Prescription Drugs Price Setting and Generic Drugs Prescription concerning Consumer Protection Law in Indonesia

Jenny Jatemin, Jovita Irawati
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Abstract

Health is one of the most important human rights in human life. Access to affordable prescription drugs is still a problem for people with out-of-pocket expenses. Generic prescription drugs that are much cheaper than non-generic drugs are still low, especially in non-government healthcare facilities. This research aims to provide suggestions of regulation on price control of prescription drugs and generic prescription drugs that will assure certainty and affordability for the public. The methodology is doctrinal legal research and is supported by empirical studies. The research finding consist of two things, namely the price of prescription drugs and the prescription of generic drugs. The first finding is that Highest Retail Price (HET) set by the manufacturer is potentially to be unlimited because there is no limit control. Currently, there are many drugs sold over HET with minimal supervision from the Government. The absence of law is found as the existing regulations are only for those listed in the National Formulary, while the rest have not been regulated. Therefore, the suggestion is to set ceiling prices for prescription drugs with comparison among generic drugs, branded generic drugs, and the originator; also create a refund mechanism for prices above HET to assure the consumers’ rights to get compensation under the Consumer Protection Law. The second finding is that only a few doctors prescribe generic drugs. Additionally, patients have not been involved in the treatment decisions.Therefore, the suggestion is to associate "the action of prescribing generic drugs" with the extension of doctor's license, namelythe Registration Certificate (STR); so that doctors will prescribe generic drugs without the need for close supervision due to their interests. With the increase of generic drugs’ prescription, the financing of health services, nationwide as well asindividually, can become more affordable.
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涉及印尼消费者保护法的处方药定价和仿制药处方
健康是人类生活中最重要的人权之一。对于自费的人来说,获得负担得起的处方药仍然是一个问题。比非仿制药便宜得多的非专利处方药价格仍然很低,特别是在非政府医疗机构。本研究旨在为处方药和非专利药的价格管制提供建议,以确保公众的确定性和可负担性。方法论是理论法学研究,并得到实证研究的支持。研究发现包括两个方面,即处方药的价格和仿制药的处方。第一个发现是,制造商设定的最高零售价格(HET)可能是无限的,因为没有限制控制。目前,有许多药物在高温下销售,政府的监管很少。存在法律缺失的现象,因为现有法规仅针对国家法规集中列出的法规,而其他法规尚未得到规范。因此,建议通过仿制药、品牌仿制药和原研药的比较,设定处方药的价格上限;此外,还应建立价格高于最高限额的退款机制,以确保消费者根据《消费者保护法》获得赔偿的权利。第二个发现是,只有少数医生开仿制药。此外,患者没有参与治疗决策。因此,建议将“开仿制药的行为”与医生执照的延长联系起来,即注册证书(STR);这样医生就会开出仿制药,而不需要密切监督,因为他们的利益。随着仿制药处方的增加,国家和个人的卫生服务融资可以变得更加负担得起。
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