The global pharmaceuticals market is characterised by the coexistence of varying standards of quality whereby patients in rich and strictly regulated countries can generally rely on the effectiveness, harmlessness and intrinsic quality of the medicines on offer to them whilst a large majority of the people in countries with limited resources run the risk of receiving or buying substandard pharmaceutical products. There are many reasons for this difference and they include the following:
- the lack of regulatory authority resources in low and middle income countries (LMIC)
- the increasing complexity and globalisation of the pharmaceuticals market
- the growing pressure on prices at the expense of a clear definition of the quality standards required
- limited awareness of the problem among key players, some of whom are the largest financial backers
- the lack of public and transparent information concerning the quality of medicines
- and, finally, the lack of political will at national and international level.
Whilst the problem posed by counterfeit medicines is the subject of a growing number of global initiatives, the problem of substandard medicines, with a worrying magnitude in LMICs on the other hand is not sufficiently taken into account. Substandard medicines, however, have an impact that is at least as negative for the health of vulnerable sections of the population as counterfeit medicines.