Key team members:

Sónia Valadas, Country Legal Head and member of the Board of Directors

Jurisdictions your role covers: Portugal

What are the most significant cases or transactions that your legal team has recently been involved in?

Legal has been actively engaged in a variety of significant projects and in a diverse range of cases, particularly those that are aligned with the company’s priorities. Legal’s active role has been instrumental in shaping strategy, maximising our assets, ensuring compliance, and safeguarding the company’s reputation and financial interests. Among recent endeavors, we managed and closed a complex negotiation with the Health Authority related to the reimbursement of priority products.

We have concluded complex litigation which has significantly reduced our company’s liability exposure. Furthermore, Legal has been pivotal in tackling market access issues and protecting our intellectual property rights.

What factors influence your team’s decision to use external legal services versus handling matters in-house, and what criteria are used to evaluate their performance?

Legal primarily manages its tasks internally, outsourcing only specific litigation matters and specialised advice to external counsels.

How does your team contribute to the overall business strategy of the company? Can you share an example of a recent legal-led initiative that had a significant impact?

Close collaboration between the Legal and Business departments is one of our key strengths. Our comprehensive understanding of company priorities, business operations, and emerging challenges significantly contributes to the overall business strategy. Our proactive involvement in early-stage discussions coupled with our agility to learn and adapt are crucial, especially given the ever-changing nature of our sector. I would say that our contribution extends beyond; Legal is a key contributor to the overall business strategy.

What are some of the biggest legal or regulatory challenges currently facing your industry, and how is your team preparing to address them?

The pharmaceutical sector is highly regulated, very dynamic, and constantly evolving, offering both new challenges and new opportunities. Staying proactive and adaptive to this complex and ever-changing legal landscape is crucial to ensure compliance and support for the company’s strategic objectives.

New therapeutical areas, innovative and disruptive therapies such as radioligands often require companies to adopt a proactive legal strategy, one that not only ensures compliance but also anticipates future regulatory trends and litigation risks. IP, clinical trials, market access, pricing, AI, data privacy are some of the challenges pharmaceuticals face to positioning Legal as a core strategic function and not a reactive, will be better equipped to minimise risks, streamline approvals, and earn trust across markets.

Pharmaceuticals face challenges with IP, clinical trials, market access, pricing, AI, and data privacy. I believe that Legal plays a crucial role in addressing these challenges. At Novartis Portugal, Legal meets the industry’s hurdles with unwavering commitment, continuous learning, and proactive collaboration. This strategy enables us to navigate the legal landscape, mitigate risks, and ensure compliance while contributing to the company’s objectives. Legal should be both a guardian of company assets and reputation and a proactive business partner.