Pharma companies fail to suspend renegotiations for CAs

Seoul High Court dismisses the appeal for suspension of execution of the second negotiation order to retrieve reimbursement of choline alfoscerate that was filed by Chong Kun Dang, etc.

The suspension of execution request for the first negotiation order was dismissed by the Supreme Court

Pharma companies keep on the legal battle even after reaching an agreement during renegotiations

Once again, the suspension of execution for the second negotiation order to retrieve reimbursement that was paid for choline alfoscerate (cholinergic agent) that was filed by pharmaceutical companies was dismissed.

 

In other words, the companies have failed to suspend the execution of both the first and second negotiation order to retrieve reimbursement.

 

According to industry sources on the 14th, the 9th Administrative Branch of the Seoul High Court dismissed the appeal to suspend execution of the order for renegotiations on choline alfoscerate products that was filed by 26 companies including Chong Kun Dang on the 8th.

 

The suit was filed for the second negotiation order that was issued by the government to negotiate the terms for retrieving the reimbursement paid for choline alfoscerate drugs.

 

At the end of last year, the Ministry of Health and Welfare ordered the National Health Insurance Service to make insurance retrieval agreements on choline alfoscerate drugs.

 

The order was to reach agreements with the companies that ‘If the clinical trial fails, the full amount of health insurance prescriptions, from the date the clinical trial design submission was submitted to the MFDS to the date of indication removal, should be returned to the NHIS,.’ After the companies refused to negotiate, the MOHW again ordered renegotiations in June last year.

 

Upon order, two groups consisting of 26 companies including Daewoong Bio and 26 companies including Chong Kun Dang filed for the cancellation and suspension of execution of renegotiations.

 

In July, the suspension of execution filed by Daewoong Bio and others was dismissed, and the suspension of execution of negotiations filed by Chong Kun Dang and others was also dismissed.

 

Chong Kun Dang and others again re-appealed but the case was again dismissed.

 

As a result, all pharmaceutical companies that requested suspension of executions failed to suspend renegotiations for reimbursement retrieval.

 

Prior to the second try, the companies had filed administrative suits and suspension of execution for the first renegotiation order as well.

 

At that time, two groups consisting of 28 companies including Daewoong Bio and 28 companies including Chong Kun Dang separately filed their cases, but both cases were dismissed by the Supreme Court.

 

The suspension of execution filed by Chong Kun Dang, etc.

 

was first dismissed in January, then again dismissed at the appeal hearing in May.

 

Chong Kun Dang and others filed for a reappeal, and but this was again dismissed last month.

 

The suspension of execution filed by Daewoong Bio and others was dismissed at the first and second trial and then dismissed again by the Supreme Court in July without hearing as discontinuance of a trial.

 

Meanwhile, the companies have also reached an agreement with the NHIS to negotiate for the retrieval of reimbursement.

 

Recently, the NHIS had reached an oral agreement for negotiations with companies to retrieve the reimbursement paid for choline alfoscerate drugs.

 

The NHIS and the companies agreed that the companies will back 20% of the health insurance prescriptions amount paid from the date of submission of the clinical trial design to the MFDS to the date of indication removal if the clinical trial on choline alfoscerate drugs fail and its indication is deleted.

 

However, despite reaching such agreements, the companies are continuing with litigations to defer negotiations.

 

The companies have filed all-round lawsuits, including suits for cancellation and suspension of execution to block negotiations, but none were dropped since.