MFDS's bill on stable supply of essential drugs in review

may pass subcommittee review on the same day

HIRA adds “drug distribution information linkage” to the scope of work for its Pharmaceutical Management Information Center

“Drugs with temporary demand increases and supply instability” added to scope of drugs reviewed by the Council for the Stable Supply of Essential Medicine

A bill to add “medicines that are essential for healthcare and require stable supply” and “medicines with similar therapeutic effects with no alternative treatments” to the list of national essential medicines, thereby resolving the issue of unstable supply of medicines, is likely to pass the Health and Welfare Committee's legislative subcommittee.

 

At the subcommittee meeting held on the morning of the 19th, the subcommittee members and the Ministry of Food and Drug Safety agreed on the intent of the legislation, but there were some disagreements over the specific wording that should be used to codify the definition, so the subcommittee agreed to pass the bill after going through the amendment process on the same day.

 

The subcommittee members and the MFDS also agreed to accept a provision to revise the designation method for essential medicines to be designated by the Minister of Health and Welfare and the Minister of Food and Drug Safety after consultation with the National Essential Medicine Stable Supply Council.

 

The bill also includes provisions to include “linking drug distribution information” in the scope of the Comprehensive Drug Management Center's duties and to allow the MFDS director to request the Drug Management Information Center to provide and link drug distribution information.

 

On the morning of the same day, the subcommittee members decided to merge the bills proposed by Representative Sun-min Kim of the People Power Party and Representative Mi-hwa Seo of the Democratic Party of Korea and continue deliberations.

 

However, as further discussions on the bill are scheduled at the afternoon subcommittee meeting, there is a possibility that it could pass the subcommittee on the same day if an agreement is reached between the government and the subcommittee members.

 

The bill expands and revises the definition and scope of essential medicines and establishes a legal basis for managing distribution information to contribute to the stable supply of essential medicines.

 

Expanding the definition of essential medicines to strengthen management of drugs with unstable supply The current law defines essential medicine as “medicines that are essential for health and medical care, such as disease control and radiation disaster prevention, but whose stable supply is difficult to ensure through market functions alone, and which are designated by the Minister of Health and Welfare and the Minister of Food and Drug Safety in consultation with the heads of relevant central administrative agencies.” Rep.

 

Sun-min Kim's bill proposed revising the definition of essential medicines to “drugs that are essential for maintaining the national health system, such as disease control and radiation disaster prevention, or that are essential for health and medical care and require a stable supply, as designated by the Minister of Health and Welfare and the Minister of Food and Drug Safety in consultation with the National Essential Medicine Stable Supply Council.” Representative Mi-hwa Seo's bill proposed amending the definition to “medicines that are essential for health and medical care, such as disease control and radiation disaster prevention, but whose stable supply is difficult to ensure through market functions alone, or drugs for which there are no substitutes with similar therapeutic effects, as designated by the Minister of Health and Welfare and the Minister of Food and Drug Safety after consultation with the National Essential Medicine Stable Supply Council pursuant to Article 83-4, Paragraph 3.” The MFDS agreed to reflect both Kim and Seo’s bills and submitted a proposed amendment to the relevant clause.

 

The MFDS proposed to revise the bill so that essential medicines would be designated by the Minister of Health and Welfare and the Minister of Food and Drug Safety after consultation with the National Essential Medicine Stable Supply Council, and to define essential medicine as drugs that are essential for maintaining the national health system, drugs that are essential for health care but difficult to supply stably through market forces alone, and drugs for which there are no substitutes with similar therapeutic effects.

 

The members of the subcommittee raised the need to define essential medicines in one line rather than listing them individually as proposed in the MFDS amendment, and requested a further amendment.

 

The subcommittee is expected to resume its review of the bill in the afternoon based on the amendment.

 

Distribution information linkage included in the scope of the Integrated Pharmaceutical Management Information Center’s duties The MFDS agreed to add “distribution information linkage” to the scope of the Integrated Pharmaceutical Management Information Center’s duties and to allow the MFDS Minister to request the provision and linkage of distribution information in consultation with the director of the information center.

 

The MFDS also accepted provisions to add “drugs that are not designated as essential medicines but require stable supply due to temporary increases in demand” to the scope of drugs managed by the National Essential Medicine Stable Supply Council and to add monitoring of essential drug supply and demand trends to the duties held by the Minister of Health and Welfare and the Minister of Food and Drug Safety.

 

The MFDS also expressed its opinion regarding the provision to specify the composition of the National Essential Medicine Stable Supply Council in the law.

 

Under the current law, the council is composed of 20 government members, including one chairperson, with the remaining details to be specified in the implementing regulations.

 

Rep.

 

Sun-min Kim’s proposal stipulates that the council shall consist of 30 members, including two chairpersons, with government and private-sector members, and that private-sector members shall constitute a majority.

 

Rep.

 

Mi-hwa Seo's proposal stipulates that the council shall consist of 30 members, including one chairperson, with government and private-sector members.

 

The MFDS proposed a council composition similar to Rep Kim’s proposal, consisting of 30 members, including two chairpersons, but added patient group representatives as recommended by Rep Seo.

 

The subcommittee plans to resume deliberations in the afternoon, as it believes that there has not been sufficient discussion on the details of the bill.