"We use technology to drive greater efficiency and cost savings across our operations."

Leonor Pissarra, Portugal Chief Legal Officer, Novartis shares how she navigates the ever-changing regulatory environment of the pharma industry, the rise of digital health technology, her risk management advice and what she looks for in external legal counsel.

Posted mardi, juin 6 2023
"We use technology to drive greater efficiency and cost savings across our operations."

Leaders League: What have been the primary challenges and opportunities you have encountered leading the legal department for over 10 years?

Leonor Pissarra: As the leader of Novartis’ legal department over the past decade, I have faced significant challenges. One of them has been adapting to the ever-changing regulatory landscape. The pharmaceutical industry is subject to numerous regulations, and staying compliant requires continuous monitoring and adjustment to new laws and regulations.

Another major challenge has been protecting intellectual property as pharmaceutical companies rely heavily on patents, trademarks, and trade secrets to safeguard their innovations. We have had to navigate complex patent litigation and defend the company's intellectual property rights against infringement, which can be a demanding and intricate process.

Data privacy and security have emerged as critical challenges for companies in recent years (...)

Data privacy and security have emerged as critical challenges for companies in recent years and Novartis is no exception. We handle vast amounts of sensitive patient data and confidential research information and therefore, as the leader of the legal department, I must ensure compliance with data protection laws, implement robust security measures, and prevent data breaches that could have severe legal and reputational consequences for the company.

On the opportunities side, mergers and acquisitions have provided Novartis’ legal department with chances to facilitate strategic transactions, conduct due diligence, and negotiate agreements. 

The rise of digital health technologies and advancements in telemedicine have opened new avenues for us to contribute to drafting agreements, addressing regulatory requirements, and ensuring compliance in these emerging areas.

The rise of digital health technologies and advancements in telemedicine have opened new avenues for lawyers to contribute.

Moreover, we have had the opportunity to develop robust patent strategies and manage patent portfolios, contributing to the company's competitive advantage and settlement agreements. 

Lastly, we have been actively engaged in regulatory advocacy and policy engagement, using legal expertise to shape regulations and create a favorable operating environment for the company. This involvement in industry associations and advocacy groups has allowed to influence regulatory policies and support the company's strategic objectives.

How has your company adapted the all the varous crisis over the last few years? 

Pharmaceutical companies, including Novartis, have adapted to the volatile world economy in recent years, facing challenges such as the pandemic, geopolitical conflicts, and inflation. 

Novartis has increased its focus on research and development, particularly in developing treatments for COVID-19, redirecting resources to prioritize areas with high market demand and unmet medical needs.

The pandemic accelerated the adoption of remote work and digital transformation. Novartis implemented a remote work policy, utilized technology for virtual collaborations, telemedicine, and digital health solutions to continue operations and connect with healthcare providers and patients.

Furthermore, Novartis implemented a decentralized trial model, telemedicine, and remote monitoring technologies to maintain trial integrity and patient safety despite disruptions.

Business continuity planning became a priority. Even though Novartis had already established quite thorough and extensive contingency plans, and crisis response strategies, the pandemic, the recent war, and conflicts have caused the need to put them in place promptly to ensure the availability of essential medicine during such crisis. 

What ad risk management advice would you offer? 

Considering my experience as a legal head of a top tier pharma company, like Novartis, I think organizations should invest in (i) developing a comprehensive risk management framework, (ii) conducting regular risk assessments, (iii) embracing smart risk-taking and (iv) collaborating with cross-functional teams to manage risks effectively. 

Firstly, I believe that developing a comprehensive risk management framework, and foster a risk-aware culture within the organization, encourage employees to identify and report potential risks. Moreover, it is essential for organizations to continuously evaluate and improve risk management strategies based on past experiences and lessons learned.

Secondly, conducting regular risk assessments to identify and evaluate industry-specific risks is also crucial. Companies need to stay updated on regulatory changes and industry trends.

Also, embracing smart risk-taking by carefully evaluating potential risks against potential rewards encourages associates to propose and explore innovative ideas while considering associated risks.

It is important for Legal to collaborate with cross-functional teams, in particular R&D, regulatory affairs, marketing, and finance, to manage risks effectively. Maintaining strong relationships with regulators, seeking guidance and addressing concerns in a collaborative manner is also worth exploring.

Likewise, staying abreast of regulatory changes and implementing robust compliance programs aligned with laws and industry standards, and engaging external legal counsel with pharmaceutical expertise to provide guidance on risk management may contribute significantly to manage risks.

By following these simple risk-taking principles, legal may facilitate a proactive and effective risk management approach, allowing the organizations to navigate risks while strategically pursuing opportunities for growth and innovation.

How is Novartis implementing new tools and technologies in order to streamline its internal processes? Is the company focusing on particular innovation goals?

In today's fast-paced business landscape, innovative tools and technology are changing the world and creating exciting opportunities for the healthcare industry, including Novartis. This rapid technological progress offers the possibility to streamline our internal processes and to reimagine the way Novartis develops medicines, allowing the company to come up with truly transformational treatments to improve and extend people’s lives. It is also helping us to improve the way we do our business – accelerating our manufacturing and production and strengthening our digital connections to the wider healthcare ecosystem.

Novartis is committed to building more agile and productive teams supported by an efficient infrastructure and digital architecture. We use technology to drive greater efficiency and cost savings across our operations. Novartis is automating core operational processes at scale by deploying robot cognitive automation. One example is an intelligent assistant that automates large parts of the writing of medical reports. Bots are also helping to resolve (either partially or fully) approximately 80% of user requests to our enterprise-wide IT helpdesk.

Novartis is also promoting training opportunities to develop digital skills among its employees. We have expanded our data science training and mentoring programs, which we launched in 2020. We have also invested in a learning platform for data science coding skills.

In 2021, Novartis completed the rollout of a new data management process – covering the entire data life cycle – to accelerate its digital transformation while ensuring data privacy. The new process spans nearly 5 million data sets, covering functions including R&D, finance, operations, and procurement. 

However, the use of new technologies such as artificial intelligence (“AI”) creates new ethical questions, including how to avoid biases in data. In 2021, Novartis published its commitment to the ethical and responsible use of AI to show the steps it is taking to be transparent, responsible and respectful of human rights in our use of AI. We created these guidelines in collaboration with leading ethicists from the International Bioethics Advisory Committee, and specialists in AI and data privacy. The position outlines our commitment to data privacy, security, accountability and environmental sustainability. We are taking steps to integrate these principles across the organization.

What do you look for in external counsel?

When we consider engaging external counsel, there are several key aspects to look for. Expertise and specialization play of course a critical role, although this should be a given when you are dealing with top-ranked law firms. It is essential that the external counsel demonstrates a deep understanding of the unique legal challenges faced by the pharma industry.

However, there are other skills that we consider key when we engage with external counsels.  

External lawyers should show a greater sense of urgency. This includes not only a faster response but also an estimated timeline when the client does not specify a deadline. Additionally, acknowledge receipt of any communications from the client should be provided as soon as possible. This helps to demonstrate a sense of urgency and ensures that the client knows that their request has been received and is being addressed.

Another critical factor is the efficiency and transparency in their billing practices, avoiding unexpected charges and delivering accurate and timely invoices. Itemized invoicing with clear breakdowns helps ensure that the company only pays for the essential legal services provided.

In terms of time management, it is decisive that a time estimate is provided, even if not explicitly requested. By offering estimated timelines for the completion of tasks or milestones, we can better internally manage the issue at stake and know what we can expect from external counsels.

Law firms should ensure easy access to their lawyers without barriers.

Additionally, law firms should ensure easy access to their lawyers without barriers. In this regard, we highlight not only lawyers’ availability, but also a closer relation without intermediaries (e.g., personal assistants). A single point of contact for the client would also be very welcome. 

We also look for responses tailored to our specific needs, including adapting legal language to non-lawyers. We expect external counsel to effectively communicate complex legal concepts in a manner that can be easily understood by individuals without a legal background. Clear and concise communication facilitates collaboration and decision-making across various departments within the company.

It is very important for us that external counsels become true partners who know our business, strategy, and goals, and that can provide tailored legal advice and solutions that meet our specific needs.

Lastly, we strive for external counsels that share our core values and principles. It ensures that both parties are aligned in terms of culture and approach to work, which is vital to ensure an effective, healthy and long-lasting partnership.