Abstract

The global community has demonstrated its appreciation and commitment to combating counterfeit goods by numerous forums, initiatives and resources organized to find solutions. Among the solutions can be found legislative approaches and, in particular, the use of criminal law as a deterrent to counterfeiting. This study describes the use of substantive criminal intellectual property law, its definition in TRIPS, and what is permissible as additional substantive law. Specifically, it addresses how to tailor criminal IP law in cases where the counterfeit good poses a threat or actually causes harm to human health and safety, and it considers this aspect of counterfeiting for any and all goods that could harm humans rather than limiting the approach to drugs and medical products. Action steps and legislative guidance for legislators are provided, allowing readers to refer to this study during national implementation efforts, such as in legislative or inter-ministerial working groups in the process of considering national trade and health matters, the category in which such counterfeit goods fall. A self test and answers are included to further expand comprehension of the limitations and possibilities of criminal law as one solution in combating counterfeit goods that cause human harm.

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