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Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement
(2002; 77 pages) [Spanish] Ver el documento en el formato PDF
Resumen
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.
Índice de contenido
Ver el documentoTHE SOUTH CENTRE
Ver el documentoFOREWORD
Ver el documentoEXECUTIVE SUMMARY
Ver el documentoINTRODUCTION
Ver el documentoI. DATA REQUIRED FOR THE REGISTRATION OF PHARMACEUTICALS
Abrir esta carpeta y ver su contenidoII. THE RATIONALE FOR DATA PROTECTION
Abrir esta carpeta y ver su contenidoIII. CONDITIONS OF PROTECTION UNDER TRIPS
Ver el documentoIV. NON-DISCLOSURE OBLIGATION
Abrir esta carpeta y ver su contenidoV. PROSCRIBED ACTS OF UNFAIR COMMERCIAL USE
Ver el documentoVI. MEANS OF PROTECTION AGAINST UNFAIR COMMERCIAL USE
Ver el documentoVII. THE EXCLUSIVITY APPROACH
Ver el documentoVIII. THE HISTORY OF THE TRIPS NEGOTIATIONS
Ver el documentoIX. CONCLUSIONS
Ver el documentoANNEX I. EXCLUSIVE USE OF DATA AND COMPENSATION UNDER THE U.S. FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT (FIFRA)
Ver el documentoBIBLIOGRAPHY
Ver el documentoBACK 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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