"MFDS' data-based drug shortage response"

Expanding a production support program for drug shortage to include up to four pharmaceutical companies

Will implement MOHW-MFDS collaborative "Pharmaceutical Production, Supply, and Prescription Data-based Supply Risk Prediction System"

"The scope of legal abortion should be defined through amendments to the Mother and Child Health Act and the Criminal Act"

Jeong Eun Keong, Minister of Health and Welfare

The Ministry of Health and Welfare (MOHW) announced that it will address drug shortages by utilizing information from the "Pharmaceutical Production, Supply, and Prescription Data-based Supply Risk Prediction System," which is currently being established by the Ministry of Food and Drug Safety (MFDS).

 

The MOHW has also proposed drug shortage response strategies, including domestically producing the raw materials and sub-materials for medicines and vaccines, as well as expanding a production support program for drugs with unstable supply to include up to four pharmaceutical companies.

 

The MOHW also stated that the introduction of abortion drugs could only be expedited after the scope of legal abortion is defined through amendments to the Mother and Child Health Act and the Criminal Act.

 

The following Q&A is based on the MOHW's responses to written inquiries from People Power Party Representative Han Ji-a and Democratic Party of Korea Representative Nam In-soon of the National Assembly's Health and Welfare Committee on August 27.

 

"Responding to unstable supply by linking production, supply, and prescription systems" The MOHW's Division of Pharmaceutical Policy and Division of Health Industry Promotion responded to Rep.

 

Han Ji-ah's inquiries about policy plans to strengthen the drug supply chain.

 

First, the MOHW stated that "securing a stable drug supply chain is essential for protecting and maintaining public life and health, and is an essential task directly related to health security." The Ministry explained that it is "monitoring drugs with supply interruptions or shortages in cooperation with the MFDS, and taking customized measures through a public-private consultative body when necessary." The MOHW also stated that it would create countermeasures by linking its system with the one being developed by the MFDS for drugs with unstable supply.

 

The MFDS is currently building a data-based drug supply risk prediction support system to enhance the prediction of unstable supply situations.

 

The system is designed to comprehensively analyze drug production, supply, and prescription information.

 

In particular, the National Assembly has a pending amendment to the Pharmaceutical Affairs Act that would strengthen the linkage of information on drugs with unstable supply between the MOHW and the MFDS.

 

The Ministry expressed its commitment to support this legislation to address drug shortages actively.

 

The National Assembly also promised to make efforts to produce drug and vaccine raw materials and sub-materials domestically, support the production of drugs with unstable supply, and stockpile essential medicines.

 

The plan is to expand the project that provides budget support for pharmaceutical companies producing drugs with unstable supply from one to four companies.

 

To respond to human infections of avian influenza and bioterrorism, the Ministry plans to prioritize the introduction of the latest overseas vaccines and stockpile them with domestically developed vaccines after their development is complete.

 

It will also focus on national cooperation to diversify the sources of imports for active pharmaceutical ingredients (APIs) from China and India.

 

"Introducing abortion drug requires an amendment to both Mother and Child Health Act and the Criminal Act" The MOHW states that amendments to the Mother and Child Health Act and the Criminal Act are essential for the domestic approval of abortion drugs like Mifepristone.

 

It stated that to create a safe abortion environment, the scope of abortion must be established through amendments to the Criminal Act.

 

While the Constitutional Court's ruling in April 2019 that the abortion ban was unconstitutional effectively nullified the relevant penal provisions, a legislative void has persisted for over six years due to the failure to pass supplementary legislation.

 

As a result, the MOHW's stance is that it is difficult to carry out abortion-related administrative tasks.

 

The MOHW plans to work closely with relevant ministries, including the Ministry of Justice and the MFDS, to support future legal and institutional improvements.

 

Minister Jeong Eun Keong gave the same response during a questioning session with People Power Party Representative Cho Bae-sook at the National Assembly's Special Committee on Budget and Accounts on August 27.

 

Minister Jeong explained, "As the Criminal Act and Mother and Child Health Act have not been amended since the unconstitutional ruling, there are safety issues." She added, "While there are no approved drugs in Korea, most countries in the world use approved drugs." And added, "The World Health Organization (WHO) also provides recommendations based on gestational age." Minister Jeong said, "I will consult with the MFDS on safe usage methods.

 

We will consider both the fetus's right to life and the woman's right to health in a balanced manner."