Regulations on INN prescribing·warehouse pharmacies

For drugs designated for emergency production or import, the bill permits the government to order pharmaceutical companies to place emergency production or import orders

Mandating INN prescribing limited to supply-unstable drugs

Regulations on the signage·advertising·opening scale standards of warehouse-type pharmacies…to resolve the problem of public overspending·misuse

It is highly likely that bills to mandate International Nonproprietary Names (INN) prescribing limited to supply-unstable drugs designated by the government, as well as bills to strengthen regulations on the signage, advertising, and opening scale standards of warehouse-type pharmacies, will be considered at the National Assembly Health and Welfare Committee's Legislation Subcommittee scheduled for the end of this month.

This is because the decision by the lawmakers who proposed the relevant legislation to request the ruling and opposition party leadership of the Health and Welfare Committee to prioritize the review of the limited generic prescribing bill and the bill aimed at resolving drug misuse and abuse caused by the opening of warehouse-type pharmacies.

On the 13th, the Health and Welfare Committee requested that ruling and opposition members submit the agenda for the First Legislation Subcommittee, which is expected to be held on the 26th.

However, sources report that since the February subcommittee schedule falls immediately after the Lunar New Year holiday, and the leadership has agreed to the March plenary session, the New Year's business reports from relevant ministries, and the holding of the subcommittee, each lawmaker's office has been advised to submit only one agenda item.

Despite this limitation, the bill to strengthen the supply chain for supply-unstable drugs and mandate limited generic prescribing, along with the bill to regulate the signage, advertising, and opening scale of warehouse-style pharmacies, are expected to be the top priority for the February subcommittee.

Both bills are considered bills affecting daily lives, and resolving the drug supply instability issue is a national task of the new administration. Furthermore, the bill to strengthen regulations on warehouse-type pharmacies has gained urgency as large-scale warehouse-type pharmacies have recently opened in Seoul and other parts of the country, intensifying the debate between proponents and opponents and increasing the need to address potential side effects through legislative review.

The bill details to resolve the drug supply instability crisis allows the Minister of Health and Welfare to designate supply-unstable drugs through the deliberation of the Drug Supply Management Committee. Among these, for drugs designated for emergency production or import, the bill permits pharmaceutical companies (manufacturers and importers) to place emergency production or import orders.

Notably, the bill mandates that physicians write the generic name rather than the brand name on prescriptions for supply-unstable drugs, with penalties for violations. This provision aims to support the safe supply of medicines to patients by mandating limited generic prescribing.

Representative Jang Jong-tae, who proposed the bill to resolve the drug supply instability issue, stated his legislative intent: "Recently, drug supply instability has been occurring frequently due to reasons such as temporary surges in demand, suspension of supply, and difficulties in securing raw materials," added, "Despite being a problem that threatens the public's right to health and causes confusion in the healthcare field, the current law lacks provisions regarding the response to drug supply instability."

The bill to regulate warehouse-type pharmacies primarily prohibits the use of terms such as 'warehouse,' 'plant,' or 'factory' on pharmacy signs or promotional materials. It also mandates a preliminary review by the Pharmacy Opening Committee under the provincial governor or metropolitan mayor when an individual intends to register the opening of a pharmacy above a certain scale.

The legislative goal is to prevent the incitement of excessive drug consumption and misuse among consumers and to strengthen the preliminary review authority of local governments and pharmacist associations regarding the opening of deformed pharmacies.

Democratic Party Representatives Seo Young-seok, Nam In-soon, Kim Yun, Jeon Hyun-hee, and Jang Jong-tae have each proposed related legislation.

An official from a ruling party member’s office on the Health and Welfare Committee explained, "We plan to submit the agenda items for the February subcommittee within the deadline," added, 
"The bill to resolve the drug supply instability crisis has high necessity and urgency for discussion, so we plan to request it as a first-priority bill for tabling."

Another official from a ruling party member’s office stated, "As warehouse-type pharmacies have opened in several locations, it has become a national interest. The Ministry of Health and Welfare has also begun drafting regulations to prevent side effects, such as drug misuse, at warehouse-type pharmacies," and concluded, "It is necessary to accelerate the legislative review."