In a joint analysis of the revised proposals on "information" to patients, the Medicines in Europe Forum and ISDB argue that direct-to-consumer "information" on prescription medicines by manufacturers exposes citizens to misleading messages, puts public health at risk and threatens Member States’s social protection systems.

> Download the Joint Analysis (pdf, in English, 156 Ko)

Brussels, 21 October 2011

Summary of the Joint Analysis
On 11 October 2011, the European Commission published its revised legislative proposals on "information" to patients on prescription-only medicines.

The most detrimental provisions (i.e. direct-to-consumer communication via printed media) were removed, and other positive pharmacovigilance provisions were inserted as a consequence of the benfluorex (Mediator°) scandal in France.

Despite the efforts made by the European Commission to improve the original proposals, the revised versions still do not meet the need of citizens for reliable and comparative information. In addition, they fail to protect citizens from advertising disguised as "information" about prescription-only medicines, and could even lead to the implementation of "reminder advertisements" in Europe.

Contrary to the European Commission's Better Regulation principle, the means put forward to achieve the aim of "better informed citizens on prescription medicines" are inappropriate, since they rely on pharmaceutical companies to communicate about the products they sell despite their unavoidable conflict of interest; and the proposals would – as a consequence of that ill-founded choice – lead to increased administrative burdens.

ISDB and MiEF urge EU Member States to continue to refuse to consider these unnecessary proposals, and to study the new pharmacovigilance measures separately.

- ISDB (International Society of Drug Bulletins)
- Medicines in Europe Forum

> Download the Joint Analysis (pdf, in English, 156 Ko)

> Download the joint Press Release (pdf, 165 Ko)

©Prescrire 1 December 2011