Data Exclusivity

What is Data Exclusivity:

  • Data exclusivity prevents drug regulators from referring to or relying on data submitted by an originator company relating to a drug’s safety and efficacy while approving bioequivalent versions of the same drug, i.e. therapeutically equivalent generics and biosimilars for a fixed period of time.
  • A drug that comes to the market for the first time undergoes extensive preclinical and clinical trials on animals initially and human beings later before it is introduced for public use — a time-consuming and expensive process.
  • Developed countries, on behalf of their pharmaceutical lobbies, seek data exclusivity in developing countries arguing that this is necessary to recognise and incentivise the efforts put in to bring a new drug to the market along with recovering the research and development costs incurred — arguments similar to those used to justify the grant of patents.
  • Pharmaceutical companies have been pushing for data exclusivity to prolong already existing monopoly and delay competition from generics even after the expiry of the 20-year patent term or to gain exclusivity on non-patented drugs.
  • In India, such a system may negate the impact of Section 3(d) of the Patents Act, which disallows evergreening patents.
  • With data exclusivity, a company could nevertheless gain exclusive rights over such drugs even though they are not patented.
  • This is because during the period of exclusivity, regulators are barred from using the originators’ data to grant marketing approval to generics; generic companies would then be required to repeat the entire cycle of clinical trials already conducted instead of merely establishing bioequivalence to prove efficacy.
  • As seen in countries where data exclusivity is granted, generic companies do not undertake such clinical trials and their versions of the drug accordingly stay off the market as long as the period of data exclusivity lasts.
  • With restricted market entry of generics, artificially high drug prices remain which puts medicines beyond public reach.
  • Apart from the financial costs, repeated clinical trials on human subjects raise ethical and moral concerns.
  • Unlike in the West, India does not offer data exclusivity and allows bioequivalent generics to be registered based on, among other things, trial data available in the public domain.
  • The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) does not mandate data exclusivity.

Source: The Hindu


Leave a Reply