Author: Kristina Keuper

  • EU pharmaceutical regulations and market access

    EU pharmaceutical regulations and market access

    How EU Medicine Pricing and Reimbursement Really Works: An Interactive Explainer

    Why can a drug be approved across the entire European Union but still be unavailable to patients in certain member states? The answer lies in the complex system of pharmaceutical pricing, reimbursement, intellectual property protection, supply chain fragility, and access program design that governs how medicines move from laboratory to patient. This interactive group chat walks you through four stories featuring the key stakeholders who shape medicine access in Europe — including the Trump administration’s Most Favored Nation pricing policy, which is now reshaping the incentives of European price negotiations in real time.

    Choose a story and press play

    Use the menu on the left to switch between the four stories. Use the playback controls to start, pause, skip forward, or step back. Adjust the speed to read at your own pace. The abbreviation reference on the right explains technical terms as they appear. Each story has five acts.

    The Cancer Drug

    EMA, Pharma Inc., Germany, Netherlands, Romania, Belgium, Patients, Doctor, Volt Europa

    Glossary

    The core problem

    In the EU, marketing authorisation for a new medicine is handled centrally by the European Medicines Agency (EMA). Once approved, a drug can legally be sold in all 27 member states. However, whether public health insurance will pay for that drug is decided at the national level — each country individually runs a Health Technology Assessment (HTA) and negotiates a price with the manufacturer. This creates a strategic game: companies launch first in high-price countries like Germany and Switzerland to set high reference prices, then delay or skip smaller and lower-income markets entirely. Almost all EU countries use External Price Referencing (EPR), benchmarking their own prices against others, which makes every national price negotiation a global pricing decision in disguise.

    A new external pressure has entered this system: the US Trump administration’s Most Favored Nation (MFN) policy references the lowest prices among 19 OECD countries — including most EU member states — as a ceiling for what Medicare pays. This creates a perverse incentive: aggressive European price negotiation now risks propagating back into the far larger US market. Germany has already introduced confidential pricing options specifically to keep its negotiated prices invisible to the MFN benchmark. The downstream consequences for patient access in lower-income EU member states are still unfolding.

    Even when pricing works as intended, patients still face structural barriers: supply chains built for cost efficiency rather than resilience, medicines that vanish from pharmacy shelves, and a parallel universe of pre-approval access programs that follow commercial logic while being described as charity. The four stories below examine each of these failure modes in turn.

    What you will learn

    Story 1 — The Cancer Drug follows a new oncology drug through the full EU pricing labyrinth: EMA approval, the launch-country sequencing strategy, confidential discount deals, patent thickets blocking generics, and the limits of what EU legislation can actually force.

    Story 2 — The Rare Disease explores orphan drugs for small patient populations, where standard cost-effectiveness thresholds break down entirely, HTA bodies face impossible choices, and patients in Poland wait while patients in Italy are already being treated — with the same drug, for the same disease.

    Story 3 — The Shortage examines why antibiotics disappeared from pharmacy shelves across Europe in 2022–2023: three decades of cost-optimised offshoring, price floors that make manufacturing unviable, 27 fragmented notification systems, and a Critical Medicines Act that monitors better than it enforces.

    Story 4 — Compassionate Use exposes the shadow system of pre-approval access: pharmaceutical companies providing free drugs to dying patients before authorisation — while collecting real-world data for their reimbursement dossier, building physician relationships, and strategically timing programs to create political pressure at HTA decision day. And deciding which countries are “strategic” enough to be included.

    All four stories feature the voices of major stakeholders: the European Commission, pharmaceutical companies, national health authorities, the pharma industry lobby (EFPIA), generic and biosimilar manufacturers, hospital pharmacists, doctors, health insurers, the WHO, patients, and Volt Europa — as well as the US administration as an external actor reshaping the game from outside.

  • Ruby & Klara

    Ruby & Klara

    Ruby & Klara

    Discover your inner world.
    Every day, knowledge and memories grow within you. And your feelings and emotions keep changing.
    Whether you’re navigating tough situations, want to structure your knowledge, or boost your resilience,
    Ruby & Klara help you sort and understand.

    Ruby

    This is Ruby.

    With empathy and foresight, Ruby guides you through the chaos into your world.

    Chat

    Let it all out
    from your head.

    As you write, Ruby sorts your thoughts and
    helps you properly categorize your feelings.

    Good morning! It’s Monday, February 9, 2026, and it’s still winter (brrr)!
    How’s it going with your scientific statement?
    I made little progress; the publications are all new to me,
    since I’m from a completely different field.
    That sounds like a real challenge!
    What troubles you most about the new publications?
    Terms, federal structures in education, limited options.
    Those are very understandable difficulties.
    How does it feel when you see these differences?
    It’s exhausting, but it doesn’t change my motivation.
    Artwork

    A visual gesture

    Ruby synthesizes colors from your feelings and uses meaningful symbols to give you a gesture of joy as an image.
    Tap the dots for their meaning.

    AI Art
    A gentle water lily embodies grace and resilience – beauty and strength blooming even in still waters.
    A glittering dewdrop stands for purity and renewal – every morning is a new chance.
    Yellow stands for optimism – a sunbeam bringing hope and new perspectives.
    A glowing feather symbolizes lightness and freedom.
    Dark magenta promotes creativity and self-love – your inner strength and uniqueness.
    Intense blue represents calm and clarity – like a still lake reflecting serenity.
    Klara

    This is Klara.

    Klara organizes your thoughts in the background.
    She builds a memory network so Ruby understands you better each day.

    Network

    Memories
    interwoven

    Klara connects your thoughts, feelings, and experiences into a dynamic network.
    This reveals patterns that help you recognize connections.

    Joy Calm Stress Work Travel Family Friends Partner Career Health Growth
    BuJo

    Your world,
    captured

    Automatic and personal.
    Ruby summarizes your world daily in a smart bullet journal.
    Add voice notes, stickers, health tracker, photos, and more.

    Your Gallery

    Your collection grows automatically.
    So you can immerse yourself in your memories anytime.

    Your Year

    Keep track of your mood.
    Every day you tell Ruby how you’re feeling.
    This creates your personal mood calendar.

    2026
    Mild
    Intense

    Ready?

    Be there when Ruby & Klara open their eyes for the first time.

    Join the Beta now
    Join the Beta

    Be there when Ruby & Klara open their eyes for the first time.
    Fields marked with * are required.

  • Artificial Intelligence

    Artificial Intelligence

    AI · Consulting & Implementation

    Artificial Intelligence –
    applied, explained, experienced

    We make AI visible: interactive dashboards, generative design and hands-on education for companies that don’t just want to use AI, but truly understand it.

    All demos on this page run live in the browser
    Services

    What we deliver

    Four focus areas with direct links to real-world examples.

    📊

    Dashboards & Statistical Forecasting

    Interactive real-time dashboards with predictive analytics: from KPI overviews to ML-driven forecasts. Raw data becomes reliable decision-making input.

    PythonPredictive ML Time SeriesPlotly
    View examples
    📈

    Data Visualization

    Complex datasets made visual – from scientific plots to interactive web visualizations. Also specialized: biological structure data, AlphaFold outputs & more.

    D3.jsPlotly AlphaFoldMatplotlib
    View examples
    🎨

    Branding & Design with AI

    Adobe Firefly for consistent brand assets: icons, illustrations, social media content. Generative AI as a creative tool always focused on your brand identity.

    Design asset
    Design asset
    Design asset
    Adobe FireflyPromptingBranding
    View examples
    🐻‍❄️

    AI Chatbots & Dynamic Content

    From simple FAQ bots to NLP-powered assistants that autonomously qualify and route customer inquiries. Knut, the polar bear in the bottom right – is a live example: privacy-compliant, European, EU AI Act-ready.

    Dynamic content means: your website speaks to every visitor individually through personalized content, language, or layout based on location, time, or behavior.

    🇪🇺 Powered by Mistral AI · European · GDPR-compliant
    🧠

    Learn & Apply AI Tools

    Practical introductions – no dry theory courses, but hands-on: prompting strategies, generative image tools (Firefly), scientific AI (AlphaFold, protein structures), industry-specific tools.

    Firefly / PromptingAlphaFold Science & ResearchBio Industry Tools
    Request a workshop
    Example Topics
    Firefly prompting for consistent branding
    Google Deepmind AI applications (e.g. AlphaFold for protein interactions)
    AI in scientific research: Tools that accelerate discovery
    Industry-specific tools upon research
    Live Demos

    AI You Can Touch

    Four interactive demos showcasing real methods – with direct business relevance. All data in the demos is synthetic unless otherwise noted.

    Demo · Clustering

    Customer Segmentation with K-Means

    Click on the canvas to place customer data points (e.g. purchase frequency vs. basket value). Press “Segment” – the algorithm automatically groups them into k clusters. In practice: the basis for targeted marketing campaigns.

    No points yet
    Demo · Churn Prediction

    Which Customer Will Churn Next?

    Adjust the sliders and watch how customer clusters shift between “stays” and “at risk.” In practice: proactive retention measures before cancellation.

    ✦ Synthetic data for method illustration

    Demo · Explainable AI

    Credit Decision with SHAP Explanation

    Set the customer data – the AI decides and explains which factors were weighted and how strongly. In practice: transparent decisions per GDPR Art. 22 & EU AI Act.

    ✓ Approved
    SHAP Factors

    ✦ Synthetic data · Illustrative model · Not financial advice

    Demo · Forecasting Model

    Revenue Forecast: What-If Scenarios

    Set market parameters and see how an ML model forecasts annual revenue in 12-month steps – with confidence interval. In practice: the basis for budget planning and investment decisions.

    Year-1 Forecast
    CAGR

    ✦ Synthetic model · Not financial advice

    Showcase

    Experience Dynamic Content Live

    Choose a scenario: Content, language, and presentation adapt automatically. Your selection is captured in real time and displayed in the chart.

    Choose a Scenario

    Dynamic Content

    This section demonstrates how content can change based on context – location, time of day, language, and more.

    Scenario Clicks from All Visitors (Live Aggregation)
    Clicks are aggregated server-side & visualized live (REST API + JSON).

    Ready to Start a Project Together?

    Whether it’s a dashboard, generative design, or an AI workshop – we’re happy to advise you, no strings attached.

    🇪🇺 Mistral AI – European 🔒 GDPR-compliant ⚡ Quick start

    What Are SHAP Values?

    SHAP (SHapley Additive exPlanations) explains how much each feature contributed to an AI model’s decision. A high positive SHAP value means: this feature strongly pushed the decision toward “approval.” Negative values have the opposite effect.

    This method is part of Explainable AI (XAI) – a key concept for transparent, fair, and regulation-compliant AI systems.