Urgency of bolar provision regulation on patented drugs for access and availability of generic drugs for public health

Abstract

Limited availability of medicines is a serious problem in fulfilling the public's right to health. The monopoly of patented medicines by patent-holding pharmaceutical companies has resulted in generic pharmaceutical companies not being able to access information about patented medicines even though the patent has expired. This certainly hinders the immediate circulation of generic versions after the patent expires. Generic medicines are important because they are easier to access, more widely available, and cheaper than patented versions of medicines. To overcome this problem, a legal means called bolar provision is regulated. Bolar provision is a permit granted by the state to generic pharmaceutical companies to use patented inventions to develop and deliver drug information without the patent owner's permission 5 (five) years before the patent protection period ends. Generic pharmaceutical companies can then market generic versions after the patent expires. The purpose of implementing Bolar provision is to provide cheap and affordable generic versions of essential drugs after the patent expires. Until this article was written bolar provisions are only regulated in Article 167 letter b of Law No. 13 of 2016 concerning patents and there are no implementing regulations specifically regulating bolar provision so that bolar provision has not been implemented. Therefore, it is important to examine how the appropriate regulations for the implementation of bolar provision. This type of research is normative legal research. The problem approach used is the legislative approach and the conceptual approach.