Gvn’t ‘Reviewing various measures to address drug shortages’

Director Jun-hyuk Kang, “The revised Pharmaceutical Affairs Act will be implemented by year-end… will secure governance for unstable supply solutions”

The Ministry of Health and Welfare (MOHW) has clarified that it is not relying solely on International Nonproprietary Name (INN) prescribing as a solution to addressing Korea’s drug shortages.

The ministry stated that its administrative goal is to identify the underlying causes and develop appropriate, stage-specific policy tools to address drug shortages in a targeted manner, in consideration of the varying causes of Korea’s unstable drug supply.

It also presented a plan to establish a social governance framework to resolve the unstable supply of medicines. This will involve operating a discussion table where doctors, pharmacists, the government, pharmaceutical companies, and patients all participate, aligned with the implementation of the revised Pharmaceutical Affairs Act.

On the 29th, Jun-hyuk Kang, Director of the Division of Pharmaceutical Policy at MOHW, stated at a National Assembly policy forum on INN prescribing for supply-unstable medicines that “the government does not believe that drug supply instability can be resolved solely through INN prescribing.”

Kang emphasized that shortages arise from a wide range of factors, including manufacturing, distribution, prescribing, and dispensing, and that the government will identify the root causes and develop appropriate measures to address them.

Kang further noted that while past government policies focused on establishing systems to foster the pharmaceutical industry, future efforts will involve administrative support for the industry from a national health security perspective to resolve the issue of unstable drug supply.

Kang said, “While there have been efforts to foster the industry in the past, there has never been support for active pharmaceutical ingredients from a public health security perspective. We have pointed out issues such as import dependency and shortage monitoring, and we are strengthening measures on that part as well, including requiring pharmaceutical companies to report supply disruptions.”

He added, “Regarding drug pricing, while we've emphasized the specificity of drugs until now, the drug pricing system announced late last year will set prices reflecting contributions to alleviating supply instability. The Ministry of Health and Welfare is examining diverse causes of supply instability and considering phased policy measures accordingly.”

Regarding governance mechanisms for addressing drug shortages, Kang stated that although such a structure did not previously exist, it will be established with the enforcement of the amended Pharmaceutical Affairs Act.

“There is currently a consultative body under the Pharmaceutical Affairs Act, but it is structured for government-only participation in maintaining the healthcare system. However, the revised Act, which takes effect late this year, provides for a new governance framework. It establishes criteria for essential medicines and enables responses to supply-unstable drugs.”

He added, “We have created a structure where representatives recommended by medical associations, pharmacist associations, and patient groups can join and discuss issues related to drugs with unstable supply within this governance framework. Regarding drug usage, we are building a substitution dispensing information system. This will streamline the substitution dispensing process within the legally defined standards, improving convenience for both physicians and pharmacists.

He added, “INN prescribing is not being discussed solely for cost savings. The government is considering INN prescribing only for essential medicines, from the standpoint of ensuring treatment continuity for patient life and health. The government is not viewing INN prescribing as the sole solution to supply instability.”