Balancing Intelectual Property Protection and Legal Risk Assessment in Registration of Covid-19 Vaccines in Malaysia.

ABSTRACT

The seriousness of the COVID-19 pandemic requires a look into the implementation of drug registration rules for COVID-19 vaccines. Amidst the surrounding exigencies, vaccines being a biological product, require comprehensive and continuing pre and post registration rules to ensure their safety and efficacy. The study focuses on Malaysia which has rules on drug registration that have been successfully applied to vaccines. The study shows that the rules have been tailor-made to emergency situations. At the moment, special rules have been introduced including to allow use of COVID-19 vaccines as unregistered product. Recognition of COVID-19 Vaccines Global Access (COVAX) facility and requirement for government sale only, are among the safety valves. The study shows that these however are temporary measures against the backdrops of possible entry of private players in the vaccination process. Therefore, regulatory responses to intellectual property (IP) related conditions underlying drug registration, and measures to ensure risk management involved in vaccine production, approval and administration are needed in the progressive rules pending further development of research in the area.