"Ban on platform wholesale act"·"warehouse pharmacy reg act" expected passage in AUG

The amendment is to be passed in its original form, ahead of full institutionalization in DEC...medical and platform industries are closely watching

The Ministry of Health and Welfare (MOHW) is expected to initiate the enactment·revision of subordinate regulations once the "warehouse pharmacy reg act" is passed

Attention is focused on whether amendments to the Pharmaceutical Affairs Act, which include restricting  non-face-to-face intermediation platforms from concurrently operating pharmaceutical wholesaling businesses and regulating exaggerated signage and advertising by "warehouse-style" or "factory-style" pharmacies, will pass the plenary session of the extraordinary National Assembly this month (August).  

​On the 4th, the Democratic Party of Korea held a strategy meeting. It proposed to the People Power Party that a National Assembly plenary session be convened on the 13th to pass delayed public welfare legislation.  

​The two pieces of legislation attracting significant interest from the healthcare industry are amendments to the Pharmaceutical Affairs Act that have already cleared both the standing committee and the Legislation and Judiciary Committee.

​They are known as the "ban on non-face-to-face platform wholesale establishment and operation act" and the "warehouse-style pharmacy signage and advertising regulation act".

​Among them, the bill banning platform wholesale operations has been delayed for nine months without being tabled before the plenary session, even after passing the Legislation and Judiciary Committee on November 26 of last year.  

​The delay stems from opposition raised by certain ruling and opposition lawmakers and the Ministry of Small and Medium Enterprises and Startups, who sympathized with pushback from the platform and venture startup industries, stalling the plenary vote on the bipartisan-approved bill.

​According to National Assembly officials, the bill is expected to be tabled and passed during this month's plenary session in its original form without modifications.

​This is because the bill was passed with bipartisan consensus, and there is no reasonable justification or rationale to undergo revisions at a point when non-face-to-face is set to be fully institutionalized on December 24.

​Key provisions of the bill include adding non-face-to-face intermediation operators under the Medical Service Act to the grounds for disqualification from obtaining an herbal medicine dealer or pharmaceutical wholesaler license, while prohibiting pharmaceutical wholesalers from selling drugs directly or through third-party wholesalers to pharmacies that have entered into service contracts with affiliated non-face-to-face intermediation operators.

​The bill also includes provisions mandating pharmacists to verify patient prescription and administration histories for narcotics or psychotropic drugs via the Drug Utilization Review (DUR) system when dispensing such controlled substances, as well as linking the DUR system with the Narcotics Information Management System (NIMS).

​Regarding the bill regulating warehouse-style pharmacy signage and advertising, an amendment to the Pharmaceutical Affairs Act sponsored by Vice Speaker Nam In-soon was independently reviewed and passed by the Legislation and Judiciary Committee on the 29th of last month.

​The core of the bill prohibits pharmacy founders from using designations as their pharmacy's formal business name that could induce drug misuse or abuse, as specified by Ordinance of the Ministry of Health and Welfare.

​A grace period provision was also established under the amendment, allowing pharmacy founders who currently use prohibited designations, such as "warehouse-style pharmacy", to retain those names for only up to six months following the implementation of the revised act.

​Upon plenary passage of the Pharmaceutical Affairs Act amendment sponsored by Vice Speaker Nam, the Ministry of Health and Welfare (MOHW) is expected to initiate the enactment and revision of subordinate regulations under the Pharmaceutical Affairs Act to restrict terms that encourage drug misuse or abuse, such as "warehouse-style pharmacies".

​A Health and Welfare Committee official of the National Assembly stated, "Both parties are agreeing on the necessity to process delayed public welfare bills during the August special National Assembly session," adding, "The Pharmaceutical Affairs Act amendment banning non-face-to-face platforms from operating drug wholesaling, which passed the Legislation and Judiciary Committee last year but remained unhandled across the year, is highly likely to be processed this month".