The South Korean government came up with a new policy package on Jan. 15 to accelerate the growth of the biotech industry. All of the 10 new projects that constitute the package are scheduled to be launched in the first half of this year. The government is going to concentrate on deregulation and the growth of the biohealth industry, too.
According to the package, a wide range of innovation will be underway in the so-called red bio sector including the public health and medical sectors, green bio including food and resources, and white bio including environment and energy so that more market demands can be created and innovation in the private sector can be promoted along with an industrial paradigm shift.
Specifically, the 10 projects are to set up systems for big data accumulation, management and utilization related to biotech research, work on promising future technologies, train more engineers by sector, improve red bio regulations, improve financial systems, form an industrial base to cover every cycle of corporate activities, overhaul industrial clusters, promote the growth of the beauty care industry, create new green bio business opportunities, and accelerate white bio market creation.
According to market research firm Business Research Group, the global biotech market is expected to grow from US$8.6 trillion to US$14.4 trillion from 2016 to 2025. Meanwhile, the national competitiveness of South Korea in the industry fell from 15th to 26th from 2015 to 2018. This is because an annual R&D investment of 3.5 trillion won is failing to lead to commercialization and business model creation in many cases.
In this regard, the South Korean government is going to get rid of unnecessary regulations so that more rare disease medicines can be developed, more business opportunities can be created and medical data can be shared with the private sector for drug and medical equipment development. Previously, the Personal Information Protection Act limited the use of medical big data to research activities for public purposes. However, the National Assembly passed an amendment to the act on Jan. 9 and false name-based medical data sharing with a third party will become possible.
In addition, the Wastes Control Act will be revised for human body fat utilization for stem cell drug development and so on. Reference case studies will be collected with research activities becoming increasingly frequent with regard to new human body-derived research resources such as microbiomes and organoids.
New approval categories will be prepared for new forms of medical devices based on virtual reality and augmented reality technologies such as cognitive behavioral therapy software. That type of devices for artificial intelligence-based image diagnosis and so on will be preferentially reviewed by the Ministry of Food and Drug Safety through subordinate law enactment. Also, companies in high-tech medical complexes will be allowed to install their manufacturing facilities in an area of 5,000 instead of 3,000 square meters, which means they no longer need to build additional manufacturing facilities after product development.