Uniphar | Commercial’s Post

How will the proposed EU pharma legislation reform and incoming HTA reform impact the industry? Uniphar | Commercial discuss in their latest insight. #EUreform #HTAreform #EUpharma

The European Commission presented its proposal for a new pharmaceutical legislation in the first half of 2023. The Swedish Government supports the overall aim of the proposal and will work to ensure that the negotiations result in a legislation that is fair, effective, predictable and sustainable over time The Swedish Government will work to ensure that a new regulatory framework provides for a transparent, predictable and efficient system with beneficial conditions for both large and smaller pharmaceutical companies, as well as the health care system. The opposite would risk patients’ access to vital medicines and treatments. https://lnkd.in/d7JPEMF2

🚫 Important Update in Pharmaceutical Supply: U.S. Company MSD (Merck) to Cease Zepatier Supply to Russia by 2024 🚫 Greetings, LinkedIn community! 🌐 I hope this post finds you well. I wanted to bring your attention to a significant development in the pharmaceutical sector that has implications for healthcare in both the United States and Russia. Recent reports from the renowned Russian newspaper Kommersant have revealed that the American pharmaceutical giant MSD, commonly known as Merck in the U.S., is set to discontinue the supply of the popular hepatitis C drug, Zepatier, to Russia after the year 2024. This announcement comes as a result of information obtained from Russia's federal healthcare watchdog. Zepatier, a medication highly regarded for its effectiveness in treating hepatitis C genotypes 1, 3, and 4 in adults, has been an integral component of treatment regimens in Russia. As of 2022, this groundbreaking drug accounted for a significant 19 percent of treatment plans supported by the Russian government. This percentage marginally decreased to 18 percent in the first half of 2023, further underscoring its prominence in the medical landscape. What sets Zepatier apart is its unique formulation, which currently lacks any equivalents within the Russian pharmaceutical market. Moreover, Merck holds the patent for this pioneering drug in Russia, a patent that will remain in effect until the year 2030. This fact emphasizes the exclusivity of Zepatier's formulation and its role in combating hepatitis C. While this change in pharmaceutical supply may pose challenges for patients and healthcare providers in Russia, it also highlights the intricate dynamics of global pharmaceutical partnerships and patent rights. Such developments often prompt crucial discussions on accessibility, research, and innovation, reinforcing the need for collaboration among stakeholders to ensure sustainable healthcare solutions. As we look towards the future, it is essential to acknowledge the significant contributions of pharmaceutical companies like MSD/Merck in advancing medical treatments and improving lives. This news invites us to contemplate the broader landscape of healthcare and the delicate balance between innovation, accessibility, and international cooperation. Let's keep the conversation going! Feel free to share your thoughts on this development and its potential ramifications for the healthcare industry. Together, we can foster insightful discussions that pave the way for a healthier world. 🌍💙 #PharmaceuticalIndustry #HealthcareInnovation #GlobalHealth #MedicalAdvancements #HealthcarePartnerships

In the face of ongoing global challenges, securing the future of Europe's healthcare systems is paramount to future success. ✍️ Read the latest from MEP Stelios Kympouropoulos on the reform of the Pharmaceutical Legislation https://lnkd.in/guJ8HpJU #partnercontent EUCOPE - European Confederation of Pharmaceutical Entrepreneurs

📢Our position paper on the revision of the EU Pharmaceutical Legislation is out! Read it here: https://bit.ly/3pLz7py Access to medicines is crucial to ensure patients’ quality of life. The European Patients' Forum recommendations call for medicines that target patients’ needs, the improvement of the access to treatments and a more patient oriented regulatory process. Congratulations to our policy team, Claudia Louati, Milana Trucl and Julie SPONY, for having outlined such a detailed overview on why this represents a once-in-a-lifetime occasion to change our healthcare system, for the better. #EPF4Patients #ItsAboutPatients #PatientsFirst

What could be the impact of EU legislative reform if it passes to EU commission? The legislation would reduce of the minimum period of regulatory protection for innovative medicines to eight years, down from 10 years under the existing legislation. This exclusivity will be extended to a maximum of 12 years if drugs are launched in all member states and address unmet medical needs to incentivize companies to reach more patients. BRUSSELS – European Union officials said a proposal to reform the EU pharmaceutical legislation will go a long way towards providing equal access to new medicines, yet the proposal faced pushback from representatives of pharmaceutical companies who argued that shortening the marketing exclusivity periods for new drugs will hurt innovation and stymie clinical research in the region. Both regulators and industry weighed in on the pharmaceutical reform proposal during a session at DIA Europe on 12 March. In April 2023, the European Commission published its proposals to reform the EU’s medicines regulations; the first such reform in 20 years. (RELATED: EU releases draft legislation that will reshape pharma regulation, Regulatory Focus 25 August 2023)

The ongoing revision of the pharmaceutical legislation marks a pivotal moment in shaping the future of healthcare innovation in the EU. Find out more from MEP Stelios Kympouropoulos https://lnkd.in/guJ8HpJU #partnercontent EUCOPE - European Confederation of Pharmaceutical Entrepreneurs

When people hear about price transparency data, they often think of common payer-provider services. But the data goes beyond that, encompassing rates for pharmaceutical drugs, medical devices, and diagnostics. At Turquoise Health, we anticipate that this data will continue to grow as new pharmaceutical requirements come into play in the upcoming months. Check out our recent blog by Wayne Luan, Carol Skenes, and Chris O'Dell for a quick overview of these upcoming changes. #Pharmaceuticals #HealthcarePolicy #PriceTransparency #LegislativeUpdate #TurquoiseHealth

The German Parliament (Bundestag) adopted a new Medical Research act on July 4, 2024, which represents a significant amendment to the nation's medication pricing and payment regulations. Among the many significant innovations it includes are standard contractual conditions for clinical trials, an independent ethical council for unique procedures, and the simplification of collaboration amongst regulatory agencies. The ability of pharmaceutical companies to maintain the confidentiality of the reimbursement prices that come from the AMNOG ( Arzneimittelmarktneuordnungsgesetz) procedure is one of the new characteristics that the Medical Research Act brings. But for this the pharmaceutical company must (1) show that it is conducting local R&D in Germany; and (2) pay a 9% discount on the agreed-upon AMNOG reimbursement amount. Will be interesting to see if this will also extend to medical devices. #germany #pharmacetical https://lnkd.in/etJWnG8h.