Reuters Europe 2025: Trade-offs in European launch sequencing

For Reuters Pharma Europe 2025, pharmaphorum is providing coverage courtesy NAVLIN Daily, a pricing and market access insights report from EVERSANA (pharmaphorum's parent company). You can see the original post, along with more Market Access news, at NAVLIN Daily.

NAVLIN Brief

• Launch sequencing, particularly for 27 Member States in the context of the ongoing EU pharmaceutical legislation review, was debated at Reuters Pharma Europe 2025
   
• The panel, consisting of Diana Sinkevich, Head of Market Access Rare Europe & International at Chiesi Rare Disease; Mike Ryan, EVP at Eversana; Alexander Natz, Secretary General at EUCOPE; and Janina Mette, VP, Global Marketing and Market Access at ALK, each offered unique perspectives on the challenges of launching in Europe under fluctuating conditions 
   
• The wide-ranging panel touched on global issues, from the Joint Clinical Assessment (JCA) in Europe to U.S. President Donald Trump’s policies that could have a ripple effect on ex-U.S. markets -- read on to find out more 

The Details

BARCELONA, Spain – In April 2023, the European Commission (EC) published two proposals to revise the existing (and often criticised as outdated) pharmaceutical legislation. Among the initial proposals was a “blanket launch incentive,” or rather, a penalty for not launching in all Member States in the two years following centralised approval.

Following negative feedback from industry and other stakeholders, the access proposal was delinked from the incentive framework. However, Member States must request that a marketing authorisation holder (MAH) file for pricing and reimbursement in their country within one year of receiving marketing authorisation. A manufacturer must then file within 12 months of the request coming from the Member State, unless it is a not-for-profit entity, an SME, or if undertakings have “received not more than five centralised marketing authorisations.”

The idea of launch sequencing, particularly for 27 Member States in two years, was debated at Reuters Pharma Europe 2025. On a panel consisting of Diana Sinkevich, Head of Market Access Rare Europe & International at Chiesi Rare Disease; Alexander Natz, Secretary General at EUCOPE; Janina Mette, VP, Global Marketing and Market Access at ALK; and Mike Ryan, EVP at EVERSANA, each offered unique perspectives on the challenges of launching in Europe under fluctuating conditions.

Alexander Natz highlighted the impact of international reference pricing (IRP) and U.S. President Donald Trump’s potential Most Favored Nation (MFN) policy on European pricing strategies, while also touching on the ongoing U.S.-EU tariff discussions. According to Natz, one solution to these potential headwinds from the U.S. is to implement differential pricing with confidential rebates in Europe. While acknowledging it is “not a new phenomenon,” he suggests “agree[ing] 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.”

Agreeing with Natz’s point of finding unity across Europe, Mike Ryan suggested Europe is going to have to “act as a single market when it comes to pharmaceuticals.” However, He raised that “the legislative difficulty of getting that across all European governments is substantial,” as “at the very heart of the European Union is subsidiarity, that each government has the right to determine its own tax regime, et cetera, and that's going to take a little bit of time to negotiate.”

To illustrate the potential in this area, he gave the example of the COVID-19 vaccine, arguing, “We've done it successfully already.” The COVID-19 vaccine was negotiated as a single price, with the same liability across all governments. As a consequence, smaller markets often got vaccinated faster than the bigger markets, which, under regular circumstances, would have been able to afford the vaccine sooner.

While Ryan’s “ultimate solution” of “all of the 450 million inhabitants of Europe having access to the same drugs at the same time” may not be on the near horizon, in the interim, he acknowledges the potential difficulties of offering cross-border care for patients, likening it to a game of “political football,” adding, “We don't want patients becoming a political football.” 

Really driving home the opportunity Europe as a market holds, he added: "Launching in all of Europe makes us a bigger market than the United States. And I would have imagined from a revenue perspective, you may lose something on price, but what you lose in price you'll make up in volume."

Diana Sinkevich spoke to the benefits of centralised dossier requirements, pointing to the Joint Clinical Assessment (JCA), but echoed the industry’s general concern that the varying GDP per capita across countries and general heterogeneity could pose challenges in developing unified pricing strategies.

Looking ahead, or rather, into moderator and Medical Journalist Sue Saville’s physical crystal ball she brings on-stage, the panel envisions a more integrated European pharmaceutical market, with potential regulatory changes, including "omnibus procedures," shaping future launch strategies.

Responding to a question about “Who benefits from the current process?” Ryan argued that “nobody does,” elaborating, “There are perceived advantages that government believe they have in terms of controlling price, which, of course, they don't. They actually influence price in the wrong direction by increasing regulation. So, I believe one of the positive outcomes of the current crisis is that it will force Europe to re-evaluate at the government level in order to ensure that we protect one of our most valuable industries and, most importantly, citizens.” 

Natz spoke about the potential of the JCA in Europe, suggesting that it “carries a lot of potential, but we need to get it right.” He added, “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. So far, it is not foreseen that there are enough slots.” His point contradicts recent reports from the coordination group that Joint Scientific Consultation (JSC) slots were “not overwhelmed.” However, companies may be adopting a watch-and-wait approach at this stage, meaning more will apply at a later stage. 

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Anna Smith is Head of News at NAVLIN Daily by EVERSANA, covering the latest developments and trends in the global pharmaceutical market access landscape. She specialises in pricing and reimbursement, health technology assessment (HTA), and healthcare policy, as well as on-the-ground reporting at events.