The artificial vessel supply stoppage crisis seemed almost over with the sole provider W.L. Gore & Associates deciding to resume the supply of some of its products for Korea.

However, the U.S. firm and the Korean government have not conducted any further discussion for a continued supply, sources said.

If the talks between Gore and the Ministry of Food and Drug Safety break down, Korean pediatric patients with heart diseases might not be able to receive urgent heart surgeries due to the shortage of artificial blood vessels.

The Korea Congenital Heart Disease Patient Group, which had been keeping a low profile for the resumption of artificial vessel supply, changed its stance to fight against the U.S. manufacturer more aggressively. The latest development bodes ill for a smooth negotiation, observers said.

Gore withdrew its products from the domestic market in September 2017. The Korean Society for Thoracic and Cardiovascular Surgery and the Korean Society of Interventional Vascular Surgery strived but failed to stop Gore from leaving. The only way to save heart patients was to stock up artificial vessels.

As the stocks ran out early this year, however, Korean children with congenital heart diseases could not receive urgent surgery and desperately waited for Gore to supply the vessels. The issue drew more social attention than the one over the company's withdrawal from Korea two years ago.

Amid mounting public pressure, the MFDS said in March that it would discuss supply resumption with Gore. On March 15, the ministry held an urgent video conference with the manufacturer to secure 20 artificial blood vessels.

However, no further discussions have progressed between the government and Gore since the supply of the 20 vessels.

Ahn Sang-ho, president of the Korea Congenital Heart Disease Patient Group, poses for a photo during a recent interview with Korea Biomedical Review.

Why is the stable supply of artificial vessels difficult?

Since Gore left Korea in 2017, it was not the government but the Korea Congenital Heart Disease Patient Group and the Korean Society for Thoracic and Cardiovascular Surgery that have made actual efforts to persuade Gore to resume supply.

Rather than the MFDS but the patient group had the initial talk to make the urgent supply of 20 products possible on March 15. During the process, the patient group did not directly accuse the company but urged the government to normalize the supply of artificial vessels.

However, the patient group recently warned the firm that it could use its force to secure a stable supply from Gore because the talks between the MFDS and Gore seemed unproductive, it said.

Ahn Sang-ho, president of the Korea Congenital Heart Disease Patient Group, met with Korea Biomedical Review recently to share what has happened after Gore pulled back from Korea.

In around March 2017, Ahn heard from a thoracic surgeon at a university hospital in Seoul that Gore might withdraw from the domestic market and found out that all of the employees at the vessel business unit resigned from the company in March 2017.

"Even if the government wanted to negotiate with the company at that time, it had no person to talk to. In the end, physicians failed to stop Gore from leaving and decided to hoard artificial blood vessels," Ahn said.

Feeling anxious, he told thoracic surgeons specialized in surgery for children with congenital heart diseases to notify him immediately if the vessels go out of stock.

Early this year, the shortage started to loom large from Asan Medical Center first.

Ahn and the Korean Society for Thoracic and Cardiovascular Surgery again requested Gore for resuming supply, but the company refused to do so. So, Ahn decided to pressure Gore Korea, not the medical devices division of Gore.

"I sent an official letter to Gore Korea after Gore's refusal. The message was clear that I would fight until the end unless the company supplies artificial vessels," Ahn said. "Although Gore Medical's revenue from Korea might be small, revenue from Gore Korea selling outdoor clothes and industrial materials is large. This way, I could send my message directly to the owners of Gore."

Then, Ahn got to have a phone call with an official at Gore Asia. The official demanded that he talk with the patient group only, neither the government nor the society, he explained.

During the phone call, Ahn demanded Gore supply non-substitutable items among essential treatment materials and Gore OKed. However, the two had different lists of "non-substitutable items among essential treatment materials."

After Gore had a video conference with the MFDS, it decided to supply 20 items in urgent need. The company also promised to supply 16‧18‧20㎜-sized artificial vessels used most frequently in the Fontan procedure.

However, Gore still refused to supply 12‧14‧22‧24㎜-sized vessels.

The company said it would supply the vessels on the condition that it gets exempted from the Good Manufacturing Practice (GMP) inspection and set the Korean price of the product at the U.S. level.

What are other remaining issues?

In a nutshell, Gore says it cannot provide artificial blood vessels unless it gets an exemption from GMP inspection.

The license on Gore products, which has been nullified immediately after Gore's withdrawal in September 2017, was reinstated when the shortage of the vessels became a social issue early this year. The reversal of the license revocation is the first case in Korea where the voluntarily nullified license became valid again.

Exempting Gore from GMP inspection is something that the MFDS can hardly accept. An alternative will be allowing Gore products as GMP-free items through the National Institute of Medical Device Safety Information.

However, the only blood vessels that Gore can provide through the National Institute of Medical Device Safety Information are 16‧18‧20㎜-sized ones. Gore does not want to supply other 12‧14‧22‧24㎜-sized vessels, regardless of GMP exemption.

For patients, this could be the biggest issue. They do not know what size they will need and when. Receiving only the most popular products means that patients cannot brace for an urgent situation.

Although the MFDS thinks it would be able to persuade Gore to provide the other vessels that Gore had refused to supply, the reality is grim, Ahn said.

"After the video conference in March, the government sent the list of necessary items, but Gore is not looking into it. The discussion is over," he said. "The video conference was not the start of the negotiation but end of it. There is no talk since then."

Ahn said Gore was neither angry nor distrustful of the Korean government.

"Gore seems to think Korea is not a good market to do medical business. The local market is small, and it could not secure a share as much as it had expected. So, it's not likely that their judgment will change," he added.

Patient group gives ultimatum to Gore

Out of desperate hope, the patient group chose to "wield its force" to pressure Gore, Ahn said.

The group sent an official letter to Gore, demanding the resumption of the supply of the treatment materials in need for patients. In the letter, he sent photos of campaigns that have urged help for children with congenital heart problems.

"We will give them a week. If Gore still refuses, we will fight. We will do everything we can such as a rally, a news conference, and one-person demonstration," Ahn emphasized.

Ahn also vowed to release English news releases about the current situation to get attention from the U.S. and Europe where Gore-Tex is popular.

"The press release will include content that Gore is not supplying artificial blood vessels which are needed for children with heart diseases in a particular country. If necessary, we will join forces with an international patient group association," he added.

Ahn went on to say that failure to provide Gore's artificial blood vessels means that treatment materials for our children's surgery will disappear.

"We can never give up. I hope Gore does not make the worst decision. Please don't bail on us and our hope, and supply artificial vessels," he said.

kss@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>