Bill to mandate generic substitutions gains momentum

“Pharmacists, distributors, and manufacturers are legally subject to government orders when addressing drug shortages

Physician-turned-lawmakers Yoon Kim and Sun-min Kim also join in on the bill’s legislation

On September 2, the ruling party introduced a bill to mandate generic (ingredient-based) prescriptions for medicines with unstable supply.

 

The bill establishes the legal basis for “shortage drugs” and allows prescribing by ingredient name instead of brand name.

 

The bill holds significance in that it amends the Pharmaceutical Affairs Act to define drugs frequently in shortage and sets out legal procedures to designate such through public-private consultations, and amends the Medical Service Act to legislate the legitimacy and standards for mandatory ingredient prescriptions.

 

In other words, the bill enforces a law that stipulates that “drugs in such unstable supply that generic prescribing must be enforced” through deliberations by a public-private consultative body.

 

Representative Jong-tae Jang of the Democratic Party of Korea, who spearheaded the amendments, has stated he will push for their swift passage.

 

The participation of fellow Democratic Party representative Yoon Kim (a physician) and Rebuilding Korea Party Rep Sun-min Kim (also a physician) is expected to reduce obstacles in upcoming committee reviews.

 

Specifically, the bill requires the Ministry of Health and Welfare (MOHW) to establish a Supply Management Committee for Shortage Drugs.

 

After deliberation and resolution by this committee, the Minister of Health and Welfare will designate shortage drugs.

 

The committee will have up to 30 members, including the Vice Minister of Health and Welfare as Chair, Deputy Commissioner of the Ministry of Food and Drug Safety (MFDS) as Vice Chair.

 

The remaining 28 will consist of : ▲Senior officials from relevant central government agencies (appointed by Presidential Decree), ▲ representatives recommended by the Chair of the Korean Pharmaceutical Association, ▲ representatives recommended by the Korean Medical Association under Article 28 of the Medical Service Act, ▲ representatives recommended by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and other relevant industry groups, as well as ▲ experts with sufficient knowledge and experience.

 

Thus, government officials, pharmacists, physicians, manufacturers, and academia will collectively decide which drugs require mandatory generic prescribing due to unstable supply.

 

The Minister of Health and Welfare will also have dedicated staff and budget authority to designate and de-designate shortage drugs, monitor supply conditions, and implement distribution improvement measures.

 

The bill also legalizes distribution interventions alongside generic prescribing.

 

If supply is deemed significantly disrupted, or upon request from another central administrative agency head, the Minister may—after committee review—order measures to improve distribution regarding sales outlets, procedures, volumes, and conditions.

 

Pharmacies, medical institutions, wholesalers, and other designated entities will be legally obligated to comply with these measures.

 

However, the Minister must first consult with the Minister of Strategy and Finance and the Chair of the Fair Trade Commission before issuing such orders.

 

The MOHW Minister will also build and operate a shortage drug management system.

 

This will allow requesting and collecting information necessary for distribution control, which includes production, shipments, sales, prescriptions, and dispensing data, from manufacturers, importers, wholesalers, pharmacies, and medical institutions.

 

This effectively grants the MOHW authority over the entire supply chain, but also increases the Ministry’s accountability when shortages occur.

 

The Minister may also designate certain shortage drugs as “emergency production/import drugs”, subject to committee review, which empowers the Minister to order manufacturers to produce or import the drugs.

 

The Medical Service Act amendment stipulates that physicians and dentists must prescribe designated shortage drugs by generic name, not brand name.

 

Violation will result in up to 5 years imprisonment or a fine up to KRW 50 million.

 

This significant level of criminal penalty is expected to draw strong opposition from the Korean Medical Association and the broader medical community.