12. October 2011 12:36
The European Commission (EC) has introduced revised proposals that clarify the level of information pharmaceutical companies supply on prescription-only medicines.
The proposals include measures for information to be allowed through limited channels of communications only and labels including prices, clinical trial data and instructions for use.
John Dalli, European Commissioner for Health and Consumer Policy, says the proposals put the “rights, interests and safety of patients first”.
The plans maintain the current advertising ban on prescription-only medication and amend original proposals first made in 2008 after concerns were raised about the increased use of the internet to gain drug information.
Although information on products would be available when specifically requested by members of the public in printed form, the proposals say information must fulfil recognised quality criteria featuring unbiased evidence-based data.
The EC also proposes that any information which has not yet been approved must also be verified by the authorities before it is published.
Mr Dalli said that the revised plans “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 authorised medicines”.
The new measures have been backed by The European Federation of Pharmaceutical Industries and Associations (EFPIA) who said it “welcomed” the proposals to improve patients’ access to information.
“EFPIA and its member companies have made it clear that they do not wish to see any ‘push’ of information on specific prescription medicines via TV, radio or print mass-media,” a statement said. “However, those citizens seeking information on their disease or therapy should be able to access it in both user-friendly formats and in their own language.”