Juncker backtracks on EU plans for pharma

Concerns that the European pharma sector would be monitored for its contribution to business – and not health – have led to the European Commission’s new leader performing a U-turn.

President-elect Jean-Claude Juncker has bowed to huge pressure, and will not now put the Directorate-General for Enterprise (DG Enterprise) in charge of overseeing the pharma sector.

The Directorate-General for Commission for Health and Consumers (DG Sanco) currently has responsibility for monitoring and supporting the pharma industry, and will now retain the role after Mr Juncker changed his mind.

The Commission came in for considerable criticism when it first floated the proposal to transfer responsibility for pharma policy – including the European Medicines Agency (EMA) – from the health to the industrial portfolio last month, with the European Public Health Alliance (EPHA) describing the move as “promoting profit over public health.”

Meanwhile, Health Action International (HAI) said it would put “the commercial, profit-driven interests of the pharmaceutical industry, rather than patients and consumers, at the heart of European policymaking on medicines,” and warned that it could jeopardise reforms such as the EMA’s new initiative on clinical data transparency.

Speaking before the European Parliament last week, Juncker said: “Responsibility for medicines and pharmaceutical products will stay with the Directorate-General for Health because I agree with you that medicines are not goods like any other.”

Pharma came under the auspices of DG Enterprise for years, and the transfer to DG Sanco during outgoing President José Manuel Barroso’s second term in 2009 was widely hailed as a long-overdue distancing of healthcare policy from commercial interests.

HAI said Juncker’s turnaround came on the back of “immense objection from civil society organisations working in public health”, as well as “concerns expressed by EU member state representatives and MEPs” during the College of Commissioners hearings.

There had already been rumblings of a climbdown ahead of Juncker’s statement last week, with Gianni Pittella, the President of the Progressive Alliance of Socialists and Democrats (S&D) group of MEPs, issuing a statement earlier this month that referred to “a new shared competence for medicines and medical devices between … DG Sanco and DG Enterprise.”

Opponents of the transfer – who mounted a Twitter campaign (#Pharma4Health) to challenge the proposal – celebrated the abandonment of the plan as a victory but warned that their concerns have not yet been fully allayed.

 

 

Giving pause for thought was Juncker’s comment that pharma policy will be “developed jointly” by Vytenis Andriukaitis – who will head DG Sanco – and Elžbieta Bieńkowska who will lead the new DG Enterprise (now covering Internal Market, Industry, Entrepreneurship and SMEs).

HAI indicated it remains concerned that DG Enterprise’s role in the development of European medicines policy will be further expanded.

“Additional industry involvement in this regard will continue to extend the interests and influence of the pharmaceutical industry at the expense of European consumers and patients,” it said, adding: “it remains to be seen how the complex task of collaboratively developing medicines policy will be achieved by two DGs with vastly different objectives and interests.”

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has insisted it did not lobby to get responsibility for pharma transferred back to DG Enterprise, although director-general Richard Bergstrom said last month that having everything for the industry in one DG would “make a lot of sense”.

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