EMA-HTA parallel reviews raise red flags

EMA's practice of providing confidential scientific advice to companies in exchange for fees has "immense potential for conflicts of interest," said a coalition of European medicines advocates, who stressed the practice should not be extended to health technology assessment bodies (HTABs). The comments came in a consultation (see BioCentury Extra, May 8).

The coalition said when EMA and HTABs sell advice on drug development, they "essentially become co-developers and financially dependent on the pharmaceutical industry." The group argued that HTABs' cost-effectiveness assessments should remain independent from regulatory agencies. The coalition said HTABs can ensure that a new product that provides no added value compared to a safer or cheaper alternative does not reach too many patients by recommending against reimbursement for the new drug. ...