Test Data Protection: Rights Conferred Under the TRIPS Agreement and Some Effects of TRIPS-plus Standards

Author(s):  
Carlos M. Correa
2020 ◽  
Vol 10 (1) ◽  
pp. 115-127
Author(s):  
Zhiwen Liang

Regulatory exclusivity, the TRIPS-plus protection for undisclosed test data, is considered as the principal means to extend market protection for brand-name pharmaceutical companies. When China joined the World Trade Organization in 2001, it promised to enact new laws or regulations that will comply with article 39.3 of the TRIPS Agreement. China's choice of implementing the TRIPS Agreement through regulatory exclusivity resulted mainly from intrinsic demands for China's strategy of innovative-driven development, and partly from the pressure of China-US trade disputes. There are two categories of regulatory exclusivities under China's laws. One is the market exclusivity for New Drugs and Traditional Chinese Medicine. The other is the data exclusivity for Innovative Drugs, Orphan Drugs, Paediatric Drugs, Innovative Biologics; and a ‘Generic Exclusivity’ for the first generic drug company that succeeds in challenging weak patents of pharmaceutical products.


2016 ◽  
Vol 32 (3) ◽  
pp. 204-214 ◽  
Author(s):  
Emilie Lacot ◽  
Mohammad H. Afzali ◽  
Stéphane Vautier

Abstract. Test validation based on usual statistical analyses is paradoxical, as, from a falsificationist perspective, they do not test that test data are ordinal measurements, and, from the ethical perspective, they do not justify the use of test scores. This paper (i) proposes some basic definitions, where measurement is a special case of scientific explanation; starting from the examples of memory accuracy and suicidality as scored by two widely used clinical tests/questionnaires. Moreover, it shows (ii) how to elicit the logic of the observable test events underlying the test scores, and (iii) how the measurability of the target theoretical quantities – memory accuracy and suicidality – can and should be tested at the respondent scale as opposed to the scale of aggregates of respondents. (iv) Criterion-related validity is revisited to stress that invoking the explanative power of test data should draw attention on counterexamples instead of statistical summarization. (v) Finally, it is argued that the justification of the use of test scores in specific settings should be part of the test validation task, because, as tests specialists, psychologists are responsible for proposing their tests for social uses.


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