Scottish Medicines Consortium (SMC)

The Scottish Medicines Consortium (SMC) is an independent NHS Scotland advisory body that evaluates newly licensed medicines for use within NHS Scotland, providing guidance on clinical and cost-effectiveness to support prescribing decisions. It operates a dedicated ultra-rare condition (URC) process — with a modified cost-effectiveness threshold and greater weight given to patient and clinical expert testimony — enabling fair assessment of orphan medicines with limited clinical trial evidence. SMC recommendations are made by expert committees and are binding for NHS Scotland health boards, making it a critical pathway for rare disease patients to access novel therapies.

Since 2006, the SMC has incorporated patient and public involvement through its Patient and Public Involvement (PPI) team and the Public Involvement Network. These mechanisms allow patients and advocacy groups to share lived experiences and highlight unmet needs, shaping final decisions.