Launching and commercializing medicines in France requires navigating a complex regulatory and market access environment. One area that often raises questions among pharmaceutical professionals is the “NS” (Non Substituable) mention, which directly affects prescribing and dispensing practices.
What is the NS mention?
The NS mention allows prescribers in France to indicate that a prescribed medicine cannot be substituted by its generic equivalent at the pharmacy level. This effectively obliges pharmacists to dispense the branded drug rather than offering a lower-cost generic alternative.
When can NS be used?
French regulations strictly control the circumstances under which a doctor can use the NS mention. It is limited to:
- Excipients with known effects: If the patient has a documented allergy or intolerance to certain excipients present in the generic version.
- Narrow Therapeutic Index (NTI) medicines: Where small differences in dosage or formulation could lead to serious therapeutic consequences.
- Specific clinical justifications: In rare cases where patient safety requires strict continuity of treatment.
Importantly, prescribers must justify the NS mention on the prescription, and misuse is discouraged by health authorities.
Why does NS matter for pharma companies?
The use of NS has significant implications for pharmaceutical strategy in France:
- Market Access & Pricing
- Widespread use of NS can limit generic penetration, impacting cost-containment objectives of payers.
- For originator companies, NS can help preserve branded market share, but this comes under close regulatory scrutiny.
- Generic Strategy
- For companies launching generics, NS represents a barrier to substitution, requiring strong physician education and confidence-building in bioequivalence and safety.
- Regulatory Compliance
- Overuse of NS can trigger inspections and sanctions, both for prescribers and for companies perceived to encourage inappropriate use.
- Patient Perception
- Patients may perceive the NS mention as a sign that generics are “less safe,” potentially undermining trust. Companies must navigate this carefully when engaging with healthcare professionals and patient associations.
Key takeaways for pharma companies
- Understand the strict rules governing NS and ensure your teams and partners are aligned.
- Prepare communication strategies for both physicians and patients, highlighting therapeutic equivalence of generics (if you are a generic manufacturer) or justifying continuity of branded treatment (if you are the originator).
- Monitor NS usage trends in your therapeutic area to anticipate pricing, reimbursement, and market share dynamics.
- Engage early with French stakeholders—including regulatory bodies, pharmacists, and patient groups—to build trust and reduce friction.
📌 At Elliogen, we help pharmaceutical companies navigate the nuances of the French market, from NS implications to broader market access and exploitant requirements.
👉Contact us at hello@elliogen.com
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