Legal Validation of NHS Policy Prioritizing Off-Label Avastin Use for Wet Age-Related Macular Degeneration under Apozyt Exemption
Introduction
The case of Bayer Plc & Anor v. NHS Darlington CCG & Ors ([2020] EWCA Civ 449) primarily concerned the legality of a policy adopted by NHS Clinical Commissioning Groups (CCGs) to prioritize the use of Avastin, an off-label drug, over its licensed alternatives Lucentis and Eylea for treating wet age-related macular degeneration (WAMD). The pharmaceutical companies appealed against the initial judgment dismissing their application for judicial review, arguing that the policy contravened EU drug licensing laws and domestic regulations.
Summary of the Judgment
The England and Wales Court of Appeal upheld the original decision by Whipple J, dismissing the appeal brought by Bayer and Novartis. The Court concluded that the NHS CCGs' policy to prefer Avastin was lawful, provided it adhered to the "Apozyt exemption." This exemption allows for the off-label use of a medicinal product under strict conditions: the drug must not be modified in a way that alters its safety or efficacy, and its use must be based on individual prescriptions.
Analysis
Precedents Cited
The judgment heavily relied on prior case law, particularly the CJEU's decision in Apozyt GmbH v Novartis Pharma GmbH (C-535/11) and its implications in subsequent cases like F. Hoffmann-La Roche Ltd v Autorita Garante della Concorrenza e del Mercato (C-179/16) and Novartis Farma SpA v Agenzia Italiana del Farmaco (C-29/17). These cases established the "Apozyt exemption," which delineates circumstances under which compounded medicines do not require separate marketing authorizations, focusing on the absence of modification and reliance on individual prescriptions.
Legal Reasoning
The Court's reasoning centered on interpreting EU Directive 2001/83/EC and the accompanying EMA Regulation. The "Apozyt exemption" was pivotal, allowing the dispensing of off-label Avastin without breaching the directive, provided two conditions were met:
- No Modification: The compounding process should not alter the medicinal product's safety, efficacy, or fundamental characteristics.
- Individual Prescriptions: Compounding must be based solely on individual prescriptions issued by authorized healthcare professionals.
The Court found that the NHS CCGs' policy complied with these conditions. Mode 2 (in-house compounding by hospital pharmacies) and Mode 3 (compounding by other NHS hospital pharmacies) were deemed lawful as they could adhere to individual prescriptions and ensure no modification occurred. Mode 4 (commercial compounding) remained unclear due to the lack of evidence regarding compliance with regulatory standards.
Additionally, the Court dismissed arguments that the policy undermined EU legislative frameworks or breached the duty of sincere cooperation under Article 4(3) TFEU. It emphasized that the policy did not prescribe specific methods of obtaining Avastin but provided a lawful framework within which NHS Trusts could operate.
Impact
This judgment has significant implications for NHS commissioning practices, particularly in optimizing healthcare costs without compromising patient safety. By upholding the legality of using compounded Avastin, the NHS can continue to adopt cost-effective treatments while adhering to regulatory standards. This precedent reinforces the flexibility allowed under EU directives for member states to manage healthcare resources efficiently, provided strict compliance with established exemptions like that in Apozyt.
Moreover, the decision highlights the importance of clear regulatory frameworks and the necessity for thorough legal and procedural adherence when implementing off-label drug use policies within public healthcare systems.
Complex Concepts Simplified
Apozyt Exemption
The "Apozyt exemption" allows for the off-label use of medications like Avastin without requiring separate marketing authorization, under two strict conditions:
- No Modification: The drug's fundamental characteristics, such as its safety and efficacy, must remain unchanged during compounding.
- Individual Prescriptions: Each compounded medication must be based on a specific prescription tailored to an individual patient's needs.
Placing on the Market
"Placing on the market" refers to the distribution of medicinal products within the EU. The Apozyt exemption delineates the cessation of "placing on the market" at the point when the drug is prescribed and administered to a patient, allowing further distribution within healthcare settings under regulated conditions.
Manufacturing Authorization
A manufacturing authorization is a legal permission required to produce or assemble medicinal products. Under the Apozyt exemption, manufacturing authorizations are not necessary for compounding Avastin for WAMD treatment, provided the no modification and individual prescription criteria are met.
Conclusion
The Court of Appeal's decision in Bayer Plc & Anor v. NHS Darlington CCG & Ors solidifies the legal foundation for the NHS to implement cost-saving measures through the off-label use of Avastin for WAMD, under the Apozyt exemption. This ensures that the NHS can manage healthcare resources effectively while maintaining adherence to safety and regulatory standards. The judgment underscores the balance between economic efficiency and patient safety, affirming the NHS's autonomy in healthcare commissioning within the bounds of EU and domestic law.
This comprehensive analysis and validation of the policy pave the way for future healthcare policies to align with both economic and regulatory frameworks, fostering sustainable healthcare practices.
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