Table 4.
Pro-generic policies to increase competition and reduce prices162
| Description or examples | |
|---|---|
| Supply side | |
| Preventing delay in generic entry | Expedited or abbreviated application processes, early working (Bolar) provisions, and biowaivers |
| Incentivising market authorisation | Incentives for manufacturers to file an application for market authorisation of a generic medicine |
| Assuring quality of generic medicines | Requirements for bioequivalence testing and the publication of lists of interchangeable medicines; transparency of reviews of such evidence; reliance on decisions taken by stringent regulators or prequalification |
| Using TRIPS flexibility | Policies that enable the use of TRIPS flexibilities, including undisclosed test data protection that does not prohibit the registration of a generic |
| Increasing competition between manufacturers | Patent pools, improving transparency of patent information, and publishing information on the prices of medicines |
| Pricing for affordability | Internal reference pricing, external reference pricing, pricing controls, the regulation of distribution chain mark-ups, and charges; pooled procurement and tenders |
| Demand side | |
| Promoting generic prescribing | Prescribing medicines by the international non-proprietary (generic) name |
| Enabling substitutions | Mandate or enable the dispensing of generic equivalents instead of branded products by pharmacists and other dispensers |
| Adapting medicines reimbursement policies | Promoting generic medicines via waiver of copayments or the application of internal reference pricing |
| Promoting independent medicines information | Banning the provision of free medicine samples, banning direct-to-consumer advertising of prescription medicines |
| Monitoring consumption | Monitor and report the consumption pattern of generic medicines |
TRIPS=Trade-Related Aspects of Intellectual Property Rights.