[Legiscope] From Drug Safety to Prescription Simplification... 8 Pharmaceutical Affairs Act Bills Shake the Pharmaceutical and Pharmacy Industries

Eight amendments to the Pharmaceutical Affairs Act piled up before the National Assembly's Health and Welfare Committee within a month, from February 11 to March 9. The influx of amendment bills for a single act at this speed is a sign that stakeholders have simultaneously engaged in legislative competition. The problem is that the eight bills point in different directions.

The eight bills are divided into three branches. In terms of drug safety and quality, Representative Kim Ye-ji proposed strengthening medication counseling and mandatory labeling of driving risks associated with medication; Representatives Baek Jong-heon and Seo Mi-hwa proposed stricter regulations on falsifying manufacturing records and unauthorized changes to permits; and Representative Kim Yoon proposed expanding the imposition of penalty surcharges on hazardous quasi-drugs. In the area of pharmacy operation and distribution, Representative Jeon Jin-sook proposed blocking wholesalers from interfering in pharmacy management; Representative Park Hyung-soo proposed establishing the right for pharmacy transferees to check prior administrative sanction records; and Representative Jeon Jin-sook submitted a mandate to verify the actual locations of promotional sales agencies. In terms of patient accessibility, Representative Jeon Jin-sook proposed establishing a basis to omit prescriptions when repeatedly dispensing the same medication to chronic disease patients, and Representative Jeon Hyun-hee proposed establishing safety standards for hazardous substances in menstrual products.

The beneficiaries and those burdened are clearly divided. If the bill to simplify repeat prescriptions for chronic diseases passes, non-face-to-face prescription platforms such as Kakao Healthcare and Doctor Now could see their business scope expand. On the other hand, the bill to block wholesalers' interference in management directly restricts the sales methods of large pharmaceutical wholesalers such as Geo-Young and Baekje Pharmaceutical, while the bill to strengthen manufacturing record and permit regulations could increase quality control costs for manufacturing-based pharmaceutical companies such as Yuhan, Dong-A Pharmaceutical, and Chong Kun Dang. If Representative Jeon Hyun-hee's bill passes, Yuhan-Kimberly and LG Household & Health Care may have to completely review the ingredients of their menstrual products. Since the response direction changes depending on which bills are merged and adopted, it is necessary to separately track the Health and Welfare Committee's review schedule in accordance with each company's interests.

This article was written based on Legiscope, a legislative tracking engine built by News Epoch.