BEUC, the European Consumer Organisation, expresses its concerns on the adaptive pathways approach which is promoted by one of the projects of the European Medicines Agency.
The position paper entitled “A fast-track approval for new medicines – Patient safety at risk?” articulates the consumers’ doubts that the new fast-track procedure can expose patients to unnecessary health risks.
“It is key for patients to have timely access to medicines, however BEUC considers that sidestepping the standard benefit-risk assessment for licensing a medicine should only be done for a very limited range of medicines and only when there is no other available alternative.”
Following the adaptive pathways approach, in fact, medicines would be put on the market before there is complete information about their safety.
BEUC underlines the importance of post-market studies, which nowadays is not always optimal. Moreover, it calls for clearer costs and reimbursement conditions and more public debate on the issue.