European Industry Associations Call for Strict Policy Measures on Off-Label Use

EFPIA, EUCOPE and EuropaBio have welcomed the publication of a European Commission (EC) study on off-label use but called for further policy measures that preserve patients’ safety and the integrity of the EU regulatory regime.

The EC report acknowledges that, beyond purely therapeutically motivated decisions, off-label use of medicines at the healthcare system level can also be driven by financial reasons. In a press release, the three European associations agree that they "strictly oppose the promotion of off-label use for economic reasons".

Welcoming the EC report's emphasis on the negative impact of off-label use for the regulatory system, such as its creation of uncertainties regarding the liability of healthcare professionals, undermining of the EU market authorization process and discouraging R&D, the associations however "regret the lack of emphasis in the report on the fact that off-label use poses additional risks for patient safety which appear all the more unacceptable when alternative on-label treatments are available and not used for financial reasons".

EFPIA, EUCOPE and EuropaBio add that the reimbursement of off-label medicines for economic reasons when on-label products exist "is not an acceptable policy option". They conclude: "We therefore call on decisions makers to put patients’ safety and the integrity of the regulatory regime first and not to support measures that would set double standards in terms of regulatory requirements for on-label medicines and off-label medicines."