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Factsheet: The EU Bolar Exemption 22 April 2022 Read more Why Clarification & Harmonisation of the Bolar Exemption and… 31 October 2023 The revised Pharmaceutical Legislation must deliver more access to medicines,… Bolar - Time for an EU action on equal access: No more… 15 January 2024 Myths to be dispelled on article 85 of the Pharma… New pricing models for generic medicines to ensure long-term healthy competitiveness in Europe OPEN REPORT INFOGRAPHIC STRATEGIC RECOMMENDATIONS Conversations on EU PHARMA OPEN PODCAST Advancing Medicines Repurposing in the EU OPEN DOCUMENT How important are generic medicines in Europe? --- medicinesforeurope comGeneric medicines bring down the price of originator drugs through market competition Without generic medicines, Europe would have had to pay €100 bn more in 2014 for its medicines Generic medicines improve the cost-effectiveness of existing therapies Generic medicines increase patient access to high-quality medicines and reduce The European market for prescription medicine is dominated by government (direct or indirect) purchasing based on obtaining the lowest price for most offpatent medicines This jeopardises the strong manufacturing - footprint in Europe, disincentiv ises investments in European manufacturing and supply chain resilience measures--- medicinesforeurope com generic-medicines who-we-areThe use of biosimilar medicines is expected to result in overall savings from 11 8 up to 33 4 billion euros for 8 EU countries between 2007 and 2020 12 biologic medicines with global sales of 78 billion euros in 2014 alone will lose exclusivity by 2020 in Europe EU approved biosimilar medicines are available for patients in over 60 countries The Generic Medicines Group is a sector group of Medicines for Europe , representing the generic medicines developers and manufacturers, which provide high-quality cost-competitive medicines to millions of patients in Europe and around the world Over 400 manufacturing and research & development sites across Europe produce your essential What is better health medicines for Europe? --- medicinesforeurope com key-topics-regulatory-and-legal-frameworkMedicines for Europe commends the European Commission for proposing an SPC manufacturing waiver which will have a positive impact on the export of European generic and biosimilar medicines, particularly for small and medium enterprises (SMEs) Nonetheless, we are concerned that the legislative proposal does not fully address the unintended effects of the SPC Regulation, specificallyMedicines for Europe and its member companies and associations support and promote a European regulatory framework that ensures patient access to high quality, safe and effective medicines and that focusses on the highest-priority issues that make the real difference for patients During the development of generic, biosimilar or value added What is medicines for Europe? People also ask--- medicinesforeurope com biosimilar-medicines--- medicinesforeurope com comprehensive-spc-manufacturing-waiver-key-for Generic medicines today The generic medicines industry is at the heart of public health delivery This industry provides essential medicines that European patients, healthcare professionals and healthcare systems rely on to treat most acute and chronic ailments ranging from cardiovascular, to diabetes and even to cancer We now supply over 67% of all medicines in Europe , and over the last ten years, generic medicines have increased access to medicines by over 100% in 7 key therapeutic areas For the treatment of high blood pressure alone, almost 50 million patients are taking generics each day, and 20 million people across Europe are now being treated for --- medicinesforeurope com medicines-for-europeWe now supply over 67% of all medicines in Europe, and over the last ten years, generic medicines have increased access to medicines by over 100% in 7 key therapeutic areas For the treatment of high blood pressure alone, almost 50 million patients are taking generics each day, and 20 million people across Europe are now being treated for Medicines for Europe Factsheets on Removing barriers to equitable access for timely competition Medicines for Europe is committed to improving access to medicines for all Europeans Yet, many patients across Europe face restricted access to medicines which undermines public health 2019The - 18-19 APRIL 2024 5th Value Added Medicines Conference 7 NOVEMBER 2023 22nd Regulatory Affairs and Pharmacovigilance Conference 27-28 SEPTEMBER 2023 View all x Stay informed on the latest from Medicines for Europe Should medicines for Europe reshape pharmaceutical policy? The European market for prescription medicine is dominated by government (direct or indirect) purchasing based on obtaining the lowest price for most offpatent medicines This jeopardises the strong manufacturing - footprint in Europe , disincentiv ises investments in European manufacturing and supply chain resilience measures --- medicinesforeurope com 2022 04 22 factsheet-the-eu-bolar-exemption--- medicinesforeurope com Medicines-for-Europe-Factsheets-on-Market-and- Biosimilar medicines were invented in Europe 20 years ago to address the pressing need for better access to biopharmaceuticals in Europe For example, a recent study demonstrated the inequity in access to biologic medicines for treatment of rheumatoid arthritis because lower income countries in Europe cannot afford such therapies --- medicinesforeurope com generic-medicines--- medicinesforeurope com key-topicsGeneric medicines account today for 67% of all dispensed medicines but for only 29% of the pharmaceutical expenditure in Europe In other words, generic medicines only account for 6% of total healthcare costs Without generic medicines, Europe would have had to pay €100 billion more in 2014 to get the same level of access to treatment as we Medicines for Europe welcomes European Commission decision to enable secure supply of hospital medicines – 08 April 2020 Letter to EU Trade Ministers European Industry trade and supply chain needs to respond to Covid-19 – 10 April 2020 Call for tenders SANTE 2020 C3 29 for the supply of medicinal products used for intensive care patients

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