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Data Exclusivity in Trade Talks


Prelims: Polity (International Agreements), Data Exclusivity, European Free Trade Association (EFTA), Generic Drugs.

Mains: General Studies-II Bilateral, Regional and Global Groupings and Agreements involving India and/or affecting India’s interests.

Why in the News ?

India has recently taken a firm stance against the inclusion of ‘data exclusivity’ clauses in its ongoing discussions with the European Free Trade Association (EFTA) for a free trade agreement. 

Source: TH

📌 FYI on Prelims:

Free Trade Agreement

  • A free trade agreement (FTA) is a pact between two or more nations to reduce barriers to imports and exports among them.
  • Under this agreement, goods and services can be bought and sold across international borders with little or no government tariffs, quotas, or prohibitions to inhibit their exchange.
  • It is the opposite of trade protectionism or economic isolationism.
  • first mentioned in 1817 by economist David Ricardo
  • India has signed 13 Free Trade Agreements (FTAs) with its trading partners including the Agreement on the South Asian Free Trade Area (SAFTA), India-Singapore Comprehensive Economic Cooperation Agreement (CECA), India-Japan CEPA, and India-Australia Economic Cooperation and Trade Agreement (ECTA).


  • Data Exclusivity: 

    • It is a clause in the draft agreement that puts a minimum 6-year embargo (a legal prohibition on commerce) on clinical trial data generated during the testing and development of a drug.
    • Thus, manufacturers seeking to produce generic versions of drugs would either need to generate such data on their own, which is an expensive proposition, or wait out for the above specified period before selling their versions in India.
  • Impact on India’s Generic Drug Industry: 

    • India’s generic drug industry has been pivotal in providing affordable alternatives to expensive medications globally.
    • However, the imposition of data exclusivity could severely hamper this industry’s growth and accessibility of affordable medicines.
    • Demand for data exclusivity has consistently emerged since 2008 from both the European Union (EU) and the EFTA during trade negotiations with India.
    • Despite this, India has consistently refused these requests.
  • European Free Trade Association:  

    •  The EFTA is the intergovernmental organisation of Iceland, Liechtenstein, Norway and Switzerland (all four are not a part of the EU).
    • It was founded by the Stockholm Convention in 1960.
    • It aims to promote free trade and economic integration to the benefit of its four Member States and their trading partners around the globe.

Generic Drug

  • It is a medication that has exactly the same active ingredient as the brand-name drug and yields the same therapeutic effect.
  • It is the same in dosing, safety, strength, quality, the way it works, the way it is taken, and the way it should be used.
  • These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine.
  • They also have the same risks and benefits as their brand-name counterparts.
  • Generic drugs do not need to contain the same inactive ingredients as the brand-name product. A generic drug can only be marketed after the brand name drug’s patent has expired. Generic drugs are usually much less expensive than brand-name drugs.


Prelims: PYQ/FAQ

Q. “closed economy” is an economy in which (2011)

(a) the money supply is fully controlled
(b) deficit financing takes place
(c) only exports take place
(d) neither exports or imports take place

Ans: d. neither exports or imports take place


  • The closed economy is that economy in which neither imports nor exports take place in that particular country. 
  • As the name suggests the country provides the consumers with everything they need from within the country’s economy.

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