The European Medicines Agency (EMA) wishes to hasten the approval process of new medicines that show real potential and apply for marketing authorisation. However, this has received some backlash from some national agencies.
The EMA introduced ‘Medicines Adaptive Pathways to Patients’ as a way to test the new pharmacovigilance process of approval in medicines that have potential in treating serious and hard-to treat diseases. Six drugs were used to test the adaptive pathway from 2014 to 2016. The adaptive pathway allows for a type of conditional approval which uses data collected from everyday real-life scenarios to determine the drug’s side-effects and/or effectiveness. Randomised controlled clinical trials comparing the effects of the medicine with current standard treatment and/or placebo can also take place in parallel.
National agencies opposed to this scheme suggest that the reduced requirements for the clinical trials (and therefore data) could lead to patients being exposed to increased risks no matter the increased restrictions. One of the main opponents is the Institute for Quality and Efficiency in Health Care in Germany (IQWiG) who believe that this approach will likely be taken advantage of and will eventually become standard practice. They contend the real-world is an uncontrolled environment and that there is an unethical aspect to the randomised controlled studies where patients are not being given approved medication.
Pharmaceutical companies and patient advocacy groups side with the EMA and propose that a new efficient process is required for new medicines. Both Eurordis and the UK’s National Institute for Health and Care Excellence (NICE) also approve of the new scheme. They suggest that patients should be told of the drug status and should be allowed to decide whether or not they wish to take it and that there should be more confidence in the real-world results.
For more information, click here.