Need of Data Exclusivity: Impact on Access to Medicine

Chakrabarti, Gargi


Pharmaceutical companies put reasonable time and money to generate safety and efficacy test data during clinical trials while applying for the marketing approval for any new chemical entity. They need protection of that data from being used by the generic produces companies for the same compounds. Data exclusivity (DE) provisions are different in different countries and respective country’s pharmaceutical industry usually influences the formulation of those provisions. DE adds an extra layer of protection for the drugs irrespective of the patent protection status, thus control access to medicine. This paper will analyze how pharmaceutical companies are trying to retain the market exclusivity by enforcing DE and how it is affecting the health issues of developing and least developed countries. It will also highlight the impact on DE on accessibility and affordability of life saving drugs. This paper will discuss the stand of developing and least developed countries including India and evaluate why these countries are not interested in implementation of DE in their national legal regime and it will also confer how to achieve balance between the economic interest of the originator companies and the public interest towards access to medicine.



data exclusivity; access to medicine; pharmaceutical patent; intellectual property protection

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