Patient safety first?

In December 2009, the new President of the European Commission (EC), José Manuel Barroso, announced that the management of pharmaceutical policy will be transferred from the EC’s Enterprise and Industry directorate to its Health and Consumer Policy directorate (known as DG SANCO), a long-awaited switch. The approach taken by the Enterprise and Industry directorate appears to have favoured drug companies’ profitability and competitiveness at the expense of public health, and this is illustrated by its current EC pharmacovigilance proposals.1

If accepted, these proposals could allow inadequately evaluated medicines to reach the market early because of the increased emphasis on ‘risk management plans’ and post-authorisation studies, rather than evidence before licensing. This has already happened with the now-withdrawn anti-obesity drug rimonabant (Acomplia). In addition, all adverse reaction data will be reported by drug companies directly to a central European database, so bypassing expert pharmacovigilance centres in Member States. The proposals would give companies a greater role in collecting safety data, even though experience has shown that they can have a vested interest in delaying pharmacovigilance decisions. For example, compensation was paid to thousands of plaintiffs who complained that data were withheld about metabolic adverse effects with olanzapine (Zyprexa), which the relevant company had not been forthcoming about.

Public health disasters (from ▼thalidomide in the 1960s to the recent rofecoxib [Vioxx] debacle) emphasise the crucial importance of independent and effective pharmacovigilance. The EC will have to demonstrate that the switch from the Enterprise and Industry directorate to DG-SANCO is not cosmetic, but will give the EC a new approach to health and medicines, that of putting patients’ safety first.

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