Finally : real progress on the Information to Patients Directive ?

Finally : real progress on the Information to Patients Directive ?
Brussels, 11 October 2011 - The European Commission released today its revised proposal on ‘Information to Patients' which looks at different ways of providing information on prescribed medicines and the role of the pharmaceutical industry in providing such information on their products directly to people. The public health community cautiously welcomes this controversial and long awaited proposal.

"The previous proposal was just a disguised way of giving pharmaceutical companies enough flexibility to promote their products directly to the public, in order to boost the sector's growth. EPHA welcomes the new tone of the proposal which has taken the public health perspective on board. We congratulate Commissioner Dalli for producing a revised version of the proposal. However we remain cautious of the man derogations and hope that this is resolved in discussions with the European Parliament and the Council." Stated Monika Kosinska, Secretary General of EPHA.

EPHA - the European Public Health Alliance - Europe's leading NGO advocating for better health released its position earlier this week in which the Alliance highlights the impact the provision of information can have on Public Health as well as the obligations of the pharmaceutical industry.

Comparing the European Commission's proposal with the recommendations of the public health community, Kosinska stressed that "we note with satisfaction that the pharmaceutical industry will have obligations to provide certain information after authorisation from competent authorities and not only the possibility to make available promotional materials of their choice. It is of utmost importance that this is regulated by law and not by the pharmaceutical industry themselves, despite the opt-outs that we can see built in to this draft."

The internet has been a 'sticking point' in the debates surrounding Information to Patients. EPHA agrees that the internet can be a useful place to provide information, however in the case of medicines information, this should be limited to the Patient Information Leaflet and other medicines safety information. This should be accessed though a portal or database with a single point of entry so as to avoid confusion and the proliferation of misleading information. Unfortunately, this is not the approach chosen by the European Commission which still prefers ‘information' to be provided by pharmaceutical companies directly on their website.

"The role of the internet should be limited to providing access to the Patient Information Leaflet and medicines' safety information from a single portal : providing it on pharmaceutical company websites would be misleading, confusing and inappropriate." Regrets Kosinska.

The previously proposed directive did not meet the needs of people for reliable, objective, unbiased, user-friendly and comparative health information. In the coming months, EPHA will commit to further voice the concerns of patients, health professionals and other public health organizations on which information people should receive on prescription medicines.


Note to Editors :

1. EPHA is is the European Platform bringing together public health organisations representing health professionals, patients groups, health promotion and disease specific NGOs, academic groupings and other health associations. Our vision is of a Europe with universal good health and well-being, where all have access to a sustainable and high quality health system : A Europe whose policies and practices contribute to health, both within and beyond its borders.

2. EPHA position on Information to Patients is accessible at