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The Crossroad between Intellectual Property and Clinical Trials: Balancing Incentives for Innovation with Access to Healthcare


Affiliations
1 Gujarat National Law University, Gandhinagar, Gujarat — 382 421, India
 

Intellectual property (IP) is essential for encouraging innovation in the pharmaceutical business, particularly in clinical trials. However, IP can also limit access to healthcare by making drugs and treatments unaffordable for certain populations. The pharmaceutical industry relies heavily on intellectual property protections to incentivize innovation and support the development of new drugs. Moreover, clinical trials play an indispensable part in the medication development process, providing the evidence needed to support regulatory approval and marketing. The intersection of intellectual property and clinical trials raises important legal and ethical issues that need to be carefully considered. This article analyses the significance of intellectual property in the process of drug innovation, its impact on clinical trials, and the ways in which intellectual property might affect the accessibility and price of new treatments. This paper also explores the balance between incentivizing innovation through IP and ensuring access to healthcare, notably within the setting of clinical trials.

It examines the history of intellectual property laws in the pharmaceutical industry, how patents and exclusivity encourage innovation, and how these incentives affect healthcare access. The paper also discusses alternative models for incentivizing innovation, such as open-source drug development and prize-based systems. The article concludes that while intellectual property is vital to encourage innovation in the pharmaceutical business, it must be balanced with efforts to assure universal access to healthcare. We argue that policymakers and industry stakeholders must work together to develop policies and practices that promote innovation while ensuring that new drugs are accessible and affordable to all.


Keywords

Intellectual Property, Clinical Trials, Innovation, Access to Healthcare, Pharmaceutical Industry, Patents, Exclusivity, Open-Source Drug Development, Prize-Based Systems.
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  • The Crossroad between Intellectual Property and Clinical Trials: Balancing Incentives for Innovation with Access to Healthcare

Abstract Views: 125  |  PDF Views: 85

Authors

Aditi Nidhi
Gujarat National Law University, Gandhinagar, Gujarat — 382 421, India

Abstract


Intellectual property (IP) is essential for encouraging innovation in the pharmaceutical business, particularly in clinical trials. However, IP can also limit access to healthcare by making drugs and treatments unaffordable for certain populations. The pharmaceutical industry relies heavily on intellectual property protections to incentivize innovation and support the development of new drugs. Moreover, clinical trials play an indispensable part in the medication development process, providing the evidence needed to support regulatory approval and marketing. The intersection of intellectual property and clinical trials raises important legal and ethical issues that need to be carefully considered. This article analyses the significance of intellectual property in the process of drug innovation, its impact on clinical trials, and the ways in which intellectual property might affect the accessibility and price of new treatments. This paper also explores the balance between incentivizing innovation through IP and ensuring access to healthcare, notably within the setting of clinical trials.

It examines the history of intellectual property laws in the pharmaceutical industry, how patents and exclusivity encourage innovation, and how these incentives affect healthcare access. The paper also discusses alternative models for incentivizing innovation, such as open-source drug development and prize-based systems. The article concludes that while intellectual property is vital to encourage innovation in the pharmaceutical business, it must be balanced with efforts to assure universal access to healthcare. We argue that policymakers and industry stakeholders must work together to develop policies and practices that promote innovation while ensuring that new drugs are accessible and affordable to all.


Keywords


Intellectual Property, Clinical Trials, Innovation, Access to Healthcare, Pharmaceutical Industry, Patents, Exclusivity, Open-Source Drug Development, Prize-Based Systems.

References