Discussion about emergency OTC medicines has resurfaced

Park Yong-jin, vice chairman of the Presidential Regulatory Rationalization Committee, "Convenience stores must be allowed to stock more emergency OTC medicines…will reach a social consensus"

The Ministry of Health and Welfare (MOHW) agrees to expand up to 20 items by year-end…can be realized through announcements without needing legal reforms

Pharmaceutical industry insiders, "Could be faster than drug delivery"…tension builds ahead of National Assembly inspection

Photo of emergency over-the-counter medicine items 

As the pharmaceutical community focuses on expanding drug delivery under non-face-to-face treatment, another pending issue around expanding the lineup of convenience store emergency over-the-counter medicines is resurfacing.

After the Ministry of Health and Welfare (MOHW) officially announced its plan to expand emergency over-the-counter medicine items this year, the Presidential Regulatory Rationalization Committee (formerly the Regulatory Reform Committee) also said it would build social consensus to increase pharmaceuticals sold at convenience stores.

Park Yong-jin, vice chairman of the Presidential Regulatory Rationalization Committee, recently appeared on KBS Radio's 'Jeongyeok Sisa' and cited convenience store emergency over-the-counter medicines as one of the committee's regulatory improvement tasks.

Park stated, "Convenience stores should be able to stock a few more emergency medicines," adding, "While the pharmaceutical society strongly opposes this, we are considering avenues to forge a social consensus."

Although specific expansion items or timelines were not immediately proposed, the remarks are noteworthy because a presidential committee addressed expanding emergency over-the-counter medicines as a regulatory reform agenda directly tied to public livelihood.

In line with Vice Chairman Park's remarks, the Public-Private Joint Regulatory Rationalization Task Force under the Office for Government Policy Coordination is also reportedly preparing public deliberation procedures to address the expansion of emergency over-the-counter medicine items as a regulatory conflict resolution task among stakeholders. The task force recently placed a service order to organize a 'Regulatory Conflict Resolution Debate,' with expanding emergency over-the-counter medicine items in convenience stores mentioned as a primary topic of discussion.

The task force is reportedly reviewing plans to hold one or two debate forums in November to gather opinions from stakeholders and experts. Rather than pursuing blanket deregulation, the initiative aims to find common ground through stakeholder discussions and use the resulting feedback to implement concrete regulatory improvements in the future.

The government had already formulated its policy direction through the Ministry of Health and Welfare. Minister of Health and Welfare Jung Eun-kyeong said during a presidential briefing in July that the ministry would expand the list of emergency over-the-counter medicines sold at convenience stores and retail outlets in pharmacy-free villages by year-end. The ministry is considering a proposal to expand the currently available 11 items to 20.

Under the current Pharmaceutical Affairs Act, up to 20 items can be designated as emergency over-the-counter medicines. Although public notification currently lists 13 items, production has ceased for two specific Tylenol products, leaving about 11 items actually available.

A primary concern within the pharmaceutical community is that expanding the emergency over-the-counter medicine lineup does not require amending the Pharmaceutical Affairs Act through the National Assembly.

Once the health ministry reviews expert opinions and consumer demand to identify additional items, it can expand the list to 20 items under current law by amending the public notice designating emergency over-the-counter medicines. In contrast, expanding retail outlets—such as easing the 24-hour operation requirement pursued alongside this—requires amending the Pharmaceutical Affairs Act.

The government previously formed the Emergency Over-the-Counter Medicine Designation Deliberation Committee in 2017 to discuss expanding the list, but it failed to conclude because of disagreements between pharmaceutical associations and the convenience store industry. Discussions on expanding the list subsequently stalled for an extended period.

However, observations suggest that the circumstances are different this time, as the health ministry proposed a timeline to pursue the initiative within the year during the presidential briefing, followed by direct mentions of the need for expansion from the Presidential Regulatory Rationalization Committee.

'Could be faster than drug delivery'… pharmacy society's response priority also tested

The pharmaceutical community is currently concentrating its response capabilities on opposing the government's policy to expand drug delivery under non-face-to-face treatment. Led by the Emergency Response Committee of the Korean Pharmaceutical Association, pharmacists held a nationwide rally, followed by relay protests in front of the National Assembly, highlighting prescription drug delivery as a top priority.

Expanding emergency over-the-counter medicines is also among the core issues the National Assembly must resolve, alongside the scope of practice for herbal pharmacists and warehouse-style pharmacy concerns.

However, some in the pharmaceutical community point out that, in terms of the pace of institutional change, expanding emergency over-the-counter medicines could be an even more imminent issue.

An official from a regional pharmaceutical association noted, "While expanding drug delivery under non-face-to-face treatment requires relative time as it must be resolved through statutory revisions, expanding emergency over-the-counter medicines can be pursued simply by revising the public notice without legislative amendments. Since this is comparatively easier for the government to execute, the pharmaceutical community may need to view the convenience store OTC issue as more pressing."

The issue of emergency over-the-counter medicines was already addressed during last year's parliamentary audit.

During the National Assembly Health and Welfare Committee audit, Minister Jung agreed that the items and sales requirements should be adjusted to reflect changing circumstances, given that more than 10 years had passed since the emergency over-the-counter medicine system was introduced.

This year, with the health ministry taking a step further by formalizing plans to pursue expansion within the year during the presidential briefing, and the Regulatory Rationalization Committee delivering an aligned message, the issue is expected to resurface in the upcoming parliamentary audit.

A pharmaceutical industry insider commented, "While past discussions on expanding emergency over-the-counter medicines failed to conclude due to wide differences between the pharmaceutical society, convenience store operators, and consumer advocacy groups, attention must be paid to the fact that the government has set a concrete timeline for implementation within this year," adding, "Rather than simply reiterating opposition to the expansion, the pharmaceutical community needs to provide specific alternatives to improve drug accessibility alongside assessments of current convenience store sales management practices."