ICTSD Outputs and Activities on Biotechnology, Trade and Sustainble Development

Biotechnology: Addressing Key Trade and Sustainability Issues

B.2 Multilateral trade rules

Q11 How should biotech regulations be notified?

Notification requirements are considered essential to achieving one of the fundamental aims of the WTO system: a greater degree of clarity, predictability and information about trade policies, rules and regulations of Members. In this regard, a direct link between notification requirements and transparency is often made in the WTO context. In the biotechnology context, the concept of ‘transparency’ is broader – including concerns regarding accurate information for an adequate scientific and public debate, and assessment of risks – but also incorporates the need to have access to information and to be able to influence biotechnology and biosafety-related decisions (van Dommelen, 2000). Under the SPS and TBT agreements, notification requirements are used to inform other WTO Members about new or changed regulations that affect trade, including through the obligation to respond to any specific questions other WTO Members may have. Notification requirements are complemented by rules regarding the publication of regulations. As will be seen below, both notification and publication rules came into play in the EC-Biotech case.

Article 2.9 of the TBT Agreement establishes that whenever a technical regulation is not based on international standards and “may have a significant effect on trade”, countries are required to notify other WTO Members through the WTO Secretariat, allowing for comments and taking these comments into account. To provide the opportunity for meaningful participation, notification requirements must be fulfilled at “an early appropriate stage”. Nevertheless, where urgent problems of safety, health, environmental protection or national security arise or threaten to arise, a country may omit the notification requirements as it finds necessary. It must, however, upon adoption of the technical regulation, fulfil several requirements including notifying other WTO Members through the WTO Secretariat and providing copies of the regulation upon request, allowing for comments and taking these comments into account.

Under the SPS Agreement WTO Members are obliged to notify other Members of changes and provide them with information on their sanitary or phytosanitary measures. In particular, and similarly to the TBT Agreement, when measures are not based on international standards and may have a significant effect on trade of other Members, countries must notify other Members through the Secretariat, allowing reasonable time for other Members to make comments in writing, discussing these comments upon request and taking the comments and the results of the discussions into account. However, where urgent problems of health protection arise or threaten to arise, a country may omit notification requirements. Nevertheless, once the measure is adopted, the country must, inter alia, immediately advise other Members of the regulations, allowing for comments and taking them into account.

The SPS Committee has adopted a number of recommendations in regard to notification procedures. In November 2000, the WTO Secretariat also prepared a handbook entitled How to apply the Transparency Provisions of the SPS Agreement. The handbook clarifies that the SPS Agreement does not require countries to notify the WTO of specific SPS decisions – for example, the marketing approval of a product containing GMOs – but rather of any proposed generally applicable SPS regulation such as a law, a decree or an ordinance, as well as proposed modifications to such regulations. Moreover, the obligation to notify only applies if there is no international standard, guideline or recommendation; or the proposed regulation is different to an existing international standard, guideline or recommendation; and if the regulation may have a significant effect on trade of other countries. When a regulation contains elements that fall under both the SPS and TBT agreements, it should be notified according to both.