For Regulatory Authorities

For Regulatory Authorities

In 2015, the European Union celebrated the 50th anniversary of the EU pharmaceutical legislation. Much of the impetus behind the adoption of the first EU law on pharmaceuticals stemmed from the determination of the EU Member States to avoid the repetition of a thalidomide-like disaster and safeguard public health by ensuring that no medicinal product is marketed without prior evidence-based authorisation.

Thanks to EU-wide action, patients throughout Europe have significantly benefitted from the high-standards set on market authorisation, good-manufacturing practices and post-market surveillance procedures.

The EU legislation suggests that in certain cases a physician may prescribe a medicine off-label. However, according to the provision itself, these cases are limited to the identification of special medical needs of the patient, as carefully assessed by the physician himself on a case-by-case basis.

As a consequence, healthcare authorities that promote off-label products for cost-containment purposes, not only jeopardize patient safety but undermine the EU regulatory framework designed to protect European citizens.

Promoting off-label medicines for economic purposes creates double-standards in patient care and implies that patients’ safety can be undermined due to commercial considerations.