The European Commission’s proposal to amend the rules covering drug information provided by the industry to patients is “clearly driven by the pharmaceutical industry’s interests, not by the interests of patients,” claims leading UK patient advocacy group The Picker Institute.

The proposal’s “exclusive focus on allowing pharmaceutical companies to provide direct to patient/public information conflicts with the Commission’s stated intention,” which is that patients’ interests must come first, it adds.

The Picker Institute’s comments appear in its response to the Commission’s public consultation on its plan for a legal proposal on information to patients, which seeks to ensure “good-quality, objective, reliable and non-promotional information on prescription-only medicinal products” and harmonise its provision throughout the European Union. Currently, access to such information is very unequal among the member states, says the consultation document.

As well as putting the interests of patients first, the Commission says its proposal would retain the role of health care professionals as the primary source of health information and maintain the current ban on direct-to-consumer (DTC) advertising of prescription medicines. It would ensure a clear distinction between advertising and non-promotional information, proposing that: “basically, communication not covered by the definition of advertisement should be regarded as information.” This distinction would create a framework for the industry to provide “certain information on their medicines,” enabling patients and the public to obtain “objective information from reliable sources,” it says.

The Picker Institute’s response acknowledges the current problems of unequal access and says it would “wholeheartedly support genuinely patient-focused initiatives to ensure equality in the provision of, and access to, information.” However, it claims that the proposal seeks “to allow pharmaceutical companies to provide direct-to-consumer information about prescription-only medicines,” and urges the Commission to reconsider it.

Moreover, the initiative depends on there being a workable distinction between “advertising” and “information,” but no groundwork has been done to develop this, says the Institute; without it, the distinction will be unworkable in practice and the proposal would have the effect of undermining the ban on DTC advertising, it adds.

Nor does the proposal reflect the evidence base regarding patients’ information needs, which shows that the most significant unmet need is for comparative and comparable information to enable them to make informed decisions on the most appropriate treatment. The “DTC information” which could be provided to consumers under the proposal would not enable them to compare different products, and this “clearly demonstrates that the pharmaceutical industry’s interests are the priority, not patients’ interests,” says the Institute. Patients should be able to make rational decisions, but advertising does not support this, it adds.
The Commission’s Directorate-General for Enterprise and Industry is calling for responses to the consultation from all interested parties, to be received by April 7.