“Opportunity to dominate new markets”... Daeryun successfully completes ‘2025 Pharmaceutical/Bio Settlement’ webinar

Analysis of key issues such as pharmaceutical patents and SOP issues... Sharing risk management methods applied in practice
Daeryun “The rapidly changing pharmaceutical and bio environment… We will become a ‘legal compass’ that helps companies grow”

Daeryun Law Firm announced on the 29th that it successfully completed the ‘2025 Pharmaceutical and Bio Sector Settlement – ​​Medical, Bio and Healthcare Group Seminar’ webinar (online seminar).

This webinar, held on the 28th at the Park One Daeryun main office in Yeouido, Seoul, was designed to conduct an in-depth analysis of the patent disputes and personnel and labor issues that heated up the pharmaceutical and bio industries last year and to explore practical response strategies for companies in preparation for the rapidly changing regulatory environment.

On this day, the webinar was broadcast live online, and many people in charge and practitioners from related industries, including pharmaceutical companies, bio ventures, and healthcare companies, participated and showed great interest.

Attorney Lee Il-hyung, head of Daeryun Pharmaceutical Bio Healthcare Center, appeared as a presenter. This lawyer, who holds a pharmacist's license, analyzed major cases he personally worked on, such as the '13-valent pneumococcal vaccine ruling', and delivered practical implications based on his extensive experience in litigation in the medical and pharmaceutical field.

Attorney Lee explained, “It is important to note that the court recognized the special nature of the bio process and interpreted the scope of the ‘research and testing exception’ broadly,” adding, “As much of the legal uncertainty related to the production of semi-finished products has been resolved, an opportunity has been created for companies to pursue R&D and global cooperation using public technology more stably and confidently.”

Attorney Lee then continued to make suggestions from a human resources and labor perspective regarding the issue of illegal dispatch, which is a chronic risk in the pharmaceutical industry. He focused on the relationship between the main contractor's obligation to comply with standard operating instructions (SOP) and whether illegal dispatch was established.

He said, “In strictly regulated industries such as pharmaceuticals and bio, it is reasonable to view requiring compliance with SOPs as a legitimate exercise of quality control rights rather than command and order to personnel.” However, he advised, “If the SOP goes beyond simple standards for results and specifically controls the work method, there is still a risk,” and “the management system must be reorganized so that direct work instructions from the main contractor are thoroughly blocked and the partner company operates as an organization with its own expertise rather than simply supplying manpower.”

Lastly, practical response measures in line with changed laws, such as the Digital Medical Products Act that went into effect last year, were also shared. Attorney Lee emphasized, “The implementation of the Digital Medical Products Act is an opportunity to dominate new markets such as digital therapeutics through the use of real-world data (RWD),” and added, “Companies must proactively establish cybersecurity and quality management strategies in line with the changed certification system and create new business opportunities.”

Daeryun CEO Kim Kook-il said, “The role of a law firm is to help companies focus on their core business without wavering in the rapidly changing pharmaceutical and bio regulatory environment. Going forward, Daeryun will not miss out on changing industry trends and will faithfully fulfill its role as a legal compass for the sustainable growth of companies.”

Reporter Kim Jong-cheol (jckim99@sportsseoul.com)

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