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Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement
(2002; 77 pages) [Spanish] Voir le document au format PDF
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As a condition for registering pharmaceutical products, national authorities normally require registrants to submit data relating to drugs’ quality, safety and efficacy (“test data”), as well as information on the composition and physical and chemical characteristics of the product. A particularly important issue is the direct or indirect use of the data for subsequent registration of products similar to those originally registered. The World Trade Organization’s Trade Related Aspects of Intellectual Property Agreement (TRIPS), Article 39.3, requires member countries to establish protections for submitted test data. But this requirement is in fact narrowly drawn, and countries maintain substantial flexibility in implementation. The public interest in limiting protections for data is to promote competition, and to ensure that data protections do not become the means to block the timely entrance of generic competitors to off-patent drugs. Generic competitors drive down price, thereby promoting greater accessibility of medicines. Article 39.3 requires governments to provide protection to marketing approval data only under certain conditions. Test data must be protected if national authorities require its submission. Article 39.3 does not require protection be given to already public data. Protection is required only for new chemical entities. Members have considerable discretion in defining “new,” and may exclude applications for second indications, formulations and dosage forms. And, prior to granting protection, national regulatory authorities may request the applicant to prove that the information for which protection is sought is the result of significant investment. Article 39.3 requires countries to protect against “unfair commercial use” of marketing approval data.
Table des matières
Afficher le documentTHE SOUTH CENTRE
Afficher le documentFOREWORD
Afficher le documentEXECUTIVE SUMMARY
Afficher le documentINTRODUCTION
Afficher le documentI. DATA REQUIRED FOR THE REGISTRATION OF PHARMACEUTICALS
Ouvrir ce répertoire et afficher son contenuII. THE RATIONALE FOR DATA PROTECTION
Ouvrir ce répertoire et afficher son contenuIII. CONDITIONS OF PROTECTION UNDER TRIPS
Afficher le documentIV. NON-DISCLOSURE OBLIGATION
Ouvrir ce répertoire et afficher son contenuV. PROSCRIBED ACTS OF UNFAIR COMMERCIAL USE
Afficher le documentVI. MEANS OF PROTECTION AGAINST UNFAIR COMMERCIAL USE
Afficher le documentVII. THE EXCLUSIVITY APPROACH
Afficher le documentVIII. THE HISTORY OF THE TRIPS NEGOTIATIONS
Afficher le documentIX. CONCLUSIONS
Afficher le documentANNEX I. EXCLUSIVE USE OF DATA AND COMPENSATION UNDER THE U.S. FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT (FIFRA)
Afficher le documentBIBLIOGRAPHY
Afficher le documentBACK COVER
 

Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement

© South Centre, 2002. Reproduced with permission


SOUTH
PERSPECTIVES


Published in collaboration with the
Department of Essential Drugs and
Medicines Policy of the
World Health Organization

Carlos María Correa
University of Buenos Aires

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Le Portail d'information - Médicaments essentiels et produits de santé a été conçu et est maintenu par l'ONG Human Info. Dernière mise à jour: le 5 novembre 2014