Spiros Drosos’ commentary was included in a Pink Sheet article detailing how the European Union (EU) is in the final phase of reforming its pharmaceutical legislation. Spiros focuses on how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc.
Spiros said the approach taken to drug advertising was “evolutionary, rather than revolutionary… largely preserving the current framework and codifying principles from EU case law.” “One notable change, however, concerns comparative advertising,” Spiros told the Pink Sheet.
“At the EU level, comparative claims are permitted so long as they confirm or clarify and do not distort information in the relevant product summaries of product characteristics (SmPCs). This is the same legal standard as for other types of advertising claims for medicines,” he explained.
Under the proposed new rules, which can be found in Recital 136 and Article 176 of the directive, a promotional claim that one medicine is more effective than another would only be permitted if “demonstrated and supported” by the SmPC, according to the commission’s proposal. “This could result in a different, more onerous, legal standard applying for comparative advertising versus ordinary, positive promotion,” Spiros warned, adding that “navigating these differences could be potentially challenging for pharmaceutical companies and regulators alike.”
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