全球法律精英对话第二期 | 康希诺周媛：专业为矛，热爱为盾，为企业提供更好的服务

大家好我叫周媛，目前任职于康希诺生物有限公司，担任法律合规部、内审部高级总监一职，负责法务合规、知识产权以及内审、内控的工作。

今天很高兴来到LCOUNCIL与大家分享和交流。来到康希诺其实是一个缘分，因为2018年我刚刚迎来了第一个新生命，这也是重新给了我一个机会去审视自己的工作和职业发展。

猎头很偶然联系我说有一家由海外科学家回国创业从事疫苗领域的公司，在招聘法务相关的这个职位。那当时我听到第一反应是我可能不是从事这个行业的，在我过往的所有职业经历当中，都是从事的金融、投资并购相关的领域，与医药行业实际上没有太多接触。但是当听到说这是一家做疫苗的企业，恰巧我是18年生的小孩，可能是法律职业人的习惯，我开始去深入研究这一领域相应的一些内容，包括儿童用药、疫苗等等的这样一些信息。在这个过程当中，我发现国内外的儿童医疗水平，还是有一些差距和不同的，所以当时其实是本着对这个行业的兴趣和好奇，后来真正与公司的创始人在面试过程中深入交流之后，我发现自己其实很喜欢这个行业，一下子也就投入到了这个公司和这个行业当中。

Hello, my name is Zhou Yuan. I'm currently working at CanSino Biologics Inc. as the Senior Director of Internal Audit in the Legal Compliance Department. In the company, I am responsible for legal compliance, intellectual property rights, internal audit and internal control.

I am delighted to be here at LCOUNCIL today to share and network with you. It's actually fate to be here at CanSinoBIO because I just welcomed my first new baby in 2018, and it's a renewed opportunity for me to look at my work and career development.

By chance, I was contacted by a headhunter, who told me that a company in the vaccine field, founded by an overseas scientist, was looking for a position in legal affairs. At that time, my first thought was that I might not be engaged in this industry. In all my past professional experiences, I was engaged in finance, investment and M&A related fields, and I actually did not have much contact with the pharmaceutical industry. However, when I heard that this is a vaccine company, coincidentally, I was born in 18 years, probably because of the habit of legal professionals, I began to study the corresponding content of this field, including children's drugs, vaccines and other such information. In the process, I found that there are still some gaps and differences in the level of children's medical care at home and abroad, so at that time it was actually based on the interest and curiosity of this industry, and then after really communicating with the founder of the company in the interview process, I found that I actually like this industry, and I was instantly devoted to this company and this industry.

因为在我之前所有的从业经验当中，都是围绕着金融投资、并购领域，相对来说它是一个闭环的管理模式，我们更多去关注的可能是银保监会、证监会等等这样的金融机构相关的法律法规要求。这些工作内容，我相对来说其实是非常熟悉的。

但医疗领域从整个大的行业来说，它属于制造业，那进入到制造业、医疗行业之后，我发现我面临的工作其实不再是一个闭环的模式，更多时候我的工作节奏和内容要随着众多的法律法规的更新迭代去调整，我在这个过程中也要不断地去学习。

同时这个行业呈现出一个散状的结构，可能跟着业务的发展，伴随公司不同的阶段，也有新的工作或者是任务要去做，这其实是一个比较大的挑战。

Because in all my previous experience in the field of financial investment, mergers and acquisitions, relatively speaking, it is a closed-loop management model, we pay more attention to the Banking and Insurance Commission, the Securities and Futures Commission and so on such financial institutions related to the requirements of laws and regulations. I am relatively very familiar with the content of these jobs.

However, in terms of the whole industry, the medical field belongs to the manufacturing industry. Then, after entering the manufacturing and medical industry, I found that the work I faced was actually no longer a closed-loop model, and more often than not, the pace and content of my work had to be adjusted in line with the updating of numerous laws and regulations.

At the same time, this industry presents a scattered structure, which may follow the development of the business, along with the different stages of the company, there are also new jobs or tasks to be done, which is actually a bigger challenge.

近年来，其实医疗行业不管是从前端的研发到临床，还是到商业化等等，都出台了很多很多的法律法规。就医疗行业来看，有很多不同的细分领域，比如说仿制药和生物医药、医疗器械等领域都有许多不同点。结合我自己的工作实际来说，我想跟大家分享几点。

作为生物制药企业而言，其实在过去几年，我们能非常明显的感受到，国家在不同层面上对这一块进行了相应的完善和立法。如果说到具体的热点问题，我想可能更多包括贸易合规、行业准入、遗传资源管理、数据合规，这些都属于我们行业的热点问题。

In recent years, in fact, the medical industry has introduced many, many laws and regulations, no matter whether it is from the front-end research and development to the clinic, or to commercialisation and so on. As far as the medical industry is concerned, there are many different segments, such as generic drugs and biopharmaceuticals, medical devices, etc. There are many different points. In the context of my own work, I would like to share a few points with you.

As a biopharmaceutical company, in fact, in the past few years, we can feel very clearly that the state has improved and legislated accordingly on this piece at different levels. If we talk about specific hot issues, I think they may include trade compliance, industry access, genetic resource management, data compliance, which are all hot issues in our industry.

但是我今天更多想探讨的是这些热点问题背后的原因是什么？

对于我们企业个体和行业整体而言，我们应当更多关注以下几个方面：

第一，这些问题之所以成为热点问题，一定是因为出台了相应的法规法律，但是同时可能缺少或者是短期内没有实施细则去指导企业或行业如何落地去实施这些法律法规。

第二，这与企业的发展和行业的特性有关。我们上面谈到，不同的行业、企业有不同的发展阶段，存在不同的金融业态、交易结构，这些不同点，在适用相关的法律法规的时候有一些不同的解释，面临不同的困境和困难，那往往这个时候我们法律工作者要结合这些法律法规、新规出台背后的实际目的和原因，以及我们在业务当中遇到的情况来解释和结合适用。

除此之外，能够成为一个热点的原因，也是因为我们近两年看到相应法规出台之后，发生了一些实际的处罚案例。其中一些案例影响力是比较大的，在行业里面也引起了震动，起到了一定的警示作用。企业本身需要发展，这些处罚案例发生时，一定程度上会对企业本身产生很大震动和影响，企业此时为了规避自身被处罚的风险，要考虑这些处罚的原因是什么，行政机关作出此类处罚背后目的是什么、以及企业经营过程中为什么会面临这样的处罚？以及我们作为法律人，在去适用这些法律的时候，如何能够避免类似的处罚在自己的企业发生？如何做能够更好地为我们企业的经营发展保驾护航？

刚才提到很多的热点问题，包括行业当中的一些处罚案例，其实对我们法律工作者的要求是越来越高了，也就意味着我们的工作要尽可能前置化，把一些法律风险在交易之初、决策之初，就进行相应的应对和提示，并提出相应的解决措施。这也是近两年法务工作呈现的一个整体趋势。

What I want to explore more today is what are the reasons behind these hot issues.

For our individual companies and the industry as a whole, we should pay more attention to the following aspects :

Firstly, the reason why these issues have become hot issues must be due to the introduction of corresponding regulations and laws, but at the same time, there may be a lack of or no implementation details in the short term to guide enterprises or industries on how to implement these laws and regulations on the ground.

Secondly, this is related to the development of enterprises and the characteristics of the industry. We talked about above, different industries, enterprises have different stages of development, there are different financial business, transaction structure, these different points, in the application of relevant laws and regulations have some different interpretations, facing different dilemmas and difficulties, that often this time we legal practitioners have to combine the laws and regulations, the actual purpose and reasons behind the introduction of the new regulations, as well as we encountered in the business of the The situation is interpreted and applied in combination.

Apart from that, the reason why a topic can become a hot topic is also because we have seen in the past two years that after the introduction of the corresponding regulations, some actual penalty cases have occurred. The impact of some of these cases is relatively large, in the industry has also caused a shock, played a certain role in warning. Enterprises themselves need to develop, these penalties occur, to a certain extent, the enterprise itself will have a great shock and impact, enterprises at this time in order to avoid the risk of being punished, to consider the reasons for these penalties, the administrative authorities to make such penalties behind the purpose of what, and why the business process will face such penalties? And how can we, as lawyers, avoid similar penalties in our own enterprises when applying these laws? What can we do to better protect our business development?

Just now mentioned a lot of hot issues, including some penalty cases in the industry, in fact, the demand for our legal workers is getting higher and higher, which means that our work should be front-loaded as much as possible, so that we can respond to and prompt some legal risks at the beginning of the transaction and decision-making, and put forward corresponding measures to solve them. This is also an overall trend of legal work in the past two years.

如果说传统的法务工作或者是合规工作只是提出规则和要求，只是在合同端去做一些工作的话，那这两年随着国家相应的法律法规的出台和完善，医疗行业本身对行业内部的自身要求不断提高，实际上法律工作的范围和工作程序也在不断的前置和扩大。

我从我的工作实际当中，有几点想和大家分享：

第一是要保持对这个行业和对法律工作的热情。要把自己的法务工作与业务进行深度的融合，与业务工作者之间要达成相互理解的状态。我们既要理解业务本身是如何开展的，背后的目的和诉求是什么，企业的发展战略是什么。同时，我们也要让业务端对法务工作有所了解。法务工作者，不会也不是一味地去否定，而是希望能够与业务共同找到一个解决的途径，共同去把事情做好，这样互联互通的交互式工作模式，对我们法务工作者或者法律工作者、合规工作者本身来说提出了更高的工作要求。我们都要去了解业务，了解这个行业，了解公司所处于的发展阶段，了解业务端的商业诉求，以及在业务开展上遇到的困难。只有充分了解了业务板块和背后的工作，才能在我们面对一些法律问题的时候，帮助我们给出一些落地的、实际可行的解决方案和操作路径。

第二，由于法律、合规工作的特殊性，我们必然会与业务端存在一定的矛盾，也就需要更多的相互理解。但更多的时候，行业中都在强调法务工作者要树立底线思维，我们要十分清楚对于公司而言，哪些是是绝对不可以去触碰的红线，哪些行为是不可以去做的，同时，我们也要了解背后的法律法规，这绝对不止是一个底线思维的问题。

第三，法务工作、合规工作是一个价值创造的过程。在法务及合规工作中，仅仅保持底线思维其实是不够的，更要求我们的从业者要有价值创造的意识。由于工作本身的性质和形式，决定了它的价值创造往往比较滞后，或者说它的价值创造并不是十分典型的。那如何才能产生这种价值创造？仅仅靠底线思维是不够的，我们更多的是需要了解行业的动态、行业的发展、公司的诉求和战略，结合法律法规去适用，给出公司未来的目标和发展方向。

所以，合规工作者绝不仅仅只是一个警察的角色，或者说合规不应该是警察的角色。很多时候我们在做合规工作的时候，也是希望能够做到体系化，希望在公司中形成一种合规文化。这就是一种价值创造的表现形式。

If the traditional legal work or compliance work only puts forward rules and requirements, and only goes to do some work at the contractual end, then in the past two years, with the introduction and improvement of the corresponding laws and regulations of the country, the medical industry itself has been improving its own requirements within the industry, and in fact, the scope of the legal work and the work procedures have also been continuously front-loaded and expanded.

I have a few points I would like to share with you from my work practice：

The first is to maintain a passion for the profession and for legal work. We have to integrate our legal work with the business in depth and reach a state of mutual understanding with the business workers. We have to understand both how the business itself is conducted, what the purpose and demands behind it are, and what the development strategy of the enterprise is. At the same time, we also need to let the business side of the legal work to understand. Legal workers, will not and is not just to negate, but hope to be able to find a solution with the business together, and work together to do things well, so that the interactive mode of interconnected work, on our legal workers or legal workers, compliance workers themselves put forward a higher work requirements. We all need to understand the business, understand the industry, understand the development stage of the company, understand the business requirements of the business end, as well as the difficulties encountered in business development. Only with a full understanding of the business sector and the work behind it, can we face some legal issues, help us give some grounded, practical solutions and operational paths.

Second, legal work or compliance work itself is part of the risk management work, we are bound to have certain contradictions or conflicts with the business side, at this time, the need for mutual understanding. But more often than not, the industry is stressing the legal workers to establish the bottom line thinking, we have to be very clear for the company, which is absolutely can not touch the red line, which behaviour is not allowed to do, at the same time, we also need to understand the laws and regulations behind, which is definitely more than just a bottom line thinking problem.

Third, legal and compliance work is a process of value creation. In legal and compliance work, it is actually not enough to maintain a bottom-line thinking, and it is even more important for our practitioners to have a sense of value creation. Due to the nature and form of the work itself, it is determined that its value creation tends to lag behind, or its value creation is not very typical. So how can we generate this value creation? Bottom-line thinking alone is not enough, we need to understand more about the dynamics of the industry, the development of the industry, the company's aspirations and strategies, and apply them in conjunction with the laws and regulations to give the company's future goals and development direction.

Overall, compliance workers are never just a police role, or compliance should not be a police role. Very often when we do compliance work, we also want to be systematic and we want to create a compliance culture in the company. This is an expression of value creation.

其实我很感谢康希诺一直以来给我这样的机会和信任。因为我初到康希诺的时候，实际上是没有法务部的，也没有法务工作人员或者合规工作人员，也没有相应的负责人。可以说我是从一人法务做起。大家可能会疑惑为什么会出现这样的情况，从我个人的角度和我对行业的理解来说，其实这是一个非常正常的现象。

就生物医药行业而言，很多企业在早期的发展阶段，更多地会把精力和资源投入到研发、技术、生产等领域当中，持续在这些方面发力。只有这样，才能在前期阶段实现企业的诉求和目的。

但是当达到了一定规模或者一定发展阶段之后，企业本身对于经营风险、法律、财务、人员等其他方面地管理，就要上升到另外一个层面，此时公司才会将精力投注在法务团队的构建上。我也是在那样的一个时机加入到了康希诺。

我到康希诺的时候，主要负责的是法务工作，但在法务工作的过程当中，我发现公司在合规、在内控管理、在知识产权上，都需要进一步地加强，我的法务工作在这些层面上也产生了新需求。而这些需求如果仅仅是靠业务部门自己去实现，其实不太不现实。因为这些层面本身与法务工作有很多强关联，存在诸多错综复杂的联系和交替。所以在工作的逐步推进中，就慢慢的形成了法务合规、知识产权、内审、内控这样的一种管理模式。

I'm actually very grateful to CansinoBIO for always giving me this opportunity and trust. Because when I first came to CansinoBIO, there was actually no legal department, no legal staff or compliance staff, and no corresponding person in charge. It can be said that I started from a one-person legal department. People may wonder why this is the case. From my personal perspective and my understanding of the industry, this is actually a very normal phenomenon.

As far as the biopharmaceutical industry is concerned, many enterprises in the early stage of development will put more energy and resources into research and development, technology, production and other areas, and continue to make efforts in these areas. Only in this way can the enterprise's demands and purposes be realised in the early stages.

But when a certain scale or a certain stage of development, the enterprise itself for business risks, legal, financial, personnel and other aspects of the management, to rise to another level, when the company will bet on the construction of the legal team. It was at that time that I joined CansinoBIO.

When I came to CansinoBIO, I was mainly responsible for legal work, but in the course of my legal work, I found that the company needed to further strengthen its compliance, internal control management, and intellectual property rights, and my legal work created new needs at these levels. It is not realistic to rely solely on the business department to fulfil these needs. Because these levels themselves and legal work have a lot of strong correlation, there are many intricate links and alternation. So in the gradual progress of work, it slowly formed a legal compliance, intellectual property rights, internal audit, internal control such a management model.

在我们的人员组建过程当中，我们也是吸取了一些行业的先进经验。

从公司的自身的需求出发，把自己的梯队和组织建立起来。我当时就建设自己的法务与合规部，在和管理层进行交流的时候，作了大量的准备工作。我就队伍建设的必要性、人员组成及其他相关情况作了检索，并查阅了相关资料；向公司领导说明了法务合规、知识产权、内审内控本身在业务端的区别、职能和风险防范的目的，对人员的招录等细节性问题向管理层作了详细的汇报。目前成型的结构也跟国家所倡导的法务合规、内控、风险管理一体化的平台是相一致的。

我尤其想要谈的一点是，我当时在人员的招录上的一点心得。

在这一工作推进之初，我对国家所倡导的合规体系背后的逻辑作了一定的研究。我发现在法务、合规、内审内控这些方面，目的、工作内容、人员上的区别是很明确的。我们在人员招录中也关注法务、合规、内审内控、知识产权不同的服务目的，所以实际上我们的团队当中不只是法务人员，法务人员只占到了我们总体人员的1/3。在合规部，我们的人员是来自于业务端、行业端或者是之前有合规工作经验的人员。在知识产权部门，他们是具有生物医药背景的、从事知识产权技术管理的人员。在内审内控端，他们更多是来自于有财务背景、从事过财务或者是审计工作的人员。这些复合型的人员共同组成了我们的部门，对于整个部门的工作，以及相应的各自板块下的工作，都起到了一个非常好的助力作用。

举一个例子，当我在审核一份合同的时候，非常希望知道其中关于知识产权的相关信息，以及未来这个项目可能产生的成果。在这个过程中，我们的法务人员和知识产权人员会有一个非常密切的合作。

再如，在内审内控当中，在做一些审计项目的时候，我们如果发现某一些高风险领域存在合规风险，我们的业务合规人员会与审计部门相配合，了解清楚可能存在的风险，以及风险背后的原因是什么。这样的工作模式和形态对我们工作的高效开展是十分有助益的。

除此之外，我们每一个板块人员虽然有自己的专业，但其实也有能够成长和提高的诉求。这样的管理模式和人员组成，能够更好地从其他的板块当中汲取营养，反哺自己。无论是法务、知识产权、合规以及内审内控工作，都可以实现这种反哺。在不断的合作交流当中，从其他的工作板块中汲取营养，在自己的领域下更加纵深地开展业务，把所有的工作从事前、事中、事后不同的阶段进行闭环的管理，实现全员提升，同时也提高工作效率。

In the process of forming our staff, we have drawn on some of the best practices in the industry.

We had to build up our own ladder and organisation from the company's own needs. I was building my own Legal & Compliance Department and made a lot of preparations while talking to the management. I made searches on the necessity of team building, composition of personnel and other relevant information, and consulted relevant materials; I explained to the company leaders the difference between legal compliance, intellectual property rights, internal audit and internal control themselves at the business end, their functions and the purpose of risk prevention, and gave a detailed report to the management on the recruitment of personnel and other detailed issues. The current structure is also in line with the integrated platform of legal compliance, internal control and risk management advocated by the state.

In particular, I would like to share a little bit of what I learnt about the recruitment of personnel at that time.

At the beginning of this effort, I did some research into the logic behind the compliance system advocated by the state. I found that in the areas of legal affairs, compliance, internal audit and internal control, the differences in purpose, job content and personnel are very clear. We also pay attention to the different service purposes of legal, compliance, internal audit and internal control, and intellectual property rights in our recruitment, so in fact, our team is not only legal staff, but legal staff only accounts for 1/3 of our overall staff. in the compliance department, our staff are from the business side, the industry side, or those who have previous experience in compliance work. In the IP department, they are people with biomedical backgrounds who are engaged in IP technology management. On the internal audit and control side, they are more likely to come from financial background and have worked in finance or auditing. These composite personnel together form our department, which plays a very good role in boosting the work of the whole department and the corresponding work under the respective boards.

As an example, when I am reviewing a contract, I would very much like to know what information it contains about the intellectual property rights and what the project might produce in the future. There is a very close co-operation between our legal and IP staff in this process.

For example, in internal audit and internal control, if we find that there are compliance risks in certain high-risk areas when we are doing some audit projects, our business compliance officers will co-operate with the audit department to understand clearly the possible risks and the reasons behind the risks. This working model and format is very helpful for the efficient conduct of our work.

In addition to this, each of our board members has their own specialities, but they also have their own needs for growth and improvement. With such a management model and staff composition, we are better able to draw on the nutrients from other departments to feed ourselves. Whether it is legal affairs, intellectual property rights, compliance, internal audit and internal control work, we can achieve this kind of feedback. In the course of continuous cooperation and exchange, we can draw nutrition from other work sections, carry out business more deeply in our own field, and manage all the work in a closed loop at different stages of before, during and after the event, so as to achieve the improvement of all the staff and enhance the work efficiency at the same time.

说到对自己的期待，我想首先是热爱。我希望自己能够永远保持对于医疗行业、对于企业工作的热爱，我相信作为每一个法律工作者而言，热爱是我们不断去提高自己，不断去研究问题、直面并克服困难的内驱力。我相信，只有热爱才能作为我们的初心，促使我们的工作中更好的发挥我们的能量。

除此之外，我觉得要保持自己的专业性，这包括两个方面。第一个方面是法律合规工作的专业性。因为随着各种行业新规的不断出台，我希望在具体工作中，我们能够深入到业务，结合业务实际做相应的解释和适用，提出能够落地施行的措施，更好地为企业去服务，保持我们的专业性。这一过程也是我们对自己提出更高要求的体现。与此同时，我们还要对技术、商业运营加深了解，把自己的工作嵌入到各个环节当中，让自己的专业性在这些工作当中得以体现，能够更好地为企业去服务。

最后，很感谢LCOUNCIL给我这样的机会，能够与大家分享和交流。我们在比较早的时候就已经和LCOUNCIL搭上了线，他们的同事也会经常向我推送很多医药医疗领域以及其他和我们企业法务相关的课程。我也通过LCOUNCIL平台了解到了很多其他行业法务的工作方式和优秀成果。也希望LCOUNCIL能够发展得越来越好，为我们的法律工作者提供一个更好的学习和交流的平台，谢谢！

When it comes to what I expect of myself, I think the first thing is love. I hope that I can always maintain my love for the medical profession and corporate work. I believe that as every legal practitioner, love is the driving force for us to continuously improve ourselves, to study problems, and to face and overcome difficulties. I believe that only love can serve as our first heart and motivate us to make the best use of our energy in our work.

Beyond that, I think it's important to keep yourself professional. This includes two aspects. The first aspect is the professionalism of legal compliance work. With the continuous introduction of new regulations in various industries, I hope that in our specific work, we can go deep into the business, make corresponding interpretation and application in light of the actual business, and put forward measures that can be implemented on the ground, so as to better serve the enterprises and maintain our professionalism. This process is also a reflection of our higher requirements for ourselves. At the same time, we also need to deepen our understanding of technology and business operations, embedding our work in various links, so that our professionalism can be reflected in these tasks and better serve the enterprise.

Finally, I am grateful to LCOUNCIL for giving me this opportunity to share and exchange ideas with you. We have hooked up with LCOUNCIL at a relatively early stage, and their colleagues would often push many courses in the pharmaceutical and healthcare fields as well as other courses related to our corporate legal affairs to me. Through LCOUNCIL, I have learnt a lot about the working style and excellent achievements of legal practitioners in other industries. I hope LCOUNCIL can develop more and more, and provide a better learning and communication platform for our legal practitioners!

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