(2004; 110 pages)
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).