Substandard and falsified medicines are a pressing problem that must be addressed. There is a critical need to find legislative and policy approaches that would reduce the spread of such products without hindering access to good-quality, safe and efficacious medicines – particularly affordable generics of assured quality. This Discussion Paper provides recommendations on the principles that should guide legislation in this area as well as recommended model provisions.
The Paper also discusses the inappropriateness of anti-counterfeit measures as a policy approach for curtailing the spread of substandard and falsified drugs and the need to develop an alternative, public health-driven agenda for improving access to safe and efficacious medicines of good quality.