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Balancing IP Laws and Generic Manufacturing to Propel Pharmaceutical Sector

Apr 26,2024

Serving as a valuable opportunity to acknowledge the indispensable role of Intellectual Property (IP) in driving innovation and a spirit of scientific enquiry in the pharmaceutical sector, the World Intellectual Property Day is an occasion to commemorate the crucial role of intellectual property protection in advancing scientific frontiers, catalysing medical breakthroughs and nurturing ideas aimed at enhancing human well-being.

In the pharmaceutical realm, IP ensures patient access to novel medicines while facilitating the research and development of future treatments and cures. Moreover, it serves as a catalyst for collaboration among industry players, academic institutions and small biotech firms, leveraging scientific expertise and capabilities to enhance healthcare outcomes and introduce approaches that benefit economies and strengthen the industry while improving the overall quality of life of the masses.

A recent report of a study conducted by the Organisation of Pharmaceutical Producers of India (OPPI) and EY Parthenon has underscored the immense potential of the Indian pharmaceutical industry to not only meet but surpass expectations. This potential hinges on strategic investments and a commitment towards transformative innovation driven by value. The report is based on the feedback of 40 Chief Experience Officers (CXOs) from leading Indian and global pharmaceutical companies, where 30 per cent of the respondents highlighted the need for putting a robust research and innovation system in place.

India is more inclined towards its generic manufacturers than innovators, which is evident from its stance against the inclusion of data exclusivity provisions, especially in Free Trade Agreements (FTAs), with the aim of safeguarding the interests of the domestic generic drug industry. Data exclusivity protects technical data or clinical trials data generated by innovator companies to prevent competitors from producing cheaper versions of medications unless they collect their own clinical trials data or wait for the exclusivity rights of innovators to lapse.

This can compel generic manufacturers to either wait out the exclusivity period or undergo costly clinical trials afresh. Data exclusivity can also impede the process of issuing compulsory licences to generic manufacturers, limiting access to lower-priced medicines. The scope and terms of data exclusivity are, therefore, highly relevant to the pharmaceutical industry as well as the public, particularly with regard to the supply of new medicines and access to existing ones. Moreover, the vast financial resources and extended time required for gathering and generating pharmaceutical registration data for a new drug can create a market barrier that is too high for generic manufacturers.

There is a pressing need for the government to enhance support for disruptive innovation, particularly through the enactment of more stringent IP laws, especially in cases involving rare diseases and diseases of critical nature. Currently, rare diseases pose a less attractive investment proposition for the industry due to a disproportionate investment-to-return ratio. The government should incentivise research in such areas so that the innovation ecosystem is not guided by profit considerations alone. By enforcing regulations for IP pertaining to medical solutions in critical care segments, India can leverage its research potential and demographic diversity to emerge as a global hub of research in this field.

IP laws have historically catalysed diverse treatment options, addressing global health challenges effectively. Extending IP protection can empower more pharmaceutical and research firms to invest in the demanding process of innovation. Yet, it’s imperative that such laws are crafted and implemented in a way that continues to facilitate access to affordable medications, especially in low and middle-income regions. Striking the right balance will be crucial for India as it seeks to enhance its role as a global leader in pharmaceuticals and uphold its commitment to public health.

The article is written by Saransh Chaudhary, President, Global Critical Care, Venus Remedies Ltd and CEO, Venus Medicine Research Centre (VMRC)

Source: Pharma

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