A bill to revise the Pharmaceutical Affairs Act related to “solving the problem of unstable supply of essential medicines,” one of President Lee Jae Myung's presidential campaign promises, has passed the Health and Welfare Committee's legislative subcommittee
Immediately after the passage, the Ministry of Health and Welfare announced that it would first establish the government's definition of “unstable supply,” drawing public attention.
An official at the ministry’s Drug Policy Division recently made this remark, while explaining the progress in solving the problem of unstable supply of essential medicines, at a meeting with reporters from media outlets specializing in medical and pharmaceutical news. The official requested anonymity for policy reasons.
Recently, a revision to the Pharmaceutical Affairs Act proposed by Rep. Seo Mi-hwa of the ruling Democratic Party of Korea and Rep. Kim Sun-min of the opposition Rebuilding Korea Party passed the Health and Welfare Committee's first subcommittee on legislation. The main contents of the revision include “expanding the definition of essential medicines, improving the designation method, and adding pharmaceutical distribution information to the scope of duties of the Korea Pharmaceutical Information Service (KPIS).”
In response, the Ministry of Health and Welfare is considering how to proceed with social consensus on establishing proper definitions and criteria for medicines with unstable supply.
“It is not easy to define ‘unstable supply,’ and even if a definition is established, it may not be easy to determine whether a medicine meets the definition when an actual situation of unstable supply arises,” the official said.
The list of essential medicines is determined through discussions between the Ministry of Health and Welfare and the Ministry of Food and Drug Safety under the Pharmaceutical Affairs Act; therefore, it remains the same. However, there are some differences in the list of medicines subject to withdrawal prevention measures. It is necessary to review ways to ensure consistency in these areas, he added.
“We need to consider the method of managing drugs with unstable supply, such as whether to create a list. If a list is created, issues may arise regarding whether drugs should be removed from the list once supply instability is resolved,” the official acknowledged.
The official explained, “There is no system in place to monitor drugs with unstable supply by checking the inventory or usage of medical institutions. Even if a claim is submitted to the Health Insurance Review and Assessment Service, it takes about three to four months for the Ministry of Health and Welfare to confirm the data collection. This is also a problem. Non-reimbursed drugs are not even claimed, and general drugs are consumed without going through medical institutions, so monitoring is not easy.”
The Ministry of Health and Welfare is considering establishing its definition of supply instability and seeking public opinion.
“It would be faster to first create a government proposal and then proceed with discussions. Discussing various proposals simultaneously makes it difficult because everyone presents their own ideas. If the government takes the lead in conducting research to create a proposal, we can then discuss monitoring methods based on that proposal,” the official said.
The official recalled similar previous experiences. “When the public-private consultation body on supply instability was first established, the first topic of discussion was how to define supply instability, which was not easy,” he said. “After August, there is a risk of a resurgence of Covid-19, so there will definitely be issues with shortages of cold medicine and other items. Therefore, it is necessary to start preparing for supply instability now.”
In conclusion, he said, “Although the president’s campaign pledge included ‘resolving the issue of unstable supply of medicines,’ it focused on essential medicines. Given the large number of drug items in Korea, we need to realistically consider how to define medicines with unstable supply. Even if the risk expands later, we need to discuss what is really necessary first and then conduct research to gradually expand the scope to cold medicines and painkillers.”