"Healthcare start-ups need to cover insurance fees to attract innovative challengers" 

Ministry of Health and Welfare, Ministry of Food and Drug Safety, clarify subordinate legislation of the Chumba Act and emphasize the role of a linker‥Stance on separate review of insurance premiums 

It was pointed out that if you want to foster excellent health industry ventures, you should start with insurance fees.

At a debate on 'How to Revitalize Healthcare Venture Companies' hosted by Representative Kang Sun-woo of the Democratic Party of Korea on the 5th, opinions from the field were raised that in order to foster healthcare venture companies that will produce innovative results, it is necessary to establish a market that can be challenged by competent researchers, i.e., an insurance fee system.

Lee Yi-il, CEO of Xcell Therapeutics, called for creating an environment where venture and startup companies can actively challenge the development of advanced biopharmaceuticals and innovative new drugs. He pointed out that companies cannot jump into a market that does not even have a price for drugs.

Lee said, "Bio ventures are centered on innovative new drugs and advanced biopharmaceuticals, and with the implementation of the 'Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals (Chumba Act)' at the end of August, clinical trials for the development of advanced biopharmaceuticals can begin in earnest. However, I am worried that the law will become famously ineffective because the foundation for the insurance drug pricing policy has not been prepared." "The foundation for the insurance drug pricing policy should be prepared quickly from now on so that many researchers can challenge advanced biopharmaceuticals and new drug development research," said Lee.

Mr. Lee added, "If there is no immediate drug price, it means there is no market. It is important to keep in mind that even if you spend a lot of money and time developing a drug, if there is no market for it, it will not attract the challenge of excellent researchers." He pointed out that lowering the threshold for special listing of technology to support innovative drug development companies would be an alternative.

There was also an opinion that hospitals, which are the actual users of healthcare technologies and products, should actively participate in the project and come up with a way to achieve effective results.

"Most of the consumables used in hospitals are imported, and some essential products such as pediatric blood vessels have experienced supply and demand fluctuations due to low numbers," said Kim Byung-chae, a professor at Chonnam National University Hospital. "Hospitals, as end consumers, should directly participate in the development of (essential materials, etc.) and provide feedback when performance occurs, but there is no structure to reward performance." "Hospitals provide human and material resources, but there is no profit to return to the hospital, so it is necessary to create a virtuous cycle by establishing a medical technology business group," he said.

In response, government officials said they will include such field concerns in the subordinate legislation of the Chumba Act, which is in the final stages of being finalized, and will strive to activate health industry ventures by faithfully fulfilling the 'bridge role' of public institutions.

Lee Sang-jin, head of the Health Industry Policy Division at the Ministry of Health and Welfare, said, "The Chumba Act was passed after four years of discussions, and we are working on the finalization of subordinate laws with the Ministry of Food and Drug Safety. We are also reviewing organizational reorganization, comprehensive plans, and mid- and long-term plans for the implementation of the Chumba Act." "You know (in the field) why it took four years to pass the bill, even though it is said that the compensation system should be properly established.  Since it was passed after a compromise, we will fully discuss (the number issue)," he said.

"We know that the role of health insurance is important for marketization. Applying whether and to what extent to cover health insurance is a separate track (from approval), and it will be necessary for a separate discussion process to determine the level of insurance fee," he said, adding, "I will convey my opinion to the department in charge so that it can be expedited."

Shin Jun-soo, head of the KFDA's Biopharmaceutical Policy Division, said, "As a regulatory agency, KFDA is in charge of safety management, but it can also play a role as a development promoter. We will fully collect opinions in the process of preparing sub-regulations of the Chumba Act, such as submitting data from companies developing advanced biopharmaceuticals in advance, conducting customized examinations, and providing preliminary reviews at each stage." "We will strengthen cooperation with related ministries and enhance licensing consultations to help venture companies expand overseas."

"There are many concerns about which areas to support in the face of an influx of health industry startups, but public institutions should act as a bridge between stakeholders so that limited resources can be used efficiently," said Uhm Bo-young, head of the Industry Promotion Division at the Korea Healthcare Industry Promotion Agency. "The agency can connect those who want to start a business to the right infrastructure when they come to us. We will fulfill our role as a bridge."

The pharmaceutical association also said it will actively support the growth of health industry ventures.

"We are preparing to raise 7 billion won in seed money through a joint consortium to invest in good healthcare ventures. We want to help excellent companies go global." "We believe that existing pharmaceutical companies can increase the chances of success for venture companies because they have experience in licensing and overseas expansion. We look forward to working together."

Source: https://www.medipana.com/article/view.php?news_idx=260980&sch_menu=1&sch_gubun=5