Role Of IPR In Regulating Drug License

Bedanti Sharma, Presidency University, Itgalpura, Yehalanka Bangalore

ABSTRACT

In the dynamic terrain of pharmaceuticals, the intersection of Intellectual Property Rights (IPR) and drug licensing plays a crucial role in shaping the accessibility, affordability, and innovation within the global healthcare system. This paper digs into the miscellaneous aspects of IPR as a regulatory framework for drug licensing, exploring its impact on drug development, market competition, and public health. The pharmaceutical industry heavily confides on intellectual property protection, primarily through patents, to stimulate innovation by providing a limited dominance to inventors. However, the delicate balance between stimulating innovation and ensuring access to essential medicines has aroused debates and discussions on the ethical and economic implications of IPR in the pharmaceutical sector. This paper analyzes the evolution of IPR in the context of drug licensing, highlighting its role in fostering innovation by granting exclusivity to drug developers. Simultaneously, it addresses the challenges posed by these exclusivities in terms of limiting market competition and impeding the timely availability of affordable generic drugs. The study also examines the role of regulatory authorities in extenuating potential abuses of IPR, emphasizing the need for a balanced and flexible approach that accommodates the interests of both innovators and the general public. It explores the concept of compulsory licensing as a mechanism to address public health emergencies and enhance access to essential medicines, while also considering the impact on the encouragements for future research and development. Additionally, the paper analyzes the implications of international agreements, such as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), in shaping the IPR landscape for drug licensing on a global scale. It discusses the influence of these agreements on the harmonization of intellectual property standards and their impact on the availability of affordable medicines in developing countries. In conclusion, the role of IPR in regulating drug licensing is a complex and dynamic field that necessitates a careful balancing act between upbringing innovation, ensuring market competition, and safeguarding public health. This paper contributes to a refined understanding of the intricate relationship between IPR and drug licensing, offering insights into potential reforms and policy considerations for a more equitable and sustainable pharmaceutical ecosystem.