• The Korean Society of Law and Medicine
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• v.22 no.1
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• pp.91-124
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• 2021

In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.20
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• pp.8797-8800
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• 2014

Objective: To analyze cost-effectiveness of morphine, MS contin and oxycodone in the treatment of cancer pain, providing guidance for rational drug use in the clinic. Methods: Confirmed by histology, a total of 171 patients with various cancers who required analgesic treatment were selected and divided into 3 groups, 57 cases for each group, given morphine, MS contin and oxycodone, respectively. If there appeared a poor short-term effect or aggravated sudden pain during the treatment, a short-acting morphine injection was given and adverse reactions were processed by symptomatic treatment. The pain relief rate and adverse reactions of groups were observed and pharmacoeconomics evaluation was undertaken. Results: The pain relief rates with morphine, MS contin and oxycodone were 89.5%(51/57), 91.2%(52/57) and 93.0%(53/57), respectively, with no difference samong groups (${\chi}^2=4.4489$, P=0.6162). The occurrence rates of adverse reactions were 59.7%(34/57), 54.4%(31/57) and 43.9%(25/57), again with no significant variation (P>0.05). The ratios of cost-effectiveness (C/E) for the 3 groups were $14.6{\pm}7.21$, $15.0{\pm}7.44$ and $16.1{\pm}8.10$. When the price of 3 kinds of analgesics was reduced by 10%, the ratios of cost-effectiveness were $12.2{\pm}6.53$, ($13.4{\pm}6.08$ and $14.5{\pm}6.74$ but there was no differences when compared with before the price adjustment (t=1.86, P=0.0651; t=1.30, P=0.1948; t=1.17, P=0.2453). Conclusion: Morphine, MS contin and oxycodone give similar pain relief and adverse reaction rates but of all, morphine is the preferred drug for the treatment of cancer pain from the perspective of pharmacoeconomics.