Need of Data Exclusivity: Impact on Access to Medicine

Abstract

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 for that data to prevent it from being used by generic producer companies for the same compounds. Data exclusivity provisions are different in different countries and each country’s pharmaceutical industry usually influences the formulation of those provisions. Data exclusivity adds an extra layer of protection for the drugs irrespective of the patent protection status, thus controlling access to medicine. This paper analyses how pharmaceutical companies are trying to retain the market exclusivity by enforcing data exclusivity and how it is affecting health issues in developing and least developed countries. It also highlights the impact of data exclusivity on accessibility and affordability of life saving drugs. This paper discusses the stand of developing and least developed countries including India; evaluates why these countries are not interested in implementation of data exclusivity in their national legal regime and also proposes how to achieve balance between the economic interest of the originator companies and public interest towards access to medicine.