EFPIA's Witty to meet new EU health commissioner
This article was originally published in SRA
Andrew Witty, president of the European pharmaceutical industry federation EFPIA, is due to meet the new EU health commissioner, John Dalli, on 2 March.
This will be the first formal meeting between the industry and the new commissioner, who is now in charge of pharmaceutical policy as well as general health and consumer affairs. An EFPIA spokesman said that it would be a “kick-off” meeting, and that there were no particular topics on the agenda1.
However, it is likely that the pharmaceutical package of draft legislation on pharmacovigilance, counterfeits and information to patients will be among the issues under discussion.
The package is currently proceeding through the EU legislative process, and the three proposals are due to be adopted by the European Parliament‘s environment and public health committee (ENVI) in March, April and May respectively. But the patient information strand of the package, which would give the pharmaceutical industry a role in providing information on prescription drugs to the public, is proving highly controversial. Although it is still on the parliament’s agenda, it has been shelved by the Council of Ministers, mainly over concerns that it could weaken the ban on advertising of prescription drugs to the public2.
Commissioner Dalli has accepted that the proposal needs changing if it is to make further progress. He told MEPs last year that he planned to “reassess” the proposal and “inject a stronger patient perspective”, noting that he wanted to avoid situations where people made decisions about their health without taking professional advice. However, it is not yet known exactly what changes Mr Dalli has in mind, and the future of the proposal remains uncertain.
The matter was discussed last week at a “health check debate” organised by European Voice (part of the Economist Group) and sponsored by EFPIA and Novartis. Speaking were Christofer Fjellner, the ENVI’s rapporteur for the proposal; Richard Bergström, director of the Swedish industry association LIF; Dr Konstanty Radziwill of the standing committee of European doctors (CPME); and Jan Geissler, director of the European cancer patients coalition (ECPC). There was no representation from the commission.
According to the EFPIA spokesman, Mr Fjellner complained at the meeting that the council was not engaging properly with him, and that without such engagement it would not be possible to improve the patient information proposal. A council representative said that a major problem for some countries was the high cost of pre-vetting information materials produced by companies, while the CPME insisted that information on prescription medicines should only be given to patients by doctors.
The pharma package is being overseen by Mr Dalli after responsibility for pharmaceuticals (as well as medical devices and cosmetics) passed to the health and consumer directorate (DG SANCO) from the enterprise and industry directorate (DG ENTR) in February3. Pharmaceuticals now form unit 8 of DG SANCO’s “C” department (public health and risk assessment); Martin Terberger, who headed pharmaceuticals at DG ENTR, has transferred with the unit to SANCO.
References
1. Personal communication, EFPIA, 1 March 2010
2. The Regulatory Affairs Journal – Pharma, 2010, 21(1), 51-52
3. The Regulatory Affairs Journal – Pharma, 2010, 21(3), 184-185