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As Europe departs for its annual holiday the question remains unresolved as to what to expect from the new European Parliament in terms of the principal interest of readers of Applied Clinical Trials.
As Europe departs for its annual holiday—sacrosanct, even amid the continuing economic woes, the multiple crises in the Middle East, and the dark mysteries of Russia's intentions in its former satellites—the question remains unresolved as to what to expect from the new European Parliament in terms of the principal interest of readers of Applied Clinical Trials.
The only indication to emerge since the new parliament took office in July is an opinion from the health committee on the budget for the European Medicines Agency for next year. It isn't much to go on, since the EU budget covers a much wider range of issues than the funding of the EMA, and the opinion is at present only a draft anyway. But in the absence of firmer evidence, what it says can be construed as a broad endorsement of the agency, but with a very firm grip on keeping operating costs under control. The draft opinion carries more weight than it might otherwise, because it has been written by the health committee's new chairman, Giovanni La Via—who is a bit of an unknown quantity in the health field, but who has a strong reputation in budgetary and economic affairs.
His suggestion as to what his committee should say is that the EMA (and other of the European Union's agencies, including the European Center for Disease Prevention and Control, the European Chemicals Agency, and the European Food Safety Authority) is "vital for the implementation of Union policies and programs."
He goes on to argue that each of the agencies should be assessed "on a case-by-case basis" so that they can be accorded the appropriate budget and human resources. They should have, he says, "the appropriate financial means and staff to enable them to fulfill properly the tasks assigned to them." This sounds on the face of it quite hopeful for the EMA, which faces a huge increase in workload. But no sooner has La Via argued for adequate funding then he qualifies his view by insisting that "agencies have to bear their fair share of cost savings, as do other institutions." So, he says, they should gradually cut their staff numbers by 5% between now and the end of 2017.
Specifically on the EMA, he notes that the proposed contribution from the EU budget to the agency's operations totals €33,015 million ($44,190 million) for 2015. This, he points out approvingly, "does not cover any additional contribution relating to the implementation of the pharmacovigilance legislation"—a major part of the increase in the agency's responsibilities, and fully in force since this summer. "The agency will have to adapt its existing resources to cover the pharmacovigilance activities," La Via continues pitilessly, because "the costs of this activity are to be covered by fees.” In other words, the agency will have to make sure it gets enough money out of drug companies—and if it doesn't manage that, it will just have to make do.
It's an uncompromising line. But La Via, a center-right, 51-year-old from Sicily, is known for speaking his mind. He is an academic, specializing in economics and agricultural policy, and has been an MEP since 2009 and is leader of the Italian center-right Nuovo Centrodestra MEPs in the parliament. Although he has not, until now, been a member of the parliament's health committee, he has intervened trenchantly in recent debates on health matters in the full parliament, with a focus on patient safety and transparency.
In the debate on clinical trials, he said, "it is necessary to guarantee that rigorous norms are followed in the European Union to assure patient care and treatment and access to data in the form of full clinical trial reports, as well as to promote scientific research and innovation.” And debating the proposals for the updated Innovative Medicines Initiative, he said he was in favor, but with reservations, including favoring "a better level of transparency, public access to the curriculum vitae of members of the administrative council, and information on the possibilities of cutting spending and making better use of resources." His interventions in debates on medical devices and in vitro diagnostic medical devices also endorsed proposals to tighten up regulation in the interests of patient safety. So his influence on the direction taken by the committee he has now taken charge of for the next few years will be a subject to watch closely when the parliament reconvenes in September.