All agreed to the legislation of the CSO reporting system

Gov, KPBMA, KRPIA & KPA

The Korea Pharmaceutical Association said, "Please give pharmaceutical companies CSO management obligations and authority"

We need to strengthen the disposition by introducing punitive fines

The MOHW, as well as KPBMA, KRPIA, and Korean Pharmaceutical Association, approved the mandatory government and local government reporting bill by CSO.

 

Except for the opinion that the regulations related to the CSO reporting system should be tightened compared to the legislation pending in the National Assembly, no organizations opposed it.

 

Depending on the results of this month's subcommittee's review, the legislation is expected to be completed within this year and implemented as early as early as next year due to the government's fear.

 

This is the result of confirming the review data of the National Assembly's Health and Welfare Committee's bill 1 subcommittee on the revision of the Pharmaceutical Affairs Act and Medical Device Act on the introduction of the CSO reporting system for medicines and medical devices on the 23rd.

 

The bill, proposed by Rep.

 

Kim Sung-joo of the Democratic Party of Korea, requires CSOs to report to the heads of cities, counties, and districts as prescribed by Ordinance of the MOHW.

 

Pharmaceutical companies, which are pharmaceutical suppliers, can entrust drug promotion work only to CSOs who have been reported.

 

Consignment of drug promotion work to unreported CSOs was sentenced to up to three years in prison or fined up to 30 million won, and CSOs were prohibited from re-consigning drug promotion work.

 

Violation of this will result in imprisonment for up to three years or a fine of up to 30 million won.

 

In addition, CSO representatives, executives, and workers were obligated to complete the drug sales order training.

 

Violations will be fined up to 1 million won.

 

All KPBMA, KRPIA, and Korean Pharmaceutical Association agreed Both organizations representing the domestic and foreign pharmaceutical industries and pharmacist organizations, including the government, approved the bill.

 

Rather, it submitted an opinion to further specify the CSO reporting method or raise the level of regulation.

 

The MOHW predicted that the CSO reporting system will clarify those subject to CSO for medicines and medical devices and incorporate them into the legal system so that administrative authorities can manage and supervise them.

 

The MOHW agrees with Rep.

 

Kim Sung-joo's proposal to eventually strengthen the management of the distribution order of medicines and medical devices by blocking indirect illegal rebates through CSO by establishing the obligation to prohibit rebates.

 

KPBMA also approved the bill.

 

However, it urged pharmaceutical companies to clarify the purpose of the law by adding content that imposes management obligations for CSOs.

 

KRPIA demanded stricter regulations against the bill, asking pharmaceutical companies to specify legal grounds for CSO to request information such as whether to report under the Pharmaceutical Affairs Act and whether representatives, executives, and employees complete rebate prohibition training.

 

The Korean Pharmaceutical Association also said the bill could contribute to preventing illegal rebates by identifying the current status of CSO and ensuring transparent distribution networks.

 

The Korean Pharmaceutical Association further proposed the introduction of a punitive fine in consideration of the reality that it is difficult to eradicate illegal rebates.

 

Only the provisions for re-consignment of CSO in the validity of the bill are changed.

 

Hong Hyung-sun, an expert at the National Assembly's welfare committee, also agreed with the purpose of the bill to make the distribution order of medicines and medical devices correct.

 

It did not prohibit re-consignment between CSOs, but expressed an opinion on changing the provisions so that the consignment route could be identified.

 

In order for the CSO to re-consign drug promotion work to another CSO, it is to stipulate that the original drug provider is informed of the facts as prescribed by the MOHW.

 

In addition, pharmaceutical companies and CSOs presented revised opinions on the contents of the promotion work consignment and the clause requiring the other party to prepare a "consignment report" within one month from the contract date and keep it for five years with evidence.

 

Violation of this would result in imprisonment for up to one year or a fine of up to KRW 10 million, and the CSO definition would include cases where drug promotion work was re-consigned.

 

In addition to preparing grounds for cancellation of designation by CSO educational institutions, Hong also proposed an incidental amendment to establish a hearing procedure in case of cancellation of designation.