Amid the public outrage over the government’s inability to secure a stable supply of artificial blood vessels for children with heart problems, officials said they would consider global trends in price negotiations with W.L. Gore.
The Ministry of Health and Welfare is scheduled to report the case of the supply shortage of Gore’s artificial blood vessels to the National Assembly on Monday.
According to the ministry’s report, Gore voluntarily abandoned Korean license of its products when it left the local market in November 2017.
The company decided on the market withdrawal after the Ministry of Food and Safety’s Good Manufacturing Practice (GMP) inspection into the firm in May 2016 and the lowering of the reimbursement for Gore’s products after an investigation into manufacturing costs, the ministry said.
At the time, Gore discontinued the supply of 48 items out of 50 treatment materials and maintained the supply of the rest two.
In May-June 2017, ministry officials met with Gore’s executives in charge of North Asia to demand the resumption of the supply of essential materials. They also collected opinions from the medical community and patient groups.
In December 2017, the government allowed the prices of Gore’s two remaining products to rise. It identified the quantity of the remaining items in March last year and established measures to guarantee the appropriate level of prices of rare and essential treatment materials in September.
Recently, officials from the health and welfare ministry, the Ministry of Food and Drug Safety, and the Health Insurance Review and Assessment Service made an urgent visit to Gore’s headquarters. In response, the company decided on Monday to immediately supply 20 artificial blood vessels for urgent Fontan procedures for local pediatric patients.
The health and welfare ministry said it would resolve the fundamental problems of the short supply of Gore’s products. It said it would promptly push for the registration of Gore’s products in the national health insurance system and start negotiating the resumption of Gore’s supply for the domestic market, jointly with the food and drug safety ministry.
If Gore demands a hike in the maximum price of its products, the government will consider the criteria for setting the maximum price of rare and essential treatment materials and global prices, according to the health and welfare ministry’s report to the Assembly.
Gore’s artificial blood vessels are being shipped to Korea and are expected to arrive at Asan Medical Center by Monday next week.
“Artificial blood vessels are being delivered to Korea. They will be delivered to Asan Medical Center by Monday, I heard,” said Ahn Sang-ho, representative of the association of patients with congenital heart defects.
With the 20 artificial blood vessels, six children can receive heart surgeries soon.
However, the urgent supply of the 20 products does not solve the problem for other patients. Gore has yet to decide whether to resume the supply for Korea.
The resumption of Gore’s supply hinges on the negotiation between the government and the company. The U.S. firm is known to have demanded the food and drug safety ministry guarantee the price to the level of U.S. and include tariffs and other costs in the sales price. The company reportedly demanded the government exempt it from GMP reviews.
If the government accepts the conditions, the company is apparently to start resupplying its products.
It is still unknown whether the government will do so, however.
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