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Measures Affecting the Approval and Marketing of Biotech Products

Key Facts
Short Title: EC — Approval and Marketing of Biotech Products
Respondent: European Communities
Third Parties: Argentina; Brazil; Canada; Chile; Colombia; El Salvador; Honduras; Mexico; Paraguay; Peru; Uruguay; China; Chinese Taipei; Norway; Australia; New Zealand; Thailand;
Complaintant(s): United States;
Dispute Number: DS291
Link to Dispute Site: http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds291_e.htm
Dispute Subject(s): Agricultural Products; GMOs (Biotech Products); Import Measures;
Dispute Status: Pending
Complaints by the United States (WT/DS291), Canada (WT/DS292) and Argentina (WT/DS293).

On 13 May 2003, the United States and Canada requested consultations with the EC concerning certain measures taken by the EC and its member States affecting imports of agricultural and food imports from the United States and Canada. Regarding EC-level measures, the US and Canada asserted that the moratorium applied by the EC since October 1998 on the approval of biotech products has restricted imports of agricultural and food products from the US and Canada. Regarding member State-level measures, the US and Canada asserted that a number of EC member States maintain national marketing and import bans on biotech products even though those products have already been approved by the EC for import and marketing in the EC. On 14 May 2003, Argentina requested consultations with the EC on the same matter.

According to the US, the measures at issue appear to be inconsistent with the EC's obligations under:

* Articles 2, 5, 7 and 8, and Annexes B and C of the SPS Agreement;

* Articles I, III, X and XI of the GATT 1994;

* Article 4 of the Agriculture Agreement; and

* Articles 2 and 5 of the TBT Agreement.

According to Canada, the measures at issue appear to be inconsistent with the EC's obligations under:

* Articles 2.2, 2.3, 5.1, 5.5, 5.6, 7 and 8, and Annexes B and C of the SPS Agreement;

* Articles 2.1, 2.2, 2.8, 5.1 and 5.2 of the TBT Agreement;

* Articles I:1, III:4, X:1 and XI:1 of the GATT 1994; and

* Article 4.2 of the Agriculture Agreement.

Canada also considered that the measures at issue nullify or impair benefits accruing to Canada in the sense of Article XXIII:1(b) of the GATT 1994.

According to Argentina, the measures at issue appear to be inconsistent with the EC's obligations under:

* Articles 2, 5, 7, 8 and 10, and Annexes B and C of the SPS Agreement;

* Article 4 of the Agriculture Agreement;

* Articles I, III, X and XI of the GATT 1994; and

* Articles 2, 5 and 12 of the TBT Agreement.

In dispute WT/DS291, Australia, Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, New Zealand and Peru requested to join the consultations, The EC informed the DSB that they had accepted the requests of Australia, Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, New Zealand and Peru to join the consultations.

In dispute WT/DS292, Australia, Argentina, Brazil, India, Mexico, New Zealand and the United States requested to join the consultations. The EC informed the DSB that they had accepted the requests of Australia, Argentina, Brazil, India, Mexico, New Zealand and the United States to join the consultations.

In dispute WT/DS293, Australia, Brazil, Canada, India, Mexico, New Zealand and the United States requested to join the consultations. The EC informed the DSB that they had accepted the requests of Australia, Brazil, Canada, India, Mexico, New Zealand and the United States to join the consultations.

On 7 August 2003, the United States, Canada and Argentina each requested the establishment of a panel. At its meeting on 18 August 2003, the DSB deferred the establishment of the panels. Further to second requests to establish a panel from the US, Canada and Argentina, the DSB established a single panel at its meeting on 29 August 2003.

On 23 February 2004, the United States, Canada and Argentina requested the Director-General to compose the panel. On 4 March 2004, the Director-General composed the panel. Argentina (in respect of the United States' and Canada's complaints), Australia, Brazil, Canada (in respect of the United States' and Argentina's complaints), Chile, China, Colombia, El Salvador, Honduras, Mexico, New Zealand, Norway, Paraguay, Peru, Chinese Taipei, Thailand, Uruguay and the United States (in respect of Canada's and Argentina's complaints) reserved their third-party rights.

On 12 July 2004, the Chairman of the Panel informed the DSB that it would not be able to complete its work in six months, due, inter alia, to the parties' common request for additional time to prepare their rebuttals. On 18 August 2004, the Chairman of the Panel informed the DSB that that the Panel estimated that it would issue its final report to the parties by the end of March 2005, and that the delay was due to the parties' common request for additional time to prepare their rebuttals as well as the Panel's decision to seek scientific and technical expert advice pursuant to Article 11 of the Agreement on Sanitary and Phytosanitary Measures and Article 13 of the DSU. On 2 November 2004, the Chairman of the Panel informed the DSB that as a result of the time taken to identify and select experts and, more importantly, in view of a joint request by all four parties that they be granted additional time to prepare their further submissions to the Panel, it would not be possible for the Panel to issue its final report to the parties by the end of March 2005, and that the Panel estimated that it would issue its final report to the parties by the end of June 2005. On 13 June 2005, the Panel informed the DSB that the Panel estimated that it would issue its final report to the parties by the end of October 2005. On 11 August 2005, the Panel estimated that it would issue its final report to the parties by the end of December 2005. On 21 December 2005, the Chairman of the Panel informed the DSB that the Panel required additional time to prepare and finalize its report. The Panel estimated that it would issue its final report to the parties be the end of March 2006. On 30 March 2006, the Chairman of the Panel informed the DSB that it would not be possible to issue its final reports to the parties at the end of March 2006 as the Panel has yet to receive, in the second half of April, further comments from the parties on its interim reports. The Panel estimates that it will issue its final reports to the parties by mid-May 2006. It is estimated that the final reports will be circulated to Members no later than the end of September 2006.

On 29 September 2006, the panel reports were circulated to Members. The Panel found that the European Communities applied a general de facto moratorium on the approval of biotech produvcts between June 1999 and August 2003, which is when this Panel was established. Before the Panel, the European Communities had categorically denied the existence of such a moratorium. The Panel further found that, by applying this moratorium, the European Communities has acted inconsistently with its obligations under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement because the de facto moratorium led to undue delays in the completion of EC approval procedures. The Panel, however, found that the European Communities has not acted inconsistently with its obligations under other provisions raised by the complaining parties, including Articles 5.1, 5.5, 5.6, 2.2 or 2.3 of the SPS Agreement.

With regard to the product-specific EC measures, the Panel found that the European Communities has acted inconsistently with its obligations under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement in respect of the approval procedures concerning 24 out of 27 biotech products identified by the complaining parties because there were undue delays in the completion of the approval procedures for each of these products. The Panel found, however, that the European Communities has not acted inconsistently with its obligations under any other provisions raised by the complaining parties, including Articles 5.1, 5.5 and 2.2 of the SPS Agreement , with regard to any of the products concerned.

With regard to the EC member State safeguard measures, the Panel found that the European Communities acted inconsistently with its obligations under Articles 5.1 and 2.2 of the SPS Agreement with regard to all of the safeguard measures at issue, because these measures were not based on risk assessments satisfying the definition of the SPS Agreement and hence could be presumed to be maintained without sufficient scientific evidence.

At its meeting on 21 November 2006, the DSB adopted the panel reports.

Implementation Status of Adopted Reports

At the DSB meeting on 19 December 2006, the European Communities announced its intention to implement the recommendations and rulings of the DSB in a manner consistent with its WTO obligations. However, due to the complexity and sensitivity of the issues involved, the European Communities would need a reasonable period of time for implementation. Pursuant to Article 21.3(b) of the DSU, the European Communities was ready to discuss an appropriate timeframe with Argentina, Canada and the United States.

On 21 June 2007, the United States and the European Communities, Canada and the European Communities, and Argentina and the European Communities respectively notified the DSB that they had agreed that the reasonable period of time for the European Communities to implement the recommendations and rulings of the DSB shall be twelve months from the date of the adoption of the panel reports. Accordingly, the reasonable period of time expires on 21 November 2007. On 21 November 2007, the parties informed the DSB that they had agreed to modify the reasonable period of time so as to expire on 11 January 2008.

On 11 January 2008, the European Communities and Canada, with respect to dispute WT/DS292, informed the DSB that they had agreed to modify the reasonable period of time so as to expire on 11 February 2008. On 11 February 2008, the European Communities and Canada, informed the DSB that they had agreed to modify once more the reasonable period of time so as to expire on 30 June 2008. On 23 June 2008, the European Communities and Canada, informed the DSB that they had agreed to modify once more the reasonable period of time so as to expire on 31 July 2008. On 29 July 2008, the European Communities and Canada, informed the DSB that they had agreed to modify once more the reasonable period of time so as to expire on 31 December 2008. On 16 December 2008, the European Communities and Canada, informed the DSB that they had agreed to modify once more the reasonable period of time so as to expire on 1 March 2009.

On 11 January 2008, the European Communities and Argentina, with respect to dispute WT/DS293, informed the DSB that they had agreed to modify the reasonable period of time so as to expire on 11 June 2008. On 11 June 2008, the European Communities and Argentina informed the DSB that they had agreed to modify the reasonable period of time so as to expire on 12 August 2008. On 12 August 2008, the European Communities and Argentina informed the DSB that they had agreed to modify the reasonable period of time so as to expire on 1 December 2008. On 1 December 2008, the European Communities and Argentina informed the DSB that they had agreed to modify the reasonable period of time so as to expire on 1 March 2009.

On 14 January 2008, the European Communities and the United States informed the DSB that they had reached an agreement on procedures under Articles 21 and 22 of the DSU with respect to dispute WT/DS291. On 17 January 2008, the United States requested authorization from the DSB to suspend concessions and other obligations with respect to dispute WT/DS291. On 6 February 2008, the European Communities objected to the United States' request for authorization to suspend concessions and other obligations and referred the matter to arbitration under Article 22.6 of the DSU. At its meeting on 8 February 2008, the DSB agreed that the matter had been referred to arbitration under Article 22.6 of the DSU. On 15 February 2008, the European Communities and the United States requested the Arbitrator to suspend its work pursuant to their agreed procedures under Articles 21 and 22 of the DSU. In accordance with the parties' joint request, the Arbitrator suspended the arbitration proceedings from 18 February 2008 until the United States requests their resumption under the circumstances agreed between the parties on 14 January 2008.

Panel Proceedings
Brief DateBrief Description
03/23/2005Executive Summary of the U.S. Opening Statement at the Second Meeting (Expert Issues) (pdf)
03/23/2005Executive Summary of the U.S. Opening Statement at the Second Meeting (Legal Issues) (pdf)
03/18/2005Comments of the United States on the EC's Responses to the Panel's Questions after the Second Meeting (pdf)
03/11/2005Responses of the United States to the Additional Questions by the Panel Posed in the Context of the Second Substantive Meeting with the Parties (pdf)
02/22/2005U.S. Opening Statement at the Second Meeting (Legal Issues) (pdf)
02/21/2005U.S. Opening Statement at the Second Meeting (Expert Issues) (pdf)
12/03/2004Executive Summary of U.S. Supplementary Rebuttal Submission (pdf)
11/15/2004U.S. Supplementary Rebuttal Submission (pdf)
08/16/2004Comments of the United States on Suggested Questions for Scientific or Technical Experts (pdf)
07/19/2004Rebuttal Submission of the United States (pdf)
07/29/2004Executive Summary of the U.S. Rebuttal Position (pdf)
07/27/2004Comments of the United States on the EC's Final Position on Whether to Seek Advice from Scientific Experts (pdf)
06/17/2004Executive Summary of the Oral Statement of the United States at the First Panel Meeting (pdf)
06/16/2004Responses of the United States to the Questions by the Panel and the European Communities Posed in the Context of the First Substantive Meeting with the Parties (pdf)
06/02/2004Oral Statement of the United States at the First Panel Meeting (pdf)
04/30/2004Executive Summary of the First Submission of the United States (pdf)
04/21/2004First Submission of the United States (pdf)
04/15/2004Executive Summary of the Response of the United States to the Request for a Preliminary Ruling Submitted by the European Communities (pdf)
03/29/2004Response of the United States to the Questions by the Panel Pertaining to the Request by the European Communities for a Preliminary Ruling (pdf)
03/24/2004Response of the United States to the Request for a Preliminary Ruling Submitted by the European Communities (pdf)