What are the most significant cases or transactions that you have been involved in over the past year?

Introduction of an Innovative Therapeutic Platform in Japan: Our legal team played significant role in the transactions that enables us to develop innovative therapeutic platform, radioligand therapy (RLT), for the benefit of patients and healthcare practitioners in the Japanese market.  Due to complexity of regulatory environment, legal team has been expected to be creative to provide solutions for operations of the new platform to deliver RLT medicines to patients and to address unmet medical needs.

To establish the platform in Japan, the company needs to collaborate with global and local external business partners, industrial associations, academia, and patient groups.  Our legal team has been cross-functionally working with Business Development, Drug Development, Commercial and other functions, and working not only for contracting and regulatory framework but also antitrust and other sensitive legal assessment to make each transaction feasible.

While our efforts are still ongoing to launch new products in the future, a recent important milestone was that the company publicly announced USD100million investment into the manufacturing site in Japan in last November to commit to RLT platform for the benefit of patients and healthcare practitioners in Japan.

Based on your experience, what is the key to collaborating successfully with business partners?

The key would be trust based on common understanding of business strategy and the corporate value.  In order to build such trust, in-house lawyers are expected to set right issues to be discussed with business partners and clearly show the rationale of its own opinion.  It is also important to identify hidden issues and challenges and raise relevant concern transparently to improve the entire organization from an enterprise mindset.  For that purpose, we keep learning and building our capability so that we play navigation role by suggesting multiple possible scenarios and relevant risks along with proposed actions as a strategic partner to drive our business for the benefit of patients, customers and stakeholders across the ecosystem.

Which political, economic or regulatory changes have impacted your work the most in the past year?

In Japan, from the perspective of economic security and resolving drug lag and loss problems, the government has begun to work on strengthening pharmaceutical development. The company, who have been providing innovative medicines to the Japanese market until now, also need to incorporate into our strategy what we can do in such changing environment. As Legal function, we feel that a strategic review is expected in our current and future relationships with stakeholders in the healthcare ecosystem.

Apart from legal matters, has the team worked on other company initiatives you would like to highlight?

Our team has cross-functionally worked to address increasing social concern of harassment for better workplace.  The Japanese government is generally taking initiatives to encourage employers to make better working places to address upcoming labor shortage and aging society.  In addition, the amendment to the Criminal Codes in 2023 clarified the scope of sexual crimes and the sanction became stricter, and some behavior that used to be considered as sexual harassment could be sexual “crime” beyond the category of mere harassment.  Customer harassment has been actively discussed in various occasions since 2023, and the Hotel Business Act was amended to enable hotels to refuse troublesome customers.  The Tokyo Metropolitan government started considering local regulations to prevent customer harassment followed by consideration of possible national legislation by the Ministry of Health, Labour and Welfare.

While the company has had already internal rules of anti-harassment in line with the governmental guidelines, it is necessary to update the operations under the internal rules to respond to the social trend above.

We discussed any possible challenge in case of both suspicious harassment by customer and against suppliers.  While the company has already focused on prevention of sexual harassment and “power” harassment like most of other companies in Japan, there is still opportunity for us to focus on customer harassment to protect our associates and reputation by taking pragmatic actions.

Based on co-creative discussion, we took several actions, e.g. clarifying operations under the current internal rules covering customer harassment, internal training that newly covers customer harassment and message of internal and external commitment to build trust with society, ahead of possible local regulations.

In addition, I have started working as an executive sponsor for Employee Resource Group of LGBTQ+ to promote our DE&I culture.