26 ASIAN LEGAL BUSINESS – SEPTEMBER 2023 WWW.LEGALBUSINESSONLINE.COM ROUNDTABLE which provides a better level playing field for smaller players. Jisun Nam, head of legal department, Hanmi Pharmaceutical: Due to the COVID-19 pandemic, there have been significant regulatory changes and exceptions in the pharmaceutical and healthcare sectors. For instance, restrictions exist for telemedicine and medicine delivery in South Korea; however, exceptions were implemented during the pandemic to protect public health. These changes have provided a crucial opportunity for experiencing how existing regulations might need to be eased or controlled. Also, many business opportunities have emerged for utilising these changes regarding this industry. Furthermore, the importance of research and efforts for promoting human health has been emphasised. Collaboration possibilities between different fields have increased. This has also led to increased activity in research and attempts to develop new drugs or repurpose existing drugs. Pharmaceutical and healthcare companies have needed to respond swiftly and prepare with adaptable strategies. Consequently, in-house teams are required to deliver results and capabilities in terms of both knowledge and speed. ALB: In light of the shifting economic and geopolitical landscape in the jurisdiction(s) of your company, how are you adjusting legal strategies to power business growth while ensuring compliance with evolving regulatory developments and policy priorities? Zhou: The strategy and objectives of legal work are inextricably linked to the general environment and development stage of the company, and it is indeed a difficult and arduous task to achieve sustained support for business growth while taking the ever-changing regulatory environment into account. To do this work well, I believe it’s essential to consider two foundations. The first is to have an in-depth understanding of the industry in which we are engaged, especially the segments under the industry, including the characteristics of research and development, industrialisation, and commercialisation. Besides, if we have a global layout, we may also have a full understanding of the business characteristics of its international target markets. Secondly, we need to return to the legal work itself, which encompasses carrying out legal risk identification, analysis and assessment based on the in-depth analysis of the business, and establishing a good set of internal legal risk controls. Adjusting the specific legal risk control measures in accordance with continuous changes in the internal and external environments in a timely manner, which can be achieved by combining the company’s strategy, business development and changes in regulatory policies together. Importantly, we need to obtain the understanding and support from relevant departments and management team within the company when implementing the above work. Yeo: In times where companies operate in both developed and developing countries, there is no one-size-fits-all all business and/or legal strategies. More so, we are mindful that different countries and regions will require different focus. We look to fine-tune legal strategies by looking carefully at where our business needs are, how they have changed in different geographical regions, and putting in emphasis on them where it matters. Amidst deep diving into the needs of different regions, we make a point to ensure that compliance is always paramount to the integrity of our business. ALB: On that note, how do you anticipate legal and regulatory challenges in your jurisdiction(s) in areas including drug innovation, licensing and approval, and patent disputes, and what will be your approach to navigating these operational complexities and legal nuances? Zhou: As an innovative vaccine biopharmaceutical company in China, I predict that the risks in some areas of the pharmaceutical industry will increase in a short time significantly, including the management of human genetic resources, the application of international clinical data in China’s new drug approvals, the approval of cross-border biologic products transactions, as well as international patent dispute risks on innovative medicines and platform technologies especially those having great commercial values. In order to deal with these risks, I suggest that the first and foremost thing is to maintain close communication with regulators and industry experts. As enterprises, we should understand the legislation’s purpose and the regulatory’s focus to prepare well for business scenario prediction and legal analysis. Based on the above work, we need to collaborate with relevant internal departments to formulate relevant rules and processes, and reasonably and appropriately set up the control measures at the key control points. Lastly, we also need to conduct internal training and dissemination about the new regulations and policies in the company, so that the conducting level knows what to do and management level knows why to do it. At the same time, as I have mentioned earlier, with the internal and external environment changes, the legal department should also dynamically update and adjust the relevant risk assessment and initiatives to maintain the flexibility and appropriateness of the work. Yeo: In this highly competitive environment of innovation and the need to be the first, it is critical for all internal support functions to put mind maps in place and plan with the end in mind. Prepare for the unexpected hiccups. For the legal team, it is to ensure legal documentation, licensing and approval are first thought through and communicated with partners, regulators, and suppliers beforehand. Once the groundwork is laid, the project or innovation can more effectively take place and take root. ALB: How has your role as GC in the pharmaceutical and healthcare sector in your jurisdiction evolved and what would you describe as some of the most important skills to succeed in your position? Zhou: I often joke that I am a grass-roots GC, which, in fact, is the truth because I started my career in CanSinoBio as the sole person in legal and gradually Image (Previous page): Africa Studio/