Naokuni Kuwagata – GC Powerlist
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Japan 2025

Healthcare

Naokuni Kuwagata

Corporate officer and country legal head Japan | Novartis Pharma

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Japan 2025

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Naokuni Kuwagata

Corporate officer and country legal head Japan | Novartis Pharma

Team size: Seven

What are the most significant cases, projects or transactions that you and your legal team have recently been involved in?

Our legal team has played a significant role in the project enabling us to develop an innovative therapeutic platform, radioligand therapy (RLT), for the benefit of patients and healthcare practitioners in the Japanese market.

Our legal team made a significant contribution to a successful new drug application as scheduled by working cross-functionally to ensure the successful execution of the contractual arrangements with a German manufacturer following tough negotiations and complex collaboration.
We continue to work with various external stakeholders to ensure our new products are available to patients immediately upon launch.

Furthermore, our dedicated support for this project is ongoing. Following the announcement of a US$100m investment into the manufacturing site in Japan, as described in my response last year, the media recently reported on the Safety Blessing Ceremony of the site expansion, and our project has become known as the introduction of a new therapeutic platform in the Japanese market.

How do you approach managing legal aspects during periods of instability or crisis to ensure the organisation’s resilience?  

As part of the company’s leadership team, I must be aligned on how we respond to instability or crisis in accordance with our corporate mission and values.

Legal considerations form one part of the many factors influencing decision-making, and I strive to be involved and present so that I have access to the same level of information, which also serves as a basis for legal analysis, within the organisation.

During periods of instability or crisis, the situation is constantly evolving, and I need to keep multiple possible scenarios in mind by consulting with other stakeholders; some scenarios are more likely, while others are less so. Depending on each scenario, I consider the actions we can or should not take by assessing their legal feasibility.

I must remain flexible because the situation can change rapidly and may not always be within our control. I also recommend that we seek advice from third-party experts to ensure objectivity in our decision-making.

Based on your experiences in the past year, are there any trends in the legal or business world that you are keeping an eye on that you think other in-house lawyers should be mindful of?  

As the scope of generative AI usage expands in the business world and our daily lives, the relevant technology is rapidly developing. Likewise, the legal industry is no exception, with such advanced technology being incorporated into legal-tech businesses and large law firms making significant investments. This trend is set to have a considerable impact on how legal work is conducted, how legal departments should be structured, and the skill sets expected of in-house lawyers, both in terms of managing the risks of generative AI and leveraging its capabilities.

Looking forward, what trends do you foresee in the legal landscape over the next five to ten years that companies should prepare for?  

Over the next five to ten years, I anticipate significant shifts in the legal landscape driven by geopolitical realignments, regulatory divergence among liberal democracies, and evolving corporate compliance expectations. Should a second Trump administration introduce substantial policy changes, the immediate regulatory adjustments over the next two to three years could have lasting effects, shaping both domestic and international legal frameworks.

These changes are likely to include increasing complexity in trade and sanctions laws, stricter corporate governance and compliance standards, a reshaping of data privacy and cybersecurity regulations, the evolution of antitrust and competition law, as well as legal adaptations to emerging technologies.

In light of these trends, companies should proactively monitor policy developments, strengthen their compliance infrastructure, and engage in strategic foresight to ensure resilience amid this evolving legal landscape.

Naokuni Kuwagata - Japan 2024

Corporate officer and country legal head Japan | Novartis Pharma

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Naokuni Kuwagata - Japan 2023

Corporate officer and country legal head Japan | Novartis Pharma

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