[Reporter’s View]Contradictions in the CSO reporting system

which was announced after 3 years of preparations

The implementation of the CSO reporting system is now just 2 weeks away.

 

It means that after the 19th of this month, no one will be able to engage in sales and promotion activities in the pharmaceutical industry without a CSO report certificate.

 

Although there are only 2 weeks left until the law takes effect, there is still confusion among CSOs and pharmaceutical companies that entrust the CSOs with promotion and sales tasks.

 

This is because the specific implementation rules for the system are yet to be set.

 

This lack of preparation was highlighted during a Briefing Session on the CSO Enforcement Rules that was held on the 2nd of this month.

 

The Ministry of Health and Welfare held the briefing session jointly with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association.

 

The briefing was livestreamed on KPBMA’s YouTube channel.

 

The session attracted much attention, with more than 2,000 online viewers.

 

However, in the YouTube comment section, most people expressed frustration.

 

It was hard to find viewers who found the MOHW’s explanation helpful.

 

In particular, many people were frustrated with the process of filing the CSO report.

 

The MOHW’s explanation of the process was contradictory.

 

According to the MOHW, it is illegal for CSOs who have not completed their registration before the 19th to conduct promotional activities.

 

The problem is that the report certificate cannot be issued before the 19th.

 

Without the certificate, the activities are illegal, but the certificate cannot be issued on the date, which causes a contradiction.

 

On this, the MOHW explained that since the law comes into effect on the 19th, local governments cannot issue certificates before the date.

 

The MOHW’s workaround to the dilemma was issuing a ‘receipt.’ Companies that need the certificate before the 19th can submit the necessary documents then to their respective local public health centers, receive a receipt certificate, and use it until the report certificate is issued.

 

For pharmaceutical companies and CSOs, this means that they will have to sign double consignment contracts.

 

Moreover, even this is not possible in the immediate future.

 

In order for the MOHW to ask local governments to issue a receipt certificate instead of a report certificate, an enforcement rule must be promulgated, but the MOHW is still in discussions with the Ministry of Government Legislation on how to prepare detailed enforcement rules.

 

This grows doubt on whether the government really did prepare for the system for over 3 years.

 

The MOHW promoted the enactment of the CSO reporting system in September 2021 through a lawmaker's proposal.

 

In April last year, the CSO reporting system was introduced with the amendment of the Pharmaceutical Affairs Act.

 

In other words, there was at least a year to at most 3 years for the government to prepare for the system.

 

Nevertheless, there are now 2 weeks to go before the system’s implementation, and detailed rules for implementing the law are still not in place.

 

In addition to the certificate issue, there are still no detailed regulations on who needs to report, the scope of economic benefits that may be provided, and training obligations.

 

The MOHW has said it expects to issue the implementation rules within the next week.

 

Even if the rules are promulgated a lot of confusion will remain in the field.

 

The scheme, which aims to stamp out illegal rebate practices, has been bogged down since its inception.

 

Can the system really be implemented in two weeks?