COUNTERFEIT MEDICINE: SHOULD PARALLEL IMPORT OF MEDICINE BE BANNED IN MALAYSIA?

Abstract

Parallel import is the activity of importing and reselling products without the patent holder's permission. Parallel importation is legal on the principle of flexibility found in the TRIPS Agreement under the provisions of Article 6 (exhaustion of intellectual property) and Article 8 (scope of public health interest) to guarantee access to medicinal products. However, whether parallel imports are regulated or otherwise by countries is provided for under Paragraph 5(d) of the Doha Declaration on TRIPS and Public Health 2001 which states that member countries are given the freedom to determine their exhaustion regime. This explains why there are countries that allow parallel trade in medicines whereas some do not. The main reason for some countries (including Malaysia) not allowing parallel imports is the belief that parallel importation is associated with the penetration of counterfeit medicines into the market. Therefore, this paper aims to determine the relationship between parallel imports and incidents of counterfeit medicinal products in the country. The discussions include measures that can be implemented to ensure the quality, safety, and efficacy of parallel import drug products are not compromised. In conclusion, findings from this study suggest that the parallel import of medicine is not related to the increase in cases of counterfeit medicine, hence should not be banned in Malaysia.