Since the introduction of conditional marketing authorisation by the European Medicines Agency in 2004, patients have gained access to drugs which fulfil an urgent and unmet need. A paper published in European Journal of Internal Medicine examines whether the conditionally approved drugs manage to obtain comprehensive evidence confirming that the risk-benefit balance is positive to obtain full marketing authorisation and the time taken to reach it.
The authors identified 24 products conditionally authorised for sale, between the years 2006-2015, out of which 9 were orphan drugs and 3 had orphan status. Till date 10 medicinal products have been switched to regular approval while 14 of them are still under conditional approval.
The authors demonstrate that the median time for the ten conditional approvals to finish their specific obligations and switch to regular marketing authorisations was five years, noting delays, discrepancies and lack of information on some of these drugs.
Overall, the median time allowed to address the specific obligations is four years. The median time to fulfil obligations for drugs still conditional is nearly twice that of those converted. Of the 14 medicinal products still under conditional approval, nine have specific obligations whose timeframes go beyond 2015 but some of these did not have up-to-date information on the trials that need to conducted to address the obligations. Out of the drugs that have to fulfil their obligations this year, almost all of them have delays and discrepancies.
From the data gathered the authors caution that the conditionally approved drugs without fully established clinical value are in the market for long periods and question whether the public health advantage outweigh the risks of limited clinical information.