Eli Lilly interview: Innovation and compliance, active ingredients

Yes indeed, as our critical mission is to bring innovative drugs to the market. It is the very core of our business and we spend immense resources to create new drugs that, at the end of the day, will help patients. Our research center in Shanghai is a well-sized and state-of-the-art facility aimed at delivering products that carry the company's vision and achieve its goals.

We operate in a highly regulated and rather sensitive industry so we follow all policy measures that have an impact on R&D and innovation in biopharmaceuticals, and do our best to leverage these developments. It is absolutely encouraging to see that China is on the path of fostering more innovation.

A big challenge faced by many general counsel at foreign companies in China is having to bridge the gap between Chinese business culture and headquarters, such as by clearing up what the local partner means by “This is China” and certain regulatory intentions. How do you make sure that everyone is on the same page?

That is one of the key roles for general counsel at MNCs in China–to be able to act as a bridge between the local business and HQ. A recent survey indicated that there has increasingly been a stronger desire of HQ to understand the Chinese business environment so as to provide more meaningful insight and advice. And for them to do that, it is up to the management team in China to articulate clearly how and why things happen and certain decisions are made. This is why it's so important to look through the black text of the law and understand its legislative intent.

One thing I learned is to keep things simple; things run most efficiently when decision-making follows basic and consistent principles, no matter how ambiguous the environment is. We have to always apply–and make sure everyone understands–the overarching reason of why our company exists, which is to benefit the people. If we always remember that, it won't be too challenging to find the best way to help the company deliver healthy and sustainable growth.

I also find it important that in-house lawyers are aligned around the same storyline what our place in the company is. I would not say our job is merely to quote the law, but as a group of well-trained and highly-respected professionals, we provide knowledge and expert-backed solutions all while assisting the leaders of the company set the right strategies and courses.

As to “This is China”, the way I see it, the time has passed for when it could be the answer to every challenge and inquiry. It is still true that China is very much different from where many of the MNCs are headquartered, and cross-cultural nuances must be recognized. That said, the most fundamental values that guide our day-to-day decision-making and behavior–for Lilly, they are integrity, driving excellence and respect for people–are universal. Integrity is never more important in one market than in another. But we need to consider the cultural differences in order for our values to resonate with every single employee. I think this is what executives refer to when they say that “China is unique”.

Jane Huang, general counsel, Lilly China

Every company has a global compliance culture and employee handbook—did yours have to be specifically tailored to China?

Rules and policies have to be tailored to all local markets, not just China. For Lilly China, we strive to comply with all applicable laws and regulations, and those sometimes include laws outside of China too. For example, as the China arm of a U.S.-based company, we need to understand and comply with the U.S. Foreign Corrupt Practices Act. When we are involved in projects that have a cross-border element, such as the transfer of personal information of residents of multiple jurisdictions, we must respect the rules of other countries too. Of course, the majority of our work relates to the local law. General counsel need to be very familiar with how the laws of their jurisdiction are interpreted and enforced, so that they can be applied to the specific needs of the company in that market.

We have a very capable compliance and internal control team that provides good training and protection for the company and our staff. It's good to have this strong system in place but equally effective is if the top-to-bottom management team is consistent with its policies.

Are there any recent regulatory developments in life sciences that you are monitoring?

The Chinese government has been working hard to implement the rule of law. Quite a few changes and drafts have recently been introduced by various agencies that impact patents, drug registration, clinical trials, anti-corruption and anti-monopoly. We have been actively working with the regulators to get a better sense of how the industry is expected to operate and where it is headed.

Some of the reforms being carried out will have a deep impact on the healthcare industry. The drug registration system backlog in China has remained an issue for a while, but the CFDA [China Food and Drug Administration] has been making solid efforts to address this, such as by expanding its team, benchmarking the processes and standards of other mature jurisdictions, and strengthening clinical trial inspections.

What are your thoughts on e-health in China?

We are watching developments in e-health, but conditions remain quite uncertain. We prefer to take a discreet approach and are working hard to understand how the internet and other innovative tools may help us better serve patients without compromising the regulatory obligations we as a healthcare company must meet to protect patients' safety and privacy. There hasn't been any indication that foreign parties wouldn't be able to get involved in the platform. We definitely are interested in exploring in this new arena and want to be innovative in the right way, and for the right reasons.

能为我们介绍一下您的法律团队吗？您负责在中国的多少家办事处和机构？

我是礼来制药的总法律顾问兼法务副总裁。礼来大约在10年前开始建立本地法律团队，我是在2009年入职的。目前我们团队有六名律师，涵盖有关一般公司法和医疗的各类事项。

我们在上海设立了销售和商业总部以及独立的研发基地，在苏州有一家工厂，制造礼来的许可产品。最近礼来的动物保健部门Elanco从诺华收购了动物保健业务，并已经与中国的业务整合。

研发问题占到您的大部分工作吗？

是的，的确如此，因为我们的重要使命是向市场推出创新药物。这是我们业务的核心，我们投入大量资源来研制新药，最终使患者受益。我们在上海的研发中心是大规模的先进设施，致力于打造产品，实现公司的愿景和目标。

我们所处的行业属颇为敏感的行业，监管严格，所以我们遵守对生物制药的研发和创新有影响的所有政策措施，并尽全力把握这些发展带来的机遇。看到中国正朝着培育更多的创新之路而行，实是非常鼓舞人心的。

对于外企在中国的许多总法律顾问而言，他们面临的一大挑战是在中国商业文化和总部之间搭建桥梁，例如解释所谓的“中国办事方式＂以及某些监管意图。您如何确保各方相互理解，达成一致？

这是跨国公司在中国的总法律顾问的主要职责之一——在本地业务和总部之间起到桥梁沟通作用。近期一份调查显示，总部了解中国商业环境的意向越来越强烈，为的是能够提供更多有意义的见解和建议。为了做到这一点，中国管理团队需要清楚解释办事和决策的方式及原因。因此很重要的一点是看穿白纸黑字的法律条文，理解背后的立法意图。

我学习到的另外一点是简化问题；无论环境如何不明确，当决策遵循基本统一的原则时，做事最为高效。我们必须时刻应用、并确保每个人都理解公司存在的最根本的目的，就是要造福人类。如果我们始终牢记这一点，要找到最佳方式来帮助公司实现健康、可持续的增长就不再那么困难了。

同样重要的一点是，公司内部律师要配合其在公司的定位。我认为我们的工作不仅仅是援用法律，而是要成为一支训练有素、受人高度尊敬的专业团队。我们提供以知识和专家为支持的解决方案，同时协助企业领导人制定正确的战略和方向。

此外，我认为用所谓的“中国办事方式＂来回应所有挑战和问询的时代已经一去不复返了。中国的确与许多跨国企业总部的所在地存在很大区别，我们也必须认识到跨文化的细微差异。但即便如此，对礼来而言，引导我们日常行为和决策的最根本的价值观仍然和普世一样，即行为正直、推动卓越和尊重他人。行为正直在每个市场都同样重要。但我们需要考虑文化差异，使我们的价值观与每名员工产生共鸣。我认为，这就是高管们所指的“中国特色＂。

每家公司都有全球合规文化和员工手册 ——礼来中国的手册是否为中国量身打造？

规则和政策需要经过调整以适应所有本地市场，不仅仅是中国。对礼来中国而言，我们努力遵守所有适用的法律法规，有时还包括中国以外的法律。例如，礼来的总部位于美国，所以礼来中国需要理解和遵守美国《反海外腐败法》。当我们参与有跨境元素的项目，例如多个司法管辖区居民的个人信息转移，就必须遵守其他国家的规则。当然，我们的大部分工作与本地法律有关。总法律顾问必需对所在司法管辖区的法律的解释和执行方式了如指掌，这样才能应用于公司在这一市场的特定需求。

我们有一支优秀的合规和内控团队，为公司和我们的员工提供良好的培训和保护。拥有强大的体系固然是好，但同样有效的是管理团队至上而下遵守政策。

在生命科学领域，近期有哪些监管发展是您密切关注的？

中国政府努力实行法治。不同机构近期推出了多项变革和草案，影响专利、药物注册、临床试验、反腐败和反垄断。我们与监管部门积极合作，以便更好地了解行业计划实现的运营方式和发展方向。

一些正在实施的变革将对医疗行业产生深入影响。中国药物注册系统的积压问题已持续了一段时间，中国食品药品监管总局一直在努力解决这一问题，例如扩大团队力量、借鉴其他成熟司法管辖区的程序和标准，强化临床试验检查等。

您如何看待中国的电子医疗？

我们在关注电子医疗的发展，但是依然有诸多不确定因素。我们宁可采取谨慎的策略，并正在努力了解因特网和其他创新工具可以怎样帮助我们更好地服务于患者而不会损害患者的安全和隐私；因为，保护患者的安全和隐私是我们作为一家医疗公司，在监管方面所必须负的责任。没有任何迹象显示外方不能参与这一平台。我们对探索这一新领域非常有兴趣，并希望以正确的方式、以适当的理由实现创新。