The European Medicines Agency has been told that its confidential discussions with drugmakers on their development plans for new medicines in exchange for fees presents a threat to the independence of pricing and reimbursement decisions.
EMA is also rapped for its plans to extend this “potentially harmful practice” to health technology assessment (HTA) bodies in the European Union (EU), in a joint response submitted to the Agency’s public consultation on these proposals by Health Action International (HAI) Europe, the International Society of Drug Bulletins (ISDB), the Medicines in Europe Forum (MiEF) and the Association Internationale de la Mutualite (AIM).
“There is immense potential for conflicts of interest to arise when the EMA, through its Committee for Medicinal Products for Human Use, provides advice about specific pharmaceutical products in exchange for fees, then later decides the marketing authorisation for these products,” says HAI Europe policy adviser Ancel-la Santos Quintano, who is calling for “this dubious practice” to be ended, not refined and broadened to HTA bodies.
“When the EMA and national HTA bodies sell scientific advice to pharmaceutical companies to aid in drug development, they essentially become co-developers of medicines and financially dependent on the pharmaceutical industry,” adds ISDB president Joerg Schaaber. “Establishing financial and business ties with the pharmaceutical industry undermines the independence of HTA bodies, as well as the critical roles that both the EMA and HTA bodies have in protecting public health,” he says.
The coalition partners are also concerned that the EMA draft guidance document describes the scientific advisory process between the Agency, HTA bodies and the pharmaceutical industry as “confidential.”
“Public institutions, such as the EMA, must at all times be transparent and accountable,” says MiEF coordinator Pierre Chirac. “Advice to pharmaceutical companies by drug regulatory authorities and HTA bodies is not only unnecessary if scientific data is robust and clinical trials are designed to address legitimate public health needs, but dangerous because of its potential to result in regulatory capture, particularly when the process is conducted in secrecy,” he warns.
Instead of providing customised advice to drugmakers, the coalition calls on EMA to continue developing guidelines that help firms make development decisions that address genuine public health needs.
It also urges HTA bodies, in their development of in-depth reviews, to refuse early discussions about drug development with EMA and pharmaceutical companies and, instead, to require full access to clinical trial data and complete assessment reports for medicines.
