Special agreement for re-evaluation of α-GPC is urgent

Stop wasting health insurance finances

Amendments to the Health Insurance Act on Drug Price Lawsuit "Mutual responsibility of the pharmaceutical and government according to win and loss

Nam In-soon a member of Democratic Party of Korea

Nam In-soon, a member of Democratic Party of Korea, stressed that there is a need for a 'special contract to return the reimbursement price' between the NHIS and pharmaceutical companis that applied for the clinical re-evaluation of Choline alfoscerate.

 

In clinical reevaluation, a pharmaceutical company that failed to prove the usefulness of Choline alfoscerate for indications other than dementia should sign a special contract to return the entire reimbursement price paid during the reevaluation period to prevent unfair pharmaceutical companies from applying for reevaluation for the purpose of deleting the indication or avoiding damage.

 

She raised the need for a special contract for returning Choline alfoscerate reimbursement, and furthermore, the Health Insurance Act, which reimburses pharmaceutical companies unfair benefits according to the results of winning or losing administrative litigations such as drug price cuts and positive list system, or compensating for damages to pharmaceutical companies caused by the government's incorrect disposition.

 

The revised bill is also planned.

 

On the 28th, she said that the deadline for submitting the application for clinical reevaluation of Choline alfoscerate is less than two months, so it is urgent to issue an executive order for the special contract to return the reimbursement of the MOHW.

 

The MFDS announced December 23 as the deadline for submission of clinical reevaluation plan for Choline alfoscerate.

 

Accordingly, 134 pharmaceutical companies with Choline alfoscerate are preparing to submit re-evaluation plans for 255 items.

 

She believes that prior to reevaluation, Pharmaceuticals with Choline Alfoscerate and the NHIS should sign a special agreement to return all reimbursement prices paid by the pharmaceutical company within the reevaluation period in case of clinical failure, so that pharmaceutical companies which apply for reevaluation will be able to delay the duration of indication maintenance.

 

In particular, she pointed out that it would be difficult to prevent unnecessary damage of health insurance finances because there is no basis for returning the reimbursement price of Choline alfoscerate sold by pharmaceutical companies during the clinical reevaluation period, which takes more than 3 years if the drug efficacy fails to prove unless a special contract is signed.

 

In addition, for a special agreement between Choline alfoscerate pharmaceutical company and the HIRA, the procedure for issuing an administrative order is required by the MOHW, but it is not enough time because the administrative order procedure must be followed before the deadline for the application for reevaluation.

 

Beyond clinical re-evaluation of Choline alfoscerate, she was also contemplating a revised bill of the Health Insurance Act related to the administrative disposition of pharmaceutical reimbursement such as drug price reduction and positive list system.

 

In this year's National Audit of the Health and Welfare Committee, as pharmaceutical companies' administrative lawsuits for cancellation of notifications and provisional disposition for suspension of execution became issues, the necessity to advance lawsuits related to the drug price of Choline alfoscerate as well as all medicines emerged.

 

As a single example, there is no legal regulation that allows the government to return the amount of prescriptions and benefits for indications other than dementia paid during the period following the first trial, a trial on an appeal case, and a trial at the Supreme Court when the pharmaceutical companies in the Colin Alpo lawsuit finally lose.

 

This is why there are criticisms that it is highly likely that pharmaceutical companies will abuse the lawsuit to neutralize the effect of drug price cuts or delay the effective time to pursue unfair drug prescription profits.

 

Assuming the actions the MOHW can take if Choline alfoscerate pharmaceutical company loses under the current legal system, it is about the disposition of government loss payment notice and reimbursement claim against the unpaid pharmaceutical company.

 

This means that the reimbursement redemption is not legalized, so separate administrative orders and additional lawsuits are carried out.

 

In response, she plans to make an amendment to the Health Insurance Act to compensate for the unfair repayment of pharmaceutical companies' unfair benefits according to the results of a drug price reduction lawsuit between the pharmaceutical company and the government, or to compensate for the damages in sales of drugs that pharmaceutical companies unfairly suffered due to government administrative measures.

 

In a drug price cut lawsuit, it is a two-way bill that establishes a law to recover unfair benefits incurred during the lawsuit if a pharmaceutical company loses, and calculates and compensates the damage caused by the disposition by the government, such as drug price cuts.

 

She plans to collect opinions from the MOHW, the MFDS, the NHIS, and the HIRA, as well as domestic and foreign pharmaceutical companies, civic groups, and related academic societies.

 

Since the impact on the government administration and pharmaceutical industry is great, the goal is to collect opinions from various fields and reflect them in the legislation.

 

She said the immediate urgent thing is that the MOHW issues an executive order to sign reimbursement return contract between the pharmaceutical company and the NHIS before the MFDS conducts clinical reevaluation of Choline alfoscerate.

 

She also explained that the contract could eliminate the cases of pharmaceutical companies applying for unfair re-evaluation and prevent possible financial damage to health insurance during the re-evaluation period.

 

In addition, she said that she plans to promote legislation to supplement and improve problems arising from administrative disposition lawsuits related to drug prices, including lawsuits for canceling Choline alfoscerate’s positive list system and temporary disposition for suspension of execution.

 

In addition, she emphasized that the major framework of the current legislation is to redeem the treasury for unfair benefits when a pharmaceutical company loses and to compensate for unnecessary sales damage suffered by pharmaceutical companies when the government loses.