A Critic on Legal, Ethical, and Regulatory Issues of Off-Label Medicines Shepardizing Intellectual Property Law towards Pharmacoeconomics: A Discussion of Pfizer’s Norvasc Patent Case
Authors: Llarena Zharama M. 
Published: October 2023

Purpose: Pharmacoeconomics is a pharmacy discipline designed to tackle issues on clinical, ethical, and safety factors leading to advocacy of healthcare corporate governance in fulfillment of the pillars of sustainable development. Thus, it is necessary to discuss illegal diversions of Intellectual Property of drug patents as these legal problems serve as impediments to Pharmacoeconomics. This paper aims to elucidate the advantages of Off-label medicines in favor of clinical, ethical, and safety aspects of Pharmacoeconomics towards patient safety and treatment for welfare.

Methodologies: Quantitative measurement is crucial for validation of drug quality products. It is used for comparison of both legal and illegal diversions of healthcare corporate governance. Patent Law and its policy options are tools to measure the violations of the perpetrator under Intellectual Property Law. Meanwhile, the British National Formulary follows the Human Medicines of 2012 and communicate with FDA for the implementation of off-label medicines as policy for clinical practice under legal removal of patent protection for medical research and practice. This study follows a diagnostic design as a research method based on ethical, regulatory, and legal presentations to characterize problems involved in drug management system towards efficiency of evidence-based medicine practice utilizing theories, models, and frameworks towards financial intelligence.    

Findings: The elucidation of Kano Model Framework exhibits the aberration and compliance of patent drugs towards compliance of healthcare corporate governance. Based on exhibition of intellectual property law, it can be extended to fulfill the goals of sustainable development of monetary success and hence, the human society can be reflected as their success to their financial intelligence as their inventorship is declared as non-obviousness to public welfare and safety. Moreover, the moral standard of ethical decision-making illustrated the importance of opting to off-label medicines emphasizing cost-efficiency goals of Pharmacoeconomics in drug therapy. Hence, the Shariah Jurisprudence Method for Pharmacoeconomics is the modelling of Clinical Pharmacy Practice towards Healthcare Corporate Governance in fulfillment of business ethics as public welfare and safety of human society.

Recommendation: Kano Model Framework is an integrated tool of measuring the success of healthcare corporate governance. With the elucidation aids of modelling the importance of Pharmacoeconomics, it is recommended to develop ways of making artificial intelligence as a sole success, profit, benefit, and contribution to clinical pharmacy practice, starting from its drug development up to its intended purpose of human drug treatment in healthcare setting, in relation to its accompanied FDA regulating bodies, as British National Formulary team compliance of maintaining the crucial functions of observing and monitoring document for patient safety.