Xiaoxiang Ye – GC Powerlist
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China 2019

Xiaoxiang Ye

Vice president, general counsel, chief compliance officer and head of risk management of Eisai China | Eisai China Holdings

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China 2019

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Xiaoxiang Ye

Vice president, general counsel, chief compliance officer and head of risk management of Eisai China | Eisai China Holdings

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What are the most important transactions and litigations that you have been involved in during the last two years? We witnessed Lenvatinib, one great product, being marketed in China. As an important part of Lenvatinib’s strategy, legal assessment and arrangement was essential. There were hundreds of legal programmes as well as compliance evaluation for its commercial promotion. Also, following Eisai and MSD’s global co-development and co-commercialisation, we handled and completed a CPA (capacity purchase agreement) with MSD China, which was certainly a tough and exciting campaign.

What are the unique challenges, if any, of working in-house for a foreign multinational in China?
I do think the most important thing is changing the role of in-house counsel from a risk assessor to a risk solution provider on the basis of reaching an excellent balance between global policies and the local business situation. In this sense, characteristics such as learning business capacities, being open to diversity, being courageous, wisdom and judgement will allow in-house lawyers to become more and more important. What political, economic or regulatory changes have impacted the company and you recently? As we know, big changes are afoot in the Chinese pharmaceutical market. Whether it’s new policies that we have put in place in relation to the amount of procurement or new regulations, they all send important signals that the old business model is disappearing and a new time is coming. Innovation of operation in the Chinese pharmaceutical field will be the key to achieve success in the future. As legal professionals, we must meet the paradigm shift with business changes.

When selecting a law firm, what criteria do you evaluate the potential firms by? Besides professional competence, I think two points should be put into any decision-making process. One is the degree of tacit understanding for both the industry and our company as well as our legal team. The other is cost, which means whether the cost performance is appropriate.

Do you use any “legal tech” products and do you find them a helpful management device? Frankly, there is no perfect legal tech product in the market, although my team and I would like to try any tech product available.

In what ways do you see the in-house legal role evolving in your region over the next few years? Considering the business environment and risks in the Chinese pharmaceutical field, we will focus on working towards better regional risk control. For this purpose, I don’t think each team’s legal, compliance, audit or finance management alone will be replaced by one large risk control system. I will try a new model for the integration of resources, engaging compliance, legal and other related teams to provide highly efficient risk solutions. As the foundation of risk management, higher professional requirements will be placed on the legal team. What will be the main focus for the company in the next 12 months and how do you intend to assist with this? As big changes are happening in the Chinese market, innovation will be the main focus for Eisai in the near future. It has two meanings for the legal team. Firstly, legal is not an isolated island and also needs innovation, which means we shall review our legal structure, SOPs and decision-making processes as well as update our understandings for the business. On the other hand, trial and error always comes with innovation. For the legal side, we must focus on risk control mechanisms and provide various risk solutions. Our ultimate value is to become an indispensable part of top level design.   FOCUS ON… It is foreseeable that due to the compression of price space brought up by a series of policies, the original research drug companies will have to improve their marketing strategy and innovate the business model. In the meantime, the medical representative filing system and other policies that restrict hospitals’ promoting activities will cause radical changes in the original academic promotion model which is characterised by intensive in-hospital meetings. Under the new circumstances, innovation will be the main focus for Eisai in the near future. It has two meanings for the legal team. Firstly, legal is not an isolated island and also needs innovation, meaning we shall update our understandings for the business. Secondly, we should provide more constructive legal solutions. The new commercial era will create entirely new business projects, such as online prescription drug promotion and sales, and how to use digital means to standardise the clinical doctor’s prescription. Many subjects do not have clear provisions in law, which will require the legal team to establish a business framework within the legal scope to build a legally compliant transaction structure for projects that exist in ambiguous legal areas. On the other hand, risks always come with innovation. For the legal side, we must pay more attention to the risk control mechanism. Based on the possibly entire new transaction design, the legal team must fully monitor and detect risks in time during the transaction operation, as well as constantly improve the design, and complete the positive interaction between the business and legal function in the dynamic of model design: risk evaluation, a model improvement and risk re-evaluation. So for example, one great product – Lenvatinib – was marketed in China last year. As an important part of Lenvatinib’s strategy, there were hundreds of legal programmes as well as compliance evaluations for its commercial promotion. In this case, many projects that might face potential risk issues were redesigned from the legal perspective and finally gained huge success. In this sense, it truly reflects an in-house legal function’s ultimate value: becoming an indispensable part of top level design.

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