The role of general counsel at pharmaceutical and healthcare companies has become increasingly complex, particularly with the increased focus on health and wellbeing following the COVID-19 pandemic. GCs today must possess a diverse skill set that stretches far beyond legal expertise, if they are to effectively help their organisations meet legal and regulatory requirements while driving innovation and ensuring the highest standards of patient care.
ALB: How has three years of the COVID-19 pandemic revolutionised the pharmaceutical and healthcare field, and what are some of the new challenges and opportunities for the industry and the in-house legal departments?
Christy Zhou, senior director, legal and compliance and internal audit departments, CanSino Biologics: I would like to answer this question with the development progress of our company and department in the past three years. In 2020, we just had a total of about 400 employees in our company and two legal professionals in the
legal department. However, by 2023, we have already had more than 1,500 employees in our company with several subsidiaries and branches globally and have established our mRNA technology platform during this period. With the development of our company, the legal department has grown into the Legal and Compliance Department, which has 14 employees in charge of legal, compliance and intellectual property. From the abovementioned development of our company and the department, we could find that the past three years really brought new opportunities to the whole pharmaceutical industry especially advanced pharmaceutical manufacturing, and some technical areas has undergone a rapid development under the epidemic pressure achieving lots of technological breakthroughs and quickly entering the stage of industrialisation and commercialisation. Meanwhile, the pharmaceutical industry, especially biotech enterprises, has their own characteristics and rules of development so when facing these opportunities, such rapid development of the enterprise itself has also brought challenges in all aspects including strategy, operation, management, and so on.
With such development of the industry and the company, on the one hand, as the legal management department, we must quickly adapt to the industrialisation and commercialisation of the development of the demand for legal work and such requirement is bound to be a challenge to the personnel, organisational structure, internal management. On the other hand, the development of the industry is also accompanied by continuous improvement of the regulation, which has continuously expanded the scope of legal work and put forward higher requirements for the reﬁnement of legal work. If we could ﬁnd practical ways and implementation of these two aspects, to expand the traditional boundaries of legal work and improve the quality and efﬁciency, I think it gives legal work a huge opportunity for development in the long-term perspective.
Ethel Yeo, general counsel, Parkway Pantai: During COVID, pharma and healthcare services were essential services that were required to continue operating under very restrictive and ever-changing regulatory and physical landscape. One key challenge was securing medical supply chain in all stages of production, ensuring supplies arrive timely, from production to laboratories to end users in hospitals.
While supply chain across all industries is impacted, for pharma and healthcare, it was all the more critical. We have taken this opportunity to explore digitalisation in sourcing and supply chain stock-taking to ensure accuracy in usage vs. needs. This promotes efﬁciency and reduces wastage in the face of rising or unpredictable costs of medical supplies. It has also prompted healthcare service providers to explore upstream investments.
What this means for the legal team is how to lock in potential partners quickly with efﬁcient supply chain/distribution agreements, digitalisation platform agreements and so on, to potentially reallocate rights and obligations which provides a better level playing ﬁeld for smaller players.
Jisun Nam, head of legal department, Hanmi Pharmaceutical: Due to the COVID-19 pandemic, there have been significant regulatory changes and exceptions in the pharmaceutical and healthcare sectors. For instance, restrictions exist for telemedicine and medicine delivery in South Korea; however, exceptions were implemented during the pandemic to protect public health. These changes have provided a crucial opportunity for experiencing how existing regulations might need to be eased or controlled. Also, many business opportunities have emerged for utilising these changes regarding this industry. Furthermore, the importance of research and efforts for promoting human health has been emphasised. Collaboration possibilities between different ﬁelds have increased. This has also led to increased activity in research and attempts to develop new drugs or repurpose existing drugs. Pharmaceutical and healthcare companies have needed to respond swiftly and prepare with adaptable strategies. Consequently, in-house teams are required to deliver results and capabilities in terms of both knowledge and speed.
ALB: In light of the shifting economic and geopolitical landscape in the jurisdiction(s) of your company, how are you adjusting legal strategies to power business growth while ensuring compliance with evolving regulatory developments and policy priorities?
Zhou: The strategy and objectives of legal work are inextricably linked to the general environment and development stage of the company, and it is indeed a difﬁcult and arduous task to achieve sustained support for business growth while taking the ever-changing regulatory environment into account.
To do this work well, I believe it’s essential to consider two foundations. The ﬁrst is to have an in-depth understanding of the industry in which we are engaged, especially the segments under the industry, including the characteristics of research and development, industrialisation, and commercialisation. Besides, if we have a global layout, we may also have a full understanding of the business characteristics of its international target markets. Secondly, we need to return to the legal work itself, which encompasses carrying out legal risk identiﬁcation, analysis and assessment based on the in-depth analysis of the business, and establishing a good set of internal legal risk controls. Adjusting the speciﬁc legal risk control measures in accordance with continuous changes in the internal and external environments in a timely manner, which can be achieved by combining the company’s strategy, business development and changes in regulatory policies together. Importantly, we need to obtain the understanding and support from relevant departments and management team within the company when implementing the above work.
Yeo: In times where companies operate in both developed and developing countries, there is no one-size-ﬁts-all all business and/or legal strategies. More so, we are mindful that different countries and regions will require different focus. We look to ﬁne-tune legal strategies by looking carefully at where our business needs are, how they have changed in different geographical regions, and putting in emphasis on them where it matters. Amidst deep diving into the needs of different regions, we make a point to ensure that compliance is always paramount to the integrity of our business.
ALB: On that note, how do you anticipate legal and regulatory challenges in your jurisdiction(s) in areas including drug innovation, licensing and approval, and patent disputes, and what will be your approach to navigating these operational complexities and legal nuances?
Zhou: As an innovative vaccine biopharmaceutical company in China, I predict that the risks in some areas of the pharmaceutical industry will increase in a short time signiﬁcantly, including the management of human genetic resources, the application of international clinical data in China’s new drug approvals, the approval of cross-border biologic products transactions, as well as international patent dispute risks on innovative medicines and platform technologies especially those having great commercial values.
In order to deal with these risks, I suggest that the ﬁrst and foremost thing is to maintain close communication with regulators and industry experts. As enterprises, we should understand the legislation’s purpose and the regulatory’s focus to prepare well for business scenario prediction and legal analysis. Based on the above work, we need to collaborate with relevant internal departments to formulate relevant rules and processes, and reasonably and appropriately set up the control measures at the key control points. Lastly, we also need to conduct internal training and dissemination about the new regulations and policies in the company, so that the conducting level knows what to do and management level knows why to do it. At the same time, as I have mentioned earlier, with the internal and external environment changes, the legal department should also dynamically update and adjust the relevant risk assessment and initiatives to maintain the ﬂexibility and appropriateness of the work.
Yeo: In this highly competitive environment of innovation and the need to be the ﬁrst, it is critical for all internal support functions to put mind maps in place and plan with the end in mind. Prepare for the unexpected hiccups. For the legal team, it is to ensure legal documentation, licensing and approval are ﬁrst thought through and communicated with partners, regulators, and suppliers beforehand. Once the groundwork is laid, the project or innovation can more effectively take place and take root.
ALB: How has your role as GC in the pharmaceutical and healthcare sector in your jurisdiction evolved, and what would you describe as some of the most important skills to succeed in your position?
Zhou: I often joke that I am a grass-roots GC, which, in fact, is the truth because I started my career in CanSinoBio as the sole person in legal and gradually completed the process of building legal departments and systems from zero to one. While such route of development is inseparable from the rapid development of the company itself, it puts forward more demands on my work and management scope in turn. In the process, the company’s leaders, beneﬁtting from their international vision and foresight, have been helping and supporting me and asking me to look at my work from the perspective of a GC even though I wasn’t one then.
Overall, the scope and departments I managed went through three development stages. The ﬁrst stage is to expand from legal affairs to internal control, the second stage is to separate the compliance section from legal affairs and internal control, and at the same time, to clarify the overall management of the company’s intellectual property rights (IPR), for which we established our own IPR team and the third stage is to separate internal control and internal auditing from legal affairs and compliance, improving the management lines and responsibilities of the internal audit-ing department.
It may be too early to say that I have been successful in my position. As I mentioned, the development of our department and the evolution of its functions are inseparable from the rapid development of the industry and the company, and the high-level requirements of the company’s management. So, I prefer to say what important factors may have been crucial for me to take on these jobs. I suppose there are three main points important to me. The ﬁrst is the ability to learn. The role, function, and development of the organisational structure, will inevitably determine that I need to be like a sponge to fully absorb knowledge of the professional ﬁeld as well as the business field and management skills, only by which I could accomplish the tasks with ease when taking new responsibilities.
The second factor is a high sense of responsibility. As the company’s internal legal leader, such a position itself is responsible for managing some important risks of the company. I believe only with a high sense of responsibility and even a high sense of mission, I could seek solutions with the behaviour of beginning with the end in mind when meeting all kinds of difﬁculties.
The third factor is the capability of “founder thinking”. If you want to obtain support and understanding from internal departments and management team to accept, recognise and perceive the value of legal work, you need to think with the perspective of “founder thinking” to plan and arrange our work, so that the upstream and downstream relating to legal work could understand what legal is, how to carry out the work, and what it can bring to them.
Yeo: Three key attributes: 1) integrity and ownership; 2) creativity; 3) agility. The second and third attributes are increasingly important for GCs seeking to run ahead of, and alongside, business strategies.
ALB: Healthcare and life science are among the sectors where continuously strong growth is widely predicted in the medium to long term. Together with emerging technologies and novel legal issues arising from globalisation and supply chain challenges, what does it mean for the demand of legal talents in this space, and how is that reshaping your department’s talent strategy?
Zhou: Indeed, the pharmaceutical and healthcare and life sciences industry will be one of the industries that will continue to grow in the future long term. However, at the same time, globalisation also brings more new issues, actually raising higher demands on legal talents in this ﬁeld, which specifically involve the understanding of the legislative purpose, background and supervision scale of new rules and regulations, the knowledge and understanding of the industry and speciﬁc business depth, the ability and level of legal risk assessment, as well as the application of legal risk control measures before and during the event. In our department, the personnel composition is diversiﬁed, not only limiting to the talents with pure legal backgrounds, but also with a hope to have talents with technical backgrounds, financial backgrounds and business backgrounds to join us. Only in this way could we have a more comprehensive control and management of emerging technologies and new legal issues. In addition, we also attach great importance to identifying the connecting points of different teams within our department, and clarifying the responsibilities and control measures at speciﬁc connection points, to achieve the accuracy and consistency of information communication under legal management. During this process, the talents in different teams in our department will deepen their understanding and knowledge of each other’s work to achieve the long-term growth and development of the talents in different legal management teams, enhancing the value of the entire department and work in the company.
Yeo: While there’s strong growth in the healthcare space via M&A, the expertise needed from an in-house counsel is certainly over and beyond mere M&A skilled lawyers. Due to the speed of growth in every imaginable direction, it is important for an in-house team to remain nimble, multi-skilled and being not afraid to get their hands dirty. The outlook for hiring legal talents is to keep versatile and keen learners with strong core expertise but join the team to be exposed to different areas of practise to continue to keep the team multi-skilled and conﬁdent to deal with new challenges.
Nam: The pharmaceutical and healthcare industry is a prominent sector encompassing the convergence of technology, legal aspects, and government regulations. Due to the diverse nature of subfields within this industry, we often notice that the languages of each department are quite different, even within the same company. In this context, the legal department is required to have rapid comprehension of new matters and the ability to grasp concepts swiftly. Not only is coordination with operational departments crucial, but the ability to understand the fundamental essentials of contracts and legal principles is also necessary. We are enhancing the capabilities of our department through activities such as monitoring industry trends and conducting internal seminars to prepare for external environmental changes.