Dalli's Formula Fails the Efficacy Test

April 1, 2011

Pharmaceutical Executive

Pharmaceutical Executive, Pharmaceutical Executive-04-01-2011, Volume 0, Issue 0

EU leadership on pharma policy leaves many wondering of the right man is at the helm

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.

What of Economics?

If on drug industry regulation he has been—at the very least—ambiguous, on the equally important area of economics he has been conspicuous by his absence. His scope for action here is, admittedly, limited, because while the EU claims to have an industry policy, decisions on drug pricing and reimbursement remain strictly a matter of national decision-making. That said, the EU does have the notional power to ensure that national pricing and reimbursement decisions are reached in a fair and transparent manner—considered a priority by an industry suffering savage and serial cuts across Europe, amounting to more than €5.5 billion ($7.7 billion) lopped off company sales in 2010. A long-overdue policy decision was made, before Dalli came into the picture, to update the EU's 1988 rules. Has Dalli pushed that process along? He has not. Despite his responsibility for pharmaceutical industry policy, he has let the subject languish. And on the rare occasions that he has spoken of the medicines industry itself, the tone has invariably been as it was at a keynote speech in London last November: "Our aim," he said, "is to foster the uptake of health technology assessment—for pharmaceuticals, medical devices, and also for health interventions and procedures—to assess the comparative advantage of a new technology vis-à-vis patient outcome or cost effectiveness."

Meanwhile, Antonio Tajani, European commissioner for enterprise and industry, who suffered the removal of pharma policy from his portfolio in the reshuffle of responsibilities when the new Commission was appointed, is determined to keep a finger in the pie, and has filled—with alacrity—the vacuum repeatedly left by Dalli. He took Dalli's place in a European Parliament debate on pharmacovigilance; he has launched his own initiative to bring corporate social responsibility into the pharma industry in Europe; and it is his officials who are making the running on updating the transparency rules on pricing and reimbursement.

Darkness Still ... Before Dawn?

Nor has the extended empire that Dalli was awarded resulted in him bringing increased coherence or dynamism to medicines-related policy. Quite the contrary. The respected head of the Commission's pharmaceuticals unit, which was transferred out of the industry commissioner's hands and into Dalli's portfolio, left, and his replacement has yet to win admiration. The European Medicines Agency, also now part of Dalli's fief, has been repeatedly in trouble all year: It was obliged to perform U-turns by the EU ombudsman after initially refusing to supply data on some of its controversial decisions; it stands accused of failing to act when French regulators ignored the risks of Mediator (the Servier diabetes treatment pulled from the market in 2009 after decades of use, and suspected of causing several hundred deaths); its former head is defending himself against allegations of conflict of interest after jumping into consultancy; and the European Centre for Disease Control, another of the agencies placed under Dalli's command, has spent awkward months justifying its own record in decision-making during the H1N1 pandemic.

Not all of this is Dalli's fault, but not much has emerged from his office to suggest that a new dawn will shortly break through the clouds—or that any discernible end-points will be reached as the test of his efficacy shifts into its second year.

Reflector is Pharm Exec Europe's anonymous columnist, a commentator so close to the action in Europe that his identity must remain secret

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