Europe's Trust Gap - Pharmaceutical Executive


Europe's Trust Gap

Pharmaceutical Executive

Much of the equally unedifying saga of the EMA's conflicts of interest has already been recounted at length in this column and elsewhere, since the equally abrupt departure (but in different circumstances) of its executive director, Thomas Lonngren, nearly two years ago. Lonngren's overnight switch from being head of Europe's drug regulatory agency to acting as a consultant to the pharmaceutical industry was shocking enough in itself. The insouciant complicity of the agency's management board in condoning this move was even more troubling. Inevitably, questions were raised over the agency's handling of conflicts of interest—and probes into its performance revealed deficiencies so evident that the European Parliament decided to refuse approval of the agency's accounts.

Throughout the whole of 2012, the EMA—now under new management—has battled to regain its credibility as a reliable defender of the public interest. It failed to do so in time for a crucial Parliament vote in the spring. "The agency did not apply the staff regulations properly, which in turn raises serious questions about their application of the rules in general," said the budgetary control committee, expressing dissatisfaction with checks on the completeness of declarations of interest. Monica Macovei, the MEP who was piloting the debate in the Parliament, noted concerns "over allegations that the agency's former executive director created his own consultancy firm while still in office" and spoke of "concerns on the actual independence of the agency."

Vigorous attempts by the agency to clean up its act did win back some support from the Parliament. By early September, the Parliament's health committee accepted that the changes made over the preceding months had eased concerns. By the end of the month, the budgetary control committee had also softened its stance, and was recommending approval of the accounts.

It was therefore all the more surprising that in early October the European Court of Auditors unveiled a highly critical report of its own investigation of the EMA. The agency had not "adequately managed conflict of interest situations," and it relied on experts with connections to the industry "in drafting scientific opinions which underpin vital decisions affecting the health and safety of consumers."

"Most scientific opinions and decisions prepared by the agency also use the research carried out or financed by industry," and the EMA "has to rely on trials conducted by organizations and companies that have vested interests in the products concerned," it thundered. "Conflict of interest policies and procedures do not cover national experts working on the tasks outsourced to the national authorities," and "the EMA does not perform any verification of the conflict of their interest policies and procedures."

What was the public expected to conclude from such a damning evaluation—and what was the public expected to infer about the rigour of the European Parliament's monitoring of the EMA's adjustments made during the year? Not a lot, perhaps, because the Court of Auditors admitted that its research was completed even before the end of last year —and, yet more seriously, it confessed that it was utterly incapable of offering any view at all on whether the failings it had identified persisted.

It will take months for the dust to settle from these episodes of confusion and these demonstrations of incompetence. The downside for industry is that it too suffers from additional suspicion, merely by association. It should not be tempted to seek to exploit the current weaknesses of authority. On the contrary, the potential upside of the situation is that it could encourage industry to redeem its own reputation. If it is smart, it will seize on this opportunity to present itself as responsible, and capable of a great deal of effective self-regulation, even when those who are supposed to regulate it are incapable of doing so adequately. But to do that effectively, the industry will not only have to present itself as responsible. It will have to be responsible—and that could prove a far greater challenge.

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


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