3. Off-label use

2. Legal framework in Europe

2.1. Off-label use - advertising

Article 87 of Directive 2001/83/EC prohibits advertising of a medicine for which a MA has not been granted. Since any advertising must comply with the SmPC, advertising the off-label use of an authorised medicine is also prohibited.

Promotion of off-label use would bypass and undermine the rigorous regulatory approval process. It would raise serious concerns over patient safety as it would promote the use of medicines in indications for which the relevant regulatory authorities have not performed a benefit-risk analysis.

Of note: some EU Member States have passed legislation that promotes the off-label use of medicines on economic grounds versus alternative, authorised medicines. Various groups (e.g., EFPIA, EUCOPE and EuropaBio[1]) question whether this trend is in line with EU law and in summary state that by encouraging off-label uses that have not been subject to the same rigorous controls and safeguards as on-label medicines, member states such as Belgium, France, Italy and the UK, bypass the regulatory process and undermine the European Union's underlying objective of guaranteeing patient safety.  Further, the ‘GOLUP declaration on good off-label use practice’ highlights the importance of preserving the European regulatory framework to ensure the safety of patients, while ensuring good off-label use of medicines for patients in need[2].

[1] Statement on bio-pharmaceutical industry complaint to the European Commission against a new Italian law promoting off-label use of medicines for economic reasons. 20 February 2015

[2] Declaration on Good Off-Label Use Practice. European Brain Council 2017