Ni Fang’s Post

The #EUPharmaLegislation will shape the future of R&D in Europe for decades to come. What would be the impact of the Commission’s proposals on EU competitiveness, research and patients? Find out more in the #CompetitivenessCheck report: https://lnkd.in/ermFxWen #WeWontRest

🌍📊 The Impact of Pharmaceutical Legislation on Europe's Competitiveness 📈💊 The recent research by the EFPIA - European Federation of Pharmaceutical Industries and Associations sheds light on the potential consequences of the European Commission's draft Pharmaceutical Legislation on our region's innovative life science sector, patient care, and competitiveness. As the global pharmaceutical landscape evolves, this research serves as a critical call to action. The findings emphasize the need to strike a balance between protecting intellectual property and fostering innovation. The pharmaceutical industry plays a pivotal role in healthcare advancements, and it's essential that we create an environment where companies are incentivized to invest in research, development, and manufacturing right here in Europe. The loss of innovation is not only a setback for the industry but also affects the lives of millions who rely on cutting-edge medicines to transform their health. In the face of these challenges, it's crucial for policymakers, industry stakeholders, and the scientific community to come together to ensure that Europe remains a global leader in pharmaceutical innovation. 🤔 How do you think we can strike the right balance between protecting intellectual property and fostering innovation in the pharmaceutical industry? Share your thoughts and ideas in the comments below. Let's engage in a constructive dialogue and work collaboratively to address these concerns, safeguard patient access, and bolster Europe's position as a hub for life science breakthroughs. #PharmaceuticalIndustry #Innovation #Healthcare #Research #Competitiveness #PatientCare #Europe #GlobalHealth #PolicyMatters

This competitiveness check highlights that the current #EUPharmaLegislation proposal is expected to accelerate a decline in Pharma R&D investment. Some of the details of the report particularly struck me:  - Europe’s share of global R&D investment could fall by a third by 2040, representing €2 billion in lost investments each year. - Germany (followed by Belgium and France) is estimated to be hit hardest, with around €626 million of annual R&D revenues to be lost. Ultimately, patients will bear the brunt of these setbacks. The challenge for the coming decades is not if medical innovation will happen but rather where it will happen and how patients in Europe can benefit from innovative drugs. As a company with strong ties to Europe and substantial contributions to European R&D, Bayer is committed to working with all stakeholders to strive for a patient-focused, competitive pharmaceutical landscape in Europe.

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ArabMed-CRO: Advancing Clinical Research, Amplifying Impact. (Formerly Mesned-CRO) https://lnkd.in/e4zwswSg

Europe’s Life Sciences eco-system is under intense pressure. Increasingly, the EU is no longer THE place to develop and manufacture medicines. With institutional changes and an increasing focus on #competitiveness we have an opportunity to change this! Proud to have chaired the EFPIA Industrial Policy Task Force over the past few months to develop concrete solutions to the new instutions to help them #imagine a European Life Science Sector that: - delivers scientifc and medical breakthroughs - first - transformed the lives of patients and changed the course of public health - achieved this, while driving Europe's economic growth, resilience and security https://lnkd.in/ezb5u-bZ

Confused by the new German cost-containment bill? Join Lumanity's • Suzette Matthijsse, PhD at #ISPOREurope where she will deliver a case study exploring the most significant implications for pharmaceutical pricing and reimbursement in Germany following the approval of the cost-containment law and how the new bill interacts with the new European Regulation on HTA. Find out more on our website: #HEOR #HealthEconomics #OutcomesResearch #HTA #RWE

Last week I had the opportunity to participate in the event 𝘚𝘩𝘢𝘱𝘪𝘯𝘨 𝘢 𝘌𝘶𝘳𝘰𝘱𝘦𝘢𝘯 𝘪𝘯𝘯𝘰𝘷𝘢𝘵𝘪𝘰𝘯 𝘦𝘤𝘰𝘴𝘺𝘴𝘵𝘦𝘮 organized by the EU Innovation Network (EU-IN) and the Agencia Española de Medicamentos y Productos Sanitarios, in collaboration with the European Medicines Agency. The objective of this event was to inform all stakeholders about the initiatives and tools that the EU-IN is putting in place to support research for emerging therapies and technologies. One of the main challenges experienced in the research is to bring ideas from the academia to the patient due to economic but also regulatory and clinical strategy reasons. Academic and hospital researchers usually face difficulties in understanding the best strategy and the requirements for getting their investigational products and devices on the market. That’s why EU-IN is promoting new activities such as this event to address this major challenge. Among the initiatives implemented are the Simultaneous National Scientific Advice (SNSA) and Centralized Scientific and/or Regulatory Advice (SAWP), which allow researchers/developers to request scientific advice. Similar strategies have been launched for medical devices. A pilot is running to enable expert panels to provide scientific advice to manufacturers of high-risk medical devices. It was a pleasure to attend the event and see how all European parties including the European Medicines Agency and the European Commission are working together to promote research for innovative medicines and medical devices. Always accompanied by my partner in crime Diana Posa Podean 💙 https://lnkd.in/dTBHssVA

The second half of 2023 took a special turn for me... from being a full time professional, mum, wife and friend I suddenly turned into a patient; as I got a very complicated leg fracture after a ski-accident on my favorite slopes in Austria. A forced pause button... Whilst the rest of the world kept on turning, including the discussions on the EU pharma package, I kept hope and realized how lucky I am to live in a country were I have access to the best medical care and how lucky I am to be working for a company that gave me time to focus on my health and recovery. Since I came back in September I was pleased to see that we have made progress in sharing insights and thoughts on why it is so important to keep a strong IP framework in Europe, strong and predictable IP is one of the corner stones to build an industrial policy to attract future investments in healthcare innovation. IP supports the journey of a medicine from the academic research bench, through clinical trials until an approved treatment for patients. This is what I learned when I went to discuss the role of IP with Thomas De Beer, Professor at the Faculty of Pharmaceutical Sciences at Ghent University University, and Dirk De Smaele, Janssen Global Head Chemical Development & Supply.   With my team, we further reflected on the learnings from these conversations in our latest article published on POLITICO.EU. In 2020, clinical trial activity in Europe accounted for 19.3% of the global share, down from 25% average over the last decade. Strengthening our IP framework would help to reverse the decline of EU‘s share in clinical trials globally.   But what is the link between IP and clinical trials, you might ask? The regions with the most stable and predictable IP and regulatory frameworks have a comparative advantage in attracting clinical trials. Running clinical trials in a region allows patients to test potentially life-saving experimental treatments at their doorstep. Also, we should not forget that clinical trials keep top physicians and researchers in the region, creating opportunities for them to be at the head of innovation and become opinion leaders in their field of expertise. The ongoing revision of the EU Pharmaceutical Legislation should work for everyone, help to make the EU the place where innovation will thrive, and where no patient will be left behind.   #EUPharmaLegislation #ClinicalTrials #MyCompany #industrialpolicy  

Exciting update! 🌟 1. Addressing Challenges with COMBINE Project: The COMBINE initiative tackles hurdles in joint studies involving medicinal products, medical devices, and in vitro diagnostics in Europe. It's all about harmonizing regulatory frameworks to foster innovation, safety, and efficiency in clinical research across the EU. 2. MDCG Endorsed Documents and Guidance: Dive into our latest documents and guidance endorsed by MDCG! These materials provide preliminary reassessment review for MD and IVD regulations within the EU. Essential reading for industries and manufacturers across all EU nations. 3. Recently, the Regional Consultation of the Americas on Human Genomics and Health was held in Brazil, in collaboration with PAHO. This event, which was part of the scientific agenda of the Secretariat of Science, Technology, and Innovation, aimed to promote the widespread use of genomics for both individual and public health. Stay informed, with Pure Global! 🚀 Contact us: https://lnkd.in/ei5BRcgN #MedTech #IVDR #MDR #PureGlobal #Genomics #Regulations #EU #Innovation