DISPUTE SETTLEMENT

DS: Argentina — Measures Affecting the Import of Pharmaceutical Products

This summary has been prepared by the Secretariat under its own responsibility. The summary is for general information only and is not intended to affect the rights and obligations of Members.

  

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(as cited in request for consultations)
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Summary of the dispute to date

The summary below was up-to-date at

Consultations

Complaint by India.

On 25 May 2001, India requested consultations with Argentina concerning Argentina’s Law No. 24.766 and Decree No. 150/92. According to India, these measures constitute unnecessary obstacles to international trade and prevent Indian medicines, drugs and other pharmaceuticals from entering into the Argentinean market, thus discriminating against Indian drugs vis-à-vis like products of other countries and of Argentina.

According to India, the above measures require that before entering the Argentinean market, all drugs and other pharmaceuticals must be registered with the National Administration of Drugs, Foodstuffs and Medical Technology, Ministry of Health of Argentina. The above Decree contains two annexes listing countries.

  • In respect of Annex I countries, pharmaceutical products are required to be manufactured in facilities approved by the relevant governmental bodies of these countries or by the Argentinean Ministry of Health and meet the National Health Authority’s manufacturing and quality control requirements.
     
  • In respect of Annex II countries, manufacturing facilities are required to be inspected and approved by the Ministry of Health of Argentina before export of these pharmaceutical products into Argentina.

According to India, it does not figure in either of those two annexes. This alleged discrimination would have led to total lack of market access for Indian drugs and pharmaceutical products in Argentina. India considered that infringement of the following provisions have taken place: Articles 2 (especially 2.2), 5 (especially 5.1 and 5.2) and 12 of the TBT Agreement; Articles I and III of the GATT 1994; and Article XVI:4 of the Agreement establishing the WTO.

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