[Reporter's View] Clarify support for unstable supply drugs

The Ministry of Food and Drug Safety is reportedly preparing support measures to stabilize the supply of national essential medicines and other items with unstable supply.

 

The MFDS initially announced its intention to specify the urgent measures required by the industry to stabilize supply, such as emergency imports, custom manufacturing, and administrative support, within the first half of this year.

 

However, it was not specified within the first half of the year, and it is said that the authorities are still considering how to specify and disclose the measures.

 

Support for stabilizing the supply of drugs is provided by the Pharmacuetical Management Support Team of the MFDS.

 

The team was newly established in March 2024 after the tasks previously handled by the Pharmaceutical Policy Division within the Pharmaceutical Safety Bureau were transferred due to the growing need to respond to public health crises caused by COVID-19.

 

The Pharmaceutical Management Support Team will operate on a temporary basis until January 31, 2027, and is currently responsible for securing a stable supply system for essential medicines, ensuring the swift and stable supply of medical products in crisis situations, as well as other related tasks.

 

In particular, it is responsible for tasks such as the designation of essential medicines, reporting on supply disruptions or shortages, monitoring supply and demand, providing administrative support and communicating with companies, and taking measures to maintain the supply of discontinued items.

 

In this process, the pharmaceutical industry has consistently requested that administrative support measures be clearly stipulated in writing.

 

Support measures are necessary to ensure the continued supply of essential medicines in cases of supply disruptions, as there have been instances where price increases were implemented for certain items.

 

Therefore, there is a growing demand for the sharing of individual cases to clarify what support can be provided for which specific items.

 

The MFDS is also preparing guidelines that include various administrative support measures, but the problem is that it is struggling with whether to use these guidelines internally or disclose them externally.

 

If the guidelines are disclosed externally, administrative support may be applied to all items, which would inevitably increase the administrative burden.

 

In the case of stabilizing the supply of pharmaceuticals, support measures may vary by product, and if the guidelines are made public, some companies may raise issues regarding the varying standards.

 

However, formalizing administrative support could be one of the most effective measures to help companies stabilize supply.

 

Companies may need to bear the burden of administrative costs and continue producing items that could otherwise be discontinued, so it is crucial for the government to clarify the specific support it can provide.

 

Therefore, if guidelines are established, they should be publicly disclosed rather than kept internal, and administrative support measures should be properly established through a case-by-case approach.