Regulatory sandbox for OTC drug vending machines revisited

Company “strengthened biometric authentication and control technology”… raises a strong need for pilot exemption

Korean Pharmaceutical Association and Ministry of Health and Welfare oppose “risks of unmanned sales”…heated debate continues

Positive atmosphere reportedly forming within Ministry of Trade, Industry, and Energy…five-year unresolved issue resurfaces

Discussions surrounding a regulatory sandbox pilot exemption for “smart vending machines for over-the-counter essential medicines,” which has remained unresolved for years, have recently resumed. With the expert committee under the Ministry of Trade, Industry and Energy’s Regulatory Exemption Deliberation Committee convening again after about 2-3 years, debate over permitting unmanned sales of OTC essential medicines appears to be reigniting.

In particular, it is reported that a heated debate ensued during this meeting, with the industry strongly advocating for the pilot exemption by emphasizing the need for installation in medically underserved areas and technological advancements, while the Korean Pharmaceutical Association and the Ministry of Health and Welfare clearly stated their opposition, as they have in the past.

According to multiple sources on the 15th, the Ministry of Trade, Industry, and Energy held the “5th Expert Committee Meeting of the Regulatory Rationalization Committee” at the end of last month to discuss a proposal for a pilot exemption regarding smart vending machines for over-the-counter medicines.

This marked the first reopening of discussions on the issue in approximately two to three years after deliberations had effectively been suspended. It was reported that attendees included representatives from the Korean Pharmaceutical Association, the Ministry of Health and Welfare, the Ministry of Trade, Industry and Energy, the applicant company Urban Sharing Economy, as well as legal and academic experts.

The core of this proposal is to allow the sale of over-the-counter medicines through unmanned smart vending machines. Previously, the company had applied for a regulatory sandbox, proposing a smart vending machine model that integrates biometric authentication and remote control systems based on 13 over-the-counter medication items currently sold at convenience stores.

At the time, the Korean Pharmaceutical Association strongly opposed the proposal, expressing concern that the unmanned sale of medications could expand gradually following the approval of video-based dispensing machines. As discussions failed to reach a conclusion for an extended period, the matter remained effectively on hold.

However, during this latest meeting, the Ministry of Trade, Industry, and Energy reportedly emphasized that “a conclusion needs to be reached on the issue that remained unresolved for 5 years,” strongly advocating for the necessity of a pilot exemption.

It is reported that the company presented an additional plan to focus installations on medically underserved areas, such as remote islands and mountainous regions, where access to pharmacies and convenience stores is limited, in addition to its existing proposal.

It is also reported that they emphasized the stability of the technology, noting that biometric authentication and control systems had been further refined during the period when discussions were suspended.

On the other hand, the Korean Pharmaceutical Association and the Ministry of Health and Welfare reaffirmed their opposition. They reiterated the existing logic that pharmaceutical sales should be premised on face-to-face medication guidance and safety management systems, and that expanded unmanned sales could lead to misuse and safety concerns.

During the meeting, a heated debate reportedly continued over whether to proceed with the pilot exemption.

An official who attended the meeting stated, “Toward the end of the meeting, the atmosphere even reached the point where we were about to decide on proceeding with the exemption via a show of hands, but the debate between supporters and opponents continued for a long time. Ultimately, the Ministry of Trade, Industry and Energy decided to refer the matter to the next expert committee.”

At the meeting, ministry officials reportedly stated that a sixth expert committee meeting would be convened within 1-3 months to make a final decision on whether to proceed with the pilot exemption.

Within and outside the industry, some observers believe a partially positive sentiment toward the project is forming inside the Ministry of Trade, Industry, and Energy. In fact, several participants at the meeting reportedly expressed opinions sympathetic to the need for pursuing the pilot project.

However, given the continued strong opposition from the Ministry of Health and Welfare and pharmacy organizations, as well as the possibility that allowing unmanned pharmaceutical sales could expand into a broader social controversy, significant conflict is expected before a final conclusion is reached.