EU Health Commissioner takes over pharma portfolio

Responsibility for the development of pharmaceutical and biotechnology policy has been taken out of the hands of the Enterprise and Industry Commissioner and transferred to the Health and Consumer Policy directorate, DG Sanco, under Commissioner-in-waiting John Dalli.

The shift means that DG Sanco takes over responsibility for the European Medicines Agency (henceforth to be known as the EMA rather than the EMEA).

The health commissioner also takes on the task of bringing forward the basket of regulations and guidance, collectively known as the 'pharmaceutical package', which includes the deliberations over a proposed Directive on counterfeit medicines as well as other projects on patient information and pharmacovigilance.

Progress on the pharmaceutical package - which already seems to be proceeding at an almost glacial pace - may be held up still further while the handover takes place, while the scale of the workload for DG Sanco under the new EC structure could also delay matters.

Recently re-elected Commission President Jose Manuel Barroso has placed a huge task on the desk of Dalli, who also inherits a cosmetics unit from DG Enterprise, responsibility for agrobiotech from DG Environment, as well as control the European Centre for Disease Control (ECDC) and the Executive Agency for Health and Consumers (EAHC). Dalli is currently the Maltese minister for social policy.

The new Commission will now have to be approved by a qualified majority in both the European Parliament and the Council of the EU, which could take place in January. If ratified, the new structure will be in place until the end of October 2014.

Reactions

Barroso's appointment has been welcomed by consumer advocacy groups and non-governmental organisations (NGOs), which noted that in most EU member states pharmaceuticals comes under the health ministry jurisdiction, not industry.

 "We are certain that this governance change puts public interests and the health of Europeans at the centre of vital decisions affecting our health," said the European Public Health Alliance (EPHA), which has been pushing for such a move for years.

"With the responsibility for pharmaceutical and medical devices policies and for the European Medicines Agency too, the Health and Consumer Policy Commissioner is now better equipped to lead a consistent and coherent approach to public health policy and more specifically to ensure protection of patients and safety of medicines throughout the EU," said the EPHA's secretary general Monika Kosinska.

Meanwhile, the pharmaceutical industry had lobbied against the move on the grounds that DG Sanco may not be able to strike an effective balance between public health demands and the enormous economic importance of the industry to the EU's competitiveness.

The European Federation of Pharmaceutical Industries Association (EFPIA) responded to the news in cautious fashion, welcoming Dalli's appointment but expressing the hope that DG Sanco will recognise the role of the industry in maintaining "a significant positive trade balance, high-quality employment and substantial investment in European-based research."


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