Steven Hacking’s Post

The UK’s #LifeSciences sector, valued at £90 billion, occupies a pivotal position in the landscape of innovation and economic growth. Recently, the UK Government unveiled a substantial £650 million “war chest” aimed at bolstering the life sciences industry. Simultaneously, the #EuropeanUnion’s pharmaceutical regulatory framework is poised for significant transformations. Against this backdrop, our article delves into the critical legal and policy developments that will shape the UK life sciences sector in the coming months. From empowering innovation to fostering growth, these initiatives promise a dynamic and forward-looking future. Read more here: https://lnkd.in/ecXWr4wJ #LifeSciences #Innovation #Regulation #UKSector

Very interesting times ahead for the #LifeSciences sector both in the UK and across the EU. Our latest briefing discusses key upcoming reform initiatives that organisations should be aware of in areas including medical devices, clinical trials and market access. And it would be hard not to mention #DisruptiveTechnology and #AI…

Current vs. Desired State of Patent Term Extensions (SPC) in the EU The European Parliament is currently discussing a reform of the Supplementary Protection Certificate (SPC) system for pharmaceuticals to streamline the process and ensure uniform protection across EU member states. Current State: Separate Applications: Pharmaceutical companies must file SPC applications in each country separately, resulting in significant administrative burden and high costs. Regulatory Differences: Variations between countries in the examination and approval processes create inconsistencies in drug protection across the EU. Desired State: Centralized Application Process: The proposed reform includes a single SPC application mechanism valid across all EU countries, aimed at reducing administrative complexity and associated costs. Unified Examination: Establishing an EU body to review SPC applications and make unified decisions, promoting consistency across member states. Cost Reduction: Lowering the financial and time burdens of securing SPCs, particularly benefiting small and medium-sized pharmaceutical companies. Reactions to the Proposal: Industry Support: Pharmaceutical companies favor the reform, arguing that it will streamline the process and help protect their R&D investments. Public Health Concerns: Public health organizations worry that the reform may extend drug monopolies, delay the entry of generics, and lead to higher drug prices. The discussions are ongoing, with a final decision expected in the coming months. #EUReform #SPC #PharmaPatents #DrugPricing #PublicHealth #InnovationProtection

The conclusion of Medicare's drug price negotiations marks a significant turning point, but the battle isn't over. Pharmaceutical companies and industry groups have filed lawsuits challenging the Inflation Reduction Act (IRA). Their primary arguments include constitutional concerns, claiming the program stifles innovation and unfairly compels companies to accept government-imposed prices. Despite these legal hurdles, all manufacturers involved have agreed to negotiate, indicating the program's resilience. With decisions expected by 2024, the outcome could shape the future of drug pricing in the U.S. Read more at https://rb.gy/v1jfo3 #LifeSciences #Medicare #HealthcareInnovation #DrugPricing #PolicyImpact #AIInHealth

Service of written pleadings via other electronic systems than the CMS cannot be considered effective service under Rule 278.1 RoP. That is what the judge-rapporteur of the Court of Appeal held in the order of 8 August 2024 in Alexion Pharmaceuticals v Amgen: https://lnkd.in/eg9STPHA Therefore, a prior communication between the parties themselves of the written pleading via another electronic system like the German special electronic lawyer’s mailbox cannot be considered as effective service for determining when the applicable time periods starts running.   For case law on Rule 278 RoP: https://lnkd.in/ebpvfsaf   #upc, #upcnugget

Complimentary Webinar on March 27th co-hosted by Marbls, Informa Connect Life Sciences, and Novartis! Registration is Open! In collaboration with Novartis, Marbls is excited to invite to you to a Webinar on the evolving legislative landscape of State Price Transparency Reporting and how it impacts pharmaceutical manufacturers. Join us as we discuss state requirements, the challenges they pose around data collection and the importance of maintaining compliance with each state entity. Agenda Highlights:  - Impacts of the latest legislation on your price reporting  - Trends in laws around PDABs and price increase triggers  - Challenges manufacturers face in data aggregation   - Advantages of introducing automation to your reporting practices If you’re interested in joining, register here: https://lnkd.in/e9kCvdV8 Please reach out to Ritu Pandey for more details or let us know if you have any questions on price transparency reporting requirements. #lifesciences #pricing #contracting #sptr #statepricetransparency Arnab Sikder Ralph Lynn

In a recent ruling, the European Union Court has upheld a fine of €13.96 million (approximately Rs 125.62 crore) on Ipca Laboratories’ subsidiaries, Unichem and Niche Generics, related to a patent dispute settlement agreement with the Servier group. Key Details: - Entities Involved: Unichem Laboratories Ltd and Niche Generics Ltd, subsidiaries of Ipca Laboratories. - Dispute Background: The fine pertains to a settlement agreement over the Perindopril drug patent with Servier, a French pharmaceutical company. - Patent History: Perindopril, used for treating hypertension and heart failure, had its patent challenged by multiple companies, including Unichem and Niche. - Allegation: It was alleged that the settlement agreement breached EU competition law. Financial Impact: - Fine Amount: €13.96 million (approximately Rs 125.62 crore). - Provision Made: Ipca Labs and Unichem have already made provisions for the fine in their financial statements. - Company Statement: Ipca Laboratories has stated that there will be no material impact on the company’s operations due to this fine. Stay informed on significant legal and regulatory developments impacting the pharmaceutical industry with Global Regulatory Insights. #IpcaLabs #EUCourt #PatentDispute #Pharmaceuticals #CompetitionLaw #GRI

Germany to reform drug pricing and reimbursement laws as the next step of the “new Strategy Pharma”: the aim is to restrict international reference pricing. Will this proposal boost the German pharmaceutical sector? Find out more here: https://lnkd.in/g7TEmxXU #law #future #Germany #MedicalResearchAct #drugpricing   #drugreimbursement #newStrategyPharma #lifesciences #healthcare 

UCPMP 2024 has introduced changes in the framework to regulate and foster ethical interactions between pharmaceutical/medical devices organisations and healthcare professionals, with a focus on enhancing transparency, integrity and accountability. How will the changes impact these organisations and what should they be doing to ensure compliance? To learn more: https://bit.ly/4b51eC9 #RethinkRisk #FitForFuture #UCPMP2024 #RegulatoryCompliance #PharmaCompliance Sivarama Krishnan | Nikunj Seth | Kamal Jain | Darshan Patel | Sneha Agarwal

What an exciting and dynamic discussion! Debating the New EU Pharma Legislation in the Danish Parliament Today 💊🇪🇺 Strong voices raised important questions, with one standout: Should we have a Europe-wide Amgros? 🤔 This could have a profound impact on costs, availability, and accessibility of medicines across the EU. Many question whether our role in the equation could be developed and become a more powerful force in the areas of purchasing, forecasting, and contracting pharmaceutical products. Maybe not just in the hospital sector... By doing so, could we build a more competitive and stable market that benefits all European citizens? 💡 #Pharma #EUlegislation #Sykehusinnkjop #NPF Outstanding Flemming Sonne