ABSTRACT
The pharmaceutical industry’s innovator companies play a critical role in the advancement of public health through the discovery and development of novel therapeutic agents aimed at the prevention, diagnosis, and treatment of diseases. These entities allocate substantial financial and human capital to intensive research and development (R&D) processes, often resulting in path-breaking pharmaceutical innovations. The sustainability of such innovation is significantly underpinned by the protection afforded under patent law, which grants time-limited exclusive rights to exploit the invention. These patent rights confer a temporary legal monopoly, enabling patent holders to prevent unauthorized manufacturing, use, or commercialization of the patented products, and to recoup R&D expenditures through market exclusivity and premium pricing models.
However, the monopolistic nature of patent protection frequently results in elevated drug prices, thereby restricting access to essential medicines, particularly in low- and middle-income populations. In the post-patent-expiry landscape, generic pharmaceutical manufacturers assume a vital role by producing cost-effective bioequivalent alternatives, thereby enhancing the affordability and availability of critical drugs across socio-economic strata.
This paper examines the complex interplay between the proprietary interests of innovator companies and the public health imperative of accessibility facilitated by generic drug manufacturers, especially in India. The policies and regimes that can help in increasing affordability and reachability of medicines to every group of people. It also evaluates mechanisms such as patent pools, compulsory and voluntary licensing regimes, public-private partnerships, and the role of governmental and non-governmental interventions in mediating these competing interests. The analysis underscores the need for a balanced legal and policy framework that incentivizes pharmaceutical innovation while promoting equitable access to life-saving therapies. Ultimately, the study advocates for a recalibrated intellectual property regime that aligns with the principles of global health equity and sustainable development.
KEYWORDS: Pharmaceutical pricing, Intellectual property rights, Public health ethics, Affordable healthcare, Medicines Patent Pool (MPP), India’s patent law, Compulsory licensing, Generic medicines`
INTRODUCTION
Medical or pharmaceutical patents refer to intellectual property rights granted for innovations related to medicines, medical devices, biologics, and vaccines. These patents confer exclusive rights upon the patent holder, allowing them to prevent others from manufacturing, selling, or distributing the patented product without authorization. While such rights incentivize innovation and investment in research and development, they also enable patent holders to exercise market monopolies, often setting prices at their discretion. This monopolistic control can lead to significant disparities in access, particularly among populations from diverse economic backgrounds, ultimately affecting the affordability and availability of essential healthcare.
On the other hand, generic pharmaceutical companies offer medications at significantly lower prices, making essential drugs more accessible to the public. However, the production and sale of generics are legally restricted until the expiry of the original patent—typically a period of 20 years. This extended exclusivity can be especially burdensome for economically disadvantaged populations who are unable to afford high-priced patented medicines during this time. India, recognized as one of the world’s largest manufacturers of generic drugs, plays a critical role in making affordable healthcare accessible.
Amid the ongoing interplay between innovator and generic pharmaceutical companies, it is often the underprivileged who bear the brunt, as they are unable to afford or access essential medicines. This paper proposes various strategies aimed at bridging this gap by enhancing both the affordability and accessibility of medications, while also ensuring fair compensation for innovators and safeguarding their contributions. To underscore the urgency of prioritizing affordability within the pharmaceutical industry, a recent case study is presented before delving into the proposed solutions.