Legalizing order for manufacturer to supply essential drugs

Rep. Young-seok Seo proposed a bill detailing revisions to the Pharmaceutical Affairs Act…"Entrusting the Korea Orphan & Essential Drug Center to be responsible for the actual delivery of stably supply"

A bill has been proposed in the Korean National Assembly to stipulate the Government Supply System in the Pharmaceutical Affairs Act to ensure the stable supply of National Essential Medicines, which are frequently in short supply due to low profitability.

 

The bill also includes an article expanding treatment opportunities for patients using essential medicines by entrusting the practical work of ensuring a stable supply to the Korea Orphan & Essential Drug Center.

 

On November 24, Democratic Party of Korea Rep.

 

Young-seok Seo announced that he had officially proposed this amendment to the Pharmaceutical Affairs Act.

 

Rep.

 

Seo stated that the number of discontinued products has recently been increasing, primarily in essential medicines with low commercial viability.

 

He noted that the government is currently operating a Government Supply System, such as supporting drug production through agreements with pharmaceutical companies or directly importing overseas pharmaceuticals, when supply is halted due to a company's product withdrawal.

 

However, Rep.

 

Seo expressed concern that the current law does not explicitly provide a legal basis for the Government Supply System, limiting its application and expansion.

 

He further pointed out that, concerning this issue, the legal basis for supporting the resumption of production of medicines not supplied domestically is also inadequate.

 

Therefore, Rep.

 

Seo introduced a bill that legally mandates the Government Supply System for essential medicines and entrusts its practical implementation to the Korea Orphan & Essential Drug Center.

 

In detail, the bill allows the Minister of Food and Drug Safety (MFDS) to mandate a pharmaceutical manufacturer to manufacture National Essential Medicines for products not currently manufactured or imported into Korea when a stable domestic supply is necessary.

 

This bill is to be newly established under Article 41-2, titled 'Manufacture and Supply of National Essential Medicine,' of the Pharmaceutical Affairs Act.

 

In such cases, the MFDS Minister may prepay all or part of the manufacturing costs to the relevant pharmaceutical company.

 

Furthermore, the MFDS Minister can provide administrative and technical support to ensure a swift review process when the company applies for a product license.

 

The MFDS Minister is also mandated to entrust the duties of manufacturing, storage, and supply of National Essential Medicines to the Korea Orphan & Essential Drug Center.

 

The proposed bill also introduces a new article, 'Article 43-2 Emergency Import of Medicines,' into the Pharmaceutical Affairs Act.

 

This new bill allows the MFDS Minister to supply medicines domestically through methods such as importation and provide related information to patients when an urgent domestic supply is deemed necessary or when the head of a relevant central administrative agency or related organizations and groups requests the supply.

 

Rep.

 

Seo explained, "This bill legally specifies the government system for the stable supply of essential medicines and entrusts the practical execution to the Korea Orphan & Essential Drug Center," and added, "It will guarantee treatment opportunities for patients requiring essential medications."