How to stabilize supply of national essential medicines

Through INN prescriptions of drugs with unstable supply and demand

NA Health and Welfare Committee points out issues….MFDS responds, ‘under MOHW jurisdiction’

Changed the supply discontinuation drug reporting criteria from 60→180 days...will be enforced in April next year

While prescribing drugs by ingredient name and introducing international nonproprietary names (INNs) are being discussed as measures to stabilize the supply of drugs, voices have emerged calling for a system that allows the use of the same ingredient drugs as nationally essential medicines.

 

The issue of stabilizing the supply of not only national essential medicine but also drugs that are constantly experiencing supply and demand instability is one of the most frequent questions asked by the National Assembly's Health and Welfare Committee's national audit this year.

 

According to the written inquiries submitted by the MFDS to the National Assembly on the 17th, 7 lawmakers - Yoon Kim, Hee-Seung Park, Jong-Heon Baek, Mi-Hwa Seo, Young-Seok Seo, Byung-Hoon So, and In-soon Nam - inquired about stabilizing the supply of medicines.

 

Representative Yoon Kim pointed out the unstable supply of national essential medicines and asked how the MFDS plans to promote the use of drugs with the same ingredient name.

 

“Changing the method of prescriptions is the responsibility of the Ministry of Health and Welfare,” said the MFDS, adding, ’The MFDS will cooperate with the competent ministry, which is MOHW, if requested.” For national essential drugs, the Stable Supply Consultative Group is discussing comprehensive measures, improving the criteria for designating pediatric drugs as national essential medicines and the designation and removal national essential medicines.

 

In particular, in the case of pediatric drugs, products that are essential for pediatric patients but have unstable supply are designated as national essential medicines.

 

The MFDS said, “In the case of medicines whose supply is expected to be interrupted (shortage) due to insufficient production, we will jointly respond with the Ministry of Health and Welfare through the Public-Private Consultative body for Unstable Supply and Demand of Medicines, reviewing measures including raising drug prices.’ Representative Hee-Seung Park inquired about the reasons for the supply chain instability of national essential drugs, to which the MFDS responded, “We understand that the supply chain instability of national essential drugs is intensifying due to a combination of factors such as increased demand due to infectious diseases such as COVID-19 and deterioration of solvency due to rising production costs.” There was also an inquiry about the supply interruption report, which is required to be reported to the MFDS 60 days before the supply interruption.

 

On this, the MFDS announced on the 4th of this month that the ‘Rules on the Safety of Drugs, Etc.’ will be amended to change the supply interruption reporting criteria from 60 days to 180 days in advance from April 5th next year.

 

Until now, reporting drug shortages had been a recommended measure, but from next year, it will become mandatory.

 

“In order to promptly receive drug supply interruption reports, the deadline for reporting supply interruptions has been moved up from 60 days to 180 days in advance,” said the ministry, adding, “If a pharmaceutical company has a plan to reduce production and imports below a certain standard, it must file a report within 1 month.” Representative Jong-Heon Baek called for a stable supply plan through the expansion of domestically produced drugs.

 

“We support domestic pharmaceutical companies to develop manufacturing process technologies for national essential medicines that are highly dependent on imports and require stable supply and demand, and will continue to strive for the stable supply and self-sufficiency of raw materials and finished products for national essential medicines that are essential for healthcare,” the MFDS explained.

 

Through the self-sufficiency of national essential medicines project, which has been underway since 2022 with the Korea Orphan & Essential Drug Center and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, the associations completed the development of 3 raw materials (amiodarone, ketoconazole, and benserazide) and 2 finished drugs (amiodarone injection and tablets) in the first phase (2022-2023).

 

As the second phase (2024~2026) of the project, the company is developing 3 raw materials (acetaminophen, ipratropium, and furosemide) and 2 finished products (acetaminophen and furosemide).

 

The MFDS also responded to Representative Young-Seok Seo’s inquiry about the need to monitor the process of distributing medicines that are difficult to supply to pharmacies and medical institutions.

 

The MFDS said, “The MOHW is in charge of reporting on the supply of medicines, and the two ministries are responding to timely identification of supply and demand issues through smooth information exchange.

 

We will continue such information exchange in the future so that the relevant ministries can jointly respond to drug supply insecurity.” It was also pointed out that compared to direct response measures such as emergency import or made-to-order production, the measures made by the ministries end at indirect measures such as monitoring and encouraging production.

 

“There are many reasons for drug supply interruptions, such as production issues and raw material supply problems, and we are responding to each cause by reviewing the existence of substitute drugs and consulting with experts,” the MFDS said, adding, “We will prepare a response manual for drug supply interruptions in the future.”