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Regulatory News: Revision to EU Commission Guidance on Prescription Information

31st October 2011

On 11 October 2011 the European Commission adopted new proposals to clarify the information that drug manufacturers may supply on prescription-only medicines (POM).

The proposals maintain the existing direct to customer advertising ban for POMs in Europe, but for the first time will permit marketing authorisation holders to make drug information available direct to the patients.  However the information must conform to strict criteria and, crucially, only be supplied upon request.

The amendments to Directive 2001/83/EC are seen as a response to the growing demand for high quality information in an age where information is abundant but of variable quality and therefore difficult for patients to understand. The amendments propose that:

• only certain information on prescription drugs be permitted, such as  that on labels and packaging leaflets, and that concerns clinical trials or instructions for use

• information on POMs would only be permitted via limited channels of communication, such as officially-registered internet websites

• the distinction between advertising and information be clarified to enable uniform interpretation across all Member States ensuring patient safety with the right to access quality, non-promotional information on medicinal products in their own language

• the information must meet quality criteria e.g.
          o  be unbiased
          o meet the needs and expectations of patients
          o be evidence-based
          o up-to-date
          o understandable
          o factually correct and not misleading

• information must not include comparisons between medicinal products  and

•  information not previously approved will be verified by competent authorities prior to being made available to the public

The European Public Health Alliance and European Consumers Organisation have both given a cautious welcome to the amendments but warn of a need to guard against disguised advertising.

Meanwhile the European Federation of Pharmaceutical Industries and Associations (EFPIA) says it supports the application of quality criteria that will distinguish information from advertising and ensure patients can receive helpful, non-promotional information on medicines.

The European Parliament and Council of Ministers will now debate the revised proposals.

Reviewed by Hannah McNeil, Regulatory Affairs Executive