Pharmaceutical industry leaders gathered at Reuters Pharma Europe 2025 in Barcelona to address the complex challenges of European launch sequencing amid evolving regulatory frameworks and market access considerations.
European Launch Sequencing Debate Takes Center Stage
A panel of industry experts engaged in a critical discussion about the challenges of launching pharmaceutical products across the European Union's 27 Member States. The conversation comes at a pivotal time as the European Commission continues to revise pharmaceutical legislation that initially proposed penalties for companies failing to launch in all Member States within two years of centralized approval.
The panel featured Diana Sinkevich, Head of Market Access Rare Europe & International at Chiesi Rare Disease; Alexander Natz, Secretary General at EUCOPE; Janina Mette, VP of Global Marketing and Market Access at ALK; and Mike Ryan, EVP at EVERSANA.
Following industry pushback, the European Commission modified its approach. The current proposal requires marketing authorization holders to file for pricing and reimbursement within 12 months of receiving a request from a Member State, with exceptions for not-for-profit entities, SMEs, and companies with five or fewer centralized marketing authorizations.
International Reference Pricing and Cross-Border Challenges
Alexander Natz highlighted how international reference pricing (IRP) significantly impacts European launch strategies. He also noted the potential ripple effects of U.S. policies, particularly the possible revival of Donald Trump's Most Favored Nation (MFN) policy, which could substantially influence pricing decisions in Europe.
"One solution to these potential headwinds from the U.S. is to implement differential pricing with confidential rebates in Europe," Natz suggested. While acknowledging this isn't a novel concept, he proposed "agreeing on a concept which is one European price with confidential rebates to the European countries, which is adapted to their GDP per capita, but we need to keep that rebate or discount confidential."
Unified European Pharmaceutical Market
Mike Ryan emphasized that Europe must "act as a single market when it comes to pharmaceuticals" to maximize its potential. He acknowledged the substantial legislative challenges in achieving this goal, noting that "at the very heart of the European Union is subsidiarity, that each government has the right to determine its own tax regime."
Ryan pointed to the COVID-19 vaccine rollout as a successful precedent for unified European action. "The COVID-19 vaccine was negotiated as a single price, with the same liability across all governments," he explained. This approach sometimes resulted in smaller markets gaining access to vaccines faster than larger ones that would typically have earlier access.
"Launching in all of Europe makes us a bigger market than the United States," Ryan noted. "From a revenue perspective, you may lose something on price, but what you lose in price you'll make up in volume."
Joint Clinical Assessment and Future Directions
Diana Sinkevich spoke positively about the benefits of centralized dossier requirements, specifically highlighting the Joint Clinical Assessment (JCA). However, she echoed industry concerns about the varying GDP per capita across countries and the heterogeneity that complicates unified pricing strategies.
Looking ahead, the panel envisioned a more integrated European pharmaceutical market. Alexander Natz emphasized that the JCA "carries a lot of potential, but we need to get it right." He stressed the importance of sufficient interaction opportunities between companies and decision-makers, noting, "We need to have the opportunity in the EU HTA to have enough slots for interaction between the company and the decision-makers and coordination group."
Access and AI: Additional Conference Highlights
In parallel sessions at the conference, discussions centered on expanding access to medicines and integrating artificial intelligence into pharmaceutical operations.
Jay Iyer, CEO of Access to Medicine Foundation, argued that "Access needs to be something board members measure themselves against," while Lutz Hegemann, President of Global Health & Swiss Country Affairs at Novartis, advocated for greater adoption of outcome-based agreements in high-income countries as models for low- and middle-income countries.
The conference also featured significant discussion about AI implementation in pharmaceutical operations. Teva's Alyssa Fenoglio, Vice President and Global Head of Digital Commercial, warned, "This is the inflection point. If you haven't already started, you're behind." She emphasized that successful AI integration depends primarily on people rather than waiting for top-down directives.
Johanna DeYoung, Managing Director of Life Sciences at Slalom, offered a memorable analogy: "Agentic AI is like Batman having a Robin who never sleeps," highlighting AI's ability to work continuously and solve problems beyond fragmented intelligence. She urged the industry to "move from being custodians of data to connectors of data. Otherwise, we're just building skyscrapers on landfills."
As the pharmaceutical industry navigates these complex challenges of market access, regulatory changes, and technological integration, the discussions at Reuters Pharma Europe 2025 underscore the need for collaborative approaches and innovative solutions to ensure equitable access to medicines across European markets.
