Innovation beyond invention will bring novel medicines to Europe’s patients
When it comes to launching a new medicine in Europe, I believe it has never been more important to fully understand the region’s complexities and the commitment needed to succeed.
On one hand, healthcare systems are struggling as demand rises, cost pressures grow, and too many people wait too long for better treatment options. On the other, scientific advances are creating new possibilities to address unmet needs. Novel medicines have the potential for life-changing impact – but this will only be realised if they can reach the patients who need them.
In Europe right now, that means navigating the evolving regional and national pathways and processes that bridge between a new medicine and the patients that stand to benefit. It means doing this in an environment undergoing profound shifts as the impact of potentially transformative legislation comes into focus, supply chain volatility increases, and geopolitics forces even greater prioritisation pressures.
In this situation, unlocking the potential of novel medicines for Europe’s patients demands innovation beyond invention: sustained, persistent innovation in implementation at every step from development to regulatory, pricing, market access, commercial, and manufacturing and supply.
As CEO of a Europe-based pharmaceutical company with significant focus on in-licensing European assets, I often speak with biotech leaders who are weighing up whether to partner or to go it alone. Below are my key insights and recommended steps for success if setting sights on the continent.
Insight 1: Expertise doesn’t necessarily transcend borders
Europe remains one of the world’s largest – and most complex – pharmaceutical markets.[1],[2] Medicines are authorised centrally through the European Medicines Agency, but companies must contend with fragmented national systems for pricing and reimbursement alongside divergent rules on data use, clinical trials, manufacturing, environmental compliance, and supply security.
In response to this complexity, the EU is pursuing a promising package of reforms. These include the overhaul of pharmaceutical legislation, joint clinical assessments under the EU Health Technology Assessment Regulation, faster and more flexible clinical trial rules, and initiatives such as the Critical Medicines Act aimed at streamlining regulation and improving access.
These are very positive steps forward, with real potential to improve processes for governments, industry, and ultimately patients. They are, however, works in progress, and fragmentation and differences in rules, timelines, and expectations persist.
The reality is that you need expertise in every country in which you want to launch. A team sitting outside the region or a single ‘EU team’ based in France won’t be in a good position to negotiate reimbursement in Germany, however strong their domestic track record. Footprint matters and you need on-the-ground experience in each country, guided by a crystal-clear understanding of what it takes to succeed there. If this sounds inefficient, consider the alternative: missed opportunities, potential missteps, and avoidable delays.
Insight 2: Reliable supply of medicines for patients in Europe isn’t guaranteed
Worldwide, there is increasing demand for medicines at a time of growing supply chain volatility.[3] The complexity of international pharma supply chains and their sensitivity to energy costs, trade uncertainties, and the effects of geopolitical issues can all contribute to supply challenges.[4],[5] In addition, many companies have shifted manufacturing outside of Europe and then face challenges with reliable supply on the continent.[6]
If you are a biotech looking to partner to enter Europe, it’s vital to understand the depth and track record of a potential partner’s manufacturing, quality, and supply capabilities – delivering medicines on time and in full. It is equally as important to scrutinise the organisation’s skills, experience, and processes in mitigating risks and managing any challenges. It takes real expertise in business continuity and resilience planning to ensure that supply remains constant, even if that means relocating production or rerouting distribution to maintain continuity in the face of unexpected disruptions.
Cutting-edge manufacturing, quality, and supply capabilities should be anchored in deep expertise, with a highly skilled Europe-based in-house team. Where manufacturing flexibility or greater scale may be required, there should be a seamless extension of these capabilities through contract manufacturers – enabling you to have confidence that your asset can be delivered effectively.
Insight 3: A partner needs to be right-sized and have the right expertise
According to consulting firm ZS, of the 141 novel drugs launched in the US by biotech first-timers between 2011 and 2024, fewer than half had launched in Europe as of February 2025.[7]
In addition, international reference pricing pressures and reduced healthcare spending in Europe risk contributing to commercial decisions to deprioritise new medicine launches on the continent in favour of other markets – according to Reuters, drug launches in EU markets have fallen by 35% since May 2025.[8]
It is understandable that, amid all this, one might look across the Atlantic and think ‘too complicated – let’s not go there’. However, Europe remains home to some of the world’s largest economies and most advanced healthcare systems and represents a vast economic opportunity for biotech. Choosing the right partner, whose strengths complement our own, can help act on this opportunity effectively.
First, look for local expertise – it is essential that a partner has a deep understanding of Europe beyond the regulatory complexities alone. It is also critical to fully understand the rapidly shifting geopolitical landscape and the implications from a regional and national perspective – with the ability to navigate these changes with agility.
It is also important to think about priorities. Is a bigger partner really better – or is it more important to have a partner who is ‘right-sized’ for the asset, who will prioritise, and continue to prioritise, the asset in their broader portfolio? What matters most – disease area experience or deep-rooted, current and proven expertise in the countries where the greatest potential is seen? And what about European manufacturing, quality, and supply capabilities? Should they be higher on the list of priorities?
Laying the groundwork for partnering
For a biotech with a promising asset at an earlier stage, it’s a timely moment to consider where to be when ready to partner. Keeping the option open to launch in Europe means asking how many trial patients will be recruited from the region and in which countries. And when to start engaging with regulators. Opening a dialogue with European and national regulatory bodies early can give a vital steer on any necessary strategy adjustments or trade-offs to optimise the path to approval. The same goes for reimbursement: engaging with reimbursement bodies will help shape a value demonstration and evidence package that works across borders. Importantly, consider the expertise to connect with now to help navigate the path ahead.
Europe’s patients are waiting
Our industry tends to think of the process of getting a novel medicine to patients as a series of high-stakes milestones to get right: Phase 1, 2, 3 trials, regulatory submission, approval, reimbursement. To succeed in Europe today, the key is to recognise that every small step before, after, and in between these critical milestones demands ambition, innovation, and expert implementation, too.
Patients across Europe are waiting and getting them the medicines they need is achievable – with deep in-market understanding, the right skills and a commitment to the region, we can change lives.
[1] EFPIA. The Pharmaceutical Industry in Figures. 2024. Last accessed April 2026. Available at: the-pharmaceutical-industry-in-figures-2024.pdf
[2] Market Data Forecast. Europe Pharmaceutical Market Report. 2026. Last accessed April 2026. Available at: https://www.marketdataforecast.com/market-reports/europe-pharmaceutical-market
[3] Intuition Labs. Global Pharmaceutical Market: 2025 Analysis & Key Trends. 2026. Last accessed April 2026. Available at: https://intuitionlabs.ai/pdfs/global-pharmaceutical-market-2025-analysis-key-trends.pdf
[4] EY. Pharma Supply Chains of the Future. 2022. Last accessed April 2026. Available at: https://www.ey.com/content/dam/ey-unified-site/ey-com/en-gl/insights/life-sciences/documents/ey-pharma-supply-chains-of-the-future-004317-22gbl.pdf
[5] Tsagkaris C, Laubsher L, Matiashova L, Lin LC, Isayeva A. The impact of energy shortages on health and healthcare in Europe. Health Science Reports. 2023 Jan 26;6(2):e1075.
[6] European Court of Auditors. Critical shortages of medicines EU measures were of added value, but structural problems remain. 2025. Last accessed April 2026. Available at: https://www.eca.europa.eu/ECAPublications/SR-2025-19/SR-2025-19_EN.pdf
[7] ZS. U.S. and European first launch trends and implications for emerging biopharma. 2025. Last accessed April 2026. Available at: https://www.zs.com/insights/us-novel-first-launches-implications-emerging-biopharma
[8] Reuters. Drugmakers delay some European launches with a wary eye on Trump's pricing policies. 2026. Last accessed April 2026. Available at: https://www.reuters.com/business/healthcare-pharmaceuticals/drugmakers-delay-some-european-launches-with-wary-eye-trumps-pricing-policies-2026-03-31/
About the author
Janneke van der Kamp is chief executive officer of Norgine, a mid-sized EU-based pharmaceutical company with 1,500 employees and approximately $650 million in annual sales. Van der Kamp brings over two decades of pharmaceutical leadership experience, having held senior roles at Novartis, including head of pharma region Europe, and served as chief commercial officer at Grünenthal. At Norgine, van der Kamp is fostering a culture of empowerment, collaboration, and purpose-driven impact.
