TableĀ 1

Advantages and disadvantages of the adaptive licensing

Advantages of adaptive licensingDisadvantages of adaptive licensing
Anticipated access to medicines for the treatment of serious diseases with no therapeutic alternativesGreater degree of uncertainty of the risk/benefit profile of the drug
Immediate information on the effectiveness of the drug in real lifeNo assessment of the toxic effects of long term therapy
Rapid production of profits for pharmaceutical companies with reduction of the costs of clinical trialsLack 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