Who's in Charge of Medicines in Brussels?


Applied Clinical Trials

So now we know who is to do what on health issues in the new European Commission. Or do we?

So now we know who is to do what on health issues in the new European Commission. Or do we?

The furor that the new boss of the commission, Jean-Claude Juncker, unleashed with the plans for his new team weeks before it took office is still reverberating around Brussels. First, he said he was taking responsibility for health industries away from the health commissioner and giving them to the industry commissioner. This pleased pharma companies, who feel more in tune with officials with an understanding of industry affairs. But it infuriated healthcare campaigners, several health ministers, many members of the European Parliament, and numerous patient and health professional organisations. They insisted that health technology should be subject to the imperatives of health, and not the imperatives of profit.

Initially, Juncker shrugged off the criticisms, insisting that he was focusing on growth and competitiveness. But the complaints grew, and when Juncker perceived that the concerns might put at risk the necessary approval for his team from the parliament, he made some concessions. "Responsibility for medicines and pharmaceutical products will stay with the Directorate-General for Health"—in other words, under the health commissioner Vytenis Andriukaitis. "The relevant policy will be developed jointly by Vytenis Andriukaitis and by Elżbieta Bieńkowska," his industry commissioner, he said.

That drew some shrieks of delight from the health lobby. The new commission is on our side, and the new commission president listens to European citizens, said his erstwhile critics. The industry, which had run into trouble for being too explicit in its welcome of Juncker's original plan, played the news down, saying it would work well with whoever was in charge, and that it wasn't so important anyway.

But in the week before the new commission took office—on November 1—the triumphalism started to give way to anxiety. For a start, the Juncker U-turn didn't seem so clear in the cold light of day. Two commissioners in charge might not, some sceptics remarked, free health policy from industry policy. And it emerged that Juncker had been less than clear about what he intended to do with control of medical devices—a hot topic in Europe since recent scandals over breast implants damaged consumer and patient confidence in the industry and in the controls on it. Who would be in charge of that sector, and—crucially—who would be calling the shots as new legislation to bring it into line was being finalized in the coming months?

HAI Europe raised the question of "how the complex task of collaboratively developing medicines policy will be achieved by two departments with vastly different objectives and interests." It was concerned that the implication could be an expansion of industry influence on European medicines policy, "at the expense of European consumers and patients." And just three days before the commencement of the mandate for the new commission, a coalition of MEPs, patients and civil society health organizations wrote an open letter demanding that Juncker make his meaning clear. "Shadow zones persist," said Belgian socialist MEP Marc Tarabella. "The ambiguity of Mr Juncker’s statement, and his subsequent silence on the issue, is of real concern," said British socialist MEP Glenis Willmott, a leading figure in discussions of the new medical devices legislation. French Green MEP Michèle Rivasi, also involved in those talks, said the devices sector should be brought under control of the health commissioner.

However, Juncker made no public reply, and it was left to his staff to "confirm that medicines and pharmaceutical products stay in the health and consumers directorate-general, and cosmetics and medical devices go to the new directorate-general for internal market and services, industry and enterprise." Which settles who will be in charge in terms of hierarchy, but reveals nothing of how that will work out in practice. "In all cases, the relevant policy will be developed jointly by Vytenis Andriukaitis and by Elżbieta Bieńkowska, respectively the Commissioners for Health and Food Safety and for Internal Market, Industry, Entrepreneurship and SMEs," added a Juncker spokesperson.

Which leaves everyone pondering, as the new commission begins its five-year term in office, who is to do what on health issues.

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