R&D legal head, Japan | Novartis Pharma
Hideo Suzuki
R&D legal head, Japan | Novartis Pharma
What are the most significant cases, projects and/or transactions that you and/or your legal team have recently been involved in?
I provide critical legal counsel and strategic advisement to the leadership team of the research and development departments at Novartis. My primary role is to facilitate the success of medicine development management through careful legal guidance. I resolved key issues that frequently emerged at the intersection of scientific and technological aspects and legal considerations. Notably, I supported the agreement to speed up clinical development, ensured compliance with eSignature use under electronic signature laws and good practice regulations, and advised the team on potential business expansion from clinical development to clinical research in Japan.
How do you approach managing legal aspects during periods of instability or crisis to ensure the organisation’s resilience?
In managing legal matters during periods of instability or crisis, I focus on the intersection of law and technology, where issues often emerge due to a lack of professionals with expertise in both domains. I bridge this gap by identifying and addressing challenges that fall outside the scope of traditional specialists. By leveraging my background in science and technology alongside legal expertise, I help ensure organisational resilience through the effective resolution of complex, cross-disciplinary issues.
How does your team contribute to the overall business strategy of the company? Can you share an example of a recent legal-led initiative that had a significant impact?
To successfully digitise the organisation with support from the legal department, while remaining compliant with electronic signature legislation, our legal team plays a central role in ensuring compliance, all whilst retaining traditional print-based authorisation methods such as Inkan stamping. Given our position within the pharmaceutical industry, the security and integrity of data are critical to obtaining medicine approvals. To prevent unauthorised data use arising from inadequate management controls, we have recently taken the decision to actively utilise a previously underused digital signature function. As part of this initiative, we established a comprehensive signature policy in our Japan office, covering both wet signatures and digital signatures. This policy has supported wider adoption of the eSignature system among our staff.
Have you had any experiences during your career as a lawyer that stand out as particularly unique or interesting?
My career as a lawyer is uniquely enriched by my extensive background as a digital solution architect, allowing me to bridge the gap between law and technology. In my role as a corporate in-house counsel, particularly within the field of clinical development at Novartis, I have provided essential legal support for innovative medicine platforms. This work often involves addressing legal issues that are not typically encountered in conventional pharmaceutical businesses. It requires a sound understanding of platform architecture in order to offer well-informed legal guidance, whilst ensuring compliance with relevant regulations, such as Japan’s Pharmaceutical Affairs Law and the Electronic Material Safety Act.
Looking forward, what trends do you foresee in the legal landscape over the next five to ten years that companies should prepare for?
With the growing use of generative AI, routine tasks currently performed by humans will be taken over by automated systems. However, the implications of new and emerging technology areas remain largely unexplored, providing an opportunity for lawyers to operate like consultants, providing legal and technological advice simultaneously. There will be an expansion of so-called platform businesses beyond the realm of information technology, including fields such as innovative medical solutions. In situations where instant accuracy cannot be guaranteed, the value of predictions and advice based on logical estimation with legal professionals becomes an important aspect that AI cannot yet accommodate. The logical deduction and issue-spotting capabilities of lawyers will be crucial for any business. In the future, companies will need lawyers who combine legal and business perspectives for optimal results.
