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26 April 2017 Question Bank


26th APRIL 2017 


(1 Question)


Answer questions in NOT MORE than 200 words each. Content of the answer is more important than its length.

Links are provided for reference. You can also use the Internet fruitfully to further enhance and strengthen your answers.


1.      What is "data exclusivity"? How is it different from patent right? Discuss its impact on generic drugs?

(Repeat Question from 10 Feb 2017 Question Bank)





What is Data Exclusivity?:

  • Data exclusivity is a kind of intellectual property protection wherein clinical trial and other data submitted by an originator drug company cannot be used or relied upon by a drug regulatory authority to approve a generic version of that drug for a certain period of time.
  • This means that if the generic company wants to get regulatory approval during the period of data exclusivity (presently 4 years under Indian laws), it needs to duplicate the expenses and time taken to take its product through clinical trials.
  • The notion is that without such protection, the originator company lacks the necessary commercial incentive to conduct expensive trials and take a potential drug to the market. Blocking generic entry for some years will, the theory goes, help drug companies invest in clinical trials.
  • It was justified using the argument that clinical trials are the most expensive part of drug development and hence there is a necessity to provide drug developers the ability to limit access to that data so as to incentivise research.
  • If the period of data exclusivity completely overlaps with the patent duration, there is usually no substantial effect as the patent would anyway prevent generics from releasing the product.
  • However, off-patent or non-patented products can also be granted data exclusivity - in which case they would enjoy years of exclusivity.
  • Data-exclusivity rights are also not necessarily ‘bound' by the same exceptions and flexibilities that patent rights are.
  • Also it is a TRIPS plus protection.

Undermining accessibility

  • Though, on the surface, the provision looks reasonable, data exclusivity is a deeply uncompetitive policy that serves to undermine generic competition in a troubling way.
  • In fact, it is possibly a stronger restriction than patent protection itself.
  • Patent protection can be challenged if the product is not sufficiently novel, or violates existing national standards for obtaining patent protection, thereby clearing the way for generic competition.
  • This is, in fact, what happened to Novartis in India over Gleevec, an anti-cancer drug.
  • Simultaneously, generic companies can, and do innovate around patents and produce chemical entities that have the equivalent efficacy of the original drug. But for the generic version to be able to come to the market, it is essential that it be able to use the proof of efficacy and safety that is generated by the clinical trial.
  • The restriction on the use of test data would therefore require a generic company to undertake clinical trials by itself, which is both unfeasible (in terms of expense) and unethical (since it would expose patients to trial protocols, during which some patients would have to receive a placebo when a proven cure is available).
  • For almost all generics will simply wait for the term to expire rather than undertake the expensive process of generating clinical trial data afresh, not to mention the sheer immorality of repeating animal studies and subjecting human volunteers to safety and efficacy tests in relation to the same drug molecule.
  • It is for this reason that world over, generic drugs are approved upon a simple showing of bio-equivalence: that the claimed molecule is the same as the one already approved. And therefore, there is no sense in having the generic applicant repeat all clinical trials afresh. However, bio-equivalence cannot be had for the asking but must be demonstrated through rigorous studies/data.
  • As a result, in a country like India, even in a situation where there is no patent barrier, data exclusivity would allow for a period of five to eight years during which there is no plausible way that market access could be allowed for generics, thereby reducing access to cheaper medicines for the population.

Data exclusivity under Trans-Pacific Partnership (TPP),

  • Ostensibly a ‘free trade' deal, the TPP was opposed extensively by progressives for the last two years because of its far-reaching provisions that increased corporate power over trade at the expense of workers and consumers.
  • The agreement's damaging ambitions were most evident in the proposed provisions concerning intellectual property.
  • The TPP provided explicit protections for ‘biologics' (drugs manufactured in a living organism, rather than through chemical synthesis), the first trade agreement to do so.
  • More damagingly, the agreement mandated the protection of clinical test data submitted for marketing approvals, with pharmaceutical data obtaining five to eight years of protection. This provision, called ‘data exclusivity' or ‘marketing exclusivity', prevents a generic company from relying on the clinical test results of the originator in order to prove the efficacy of its drug.
  • The provisions on biologics and data exclusivity in the TPP accompanied others - like those extending patent terms beyond 20 years; weaker patent standards that would allow a greater number of secondary or ever-greening patents on pharmaceuticals; and harsher intellectual property enforcement.
  • Leading public health organisations termed the TPP the worst trade agreement on access to medicines.

No change in U.S. approach

  • U.S. President Donald Trump's first acts as President was toveto U.S. participation in the Trans-Pacific Partnership (TPP), a trade deal among 12 Pacific economies that was a decade in the making.
  • President Trump's remarks in early January emphasised his desire to end "global freeloading" stating that "foreign price controls reduce the resources of American drug companies to finance drug and R&D innovation... our trade policy will prioritise that foreign countries pay their fair share for U.S.-manufactured drugs, so our drug companies have greater financial resources to accelerate development of new cures."
  • In India, we will need far greater government commitment to the use of the public health safeguards in our patent law to survive this era and ensure the health of the country's citizens.

Data exclusivity under Regional Comprehensive Economic Partnership (RCEP)

  • The damaging provisions of TPP have migrated to other agreements like the Regional Comprehensive Economic Partnership (RCEP) agreement which involves 16 countries.
  • Courtesy of Japan and South Korea, the RCEP negotiations feature several of the intellectual property provisions of the TPP.
  • This should be of great concern for access to medicines globally, as countries involved in the RCEP negotiations include key generic drug-producing countries, including India.

Data exclusivity in India:

  • The Satwant Reddy Committee Report in 2007, recommended that data exclusivity not be required for pharmaceutical products but that agro-chemicals be given a three year data exclusivity protection by way of amending the Insecticides Act, 1968.
  • This recommendation was based not on a reading of TRIPS but on a ‘broad industry consensus'.
  • The resultant bill, the Pesticides Management Bill, 2008 introduced data exclusivity.

Recent government proposal:

  • A recent government proposal attempts to change the 4 year time limit for State-level drug regulatory approvals to 10 years.
  • India has long resisted U.S. and EU pressure to institute data exclusivity norms, seeing it as a barrier to generic entry and more affordable drug prices. However, a rather curious provision in the Drugs and Cosmetics Act (DCA) could arguably constitute a de facto kind of data exclusivity.
  • Under the Act as it stands now, a new drug continues to remain "new" even after it has been approved once by the Central regulator (Drugs Controller General of India, or DGCI) upon submission of local clinical trial data establishing safety and efficacy in India. However, it loses "newness" after four years, which means a drug manufacturer can short-circuit the process and go directly to a State regulatory authority and procure drug approval. It is this four-year period that is now sought to be enhanced to 10 years, an extension that the IPA argues constitutes an enhancement of data exclusivity norms in favour of large pharma companies, particularly MNCs. Others insist that there is no such data exclusivity norm in India.
  • Who is right? And who is wrong? This depends in large part on the kind of data that generic companies have to submit in order to gain approval for their follow-on drugs. If they are forced to submit the same kind of clinical trial data that originators have submitted to the regulatory authority, then this does amount to data exclusivity.
  • The Act is not very clear on the kind of studies/data that a generic applicant is meant to submit.
  • And this precisely is why in our rather complicated federal structure of drug regulation, comprising both a Central authority, namely the DCGI, and a vast array of State-level regulators, drug manufacturers opt to simply wait for four years and then approach State authorities rather than risking a more rigorous Central clearance.
  • However, this does not mean that all is well on the Central regulatory front. A damning parliamentary committee report some years ago found that in the vast majority of cases, the DCGI doesn't even insist on separate local clinical trial data for new drugs. Rather they routinely dispense with the requirement of local clinical trials under a broad "public interest" exception.


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