Naokuni Kuwagata – GC Powerlist
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Japan 2026

Healthcare and pharmaceuticals

Naokuni Kuwagata

Corporate officer and country legal head Japan | Novartis Pharma K.K.

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Japan 2026

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Naokuni Kuwagata

Corporate officer and country legal head Japan | Novartis Pharma K.K.

Team size : 7

What are the key projects that you have been involved in over the past twelve months?

Over the past twelve months, I have been closely involved in the launch of Japan’s first radioligand therapy approved for PSMA-positive metastatic castration-resistant prostate cancer. Since joining the company in 2021, I have provided continuous legal support to our RLT portfolio, advising on complex contracting schemes with global headquarters and domestic and international business partners, as well as on Japanese regulatory requirements and antitrust considerations in a still nascent and concentrated market.

RLT represents a key strategic therapeutic platform for the company, and this project went beyond a single product launch. It has played a pivotal role in expanding treatment options for cancer patients in Japan, while establishing a scalable legal and collaboration framework to support the development and commercialisation of a broader RLT portfolio in the future.

Please describe a situation where your advice had a significant impact on business outcomes or objectives.

In practice, assessing harassment allegations is often complex, and disciplinary actions can lead to labour disputes. At the same time, the company has a duty to ensure a safe workplace, which is essential to protecting employees and maximising performance.

As a legal and management leader, I have driven cross-functional discussions to identify legally relevant facts using appropriate assessment methodologies, enabling well-balanced decisions that fulfill our obligations even while managing litigation risks. These efforts were also shared more broadly through my publication in a legal journal last year.

AI remains at the forefront of conversations about the future. How can in-house counsel ensure the successful integration of legal tech, while maintaining the human element?

Successful integration of legal technology, particularly AI, requires a dual approach: embedding tools into legal workflows while maintaining clear human accountability. Legal functions operate in high-risk environments, where laws differ across jurisdictions, making centralised oversight complex, and where errors can lead to regulatory sanctions and reputational damage.

Through internal learning initiatives, one key insight has been that AI literacy is essential — understanding both its capabilities and its limitations. Legal tech is not used only by in-house counsel, it is also increasingly accessible to business professionals as well. In this context, in-house legal teams are uniquely positioned to engage with practical use cases through their advisory role in AI-related projects, ensuring that adoption is both responsible and aligned with business needs.

Importantly, legal tech does not replace in-house counsel. The value of legal professionals lies in interpreting and contextualising AI-generated outputs, translating them into sound legal judgment. This expectation is also reinforced in the context of legal privilege, where trust in in-house counsel as accountable human experts is increasingly emphasised. Ultimately, legal tech enhances, rather than substitutes, the role of in-house counsel.

Are there any upcoming challenges that in-house teams should be preparing for over the next twelve months?

Over the next twelve months, in-house legal teams will need to navigate an increasingly fragmented regulatory environment shaped by geopolitical dynamics. 2026 is a major election year, with high-stakes votes across the United States, and Europe likely to influence domestic policy agendas and international alignment.

In the United States, the outcome of the midterm elections will shape the administration’s ability to advance trade, industrial and regulatory policies. At the same time, China continues to pursue state-driven economic strategies, while Europe is actively promoting its own regulatory frameworks, particularly in areas such as competition and data governance. These developments reflect a broader trend in which legal and regulatory tools are increasingly used to advance national strategic objectives.

At the multilateral level, global forums are being reconfigured, with outcomes often taking the form of non-binding principles or guidelines. However, these “soft law” frameworks can have a significant practical impact, influencing corporate behavior and shaping national legislation over time.

For in-house counsel, the key challenge is not only ensuring compliance within individual jurisdictions, but also managing inconsistencies across regimes — requiring a more strategic role in interpreting and integrating evolving legal frameworks.

Naokuni Kuwagata - Japan 2025

Corporate officer and country legal head Japan | Novartis Pharma

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Naokuni Kuwagata - Japan 2024

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Naokuni Kuwagata - Japan 2023

Corporate officer and country legal head Japan | Novartis Pharma

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