The European Commission (EC) has adopted revised proposals clarifying the information that industry can supply to the public on prescription-only medicines, while maintaining a strict ban on direct-to-consumer advertising.
Only certain information will be allowed to be communicated, including information on the label and packaging leaflets, pricing information, instructions for use, and information on clinical trials. Channels of communication will also be strictly limited to media such as officially registered internet websites and printed information made available when specifically requested by members of the public. Dissemination in general print media, radio and television will not be permitted.
In addition, the information will have to fulfill certain quality criteria. The information must be unbiased, evidence based and factually correct, understandable, and must meet the needs and expectations of patients. Information that has not previously been approved will need to be verified by competent authorities prior to dissemination.
In a statement, John Dalli, European commissioner for health and consumer policy, said: "The revised proposals put rights, interests and safety of patients first. They oblige industry to provide certain key information to patients and set clear rules for additional, voluntary information on prescription medicines. In addition, they further strengthen the control of authorized medicines."
The EC’s first proposal was released in 2008 as part of the ‘Pharmaceutical Package’, but was amended during a vote in 2010 of MEPs of the European Parliament’s Health Committee. According to a statement of the European Public Health Alliance (EPHA), 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.”
However, the latest proposal seems to have alleviated this concern as it has been welcomed by EPHA and the European Federation of Pharmaceutical Industries and Associations.
“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,” said Monika Kosinska, secretary general of EPHA, in the EPHA statement.
According to a statement from the EC, patients are taking increased interest in the medicines they take and want more of a say in how they are treated. “At the same time, patients are confronted with a growing volume of information from various sources and often find it difficult to identify reliable information about medicines,” said the statement. “The increased use of the internet over recent years makes the need for clarity even more important. Online information on medicines must be accurate and reliable.”