𝗡𝗲𝘄 𝗘𝗨 𝗱𝗶𝗿𝗲𝗰𝘁𝗶𝘃𝗲: 𝗢𝗽𝘁𝗶𝗺𝗶𝘇𝗶𝗻𝗴 𝗽𝗵𝗮𝗿𝗺𝗮 𝗹𝗮𝘂𝗻𝗰𝗵 𝘀𝗲𝗾𝘂𝗲𝗻𝗰𝗲𝘀 𝗮𝗻𝗱 𝗻𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗜𝗥𝗣 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 #Pharma #LaunchStrategy #EU
#marketaccess>> Impact of the New EU Directive on Pharmaceutical Launch Strategies 💊 On April 10, 2024, the European Parliament adopted a groundbreaking “pharmaceutical package” that significantly alters the EU’s pharmaceutical landscape. The new directive introduces Article 58a, mandating specific deadlines for pricing and reimbursement (P&R) submissions, with profound implications for international reference pricing (IRP) and launch strategies. 🔍 Key Highlights: 🔹 Marketing authorization holders must submit P&R applications within 12 months of a Member State's request. For small and medium-sized manufacturers, this can extend to 24 months. 🔹 Condensed Timelines: The directive is likely to shorten EU market launch timelines, reducing flexibility in launch sequencing. 🔹 Accelerated Launch Risks: Simultaneous launches may lead to resource overload and manufacturing challenges. Price spillover risks due to IRP could impact revenue. 🔹 Early Patient Access: Patients gain quicker access to innovative therapies. 🔹 Revenue Realization: Faster market entry can accelerate revenue generation. 🔹 Resource and Supply Strain: Increased burden on resources and manufacturing. 🔹 IRP Risks: Potential decrease in net revenue by 5.2% due to price spillover, with average net price falling from €0.71 to €0.66. 🔹 Price Negotiation: Required price concessions might reduce the product’s value. Source: https://lnkd.in/dFzANSYM #pharma #marketaccess #launchstrategy #eu