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KMID : 1142220200150020117
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Regulatory Research on Food, Drug & Cosmetic
2020 Volume.15 No. 2 p.117 ~ p.123
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A Review of an Evaluation Report on the Performance of the EU’s Orphan Regulation and Pediatric Regulation
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Lim Eun-A
Choi Sang-Eun
Park Eun-Ja
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Abstract
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The European Commission published a final report on the performance of the EU’s Orphan regulation and the Pediatric regulation in November 2020 ahead of the revision of the two regulations. Recently unmet medical need is an issue so that the report is considered to be a good reference for planning to develop the future Korean healthcare and pharmaceutical industry in the fields. Thus this study is aimed to review it and discuss the implications in it. In the early 2000s, EU enacted legislation on orphan drugs and pediatric medicines to address unmet medical needs and to increase clinical researches for pediatric medicines. The two fields are unattractive areas to developers due to low return on investment, where market failures exist. To address these problems, incentives or rewards were provided to developers, including extension of market exclusivity, provision of scientific advice or fee waivers. However, the extension of market exclusivity incurs costs for the health system through the delay in the market of generics. Therefore, policies that can maximize benefits while solving unmet medical needs will be required. The European Commission evaluated the performance of the two regulations based on the standards of effectiveness, efficiency, relevance, coherence, and EU added value. The results show that availability and the number of clinical studies for children had improved but unmet medical needs which was the ultimate purpose had still remained.
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KEYWORD
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Orphan drugs, Pediatric medicines, Unmet medical needs, Availably, Market exclusivity
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