All Change for Pharma at the European Commission


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-10-01-2014
Volume 23
Issue 10

Reshuffling to heavily impact life sciences policy in Europe.

The five-yearly changing of the guard among senior European Union officials is approaching, and this time around it will be more than just a few new names and fresh faces. The president of the new European Commission, Jean-Claude Juncker, plans to shake things up during his mandate—and pharmaceuticals will be one of the policy areas to feel the wind of change.

Juncker, a former prime minister of Luxembourg, has won the role of Commission president after a bizarre and byzantine selection process that did neither him nor the European Union (EU) much credit. But there he is, and he is determined to use his position to inject some new dynamism into the EU and to remedy some of the sclerosis that has overtaken it in recent years. As a center-right politician, there is a distinctly pro-business tone to his approach—which will bring some relief to drug companies, but which is already provoking dismay among consumer groups.

One of Juncker's planned modifications, announced in early September but still subject to approval by the European Parliament before the new Commission can take office on its scheduled date of Nov. 1, is to put a former health minister in charge of the health portfolio. Vytenis Andriukaitis, a surgeon by profession, has been Lithuania's health minister since 2011. He won praise for his chairmanship of the EU health ministers during his country's turn in the EU presidency in the second half of last year—including for his management of a compromise on the clinical trials regulation, and for raising the profile of health policy in the EU with a major conference in Vilnius.

That has already pleased some of the European health lobbies. It is a long time since a health commissioner has had any professional involvement in health. And it is probably the first time that a health commissioner has actually wanted the job: traditionally, health is not a portfolio that candidate commissioners fight to obtain, but Andriukaitis had already indicated his interest in doing the job.

In his instructions to Andriukaitis, Juncker is realistic about what can be accomplished as far as European health policy. He notes that in the area of human health, the role of the Commission is "limited," and "the specific exclusion of national health policy and of the management of health services illustrate the importance of respecting the rules on subsidiarity and proportionality"—in other words, no EU rules on things that can be better dealt with at national level. "At the same time," says Juncker, "the EU can clearly help member states address the challenge of increased calls on health services and more complex technological choices at a time of intense pressure on public finances."

Control shift for pharma regulation

But the pro-business approach is clearly seen in Juncker's plan to shift responsibility for drugs out of the health commissioner's domain and put it under the commissioner in charge of industry affairs. In a reshuffle of the Commission's operational departments, Juncker is to remove the task of regulating drugs and medical devices from the health directorate general, and put it, instead, into the directorate general responsible for industry and the internal market. The European consumer organization, BEUC, immediately condemned the shift. "With this change, the European Commission sends the signal that economic interests come before those of patients," said BEUC's health expert, Ilaria Passarani.

Pharmaceuticals and medical devices will now become part of the fief of Elzbieta Bienkowska, the 50-year-old former Polish infrastructure minister, who Juncker has designated as commissioner for the internal market, industry, entrepreneurship, and smaller firms.

Juncker is determined to maximize the beneficial impact of the single market. In the same vein, he counsels against excessive regulatory intervention. "To support innovation and competitiveness, we must not come with too prescriptive and too detailed recommendations." He is particularly attentive to the needs of smaller firms. The avoidance of unnecessary red tape is essential, he says.

Industry welcome

The European Federation of Pharmaceutical Industries and Associations has welcomed the new structure. It claims that the outcome owes much to its own urgings: "The president of the Commission has taken on our views and put together all units that are relevant for our business in Europe"—units that were, stresses EFPIA, previously spread over distinct departments responsible for health and consumer affairs, internal market, and enterprise. Juncker's business-friendly tone is also discernible—indeed trumpeted—in his approach to research. Carlos Moedas, who was until recently the secretary of state in the Portugese prime minister's office, has been named as the next commissioner for research, science, and innovation. Juncker has told him to promote "the international excellence of the EU's research and science" and strengthen research capacities and innovation strategies across all the member states.

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