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The State of Medicine Quality in the Mekong Sub-Region

Sauwakon Ratanawijitrasin
Souly Phanouvong

5 - Regulating medicine: regulatory spheres and gap

Texte intégral

1The reviews and analysis in the above sections demonstrate that there are differences in 1) the legal definitions regarding what medicine quality means and what is acceptable by law, as well as measures to regulate them; and 2) what is specified by the contents of the law and what is actually happening in the health care system. The conceptual framework of regulatory spheres can provide a theoretical foundation for examining these phenomena. The existence of a regulatory function in a country does not necessarily mean that the function covers the entire range of pharmaceutical products and/or activities. Nor does it mean that the control described in the country’s legislation is always fully put into practice.

2Moreover, a country may choose to enact laws to only regulate certain areas of its pharmaceutical supply system. For example, the universe of all the products claimed to have effects on human health (therapeutic, preventive, etc.) can be thought of as the area within the boundary of the outermost circle – the ‘global sphere’. The medicine regulatory authority (MRA) may choose to register all products, or only certain categories. It may decide not to register herbal medicines, but to require that all other pharmaceutical products be registered. The exempted products thus fall into area A, while other drugs are within the boundary of the next circle, area B – the ‘regulatory sphere’.

Figure 35: Conceptual spheres of regulatory control

Figure 35: Conceptual spheres of regulatory control

Source: Ratanawijitrasin and Wondemagegnehu 2002

3In any given year, the DRA may be able to inspect manufacturing, importation and distribution facilities, and to collect samples for quality testing in a limited number of product categories. These products can then be considered as being contained within the third largest circle – the ‘monitoring sphere’. Some of these drugs pass the quality test, represented by area C, while a percentage of them may be found substandard or counterfeit, or else are not registered (defined as counterfeits in some country). These failed/illegal products can be visualized as falling within the next area, area D – the ‘violation sphere’. Legal sanctions may be imposed in all or a proportion of the violation cases found, which are contained in the smallest circle, area E – the ‘sanction sphere’. Discovered violations do not necessarily represent all the violations that exist. They are likely to be violations that are beyond the reach of regulatory authorities and other monitoring mechanisms (area G). It is also possible that monitoring fails to uncover a number of violations within the monitoring sphere (area F).

4Additionally, although violations are not indicated for area A, this does not imply that all products that fall within this area are effective, safe and of good quality. It is rather that the relevant legislation currently does not cover this area. The regulatory sphere can be expanded once it is deemed necessary for society to regulate additional products contained in area A, and when its capacity to do so is adequate.

5The four main regulatory functions – product registration; licensing and inspection of manufacturing, importation and distribution, control of drug promotion and advertising; and price control – are conceptually presented below.

Figure 36: Conceptual spheres of the four main regulatory functions

Figure 36: Conceptual spheres of the four main regulatory functions

Source: Ratanawijitrasin and Wondemagegnehu 2002

6Each of the core drug regulatory functions is placed in a segment within the conceptual sphere. The outer layer of the second segment of the diagram covers all facilities engaged in the activities of pharmaceutical manufacturing, importation and distribution. The next layer of the segment represents those where a licence is required to operate. The third layer represents the manufacturing, importation and distribution facilities inspected. Cases of violation of GMP, GDP and other requirements are represented in the fourth layer, while sanctioned cases are found in the innermost layer. Similar diagrammatic representations can be made for product registration, control of drug promotion and information, and price control.

7The lines that set the boundary between the spheres may not be at the same level from one segment to the next, since government regulations may be more extensive, monitoring more thorough, violations more rampant, and sanctions more strictly imposed in one functional area than in others. If quantitative data is available for each of the sub-segments in the spheres, the size of each sub-segment can be computed and a map of the drug regulatory system drawn for visualizing the legal domains and the extent to which drug regulation is undertaken.

Table des illustrations

Titre Figure 35: Conceptual spheres of regulatory control
Légende Source: Ratanawijitrasin and Wondemagegnehu 2002
Fichier image/jpeg, 126k
Titre Figure 36: Conceptual spheres of the four main regulatory functions
Légende Source: Ratanawijitrasin and Wondemagegnehu 2002
Fichier image/jpeg, 208k

© Institut de recherche sur l’Asie du Sud-Est contemporaine, 2014

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