Philosophical Interpretation of Article 24 of the Medicines Act: Drug Safety, Efficacy, and Quality Control

Abstract

Article 24 of the Medicines Act serves as a cornerstone in the regulatory framework governing pharmaceuticals in the United Kingdom. This article emphasizes the rigorous evaluation of drug safety, efficacy, and quality through a structured, multi-phase process involving pre-clinical studies, clinical trials, and post-marketing surveillance. This paper explores the philosophical underpinnings of Article 24, delving into its ethical, epistemological, and regulatory dimensions. The ethical analysis focuses on balancing public health and individual rights, the principle of informed consent, and equitable access to high-quality medicines. The epistemological discussion highlights the commitment to evidence-based medicine, scientific rationalism, and the critical role of regulatory bodies like the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory perspective examines the comprehensive and precautionary approach to drug approval and quality control, emphasizing global harmonization and collaboration. By integrating these perspectives, the paper underscores the significance of Article 24 in ensuring that only safe, effective, and high-quality medicinal products are available in the UK, thereby setting a model for global regulatory practices.