Hindi English Translation || Editorial || Brave new world: On the India-European Free Trade Association agreement and IPR

Brave new world: On the India-European Free Trade Association agreement and IPR

India must invest in (में निवेश करें) fundamental research to be able to develop reliable (भरोसेमंद, स्वीकार्य) drugs

Expectations are high that a free trade agreement (मुक्त व्यापार समझौते) involving India and the European Free Trade Association (EFTA) is close to fruition (realization, achievement, accomplishment, completion). However, a bone of contention relates to intellectual property rights (बौद्धिक संपदा अधिकार), and has persisted (दृढ़ रहना, लगा रहना) as an issue since 2008. Switzerland and Norway, which are prominent (प्रमुख) members of EFTA, host several of the pharmaceutical (relating to the aspects like preparation, dispensing, and effective utilization of medicinal drugs) and biotechnology companies that are responsible for several of the drugs (दवाई) and therapeutics (the remedial treatment of disease/disorders; therapy, medical attention, medical care) that underpin (support, uphold, bolster, reinforce, strengthen) health care globally. The nature of the pharma industry — it costs much to discover a useful effective drug and relatively (अपेक्षाकृत) little to make generic (सामान्य) copies of it — with demand that is far (much) disproportionate to affordability (सामर्थ्य), means that there is a constant tussle (fight, clash, quarrel, argument, contention) between the inventors and the generic-drug companies. Patenting (an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem), or an exclusive monopoly (एकाधिकार) for a fixed number of years to originators (प्रवर्तक) and a reciprocal (पारस्परिक) right by governments to issue directions (order, regulation, instruction) for ‘compulsory licensing,’ thereby (फलस्वरूप) selectively (specifically, particularly, judiciously, carefully) breaking such monopolies in the interest of (के हित में) public health, has brokered (settle, arrange, negotiate, pull off, mediate (an agreement)) the peace and sustained (continue, carry on, keep up, maintain, bolster up) the global pharma industry for decades (a period of ten years). But new legal innovations such as data exclusivity (the quality of being exclusive) continue to inveigle themselves in free trade (a policy to eliminate barriers/limits/regulations against imports and exports) negotiations. Under this provision (clause, condition, stipulation, requirement, term), all the clinical-trial data that concerns the safety and efficacy (In medicine, the ability of an intervention (for example, a drug or surgery) to produce the desired beneficial effect; effectiveness, efficiency, power) of a drug generated by the originator firm becomes proprietary (patented, licensed, branded, own-brand) and out of bounds (off limits, restricted, reserved, not permitted) for a minimum period of six years. Permission to make a generic is possible if a country’s regulator (an association/statutory body that supervises a particular business activity) can rely on (depend on, trust, believe in, turn to, lean on, bank on, count on) supplied clinical trial data to approve a drug. For this, generic makers usually rely on the originator’s published data.

The principle of data exclusivity (a form of intellectual property protection that applies specifically to data from pharmaceutical clinical trials. While innovator firms run their own clinical trials to gain marketing approval, generic manufacturers typically rely on the innovator’s clinical trials for the same approval. Data exclusivity rules keep generic firms from relying on that data for 5 to 12 years, depending on the specific law) is present among European countries as well as (in addition (to), furthermore, besides, additionally, moreover) in agreements involving many developing countries. Were it to take effect (come into force) in India, it could significantly hinder (prevent, stop, avert, block, deter, obstruct) India’s drug industry which is also a major exporter of affordable drugs. Indian officials have rejected data exclusivity as a point of negotiations (talks, discussions, dialogue) in the FTA, though leaked drafts of the agreement suggest that it is alive (continuing, going on, on the agenda). However, India’s rise up the drug manufacturing chain in the last few decades means that it must invest in an ecosystem (complex situation/environment) that can conduct ethical drug trials and make new molecules and therapeutics from scratch. The paradigm (a model or pattern of something; example, prototype, standard, criterion) that drug development will always be expensive and confined (limited/restricted to a particular location) to the West (The Western world/civilization consisting of the majority of Europe & the North America) need not be permanent, as was seen in the development (growth, advancement, progress) of several novel (new, unusual) technology approaches to developing vaccines in India during the COVID-19 pandemic (the worldwide spread of a new disease; The illness spreads around the world and typically affects a large number of people across a wide area). But as preparation, India must invest substantially (considerably, appreciably, significantly) more in fundamental research to incubate (give support and aid the development of something) the local drug industry into the future.

Courtesy: The Hindu

Important Word List With Meaning

1.intellectual property rights (IPRs) (noun)

Hindi Meaning - बौद्धिक संपदा अधिकार
English Meaning - the rights given to persons over the creations of their minds. They usually give the creator an exclusive right over the use of his/her creation for a certain period of time. The IPRs are legal rights that protect creations and/or inventions resulting from intellectual activity in the industrial, scientific, literary or artistic fields. Copyright, patent, and trademark are all different types of intellectual property (IP).

2.invest in (verb)

Hindi Meaning - में निवेश करें
English Meaning - to put in one’s time, effort, money & energy to a specific task (in order to get an advantage).

3.reliable (adjective)

Hindi Meaning - भरोसेमंद, स्वीकार्य
English Meaning - acceptable, trustworthy, credible, dependable.

4.drug (noun)

Hindi Meaning - दवाई
English Meaning - medicine, medication.

5.free trade agreement (FTA) (noun)

Hindi Meaning - मुक्त व्यापार समझौते
English Meaning - a treaty/pact between two or more countries to facilitate trade and eliminate trade barriers.

6.persist (verb)

Hindi Meaning - दृढ़ रहना, लगा रहना
English Meaning - continue, carry on, go on, keep going.

7.prominent (adjective)

Hindi Meaning - प्रमुख
English Meaning - main, important.

8.relatively (adverb)

Hindi Meaning - अपेक्षाकृत
English Meaning - comparatively, fairly, reasonably, approximately, somewhat.

9.generic (adjective)

Hindi Meaning - सामान्य
English Meaning - (in general) general, common, collective, all-inclusive, all-encompassing, comprehensive.

10.affordability (noun)

Hindi Meaning - सामर्थ्य
English Meaning - the capacity to afford the cost/price of something.

11.monopoly (noun)

Hindi Meaning - एकाधिकार
English Meaning - exclusive/complete control of something by a person/organization.

12.originator (noun)

Hindi Meaning - प्रवर्तक
English Meaning - inventor, founder, developer, innovator.

13.reciprocal (adjective)

Hindi Meaning - पारस्परिक
English Meaning - mutual, shared, common, joint, correlative, corresponding.

14.thereby (adverb)

Hindi Meaning - फलस्वरूप
English Meaning - as a result of that.

15.in the interest of (phrase)

Hindi Meaning - के हित में
English Meaning - for the advantage/benefit of.

16.India-European Free Trade Association agreement (India-EFTA)

English Meaning - India and the EFTA have been negotiating the pact, officially dubbed as Trade and Economic Partnership Agreement (TEPA), since January 2008 to boost economic ties.

17.The European Free Trade Association (EFTA) (noun)

English Meaning - it is a trade organisation and free trade area consisting of four European states- Iceland, Liechtenstein, Norway and Switzerland.

18.trade agreement/trade pact (noun)

English Meaning - A trade agreement is a contract/agreement/pact between two or more nations (countries/states) that illustrates how they will cooperate to guarantee mutual benefit in the field of trade and investment. They decide the tariffs and duties that nations/countries impose on imports and exports.

19.fruition (noun)

English Meaning - realization, achievement, accomplishment, completion.

20.bone of contention (or) point of contention (noun)

English Meaning - a main subject/topic of an argument or disagreement; point at issue, matter in question

21.pharmaceutical (adjective)

English Meaning - relating to the aspects like preparation, dispensing, and effective utilization of medicinal drugs.

22.therapeutics (noun)

English Meaning - the remedial treatment of disease/disorders; therapy, medical attention, medical care.

23.underpin (verb)

English Meaning - support, uphold, bolster, reinforce, strengthen.

24.generic (adjective)

English Meaning - (in medicine) unbranded, untrademarked, non-proprietary.

25.far (adverb)

English Meaning - much.

26.disproportionate (adjective)

English Meaning - unreasonable, excessive, unfair, uneven, unbalanced.

27.tussle (noun)

English Meaning - fight, clash, quarrel, argument, contention.

28.patent (noun)

English Meaning - an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem.

29.exclusive (adjective)

English Meaning - sole, unique, only, especial.

30.direction (noun)

English Meaning - order, regulation, instruction.

31.selectively (adverb)

English Meaning - specifically, particularly, judiciously, carefully.

32.broker (verb)

English Meaning - settle, arrange, negotiate, pull off, mediate (an agreement).

33.sustain (verb)

English Meaning - continue, carry on, keep up, maintain, bolster up.

34.decade (noun)

English Meaning - a period of ten years.

35.exclusivity (noun)

English Meaning - the quality of being exclusive.

36.data exclusivity (noun)

English Meaning - a form of intellectual property protection that applies specifically to data from pharmaceutical clinical trials. While innovator firms run their own clinical trials to gain marketing approval, generic manufacturers typically rely on the innovator’s clinical trials for the same approval. Data exclusivity rules keep generic firms from relying on that data for 5 to 12 years, depending on the specific law.

37.inveigle (verb)

English Meaning - coax, persuade, convince/cajole.

38.free trade (noun)

English Meaning - a policy to eliminate barriers/limits/regulations against imports and exports.

39.negotiations (noun)

English Meaning - talks, discussions, dialogue.

40.provision (noun)

English Meaning - clause, condition, stipulation, requirement, term.

41.human trial/clinical trial (noun as modifier)

English Meaning - a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.

42.efficacy (noun)

English Meaning - In medicine, the ability of an intervention (for example, a drug or surgery) to produce the desired beneficial effect; effectiveness, efficiency, power.

43.proprietary (adjective)

English Meaning - patented, licensed, branded, own-brand.

44.out of bounds (adjective)

English Meaning - off limits, restricted, reserved, not permitted.

45.regulator (noun)

English Meaning - an association/statutory body that supervises a particular business activity.

46.rely on (phrasal verb)

English Meaning - depend on, trust, believe in, turn to, lean on, bank on, count on.

47.as well as (phrase)

English Meaning - in addition (to), furthermore, besides, additionally, moreover.

48.take effect (phrase)

English Meaning - come into force.

49.hinder (verb)

English Meaning - prevent, stop, avert, block, deter, obstruct.

50.affordable (adjective)

English Meaning - inexpensive.

51.suggest (verb)

English Meaning - indicate, denote, signify, signal.

52.alive (adjective)

English Meaning - continuing, going on, on the agenda.

53.ecosystem (noun)

English Meaning - complex situation/environment.

54.start from (the) scratch (phrase)

English Meaning - to start doing something again from the very beginning, especially without using/relying on anything that previously exists.

55.paradigm (noun)

English Meaning - a model or pattern of something; example, prototype, standard, criterion.

56.confined (adjective)

English Meaning - limited/restricted to a particular location.

57.the West (noun)

English Meaning - The Western world/civilization consisting of the majority of Europe & the North America.

58.development (noun)

English Meaning - growth, advancement, progress.

59.novel (adjective)

English Meaning - new, unusual.

60.pandemic (noun)

English Meaning - the worldwide spread of a new disease; The illness spreads around the world and typically affects a large number of people across a wide area.

61.substantially (adverb)

English Meaning - considerably, appreciably, significantly.

62.incubate (verb)

English Meaning - give support and aid the development of something.