EU Commission may revise guidance on pharma literature

By Natalie Morrison

- Last updated on GMT

Related tags European commission

The EU Commission could soon revise its guidance for information allowed on packaging of prescription-only medicines, after European Parliament urged it to update its original policy.

The proposals​, which amend those put forward by the Commission in 2008, would maintain the current advertising ban on prescription medicines and require that all information included on printed labels and leaflets meet strict criteria​.

In its paper, the Commission recognizes that patients are increasingly conscious of the medication they take, but that they are confronted by a flood of conflicting information from sometimes unreliable sources.

It adds that increased use of the internet make the need for clarity even more important, and says that online information on medicines must be accurate and reliable.

John Dalli, the European Commissioner for Health and Consumer Policy, said in a statement: "The revised proposals put rights, interests and safety of patients first.

“They oblige industry to provide certain key information to patients and set clear rules for additional voluntary information on prescription medicines, and they further strengthen the control of authorised medicines.”

Welcomed change

The new proposals have received a cautious thumbs-up from the European Public Health Alliance (EPHA).

EPHA slammed the original 2008 submissions, saying the Commission was allowing pharmaceutical companies to unabashedly promote themselves in a bid to boost the sector.

In his response to the latest action, Monika Kosinska, secretary general of European Public Health Alliance (EPHA), said:"EPHA welcomes the new tone of the proposal which has taken the public health perspective on board.

“We congratulate Commissioner Dalli for producing a revised version of the proposal.”

But still wary of how plans will pan out, he added: “However we remain cautious of the man derogations and hope that this is resolved in discussions with the European Parliament and the Council."

Related topics Drug Delivery Regulations

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