Interview with Tereza Ber, General Counsel at Zentiva
Europe’s pharmaceutical industry operates under sustained pressure. Comprehensive reform of EU pharmaceutical legislation, environmental regulation and supply security requirements are all moving simultaneously. For companies operating at scale, this is not policy theory. These shifts directly determine whether medicines remain affordable, available for patients in Europe and economically viable to be manufactured and marketed there.
In this environment, the role of General Counsel has changed fundamentally. No longer confined to legal risk management, it sits at the intersection of regulation, operations, investment, and trust, influencing how decisions are made when the stakes are high and information is incomplete.
Tereza Ber, General Counsel at Zentiva, reflects on how her role has evolved and why legal leadership today is as much about judgment and clarity as it is about law.
How has your General Counsel role evolved at one of Europe’s leading pharmaceutical companies?
When I joined Zentiva, the focus was very much on managing legal risk. That foundation remains essential, but the role has expanded significantly. Today, I oversee legal, IP, compliance, corporate governance, and M&A support. These are not parallel functions operating in isolation. Together, they shape how the company makes decisions and how confidently it can execute them.
What has changed most is timing. Legal is no longer brought in to validate or execute decisions after they are made. We are involved at an early stage, when the real choices are still open and trade-offs are being defined. That is where legal input often has the most value, directly influencing where we invest, how we structure growth, and which risks are worth taking to secure long-term supply and returns.
In practice, the role of my team is to enhance the quality of decisions that are made. We operate across more than 30 markets and close to 50 legal entities, each with its own regulatory, political, and operational realities. Our job is to structure complex issues so the business can clearly anticipate consequences, understand risk exposure, and decide with confidence.
It’s like playing multiple games of chess: different countries, different timelines, and different rules, which can change mid-game. You can’t control every move, but you can stay several steps ahead if you understand where pressure might build, what is likely to change, and what will not.
What have been the most rewarding highlights of the role?
Two stand out, in particular.
The first is culture. Seeing colleagues raise concerns early, even if it is uncomfortable, tells me that integrity is taken seriously at Zentiva. This does not happen by accident. It reflects deliberate and consistent work by the compliance function: training, explanation, open dialogue, and visible leadership support. That effort translated into behaviour, especially under pressure, is what matters.
The second is impact. Legal work is most rewarding when it visibly improves outcomes.
That includes supporting acquisitions that expand our portfolio with new products, or enabling medicines to move from development into launch in robust regulatory frameworks. The same applies to intellectual property, where overcoming complex IP barriers of originators requires clear, well-judged strategies. This is where the IP team plays an essential role, helping bring medicines to patients sooner.
In those moments, legal leadership contributes not just to value protection, but also to value creation.
How are you approaching AI in the legal function?
Very pragmatically.
AI is not a vision statement. It is infrastructure. Used well, it helps to manage scale, consistency, and speed. Used poorly, it creates risk.
We already see value in areas such as regulatory intelligence, pharmacovigilance processes, contract analytics, and compliance monitoring. These are high-volume, repetitive tasks where errors matter, and automation can materially improve quality.
At the same time, judgment remains non-negotiable. As a company, we are building governance frameworks that ensure transparency, data integrity, and accountability, working closely across legal, IT and data security, compliance, and the business.
And in the context of the legal function specifically, the objective is not to replace lawyers. It is to free them from administrative work so they can focus on analysis, judgment, and constructive challenge. And AI should create the space for lawyers to be closer to the business: listening, challenging, building real relationships - simply doing the human work that makes the job meaningful.
What challenges and opportunities emerged during and after the Covid pandemic?
Covid stripped everything back to essentials. Supply chains broke. Regulations changed overnight. Uncertainty became constant. The priority was clear: secure supply of essential medicines for patients. That required speed, coordination, innovative solutions, and constant dialogue with regulators across multiple jurisdictions. It also reinforced something important. Agility and compliance are not opposites. You can move fast if governance is clear and decision-making is disciplined.
Those lessons shape how we respond to today’s crises, from geopolitical disruptions to sustainability mandates. Resilience has become part of our DNA.
What stands out when you look back at changes of ownership, structure, and scale?
Each ownership phase has shaped Zentiva in a distinct way and strengthened the organisation.
The carve-out from Sanofi in 2018 marked our transition to independence as a European company. It required building governance, compliance frameworks, and operating discipline from the ground up, without disrupting continuity for employees and patients. That period was formative: it defined how we run the company and how we take responsibility for our own standards.
Under Advent’s International ownership, the focus shifted to growth and transformation. Advent invested heavily in our capabilities, manufacturing footprint, R&D, portfolio expansion, and targeted M&As. For legal and compliance, the task was to support that growth while maintaining control, transparency, and consistency across an increasingly complex organisation.
Being a target brings a specific kind of pressure. As a company, you are examined closely and from many angles. Having been through that dynamic before, we know what it requires. Credibility comes from demonstrating that the organisation is well governed, compliant, and in control. That means being clear about what works, transparent about what does not, and able to show that issues are understood and actively managed.
As we prepare for the next phase with a new shareholder, the emphasis is on readiness and continuity. Strong governance, clear risk management, and regulatory alignment are foundations we have built before and know how to reinforce again.
Looking across all these transitions, one thing remains constant: legal leadership is about judgment. Knowing when to enable speed, when to slow things down, and where lines must be drawn applies just as much to running the business day to day as it does in moments of change. I am very clear with my team about where our value lies: helping the business move by making smart, calculated risk decisions, at the required pace. That experience gives us confidence as we enter the next phase, knowing which fundamentals must remain constant even as ownership changes.
From a GC perspective, what are your current compliance and risk priorities?
Compliance is the foundation of trust in our industry; it is not a procedural exercise. Every operational decision carries a compliance dimension, and the consequences of getting it wrong are real.
For example, one of the most pressing issues today is the Urban Wastewater Treatment Directive. The extended producer responsibility mechanism, based on the so-called toxic load of medicines, is deeply problematic. It relies on incomplete science, imposes disproportionate costs, and risks driving shortages of essential medicines. For generics, already operating on thin margins, this threatens affordability and access for millions of patients. Zentiva, together with Medicines for Europe, is challenging this approach through legal action and advocacy. Our position is clear: sustainability must be achieved without jeopardising patient care.
Beyond environmental regulation, we are deeply engaged in the EU pharmaceutical legislation. Decisions on data exclusivity, the Bolar exemption, medicine shortages, environmental risk assessments, digital product information, and the Critical Medicines Act are shaping Europe’s healthcare resilience for years to come. We advocate for predictable rules that reward reliability, strengthen supply security, and support fair competition.
At the same time, core risks remain constant. Anti-corruption, competition law, and ethical conduct require continuous attention. Trust is built slowly and lost quickly.
How do you manage compliance across diverse markets?
With discipline and realism.
We use a hybrid model. A small central team sets standards and provides guidance. Strong local compliance leaders ensure those standards work in practice. That balance creates consistency without losing local intelligence.
Technology plays a growing role. Without advanced tools, sanction compliance or regulatory monitoring at scale would be extremely difficult. AI-supported solutions help prioritise risk and manage volume.
But culture remains decisive. Systems do not create compliant organisations. People do. That is why leadership engagement and training matter as much as policies.
How has Zentiva’s growth in Central and Eastern Europe benefited patients and healthcare systems?
Growth translates into access. Generics account for most prescriptions by volume in Europe while representing a much smaller share of healthcare spending – 70 % of all dispensed medicines and 19% of value, according to IQVIA, 2024. That is what makes them essential.
In Central and Eastern Europe, our expansion has improved availability across chronic therapy areas and reduced pressure on healthcare budgets. Local manufacturing shortens supply chains, reduces dependence on imports, and lowers the risk of shortages. It also creates skilled jobs and strengthens communities. The impact is tangible: better access, more predictable supply, and stronger health systems.
What does that growth mean for security of supply and the generics market?
Security of supply is now a strategic issue. Recent analyses show that in parts of Europe, a worrying share of critical generic medicines can be supplied by a single manufacturer. That concentration is risky for patients.
Our European manufacturing base, complemented by a diversified global footprint including India, is designed to counter that risk. During Covid and subsequent shortages, our plants delivered uninterrupted supply. That experience confirmed the value of local production.
Procurement practices, however, must evolve. Downward-only pricing undermines economic viability and discourages investment. We support multi-winner, multi-criteria tenders that value reliability, environmental compliance, and capacity. Patients need affordability, but they also need certainty.
What keeps you motivated in a role that is often demanding and high-pressure?
I genuinely enjoy the work. Every hour brings a different issue, often in a different country, with different legal, regulatory, and cultural dimensions. That variety is energising, especially when you are working with a strong team of like-minded, thoughtful people who take ownership and are comfortable operating in demanding situations.
At its core, my role involves setting direction when there is no obvious answer. It is about framing the problem, weighing options, deciding which path to take, and giving our company the confidence to move. When that clarity helps the business progress, protects patients, or avoids a serious risk, it is deeply satisfying.
It’s demanding, but never boring. And that’s exactly how I like it.
