Utilizing TRIPS Flexibilities for Public Health Protection Through South-South Regional Frameworks
(2004; 110 pages) [Spanish] Ver el documento en el formato PDF
Índice de contenido
Ver el documentoTHE SOUTH CENTRE
Ver el documentoPREFACE
Ver el documentoABBREVIATIONS
Ver el documentoEXECUTIVE SUMMARY
Abrir esta carpeta y ver su contenidoI. INTRODUCTION
Abrir esta carpeta y ver su contenidoII. INTELLECTUAL PROPERTY AND ACCESS TO ESSENTIAL MEDICINES IN DEVELOPING COUNTRIES
Cerrar esta carpetaIII. CONSTRAINTS ON NATIONAL EFFORTS TO IMPLEMENT TRIPS FLEXIBILITIES FOR PUBLIC HEALTH PURPOSES
Ver el documentoIII.1 Lack of Technical Expertise to Incorporate and Implement TRIPS Flexibilities in National Law and Policy
Ver el documentoIII.2 Insufficient Domestic Research and Manufacturing Capacities in the Pharmaceutical Sector
Ver el documentoIII.3 Insufficient Technical and Infrastructural Capacities for Medicines Regulation
Ver el documentoIII.4 Difficulties in Establishing Efficient Pharmaceutical Management and Procurement Systems
Ver el documentoIII.5 Bilateral and other TRIPS-plus Pressures
Ver el documentoIII.6 Difficulties in Tackling Anti-Competitive Practices and Abuse of Intellectual Property Rights
Abrir esta carpeta y ver su contenidoIV. OVERCOMING CONSTRAINTS IN THE USE OF TRIPS FLEXIBILITIES THROUGH SOUTH-SOUTH REGIONAL FRAMEWORKS
Abrir esta carpeta y ver su contenidoV. CONCLUSIONS AND RECOMMENDATIONS
Ver el documentoBIBLIOGRAPHY
Ver el documentoBACK COVER
 

III.3 Insufficient Technical and Infrastructural Capacities for Medicines Regulation

Another constraint on the use of TRIPS flexibilities is the insufficiency of technical and infrastructural capacities for the regulation of medicines. For example, countries normally require that all medicines offered for sale in their territories be locally registered. Many developing countries, however, lack the facilities and expertise needed to review the safety, efficacy and quality of drugs destined for their national markets, and remain dependent on foreign authorities to set the necessary standards and do the necessary testing. A 1993 study of 36 African countries conducted by the WHO found that only three had a "limited drug regulatory capacity". Not one African nation had what the WHO called a "comprehensive drug regulatory capacity".45 One of the major challenges both within countries and within regions in the South therefore relates to medicines registration and regulation.

45 Status of Drug Regulation and Drug Quality Assurance in WHO African Region and Selected Countries, WHO, March 1999, cited in Love (2001).


Regulatory approval processes raise a number of problems which affect the effectiveness with which TRIPS flexibilities can be used to improve availability and access to essential medicines. For example, the speed and efficiency of the procedure for the registration of medicines has important implications for the effectiveness of the early working exception. The slow speed of the registration process denies generic companies the benefits that the early working exception is supposed to provide.

Another regulatory issue that arise relates to post-marketing surveillance. Lack of proper post-marketing surveillance, for example, makes it difficult for authorities to prove abusive behaviour by patent holders in the pharmaceutical market, thereby making compulsory licensing on this ground more difficult. Lack of advertising regulations can also be a problem for the use of TRIPS flexibilities. Aggressive misleading promotion and advertising of brands has been reported to have adverse effects as consumers become averse to generics. Efforts to promote generics in some countries such as Pakistan, Nigeria and the Philippines have revealed a poor public perception of lower-priced drugs.46 Advertising regulations through mechanisms that set and enforce guidelines for drug promotion are thus needed to avoid advertisements that may be false, lacking in fair balance, or are otherwise misleading.

46 See Velasquez and Boulet (1999).

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