Kyowa Kirin International

Roswitha Reisinger

Roswitha is a seasoned General Counsel with 20 years of experience in the life sciences industry. After specialising in intellectual property law within private practice, she transitioned to legal and compliance roles at pharmaceutical giants like Eli Lilly and Company. Currently the Head of Legal, Compliance, ESG and Risk Management at Kyowa Kirin, Roswitha thrives at the intersection of law, business and sustainability. Her expertise spans building high-performing teams, fostering cross-functional collaboration and embedding robust compliance programs. Roswitha’s passion lies in leveraging innovation and technology to protect corporate interests while driving sustainable growth. Holding a Harvard-Business-School accelerated degree, focussed on management, leadership, change, and innovation. In her current role as SVP General Counsel & Chief Compliance Officer, she acts as a strategic advisor and partner to the CEO and President, as well as the Executive Team, and she also leads an experienced legal team of attorneys and compliance professionals.

Through this interview, Reisinger discusses the key challenges, technological advancements and proactive strategies required for legal and compliance professionals to navigate the rapidly evolving life sciences landscape while enabling responsible innovation that improves patient outcomes and drives sustainable growth.

What Challenges Have You Witnessed In The Life Sciences Sector, And How Have They Impacted The Field?

The life sciences industry faces mounting pricing pressures–a pervasive challenge. A key hurdle for companies focusing on rare diseases is ensuring patients receive proper treatment promptly. This is an area where emerging technologies could provide immense value by accelerating patient identification and access to appropriate therapies.

Rapid tech advancements significantly impact the industry. Artificial intelligence (AI) is a prime example, and it is rife with potential benefits if deployed responsibly and ethically. But, legislation often lags behind the pace of technological innovation, presenting regulatory challenges.

Geopolitical risks have unfortunately escalated over the past decade, adding complexity to an already intricate global landscape. Environmental, Social and Governance (ESG) principles, particularly climate change initiatives, have emerged as a prominent trend influencing business strategies and legal/compliance functions.

These multifaceted issues–patient access, technological disruption, geopolitical tensions and ESG’s rise - represent some of the defining trends and tests confronting the life sciences sector and legal professionals operating within it. Navigating them adeptly requires foresight, cross-functional collaboration, and a keen understanding of their intersections and implications.

Are there any innovative advancements transforming the healthcare business regarding legal and compliance management?

A key transformation catalysing the life sciences industry lies in leveraging technology effectively. This also extends to the legal profession, although lawyers tend to be more conservative by nature. The life sciences field is among the most heavily regulated industries, cultivating a generally risk-averse mindset.

Emerging trends are influencing and reshaping legal practices. Technology, particularly artificial intelligence (AI), presents significant opportunities. Contract management automation through AI is an area garnering attention as the capabilities of AI tools rapidly evolve from what was available just three years ago.

The wealth of data generated from compliance monitoring activities holds untapped potential. Harnessing this data intelligently could yield valuable insights to enhance monitoring processes and uncover new perspectives.

While the industry has historically been cautious about rapid change, there is a growing realisation that embracing technological innovations thoughtfully can drive efficiencies and create competitive advantages. Adapting to these trends by exploring AI, data analytics, and other disruptive technologies will be crucial for delivering greater value to the legal profession operating in this sphere.

Could you speak about some of the projects or initiatives you have led recently?

Twice annually, we conduct a forward-looking risk and opportunity assessment exercise, analysing potential risks and opportunities over the next 5 to 10 years. This review considers prevalent industry trends such as pricing pressures, supply chain vulnerabilities, geopolitical tensions, cybersecurity threats, mounting ESG expectations, and the responsible adoption of artificial intelligence. Taking a longer-range perspective allows us to proactively identify emerging challenges and opportunities. By aligning this analysis with our strategic objectives, we can position ourselves to navigate uncertainties and capitalise on developments. Ultimately, this exercise empowers us to consistently deliver on our commitment to patients over the long term. Adopting a proactive mindset is imperative for managing the rapidly evolving dynamics of the life sciences sector and ensuring resilience in fulfilling our purpose of improving lives.

How do you envision the future of global healthcare businesses regarding legal and compliance aspects? What advancements would you like to see in this area?

The global healthcare system faces significant challenges, including an ageing population and constrained government budgets. However, medical breakthroughs and technological progress offer tremendous opportunities for innovation, particularly demonstrated by the COVID-19 vaccine development. The legal and compliance function is crucial in navigating this landscape by staying informed about evolving legislation and shaping future regulatory frameworks. As trusted advisors, we provide holistic perspectives to leadership, balancing business objectives with regulatory compliance and ethical conduct. To excel, legal and compliance professionals must blend subject matter expertise with an innovative mindset, continuing to learn and critically analyse complexities. Embracing transformative solutions responsibly will be key to realising healthcare’s potential.

What advice would you offer to other leaders in the sector based on your extensive experience?

As legal and compliance professionals, our approach to navigating complexity involves remaining open-minded, thinking ahead and staying attuned to emerging trends. Our responsibilities include protecting corporate assets, safeguarding reputation and enabling comprehensive risk management to support strategic objectives ethically and in compliance with regulations. While adherence to rules is crucial, a strong moral compass guides effective decisionmaking amid regulatory intricacies. Adopting a futureoriented mindset helps anticipate challenges, empowering us to steer companies toward sustainable growth. Our mandate is to enable innovation that improves lives while maintaining vision, integrity and diligence as strategic partners in transforming healthcare.