Dalli's Formula Fails the Efficacy Test

Apr 01, 2011

The European Union commissioner for health, John Dalli, has been in office for a year now. And unlike all his predecessors in this role, he is in charge not only of health policy, but also of pharmaceutical policy.

Has he improved the EU approach to the medicines industry? Even without being able to subject Dalli to a double-blind crossover trial against placebo, European policy formation can still be subject to some form of efficacy testing.

One of the baselines for assessing Dalli's performance is that the EU had no cogent policy for the pharmaceutical industry before he took over. For many years the EU has shuffled and fudged its approach to medicines, enmeshed by conflicting and even contradictory ambitions and constraints. A succession of high-level Europe-wide talking shops, dating back to the 1980s and culminating two years ago in the so-called "Pharmaceutical Forum," solemnly trod the same circular arguments: European medicines are good because they cure disease, and boost exports, and maintain high-tech research and manufacture in Europe ... But at worst they can kill patients, and they can be a big drain on healthcare budgets, so regulation must be tight, and costs must be kept down ... But being tough on the industry hits profits and innovation and jobs and exports and ultimately health levels ...

Leadership Issues

This fundamental dilemma remains unresolved—and so far Dalli appears not to be the man to fix it. Trapped by the same conflicts, he too has learned to speak with the forked tongue that politicians favor in medicines policy. At his first press conference in the new job, in March 2010, he promised science-based decision-making. But his job description, as spelled out to him by European Commission President José Manuel Barroso, is to "promote high standards of protection of human and animal health." So by the time he had to take positions on specific issues, his attachment to scientific rigor was less evident: On the new rules the EU is trying to put together on drug information to the public, he says that it is "important to shift the focus of the original proposal to a patient-oriented perspective.

"We must ask what information patients need, not what information industry wants to provide," Dalli insisted, warning of the need—rather unnecessarily, given that the proposal made no such suggestion—to "ensure we do not drift into advertising." He would now seem to be paralyzed by his determination to prevent industry deriving any benefit from the rule change. Although the parliament has reached a view on the draft, and Hungary, the current holder of the rotating EU chair of ministerial meetings, is keen to move ahead with it, the subject is stuck solidly in Dalli's department. The other EU institutions—and industry and patients, too—can only look on.

Similarly, Dalli hardly allowed a key role to medicines when he spoke on colorectal cancer in the European parliament last month. He was big on prevention, on fighting tobacco, on healthy lifestyles, on e-health, even on the merits of promoting cross-border rights for patients. But not a word on treatment.

And many of his pronouncements about the merits of technology are now so carefully phrased as to be almost meaningless. "I do not advocate an 'anything goes' approach to innovation," he said recently. "My vision is responsible and affordable innovation for all." And motherhood and apple pie too, no doubt.

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