Is the EU "Launch Obligation" Really as Scary as It Sounds, Dr. Alexander Natz?

In the latest episode of MAP – the Market Access Podcast, Dr. Stefan Walzer sits down with Dr. Alexander Natz, Secretary-General of EUCOPE, to unpack the biggest regulatory shifts reshaping pharmaceutical market access across Europe right now.They discuss how the EU Joint Clinical Assessment (JCA) now starts national HTA timelines as soon as a marketing authorization is filed, why the so-called "launch obligation" is far from compulsory licensing, and how MFN pricing pressure from the US is forcing companies to rethink launch sequencing across Europe. Alexander also explains why comparator selection (PICO schemes) is the real battleground for national pricing outcomes, and why the European Health Data Space could become one of Europe's biggest competitive assets.Despite the added complexity, Alexander's bottom line is clear: Europe's scale, clinical networks, and regulatory innovation still make it a market worth prioritizing — if companies understand the new rules of the game. A must-listen for anyone in pharma, biotech, market access, or pricing and reimbursement navigating Europe's shifting launch strategy.LinkedIn: Alexander NatzStay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don't forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS—and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #HealthEconomics #HTA #JCA #PharmaPolicy #EUHealthPolicy #MFN #Pharma #PricingAndReimbursement #LaunchStrategy #EuropeanHealthDataSpace #EUCOPE #mAxInsights #marketaccesspodcast

Tune in to the newest episode of MAP, the Market Access Podcast, where Dr. Stefan Walzer engages in an insightful discussion with Prof. Dr. Thomas Hammerschmidt, a leading expert in Pharmaceutical Management at the Technical University of Applied Sciences (TH Rosenheim) in Bavaria. Together, they explore the latest proposals influencing AMNOG, pharmaceutical pricing, reimbursement, and market access. Topics include dynamic mandatory rebates, patented drug tenders, price-volume agreements, and their potential consequences for pharmaceutical companies operating in Germany.The removal of combination rebates and AMNOG guardrails could foster greater innovation incentives. The key takeaway? Pharma companies must brace themselves for heightened pricing pressures, increased uncertainty, and a transformed reimbursement landscape. For teams focused on market access, pricing, and commercialization, the upcoming weeks could shape the reimbursement environment for years to come.The critical question: Can Germany balance healthcare cost containment while maintaining incentives for pharmaceutical innovation and investment?Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS—and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #Pharma #AMNOG #HealthcarePolicy #GermanyPharmaReform #PricingAndReimbursement #PatentedDrugTenders #PharmaceuticalIndustry #Germany #HealthEconomics #MarketAccessPodcast #LifeSciences #HealthcareInnovation #mAxInsights #marketaccesspodcast

In der deutschsprachigen Spezialfolge des MAP – Market Access Podcast spricht Dr. Stefan Walzer mit Prof. Dr. Afschin Gandjour, Arzt, Gesundheitsökonom und Finanzexperte, über eine der zentralen gesundheitspolitischen Fragen dieser Wochen: Was bedeuten Finanzkommission und Referentenentwurf konkret für den Arzneimittelmarkt? Reicht ein dynamischer Herstellerabschlag – oder braucht es Kosten‑Nutzen-Analysen? Wo drohen Fehlanreize für innovative Arzneimittel, insbesondere Orphan Drugs, und welche Rolle spielen vertrauliche Rabatte und internationale Referenzpreise?Wer im Pharmazeutischen Markt, Market Access oder Gesundheitspolitik unterwegs ist und verstehen muss, wie Deutschland Innovation finanzieren und Versorgung sichern kann, für diejenigen ist diese Episode ein Pflichtprogramm.Bleiben Sie auf dem Laufenden, indem Sie den Podcast auf Ihrer bevorzugten Podcast-Plattform abonnieren oder direkt auf unserer Website anhören: MAP Podcasts – und wenn euch die Folge gefallen hat, vergesst nicht, sie und den Podcast zu bewerten!MAP ist der erste und einzige zweiwöchentliche Podcast zum Thema Marktzugang, der von MArS angeboten wird – und der weltweit führende Podcast im Bereich Gesundheitsökonomie. Weitere Informationen zu MArS Market Access and Pricing Strategy finden Sie unter: https://marketaccess4-0.com/#MarketAccess #PharmazeutischenMarkt #Gesundheitsökonomie #Gesundheitspolitik #HealthEconomics #Finanzkommission #Arzneimittelpolitik #GesundheitspolitikDE #Herstellerabschlag #KostenNutzenAnalyse #GKVStabilisierung #mAxInsights #marketaccesspodcast

From Olympic ice to AI-powered leadership: What can Market Access teams learn from elite sports? In the 111+1 anniversary episode of MAP – the Market Access Podcast, Dr. Stefan Walzer interviews Livia Altmann, a former Swiss Olympic ice hockey player who has transitioned into a leadership and "Human Intelligence 2.0" expert. Together, they explore how mental training, consistency, and energy management drive success in both elite sports and the business world—and why, in an AI-driven era, execution outshines knowledge.Livia shares insights on how leaders can use AI as an enabler rather than a replacement. She emphasizes the importance of maintaining control through a growth mindset, unwavering focus under pressure, and strong self-awareness to build trust, align teams, and make better decisions. If you're part of the Market Access, life sciences, or healthcare industries and want your team to thrive under pressure in the age of AI, this is a conversation you won't want to miss!Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS—and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #Pharma #HealthEconomics# #Medtech #DigitalHealth #AI #mAxInsights #HumanIntelligence #MAPPodcast #marketaccess #marketaccesspodcast #HumanIntelligence2_0 #HumanAICollaboration #AIEnabledLeadership #EliteSportsMindset #OlympicWinner #PowerSkills #HighPerformingTeams #MarketAccessLeadership

In the latest episode of MAP – the Market Access Podcast, Dr. Stefan Walzer speaks with Sreeram Ramagopalan, a global expert at the intersection of biotech value, HTA, real‑world evidence and market access. Together they unpack how the UK NICE threshold increase (from £20–30k to £25–35k per QALY) and US reforms (IRA, MFN) are quietly rewriting the rules for global launch sequencing and pricing strategy.They discuss why the US is no longer an isolated “free pricing” island, how UK and EU prices can now feed back into US revenues, and why small and mid‑size biotechs, in particular, can no longer afford to treat US and ex‑US strategies as separate worlds.If you’re in pharma/biotech, pricing & market access or RWE, and you’re not yet stress‑testing your global evidence, price floors and launch plan against MFN and NICE reforms, this episode is your wake‑up call.https://becarispublishing.com/doi/10.57264/cer-2026-0041Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS—and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #HealthEconomics #HealthPolicy #HealthcareFinance #HealthFinancing #HealthInvestment #NICEReform #IRAPricing #MFNPolicy #BiotechValueCreation #GlobalLaunchStrategy #marketaccesspodcast

In the latest episode of MAP – the Market Access Podcast, Dr. Stefan Walzer engages with Swiss healthcare strategist Cuno Moser to explore Europe's "innovation paradox" in healthcare. Despite its strengths in research, data quality, and clinical expertise, Europe struggles to transform pilot projects into scalable, reimbursable solutions. With over 27 fragmented reimbursement systems in the EU and in Switzerland, significant barriers impede progress in digital health, medtech, and AI-driven care. Beyond funding, challenges such as misaligned incentives, insufficient execution infrastructure, and flawed system design keep innovation stuck in "pilot purgatory."Looking ahead, while Europe may not lead in speed, it has the opportunity to excel in quality and trust. This could allow European health platforms to establish a competitive edge. If you're involved in digital health, medtech, AI, or market access and find your solution stalled between a promising pilot and real-world scalability, this episode is a must-listen.https://www.linkedin.com/feed/update/urn:li:activity:7437804838232453120/Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS—and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #Pharma #EuropeanHealthcare #Medtech #DigitalHealth #AIinHealthcare #mAxInsights #FromPilotToScale #InnovationParadox #ScalingHealthInnovation #QualityOverSpeed #MAPPodcast #marketaccess #marketaccesspodcast

In the latest episode of the MAP – Market Access Podcast, Dr. Stefan Walzer speaks with pricing and access expert Shrutya Bhalla about how primary research must evolve in an era of AI, policy shocks, and accelerating market complexity. The key takeaway: high‑quality primary research is no longer just about collecting insights – it must enable real strategic choices on pricing, access, launch sequencing, and evidence generation. This means moving from slow, static projects to continuous, platform‑driven, AI‑supported research, using AI for speed, automation and better hypotheses while keeping humans firmly in the lead for judgment, context and responsibility, and building research that is robust enough for MFN, new US tariffs, and fast‑changing global policy environments.Shrutya also shares how new stakeholder research platforms like Mulya, and innovations such as Market Access 4.0 tools like mAxInsights, DO-Bo, Q-Bo and Wafle, are redefining how we run payer research: faster, more economical, and closer to real‑time decision needs. If you work in market access, pricing, Health Economics and Outcomes Research (HEOR) or commercialization, this episode is a must‑listen to understand where primary research is headed.Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS—and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #PricingAndReimbursement #PrimaryResearch #GlobalHealth #Mulya #mAxInsights #DO-Bo #Q-Bo #Wafle #Pharma #AIinHealthcare #PayerInsights #CommercialStrategy #MAPPodcast #marketaccess #marketaccesspodcast

In this episode of the MAP – Market Access Podcast, Dr. Stefan Walzer speaks with Hatice Küçük Beton, Executive Director of the G20 Health and Development Partnership, about how to make global health truly investable – and keep it on the political agenda once the immediate crisis fades. They explore why high-level leadership, from Angela Merkel’s role during Germany’s G20 presidency to Japan’s joint health–finance initiative, was crucial in moving health from a “social cost” to a strategic economic and security issue. Hatice explains how bringing health and finance ministers to the same table – and getting them to speak the same financial language – has begun to reshape thinking around budgets, risk and long‑term system resilience.The conversation then dives into what a practical health investment framework could look like, with clear positive qualifiers, benchmarks and disqualifiers to guide capital into high-impact areas without overburdening investors with new bureaucracy. Hatice and Stefan discuss why health must be de‑politicised and reframed as a pillar of economic resilience, geopolitical security and human wellbeing – not a “nice to have” public service – and why returns on health investments should not be taboo. If you work in market access, health economics, policy, pharma, medtech or healthcare investment, this episode offers concrete ideas on how smarter, market‑driven health investment can shape global and national health systems by 2030.Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS—and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #GlobalHealth #G20 #HealthEconomics #HealthInvestment #HealthFinancing #HealthPolicy #HealthcareFinance #G20Health #ImpactInvesting #marketaccess #marketaccesspodcast

In the latest Market Access Podcast episode, host Stefan Walzer sits down with Bernard “Bernie” Bichsel – one of Europe’s most experienced voices in medtech regulation and former Head of the Medical Devices Division at Swissmedic – to unpack how regulation and market access truly fit together. They discuss why medical device regulation in Europe is still young compared to pharma, why the MDR/IVDR “notified body bottleneck” is largely yesterday’s problem, and how smart startups build regulatory timelines, costs, and clinical evidence into their plans from day one.They then zoom out to Omnibus, the AI Act, and geopolitics, and what all of this means for the attractiveness of Europe vs. the US, China, India, and the rapidly growing Arabic region as medtech markets. Despite the challenges, Europe still offers world‑class innovation, strong universities, and a powerful SME ecosystem – and remains a key region for medtech investment. If you’re a medtech founder, regulatory lead, or market access professional, this episode will help you rethink when and how you integrate regulation and reimbursement into your strategy.Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS—and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #MedTech #MDR #IVDR #RegulatoryAffairs #HealthEconomics #medtech #medtechregulation #Reimbursement #Startups #EUHealthcare #marketaccess #marketaccesspodcast

In this episode, Stefan Walzer talks with experienced Market Access manager Helmut Butscher about concrete AI applications across the full Market Access value chain. They explore how AI accelerates systematic literature reviews, unlocks real‑world evidence from complex data sources, supports HTA dossier preparation, and enables smarter decisions on pricing, reimbursement and global launch sequencing. They also address the limits and risks of AI in a highly regulated setting – from opaque HTA and payer decisions to regulatory uncertainty around AI‑generated evidence and the ethical tension between efficiency and fairness in health technology assessment.Stefan and Helmut then look ahead to the evolving role of the Market Access manager – not as someone replaced by algorithms, but as a central orchestrator who uses AI as a powerful sparring partner to make better, faster and more transparent decisions. Whether you work in Market Access, HEOR, pricing, strategy or related fields, this episode offers a clear, practice‑oriented view on how to start using AI meaningfully in your daily work – and where it pays to remain cautious.Stay connected by subscribing on your favorite podcast platform or listening directly on our website: MAP Podcasts —and if you enjoyed the episode, don’t forget to rate it and the podcast!MAP is the first and only bi-weekly market access podcast provided by MArS—and the global #1 podcast in the field of health economics. For more information about MArS Market Access and Pricing Strategy, visit: https://marketaccess4-0.com/#MarketAccess #OrphanDrugs #RareDisease #DrugPricing #HealthEconomics #CostEffectiveness #BudgetImpact #RealWorldEvidence #InnovativeContracting #GeneTherapy #HealthcarePolicy #Payers #MAPPodcast #marketaccess #marketaccesspodcast