Advantages and disadvantages of the adaptive licensing
| Advantages of adaptive licensing | Disadvantages of adaptive licensing |
|---|---|
| Anticipated access to medicines for the treatment of serious diseases with no therapeutic alternatives | Greater degree of uncertainty of the risk/benefit profile of the drug |
| Immediate information on the effectiveness of the drug in real life | No assessment of the toxic effects of long term therapy |
| Rapid production of profits for pharmaceutical companies with reduction of the costs of clinical trials | Lack of significance of the results obtained from studies conducted on a restricted population |
| Little interest of pharmaceutical companies to conduct post-marketing studies for an approved drug and which provides profits | |
| Need to define the modalities of implementation of the adaptive licensing project |