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October 20, 2021

Comment: Would Offering Protection To Pharmaceutical Test Data As Trade Secrets Affect The Indian Drug Market?

Author: Intern - Ashley George

Data exclusivity is a practice in which drug regulatory agencies prohibit the innovator company’s test data to be utilised in the registration of a generic version of that treatment. Since the marketing approval procedure is time-consuming and costly, the creators of regulatory data want exclusive periods of protection for their investments and resultant data collection. Generic producers in India, on the other hand, push for minimal protection in order to secure faster marketing approvals. The author believes that providing IP protection to clinical test data would ultimately, have a negative effect on the commercial drug market in India.

To support the argument of the author against the data exclusivity practice is, primarily, based on the detrimental impact it could have on public health. The accessibility to affordable generic drugs by the public at large remains a priority, however, this should not be accomplished at the expense of its quality and effectiveness. Moreover, generic companies usually lack the financial capabilities to undertake the entire task of conducting clinical trials and assimilating data.

In India, wages per capita income is lower in comparison to with first-world countries [1], and the unavailability of generics would inevitably result in high prices for many life-saving drugs. A prolonged delay in performing clinical studies by drug manufacturers will result in a delay of availability of such drugs at a reasonable price in the market, which is often a time-sensitive problem. This would also result in pharmaceutical giants having monopoly over such drugs. Hence, many life-saving drugs will be out of reach for individuals suffering from the deadliest diseases due to the lack of cheaper generics.

It is also noted that the clinical trial process involves ethical questions, as the proposed drugs have to be tested on animals and then on the human beings. If data exclusivity practice is adopted, then generic drug manufacturers will be compelled to undertake clinical trials for getting the marketing approval of the generic version of the same medicine. This would lead to duplicative testing and would amount to unnecessary and possible human injury associated with such process.

Therefore, if data exclusivity practice is approved, generic companies would encounter more challenges in securing marketing approvals, thereby increasing the cost of drugs available to consumers. This would negatively impact the availability of generic drugs at affordable prices in the market. Thus, the author strongly opines that the data exclusivity practice would have an adverse impact on the Indian pharmaceutical market, and should not be allowed.

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[1] World Bank, GDP Per Capita, available at https://data.worldbank.org/indicator/NY.GDP.PCAP.CD.

Disclaimer: Views, opinions, interpretations are solely those of the author, not of the firm (ALG India Law Offices LLP) nor reflective thereof. Author submissions are not checked for plagiarism or any other aspect before being posted.

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