MOHW agrees to relax convenience store medicine policy

Easing the 20-item upper limit on safe household medicine items…the Ministry agrees to relax the 24-hour operation requirement for eup, myeon, and dong areas

Concerns about convenience versus drug misuse…opposing views toward amendment to the Pharmaceutical Affairs Act

The Ministry of Health and Welfare (MOHW) has cast a vote in favor of an amendment to the Pharmaceutical Affairs Act that legislates the '20-item limit' on the number of safe household medicine items, currently prescribed by the Pharmaceutical Affairs Act, to a Presidential Decree (Enforcement Decree) to allow for lower-level legislation.

The Ministry also expressed support for a provision that eases the '24-hour operation' requirement, which is a mandatory registration criterion for sales outlets, in eup, myeon, and dong where there are no pharmacies or safe household medicine sales outlets.

In addition, the Ministry presented a specific proposal to delay enforcement by one year from implementation date to prepare for various matters related to institutional improvement, such as the establishment of subordinate statutes.

The bill currently under discussion is facing significant backlash from the pharmacist community, as it could lead to the complete removal of regulations on the number of safe household medicine items in convenience stores and to the expansion of the sale of general medicines outside pharmacies. However, with the competent MOHW expressing support, the likelihood of its passage has increased.

In addition to the MOHW, the Korean Society of Oriental Pharmacy, the Korea Alliance of Patients Organizations, the Consumers Union of Korea, and the Korea Association of Convenience Store Industry also supported the legislation. The Korean Pharmaceutical Association was the only organization to oppose the bill.

On the 10th, the amendment to the Pharmaceutical Affairs Act, proposed by Representative Han Ji-ah of the People Power Party, is planned to be tabled at the plenary session of the National Assembly's Health and Welfare Committee.

Rep. Han Ji-ah's stands that fixing the number of safe household medicine items in the Pharmaceutical Affairs Act is hindering the ability to respond flexibly and administratively to changes in the pharmaceutical market and environment, as well as to public demand.

This is the reason for introducing a bill that provides a delegation provision, allowing the number of safe household medicine items to be determined by Presidential Decree.

Rep. Han's proposal also includes a provision to establish the basis for the installation and operation of a Pharmaceutical Policy Deliberation Committee under the Minister of Health and Welfare.

Easing the 20-item upper limit on safe household medicine items... Ministry supports, Pharmaceutical Association opposes

The Ministry supported the provision delegating the regulation of the 20-item limit for convenience store medicines, which is currently fixed in the Pharmaceutical Affairs Act, to a Presidential Decree.

The MOHW also submitted a supportive opinion on relaxing the 24-hour operation requirement and the registration criterion for sales outlets on a limited basis in eup, myeon, and dong areas where there are no pharmacies or safe household medicine sales outlets, to improve accessibility to safe household medicines.

However, the MOHW stated that the enforcement date should be adjusted to 1 year after promulgation to prepare for various matters related to institutional improvement, such as the establishment of subordinate statutes.

The Korean Society of Oriental Pharmacy also agreed with the amendment to reorganize the safe household medicine system.

The Korea Alliance of Patients Organizations and the Consumers Union also supported it. The Consumers Union also expressed the view that it is appropriate to determine the regulation on the number of items through an Enforcement Rule, an Ordinance of the Ministry of Health and Welfare, rather than a Presidential Decree.

The Korea Association of Convenience Store Industry supported the bill while suggesting a modification that would require the MOHW to designate the number of household medicine items after receiving advice from a committee.

The Korean Pharmaceutical Association strongly opposed. They pointed out that although various systems to supplement medically underserved areas, such as public late-night pharmacies, health clinics, and the designation of special locations, are already in place, the management and operation of safe household medicine sales outlets and special locations remain insufficient.

The Korean Pharmaceutical Association argues that, rather than indiscriminately expanding the convenience store medicine system, the priority should be to evaluate whether the management systems of existing programs are functioning properly and to reorganize the system to ensure safe use.

The Korean Pharmaceutical Association stated, "To resolve the pharmacy accessibility of residents in medically underserved areas such as farming and fishing villages, special locations can already be designated according to the Pharmaceutical Affairs Act, and a system is in place to allow the purchase of medicines through designated special locations. Currently, medicine is also accessible through 1,895 health clinics nationwide," and emphasized, "In particular, considering the increase in cases of acetaminophen poisoning, the lack of management of sales outlets and the increase in cases of non-compliance with requirements, and the trend of strengthening regulations abroad, we actively oppose the expansion of safe household medicine items at this point as it is a policy that directly contradicts national health."

Establishment of Pharmaceutical Policy Deliberation Committee...Ministry of Health and Welfare, Ministry of the Interior and Safety, etc., all opposed

The MOHW and the Ministry of the Interior and Safety opposed the provision establishing a Pharmaceutical Policy Deliberation Committee, arguing that it would create an environment in which pharmaceutical-related matters, such as medicines, could be discussed regularly.

The logic is that, since the Central Pharmaceutical Affairs Council exists and is established, installed, and operated by the MFDS, the establishment of an additional body is unnecessary.

The Ministry of the Interior and Safety stated, "The Pharmaceutical Policy Deliberation Committee is an advisory committee under the MOHW, but considering the purpose of the Act on the Establishment and Operation of Committees Under Administrative Agencies, it is necessary to consider plans to expand the functions of the Central Pharmaceutical Affairs Council or utilize the policy advisory committees within the MOHW rather than establishing a separate committee."

The Korean Pharmaceutical Association and the Korean Medical Association also submitted opposing views.

The Korean Pharmaceutical Association opposed it, stating, "The role of the Pharmaceutical Policy Deliberation Committee in the bill is managed by the Pharmaceutical Policy Division of the MOHW," adding, "The policy planning and drafting are performed by the Ministry's Division of Pharmaceutical Policy, while the Pharmaceutical Policy Deliberation Committee performs policy deliberation and advice. In practice, this would lead to discussing the same matter twice, causing inefficiency and making the responsibility and subject of policy decisions unclear."

The Korea Medical Association said, "Since the Central Pharmaceutical Affairs Council (CPAC) is already running, establishing a separate Pharmaceutical Policy Deliberation Committee would be a redundant installation of a committee performing similar functions, which is a waste of administrative power," adding, "There are concerns that it could lead to role conflicts between committees and inefficiency in the policy-making process."