. In general, it is a principle which outlaws discrimination amongst the products of WTO Members, and between imported and domestically produced products. According to GATT Article I, the “Most-Favoured-Nation” (MFN) clause, WTO Members are bound to grant to the products of other Members treatment no less favourable than that accorded to the products of any other country. Thus, no country is to give special trading advantage to another, or to discriminate against it. According to GATT Article III, the “National Treatment” (NT) clause, Members must treat imported products no less favourably than domestically produced products. The TBT Agreement embraces the GATT principle of non-discrimination. It states that technical regulations, standards and conformity assessment procedures must be prepared, adopted and applied non-discriminatorily.

Avoidance of Unnecessary Obstacles to International Trade

The avoidance of unnecessary obstacles to international trade is the principal objective of the TBT Agreement. The Agreement states that technical regulations, standards and conformity assessment procedures must not be prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to trade. Technical regulations and conformity assessment procedures must not be more trade restrictive than necessary to fulfil a legitimate objective, taking into account the risks that non-fulfilment or non-conformity would create.

Harmonization

The TBT Agreement encourages WTO Members to base their technical regulations, standards, and conformity assessment procedures on international standards, guides and recommendations, when these exist or their completion is imminent, except when they are deemed to be inappropriate or ineffective. The call for harmonization is designed to avoid the emergence of undue layers of technical requirements and assessment procedures, and to encourage the use of ones developed by the international community. To complement this requirement, the Agreement calls upon Members to participate in the work of international standardizing and conformity assessment bodies. It recognizes that there may be instances in which Members would need to derogate from the obligation to harmonize, and, for certain specific instances, allows them to do so.

Equivalence and Mutual Recognition

The TBT Agreement calls upon Members to recognize other Members’ technical regulations as equivalent to their own, even when they differ from theirs, provided they are satisfied that they adequately fulfil their objectives. As international harmonization is a time-consuming process, and is sometimes one which is difficult to achieve, the Agreement encourages Members to accept each other’s regulations as equivalent until full-fledged international harmonization becomes possible. With respect to conformity assessment procedures, the Agreement calls upon Members to enter into mutual recognition agreements for the acceptance of each other’s assessment results. The purpose of this provision is to avoid multiple product testing and its associated costs.

Transparency

Transparency is a central feature of the TBT Agreement, and is comprised of: notification obligations, the establishment of enquiry points, and the creation of the WTO TBT Committee. Notification means the circulation of information by a WTO Member to other Members on matters relating to the Agreement. Notification obligations include: notifying the measures taken to implement the provisions of the TBT Agreement nationally (such as how its provisions have been incorporated into domestic legislation); notifying draft technical regulations, conformity assessment procedures and standards, and providing other Members with sufficient time to comment on them (with the obligation of taking these comments into account); and, notifying entry into any bilateral or multilateral agreements regarding technical regulations, standards or conformity assessment procedures.

The TBT Agreement stipulates that each WTO Member must establish an enquiry point that can respond to questions on technical regulations, standards and conformity assessment procedures (whether proposed or adopted), and supply relevant documents. The Agreement has also established a TBT Committee in the WTO, which is a standing body that acts as a forum for consultations on all issues pertaining to the Agreement. Participation in the Committee is open to all WTO Members.

Developing Countries

Under the TBT Agreement special and differential treatment for developing countries is authorized, and developed countries are encouraged to provide developing countries with technical assistance on matters pertaining to the Agreement.

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