Brussels, 11 October 2011
Press Statement by Commissioner Dalli - Adoption of revised proposals on information to patients
Ladies and gentlemen
I am glad to inform you that [this morning] the European Commission adopted its revised proposals setting out EU-wide rules on information on prescription-only medicines.
As I promised during my hearing as commissioner-designate before the European Parliament, these revised proposals take forward the valid rationale of the initial proposals from 2008, but re-define them from a patients' perspective.
The initial rational remains valid: Patients are increasingly interested in learning more about the medicines they take. And more and more patients want to have a say in how they are treated. However, the information they are obtaining today in printed form or on the Internet is very diverse and often not reliable.
To improve this situation, we need better information for patients. It needs to be more targeted and more adapted to the needs of patients. This requires joint efforts from healthcare professionals, patients associations, public authorities, but also from industry. Improved information to patients is thus subject of many different initiatives, which go far beyond today's proposals which focus on information from industry.
In order to allow patients to benefit from this knowledge of the manufacturers and to protect them from undue promotion, the proposals set out strict rules on the information that companies may provide on prescription-only medicines to the public. Direct-to-consumer advertising is - and remains - strictly forbidden.
Redefining the initial proposals from a patients' perspective has important consequences which are reflected in the modified proposals:
First, the new proposals do not just set out rights of industry. Instead, they oblige companies to publish certain information such as the labelling and the package leaflet.
Second, information would only be allowed though limited channels of communication, excluding general print media.
Third, as a matter of principle, such information may only be published after an ex-ante control by the public authorities. Exceptions are only foreseen for existing control systems or in case of constitutional problems.
The proposals require that any information must be clear, objective, reliable and, of course, up-to-date. National authorities would be responsible for monitoring compliance.
Beyond the provisions on information to patients, the modified proposals contain also strengthened rules on the post-authorisation monitoring of medicines. These changes respond to recent problems with the so-called Mediator case. As these changes are important to further improve patient safety, we used the opportunity of today's modified proposal and included them as an addendum.
The recent Mediator-case led the Commission to carefully check the mechanisms in place to deal with safety issues. Patients' safety must come first. There cannot be any compromise on the health and life of our patients! I therefore used the Mediator case as stress test for the new pharmacovigilance legislation which was adopted end of last year.
The result was that the new rules remedy most of the problems, but that certain further changes are necessary. These are taken up now:
First, whenever a Member State takes action on a medicine due to serious safety concerns, this will automatically trigger an examination at EU-level in order to ensure equal safety for patients throughout the European Union.
Second, companies who voluntarily withdraw a medicine from the market, will be obliged to explain the reasons. Withdrawal for safety concerns must not be disguised as commercial activity, in order to ensure appropriate follow-up.
Third, authorised medicines that require special surveillance by national authorities, will be included in a publicly-available list of medicines.
The proposals will now be debated once more by both the European Parliament and by the Council of Ministers.