Dalli's Formula Fails the Efficacy Test - Pharmaceutical Executive

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Dalli's Formula Fails the Efficacy Test


Pharmaceutical Executive


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--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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