“Enabling patients’ access to medicines is no longer a job for regulators alone. Today, we need to work with all decision-makers in healthcare to make sure that medicines that can make a real difference to people’s lives can actually reach them,” said EMA Executive Director Guido Rasi.
So, EMA and European Network for Health Technology Assessment (EUnetHTA) made their interconnections closer to provide a single gateway for requests for parallel consultations with EMA and HTA bodies in the Member States of EU.
Following regulatory approval, HTA bodies assess the value of the medicine versus other treatments available and, based on this assessment, provide recommendations to payers and other decision-makers. While there is some overlap between evidence requirements of regulators and HTA bodies, each may have specific requirements that need to be accounted for in the development plan.
This new initiative replaces the existing tool for parallel scientific advice by EMA and HTA bodies which required medicine developers to contact Member States’ HTA bodies individually. Now only one request is required.
The main goal of this initiative is to facilitate patients’ access to new medicines and obviously to make drug marketing after approval easier which also will benefit the industry. Risks and pitfalls of this initiative are not obvious yet. although it may occur that this change is only mutually beneficial for everybody.