Regulations are required on GMP violations

need to analyze the cause of the GMP crisis, and regulate the solution

The National Assembly is discussing legislation with health authorities on health insurance finances for the recovery of drug benefits from pharmaceutical companies, which filed a lawsuit to cancel the disposal of drug price cuts for fraudulent purposes.

 

It is also discussing ways to enhance stability of quality of domestic manufactured medicines by supporting and strengthening GMP regulations.

 

The National Assembly, the MOHW, and the MFDS are discussing the proposed revision of the Health Insurance Act and the Pharmaceutical Affairs Act.

 

As the National Assembly recently completed the review of the supplementary budget bill and agreed to form a legislative body including the chairman of the Legislation and Judiciary Committee, it is expected that the bill will begin in earnest next month.

 

The two bills are expected to have a significant impact on drug benefits and drug manufacturing and production sectors in the domestic pharmaceutical industry.

 

Kwon Deok-chul, Minister of Health and Welfare, also acknowledged the need for a bill to recover reimbursed drug benefits from pharmaceutical companies that filed administrative lawsuits to delay or disable the government's drug price reduction and suspension.

 

When a pharmaceutical company deliberately filed an administrative lawsuit to avoid the government's legitimate drug reduction, it will impose the right to plan for the recovery of drug benefits and penalties.

 

There is a possibility that the government will compensate for the damage caused by pharmaceutical companies when they finally won the government's drug price lawsuit and the drug price reduction has been proven unfair.

 

Choline alfoscerate, which was confirmed to reduce the benefit due to some of its indications last year, is still showing a large amount of prescription in 2020, with a prescription amount of ₩42,574,1.53 million.

 

Choline alfoscerate recorded more than ₩200 billion in prescriptions in the first half of this year.

 

Nam In-soon, a memver of the Democratic Party of Korea, criticizes, "Even though the benefit reduction by adaptation has been confirmed, pharmaceutical companies are wasting hundreds of billions of won a year in health insurance finances." The bill is expected to have the effect of preventing a recurrence of such controversy through legislation.

 

The purpose of legislation for GMP support and regulation of domestic pharmaceutical manufacturers is to prevent GMP serial violations.

 

It plans to significantly increase the level of punishment for pharmaceutical companies that violate GMP and cancel GMP certification or item permission for pharmaceutical companies that violate GMP regulations even once by introducing the so-called "one strike out" system.

 

In addition to the GMP legislation, which focuses solely on strengthening punishment of pharmaceutical companies, the government is also preparing legislation to prevent violations of GMP by strengthening the authority of the chief manufacturer.

 

The current law neglects the situation of violating GMP even though it is aware of the illegal fact because the authority of drug manufacturers such as director of Pharmaceutical Manufacturing is relatively unclear or weak.

 

Attention is focusing on what kind of legislation the National Assembly and regulatory authorities will finally come up with to support and regulate domestic pharmaceutical GMPs An official of the National Assembly's Health and Welfare Committee said, "The bill to prevent drug cuts has formed a consensus between the welfare committee members and the MOHW." "The two bills will be discussed in earnest when pending issues such as the second supplementary review are dealt with," he added.