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Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement
(2002; 77 pages) [Spanish] View the PDF document
Table of Contents
View the documentTHE SOUTH CENTRE
View the documentFOREWORD
View the documentEXECUTIVE SUMMARY
View the documentINTRODUCTION
View the documentI. DATA REQUIRED FOR THE REGISTRATION OF PHARMACEUTICALS
Open this folder and view contentsII. THE RATIONALE FOR DATA PROTECTION
Open this folder and view contentsIII. CONDITIONS OF PROTECTION UNDER TRIPS
View the documentIV. NON-DISCLOSURE OBLIGATION
Open this folder and view contentsV. PROSCRIBED ACTS OF UNFAIR COMMERCIAL USE
View the documentVI. MEANS OF PROTECTION AGAINST UNFAIR COMMERCIAL USE
View the documentVII. THE EXCLUSIVITY APPROACH
View the documentVIII. THE HISTORY OF THE TRIPS NEGOTIATIONS
View the documentIX. CONCLUSIONS
View the documentANNEX I. EXCLUSIVE USE OF DATA AND COMPENSATION UNDER THE U.S. FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT (FIFRA)
View the documentBIBLIOGRAPHY
View the documentBACK COVER
 

VIII. THE HISTORY OF THE TRIPS NEGOTIATIONS

The history of the TRIPS Agreement negotiations also provides important evidence for interpreting Article 39.3. Such history has been accepted in recent WTO jursiprudence as an interpretative source under Article 31 (2) of the Vienna Convention on the Law of the treaties. It has been used to confirm the interpretation reached by the application of the principles of Article 31 (1) of the Convention.36

36 See, e.g. the panel report in United States-Section 110(5) of the Copyright U.S. Copyright Act, WT/DS160/R, 15 June 2000, para. 6.50; United States-Section 211 Omnibus Appropriations Act of 1998, WT/DS176/R, 6 August, 2001, para.8.378.

An early precedent of Article 39.3 can be found in the "Statement of Views of the European, Japanese and United States Business Communities",37 which also influenced the drafting of other articles of the TRIPS Agreement. In their submission, the business communities advocated for the protection of test data as follows:

"1. Information required by a government to be disclosed by any party shall not be used commercially or further disclosed without the consent of the owner.

2 Information disclosed to a government as a condition for registration of a product shall be reserved for the exclusive use of the registrant for a reasonable period from the day when government approval based on the information was given. The reasonable period shall be adequate to protect the commercial interests of the registrant".

37 See Annex III of Beier and Schricker, 1989.

This proposal clearly specified the obligation to establish a data exclusivity period. The same approach was reflected in the U.S. proposal:

"Contracting parties which require that trade secrets be submitted to carry out governmental functions, shall not use the trade secrets for the commercial or competitive benefit of the government or of any person other than the right-holder except with the right holder's consent, on payment of the reasonable value of the use, or if a reasonable period of exclusive use is given to the right-holder".38

38 See MTN.GNG/NG11/W/70, reproduced in Correa and Yusuf, 1998.

It is interesting to note that this proposal referred to the "commercial or competitive benefit" obtained by a third party, rather than to "unfair commercial use" as is the Agreement's text. The proposal is based on the effects of the use (the creation of a benefit), while Article 39.3 is based on an ethical qualification of the use as "unfair". The U.S. proposal turned on whether a commercial or competitive benefit (independently of the qualification of the use that generated it) was obtained; under Article 39.3, the key issue is whether there is unfairness in the use (as provided by Article 10bis of the Paris Convention) and not whether a third party obtains a benefit.

The negotiating parties considered requiring test data exclusivity, but rejected this approach. Bracketed text under consideration at the Brussels Ministerial Meeting (December 1990) would have required not less than five years of data exclusivity. The draft read as follows:

"Parties, when requiring, as a condition of approving the marketing of new pharmaceutical products or of a new agricultural chemical product, the submission of undisclosed test or other data, the originator of which involves a considerable effort, shall [protect such data against unfair commercial use.

Unless the person submitting the information agrees, the data may not be relied upon for the approval of competing products for a reasonable time, generally no less than five years, commensurate with the efforts involved in the origination of the data, their nature, and the expenditure involved in their preparation. In addition, Parties shall] protect such data against disclosure, except where necessary to protect the public]".39

39 See Gervais, 1998, pp. 182-183.

Notably, this text also explicitly included a prohibition on reliance on the data submitted by the originator. But this concept disappeared from the final text. The negotiating history of Article 39.3, in sum, does not support the thesis that it was intended to provide exclusive rights.40 On the contrary, it shows that such concept was rejected. It is also suggestive in this sense that the most active proponents of such approach are currently proposing to review the TRIPS Agreement in order to include an exclusivity period41.

40 The EU has pointed out that "according to one commentator, the U.S. negotiations finally decided to drop the more explicit language of above drafts because they did not view such wording as essential because, in any event, "the accepted definition at the time of protection against unfair commercial use included non-reliance for a fixed period of time for new chemical entities" (EU, 2001, p. 4).

41 In its position paper on the WTO Millennium Round, the International Federation of Pharmaceutical Manufacturers' Association (IFPMA) has called, inter alia, for the adoption of a 10-year data exclusivity period (see "What is at stake in Seattle", in www.pharma.org). See also IIPI (2000), where it is noted that Article 39.3 "requires WTO Members to protect health registration data from disclosure or unfair commercial use, but its exact boundaries of "unfair commercial use" are not entirely clear (p. 26).

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