Health advocate coalition says EMA advice for fee undermines independence of regulatory authorities
Health Action International Europe (HAI Europe), the International Society of Drug Bulletins (ISDB), the Medicines in Europe Forum (MiEF) and the Association Internationale de la Mutualité (AIM) have criticized the EMA for providing confidential “advice” to pharmaceutical companies on their development plans for new medicines in exchange for fees—a potentially harmful practice the EMA now is trying to extend to national health technology assessment (HTA) bodies in the E.U.
The coalition of medicines advocates made the criticism in a joint response to the EMA’s public consultation on its Best practice guidance for pilot EMA HTA parallel scientific advice procedures, which closed July 14.
“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 authorization for these products,” said Ancel.la Santos Quintano, policy advisor with HAI Europe. “This dubious practice should be ended, not refined and broadened to HTA bodies.”
HTA bodies are widely consulted throughout the E.U. They determine the “therapeutic added value” and appropriate level of financial reimbursement for new medicines. If a new medicine provides no additional therapeutic value in comparison with safer and cheaper well-established treatments, yet receives authorization from drug regulatory agencies, HTA bodies can recommend that it does not receive reimbursement. This limits European patients’ exposure to potential avoidable adverse drug reactions and helps minimize member states’ healthcare expenditures.
“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,” said Joerg Schaaber, president of the ISDB. “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.”
HAI Europe, ISDB, MiEF and AIM also are concerned that the EMA describes the scientific advisory process between it, HTA bodies and the pharmaceutical industry as “confidential” in its draft guidance document.
“Public institutions, such as the EMA, must at all times be transparent and accountable,” said Pierre Chirac, coordinator with the MiEF. “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.”
Instead of providing customized advice to pharmaceutical companies, the coalition of medicines advocates recommend the EMA continues developing guidelines that help drug manufacturers 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 the EMA and pharmaceutical companies and instead require full access to clinical trial data and complete assessment reports for medicines.
The EMA has provided scientific advice for a fee to the pharmaceutical industry since 2005. The same practice was applied to HTA bodies in 2010 under a pilot project. In March 2014, the EMA also launched an “adaptive licensing” project, which “builds on existing regulatory processes and intends to extend the use of elements that are already in place, including scientific advice.”