Counterattack of Valsartan’s Pharmaceuticals

Class action is realized to The National Health Insurance Service

36 pharmaceutical companies, submit a lawsuit to confirm the absence of debt to the Seoul Central District Law

“Impurity Valsartan is not liable for damages” increase in litigation partners

Pharmaceuticals filed an alleged class action lawsuit against health authorities.

 

A lawsuit was filed preemptively that the government can not accept the Valsartan claim.

 

Cost liability for follow-up of impurity drugs has been determined in court.

 

According to the industry, 36 pharmaceutical companies recently filed a lawsuit to confirm the absence of debt against the National Health Insurance Service in the Seoul Central District Court.

 

It is a lawsuit stating that it is not responsible for the valsartan damages claimed by the National Health Insurance Service.

 

The NHIS asked to pay a donation of ₩2.03 billion to 69 pharmaceutical companies in last October.

 

It is a follow-up to the Ministry of Health and Welfare's decision to return the amount of money invested in pharmacies after exchanging impurity valsartan for the remainder of their prescriptions last year.

 

It is unprecedented that pharmaceutical companies filed a lawsuit against the government in a group.

 

In 2012, the government made a move to file a lawsuit against the collective price cuts of health authorities, but did not lead to a legal workshop.

 

In 2013, the NHIS and pharmaceutical companies filed a lawsuit for damages related to drug substance preferential treatment.

 

However, at this time, the NHIS filed a lawsuit.

 

Originally, pharmaceutical companies considered the joint response to the NHIS 'lawsuit.

 

However, they agreed to take a hard-line response by preemptively bringing up class action.

 

The number of companies participating in litigation is also on the rise.

 

Pharmaceutical companies were the first to discuss whether they would co-operate for the first time immediately after receiving a bill from the NHIS in early October, at that time, 20 companies showed a positive position.

 

When it decided to file a lawsuit last month, it increased to 35 companies, and it was reported that one large pharmaceutical company was willing to join an additional company immediately after submitting the complaint.

 

Most companies with large damages have refused to pay.

 

According to the data submitted to the Democratic Party's member, Nam In-sun, 26 pharmaceutical companies paid ₩440 million in compensation.

 

The payment rate was only 21.5%.

 

The pharmaceuticals refused to pay about 80% of the recourse amount.

 

Pharmaceutical companies are claiming no responsibility for the government-claimed Valsartan damages.

 

The NHIS has proposed a product liability law on the grounds of valsartan compensation.

 

It is judged that there is a defect in the manufacturer's product and safety, and according to the product liability law, it is possible to claim for damages due to the product defect.

 

It is based on Article 3 of the Product Liability Act, which states that 'manufacturers shall reimburse those who suffer damages to life, body or property due to defects of the product'.

 

Pharmaceutical companies stress that there are no manufacturing and design flaws with impurity valsartan.

 

Carcinogen N-nitrosodimethylamine (NDMA), detected in Valsartan’s issue, is a hazardous substance in the valsartan raw material that has no standard.

 

Neither governments nor pharmaceutical companies were aware of the risk of NDMA detection in Valsartan.

 

According to the Product Liability Act, it is clear that if the manufacturer proves that a defect was not found at the level of science and technology at the time the manufacturer supplied the product, it would be liable for damages.

 

After the valsartan’s issue, the MFDS derived a test method for detecting NDMA from Valsartan raw materials and set new standards.

 

The MFDS set the NDMA standard for Valsartan to 0.3 ppm or less by reviewing the guidelines recommended by the International Pharmaceutical Regulatory Coordination Committee (ICH M7), domestic and international data, and expert advice.

 

Moreover, the hazard of impurity Valsartan was not revealed.

 

The MFDS said, “ in last December, based on individual doses and duration of patients actually taking NHA-detected drugs using Valsartan by Huahai , the possibility of additional cancer was negligibly low“ Pharmaceutical companies argue that the National Health Insurance Service does not include claims for damages.

 

The NHIS has charged Valsartan medical fees and dispensing fees, but pharmaceutical companies are not liable for compensation under the Product Liability Act.

 

An official of a pharmaceutical company said, “We took huge losses from the recovery and disposal of products that are not exposed to human hazards, and it is unfair to pay for represription fee and redispensing costs.

 

Following Valsartan, sales of Ranitidine and Nizatidine were stopped, and we decided we need to weigh the injustices of the government action”.