. /.   WORLD TRADE  
ORGANIZATION  G/TBT/W/280 
30 October 2007 
 
 (07-4709) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
SPECIFIC TRADE CONCERNS RELATING TO ACCESS OF 
PHARMACEUTICALS TO THE ARGENTINE MARKET 
 
Communication from Colombia
 
 
 
 The following communication, dated 26 October 2007, is being circulated at the request of the delegation of Colombia
. 
 
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 1. Colombia has some concerns relating to the sy stem applied by the Argentine Republic for the 
entry of pharmaceuticals into its market, specifically, with regard to the classification of countries and 
the resulting application of conformity assessment procedures, as well as the classification and application of tariffs or fees for undertaking verifica tion visits to plants located in the countries of 
origin of the pharmaceuticals.  Colombia consid ers that some of the provisions governing these 
procedures may be considered contrary to the right s and obligations to be found in the World Trade 
Organization's Agreement on Technical Barriers to Trad e, particularly those regarding the principle of 
national treatment and transparency obligations. 
2. The foregoing can be seen from the following: 
(a) Colombian pharmaceuticals are recognized in Latin America as complying with 
quality standards and good manufacturing practice, as Colombia has made mandatory for assessment and certification procedures th e guidelines laid down in report No. 32 
of the World Health Organization.  Despite the foregoing, Argentina decided to exclude Colombia from Annexes 1 and 2 contained in Decrees 150 of 1992 and 177 
of 1993 of the Argentine Republic, i.e. th e list of countries whose sanitary system and 
pharmaceuticals are reliable.  This appears to be without any country risk assessment 
justifying such a measure; 
(b) for those countries listed in Annexes 1 and 2 there is a clearly defined conformity 
assessment procedure in Decrees 150 of 1992 an d 177 of 1993, but for countries such 
as Colombia that are excluded from these A nnexes there are no details concerning the 
conformity assessment procedure to be applied, which makes it difficult for its 
products to enter the Argentine market; 
(c) the provisions in Decrees 150 of 1992 and 177 of 1993 of the Argentine Republic 
require that countries not listed in Annexes 1 and 2 submit safety studies irrespective of whether it is a new product or a medicine already being consumed in the country 
of origin.  Argentine nationals, on the other hand, do not have to meet this 
requirement in the case of existing medicines, a situation which in our view is contrary to the principle of national treatment; G/TBT/W/280 
Page 2  
 
  (d) in Colombia's view, the fees or tariffs found in Decree 1528 of 2004 of the Argentine 
Republic established for the purpose of visits  to laboratories in countries according to 
the classification indicated in the aforem entioned Decree and wishing to enter the 
Argentine market apparently do not take into account criteria such as distance, communication, transportation and other costs arising from differences between 
location of facilities of the applicant and the conformity assessment body, as required 
by Article 5.2.5 of the World Trade Organization's Agreement on Technical Barriers to Trade.  Moreover, it is not explained wh y countries that are further from Argentina 
than Colombia are subject to tariffs that ar e markedly lower than those to be paid by 
laboratories in our country; 
(e) during the review of Argentina's trade policy, the Republic of Colombia asked 
questions intended to clarify the issues in question, but as can be seen from document 
WT/TPR/M/176/Add.1, the replies given by the Republic of Argentina only concern intellectual property matters.  With regard to the issues raised in this document, it 
simply stated without any further explanation that the requirements to be met for 
applications to register medicinal specia lities are determined on the basis of a risk 
matrix composed of two variables:  (i) sanitary information on the country from which the goods are imported or in which the facility manufacturing the product is 
located;  and (ii) the risk of the product to be registered; 
(f) it is also important to point out that for almost three years the Republic of Colombia 
has tried to resolve these concerns by sending communications through the 
Colombian embassy in Argentina and through the WTO/TBT enquiry point without 
having received a satisfactory response regarding this matter; 
(g) the latest requests in this regard were th rough the enquiry point in our capital in 
communications dated 6 and 9 August and 25 September 2007, asking for the 
information on country risk studies or criteria applied when classifying countries in 
the annexes to Decrees 150 of 1992 and 177 of 1993, particularly, the comparison of 
Colombia's sanitary system with Argen tina, Mexico and Chile and the studies on 
setting the fees or tariffs indicated in Decree 1528 of 2004, Article 4, for verifying pharmaceutical facilities.  In this conn ection, on 3 October a communication was 
received through the enquiry point informing us that the aforementioned provisions had not been notified;  
(h) lastly, seeking a reply to our requests, on 26 September 2007 a communication was 
sent to the Secretariat for Trade and In ternational Economic Relations of the 
Argentine Ministry of Foreign Affairs, In ternational Trade and Worship, explaining 
the aforementioned situation and requesting a reply to our queries, but to date no 
reply has been received. 
3. Consequently, Colombia requests Argentina to respond to our requests in order to dissipate 
the concerns raised by Colombia and provide the technical studies relating to country risk and the 
studies on costs for setting the rates and classification of countries therein, which, as has been shown, 
have been requested on several occasions through the enquiry point in the capital and other means.  In 
addition, it is requested that the relevant decree s be reviewed in order to make the amendments 
needed to include Colombia in Annexes 1 or 2, as appropriate, and to establish a fee for verification 
visits to Colombian laboratories in accordance w ith Article 5.2.5 of the WTO's TBT Agreement. 
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