Title: Regulatory data protection for global economy of biopharmaceuticals: comparative legal analysis with focus on innovative biopharma in India

Authors: B. Monisha; R. Valarmathi

Addresses: School of Law, Christ (Deemed to be University), Bengaluru, 560029, Karnataka, India ' School of Law, Christ (Deemed to be University), Bengaluru, 560029, Karnataka, India

Abstract: This provides a new global economy of biopharmaceuticals with an exclusive right over clinical data, meaning that no other person or persons may use them for a specified period. This study, therefore, offers a critical analysis of complementary protection granted to biopharmaceuticals by patents and regulatory data protection (RDP) globally with respect to innovation, competition, and access to medicines. This study probes the effectiveness and the challenge RDP is making using statistical analysis, financial modelling, and comparative analysis of the regulatory framework in Central Drugs Standard Control Organization (CDSCO), Food and Drug Administration (FDA), and Emergency Market Authorization (EMA). The justification for this combination is that RDP fosters innovation due to the protection of clinical trial investments, which provides a drive for the introduction of innovative biologics but does not inhibit the launch of biosimilars. With RDP, though they are very different in what they do, patents have created an enabling environment to make sustainable innovation in biopharmaceuticals accessible. International regulatory hurdles have to emerge so that a balance that advances both innovation and affordability becomes the norm within biopharma.

Keywords: regulatory data protection; RDP; global economy of biopharmaceuticals; patent law; access to medicine; sustainable development goal; clinical trial investments.

DOI: 10.1504/IJTGM.2025.148046

International Journal of Trade and Global Markets, 2025 Vol.21 No.3, pp.319 - 353

Received: 06 Jan 2025
Accepted: 02 Mar 2025
Published online: 15 Aug 2025 *

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